mock 510(k) for UCSC Extension Regulatory Submissions Devices and Diagnostics 19315_012

Sunnyvale Surgical, Inc. 123 Easy Street

Sunnyvale, CA 94041

800-220-1570

Date March 28, 2013

Food and Drug Administration

Center for Devices and Radiological Health

Document Mail Center – WO66-G609

10903 New Hampshire Avenue

Silver Spring, MD 20993-0002

Attention: Document Control Clerk

RE: Traditional Premarket Notification, CLARITY Aneurysm Clip

Dear Sir or Madam:

In accordance with section 510(k) of the Food, Drug and Cosmetic Act as amended by the Medical

Device Amendment of 1976 and the Safe Medical Devices Act of 1990, this submission is to inform

you that Sunnyvale Surgical, Inc. intends to manufacture and market a medical device known as the

CLARITY Aneurysm Clip.

The information contained in this notification and our intent to market this device is considered

confidential commercial information and we request that the FDA consider it as such. The company

has taken reasonable precautions to protect this confidentiality.

No Premarket Approval application is pending for this same device. Clinical studies are not included

with this submission.

The attached CD contains an eCopy which is an exact duplicate of the paper copy of this submission.

All correspondence for this submission should be directed to Joanne Pelaschier, Director QA/RA, at the

above address. Alternatively, you can email me at [email protected] or phone at 800

220 1570.

Thank you in advance for your review of this submission.

Sincerely,

Joanne Pelaschier

Director QA/RA

Sunnyvale Surgical, Inc.

Section 1: User Fee Form........................................................................................................................... 3

Section 2: CDRH Premarket Review Submission Cover Sheet ................................................................ 4

Section 3: Traditional (or Abbreviated) 510(k) Notification Cover Letter ................................................ 9

Section 4: Indications for Use Statement ................................................................................................. 11

Section 5: 510(k) Summary ..................................................................................................................... 12

Section 6: Truthful and Accuracy Statement ............................................................................................ 14

Section 7: Class III Summary and Certification ...................................................................................... 15

Section 8: Financial Certification or Disclosure Statement ..................................................................... 16

Section 9: Declarations of Conformity and Summary Reports................................................................ 17

Section 10: Executive Summary .............................................................................................................. 18

Section 11: Device Description ................................................................................................................ 21

Section 12: Substantial Equivalence Discussion ..................................................................................... 27

A. Tabular Comparison to Predicate Device ................................................................................ 27

B. Textual Comparison to Predicate Device................................................................................... 31

C. 510(k) Flowchart Comparison to Predicate Device .................................................................. 33

D. Summary of Supporting Data .................................................................................................... 35

Section 13: Proposed Draft Labeling ....................................................................................................... 36

Section 14: Sterilization and Shelf Life ................................................................................................... 45

Section 15: Biocompatibility ................................................................................................................... 48

Section 16: Software ................................................................................................................................ 50

Section 17: Electromagnetic Compatibility and Electrical Safety ........................................................... 56

Section 18: Performance Testing - Bench ................................................................................................ 57

Section 19: Performance Testing - Animal .............................................................................................. 69

Section 20: Performance Testing - Clinical ............................................................................................. 71

Section 21: Design Control Activities (Special 510(k) only) .................................................................. 72

Tab 2: Predicate 510k Summaries ............................................................................................................ 73

Tab 3: Standards Certification Forms (3654) ........................................................................................... 79

Tab 4: Biocompatibility Reports .............................................................................................................. 80

Tab 5: Design Verification Reports (if necessary) ................................................................................... 81

Tab 6: Software Support Documentation (if necessary) .......................................................................... 82

Tab 7: IFU & Labeling (if not included in section 13 of 510k ................................................................ 83

Tab 8: References (if necessary) .............................................................................................................. 84

CONFIDENTIAL Page 3 of 84

Section 1: User Fee Form


Section 2: CDRH Premarket Review Submission Cover Sheet






Section 3: Traditional (or Abbreviated) 510(k) Notification Cover Letter

Device Information: Category Comments

Date of Submission March 28, 2013

Device Common Name: Aneurysm Clip

Sponsor / Submitter: Sunnyvale Surgical

123 Easy Street

Sunnyvale, CA 94101

Tel: 800-220-1570

Correspondent Contact Information: Joanne Pelaschier

Sunnyvale Surgical

123 Easy Street

Sunnyvale, CA 94101

Tel: 800-220-1570

Fax: 800-220-1571

Confidentiality Preference The information contained in this notification and our

intent to market this device is considered confidential

commercial information and we request that the FDA

consider it as such (per 21 CFR 807.95). The

company has taken reasonable precautions to protect

this confidentiality.

Device Classification Regulation & Name: 21 CFR 882.5200

Name from CFR 882.5200

Device Classification &

Product Code:

Class II,

HCH

Panel: Neurological

Prior FDA Document Numbers None

Device Proprietary Name: CLARITY Aneurysm Clip

Basis of submission New Device;

Kit Description None

Number of Devices in Submission, List if

more than one

One

See Design and Use table on the next page.


Design and Use table:

Question YES NO

Is the device intended for prescription use (21 CFR 801 Subpart D)? X

Is the device intended for over-the-counter use (21 CFR 807 Subpart C)? X

Does the device contain components derived from a tissue or other

biologic source?

X

Is the device provided sterile? X

Is the device intended for single use? X

Is the device a reprocessed single use device? X

If yes, does this device type require reprocessed validation data? X

Does the device contain a drug? X

Does the device contain a biologic? X

Does the device use software? X

Does the submission include clinical information? X

Is the device implanted? X

Page 11 of 84

Section 4: Indications for Use Statement

510(k) Number (if known): Unknown

Device Name: Sunnyvale Surgical CLARITY Aneurysm Clip

Indications For Use: The CLARITY Aneurysm Clip is intended for use in implantation for permanent

occlusion of cerebral aneurysms.

Prescription Use __X____ AND/OR Over-The-Counter Use _______

(Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

_______________________________________________________________

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of _____

Page 12 of 84

Section 5: 510(k) Summary

Device Information: Category Comments

Sponsor: Sunnyvale Surgical

123 Easy Street

Sunnyvale, CA 94101

Tel: 800-220-1570

Correspondent Contact Information: Joanne Pelaschier

Sunnyvale Surgical

123 Easy Street

Sunnyvale, CA 94101

Tel: 800-220-1570

Fax: 800-220-1571


Device Classification Number: From CFR 21 882.5200


Product Code:

Class II

HCH

Device Proprietary Name: CLARITY Aneurysm Clip

Predicate Device Information:

Sugita Titaniun Aneurysm Clip

Predicate Device Manufacturer: Mizuho America, Inc

Predicate Device Common Name: Aneurysm Clip

Predicate Device Premarket

Notification # K990202

Predicate Device Classification: 21 CFR 882.5200

Predicate Device Classification &

Product Code:

Class II,

HCH

b. Date Summary Prepared

March 28, 2013

c. Description of Device

Sunnyvale Surgical CLARITY Aneurysm Clips are designed to be used as implants for isolation of

cerebral aneurysms from normal blood flow. The CLARITY Aneurysm Clips are made of injection

molded PEEK (Zeniva® polyetheretherketone). There are six different clip designs within this 510(k).

The clips consist of a single piece which has two regions, one gripped by the clip placement tool (the

shaft) and the second (the clipper) which acts to isolate the aneurysm from blood flow. The clippers act

as a pair of jaws, opening when pressure is applied by the clip placement tool and closing as the

pressure from the clip placement tool is released when the clip placement tool is withdrawn.

The CLARITY Aneurysm Clip product includes multiple clipper shape designs: straight, bent, slightly

bent, curved, and slightly curved to allow for best access to the aneurysm(s) as they present. All

CLARITY Aneurysm Clips have a tapered jaw and use rounded teeth on the jaw for additional gripping

security.

Page 13 of 84

CLARITY Aneurysm Clips are designed for permanent implantation. They are MRI safe and

transparent to MRI and CAT scans.

d. Indications for Use

The CLARITY Aneurysm Clip is intended for use in permanent implantation for occlusion of cerebral

aneurysms.

e. Comparison to Predicate Device

The Sunnyvale Surgical CLARITY Aneurysm Clip is substantially equivalent in intended use and

technology to the predicate device, Sugita Titanium Aneurysm Clip (K990202).

Both devices provide permanent occlusion of cerebral aneurysm. Both devices use a shaft and jaw

design where the pressure of the clip application tool on the shaft results in jaws opening. Both devices

are designed such that as the clip application tool is removed, pressure on the shaft is relieved and the

jaws close, thus providing force to hold the aneurysm closed.

Both devices use a tapered jaw design. The CLARITY Aneurysm Clip uses a rounded tooth jaw design

on the clipper jaws, where rounded teeth are present on the jaw for additional gripping security. The

predicate device does not employ rounded teeth on the jaw.

The devices use different materials. The Sugita Titanium Aneurysm Clip is manufactured of Elgiloy.

The Sunnyvale Surgical CLARITY Aneurysm Clip is manufactured of Zeniva® PEEK

polyetheretherketone. The Company device may be more appropriate for those patients who will

require MRI or CAT imaging as part of post surgical medical care.

The testing described below demonstrates that the differences in the devices do not raise any

unresolved issues of safety or efficacy.

Both devices are single use only. Sugita Titanium Aneurysm Clip is provided not sterile. Sunnyvale

Surgical Aneurysm Clip is provided steam sterilized.

Company concludes that the devices are substantially equivalent.

f. Summary of Supporting Data

Biocompatibility data demonstrates that the device is in compliance with ISO 10993.

Bench testing has demonstrated that the device is in compliance with ISO 9713:2009, ASTM F0252-

06e1, ASTM F2119-07, ASTM F2129-08, ASTM F2182-11a, ASTM F2213-06, and the expectations

of the medical community and the product labeling.

Animal testing demonstrated that the device can be permanently implanted with no significant effect on

behavior, EEG measurements, or seizure latency threshold.


Section 6: Truthful and Accuracy Statement

I certify that in my capacity as the President and Chief Executive Officer of Company, I believe to the

best of my knowledge, that all data and information submitted in the premarket notification are truthful

and accurate and that no material fact has been omitted.

_____________________________________________________

Signature

______________________________________________________

Typed Name

_______________________________________________________

Date

_______________________________________________________

Premarket notification (510(k)) Number


Section 7: Class III Summary and Certification

This section does not apply. This device is a Class II device.


Section 8: Financial Certification or Disclosure Statement

This section does not apply. There is no clinical study supporting this application.


Section 9: Declarations of Conformity and Summary Reports

The CLARITY Aneurysm Clip was tested to the following list of standards and found to conform to the

requirements of those standards. Devices which are equivalent to the final product to be marketed were

used for all testing.

Standard /

Version

Standard Title Status FDA Consensus

#

Self-

Declared?

Comments /

Deviations ASTM

F2052-06e1

Standard Test Method for

Measurement of

Magnetically

Induced Displacement Force

on Medical Devices in the

Magnetic Resonance

Environment.

Met all

requirements 030 Yes No deviations

from standard

ASTM

F2119-07


Evaluation of MR Image

Artifacts from Passive

Implants

Met all


from standard

ASTM

F2129-08


Conducting Cyclic

Potentiodynamic

Polarization Measurements

to Determine the Corrosion

Susceptibility of Small

Implant Devices

Met all

requirements 17-9 Yes No deviations

from standard

ASTM

F2182-11a


Measurement of Radio

Frequency Induced Heating

On or Near Passive Implants

During Magnetic Resonance

Imaging.

Met all

requirements 030

Yes No deviations

from standard

ASTM

F2213-06

(Reapproved

2011)


Measurement of

Magnetically Induced

Torque on Medical Devices

in the Magnetic Resonance

Environment.

Met all


from standard

EN ISO

9713:2009

Neurosurgical implants.

Self-closing intracranial

aneurysm clips

Met all

requirements N/a Yes No deviations

from standard


Section 10: Executive Summary

Category Comments

Sponsor: Sunnyvale Surgical, Inc.

123 Easy Street

Sunnyvale, CA 94041

800-220-1570

Correspondent Contact

Information:

Joanne Pelaschier

123 Easy Street

Sunnyvale, CA 94041

800-220-1570



Code:

Class II, HCH

Device Classification

Name:

Aneurysm Clip (21 CFR 882.5200)

Device Proprietary

Name:

CLARITY Aneurysm Clip

Predicate Device Information:

Predicate Device: Sugita Titanium Aneurysm Clip

510(k) K990202

Predicate Device Manufacturers: Mizuho America, Inc.

Predicate Device Common Name: Aneurysm Clip


Predicate Device Classification

and Code:

Class II

HCH

Reference Device Information:

Reference Device: RoG™ Sports Medicine Suture Anchor

510(k) K110229

Predicate Device Manufacturers: RoG Sports Medicine, Inc.

Predicate Device Common Name: Suture Anchor


Predicate Device Classification

and Code:

Class II

MBI

Date Summary Prepared

March 28, 2013


Description of Device

Sunnyvale Surgical CLARITY Aneurysm Clips are designed to be used for the permanent occlusion of

cerebral aneurysms. The clips are intended to be used in conjunction with the manual surgical tool, the

Sunnyvale Surgical LittleJaw clip placement tool.

When a clip is picked up with the LittleJaw tool, the pressure of the tool on the clip base causes the clip

jaws to open to their maximum width. After the clip is maneuvered into place, the LittleJaw tool is

removed, releasing the pressure on the clip base. The spring within the clip contracts, causing the clip

to close, occluding blood flow to the aneurysm.

The CLARITY Aneurysm Clips are formed from Zeniva® PEEK (polyetheretherketone) with no

colorants added and are not coated with any surface coating. The clips come singly packed and sterile.


Intended Use

The CLARITY Aneurysm Clips are intended for use in implantation for permanent occlusion of

cerebral aneurysms.

Comparison to Predicate Device

The Sunnyvale Surgical CLARITY Aneurysm Clip is substantially equivalent in intended use,

technology, design and materials to the predicate device: Sugita Titanium Aneurysm Clip (K990202).

The predicate device is made of Elgilory (cobalt/nickel alloy with 17% iron included.) The CLARITY

Aneurysm Clip is manufactured out of Zeniva® PEEK (polyetheretherketone) which is not present in

the Sugita Titanium Aneurysm Clip but is substantially equivalent in intended use, technology, design

and materials to the reference device: RoG™ Sports Medicine Suture Anchor (K110229).

The predicate clip and the application clip are both intended for use in implantation for permanent

occlusion of cerebral aneurysms. The reference device and the material in the application device are

both for implantation use and are both used as permanent implants.


The Sugita Titanium Aneurysm Clip and the CLARITY Aneurysm Clip both provide closing force to

occlude the arteries which provide normal blood flow to cerebral aneurysms. Both devices provide

closing force via a pair of blades or jaws which close onto the artery. Both devices are available in a

range of blade shapes and widths to allow for an appropriate fit to a wide variety of aneurysm forms

and presentations.

The predicate device is designed to be used with a device specific surgical tool, the Sugita Aneurysm

Clip Applier. Likewise, the application device is designed to be used with a device specific surgical

tool, the Sunnyvale Surgical LittleJaw clip placement tool.

The predicate device functions by occluding blood flow to the aneurysm after clip placement. The

CLARITY Aneurysm Clip is identical in function, occluding blood flow to the aneurysm after clip

placement.

The predicate device is intended for permanent implantation. The CLARITY Aneurysm Clip is also

intended for permanent implantation.

Both the predicate and the application device are provided as single use only. The predicate device is

provided non sterile. The application device is provided sterile.



Sunnyvale Surgical, Inc concludes that the devices are substantially equivalent.

Summary of Supporting Data


Electrical safety testing demonstrates that the device is in compliance with EN 60601.

Bench testing including a simulated use protocol has demonstrated that the device is in compliance

with the medical community’s expectations, the product labeling, and the following standards and

guidelines:

ISO 9713, ASTM F2052, ASTM F2213, ASTM F218, ASTM F2119.

Animal testing using permanent intracranial implantation of the CLARITY Clip demonstrated that the

CLARITY Aneurysm Clip is suitable for permanent intracranial implantation.


Section 11: Device Description

A. Description

Sunnyvale Surgical CLARITY Aneurysm Clips are designed to be used as implants for isolation of

cerebral aneurysms from normal blood flow. The CLARITY Aneurysm Clips are made of injection

molded Zeniva® PEEK (polyetheretherketone). There are six different clip designs within this 510(k).

For details of clip design, see Table 1 below.

Table 1: CLARITY Aneurysm Clip part numbers and design features

Sunnyvale Surgical

part number

Design

Number

Length of

Clip (mm)

Open Clip

Width (mm)

Clip

Shape

SUNNSURG-001 1 7-10 8.0-9.0 straight

SUNNSURG-002 2 8-10 8.0-9.0 bent

SUNNSURG-003 3 10-12 8.0-10.0 slightly bent

SUNNSURG-004 4 11-13 9.0-10.0 curved

SUNNSURG-005 5 11-13 9.0-10.0 medium curved

SUNNSURG-006 6 20-40 17.0-23.0 straight

For each of these designs, the clip can be described as one single unit, the clip, which can be described

as two different regions: a region held by the tool (the shaft) and a region which clips onto the

aneurysm (the clipper). There are two identical shaft regions per clip, which are joined at the bottom by

a continuation of the shaft material (the join).

The shafts of the CLARITY Aneurysm Clips are identical for all clipper designs used. The shaft of a

CLARITY Aneurysm Clip is flat, straight, and made of the same material as the clipper. The clipper

region is on both sides of the clip and has three main descriptors: length of clip region, open width of

clip, and shape of clip. The clipper regions vary between the different designs in: length of clipper

region, maximum clipper open width, and clip shape.


The figures below shows sketches of CLARITY Aneurysm Clips with the shaft, join (spring) and

clipper regions called out.

A: CLARITY Aneurysm Clip with straight shaft, SUNNSURG-001. From this view, the join (spring)

coils are not visible.

B: CLARITY Aneurysm Clip with curved shaft, SUNNSURG-004. From this view, the join (spring)

coils are visible and one of the curved clippers can be seen.

shaft

join

clipper

shaft

join

clipper


The figures below show the clipper jaw shapes for the CLARITY Aneurysm Clip: straight, bent,

slightly bent, curved, and slightly curved.

The figure below shows a sketch of a close up of the rounded teeth on the clip surfaces. Teeth are

present on the clip surface with ten teeth per mm.

straight

bent

slightly bent

curved

slightly curved


The CLARITY Aneurysm Clips are manufactured by injection molding of Zeniva® PEEK

(polyetheretherketone). No colorants are added and no additional surface finishes are applied to the

PEEK material after injection molding. Zeniva® PEEK has a long history of use in implants and is well

established as biocompatible. This material meets ASTM F2026-07 requirements as a

polyetheretherketone (PEEK) polymer for surgical implant applications.

The injection molding process results in a fully formed clip which contains two clipper and shaft pieces

joined via a PEEK spring. Closing force for the clip is provided through action of this PEEK spring.

The CLARITY Aneurysm Clips use this spring design to provide the closing force required to occlude

blood flow to the aneurysm. The spring of the clip is compressed when pressure is applied to the clip

shaft by the surgeon's tool, the LittleJaw clip applier (see below). As the tool is released, the pressure

compressing the spring is relieved and the clip jaws will close. This spring force is sufficient to occlude

blood flow to the aneurysm.

During the design phase of the CLARITY clip, finite element analysis (FEA) was used to predict the

stresses and mechanical behavior of Zeniva® PEEK within the application. After FEA results were

found to be consistent with acceptable mechanical behavior of Zeniva® PEEK under application

conditions, clips were formed for bench testing to validate device performance.

Blade holding force is a key parameter in aneurysm clip specifications. The blade holding force for a

clip must be sufficient to occlude blood flow to the aneurysm. CLARITY Aneurysm Clips designs

include two sets of specifications for the clip blade holding force, those for Long clip designs and those

for Regular clip designs.

Long clip designs are those for which the blade length is between 21 and 40 mm. Long clip designs

have blade holding force specifications that fall within the range of 150-160 g, measured at a point one

third of the way in from the distal limit of the clip blade. Within the Long class, each individual clip

design is assigned a design specific blade holding force that falls within the Long range.

Regular clip designs are those for which the blade length is up to and including 20 mm. Regular clip

designs have blade holding force specifications that fall within the range of 135-145 g, measured at a

point one third of the way in from the distal limit of the clip blade. Within the Regular class, each

individual clip design is assigned a design specific blade holding force that falls within the Regular

range.

The CLARITY Aneurysm Clips are intended to be used in conjunction with the manual Sunnyvale

Surgical LittleJaw tool for placement.

(Note: The Sunnyvale Surgical LittleJaw tool is a Class II device subject according to 21 CFR

882.4175 and is not the subject of this submission. The LittleJaw tool is already cleared, refer to

K12345678 for further information.)

The clips come sterile and individually packaged. The CLARITY Aneurysm Clip is a sterile, single use,

non absorbable device.

The test data provided below demonstrates that the CLARITY Aneurysm Clips have the holding force

specified for their designs and that they can performs acceptably under the conditions for which they

are intended to be used.


CLARITY ANEURYSM CLIP

B. Intended Use

The CLARITY Aneurysm Clips are intended for use in implantation for permanent occlusion of

cerebral aneurysms.

C. Substantial Equivalence



The Sunnyvale Surgical CLARITY Aneurysm Clip is made out of a material that is not present in the

Sugita Titanium Aneurysm Clip, PEEK (Zeniva® polyetheretherketone.) The material used in the

Sunnyvale Surgical CLARITY Aneurysm Clip is substantially equivalent in technology and materials

to another reference device: the RoGTM

Sports Medicine Suture Anchor (K110229).

The predicate aneurysm clip and the application aneurysm clip are both intended for use in

implantation for the permanent occlusion of cerebral aneurysms.

The reference device is a suture anchor. It is manufactured from PEEK (Zeniva® polyetheretherketone)

identical to the resin used in the CLARITY Aneurysm Clip. The reference device is cleared for the

following indications: soft tissue reattachment procedures in the shoulder, elbow, wrist/hand, foot/ankle

and knee. The reference device is inserted into bone and the allows the surgeon to secure a suture of

their selection to the top of the anchor. While the reference device and the submission device do

experience different loads and tensions in their use, the test data provided below demonstrates that the

CLARITY Aneurysm Clip performs acceptably under the conditions for which it is intended to be used.

The Sunnyvale Surgical CLARITY Aneurysm Clip and the Sugita Titanium Aneurysm Clip both isolate

cerebral aneurysms from normal circulation. Both the Sunnyvale Surgical CLARITY Aneurysm Clip

and the Sugita Titanium Aneurysm Clip are placed across the base (or neck) of the aneurysm and

function to block the normal blood flow from entering the aneurysm.


Both devices are used with clip applying tools: the Sunnyvale Surgical CLARITY Aneurysm Clip is

used with the Sunnyvale Surgical LittleJaw tool and the Sugita Titanium Aneurysm Clip is used with

the Sugita Clip Applying Forceps.

Both devices are used during surgery. In surgeries using either the Sunnyvale Surgical CLARITY

Aneurysm Clip or the Sugita Titanium Aneurysm Clip, the patient is placed under general anesthesia

and a craniotomy (opening of the skull) performed. After the aneurysm is located, the clip is moved

into position with the application tool. Both the Sunnyvale Surgical CLARITY Aneurysm Clip and the

Sugita Surgical Aneurysm Clip are brought into place with the jaws of the clip held in an open position

by their application tool. As the clip is released from the tool, the jaws close, applying pressure to the

neck of the aneurysm and cutting off blood flow.

Both the predicate device and the Sunnyvale Surgical CLARITY Aneurysm Clip use a jawed tooth

design to minimize clamp slippage after placement. The Sunnyvale Surgical CLARITY Aneurysm Clip

employs a “soft jaw” design, with a different number of teeth and a different tooth shape.

Both the predicate device and the Sunnyvale Surgical CLARITY Aneurysm Clip are single use devices

The predicate device has the lot number engraved on each clip for tracking purposes. The Sunnyvale

Surgical CLARITY Aneurysm Clip has production lot numbers laser etched onto each clip for tracking

purposes.

The predicate device is not provided sterile. It can be placed into a storage/sterilization tray for

sterilization at the hospital, in order to allow physicians to assemble the necessary collection of clip

lengths and shapes. The Sunnyvale Surgical CLARITY Aneurysm Clip is provided sterile.

Both devices are intended for permanent implantation.





Section 12: Substantial Equivalence Discussion

A. Tabular Comparison to Predicate Device

Characteristic Predicate: Device Name

Sugita Titanium Aneurysm Clip

(K990202)

CLARITY Aneurysm Clip Comparison

Indications for

Use

The Sugita Titanium Aneurysm Clips

are intended for use in implantation

for permanent occlusion of cerebral

aneurysms.

The CLARITY Aneurysm Clip is

intended for use in implantation for

permanent occlusion of cerebral

aneurysms.

Identical

Principal

Operator

Surgeon Surgeon Identical

Use Location Operating room Operating room Identical

Design Clips are provided individually

packaged.

Clips are provided individually

packaged.

Identical

Clips are provided not sterile.

Clips are provided sterile.

Different

Clip designs provided in Long shaft

length (length from 21 to 40 mm)

Clip designs provided in Long shaft

length (length from 21 to 40 mm)

Identical

Clip designs provided in Regular shaft

length (up to and including 20 mm)

Clip designs provided in Regular shaft

length (up to and including 20 mm)

Identical




(K990202)


Design

Clip designs provided with range of

jaw shapes including: straight, bent,

curved, slightly bent, slightly curved

Clip provided with straight jaw

Identical

Clip provided with fenestrated jaw.

Not provided with fenestrated jaw

Identical

Clip provided with bayonet jaw Not provided with bayonet jaw

Identical

Clip jaws shape is pyramidal, tapering

from proximal to distal end

Clip jaws shape is pyramidal, tapering

from proximal to distal end

Identical

Clip jaws are smooth, without any

toothing included in their pyramidal

surface

Clip jaws have rounded teeth included

in their pyramidal surface

Different

Materials (body

contacting)

Elgiloy (cobalt/nickel alloy with 17%

iron included).

Zeniva® PEEK

(polyetheretherketone)

with no added colorants.

Clinically equivalent, both are

intended to be used as implant

materials

Clamp

mechanism

Crossed leg clamp with pre loaded

spring providing closing force.

Crossed leg clamps with pre loaded

spring providing closing force.

Identical




(K990202)


Clamp closing

force

Clips are classified into long and

regular length, based on blade length.

Regular length clips (blade length up

to 20 mm): 110-150 g, precise values

specified for each clip within the

class.

Long length clips (blade length

between 20 and 40 mm): 150-200 g,

precise values specified for each clip

within the class.

Clips are classified into long and

regular length, based on blade length.

Regular length clips (blade length up

to 20 mm): 105-145 g, precise values

specified for each clip within the class.

Long length clips (blade length

between 20 and 40 mm): 145-195 g,

precise values specified for each clip

within the class.

Equivalent – closing force ranges are

not identical but cover a similar range

for each design class

Single Use? Single patient use Single patient use Identical

MRI

compatible

Safety compatible with MRI scans.

May cause imaging artifacts.

Safety compatible with MRI scans.

Does not cause imaging artifacts under

conditions tested. Refer to testing

results.

Identical in safety compatibility with

MRI scans.

Sterilization

Steam sterilization suggested.

Steam sterilization protocol validated.

Performance characteristics tested

after steam sterilization protocol.

Steam sterilization suggested.

Steam sterilization protocol validated.

Performance characteristics tested

after steam sterilization protocol.

Identical

How provided Single clip, packaged in a heat

resistant silicone sponge.

Sterile, packaged in a tray with

wrapper

Identical

Technology

Enables clinicians to occlude

aneurysms from normal blood flow.

Enables clinicians to occlude

aneurysms from normal blood flow.

Identical




(K990202)


Technology

Clips suitable for use with aneurysms

having necks 4 mm or wider.


having necks 4 mm or wider

Identical


with distinct necks. Not suitable for

use with aneurysm without distinct

neck (where ratio of aneurysm bulge

to neck circumference is < 3).


with distinct necks. Not suitable for

use with aneurysm without distinct

neck (where ratio of aneurysm bulge to

neck circumference is < 3).

Identical

The clip occludes blood flow to the

aneurysm, preventing further growth

of the aneurysm or bleeding from the

weakened arterial wall. Subsequent to

occlusion, the aneurysm decays

The clip occludes blood flow to the

aneurysm, preventing further growth

of the aneurysm or bleeding from the

weakened arterial wall. Subsequent to

occlusion, the aneurysm decays.

Identical


B. Textual Comparison to Predicate Device

Comparison to Predicate Device



Intended use

The predicate aneurysm clip and the application aneurysm clip are both intended for use in

implantation for permanent occlusion of cerebral aneurysms.

Technology (usage)

Both the predicate device and the application device are used during surgery for occlusion of

aneurysms.

Both devices are used with an application tool that applies force to the clip shaft, opening the jaws of

the clip.

Both devices are positioned at the neck of the aneurysm after which their positioning tool is released,

removing the pressure which held the clip open.

Both devices are for use with aneurysms with distinct necks.

Both devices are not suitable for use with aneurysms without distinct necks, where the ratio of

aneurysm bulge to neck circumference is < 3.

Both devices are suitable for use only for aneurysms with necks 4 mm or wider.

Technology (design)

The predicate aneurysm clip and the application aneurysm clip are both designed with two distinct

regions: a region that is gripped by the relevant clip applying tool (the shaft) and a region that is held

open and then allowed to close upon the aneurysm (the jaws).

Both devices provides closing force through a cross legged design built around a spring which is

compressed when the applying tool holds the shaft of the clamp.

Both devices use clip jaws with a pyramidal shape, tapering from the proximal to distal ends.

The predicate device uses a smooth clip jaw with no toothing in the design. The application device has

rounded teeth included in the pyramidal jaw surfaces.

Both the predicate and the application clip are provided in a range of shapes including straight, angled,

curved, and slight curved.


Both devices are provided in two different clip length ranges, Long and Regular. Both devices have

clip closing force ranges for the Long and Regular clip designs.

Both devices further specify a design specific clip closing force specification for each clip design

within either the Long or Regular clip length range.

Technology (materials)

The predicate device is manufactured out of Elgilory (cobalt/nickel alloy with 17% iron included.)

The application device is manufactured out of PEEK (Zeniva® polyetherketone) Zeniva® PEEK has a

long history of use in implants, such as the reference device RoG Sports Medicine Suture Anchor

(K110229). The technology and materials used to prepare the Zeniva® PEEK resin are identical for

both the CLARITY Aneurysm Clip and the reference device RoG Sports Medicine Suture Anchor, refer

to attached manufacturer's Master File.

The reference device material and the material in the CLARITY Aneurysm Clip are both for permanent

implantation and are biocompatible per ISO 10993.

Finite Element Analysis (FEA) demonstrated that Zeniva® PEEK could perform acceptably under

application conditions, yielding sufficient clip closing force for the intended use. Bench testing and

animal studies were consistent with this.

Technology (packaging and sterilization)

Both devices are packaged individually. Both devices are packaged with a tear off label for attaching to

patient charts.

The predicate device is provided non-sterile. The application device is provided sterile, steam

sterilization is used.

Conclusion





C. 510(k) Flowchart Comparison to Predicate Device

Is the predicate device legally marketed?

YES.

The predicate device was cleared under premarket notification K990202.

Do the devices have the same intended use?

YES.

The intended uses are identical, as evidenced by the similarity of the indications for use. There

are no differences in the indications for use.

Do the devices have the same technological characteristics?

NO.

Both of these devices are designed to occlude cerebral aneurysms from normal blood flow by

clamping off the neck of the aneurysm. Both devices are designed with jaws that are held in the open

configuration when the device is held within the device application tool. Both devices are designed

such that the jaws close when the application tool is released, applying sufficient force to close off the

blood vessel supplying the aneurysm.

They differ in that the predicate is machined out of Elgiloy (cobalt/nickel alloy with 17% iron

included) and the application device is injection molded out of Zeniva® PEEK (polyetheretherketone).

The predicate is electropolished for optimal surface smoothness (to decrease potential corrosion and to

lower the risk of serving as a scaffold for biofilm formation).

The predicate device has a surface coating for identification as a permanent aneurysm clamp. It

is coated with a blue coloring. The application device is not coated with any surface coating. The

application device is manufactured out of Zeniva® PEEK with no colorants added.

Do the devices raise different questions of safety or effectiveness?

NO.

The devices have the same intended use. The devices are intended for the same patient cohort.

The differences in technology do not raise different questions of safety and efficacy because the test

data provided below demonstrates that the essential performance characteristics of the devices are

identical.

Are the testing methods acceptable?

YES.

Accepted standards are used and accepted testing methodologies are employed (refer to list in


Section 9: Declarations of Conformity and Summary Reports). See sections 18 through 20 for

supporting evidence.

Do the data demonstrate equivalence and support the indications?

YES.

All mechanical testing (e.g., clamp force testing, clamp reliability testing), biocompatibility,

electrical safety testing, magnetic susceptibility testing, functional testing, and animal data demonstrate

that the CLARITY Aneurysm Clip is adequate for its intended use, as is the predicate system.

CONCLUSION: SUBSTANTIALLY EQUIVALENT DECISION


D. Summary of Supporting Data

Material compatibility: Zeniva® PEEK is compliant with ASTM F2026-10, Standard Specification for

Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications. Refer to manufacturer's

Master File, Appendix N.


Electrical safety testing demonstrates that the device is in compliance with EN 60601.

Bench testing including a simulated use protocol has demonstrated that the device is in compliance

with the medical community’s expectations, the product labeling, and the following standards and

guidelines:

ISO 9713, ASTM F2052, ASTM F2213, ASTM F218, ASTM F2119.

Animal testing using permanent intracranial implantation of the CLARITY Clip demonstrated that the

CLARITY Aneurysm Clip is suitable for permanent intracranial implantation.


Section 13: Proposed Draft Labeling

Instructions for Use:

CLARITY ANEURYSM CLIP (US Patent No. 123456; Additional Patents Pending )

Catalog Numbers: SUNNSURG-001, SUNNSURG-002, SUNNSURG-003, SUNNSURG-004,

SUNNSURG-005, SUNNSURG-006,

Caution: Federal (U.S.A.) law restricts this device to sale by or on the order of a physician.

Carefully read all instructions prior to use. Observe all contraindications, warnings and precautions

noted in these directions. Failure to do so may result in patient complications.

Read and observe the instructions for use and keep them in a safe place. The product may only be used

for its intended application, see intended use.

Contact information: Sunnyvale Surgical

123 Easy Street

Sunnyvale, CA 94041

800-220-1570 (24 hour contact line)

Instructions for use:



Device Description:

Sunnyvale Surgical CLARITY Aneurysm Clips are individually packaged and provided sterile

in double sterile packaging including instructions for use and labels. Each clip package is

labeled with the part number, part name, lot number and clip nominal closing force. The

instructions below are common to all CLARITY ANEURYSM CLIP part numbers listed above.

Refer to each clip package label for expiration date.

Sunnyvale Surgical CLARITY Aneurysm Clips manufactured out of Zeniva® PEEK

(polyetheretherketone) by injection molding. The CLARITY Aneurysm Clips are for use by

surgeons in surgery to treat aneurysms.

Indications for Use:

The Sugita Titanium Aneurysm Clips are intended for use in implantation for permanent

occlusion of cerebral aneurysms.

Contraindications: None

DANGER

The application of aneurysm clips involves the following severe risks:

Shifting or breakage of the aneurysm clip

Yawing of the jaw parts

Rupture of the aneurysm due to puncture

Incomplete contact of the clip jaws on the aneurysm neck

Cerebrovascular spasm

Sudden death.

For large aneurysms - reduction of the blood vessel cross-section close to the edge of the blood

vessel with consequential impeded circulation in the region affected.

In addition, as in any surgery, infections of the operation wound and general surgical complications

are also possible risks.


DANGER

Sunnyvale Surgical CLARITY aneurysm clips are manufactured from Zeniva® PEEK

(polyetheretherketone) and are not ferromagnetic. They are safe for MRI and CAT scans. However,

patients who have previously been clipped with other aneurysm clips may be at risk for interactions

between the clip and the magnetic field of the scanner.

Sunnyvale Surgical recommends that all patients with a history of aneurysm in need of MRI or

CAT scan undergo an X-ray to determine the number of clips and or/coils present. If aneurysm clips

or coils are present, the patient's medical records should be examined to determine if the identity

(and MRI/CAT scan compatibility can be confirmed. If the identity and MRI/CAT scan

compatibility can not be confirmed for every clip and coil present, the hospital should perform a

risk/benefit review and assessment and obtain patient consent prior to any further actions.

DANGER

Sunnyvale Surgical CLARITY Aneurysm Clips are designed for single use only. If clips exceed

their expiration date but are not otherwise compromised, they must be considered no longer sterile

and must be sterilized prior to use. Use a validated sterilization protocol for clip sterilization.

Reuse, reprocessing or re-sterilization may create a risk of contamination of the device and/or cause

patient infection or cross-infection, including, but not limited to, the transmission of infectious

disease(s) from one patient to another. Contamination of the device may lead to injury, illness or

death of the patient. Any aneurysm clip that has come in contact with a patient's blood or bodily

fluid should not, under any circumstances, be cleaned, re-sterilized or in any other way prepared for

use in another patient. Any aneurysm clip that has come into contact with any patient’s blood or

bodily fluids and which is not implanted should be disposed of in accord with local regulations.

CAUTION

To exclude damage, inaccurate functioning or incorrect clip closing force always apply each

Sunnyvale Surgical CLARITY Aneurysm Clip with the LittleJaw tool. If clip removal or

repositioning is required, remove each Sunnyvale Surgical CLARITY Aneurysm Clip with the

appropriate forceps, the BackOut forceps.

Never use the aneurysm clips with appliers or removal forceps from other manufacturers.

Sunnyvale Surgical CLARITY Aneurysm Clips are manufactured from PEEK and must be used

with the Sunnyvale Surgical tools. The LittleJaw tool has a specially lined clip holding area to

protect the clip from scratching or other damage.

For further information on suitable appliers and removal forceps, please contact Sunnyvale Surgical.


Instructions for use:

Inspection -

Upon receipt, inspect each aneurysm clip package. Carefully inspect the package prior to use

for any breach of the sterile barrier or damage to the contents. If the sterile barrier integrity is

compromised (open, torn, perforated or otherwise damaged), DO NOT USE and contact your

Sunnyvale Surgical representative

NOTE - Each permanent aneurysm clips package contains additional labels showing the Sunnyvale

Surgical part number and the production lot number of the clip. To facilitate the subsequent

radiological examination, the patient’s file (for the hospital) and the patient ID (see below) should

be marked with these labels.

Storage -

Store Sunnyvale Surgical CLARITY Aneurysm Clips in their sterile packaging in a dry and dust

free area protected from chemical fumes and extreme air or temperature fluctuations.

Pre use inspection –

If the sterility of the aneurysm clip has “expired” (use-by date)”, the aneurysm clip must be

regarded as unsterile. It must be sterilized according to the instructions given in the sections on

cleaning and sterilizing.

Open the clip packaging inside a sterile field and examine the clip prior to use. Sunnyvale

Surgical CLARITY permanent aneurysm clips are clear in color and etched with their

production lot code. Check that the clip lot number on the package and clip lot number etched

onto the clip are identical. If the lot numbers do not match, DO NOT USE. Contact your

Sunnyvale Surgical representative.

Inspect the clip. Any clip found with one or more of the following characteristics should not be

used:

Signs of damage

Incorrect jaw position

Bent components

Changed closing force

Misalignment

Prior to each use, inspect the LittleJaw tool and BackOut forceps for damage. If the LittleJaw

tool or BackOut forceps appears to be loose, bent, broken, cracked, worn, or fractured DO NOT

USE. Set them aside and contact your Sunnyvale Surgical representative.


Clip placement tools -

The Sunnyvale Surgical LittleJaw tool and Sunnyvale Surgical BackOut forceps must be used

for applying and removing the CLARITY Aneurysm Clips.

The Sunnyvale Surgical CLARITY Aneurysm Clip must never be used with appliers or removal

forceps from any other manufacturers. The LittleJaw tool and BackOut forceps have a specially

lined clip holding area to protect the Sunnyvale Surgical CLARITY Aneurysm Clips from

scratching or other damage.

Procedure prior to clip placement -

Examine the region for each aneurysm to be clipped to determine whether there are other clips

in place already and how these will affect positioning of the clips to be placed.

Examine the aneurysm itself and confirm that the neck to aneurysm ratio is within a factor of

three or greater. If the aneurysm has a neck to sack ratio of less than three, DO NOT USE the

Sunnyvale Surgical CLARITY Aneurysm Clip. The Sunnyvale Surgical CLARITY Aneurysm

Clips are not for use with aneurysms with neck to sack ratios of less than three.

Access the aneurysm and obtain vascular control upstream of the desired clip position. After

confirmation of vascular control, determine of the appropriate clip shape for use.

Picking up clips –

CAUTION

Never open an aneurysm clip with your fingers. Avoid manual and/or mechanical manipulation of

the aneurysm clip. Excessive, rough or repeated handling, especially opening and closing can

change closing force and impair clinical effectiveness.

Pick up the CLARITY Aneurysm Clip using the Sunnyvale Surgical LittleJaw tool. The clip

jaws will open as pressure is applied to the clip base through the LittleJaw tool. Use a steady

and smooth manual pressure to grasp the clip base.

When picking up the aneurysm clips, carefully pick up the whole aneurysm clip with the jaw

piece of the Sunnyvale Surgical LittleJaw tool.


CAUTION

If an aneurysm clip appears changed or shows signs of damage, e.g. incorrect jaw position, bent

parts or changed closing force, DO NOT USE and contact your Sunnyvale Surgical representative.

After picking up the aneurysm clip with the LittleJaw tool, observe the opening of the clip jaws. If

the clip jaws do not open to the full width, DO NOT USE and contact your Sunnyvale Surgical

representative.

These directions for use must also be observed when using the removal forceps.

Clip placement -

Maneuver the LittleJaw tool into position near the neck of the aneurysm and close to the blood

vessel. Align the blades of the clip with the aneurysm. Slowly and smoothly release the grip of

the LittleJaw tool, allowing the clip to close. Observe the aneurysm during release of the grip of

the LittleJaw tool. Do not remove the LittleJaw tool until the clip is seated.

Observe the position of the CLARITY Aneurysm Clip on the aneurysm. Make certain that the

clip sits on the aneurysm neck and close to the blood vessel. If there is any concern about the

clip position, use the BackOut forceps to remove and replace the clip. Sunnyvale Surgical does

not recommend more than two placement attempts per clip.

If additional clips are needed to control an aneurysm, additional clips may be placed at this

time. If aneurysms are found which are not candidates for clipping, this must be noted and a

further treatment plan developed.

Observe all clipped aneurysms for conclusive evidence of complete vascular control prior to

closing.

NOTE - if placement of the clip fails, but the LittleJaw tool is in good order and used correctly,

this may mean that the clip length or shape chosen are incorrect and that a different clip will be

successfully place.

CAUTION

To preclude the possibility of a galvanic reaction, avoid implanting permanent aneurysm clips made

of different materials and/or by different manufacturers in such a way that they touch each other.


Additional steps – label and Patient ID -

Each permanent aneurysm clips package contains additional labels showing the Sunnyvale

Surgical part number and the production lot number of the clip. To facilitate the subsequent

radiological examination, the patient’s file (for the hospital) and the patient ID (see below)

should be marked with these labels. One label should be placed on the patient's file and the

patient ID for each clip implanted.

The Patient ID contains important information concerning the aneurysm clip implanted and the

operation can be noted down on the patient ID. The contents of the Patient ID are:

– Patient data

– Hospital data

– Date of operation

– Name of surgeon

– Article number and individual serial number of the aneurysm clip implanted

To facilitate postoperative radiological examination, each patient should receive a patient ID.

Additional steps – after use

After use, dispose of product and packaging in accordance with hospital, administrative and/or

local government policy. Do not attempt to use this product before thoroughly reading the

Manual and Directions for Use. For future reference, keep these documents in a convenient,

easily accessible place.

Typical results to be expected from use of the Sunnyvale Surgical CLARITY Aneurysm Clip -

Permanent occlusion of the aneurysm(s) clipped.


Cleaning and Disinfection:

WARNING

Permanent aneurysm clips that have been implanted before or been in contact with blood, tissue, or

body fluids must be set aside for disposal. They must not be sterilized or reused.

Each aneurysm clip in its unopened original packaging has been packed and sterilized

individually and is supplied as a sterile product.

Aneurysm clips must be regarded as unsterile if the sterile packaging is open, torn, perforated or

damaged, or if the sterility of the product has “expired” because the date of use is later than the

use-by date. If desired, sterilization can be carried out on aneurysm clips.

Sterilization has to be carried out through a validated sterilization process. e.g. in a sterilizer

conforming to standards EN 285/ANSI/AAMI/ISO 11134-1993, ANSI/AAMI ST46-1993 and

validated according to EN 554/ISO 13683. Using a non-validated sterilization process may

result in the aneurysm clip being unsterile

Sterilization of the device may be accomplished by steam under generally accepted hospital in-

use conditions.. Sunnyvale Surgical does not recommend the device be sterilized by "Flash" or

chemical sterilization.

Recommended sterilization parameters are as follows:

Sterilization method – pre vacuum

Temperature – 270-275 F

Minimum exposure time (wrapped) – 5 min

Minimum exposure time (in a sterile container system) – 5 min



Section 14: Sterilization and Shelf Life

The Sunnyvale Surgical CLARITY Aneurysm Clip is provided sterile but may be sterilized at the

hospital using a validated sterilization protocol.

The Sunnyvale Surgical LittleJaw tool is provided not sterile and is designed for sterilization at the

hospital where it will be used.

The Sunnyvale Surgical CLARITY Aneurysm Clip is a designed as a single use device and is not

intended for reuse.

In the event that the Sunnyvale Surgical CLARITY Aneurysm Clip is stored for longer than its

expiration date, it must be considered no longer sterile and would need to be sterilized prior to use. In

the even that the opened clip package is placed onto a tray for an operation but the clip is not used, it

would no longer be sterile and would need to be sterilized prior to return to stock for use in any

following operation.

The Sunnyvale Surgical LittleJaw tool is designed for reuse within the hospital. Cleaning and

disinfection instructions for the Sunnyvale Surgical LittleJaw Surgical tool are not included in this

510(k) premarket notification. Rather, cleaning, disinfection, and sterilization instructions for the

Sunnyvale Surgical LittleJaw tool are provided in the labeling for the LittleJaw tool.

Listed below are the responses to the requirements set forth by the FDA memo dated December 12,

2008: Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions

for Devices Labeled as Sterile.

a. Sterilization method to be used:

Gamma Radiation

Contract Sterilizer: Sterigenics International

Contact: Patrick Stewart

5900 Obata Way

Gilroy, CA 95020

Telephone: 408-848-4035

Establishment Registration Number: 3004784675

b. Description of the method to be used to validate the sterilization cycle:

Validation of the sterilization cycle will be conducted in accordance with AAMI/ANSI/ISO 11137-

1+2+3:2006, Sterilization of health care products – Radiation, and AAMI TIR33:2005 for setting

irradiation dose used.

The Vdmax method will be used for validation of the sterilization cycle. Thirty clips (ten clips each

from three prototype production lots) will be used in an initial bioburden determination to measure the

average bioburden found in the CLARITY clips. Although the clips are smooth surfaced and do not

possess any lumens or cavities in their design, both wiping and rinsing methods will be used in

conjunction to measure bioburden.

Based on the average bioburden determined, the initial verification dose will be set according to the


guidelines in AAMI TIR33:2005. Ten clips from one lot will be irradiated at the initial verification dose

and then checked for any remaining bioburden after irradiation.

Following the initial verification of the irradiation dosage, periodic dose audits will be performed

according to the guidelines in the New Products section of the Sunnyvale Surgical Master Validation

Protocol. After four passed audits and at least one year, dose audits will be shifted to the schedule for

Production Products in the Sunnyvale Surgical Master Validation Protocol.

c. A description of the packaging to maintain the device’s sterility:

Packaging and sterilization of the device meets the conditions set forth by the FDA consensus standards

for sterile devices: AAMI/ANSI/ISO 11607-1 and 2:2006, Packaging for terminally sterilized medical

devices. Packaging is designed to be compatible with the sterilization method to retain sterile integrity

of the product and avoid damage to the devices until opened.

Additionally, the entire shipping configuration will be tested to be in accordance with ASTM D4169,

Performance Testing of Shipping Containers and Systems and ASTM F88-99, Standard Test Method for

Seal Strength of Flexible Barrier Materials. Testing data is not required per guidance described above.

The devices are packaged in the following materials: Tyvek/Mylar pouch around tray containing

device.

d. If sterilization involves EO, the maximum levels of residuals of EO and ethylene chlorhydrin

that remain on the device:

The device is not sterilized with EO.

e. Sterility Assurance Level (SAL) required:

The SAL for the device will be 10-6

or better. The probability of an organism surviving a given cycle

will not be more than one out of one million.

f. Whether the product is non-pyrogenic and the method used to make that determination:

The product will not be labeled as “Nonpyrogenic.” However, Sunnyvale Surgical has demonstrated

that the surfaces of the clamp which make contact with the brain are nonpyrogenic. See Section 15.

g. Radiation Sterilization Dose:

>25kGy. Exact amount used will be set afterthe average bioburden is measured and sterilization dose

is then set according to the Vdmax method as detailed in AAMI TIR33:2005.

h. Sterilization by User:

The device is single use only. If the user needs to sterilize the device, Sunnyvale Surgical suggests use

of a validated steam sterilization protocol.


i. Expiration Date:

The expiration date for the device will be 1 years after the manufactured date based upon the product

having passed a 1 year (accelerated) shelf life study. This study will involve test sample clips from

three lots that have been sterilized with the validated irradiation dose. The study will be performed

according to the guidelines in the FDA Guidance for Industry, Shelf Life of Medical Devices (dated

April 1991).

Packaged, terminally sterilized clips will be stored under typical distribution center conditions

(humidity, air flow, and exposure to light). For acceleration, clips will be stored at 40 C, 15 degrees

above the storage temperature specified on the labeling.

At 15 degrees above room temperature, aging due to temperature related processes happens at a rate

2.41 fold greater than at room temperature. Clips will be stored at 40 C for 5 months, equivalent to an

accelerated 12 month aging. The clips within packaging will be tested for the integrity of the package

and package seal. Copies of the Storage of Shelf Life Samples and Accelerated Aging Parameters are

available upon request.

Testing of clips will include pull tests for the pouch itself and for the seal region in specific. In addition

to testing clips off the shelf, clips from storage will be placed under simulated shipping and handling

stress to determine whether shipping and handling can compromise the seal or the package itself.

Copies of the Testing Protocol and the Simulated Shipping and Handling Stresses Protocol are

available on request. The company will support the accelerated life test data with a standard life test,

and anticipates that it will validate 1 year of shelf life prior to commercialization.


Section 15: Biocompatibility

The biocompatibility of the CLARITY Aneurysm Clip was assessed by evaluating the results of the

testing recommended by ISO 10993: Biological Evaluation of Medical Devices Part 1: Evaluation and

Testing and by reviewing the medical literature for pertinent interactions with the patient contacting

materials.

In accordance with the definition of ISO 10993, the following materials of the CLARITY Aneurysm

Clip come in direct or indirect contact with the patient:

Material Body Contact Contact Duration

Zeniva® PEEK

(polyetheretherketone)

Implant Permanent

The materials listed above were subjected to at least the following biocompatibility tests listed in the

table below. The materials were tested as whole devices that had undergone all manufacturing

processes including sterilization. All testing was conducted in accordance with the pertinent parts of

ISO 10993.

Test name Methodology Result

Cytotoxicity LDH (lactate dehydrogenase)

assay

Pass

Sensitization Guinea Pig Maximization Test

(Magnusson-Kligman Method )

Pass

Irritation Intracutaneous Test Pass

Intracutaneous reactivty Intracutaneous Test Pass

Systemic toxicity (acute) Material Mediated Pyrogen Pass

Systemic toxicity (acute) Bacterial endotoxin (LDL Test) Pass

Systemic toxicity (subacute) Intraperitoneal administration

(murine)

Pass

Genotoxicity Ames test Pass

Genotoxicity Chromosomal abberation Pass

Genotoxicity Mouse micronucleus Pass

Implantation Histopathological analysis of

implant sites (murine)

Pass

Hemocompatibility Coagulation assay Pass

Hemolysis Hemolysis assay Pass

Thrombosis In vivo method (murine) Pass

The CLARITY Aneurysm Clip passed all ISO 10993 testing. Copies of the original reports can be seen

in Appendix B of Section 21.


The CLARITY Aneurysm Clip is used intracranially and is in no way load bearing. Under use, the clip

will not experience load or torque, and after placement is not at risk of snapping or breaking due to

loads or torques.

Review of the medical literature demonstrates that this material has been used in medical devices in a

similar patient contact manner for many years. Examples of such devices include the RoGTM

Sports

Medicine Suture Anchor. As a result, it can be concluded that the medical community is satisfied that the

benefits of these materials outweigh the risks of patient interactions. No additional warnings are necessary

to mitigate any interaction risks.

The materials in the CLARITY Aneurysm Clip passed all tests recommended by the international standards,

and their interaction risks, as presented in other devices and/or described in the medical literature, can be

mitigated to a point that is acceptable to the medical community.

It can be concluded that the materials in the CLARITY Aneurysm Clip do not pose a risk of negative

interaction with the patients.

The benefits of the device outweigh the biocompatibility risks of the device.


Section 16: Software

This section does not apply. This device has no software.


A: Overview



B: Level of Concern



C: Software Location



D: Software Functionality



E: Software Development and Testing



Section 17: Electromagnetic Compatibility and Electrical Safety

This section does not apply. The CLARITY Aneurysm Clip does not have any electrical component.


Section 18: Performance Testing - Bench

The Sponsor has followed the recommendations for performance data outlined in applicable device-specific guidance document, special

control, and/or consensus standards listed below:

Item

Product

Spec

Location

Spec name/

Description/

Test purpose

Verification Method:

Standard/Testing Method/

Audit

Acceptance Criteria

Pass/

Fail

Report

Number/

Location

Comments

1 Testing to validate

structural integrity of

clips.

Test lab, BESS MTI, Inc

performed: Microscopic

examination of all stressed,

worked, and critical areas on

sterilized and non sterile

clamps.

Absence of cracks,

voids, and other visible

defects in observed

material under 100X

and 400Xmagnification

Data

collection

only

ENG_REP_1234 Samples of clips from the first

three prototype production lots

were inspected, 1% of all

future production lots will be

inspected in this manner



clips - post

sterilization.

Vickers hardness test on

sterilized and non sterile

clamps, per ASTM E384.

No significant change

in Vickers hardness

after sterilization.

Data

collection

only



were inspected.



clips after simulated

use.

See Simulated Use and Test

Protocol below.

As in 1, but after

Simulated Use in

Simulated Use Test

Protocol performed.

Data

collection

only



were tested.

4 Measurement of

nominal clip closing

force.

Closing force measured at a

distance one third of the way

from the distal end of each jaw,

using piezoelectric crystal force

meter per ISO 9713.

The mean of clip

closing force for all

clips tested (for each

design) must be no

more than 2% different

from the nominal

closing force calculated

for that design.

Each individual clip

must have a nominal

closing force within 3%

of the mean nominal

force measured for all

the clips of its design.

Pass

Pass



were tested. All twelve clip

designs were tested and results

for all twelve clip designs

nominal closing force and

variation of individual clip

nominal closing force from the

mean are within report

ENG_REP_3465


5 Repeatability of clip

closing force.

Measure clip closing force as

described in 4. Repeat

measurement three times and

evaluate results per ISO 9713.

For each clip tested, the

mean of three

measurements shall be

within 2% of the

nominal closing force

calculated for the clip's

design.

No individual clip

closing force

measurement may be

more than 3% different

from the mean closing

force measured for that

individual clip.

Pass

Pass



were tested. All twelve clip

designs were tested and results

for all twelve clip designs

closing force repeatability are

found in ENG_REP_3465


functional

performance of clips

after simulated use.

See Simulated Use Protocol

below. After Simulated Use in

Simulated Use Test Protocol

performed, clamped tubing was

checked for leakage of

fluorescently spiked saline.

No fluorescence

detectable outside the

clamped area.

Pass ENG_REP_2345 Samples of clips from the first


were tested.


functional




below. After Simulated Use in


performed, retention of blade

alignment was tested.

Blade alignment must

be within 2% of

original alignment as

measured in Alignment

Fixture



were tested.


functional



After Simulated Us (See

Simulated Use Protocol below)

clamp closing force was

measured and compared to

closing force prior to Simulated

Use Protocol

Clip closing force will

not vary by more than

2% from the closing

force values obtained

before Simulated Use

Protocol.



were tested.


functional




below.After Simulated Use in


performed, clamps were

checked for slippage on test

tubing.

No clips may slip off

tubing during the extent

of this test.

Clips must remain

within the marked areas

where they were placed

Pass

Pass



were tested.


10 Testing to determine

whether clamps

corrode during

conditions of

simulated use.


below. After the Simulated Use

Protocol, tests per ASTM

F2129-08 for Corrosion

Susceptibility were performed.

Clips must give results

(for all parameters) at

least as good at the

reference Sugita

Titanium aneurysm clip

tested.



were tested.

11 Displacement force

on clip in MRI field

ASTM F2052 Clips must give results



reference Sugita

Titanium Aneurysm

Clip tested.

Pass ENG_REP5678 Samples of clips from the first


were tested.

CLARITY clips tested showed

95% lower displacement forces

than the reference Sugita

Titanium Aneurysm Clips

tested.

12 Induced torque on

clip in MRI field




reference Sugita

Titanium Aneurysm

Clip tested.



were tested.


95% lower induced torques



tested.

13 Induced heating on

clip in MRI field




reference Sugita

Titanium Aneurysm

Clip tested.



were tested.


99% lower induced heating



tested, below limit of detection

in test method.


14 Evaluation of image

artifacts in MRI field




reference Sugita

Titanium Aneurysm

Clip tested.



were tested.


no detectable artifacts under

any conditions tested.


Sunnyvale Surgical, Inc.

TM-002: CLARITY Aneurysm Clip Simulated Use Testing

Purpose:

This test method assesses the performance characteristics of the clips after placement in a simulated use

environment.

Scope:

This testing covers the CLARITY Aneurysm Clip. The worst case design of the clips, clip design

number 5 was tested. Clip design number 5 incorporates an 11 mm clip jaw length, a 9.5 mm maximum

open clip width, and a slightly curved jaw design.

Modeling and simulation showed that of all clip designs included, clip design 5 had the greatest

calculated probability of slippage (by ten fold compared to the design with the next highest slippage

probability.) Clip design number 5 was also calculated to have the greatest potential variation in clip

closing force (by a factor of six fold compared to the design with the next highest calculated potential

variation in clip closing force.)

Equipment and Materials:

Sunnyvale Surgical LittleJaw tool (LTLJ-5)

ArteriortubeTM

artery testing material

(Arteriotools part number 123456, 5 mM internal diameter)

Fixture# FX-001: Piezoelectric clip closing force test fixture

(Calibrated 2/1/13 due 4/1/13)

Fixture# FX-002: Cranerco in line pressure monitor


Fixture# FX-003: SuckerBlo high resolution alternating peristaltic pump


Saline solution: Bicarbonate buffered normal saline (0.9 percent)

(BloodCo part number 12345, lot number 23456, expiry date 06/01/13)

Colorant: SuperStrong Pink and Fluorescent Colorant

(WorldOColor part number 1234A, lot number 1234QT, expiry date 01/01/2100)

Blood vessel fittings – custom made at Sunnyvale Surgical, see below

Fixture FX-004: Heated temperature bath


Fixture FX-005: Clip alignment tester fixture, custom made at Sunnyvale Surgical.


Beakers


Sample Size:

39 clips (13 each from three production lots) are to be used for each clip design.

9 clips are for microscopic examination by test laboratory after simulated use protocol is

performed.

30 clips are for functional testing by test laboratory after simulated use protocol is performed.

Test Method:

1. Each clip shall be sterilized as per the sterilization procedure before test begins. All clips should

be sterilized in the same load to minimize variation.

2. Check clip alignment with clip alignment tester, Fixture FX-005. Record results as “pass” or

“fail” on data sheet A.(Data sheet A is in the complete test report.)

3. Measure the nominal closing force for each clip using the method and piezoelectric force crystal

measurement system described in Sunnyvale Surgical TM-001. Record the nominal clip

closing force for each clip in column 1 of data sheet B.

4. Measure the closing force for each clip a total of three more times, using the method and

apparatus described in Sunnyvale Surgical TM-001. Record the clip closing forces in columns 2

through 4 of data sheet B.

5. For each clip under test, calculate the average of the three closing force measurements and

record in data sheet A. For each clip under test, calculate the percent difference between each of

the three clip closing measurements and the nominal closing force measured. Record percent

differences in data sheet A.

6. Prepare clips for simulated use – Fill test vessels with bicarbonate buffered saline and bring to

37 degrees. For each clip tested, take a 5 cm piece of Arteriortube tubing and fit a Blood Vessel

stopper fitting into one end of the tubing. Fill the clip with 666 microliters of bicarbonate

buffered saline with 0.001% colorant added.

7. Prepare clips for simulated use – Using the Sunnyvale Surgical LittleJaw tool, apply one

aneurysm clip onto each prepared piece of tubing. Take care to place each clip so that the jaws

close in the region between the two pink Clip Placement Lines on the Arteriotube tubing. After

clip is applied, wash the tubing thoroughly to remove any possible leaked or spilled saline with

colorant. Fill beyond the clipped portion of the Arteriotube tubing with bicarbonate buffered

saline. Allow some saline to spill out of the tubing to ensure no bubbles remain in tubing.


8. Apply a Blood Vessel Manifold fitting to the end of each piece of Arteriortube tubing. Connect

the Blood Vessel Manifold fittings to the manifold attachment on the SuckerBlo high resolution

alternating peristaltic pump. Make sure that the CranerCo in line pressure monitor is in place

between the mainfold and the SuckerBlo high resolution peristaltic pump. Check that the

feedback sensors from the CranerCo in line pressure monitor are connected to the SuckerBlo

inputs.

9. Set the SuckerBlo alternating peristaltic pump to a push-pull cycle of 60 cycles per minute with

pressure feedback of 300 mm Hg. Program the SuckerBlo for 31.56 million cycles. Cycling will

last one year.

10. During cycling, carefully check the test vessels for sufficient buffered saline and lack of

microbial growth or contamination. Cycling vessels should be checked at least once every day.

Any vessels which lose clips should be removed from test and the clips analyzed.

11. Leakage test: When cycling ends, remove each piece of Arteriotube tubing (with clip and

fittings) from the test vessel. Place the tube with clip and fittings into blacklight chamber and

excite at mid wavelength. Carefully rotate each clip under blacklight, looking for any evidence

of fluorescence around the clip application area or elsewhere. Photograph the region around the

clip application area from all sides and place photographs in the test data file. Note findings on

data sheet A. If any tubing shows fluorescence, it has leaked and the clip must be marked as

failed.

12. Blade alignment test: Check clip alignment with clip alignment tester, Fixture FX-005. Record

results as “pass” or “fail” on data sheet A.

13. Slipping test: Observe each clip on the tubing. Is the clip still seated between the pink lines

where it was originally placed? If yes, mark YES in data sheet A. If clip has slipped, note the

direction of the slip (toward the stopper fitting or away from it) and the degree of slip in mm.

14. Clamp closing force test: Measure the nominal closing force for each clip using the method and

apparatus described in Sunnyvale Surgical TM-001. Record the nominal clip closing force for

each clip in column 5 of data sheet B.

15. Clamp closing force calculation: Record the percent change in clamp closing force after

simulated use as measured against the nominal clamp closing force before simulated use.

Record the percent change in column 6 of data sheet B.

16. Clamp closing force evaluation: If the percent change in clamp closing force is less than 2%,

mark a PASS in column 15. If the percent change is greater than 2%, mark FAIL in column 7 of

data sheet B.

17. Corrosion susceptibility test: Corrosion susceptibility of each clip will be tested by

ReferenceLabs Inc. Carefully package each clip for shipping to ReferenceLabs Inc. The reports

for each clip tested at ReferenceLabs Inc. should be attached to the final Test Report. For each

clip which passes corrosion susceptibility testing, mark a PASS in data sheet A. For each clip

which fails, mark a FAIL in data sheet A.


18. MRI interaction test and Image Artifact test: Carefully package the clips for shipping to

Magnetolabs. Magnetolabs will test the clips for potential interaction in MRI magnetic fields as

documented in the MRI Interaction Test Protocol. Magnetolabs will test clips for potential

image artifact formation in MRI scans of test mystery material as documented in the Image

Artifact Test Protocol.

The MRI Interaction Test Report and the Image Artifact Test Report should be attached to the

final Test Report. For each clip which passes MRI interaction, mark a PASS in data sheet A. For

any clip which fails, mark a FAIL in data sheet A. For each clip which passes the Image Artifact

test, mark a PASS in data sheet A. For any clip which fails, mark a FAIL in data sheet A.


Acceptance Criteria:

1. Nominal closing force of all clips is within 2% of the value given for their clip design. For

nominal closing forces for each clip design, refer to Appendix.

2. For each clip, the average of three clip measurements will be within 2% of the nominal clip

closing force. No individual clip closing force measurement will vary from the nominal clip

closing force by more than 3%.

3. Each clip will pass the leakage test – after the Simulated Use is completed, no fluorescent

marker should be visible near the clip when viewed under black light.

4. Each clip will pass the blade alignment test after the Simulated Use is completed.

5. No clip will slip during the Simulated Use test. All clips will remain seated between the pink

lines where they were originally placed.

6. Clamp closing force after Simulated Use will not change by more than 2% of the original

nominal value.

7. Corrosion susceptibility testing – each clip will pass the Corrosion Susceptibility test per ASTM

F2129-08.

8. Magnetic susceptibility testing – each clip will pass the Magnetolabs testing for displacement

force in MRI field, induced torque in MRI field, and induced heating in MRI field. Test criteria

per the relevant standard and included in Magnetolabs report.

9. Image Artifact testing – no clip will show any image artifact with a total integrated volume of

greater than 1% of that of a Sugita Titanium Aneurysm Clip under identical test conditions

(field strength, mystery material, scan parameters).


Results:

1. 39 clips from each design were tested with the protocol above. Results and data below are for

clip design #1, production lot 1201A. (Additional results and data are included for clip design

#1, lot 1201B and 1201C in Appendix. Additional results and data for all other clip designs are

included in Appendix.)

2. All clips tested passed the blade alignment test before the Simulated Use Protocol began.

3. The nominal closing force expected for clip design #1 is 140.5 g. All clips tested were within

3% of the nominal closing force expected.

4. Repeat closing force measurements were made for 36 clips from design #1. For each clip tested,

the average of three measurements was within 2% of the nominal closing force measured for

that clip.

5. In no case did any single repeat closing force measurement for any clip vary by more than 3%

from the nominal closing force measurement for that clip.

6. All three clips sent for microscopic examination after the Simulated Use Protocol were free of

cracks, defects, or scars.

7. All clips passed the leakage test after the Simulated Use Protocol was executed

8. All clips passed the blade alignment test after the Simulated Use Protocol was executed.

9. All clips passed the slipping test after the Simulated Use Protocol was executed.

10. All clips had closing force values within 2% of the original nominal closing force value after

the Simulated Use Protocol was executed.

11. All clips passed corrosion susceptibility testing per ASTM F2129-08 after the Simulated Use

Protocol was executed.

12. All clips passed magnetic susceptibility testing in all criteria – displacement force in MRI field,

induced torque in MRI field, and induced heating in MRI field.

13. All clips passed image artifact testing. 35 clips showed no artifacts at all, one clip showed one

single artifact with a total integrated volume of 0.2% that observed with Sugita clip under

identical conditions.


Conclusion:

The CLARITY Aneurysm Clip closes with the stated nominal closing force (within a 2% tolerance)

when applied with the LittleJaw tool.

The CLARITY Aneurysm Clip is not dislodged, displaced, or misaligned during simulated use. The

CLARITY Aneurysm Clip does not become susceptible to corrosion and does not decrease in closing

force after simulated use.

The CLARITY Aneurysm Clip is MRI safe, with performance equal to or better than the Sugita

Titanium Aneurysm Clip with regard to displacement force in MRI field, induced torque in MRI field,

and induced heating in MRI field.

The CLARITY Aneurysm Clip provided low distortion on MRI scans, without artifacts. For 35 clips

tested, no artifacts were detectable under any conditions tested. One clip did show artifacts, but total

integrated volume of artifacts was 0.2% that of Sugita clip under identical conditions. CLARITY clips

performance was superior to Sugita Titanium Aneurysm Clip.


Table Four – Data sheet B for testing of CLARITY Aneurysm Clip design #1 in Simulated Use Protocol

1 2 3 4 5 6 7

Clip lot

number

Clip

number

Nominal

closing

force (g)

Closing

force (g)

1st

Closing

force (g)

2nd

Closing

force (g)

3rd

Closing

force (g)

Avg.

Avg. closing

force within

2% of nom.

Pass/Fail

change

1201A 1 140.2 140.2 140.2 140.2 n.a n.a n.a

1201A 2 140.4 140.2 140.4 140.6 n.a n.a n.a

1201A 3 140.6 140.8 140.7 140.5 n.a n.a n.a

1201A 4 140.2 140.2 140.2 140.2 140.2 Y P

1201A 5 140.6 140.8 140.7 140.5 140.8 Y P

1201A 6 140.4 140.2 140.4 140.6 140.2 Y P

1201A 7 140.6 140.8 140.7 140.5 140.5 Y P

1201A 8 140.2 140.2 140.2 140.2 140.2 Y P

1201A 9 140.2 140.8 140.6 140.8 140.3 Y P

1201A 10 140.4 140.6 140.4 140.6 140.2 Y P

1201A 11 140.7 140.8 140.7 140.5 140.8 Y P

1201A 12 140.5 140.2 140.4 140.5 140.5 Y P

1201A 13 140.2 140.5 140.3 140.2 140.4 Y P


Section 19: Performance Testing - Animal

Animal testing was performed to collect data on the suitability of the CLARITY Aneurysm Clip for

permanent implantation. The testing was performed per Protocol Animal-001. A summary of the

protocol and results follow.

In conclusion, the animal testing showed that the CLARITY Aneurysm Clip is suitable for permanent

implantation. There were no significant changes in behavior in implanted animals monitored. EEG

evaluations showed no significant differences between animals implanted with the CLARITY

Aneurysm Clip and those implanted with the Sugita Titanium Aneurysm Clip.

Sunnyvale Surgical, Inc

Animal Study—001

Purpose:

The objective of the animal study is to collect data on the suitability of the CLARITY Aneurysm Clip

for permanent implantation in the brain.

Study Endpoint / Pre-defined Acceptance Criteria:

Behavior of rabbits implanted was monitored on a daily basis for nine months, three months pre

implantation and six months post implantation. No significant differences in four behaviors scored

should be seen between rabbits implanted with the CLARITY clip and rabbits implanted with the

Sugita Titanium Aneurysm Clip.

Secondary endpoints of the study were to observe EEG evaluations from rabbits implanted with the

CLARITY clip and the Sugita Titanium Aneurysm Clip and to measure seizure threshold in implanted

rabbits. Rabbits implanted with CLARITY Aneurysm Clip shall not show gross differences in EEG

evaluations when compared to rabbits implanted with Sugita Titanium Aneurysm Clips. No significant

difference in seizure thresholds should be seen.

Methods and Materials:

1. Sunnyvale Surgical commissioned a six month intracranial, non-clinical implant study of 30

rabbits, divided into three groups:

12 rabbits were implanted with the Sunnyvale Surgical CLARITY Aneurysm Clip

12 rabbits were implanted with the Sugita Titanium Aneurysm Clip

6 were non implanted controls.

2. To establish a baseline, prior to implantation, all rabbits were monitored daily for three months. The

following four behaviors were monitored and scored: appetite, sleep, aggression, and curiosity.

3. To establish a baseline, prior to implantation, all rabbits underwent one EEG at the onset of the

study and one additional EEG two days before implantation.

4. To establish a baseline, prior to implantation, all rabbits underwent testing for seizure threshold

latency at the onset of the study and once more two days before implantation.


5. After three months observation, rabbits were implanted with either the Sunnyvale Surgical

CLARITY Aneurysm Clip, the Sugita Titanium clip, or underwent a sham procedure (no clip

implanted control).

6. Behavior of rabbits was monitored on a daily basis for six months. The following four behaviors

were monitored and scored: appetite, sleep, aggression, and curiosity.

7. Once each month, rabbits underwent an EEG. EEG results from each month were overlaid on the

baseline EEGs. EEGs from each month were overlaid on EEGs from all post implantation months

to analyze for negative trends.

8. Once each month, rabbits were tested to determine seizure threshold latency.

9. Study was concluded six months post implantation.

Results:

Both the rabbits implanted with the Sunnyvale Surgical CLARITY Aneurysm Clip and the rabbits

implanted with the Sugita Titanium clip showed no statistically significant changes in any of the four

behaviors monitored at any time period post implantation compared to the rabbits treated with the sham

procedure.

Both the rabbits implanted with the Sunnyvale Surgical CLARITY Aneurysm Clip and the rabbits

implanted with the Sugita Titanium clip showed no statistically significant changes in seizure threshold

latency at any time period post implantation when compared to rabbits treated with the sham procedure.

Both rabbits implanted with the Sunnyvale Surgical CLARITY Aneurysm Clip and implanted with the

Sugita Titanium clip showed no significant differences in EEGs as compared to rabbits treated with the

sham procedure at any time period post implantation.

Conclusion:

The animal testing showed that the CLARITY Aneurysm Clip is suitable for permanent implantation in

the brain.


Section 20: Performance Testing - Clinical

This section does not apply. No human testing was necessary to demonstrate substantial equivalence or

to demonstrate that the device can meet its labeling claims.

In accordance with the FDA’s Guidance, no Form 3674 “Certification of Compliance, under 42 U.S.C.

§ 282(j)(5)(B), with Requirements of ClinicalTrials.gov Data Bank (42 U.S.C. § 282(j))” is necessary

for this premarket notification since no clinical trials were conducted to support this submission.


Section 21: Design Control Activities (Special 510(k) only)

This section does not apply. This is a traditional 510(k) submission.


Tab 2: Predicate 510k Summaries







Tab 3: Standards Certification Forms (3654)


Tab 4: Biocompatibility Reports


Tab 5: Design Verification Reports (if necessary)


Tab 6: Software Support Documentation (if necessary)


Tab 7: IFU & Labeling (if not included in section 13 of 510k)


Tab 8: References (if necessary)

Documents

mock 510(k) for UCSC Extension Regulatory Submissions Devices and Diagnostics 19315_012