Questions? Contact FDA/CDRH/OCE/DID at CDRH … · 3985 Sagamore Parkway North, Suite 220 . Lafayette, IN 47904 . FDA Registration #: 3004555298 . Sterilization Site: BeamOne LLC

Records processed under FOIA request 2018-3733; Released on 2/5/2019

Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118

























Special 510(k): Device Modification ACell® MatriStem® Wound Sheets

September 21, 2009 CONFIDENTIAL TABLE OF CONTENTS i

TABLE OF CONTENTS

1 MEDICAL DEVICE USER FEE COVER SHEET .................................................... 1-1 2 CDRH PREMARKET REVIEW SUBMISSION COVER SHEET ......................... 2-1 3 510(K) COVER LETTER ............................................................................................. 3-1 4 BACKGROUND INFORMATION .............................................................................. 4-1

4.1 Device Name ........................................................................................................ 4-1 4.2 Address and Registration ..................................................................................... 4-1 4.3 Device Class ......................................................................................................... 4-1 4.4 Predicate Device Information .............................................................................. 4-1

5 TRUTHFUL AND ACCURACY STATEMENT ........................................................ 5-1 6 LABELING AND INTENDED USE ............................................................................ 6-1

6.1 Labeling ............................................................................................................... 6-1 6.2 Intended Use ........................................................................................................ 6-1

7 DEVICE DESCRIPTION AND COMPARISON ....................................................... 7-1 8 SUBSTANTIAL EQUIVALENCE ............................................................................... 8-1 9 SUMMARY OF DESIGN CONTROL ACTIVITIES ................................................ 9-1 10 510(k) SUMMARY ...................................................................................................... 10-1

11 STANDARDS DATA REPORTS…………………………………………………...11-1

EXHIBITS

Exhibit 1: Predicate Instructions for Use

Exhibit 2: Draft Labeling

Exhibit 3: Indications for Use Statement

Exhibit 4: Declaration of Conformity with Design Controls


















September 21, 2009 CONFIDENTIAL BACKGROUND INFORMATION 4-1

4 B A C K G R OUND I NF OR M A T I ON

The predicate ACell UBM Lyophilized Wound Dressing (K021637), originally cleared in

December 2002, was first commercially manufactured in 2008

. These modifications

are submitted in this Special 510(k) along with an expansion of the product line.

4.1 Device Name

The device trade names and common/classification names are:

Device Trade Name: ACell® MatriStem® Wound Sheet

Common Name: Collagen Wound Dressing

4.2 A ddr ess and R egistr ation

Manufacturer: ACell, Inc. 8671 Robert Fulton Drive, Suite B

Columbia, MD 21046 Owner/Operator #: 10026467 FDA Registration #: 3005920706

Manufacturing Site: ACell, Inc. 3985 Sagamore Parkway North, Suite 220 Lafayette, IN 47904 FDA Registration #: 3004555298 Sterilization Site: BeamOne LLC

500 West 4th Street Lima, OH 45804

4.3 Device C lass

Collagen Wound Dressings are unclassified, 79 KGN – General & Plastic Surgery.

No performance standards have been established under Section 514 of the FD&C Act for

Collagen Wound Dressings.

4.4 Pr edicate Device I nfor mation

ACell® UBM Lyophilized Wound Dressing, [K021637, concurrence 12-19-2002]

(b)(4)






September 21, 2009 CONFIDENTIAL LABELING & INTENDED USE 6-1

6 L A B E L I NG A ND I NT E NDE D USE

6.1 L abeling

Labeling for the predicate and modified devices have been changed with respect to the name of

the device, which is now branded ACell® MatriStem® Wound Sheet.

Modified devices will also be labeled per the cleared indications for use such as:

• ACell® MatriStem® Wound Sheet

• ACell® MatriStem® Burn Matrix

The draft Instructions for Use, as submitted in the original 510(k) [K021637], has been revised

for clarity to insure more effective use. The following change was made:

• Change in follow-up recommendation from

to “inspect wound for adverse reactions every 7 days.”

o Change in follow-up is based on a clinical evaluation of 13 patients.

The indication/intended use in the modified subject device labeling is unaffected by the device

modification.

For comparison, the predicate Instructions for Use are provided in Exhibit 1.

Draft labels and Instructions for Use for the MatriStem Wound Sheet/Burn Matrix are provided

in Exhibit 2.

6.2 I ntended Use

The ACell MatriStem Wound Sheet is intended for the management of wounds. This is the same

intended use as previously cleared for the predicate ACell® UBM Lyophilized Wound Dressing,

[K021637].

The Indications for Use Statement is unchanged and provided in Exhibit 3.

(b)(4)




September 21, 2009 CONFIDENTIAL SUMMARY OF DESIGN CONTROL ACTIVITIES 7-1

7 DE V I C E DE SC R I PT I ON A ND C OM PA R I SON

The device descriptions of the ACell® MatriStem® Wound Sheets are as follows:

• Lyophilized extracellular collagen matrix derived from porcine urinary bladder • Single-layer and multi-layer sheets ranging from 2 – 8 layers (50-1000 microns thick) • Rectangular sheets ranging from 2 x 4 cm to 14 x 20 cm • Disc sheets 15 mm in diameter • Fenestrated sheets (approximately 1 mm slits spaced evenly across surface) • Meshed sheets (device stretches in diamond-like pattern) • Indicator for basement membrane surface as opposed to the abluminal surface of device • Double peel pouch packaging – Tyvek®/clear polyester/polyethylene in cardboard box • E-beam sterilization, SAL 10-6 • 2-year shelf life

The only modifications that were made are:

• Addition of multi-layer sheets ranging from 2 – 8 layers ranging from 50-1000 microns in total thickness

o Some wounds may require a thicker application of matrix for healing

• Addition of 15 mm diameter disc single or multi-layer sheets o For circular wounds

• Addition of fenestrated sheets and meshed sheets o Perforated sheets adhere to wound better by allowing drainage of exudates

• Addition of indicator to identify basement membrane side of device on sheets meant for certain types of wounds

o Aids in correct application of sheet

• Change from Precision Clean® Nylon peel pouch to Tyvek®/Clear polyester/polyethylene double peel pouch

• Eliminate radiation exposure tag on pouch

• Change in labeling by eliminating “pyrogen-free” statement o All devices continue to be manufactured pyrogen-free

• Change in labeling for recommendation in frequency of patient follow-up

• Change in labeling – brand name changed from ACell® UBM Lyophilized Wound Dressing to ACell® MatriStem® Wound Sheet

The types of modifications made include performance specifications, dimensional, ergonomic,

packaging and labeling changes. These modifications do not affect the indications for use and do

not raise new issues of safety or effectiveness.





8 SUB ST A NT I A L E QUI V A L E NC E

The modified wound dressings have the following similarities to the devices which previously

received 510(k) concurrence (K021637):

• Have the same indications for use

• Have the same material

• Have the same fundamental scientific technology

• Have the same sheet configuration and sizes

• Have the same manufacturing process

• Have the same sterilization process

• Have the same 2-year shelf life

In summary, the ACell MatriStem Wound Sheet devices described in this submission are, in our

opinion, substantially equivalent to the predicate device.





9 SUM M A R Y OF DE SI G N C ONT R OL A C T I V I T I E S

The risk analysis method used to assess the impact of the modifications was a Failure Modes and

Effects Analysis (FMEA). The design verification tests that were performed as a result of this

risk analysis assessment are listed in the table below:

Modification Test Performed Acceptance Criteria

The test methods used are the same as those submitted in the original submission.

The predicate single layer device originally underwent mechanical property testing; it has been

. Each device is intended to be used as a topical application and is

held in place by the use of a secondary bandage or dressing. The device is not sutured into place

and does not perform a mechanical function of providing support to any tissue.

A Declaration of Conformity with Design Controls is provided in Exhibit 4.

(b)(4)

(b)(4)

(b)(4)



ACell, Inc. 8671 Robert Fulton Drive, Ste. B Columbia, MD 21046

Toll Free: 800-826-2926 Phone: 410-715-1700

Fax: 410-715-4511 Website: www.acell.com

510(k) Summary

Submitted by: ACell, Inc. 8671 Robert Fulton Drive, Suite B Columbia, MD 21046 Contact Person: Rodney W. Bosley, Sr. Vice President Phone: (410) 715-1700

Fax: (410) 715-4511 Date Prepared: September 21, 2009 Device Trade Name: ACell® MatriStem® Wound Sheet Common/Usual Name: Wound Dressing Proposed Classification: Dressing, Wound, Collagen

Unclassified, 79 KGN – General & Plastic Surgery

Device Description:

ACell® MatriStem® Wound Sheets are sterile, porcine-derived, lyophilized single or multi-layer extracellular matrix sheets available in various sizes with or without fenestrations or meshed. Indications For Use:

ACell® MatriStem® Wound Sheet is intended for the management of wounds including: partial and full-thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers, tunneled/undermined wounds, surgical wounds (donor sites/grafts, post-Moh’s surgery, post-laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, lacerations, second-degree burns, skin tears) and draining wounds. The device is intended for one-time use. Predicate Device:

K021637 ACell® UBM Lyophilized Wound Dressing ACell, Inc. 510(k) # Device Manufacturer

Substantial Equivalence:

ACell® MatriStem® Wound Sheets are identical to the predicate device with respect to fundamental scientific technology, materials, processing and intended use. The addition of multiple layers and fenestrations/meshes do not raise new issues of safety and effectiveness. MatriStem® Wound Sheets are substantially equivalent to the legally marketed predicate device.










September 21, 2009 CONFIDENTIAL

EXHIBIT 1

Predicate Device (K021637)

Instructions For Use



ACell UBM Lyophilized Wound Dressing Page 1 of 3

Draft INSTRUCTIONS FOR USE


ACell UBM Wound Dressing

ACell’s UBM Lyophilized Wound Dressing is indicated for use in the management of wounds including:

Applications

1) Partial and full thickness wounds. 2) Pressure Ulcers 3) Venous Ulcers 4) Diabetic Ulcers 5) Chronic Vascular Ulcers 6) Tunneled/undermined wounds 7) Surgical wounds (donor sites/grafts, post-Moh’s surgery, post laser surgery,

podiatric, wound dehiscence) 8) Trauma wounds (abrasions, lacerations, second degree burns, and skin tears), 9) Draining Wounds

The device is intended for one-time use. Caution: Federal (USA) law restricts this device to sale by or on the order of a physician or properly licensed practitioner.

ACell’s UBM Lyophilized Wound Dressing is a new material derived from porcine urinary bladder. It is a naturally occurring extracellular matrix that maintains and supports a healing environment for wound management.

Product Description

ACell UBM Lyophilized Wound Dressing is intended for the management of wounds including: partial and full-thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers, tunneled/undermined wounds, surgical wounds (donor sites/grafts, post-Moh’s surgery, post-laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, lacerations, second-degree burns, and skin tears), and draining wounds. The device is intended for one-time use.

Indications

This device is derived from a porcine source and should not be used in patients with known sensitivity or allergy to porcine material.

Contraindications

The device is not indicated for use on third degree burns.





Do not reuse or resterilize. Discard all open and unused portion of the material. Precautions

Device is sterile if the package is dry, unopened and undamaged. Do not use the material if the package seal has been broken. Use the material as soon as the package is opened for use. Discard device if mishandling has caused damage or contamination. Device should not be used on necrotic, heavily purulent wounds. All scar tissue and necrotic tissue should be debrided. Exudates should be removed and bleeding controlled before using this material.

Various complications and reactions are possible with all wound dressings. If any of these occur the material should be removed and the wound inspected.

Potential Complications

• Infection • Increasing chronic inflammation. • Allergic Reactions • Unexplained fever or chills • Excessive redness, pain, swelling or blistering.

This device in an unused and undamaged package can be stored at room temperature in a clean, dry environment. It can be stored at normal refrigeration temperatures as well. It should not be heated. It should not be frozen.

Storage

This device has been sterilized with Electron beam (E Beam) irradiation Sterilization

Application Guidelines

1) Clean the wound bed. All necrotic and scar tissue should be removed, Excessive exudates should be gently removed or irrigated. Fresh tissue edges should be obtained. Bleeding should be controlled.

2) Remove the ACell wound dressing from the container using standard aseptic/

sterile technique. Cut the piece slighter bigger than the area to be covered.

3) The material can be re-hydrated on the wound or soaked in sterile saline or Ringer’s Lactated Solution for 2-3 minutes before being placed. The material has an “up” and “down” side. Use the indicator as shown on the label to place it properly. If placed on the wound dry, moisten with sterile saline by gentle lavage.





4) In large wounds more than one sheet of ACell’s wound dressing may be necessary to obtain complete coverage. Overlap the edges slightly to assure coverage of the entire wound.

5) Cover the ACell wound dressing with a non-adherent covering such as Telfa® or

Opsite®, or similar, followed by application of a gauze sponge moistened with sterile saline. The material and the wound bed should be kept moist.

6) If no adverse reactions are occurring, the wound should be inspected every 2-3

days and exudates removed, and any non-covered wound areas should be dressed with another application of the ACell wound dressing. Do not remove material that is intact on the wound surface. If any colored exudates are present, use gentle irrigation to remove.

7) Repeat this process every 2-3 days until the wound is re-epithelialized. Attention

should be given to the tissues surrounding the edges of the wound. As wound healing occurs, redness and swelling will decrease, and drainage will become less. These are signs of wound healing and are often seen before new epithelium is obvious.

8) Continue treatment until the wound is healed.

Note: Generalized care of the patient is still very important -- good nutrition, control of underlying pathology, elevation of limb when appropriate, use of antibiotics, etc. The patient needs careful professional management. General and wound care protocols must always be up-dated as progress is observed and should be under the direction of a qualified, experienced and licensed medical professional.





EXHIBIT 2

Modified Device

Draft Labeling




September 21, 2009 CONFIDENTIAL LABELS

DRAFT LABELS

Meshed – Box Label Fenestrated – Box Label

Meshed – Outer Pouch Label Fenestrated – Outer Pouch Label

Inner Pouch contains only a bar coded label.



INSTRUCTIONS FOR USE

MatriStem® Wound Sheet MatriStem® Burn Matrix Caution: Federal (USA) law restricts this device to sale by or on the order of a physician or properly licensed practitioner. These recommendations are designed to serve only as a general guideline. They are not intended to supersede institutional protocols or professional clinical judgment concerning patient care. DEVICE DESCRIPTION The MatriStem device is a sterile, porcine-derived, naturally occurring lyophilized extracellular matrix that maintains and supports a healing environment for wound management. INDICATIONS The MatriStem device is intended for the management of wounds including: partial and full-thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers, tunneled/undermined wounds, surgical wounds (donor sites/grafts, post-Moh’s surgery, post-laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, lacerations, second-degree burns, and skin tears), and draining wounds. The device is intended for one-time use. CONTRAINDICATIONS Patients with known sensitivity or allergy to porcine

materials. Third degree burns PRECAUTIONS Debride scar tissue and necrotic tissue prior to device

application. Remove exudates and control bleeding prior to device

application. Do not reuse or re-sterilize.

Discard unused portions of device. Sterile if package is unopened and undamaged. Do not use device if package seal has been broken, if

mishandling has caused damage or contamination, or if device is past its expiration date.

POTENTIAL COMPLICATIONS Complications and reactions are possible with any soft tissue repair, including but not limited to, infection, increased chronic inflammation, allergic reaction, unexplained fever or chills, excessive redness, pain, or swelling.

NOTE: Provided the wound sheet has a sidedness indicator, when it is in the location shown in the image below, the basement membrane side of the device is facing up.

DEVICE APPLICATION 1. Clean wound bed by removing necrotic and scar tissue

to obtain fresh tissue edges. Irrigate excessive exudates. Control bleeding.

2. Remove device from container using standard aseptic/

sterile technique. Cut piece slighter bigger than area to be covered.

3. Rehydrate device in room temperature sterile saline or

sterile lactated Ringer’s solution in a sterile dish for 5 minutes prior to use.

4. In large wounds more than one device may be

necessary to obtain complete coverage. Apply wound sheet basement membrane side up. Overlap the edges slightly to assure coverage of entire wound.

5. In a wet wound, cover device with a non-adherent

dressing such as petrolatum gauze, followed by application of an absorptive dressing such as a calcium alginate. Secure dressings to wound site.

6. In a dry wound, the non-adherent dressing should be followed by application of a hydrogel dressing to keep wound moist. Secure dressings to wound site.

NOTE: Device and wound bed should be kept moist. WOUND CARE FOLLOW UP 1. Inspect wound for adverse reactions every 7 days,

remove exudates and apply new sheet to any non-covered wound areas.

2. Do not remove any remaining device that is intact on wound surface. As device is resorbed, it may form a caramel-colored gel. Gently rinse wound surface leaving the caramel-colored gel intact and apply another application of sheet.

3. Repeat wound care follow up process weekly until

wound has epithelialized.

4. Attention should be given to tissues surrounding edges of wound. As wound healing occurs, redness and swelling will decrease and drainage will become less. These are signs of wound healing and are often seen before new epithelium is obvious.

STORAGE In its unused and undamaged package, store at room temperature in a clean, dry environment. STERILIZATION Sterilized with Electron beam irradiation. HOW SUPPLIED Reorder # Size WS0303-5 3x3.5cm, 5 /box WS0303-10 3x3.5cm, 10/box WS0307-5 3x7cm, 5/box WS0307-10 3x7cm, 10/box WS0710-1 7x10cm, 1/box WS0710-5 7x10cm, 5/box WS1015-1 10x15cm, 1/box WS1015-5 10x15cm, 5/box BMF0710 7x10cm, fenestrated, 1/box BMM0710 7x10cm, meshed, 1/box Manufactured and Distributed By: ACell, Inc. 8671 Robert Fulton Dr., Suite B Columbia, MD 21046 1-800.826.2926 www.acell.com



US Pat. No. 6,576,265; US Pat. No. 6,849,273; US Pat. No. 6,890,564; US Pat. No. 6,887,495; US Pat. No. 6,861,074; Eur. Pat. No. 1239897; AUS Pat. No. 777652

ACell® and MatriStem® are registered trademarks of ACell, Inc.

QA-155.4 09/2009





EXHIBIT 3

Indications For Use Statement



Indications For Use 510(k) Number (if known): ___________________________ Device Name: ACell® MatriStem® Wound Sheet Indications for Use:

ACell® MatriStem® Wound Sheet is intended for the management of wounds including: partial and full-thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers, tunneled/undermined wounds, surgical wounds (donor sites/grafts, post-Moh’s surgery, post-laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, lacerations, second-degree burns and skin tears) and draining wounds. The device is intended for one-time use.

Prescription Use (Part 21 CFR 801 Subpart D) (Part 21 CFR 801 Subpart C)

AND/OR Over-The-Counter-Use________

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1





EXHIBIT 4

Declaration of Conformity with Design Controls



















































(b)(4) Records processed under FOIA request 2018-3733; Released on 2/5/2019
























































































































Documents

Questions? Contact FDA/CDRH/OCE/DID at CDRH … · 3985 Sagamore Parkway North, Suite 220 . Lafayette, IN 47904 . FDA Registration #: 3004555298 . Sterilization Site: BeamOne LLC