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Confidential
3MTM AttestTM 1295
Biological Indicator
510(k)
Performance Testing-Animal
19. Animal Testing
The submission device does not include animal testing. This page is included
for ease of submission packet review.
K152060 Amendment 1 Page 1
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Confidential
3MTM AttestTM 1295
Biological Indicator
510(k)
Performance Testing-Clinical
20. Clinical testing
The submission device does not include clinical testing. This page is included
for ease of submission packet review.
K152060 Amendment 1 Page 2
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3M Health Care Business 3M Center
2510 Conway Ave., Bldg. 275-5W-06
St. Paul, MN 55144 U.S.A
Monday July 13th, 2015
Food and Drug Administration
Center for Devices and Radiological Health
Office of Device Evaluation [510(K)]
Document Mail Center - WO66-G609
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
Re: Cover letter for traditional 510(k) notification for the 3M™ Attest™ Rapid
Readout Biological Indicator 1295 expanded indications for use
Dear Sir or Madam:
In compliance with the Federal Food, Drug and Cosmetic Act (as amended) and as required
in 21 CFR § 807, Subpart E, 3M Health Care submits this Premarket Notification for your
review. In accordance with 21 CFR §807.90(c), this document is submitted in duplicate, with
one paper copy and one electronic copy. The eCopy is an exact duplicate of the paper copy.
The purpose of the submission is to notify the Agency of the intent of 3M to market the
3M™ Attest™ Rapid Readout Biological Indicator 1295 with a new indication for use with
the STERRAD®100S sterilizer. This product was previously cleared by the Agency
(K140392) for use in STERRAD® 100NX and STERRAD® NX sterilizers.
Trade Name: 3M™ Attest™ Rapid Readout Biological Indicator 1295
Classification Name: Indicator, Biological Sterilization Process
Common Name: Biological Indicator
Device Classification: Class II, 21 CFR 880.2800(a)
Product Code: FRC
The 3M™ Attest™ Rapid Readout Biological Indicator 1295 is the same design as the
previously cleared device of the same model number. The device has the same materials,
performance specifications, and fundamental scientific technology.
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3M Health Care Business 3M Center
2510 Conway Ave., Bldg. 275-5W-06
St. Paul, MN 55144 U.S.A
The table below summarizes the principal factors of the design and use of the device.
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
Recent communications with ODE Infection Control Branch reviewers, both during the review of the
predicate K140392 and during unrelated product reviews, have suggested the following organization
of this particular submission as appropriate:
1) This submission includes original results of testing necessary to include additional
cycles in the Indications for Use. Discussions held with INCB during teleconferences on
June 17 and June 24, 2104 indicated the necessary testing to be Full Cycle, Half Cycle
and Recovery Protocols (Carrier and Primary Packaging Materials Evaluation & Effect
of Sterilization Process on Recovery Medium) for each additional cycle. This testing is
provided in Section 18 – Bench Testing.
2) This submission additionally includes test documentation reproduced from K140392.
Review staff have communicated that reproducing documentation from previous
premarket notifications, where possible, allows for maintaining a complete review file
within FDA systems. To that end, we have included Full Cycle, Half Cycle, and
Recovery Protocols for the previously cleared sterilizer cycles, as well as non-cycle-
specific BI resistance (D-value and Survive/Kill) and Hold Time testing which supports
both the predicate and current submission. This testing is provided as Appendices
within this submission.
3M considers the intent to market this device as confidential commercial information.
Therefore, 3M considers the information provided under this submission to be a trade secret
and confidential commercial information under 21 CFR §20.61 and requests that the Food
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3M Health Care Business 3M Center
2510 Conway Ave., Bldg. 275-5W-06
St. Paul, MN 55144 U.S.A
and Drug Administration not disclose this information either in response to a Freedom of
Information Request or by any other means.
An electronic payment of was made to FDA on June 23, 2015 in support of this
submission, and 3M’s Medical Device User Fee Payment Identification Number for this
submission is . Should you have any questions regarding this submission, please
contact me at the phone number or email listed below. In the event that I cannot be reached,
please contact Hilary Hovde at (651) 736-0364.
Sincerely,
Matthew S. Mortensen, PhD, RAC
3M Health Care Regulatory Affairs
3M Center
2510 Conway Avenue, Bldg. 275-5W-06
St. Paul, MN 55144-1000 U.S.A.
Phone (651) 737-2670 Fax: (651) 737-5320
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(b)(4)
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Page 1 of 5 Pages
Supplement
CDRH PREMARKET REVIEW SUBMISSION COVER SHEET
Form Approval OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on page 5.
Date of Submission
(If Yes, please complete Section I, Page 5)
Division Name (if applicable) Phone Number (including area code)
Street Address FAX Number (including area code)
City
Contact Name
Contact E-mail Address
Company / Institution Name
Contact Title
ZIP/Postal CodeState / Province
Division Name (if applicable) Phone Number (including area code)
Street Address FAX Number (including area code)
City
Contact Name
Contact E-mail Address
Evaluation of Automatic Class III Designation
(De Novo)
APPLICATION CORRESPONDENT (e.g., consultant, if different from above)
FORM FDA 3514 (1/13)
PMA PMA & HDE Supplement
Establishment Registration Number (if known)
Original Submission
PDP 510(k)
Other SubmissionHumanitarian Device Exemption (HDE)
Amendment
Class II Exemption Petition
Original SubmissionAdditional Information
Original Submission Original Submission
Additional InformationOriginal Submission
Amendment
No
Supplement
SUBMITTER, APPLICANT OR SPONSOR
IDE
DEPARTMENT OF HEALTH AND HUMAN SERVICES FOOD AND DRUG ADMINISTRATION
Report Amendment
TYPE OF SUBMISSION
State / Province ZIP Code Country
Country
Additional Information
Other (describe submission):
Contact Title
FDA Submission Document Number (if known)User Fee Payment ID Number
513(g)
Notice of CompletionAmendment to PDP
Original PDPRegular (180 day)SpecialPanel Track (PMA Only)30-day Supplement30-day Notice135-day SupplementReal-time Review
Abbreviated (Complete section I, Page 5)
SpecialTraditional
Original Submission:
Modular Submission
Other
AmendmentReportReport Amendment
Premarket Report
Licensing Agreement Third Party
Amendment to PMA & HDE Supplement
Company / Institution Name
Have you used or cited Standards in your submission?
Report
Yes
07/13/2015
3M Company 2110898
3M Health Care 651-737-2670
3M Center, Building 275-5W-06 651-737-5320
St. Paul MN 55144 USA
Matt Mortensen
Regulatory Affairs Specialist [email protected]
SECTION A
SECTION C
SECTION B
PSC Publishing Services (301) 443-6740 EF
Request for Feedback
Informational Meeting
Study Risk Determination
Pre-Submission
Day 100 MeetingAgreement MeetingDetermination Meeting
Submision Issue Meeting
Other (specify):
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Page 2 of 5 Pages
Additional or Expanded Indications
Request for Applicant Hold
Withdrawal
Post-approval Study Protocol
Request to Remove or Add Manufacturing Site
Request for Extension
Request for Removal of Applicant Hold
New Device
Manufacturing PackagingSterilization
Other (specify below)
Post-approval Study
Packager
Process change:
Response to FDA correspondence: Change of Applicant Address
Location change:
SterilizerManufacturer
New Indication
Request Hearing
Other Reason (specify):
Adverse ReactionDevice DefectAmendment
Change in design, component, or specification:
Report Submission:Annual or Periodic
Color AdditiveMaterial
Software / Hardware
Change in OwnershipChange in Correspondent
SpecificationsOther (specify below)
Labeling change:Indications
Performance CharacteristicsInstructions
Shelf LifeTrade NameOther (specify below)
Other Reason (specify):
Change in TechnologyNew Device
REASON FOR APPLICATION - PMA, PDP, OR HDE
REASON FOR SUBMISSION - 510(k)
FORM FDA 3514 (1/13)
REASON FOR APPLICATION - IDE
New Device
Expansion / Extension of StudyIRB Certification
Addition of Institution
Termination of StudyWithdrawal of Application
Continued Access
Unanticipated Adverse Effect
Compassionate Use RequestTreatment IDE
Notification of Emergency Use
Change in:
Design / DeviceInformed Consent
Correspondent / Applicant
Manufacturer
Protocol - FeasibilityProtocol - Other
Manufacturing Process
Response to FDA Letter Concerning:
Sponsor
Deemed ApprovedDeficient Final Report
Conditional Approval
Site Waiver Report
Current InvestigatorAnnual Progress Report
Report submission:
Deficient Progress Report
DisapprovalRequest Extension of Time to Respond to FDA
Deficient Investigator Report
Request Meeting
Final
Other Reason (specify):
Additional or Expanded Indications
SECTION D1
SECTION D3
SECTION D2
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Page 3 of 5 Pages
Trade or Proprietary or Model Name510(k) Number
Product codes of devices to which substantial equivalence is claimed
5
Manufacturer
Information on devices to which substantial equivalence is claimed (if known)
1
PRODUCT INFORMATION - APPLICATION TO ALL APPLICATIONS
2
PRODUCT CLASSIFICATION - APPLICATION TO ALL APPLICATIONS
Common or usual name or classification name
Trade or Proprietary or Model Name for This Device
3
Model Number
3
FDA document numbers of all prior related submissions (regardless of outcome)
8
2
9
3
10
Data Included in SubmissionLaboratory Testing Animal Trials Human Trials
Device ClassProduct Code C.F.R. Section (if applicable)
Classification Panel
Indications (from labeling)
Class I Class II
Class III Unclassified
Summary of, or statement concerning, safety and effectiveness information
510 (k) summary attached510 (k) statement
ADDITIONAL INFORMATION ON 510(K) SUBMISSIONS
FORM FDA 3514 (1/13)
7
3
4
8
4
2
3
6
2
7
1
11
5
12
6
3
1 1
4
5
6
4
5
6
2
3
1
4
5
6
4
1
2
5
4
1
2
5
FRC
K140392 3M™ Attest™ Rapid Readout Biological Indicator 1295
3M Company
Biological indicator
3M™ Attest™ Rapid Readout Biological Indicator 1295
FRC 880.2800
General Hospital
Use the 3M™ Attest™ Rapid Readout Biological Indicator 1295 in conjunction with the 3M Attest™ Auto-reader 490H as a standard method of routine monitoring of vaporized hydrogen peroxide sterilization processes in STERRAD® 100S, STERRAD® NX (Standard and Advanced cycles) and 100NX (Standard, Flex, Express and Duo cycles) systems.
SECTION F
SECTION G
SECTION E
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Page 5 of 5 Pages
UTILIZATION OF STANDARDS
FORM FDA 3514 (1/13)
Standards Organization
Please include any additional standards to be cited on a separate page.
The burden time for this collection of information is estimated to average 0.5 hour per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
This section applies only to requirements of the Paperwork Reduction Act of 1995. *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF ADDRESS BELOW.*
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff 1350 Piccard Drive, Room 400 Rockville, MD 20850
An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number.
7
Note: Complete this section if your application or submission cites standards or includes a "Declaration of Conformity to a Recognized Standard" statement.
1
2
3
4
5
6
DateStandards No. Standards Title Version
Standards Organization
DateStandards No. Standards Title Version
Standards Organization
Standards Organization
DateStandards No. Standards Title Version
Standards Organization
DateStandards No. Standards Title Version
Standards Organization
DateStandards No. Standards Title Version
Standards Organization
DateStandards No. Standards Title Version
DateStandards No. Standards Title Version
SECTION I
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FORM FDA 3881 (1/14) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use510(k) Number (if known)
Device Name
Form Approved: OMB No. 0910-0120Expiration Date: January 31, 2017See PRA Statement below.
3M™ Attest™ Rapid Readout Biological Indicator 1295
Indications for Use (Describe)Use the 3M™ Attest™ Rapid Readout Biological Indicator 1295 in conjunction with the 3M Attest™ Auto-reader 490H as a standard method of routine monitoring of vaporized hydrogen peroxide sterilization processes in STERRAD® 100S, STERRAD® NX (Standard and Advanced cycles) and 100NX (Standard, Flex, Express and Duo cycles) systems.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C)
FOR FDA USE ONLYConcurrence of Center for Devices and Radiological Health (CDRH) (Signature)
PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human ServicesFood and Drug AdministrationOffice of Chief Information OfficerPaperwork Reduction Act (PRA) [email protected]
“An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number.”
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Premarket Notification (510(k)) Summary
Sponsor Information:
3M Health Care
3M Center, Bldg. 275-5W-06
St. Paul, MN 55144-1000
Contact Person: Matt S. Mortensen, Ph.D., RAC
Regulatory Affairs
Phone Number: (651) 737-2670
FAX Number: (651) 737-5320
Date of Summary: July 13, 2015
Device Name and Classification:
Common or Usual Name: Biological Indicator
Proprietary Name: 3M™ Attest™ Rapid Readout Biological Indicator 1295
Classification Name: Indicator, Biological Sterilization Process
Device Classification: Class II, 21 CFR 880.2800(a)
Product Code: FRC
Predicate Devices:
3M™ Attest™ Rapid Readout Biological Indicator 1295
Description of Device:
The 3M Attest™ Rapid Readout Biological Indicator 1295 is a self-contained biological
indicator specifically designed for rapid and reliable routine monitoring of STERRAD®
vaporized hydrogen peroxide sterilization processes when used in conjunction with the 3M
Attest™ Auto-reader 490H. The 1295 BI is a single-use device composed of a polycarbonate
sleeve containing a spore carrier and media ampoule, enclosed with a color-coded cap. A
chemical process indicator printed with stripes which change from blue to pink upon exposure to
vaporized hydrogen peroxide is located on the top of the cap. The 1295 BI utilizes the same
fundamental technology that exists in current 3M Attest™ Rapid Readout and Super Rapid
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Readout BIs. The detection of fluorescence upon incubation of the 1295 BI in the 490H Auto-
reader indicates a sterilization failure.
Nonclinical Comparison to the Predicate Device
This submission is addressing clearance for use in an additional sterilizer. The 3M™ Attest™
Rapid Readout Biological Indicator 1295 is the same design as the previously cleared device of
the same model number. There device has the same materials, performance specifications, and
fundamental scientific technology.
Summary of Clinical Testing
No clinical data was included in this premarket application submission.
Indications for Use
Use the 3M™ Attest™ Rapid Readout Biological Indicator 1295 in conjunction with the 3M
Attest™ Auto‑reader 490H as a standard method of routine monitoring of vaporized hydrogen
peroxide sterilization processes in STERRAD® 100S, STERRAD® NX (Standard and
Advanced cycles) and 100NX (Standard, Flex, Express and Duo cycles) systems.
Comparison to Predicate Device
Feature Submission Device: 3MTM
AttestTM 1295 Biological Indicator
Predicate Device (K140392):
3MTM AttestTM 1295 Biological
Indicator
Indications for use
Use the 3M™ Attest™ Rapid Readout
Biological Indicator 1295 in
conjunction with the 3M Attest™
Auto‑reader 490H as a standard method
of routine monitoring of vaporized
hydrogen peroxide sterilization
processes in STERRAD® 100S,
STERRAD® NX (Standard and
Advanced cycles) and 100NX
(Standard, Flex, Express and Duo
cycles) systems.
Use the 3M Attest™ Rapid
Readout Biological Indicator
1295 in conjunction with the 3M
Attest™ Auto‑reader 490H as a
standard method of routine
monitoring of vaporized hydrogen
peroxide sterilization processes in
STERRAD® NX and 100NX
systems.
Organism Geobacillus stearothermophilus
traceable to ATCC™ 7953 Same
Viable spore
population ≥1x106 Same
Resistance
Characteristics
D-value
(Tested at 10 mg/L vaporized hydrogen
peroxide)
D10 mg/L ≥ 1 second
Survival Time ≥ 5 seconds
Same
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Survival/Kill
Window
Kill Time = 7 minutes
Shelf-life Will be based on results of completed
testing at time of marketing. 18 months
Conclusion
The 3MTM AttestTM 1295 Biological Indicator is substantially equivalent to the predicate device
in terms of their intended use, physical properties and technological characteristics. The non-
clinical testing demonstrates that the 3MTM AttestTM 1295 Biological Indicator is as safe, as
effective, and performs as well as the predicate device.
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Confidential
3MTM AttestTM 1295
Biological Indicator
510(k)
Premarket Notification
Truthful and Accurate
Statement
6. Premarket Notification Truthful and Accurate Statement
Pursuant to 21 CFR §807.87(k), I certify that, in my capacity as the position
within 3M Infection Prevention Division noted below, 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.
7/13/2015
Matthew S. Mortensen PhD, RAC, (Date)
Regulatory Affairs
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Confidential
3MTM AttestTM 1295
Biological Indicator
510(k)
Premarket Notification Class
III Certification and Summary
7. Premarket Notification Class III Certification and Summary
This is a submission of a Class II device; therefore, the following statement is
not required but is intentionally left here for ease of submission packet review.
I certify that, in my capacity as (the position held in company) of (company name) that I have conducted a reasonable search of all information known or otherwise available about the types and causes of safety and/or effectiveness problems that have been reported for the (device name). I further certify that I am aware of the types of problems to which the (device name) is susceptible and that, to the best of my knowledge, the following summary of the types and causes of safety and/or effectiveness problems about the (device name) is complete and accurate. (Attach the summary of problem data, bibliography or other citations upon which the summary is based.)
___Not Applicable___________ (Signature of Certifier) ___ Not Applicable ____________ (Typed Name) ___ Not Applicable ___________ (Date) ____________________________ (Premarket Notification [510(k)] Number)
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Confidential
3MTM AttestTM 1295
Biological Indicator
510(k)
Financial Certification or
Disclosure Statement
8. Financial Certification or Disclosure Statement
This submission does not include information from clinical studies; therefore,
per 21 CFR 807.87(i) this section is not required. This page is included for
ease of submission packet review.
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Confidential
3MTM AttestTM 1295
Biological Indicator
510(k)
Standards Data Report for
510(k)s
9. Standards Data Report for 510(k)
This submission does not reference any national or international standards,
therefore the Standards Data Report Form (FORM FDA 3654) is not
required. This page is included for ease of submission packet review.
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Confidential
3MTM AttestTM 1295
Biological Indicator
510(k)
Executive Summary
10 Executive Summary
10.1 Overview of Design
The 3M Attest™ 1295 Rapid Readout Biological Indicator (1295 BI) is a self-
contained biological indicator that contains greater than 1x106 Geobacillus
stearothermophilus spores on a carrier within the device.
The 1295 BIs have a 4 hour fluorescence response with an optional 168 hour (7 day)
visual result and are intended for use in STERRAD® hydrogen peroxide sterilization
cycles (see Section 4, Indications for Use). The biological indicator resistance
characteristics are: D10mg/L-value greater than or equal to 1 second, a Survival time of
5 seconds and a Kill time of 7 minutes. There are no calculated survival or kill
times.
10.2 Overview of Performance testing
With the exception of performance in the 100S sterilizer, the 1295 BI performance
was described in the predicate submission K140392. As described in the cover letter
to this submission, we have divided test data herein into original results for 100S
(provided in Section 18) and reproduced results from K140392 (provided as
Appendices). This was done based on ODE reviewer feedback to maintain a better
administrative record within Agency systems. A summary of the performance
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Confidential
3MTM AttestTM 1295
Biological Indicator
510(k)
Executive Summary
characteristics of 1295 BI, along with location of supporting data, is provided in the
sections below.
10.3 Substantial Equivalence
Feature
Submission Device: 3MTM
AttestTM 1295 Biological
Indicator
Predicate Device
(K140392): 3MTM
AttestTM 1295 Biological
Indicator
Indications for
use
Use the 3M™ Attest™ Rapid
Readout Biological Indicator
1295 in conjunction with the
3M Attest™ Auto-reader 490H
as a standard method of routine
monitoring of vaporized
hydrogen peroxide sterilization
processes in STERRAD®
100S, STERRAD® NX
(Standard and Advanced cycles)
and 100NX (Standard, Flex,
Express and Duo cycles)
systems.
Use the 3M Attest™ Rapid
Readout Biological
Indicator
1295 in conjunction with
the 3M
Attest™ Auto-reader 490H
as a
standard method of routine
monitoring of vaporized
hydrogen
peroxide sterilization
processes in
STERRAD® NX and
100NX systems.
Organism Geobacillus stearothermophilus
traceable to ATCC™ 7953 Same
Viable spore
population ≥1x106 Same
Resistance
Characteristics
D-value
Survival/Kill
Window
(Tested at 10 mg/L vaporized
hydrogen peroxide)
D10 mg/L ≥ 1 second
Survival Time ≥ 5 seconds
Kill Time = 7 minutes
Same
Shelf-life
Will be based on results of
completed testing at time of
marketing.
18 months
Page 20
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Confidential
3MTM AttestTM 1295
Biological Indicator
510(k)
Device Description
bromocresol purple, and a fluorescent enzyme substrate 4-methylumbelliferyl-alpha-D-
glucoside.
11.2 Performance Characteristics
With the exception of performance in the 100S sterilizer, the 1295 BI performance was described
in the predicate submission K140392. As described in the cover letter to this submission, we
have divided test data herein into original results for 100S (provided in Section 18) and
reproduced results from K140392 (provided as Appendices). This was done based on ODE
reviewer feedback to maintain a better administrative record within Agency systems. A
summary of the performance characteristics of 1295 BI, along with location of supporting data,
is provided in the sections below.
1 Cycle independent therefore not testing using any of method 1-3
Page 23
(b)(4) Performance Characteristcs
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3MTM AttestTM 1295
Biological Indicator
510(k)
Device Description
Page 24
(b)(4) Performance Characteristcs
(b)(4) Performance Characteristcs(b)(4)
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3MTM AttestTM 1295
Biological Indicator
510(k)
Substantial Equivalence
Discussion
12 Substantial Equivalence Discussion
This submission is addressing an expansion in the indications for use (i.e. additional
sterilizer) over what was cleared in K140392. The 3M™ Attest™ Rapid Readout
Biological Indicator 1295 is the same design as the previously cleared device of the
same model number. There device has the same materials, performance
specifications, and fundamental scientific technology.
Feature
Submission Device: 3MTM
AttestTM 1295 Biological
Indicator
Predicate Device
(K140392): 3MTM
AttestTM 1295 Biological
Indicator
Indications for
use
Use the 3M™ Attest™ Rapid
Readout Biological Indicator
1295 in conjunction with the
3M Attest™ Auto‑reader 490H
as a standard method of routine
monitoring of vaporized
hydrogen peroxide sterilization
processes in STERRAD®
100S, STERRAD® NX
(Standard and Advanced cycles)
and 100NX (Standard, Flex,
Express and Duo cycles)
systems.
Use the 3M Attest™ Rapid
Readout Biological
Indicator
1295 in conjunction with
the 3M
Attest™ Auto‑reader 490H
as a
standard method of routine
monitoring of vaporized
hydrogen
peroxide sterilization
processes in
STERRAD® NX and
100NX systems.
Organism Geobacillus stearothermophilus
traceable to ATCC™ 7953 Same
Viable spore
population ≥1x106 Same
Resistance
Characteristics
D-value
Survival/Kill
Window
(Tested at 10 mg/L vaporized
hydrogen peroxide)
D10 mg/L ≥ 1 second
Survival Time ≥ 5 seconds
Kill Time = 7 minutes
Same
Shelf-life
Will be based on results of
completed testing at time of
marketing.
18 months
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3MTM AttestTM 1295
Biological Indicator
510(k)
Labeling
13. Labeling
A draft of the English language portion of the IFU, the primary label and certificate of analysis
are provided below.
13.1. IFU
Product Description
The 3M™ Attest™ Rapid Readout Biological Indicator 1295 (pink cap, referred to hereinafter as the 1295
BI) is a self-contained biological indicator specifically designed for rapid and reliable routine monitoring of
STERRAD® vaporized hydrogen peroxide sterilization processes when used in conjunction with the 3M™
Attest™ Auto-reader 490H (hereinafter referred to as the 490H Auto-reader). The 1295 BI is a single-use
device.
A schematic illustrating the design of the 1295 BI is provided in Figure 1. The
self-contained design includes a carrier with spores of Geobacillus
stearothermophilus and a media ampoule containing bacteriological growth
medium which meets the requirements for growth promoting ability specified in
ANSI/AAMI/ISO 11138-1:2006/(R)2010. The spore carrier and media ampoule
are contained in a plastic vial topped with a pink cap. A chemical process
indicator printed with stripes which change from blue to pink upon exposure to
vaporized hydrogen peroxide is located on the top of the cap.
The 1295 BI utilizes the α-glucosidase enzyme system, which is
generated naturally within growing cells of Geobacillus stearothermophilus. The α-glucosidase in its
active state is detected by measuring the fluorescence produced by the enzymatic hydrolysis of a non-
fluorescent substrate, 4-methylumbelliferyl-α-D-glucoside (MUG). The resultant fluorescent by-product,
4-methylumbelliferone (MU), is detected in the 490H Auto-reader. The presence of fluorescence within 4
hours of incubation of the 1295 BI in the 490H Auto-reader indicates a sterilization process failure.
The 1295 BI can also indicate the presence of G. stearothermophilus organisms by a visual pH color change
reaction. Biochemical activity of the G. stearothermophilus organism produces metabolic by-products that
cause the media to change color from purple to yellow which also indicates a sterilization process failure.
Use of this indication method is optional and is typically restricted to special studies.
Figure 1: Design of the 3M™ Attest™
Rapid Readout Biological Indicator 1295
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3MTM AttestTM 1295
Biological Indicator
510(k)
Labeling
Readout Time
The 4-hour rapid readout has been correlated with a 7-day visual pH color change result
following the FDA’s Reduced Incubation Time protocol.
4-hour Fluorescent Result
1295 BIs have a 4 hour reduced incubation time result that correlates to the 7
day (168 hours) visual readout result ≥ 97% of the time.
Due to the high reliability of the 4-hour fluorescent result there is no advantage to incubating 1295 BIs
beyond 4 hours.
1295 BIs meet ANSI/AAMI/ISO 11138-1:2006/(R)2010 and EN/ISO 11138-1:2006.
Indications for Use
Use the 3M™ Attest™ Rapid Readout Biological Indicator 1295 in conjunction with the
3M Attest™ Auto‑reader 490H as a standard method of routine monitoring of vaporized
hydrogen peroxide sterilization processes in STERRAD® 100S, STERRAD® NX
(Standard and Advanced cycles) and 100NX (Standard, Flex, Express and Duo cycles)
systems.
Contraindications
None.
Warnings
There is a glass ampoule inside the plastic vial of the biological indicator (BI). To avoid the risk of serious
injury from peroxide burns:
Wear safety glasses and gloves when removing the 1295 BI from the sterilizer.
Wear safety glasses and gloves when activating the 1295 BI.
Handle the 1295 BI by the cap when crushing or flicking.
Residual hydrogen peroxide may be trapped within the 1295 BI if the media ampoule is damaged during
the sterilization process. If a broken ampoule is observed after processing, avoid direct contact with the
Page 27
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3MTM AttestTM 1295
Biological Indicator
510(k)
Labeling
1295 BI as it may result in hydrogen peroxide burns. Follow the disposal instructions provided at the end
of this document.
Precautions
1. Do not use the 1295 BI to monitor sterilization cycles which it is not designed to challenge:
a. Steam sterilization cycles;
b. Dry heat sterilization cycles; or
c. Ethylene oxide sterilization processes.
2. To reduce the risk associated with incorrect results:
Before sterilization, inspect 1295 BI to verify media ampoule is intact and process indicator
stripes are blue. Do not use any 1295 BIs which have a broken media ampoule or process
indicator stripes which are not blue.
Do not place tape or labels on 1295 BI prior to sterilization or incubation in the 490H Auto-reader.
Activate and incubate the 1295 BI within 1 hour after the completion of the sterilization cycle.
Do not incubate a 1295 BI if, after processing and before BI activation, it is observed to have a
broken media ampoule. Retest the sterilizer with a new biological indicator.
After 1295 BI activation, ensure media has flowed to the spore growth chamber.
3. To ensure the product functions as intended throughout the labeled shelf life, store
1295 BIs in the resealable foil pouch until use.
4. The 1295 BI is not designed for use in STERRAD® test packs, including the
STERRAD® 100NX® System DUO Test Pack.
Monitoring Frequency
Follow facility Policies and Procedures which should specify a biological indicator monitoring
frequency compliant with professional association recommended practices and/or national
guidelines and standards. As a best practice and to provide optimal patient safety, 3M
recommends that every sterilization load be monitored with a biological indicator.
Directions for Use
1. Remove 1295 BI from sealed foil pouch, then reseal pouch if other 1295 BIs remain
in pouch. Do not place any labels or indicator tape on the vial or on the cap.
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3MTM AttestTM 1295
Biological Indicator
510(k)
Labeling
Whether the media ampoule is crushed using method a) or b),
immediately remove the BI and flick it (see picture at right). Visually
verify that media has flowed into the growth chamber at the bottom of
the vial. If the media hasn’t filled the growth chamber, hold the BI by
the cap and flick it until media fills the growth chamber. Place the activated 1295 BI in a
490H Auto-reader incubation well which is color-coded pink and wait for the result. See
the 490H Auto-reader Operator’s Manual for further information related to its use.
NOTE: Activate and incubate the 1295 BI within 1 hour of the completion of the
sterilization cycle.
9. Each day that a processed 1295 BI is incubated, activate and incubate at least one
non-processed 1295 BI to use as a positive control. Follow the activation instructions
provided in Step 8 above. Write a "C" (for "control") and the date on the BI label. The
positive control should be from the same lot code as the processed biological indicator.
The positive control BI helps confirm:
correct incubation temperatures are met,
viability of spores has not been altered due to improper storage temperature, humidity or
proximity to chemicals,
capability of media to promote rapid growth, and
proper functioning of the 490H Auto-reader.
10. Incubation and Reading:
Incubate the positive control and processed 1295 BIs at 60 ± 2°C in a 490H Auto-
reader. See the 490H Auto-reader Operator’s Manual for the proper use of this
equipment. Positive results are available within 4 hours. The 490H Auto-reader will
indicate a positive result as soon as it is obtained. The final negative 1295 BI reading is
made at 4 hours. After the results are displayed and recorded, the 1295 BIs may be
discarded.
Interpretation of Results
Fluorescent Result
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3MTM AttestTM 1295
Biological Indicator
510(k)
Labeling
The positive control (unprocessed) 1295 BI must provide a positive fluorescent result (+
symbol on the 490H Auto-reader LCD display). Processed 1295 BI results are not valid
until the positive control reads fluorescent positive. The positive control should read
positive at or before 4 hours. If the positive control reads negative (- symbol on the LCD
display) at 4 hours, check the 490H Auto-reader Operator’s Manual Troubleshooting
Guide. Retest the 490H Auto-reader with a new positive control.
With processed 1295 BIs, a final negative reading (- symbol on the LCD display) after 4
hours of incubation indicates an acceptable sterilization process. A positive (+ symbol
on the LCD display) result for a processed 1295 BI indicates a sterilization process
failure. Act immediately on any positive results for processed BIs. Determine the cause
of the positive BI following facility policies and procedures. Always retest the sterilizer
and do not use sterilizer for processing loads until it has been re-qualified according to
the manufacturer’s instructions.
Optional Visual pH Color Change Result
The 1295 BI is normally discarded after the fluorescent result has been recorded. If,
however, special studies are desired, 1295 BIs may be further incubated for a visual pH
color change result. In the case of the positive control BI, a yellow color change of the
growth media will appear within 24 hours. Any observation of a yellow color within the
vial indicates a positive result.
In the case of a processed 1295 BI, a media color change from purple to yellow
indicates a sterilization process failure. A negative pH color change result, i.e., media
remains purple, can be assessed at 7 days. To avoid media dry-out, it is recommended
that the 1295 BI be transferred to a humidified incubator operating at 60ºC after the
fluorescent result has been recorded.
Storage/ Shelf Life
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3MTM AttestTM 1295
Biological Indicator
510(k)
Labeling
Store 1295 BIs in the original resealable foil pouch under normal room conditions: 59-86ºF (15-
30ºC).
Do not store 1295 BIs near sterilants or other chemicals.
The product’s expiration date is indicated on the BI and packaging by an hourglass symbol
followed by the year and month of expiration (e.g., 2017-11).
All of the information to the right of the lot‑in‑a‑box symbol indicates the lot number (e.g.,
2017‑11AD).
Disposal
Dispose of used 1295 BIs according to your health care facility policy. Steam sterilize
any positive biological indicators at 132°C (270°F) for 4 minutes or at 275°F (135°C) for
3 minutes in a dynamic-air-removal steam sterilizer prior to disposal. For processed BIs
observed to have a broken media ampoule after the sterilization process, leave the BI in
the peel-open pouch and place the pouch in packaging compatible with steam
sterilization before steam processing.
Explanation of Symbols
Do not use if package is damaged or open
Caution, see instructions for use
Single Use Only
Use by date
Batch code
Manufacturer
Catalog number
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3MTM AttestTM 1295
Biological Indicator
510(k)
Labeling
Product is designed for use with vaporized hydrogen peroxide sterilization
processes.
Made in the U.S.A. of globally sourced materials by 3M Health Care 2510 Conway Ave. St. Paul, MN 55144 1-800-228-3957 www.3M.com 3M and Attest are trademarks of 3M. Used under license in Canada. STERRAD® is a trademark of Advanced Sterilization Products, Division of Ethicon Inc., a Johnson & Johnson company.
13.2. Primary Label
13.3. Certificate of analysis
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3MTM AttestTM 1295
Biological Indicator
510(k)
Labeling
13.4 Predicate Labeling
The predicate and submission device labeling are identical with the following exceptions:
1) the Indications for Use now match Form 3881 included in this submission, and 2) the
CoA country of origin statement has been changed to state “Made in USA of globally
sourced materials”. The predicate labeling is provided in Appendix H.
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3MTM AttestTM 1295
Biological Indicator
510(k)
Shelf Life
14 Shelf Life 14.1 Stability Plan
1.0 Purpose of Study:
New product design verification
To determine if the resistance characteristics of 3M™ Attest™ Rapid
Readout Biological Indicator 1295 for hydrogen peroxide are sufficiently
stable for the claimed period, when the product is transported and stored in
accordance with label directions.
2.0 Reference Documents:
2.1 Association for the Advancement of Medical Instrumentation;
Sterilization of health care products – Biological indicators – Part 1:
General Requirements (ANSI/AAMI/ISO 11138-1:2006)
2.2 The United States Pharmacopeia 34, General Notices; 10
Preservation, Packaging, Storage, and Labeling; 1150 Pharmaceutical
Stability, 2011 (USP 34)
2.3 The Center for Devices and Radiological Health, Guidance for
industry and staff: Biological Indicator (BI) Pre-market notification
510(k) Submission, 2007 (FDA guidance document for BIs)
3.0 Product to be Evaluated:
Table 1
Test Lot or
Control Lot Product Name Product ID#/ Lot/Batch#
Page 35
(b)(4)
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3MTM AttestTM 1295
Biological Indicator
510(k)
Shelf Life
6.0 Sampling Plan:
Page 36
(b)(4) Testing
(b)(4) Testing
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3MTM AttestTM 1295
Biological Indicator
510(k)
Shelf Life
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(b)(4) Testing
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3MTM AttestTM 1295
Biological Indicator
510(k)
Shelf Life
14.2 Stability Report
9.0 Deviations from Plan:
Page 38
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3MTM AttestTM 1295
Biological Indicator
510(k)
Shelf Life
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(b)(4) Testing
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3MTM AttestTM 1295
Biological Indicator
510(k)
Shelf Life
Page 40
(b)(4) Testing
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3MTM AttestTM 1295
Biological Indicator
510(k)
Shelf Life
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(b)(4) Testing
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3MTM AttestTM 1295
Biological Indicator
510(k)
Biocompatibility
15. Biocompatibility
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3MTM AttestTM 1295
Biological Indicator
510(k)
Software
16. Software Statement
The submission device does not include software. This page is included for
ease of submission packet review.
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3MTM AttestTM 1295
Biological Indicator
510(k)
Electrical Safety and EMC
17. Electrical Safety and EMC Statement
The submission device is not electromechanical in nature. This page is
included for ease of submission packet review.
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3MTM AttestTM 1295
Biological Indicator
510(k)
Bench Testing
18. Bench Testing
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3MTM AttestTM 1295
Biological Indicator
510(k)
Bench Testing
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(b)(4) Testing
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Biological Indicator
510(k)
Bench Testing
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(b)(4) Testing
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3MTM AttestTM 1295
Biological Indicator
510(k)
Bench Testing
ANSI/AAMI/ISO 11138-1:2006(R) 2010 (Annex B) for carrier and primary
packaging materials.
Reference Documents:
STERRAD® 100S® Sterilizer Operators Manual.
Test System:
STERRAD® 100S® Sterilizer, ASP, Irvine, CA, USA.
Test Samples:
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Biological Indicator
510(k)
Bench Testing
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3MTM AttestTM 1295
Biological Indicator
510(k)
Bench Testing
Reference Standards:
FDA Guidance Document: Guidance for Industry and Staff – Biological
Indicator (BI) Premarket Notification [510(k)] Submissions, October 4, 2007.
A Growth Recovery method was developed similar to the protocol outlined in
ANSI/AAMI/ISO 11138-1:2006(R) 2010 (Annex B) for carrier and primary
packaging materials.
Reference Documents:
STERRAD® 100S® Sterilizer Operators Manual.
Test System:
STERRAD® 100S® Sterilizer, ASP, Irvine, CA, USA.
Test Samples:
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Biological Indicator
510(k)
Bench Testing
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3MTM AttestTM 1295 Biological Indicator 510(k)
Appendix A
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Page 1 of 5
Technical Report
TECH-REPORT-
Version
Status: Release
Release Date: 7/6/2014 10:55:16 AM
NOTE: Paper Copies are Uncontrolled unless Stamped ‘Controlled Copy’ in Red
Location Name Description
3M MAPLEWOOD-3MUS-MN 3M HEADQUARTERS -01J9C020
3M MAPLEWOOD-3MUS-MN 3M HEADQUARTERS - 01J9C020: 3M CENTER, MAPLEWOOD, MN, US
SIGNERS:
Attachment J J-1Attachment J J-1
K140392 S002 3M Attest™ Rapid Readout Biological Indicator 1295 and Auto-reader 490H
Page 54
(b)(4) Testing
(
(b)(4)
(b)(4), (b)(6)
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Technical Report
TECH-REPORT-
Version:
Status: Release
Release Date: 7/6/2014 10:55:16 AM
NOTE: Paper Copies are Uncontrolled unless Stamped ‘Controlled Copy’ in Red
Attachment J J-3Attachment J J-3
K140392 S002 3M Attest™ Rapid Readout Biological Indicator 1295 and Auto-reader 490H
Page 56
(b)(4) Testing
(b)(4) (
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Technical Report
TECH-REPORT
Version:
Status: Release
Release Date: 7/6/2014 10:55:16 AM
NOTE: Paper Copies are Uncontrolled unless Stamped ‘Controlled Copy’ in Red
Attachment J J-4Attachment J J-4
K140392 S002 3M Attest™ Rapid Readout Biological Indicator 1295 and Auto-reader 490H
Page 57
(b)(4) (
(b)(4) Testing
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Technical Report
TECH-REPORT-
Version:
Status: Release
Release Date: 7/6/2014 10:55:16 AM
NOTE: Paper Copies are Uncontrolled unless Stamped ‘Controlled Copy’ in Red
10.0 AttachmentsNone
Attachment J J-5Attachment J J-5
K140392 S002 3M Attest™ Rapid Readout Biological Indicator 1295 and Auto-reader 490H
Page 58
(b)(4) Testing
(b)(4) (
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3MTM AttestTM 1295 Biological Indicator 510(k)
Appendix B
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Technical Report
TECH-REPORT
Version
Status: Release
Release Date: 7/6/2014 10:53:00 AM
NOTE: Paper Copies are Uncontrolled unless Stamped ‘Controlled Copy’ in Red
Location Name Description
3M MAPLEWOOD-3MUS-MN 3M HEADQUARTERS -01J9C020
3M MAPLEWOOD-3MUS-MN 3M HEADQUARTERS - 01J9C020: 3M CENTER, MAPLEWOOD, MN, US
SIGNERS:
Attachment K K-1Attachment K K-1
K140392 S002 3M Attest™ Rapid Readout Biological Indicator 1295 and Auto-reader 490H
Page 60
(b)(4) Testing
(b)(4), (b)(6)
(b)(4)(
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Technical Report
TECH-REPORT-
Version:
Status: Release
Release Date: 7/6/2014 10:53:00 AM
NOTE: Paper Copies are Uncontrolled unless Stamped ‘Controlled Copy’ in Red
Attachment K K-2Attachment K K-2
K140392 S002 3M Attest™ Rapid Readout Biological Indicator 1295 and Auto-reader 490H
Page 61
(b)(4) (
(b)(4) Testing
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Confidential
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Release Date: 7/6/2014 10:53:00 AM
NOTE: Paper Copies are Uncontrolled unless Stamped ‘Controlled Copy’ in Red
H l
Attachment K K-3Attachment K K-3
K140392 S002 3M Attest™ Rapid Readout Biological Indicator 1295 and Auto-reader 490H
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(b)(4) (
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Confidential
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NOTE: Paper Copies are Uncontrolled unless Stamped ‘Controlled Copy’ in Red
Attachment K K-4Attachment K K-4
K140392 S002 3M Attest™ Rapid Readout Biological Indicator 1295 and Auto-reader 490H
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(b)(4) (
Records processed under FOIA Request # 2016-2618; Released by CDRH on 09-21-2016
Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118
Records processed under FOIA Request # 2016-2618; Released by CDRH on 09-21-2016
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Confidential
3MTM AttestTM 1295 Biological Indicator 510(k)
Appendix C
Page 65
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Attachment G G-3
K140392 S002 3M Attest™ Rapid Readout Biological Indicator 1295 and Auto-reader 490H
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(b)(4) (
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Version:
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NOTE: Paper Copies are Uncontrolled unless Stamped ‘Controlled Copy’ in Red
Attachment G G-4
K140392 S002 3M Attest™ Rapid Readout Biological Indicator 1295 and Auto-reader 490H
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(b)(4) (
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Records processed under FOIA Request # 2016-2618; Released by CDRH on 09-21-2016
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(b)(4) Testing
Records processed under FOIA Request # 2016-2618; Released by CDRH on 09-21-2016
Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118
(b)(4) Testing
Records processed under FOIA Request # 2016-2618; Released by CDRH on 09-21-2016
Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118
(b)(4) Testing
Records processed under FOIA Request # 2016-2618; Released by CDRH on 09-21-2016
Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118
(b)(4) Testing
Records processed under FOIA Request # 2016-2618; Released by CDRH on 09-21-2016
Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118
(b)(4) Testing
Records processed under FOIA Request # 2016-2618; Released by CDRH on 09-21-2016
Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118
(b)(4) Testing
Records processed under FOIA Request # 2016-2618; Released by CDRH on 09-21-2016
Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118
(b)(4) Testing
Records processed under FOIA Request # 2016-2618; Released by CDRH on 09-21-2016
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Confidential
3MTM AttestTM 1295 Biological Indicator 510(k)
Appendix D
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Location Name Description
3M MAPLEWOOD-3MUS-MN 3M HEADQUARTERS -01J9C020
3M MAPLEWOOD-3MUS-MN 3M HEADQUARTERS - 01J9C020: 3M CENTER, MAPLEWOOD, MN, US
SIGNERS:
Traditional 510(k) Premarket Notification 3M Attest™ Rapid Readout Biological Indicator 1295 and Auto-reader 490H
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(b)(4) (
(b)(4), (b)(6)
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(b)(4) Testing
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(b)(4) Testing
Records processed under FOIA Request # 2016-2618; Released by CDRH on 09-21-2016
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(b)(4) Testing
Records processed under FOIA Request # 2016-2618; Released by CDRH on 09-21-2016
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(b)(4) Testing
Records processed under FOIA Request # 2016-2618; Released by CDRH on 09-21-2016
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Confidential
3MTM AttestTM 1295 Biological Indicator 510(k)
Appendix E
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Location Name Description
3M MAPLEWOOD-3MUS-MN 3M HEADQUARTERS -01J9C020
3M MAPLEWOOD-3MUS-MN 3M HEADQUARTERS - 01J9C020: 3M CENTER, MAPLEWOOD, MN, US
Traditional 510(k) Premarket Notification 3M Attest™ Rapid Readout Biological Indicator 1295 and Auto-reader 490H
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(b)(4) (
(b)(4), (b)(6)
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(b)(4) Testing
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(b)(4) Testing
Records processed under FOIA Request # 2016-2618; Released by CDRH on 09-21-2016
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(b)(4) Testing
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Confidential
3MTM AttestTM 1295 Biological Indicator 510(k)
Appendix F
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3M MAPLEWOOD-3MUS-MN 3M HEADQUARTERS -01J9C020
3M MAPLEWOOD-3MUS-MN 3M HEADQUARTERS - 01J9C020: 3M CENTER, MAPLEWOOD, MN, US
Traditional 510(k) Premarket Notification 3M Attest™ Rapid Readout Biological Indicator 1295 and Auto-reader 490H
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Confidential
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TECH-REPORT
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11.0 Attachments: None
Traditional 510(k) Premarket Notification 3M Attest™ Rapid Readout Biological Indicator 1295 and Auto-reader 490H
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Confidential
3MTM AttestTM 1295 Biological Indicator 510(k)
Appendix G
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Confidential
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Location Name Description
3M MAPLEWOOD-3MUS-MN 3M HEADQUARTERS -01J9C020
3M MAPLEWOOD-3MUS-MN 3M HEADQUARTERS - 01J9C020: 3M CENTER, MAPLEWOOD, MN, US
Traditional 510(k) Premarket Notification 3M Attest™ Rapid Readout Biological Indicator 1295 and Auto-reader 490H
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(b)(4) (
(b)(4), (b)(6)
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(b)(4) Testing
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(b)(4) Testing
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(b)(4) Testing
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Confidential
3MTM AttestTM 1295 Biological Indicator 510(k)
Appendix H
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13.1.1 Instructions for Use for Attest™ Rapid Readout Biological Indicator 1295
3M™ Attest™ Rapid Readout Biological Indicator 1295 for Vaporized Hydrogen Peroxide Sterilization
Product Description The 3M™ Attest™ Rapid Readout Biological Indicator 1295 for Vaporized Hydrogen Peroxide Sterilization (pink cap, referred to hereinafter as the 1295 BI) is a self-contained biological indicator specifically designed for rapid and reliable routine monitoring of STERRAD® vaporized hydrogen peroxide sterilization processes when used in conjunction with the 3M™ Attest™ Auto-reader 490H (hereinafter referred to as the 490H Auto-reader). The 1295 BI is a single-use device.
A schematic illustrating the design of the 1295 BI is provided in Figure 1. The self-contained design includes a carrier with spores of Geobacillus stearothermophilus and a media ampoule containing bacteriological growth medium which meets the requirements for growth promoting ability specified in ANSI/AAMI/ISO 11138-1:2006/(R)2010. The spore carrier and media ampoule are contained in a plastic vial topped with a pink cap. A chemical process indicator printed with stripes which change from blue to pink upon exposure to vaporized hydrogen peroxide is located on the top of the cap.
The 1295 BI utilizes the α-glucosidase enzyme system, which is
generated naturally within growing cells of Geobacillus
stearothermophilus. The α-glucosidase in its active state is
detected by measuring the fluorescence produced by the enzymatic hydrolysis of a non-
fluorescent substrate, 4-methylumbelliferyl-α-D-glucoside (MUG). The resultant fluorescent
by-product, 4-methylumbelliferone (MU), is detected in the 490H Auto-reader. The presence of fluorescence within 4 hours of incubation of the 1295 BI in the 490H Auto-reader indicates a sterilization process failure. The 1295 BI can also indicate the presence of G. stearothermophilus organisms by a visual pH color change reaction. Biochemical activity of the G. stearothermophilus organism produces metabolic by-products that cause the media to change color from purple to yellow
Figure 1: Design of the 3M™ Attest™ Rapid Readout Biological Indicator 1295 for Vaporized Hydrogen Peroxide Sterilization
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which also indicates a sterilization process failure. Use of this indication method is optional and is typically restricted to special studies. Readout Time The 4-hour rapid readout has been correlated with a 7-day visual pH color change result following the FDA’s Reduced Incubation Time protocol.
4-hour Fluorescent Result 1295 BIs have a 4 hour reduced incubation time result that correlates to the 7 day (168 hours) visual readout result ≥ 97% of the time.
Due to the high reliability of the 4-hour fluorescent result there is no advantage to incubating 1295 BIs beyond 4 hours. 1295 BIs meet ANSI/AAMI/ISO 11138-1:2006/(R)2010 and EN/ISO 11138-1:2006.
Indications for Use Use the 3M™ Attest™ Rapid Readout Biological Indicator 1295 for Vaporized Hydrogen Peroxide Sterilization in conjunction with the 3M™ Attest™ Auto‑reader 490H to conduct routine monitoring of STERRAD® vaporized hydrogen peroxide sterilization models, NX and 100NX. The 3M™ Attest™ Rapid Readout Biological Indicator 1295 for Vaporized Hydrogen Peroxide Sterilization provides a final result in 4 hours.
Contraindications
None. Warnings There is a glass ampoule inside the plastic vial of the biological indicator (BI). To avoid the risk of serious injury from peroxide burns:
Wear safety glasses and gloves when removing the BI from the sterilizer. Wear safety glasses and gloves when activating the BI. Handle the BI by the cap when crushing or flicking.
Residual hydrogen peroxide may be trapped within the 1295 BI if the media ampoule is damaged during the sterilization process. If a broken ampoule is observed after processing, avoid direct contact with the 1295 BI as it may result in hydrogen peroxide burns. Follow the disposal instructions provided at the end of this document.
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Precautions 1. Do not use the 1295 BI to monitor sterilization cycles which it is not designed to challenge:
a. Steam sterilization cycles; b. Dry heat sterilization cycles; or c. Ethylene oxide sterilization processes.
2. To reduce the risk associated with incorrect results:
Before sterilization, inspect 1295 BI to verify media ampoule is intact and process indicator stripes are blue. Do not use any 1295 BIs which have a broken media ampoule or process indicator stripes which are not blue.
Do not place tape or labels on 1295 BI prior to sterilization or incubation in the 490H Auto-reader.
Activate and incubate the 1295 BI within 1 hour after the completion of the sterilization cycle.
Do not incubate a 1295 BI if, after processing and before BI activation, it is observed to have a broken media ampoule. Retest the sterilizer with a new biological indicator.
After 1295 BI activation, ensure media has flowed to the spore growth chamber.
3. To ensure the product functions as intended throughout the labeled shelf life, store 1295 BIs in the resealable foil pouch until use.
Monitoring Frequency:
Follow facility Policies and Procedures which should specify a biological indicator monitoring frequency compliant with professional association recommended practices and/or national guidelines and standards. As a best practice and to provide optimal patient safety, 3M recommends that every sterilization load be monitored with a biological indicator.
Directions for Use 1. Remove 1295 BI from sealed foil pouch, then reseal pouch if other 1295 BIs remain in
pouch. Do not place any labels or indicator tape on the vial or on the cap. 2. Place the 1295 BI in a peel-open pouch indicated for use in vaporized hydrogen peroxide
sterilization processes. Do not place the 1295 BI in direct contact with a chemical indicator as residue could transfer to the biological indicator and affect the result.
3. Place the pouched BI in the most challenging area of the sterilizer. The sterilizer manufacturer should be consulted to identify the area of the chamber least favorable to sterilization.
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4. Process the load according to recommended practices. 5. After completion of the cycle, don gloves and remove the pouched BI from the sterilizer.
Inspect the 1295 BI to verify the media ampoule is intact. If it is, remove the BI from the peel-open pouch and proceed to Step 6. If the media ampoule is broken, leave the 1295 BI in the peel-open pouch and follow disposal instructions. Retest the sterilizer using a new 1295 BI.
6. Check the process indicator on the top of the cap of the 1295 BI. A color change of the stripes from blue to pink confirms that the 1295 BI has been exposed to the vaporized hydrogen peroxide sterilization process. This color change does not indicate that the process was sufficient to achieve sterility. If the process indicator is unchanged, check the sterilizer physical monitors.
7. Identify the 1295 BI by writing the load number, sterilizer, and processing date on the indicator label.
8. To activate the biological indicator, while wearing gloves, place the 1295 BI in a 490H Auto-reader incubation well which is color-coded pink. Press the cap of the BI down firmly to close the cap and crush the glass ampoule. Immediately remove the BI and flick it (see picture at right). Visually verify that media has flowed into the growth chamber at the bottom of the vial. If the media hasn’t filled the growth chamber, hold the BI by the cap and flick it until media fills the growth chamber. Return the activated 1295 BI to the incubation well and wait for the result. See the 490H Auto-reader Operator’s Manual for further information related to its use. NOTE: Activate and incubate the 1295 BI within 1 hour of the completion of the sterilization cycle.
9. Each day that a processed 1295 BI is incubated, activate and incubate at least one non-processed 1295 BI to use as a positive control. Follow the activation instructions provided in Step 8 above. Write a "C" (for "control") and the date on the BI label. The positive control should be from the same lot code as the processed biological indicator. The positive control BI helps confirm:
correct incubation temperatures are met, viability of spores has not been altered due to improper storage temperature,
humidity or proximity to chemicals, capability of media to promote rapid growth, and proper functioning of the 490H Auto-reader.
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10. Incubation and Reading: Incubate the positive control and processed 1295 BIs at 60 ± 2°C in a 490H Auto-reader. See the 490H Auto-reader Operator’s Manual for the proper use of this equipment. Positive results are available within 4 hours. The 490H Auto-reader will indicate a positive result as soon as it is obtained. The final negative 1295 BI reading is made at 4 hours. After the results are displayed and recorded, the 1295 BIs may be discarded.
Interpretation of Results: Fluorescent Result The positive control (unprocessed) 1295 BI must provide a positive fluorescent result (+ symbol on the 490H Auto-reader LCD display). Processed 1295 BI results are not valid until the positive control reads fluorescent positive. The positive control should read positive at or before 4 hours. If the positive control reads negative (- symbol on the LCD display) at 4 hours, check the 490H Auto-reader Operator’s Manual Troubleshooting Guide. Retest the 490H Auto-reader with a new positive control. With processed 1295 BIs, a final negative reading (- symbol on the LCD display) after 4 hours of incubation indicates an acceptable sterilization process. A positive (+ symbol on the LCD display) result for a processed 1295 BI indicates a sterilization process failure. Act immediately on any positive results for processed BIs. Determine the cause of the positive BI following facility policies and procedures. Always retest the sterilizer and do not use sterilizer for processing loads until it has been re-qualified according to the manufacturer’s instructions. Optional Visual pH Color Change Result The 1295 BI is normally discarded after the fluorescent result has been recorded. If, however, special studies are desired, 1295 BIs may be further incubated for a visual pH color change result. In the case of the positive control BI, a yellow color change of the growth media will appear within 24 hours. Any observation of a yellow color within the vial indicates a positive result. In the case of a processed 1295 BI, a media color change from purple to yellow indicates a sterilization process failure. A negative pH color change result, i.e., media remains purple, can be assessed at 7 days. To avoid media dry-out, it is recommended that the 1295 BI be transferred to a humidified incubator operating at 60ºC after the fluorescent result has been recorded.
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Storage/ Shelf Life Store 1295 BIs in the original resealable foil pouch under normal room conditions: 59-86ºF
(15-30ºC). Do not store 1295 BIs near sterilants or other chemicals. The product’s expiration date is indicated on the BI and packaging by an hourglass symbol
followed by the year and month of expiration (e.g., 2015-05). All of the information to the right of the lot‑in‑a‑box symbol indicates the lot number
(e.g., 2015‑05AD). Disposal Dispose of used 1295 BIs according to your health care facility policy. Steam sterilize any positive biological indicators at 132°C (270°F) for 4 minutes or at 135°C (275°F) for 3 minutes in a dynamic-air-removal steam sterilizer prior to disposal. For processed BIs observed to have a broken media ampoule after the sterilization process, leave the BI in the peel-open pouch and place the pouch in packaging compatible with steam sterilization before steam processing.
Explanation of Symbols
Batch code
Use by date
Catalog number
Do not use if package is damaged or open.
Do not reuse.
Caution, see instructions for use.
Manufacturer
Mark of conformity to European Directives. For France and other countries that recognize the mark for this device.
Authorized representative for the European Community.
Product is designed for use with vaporized hydrogen peroxide sterilization processes.
Made in the U.S.A. of globally sourced materials by
3M Health Care
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2510 Conway Ave. St. Paul, MN 55144 1-800-228-3957 www.3M.com 3M and Attest are trademarks of 3M. Used under license in Canada. STERRAD® is a trademark of Advanced Sterilization Products, Division of Ethicon Inc., a Johnson & Johnson company. © 2013, 3M. All rights reserved. Issue Date: 2013-12
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13.1.2 Label on Attest™ Rapid Readout Biological Indicator 1295 The label on the 1295 BI is shown below. Its dimensions are 1.9 inches wide by 0.7 inch tall. The label will identify the product, method of sterilization (hydrogen peroxide), the indicator organism, the lot number and the expiry date. For record keeping, the user can fill in the information regarding the load, sterilizer and date for the cycle the BI is run in.
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3M Health Care Business 3M Center
2510 Conway Ave., Bldg. 275-5W-06
St. Paul, MN 55144 U.S.A
October 20, 2015
Dr. Riley Myers
Scientific Reviewer
Food and Drug Administration
Center for Devices and Radiological Health
Office of Device Evaluation [510(K)]
Document Mail Center - WO66-G609
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
Re: K152060/S001 for the 3MTM AttestTM Rapid Readout Biological Indicator 1295
Dear Dr. Myers,
As requested in your letter dated September 17, 2015, please find enclosed 3M’s written
responses to your questions related to the 510(k) Premarket Notification for 3MTM AttestTM
Rapid Readout Biological Indicator 1295. This document is submitted as one paper copy
and an electronic copy that is an exact duplicate of the paper copy.
Please contact me at the number below if you should have any questions concerning this
submission.
Sincerely,
Matt S. Mortensen, PhD, RAC 3M Health Care Regulatory Affairs
3M Center, Bldg. 275-5W-06
Phone (651) 737-2670
Fax: (651) 736-0897
St. Paul, MN 55144-1000
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K152060/S001 Summary of Responses
K152060
3M Health Care
3M™ Attest™ Rapid Readout Biological Indicator 1295
(b)(4) Deficiencies
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Page 8 of 8 – K152060/S001
(b)(4) Deficiencies
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K152060/S001
Attachment 1 – Revised 510(k) Summary
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Premarket Notification (510(k)) Summary
Sponsor Information:
3M Health Care
3M Center, Bldg. 275-5W-06
St. Paul, MN 55144-1000
Contact Person: Matt S. Mortensen, Ph.D., RAC
Regulatory Affairs
Phone Number: (651) 737-2670
FAX Number: (651) 737-5320
Date of Summary: October 19, 2015
Device Name and Classification:
Common or Usual Name: Biological Indicator
Proprietary Name: 3M™ Attest™ Rapid Readout Biological Indicator 1295
Classification Name: Indicator, Biological Sterilization Process
Device Classification: Class II, 21 CFR 880.2800(a)
Product Code: FRC
Predicate Devices:
K140392 - 3M™ Attest™ Rapid Readout Biological Indicator 1295
Description of Device:
The 3M Attest™ Rapid Readout Biological Indicator 1295 is a self-contained biological
indicator specifically designed for rapid and reliable routine monitoring of STERRAD®
vaporized hydrogen peroxide sterilization processes when used in conjunction with the 3M
Attest™ Auto-reader 490H. The 1295 BI is a single-use device composed of a polycarbonate
sleeve containing a spore carrier and media ampoule, enclosed with a color-coded cap. A
chemical process indicator printed with stripes which change from blue to pink upon exposure to
vaporized hydrogen peroxide is located on the top of the cap. The 1295 BI utilizes the same
fundamental technology that exists in current 3M Attest™ Rapid Readout and Super Rapid
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Readout BIs. The detection of fluorescence upon incubation of the 1295 BI in the 490H Auto-
reader indicates a sterilization failure.
Nonclinical Comparison to the Predicate Device
This submission is addressing clearance for use in an additional sterilizer. The 3M™ Attest™
Rapid Readout Biological Indicator 1295 is the same design as the previously cleared device of
the same model number. There device has the same materials, performance specifications, and
fundamental scientific technology.
Summary of Clinical Testing
No clinical data was included in this premarket application submission.
Indications for Use
Use the 3M™ Attest™ Rapid Readout Biological Indicator 1295 in conjunction with the 3M
Attest™ Auto‑reader 490H as a standard method of routine monitoring of vaporized hydrogen
peroxide sterilization processes in STERRAD® 100S, STERRAD® NX (Standard and
Advanced cycles) and 100NX (Standard, Flex, Express and Duo cycles) systems.
Comparison to Predicate Device
Feature Submission Device: 3MTM
AttestTM 1295 Biological Indicator
Predicate Device (K140392):
3MTM AttestTM 1295 Biological
Indicator
Indications for use
Use the 3M™ Attest™ Rapid Readout
Biological Indicator 1295 in
conjunction with the 3M Attest™
Auto‑reader 490H as a standard method
of routine monitoring of vaporized
hydrogen peroxide sterilization
processes in STERRAD® 100S,
STERRAD® NX (Standard and
Advanced cycles) and 100NX
(Standard, Flex, Express and Duo
cycles) systems.
Use the 3M Attest™ Rapid
Readout Biological Indicator
1295 in conjunction with the 3M
Attest™ Auto‑reader 490H as a
standard method of routine
monitoring of vaporized hydrogen
peroxide sterilization processes in
STERRAD® NX and 100NX
systems.
Organism Geobacillus stearothermophilus
traceable to ATCC™ 7953 Same
Viable spore
population ≥1x106 Same
Resistance
characteristics
D-value
(Tested at 10 mg/L vaporized hydrogen
peroxide)
D10 mg/L ≥ 1 second
Survival Time ≥ 5 seconds
Same
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Survival/Kill
Window
Kill Time = 7 minutes
Carrier material Polyethylene terephthalate Same
Incubation
temperature 60 +/- 2 oC Same
Readout time 4 hour fluorescence result read on 3M
490H Auto-reader Same
Chemical
indicator
H2O2 sensitive ink; appears blue until
processed, then appears pink Same
Shelf-life 18 months Same
Conclusion
The 3MTM AttestTM 1295 Biological Indicator is substantially equivalent to the predicate device
in terms of their intended use, physical properties and technological characteristics. The non-
clinical testing demonstrates that the 3MTM AttestTM 1295 Biological Indicator is as safe, as
effective, and performs as well as the predicate device.
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K152060/S001
Attachment 2 – Testing (b)(4)
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Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118
Confidential Page 1 of 4
Technical Report
TECH-REPORT-
Version: ersion>>
Status: Release<<Status>>
Release Date: 10/21/2015 9:42:17 AM
NOTE: Paper Copies are Uncontrolled unless Stamped ‘Controlled Copy’ in Red
Location Name Description
3M MAPLEWOOD-3MUS-MN 3M
HEADQUARTERS - 01J9C020
3M MAPLEWOOD-3MUS-MN 3M HEADQUARTERS - 01J9C020:
3M CENTER, MAPLEWOOD, MN, US
(b)(4) Testing(b)
(b)(4), (b)(6)
(b)(4), (b)(6)
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Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118
(b)(4) Testing
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Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118
(b)(4) Testing
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Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118
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Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118
K152060/S001
Attachment 3 – Cap and Sleeve Toxicology Assessment
Records processed under FOIA Request # 2016-2618; Released by CDRH on 09-21-2016
Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118
(b)(4) Testing
Records processed under FOIA Request # 2016-2618; Released by CDRH on 09-21-2016
Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118
(b)(4) Testing
Records processed under FOIA Request # 2016-2618; Released by CDRH on 09-21-2016
Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118
(b)(4) Testing
Records processed under FOIA Request # 2016-2618; Released by CDRH on 09-21-2016
Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118
(b)(4) Testing
Records processed under FOIA Request # 2016-2618; Released by CDRH on 09-21-2016
Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118
3MTM AttestTM Biological Indicator 1295 Cap and Sleeve Toxicology Assessment Page 5 of 17
3M Confidential Page 5 of 17
4. Ikarashi, Y., T. Tsuchiya, and A. Nakamura, Cytotoxicity of medical materials sterilized
with vapour-phase hydrogen peroxide. Biomaterials, 1995. 16(3): p. 177-183.
5. IARC. IARC Monographs on the Evaluation of the Carcinogenic Risks to Humans -
Overall Evaluation of Carcinogenicity: An Updating of the IARC Monographs Volumes
1 to 42. 1987. (Supplement 7): pp. 47-55. Lyon, France:
http://monographs.iarc.fr/ENG/Monographs/suppl7/Suppl7.pdf. Date accessed 11-10-
2014.
6. USFDA. Inactive Ingredients Database for Approved Drug Products. 2008 May 29,
2009; Available from: http://www.accessdata.fda.gov/scripts/cder/iig/index.cfm.
7. HPDB. Household Products Database. Polypropylene CASRN 9003-07-0. 2010 June,
2010 [cited 2008 October 7]; Available from: http://hpd.nlm.nih.gov/.
(b)(4) Testing
Records processed under FOIA Request # 2016-2618; Released by CDRH on 09-21-2016
Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118
(b)(4) Testing
Records processed under FOIA Request # 2016-2618; Released by CDRH on 09-21-2016
Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118
(b)(4) Testing
Records processed under FOIA Request # 2016-2618; Released by CDRH on 09-21-2016
Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118
(b)(4) Testing
Records processed under FOIA Request # 2016-2618; Released by CDRH on 09-21-2016
Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118
3MTM AttestTM Biological Indicator 1295 Cap and Sleeve Toxicology Assessment Page 9 of 17
3M Confidential Page 9 of 17
1. Eurocolor. Colourants for Food Contact Plastics: Aspects of Product Safety. 2002 [cited
2006 August 25]; Available from: www.cefic.be/files/Publications/FDL_en.pdf.
2. Eurocolour, Safe Handling of Color Pigments (European Edition),
ETAD/BCMA/VdMI/EPSOM, Editor. 1995.
3. ChemIDplus. ChemID. Linear Quinacridone RN: 1047-16-1. 2006 [cited 2006
November 27]; Available from: http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?CHEM.
4. HSDB. Hazardous Substances Data Bank. Cinquasia Red. 2003 November 27, 2006];
Available from: http://toxnet.nlm.nih.gov.
5. CPMA Quinacridone Committee. High Production Volume (HPV) Challenge Program
Test Plan for C.I. Pigment Violet 19 (CAS NO.: 1047-16-l) AND C.I. Pigment Red 122
(CAS NO. 980-26-7) and Dihydro Quinacridone (CAS NO. 5862-38-4). Document No.
201-16303A. 2006 June 2006 [cited 2006 December 10]; Available from:
http://www.epa.gov/HPV/pubs/summaries/ci19122d/c16303tp.pdf.
6. ECHA. European Chemicals Agency. 5,12-dihydroquino[2,3-b]acridine-7,14-dione.
2012 [cited 2012 December 28];
http://apps.echa.europa.eu/registered/data/dossiers/DISS-9eb276f2-5d9b-3f37-e044-
00144f67d031/DISS-9eb276f2-5d9b-3f37-e044-00144f67d031 DISS-9eb276f2-5d9b-
3f37-e044-00144f67d031.html.
(b)(4) Testing
Records processed under FOIA Request # 2016-2618; Released by CDRH on 09-21-2016
Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118
(b)(4) Testing
Records processed under FOIA Request # 2016-2618; Released by CDRH on 09-21-2016
Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118
(b)(4) Testing
Records processed under FOIA Request # 2016-2618; Released by CDRH on 09-21-2016
Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118
(b)(4) Testing
Records processed under FOIA Request # 2016-2618; Released by CDRH on 09-21-2016
Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118
(b)(4) Testing
Records processed under FOIA Request # 2016-2618; Released by CDRH on 09-21-2016
Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118
(b)(4) Testing
Records processed under FOIA Request # 2016-2618; Released by CDRH on 09-21-2016
Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118
(b)(4) Testing
Records processed under FOIA Request # 2016-2618; Released by CDRH on 09-21-2016
Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118
(b)(4) Testing
Records processed under FOIA Request # 2016-2618; Released by CDRH on 09-21-2016
Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118
3MTM AttestTM Biological Indicator 1295 Cap and Sleeve Toxicology Assessment Page 17 of 17
3M Confidential Page 17 of 17
4. CIR, Final Report on the Safety Assessment of Polyethylene. International Journal of
Toxicology, 2007. 26(Suppl. 1):115-127. Available from:
http://online.personalcarecouncil.org/ctfa-static/online/lists/cir-pdfs/pr299.pdf
5. US FDA. Cumulative Estimated Daily Intake/Acceptable Daily Intake Database. . 2012
January 27, 2012 [cited 2013 January 5]; Available from:
http://www.accessdata.fda.gov/scripts/sda/sdNavigation.cfm?filter=&sortColumn=&sd=e
disrev&page=1.
(b)(4) Testing
Records processed under FOIA Request # 2016-2618; Released by CDRH on 09-21-2016
Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118
K152060/S001
Attachment 4 – Comparison of 1295 and CycleSure BI
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Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118
(b)(4) Testing
Records processed under FOIA Request # 2016-2618; Released by CDRH on 09-21-2016
Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118
(b)(4) Testing
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Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118
(b)(4) Third Party Manufacturing Information
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K152060/S001
Attachment 5 Testing
(b)(4) Testing
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(b)(4) Testing
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Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118
(b)(4) Testing
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(b)(4) Testing
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(b)(4) Testing
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Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118