Use the 3M™ Comply™ Hydrogen Peroxide Indicator Tape 1228 to secure packs and as an external pack process indicator to differentiate unprocessed items from items processed in the STERRAD® 100, 100S, NX® (Standard and Advanced cycles) and 100NX® (Standard, Flex, Express and Duo cycles) sterilization processes and AMSCO® V-PRO™ 1 (Lumen cycle), AMSCO® V-PRO™ 1 Plus (Lumen and Non Lumen cycles), and AMSCO® V-PRO™ maX Low Temperature Sterilization System (Lumen, Non Lumen, and Flexible cycles) sterilizers. The tape is suitable for use on non-woven disposable wraps and peel pouches. The chemical indicator stripes turn from blue to pink after exposure to vaporized hydrogen peroxide.

Device Description

The 3M™ Comply™ Hydrogen Peroxide Indicator Tape 1228 consists of a non-cellulosic plastic backing material with a pressure-sensitive adhesive on one side and chemical indicator stripes on the other side.

AI/ML Overview

The provided document is a 510(k) Premarket Notification for the 3M™ Comply™ Hydrogen Peroxide Indicator Tape 1228. This document details the device's equivalence to a predicate device and provides information on non-clinical testing performed.

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device, a chemical indicator tape, are primarily focused on its ability to change color reliably under specific sterilization conditions and the stability of that color change. The reported performance confirms that the device meets these criteria.

Acceptance Criteria & Performance Metric	Reported Device Performance
Color Change in Health Care Facility Cycle
- Detectable color change from blue to pink when exposed to sterilization cycles	Verified in:
- STERRAD® 100	- Samples from 3M Comply Hydrogen Peroxide Indicator Tape 1228 turned from blue to pink. Minimum time for "pass" color match found. (Demonstrated per K020589)
- STERRAD® 100S	- Samples from 3M Comply Hydrogen Peroxide Indicator Tape 1228 turned from blue to pink. Minimum time for "pass" color match found. (Demonstrated per K020589)
- STERRAD® NX (Standard and Advanced cycles)	- Samples from 3M Comply Hydrogen Peroxide Indicator Tape 1228 turned from blue to pink. Minimum time for "pass" color specification found. (Demonstrated per K150694)
- STERRAD® 100NX (Standard, Flex, Express and Duo cycles)	- Samples from 3M Comply Hydrogen Peroxide Indicator Tape 1228 turned from blue to pink. Minimum time for "pass" color specification found. (Demonstrated per K150694)
- AMSCO® V-PRO™ 1 (Lumen cycle)	- Samples from 3M Comply Hydrogen Peroxide Indicator Tape 1228 turned from blue to pink. Minimum time for "pass" color specification found.
- AMSCO® V-PRO™ 1 Plus (Lumen and Non Lumen cycles)	- Samples from 3M Comply Hydrogen Peroxide Indicator Tape 1228 turned from blue to pink. Minimum time for "pass" color specification found.
- AMSCO® V-PRO™ maX Low Temperature Sterilization System (Lumen, Non Lumen, and Flexible cycles)	- Samples from 3M Comply Hydrogen Peroxide Indicator Tape 1228 turned from blue to pink. Minimum time for "pass" color specification found. Samples from six different lots were verified to meet requirements in these cycles.
Minimum Exposure Parameters to Affect the Change of the Indicator
- Minimum time required for the color change to "pass"	- Minimum time required for all indicator tape samples to indicate a "pass" in relation to the color match/specification was found for all listed sterilizer cycles. Samples from six different lots were evaluated for AMSCO® V-PRO™ maX Low Temperature Sterilization System cycles.
End Point Color Stability
- Stability of the final color post-exposure	- Twelve (12) months (for STERRAD cycles, and for new V-PRO cycles). Samples from six different lots were verified to be stable to storage under typical office lighting conditions for at least twelve months post-exposure in a Hydrogen Peroxide Health Care Facility Cycle (for new V-PRO cycles).
Shelf life	- Eighteen (18) months

2. Sample Size Used for the Test Set and Data Provenance

For the new AMSCO® V-PRO™ maX Low Temperature Sterilization System cycles (Lumen, Non Lumen, and Flexible cycles), the testing involved samples from six different lots of the device. The data provenance is not explicitly stated as retrospective or prospective, but it describes laboratory testing of new product lots, which implies prospective non-clinical testing. The country of origin of the data is not specified but is presumably where 3M conducts its research and development or contract testing.

For the previously cleared STERRAD cycles, the document references previous submissions (K020589 and K150694), implying the data for those cycles originated from prior non-clinical testing associated with those submissions.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

The document does not mention human experts used to establish ground truth for color change. This is a chemical indicator, and its performance is determined by a quantifiable color change observed under specific conditions. The "ground truth" here is the chemical reaction itself and comparison to a predefined color specification for a "pass."

4. Adjudication Method for the Test Set

No adjudication method involving multiple human observers is mentioned, as the "ground truth" for the color change is based on a pre-defined color specification that the indicator must meet after exposure. The document states "in relation to the color match/specification," implying an objective chemical standard rather than subjective human interpretation needing adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC study was performed or mentioned. This is a non-clinical device (chemical indicator) and its effectiveness is not assessed through human reader performance or diagnostic accuracy.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This is not applicable as the device is a chemical indicator, not an algorithm. Its performance is inherent in its chemical reaction.

7. Type of Ground Truth Used

The ground truth used for this chemical indicator is an objective color specification or standard that the tape's chemical indicator stripes must meet after exposure to a specific sterilization cycle. For instance, the tape needs to turn from blue to pink, and the pink must fall within a defined color range to indicate a "pass." The document mentions "color match" and "color specification."

8. Sample Size for the Training Set

This concept is not applicable here as this is a non-clinical chemical indicator device, not an AI/ML algorithm. There is no "training set."

9. How the Ground Truth for the Training Set Was Established

This is not applicable for the same reason as above.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

July 27, 2017

3M Company Nadia Battah Regulatory Affairs Associate 3m Center, Building 275-5w-06 St. Paul, Minnesota 55144

Re: K170563

Trade/Device Name: 3M Comply Hydrogen Peroxide Indicator Tape Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: Class II Product Code: JOJ Dated: July 10, 2017 Received: July 10, 2017

Dear Nadia Battah:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR

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Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely.

Tara A. Ryan -S

for Lori Wiggins, MPT,CLT Acting Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K170563

Device Name

3MTM ComplyTM Hydrogen Peroxide Indicator Tape 1228

Indications for Use (Describe)

Use the 3M™ Comply™ Hydrogen Peroxide Indicator Tape 1228 to secure packs and as an external pack process indicator to differentiate unprocessed items from items processed in the STERRAD® 100, 100S, NX® (Standard and Advanced cycles) and 100NX® (Standard, Flex, Express and Duo cycles) sterilization processes and AMSCO® V-PRO™ 1 (Lumen cycle), AMSCO® V-PRO™ 1 Plus (Lumen and Non Lumen cycles), and AMSCO® V-PRO™ max Low Temperature Sterilization System (Lumen, Non Lumen, and Flexible cycles) sterilizers. The tape is suitable for use on non-woven disposable wraps and peel pouches. The chemical indicator stripes turn from blue to pink after exposure to vaporized hydrogen peroxide.

Type of Use (Select one or both, as applicable)
-------------------------------------------------	--

Prescription Use (Part 21 CFR 801 Subpart D)

|X | Over-The-Counter Use (21 CFR 801 Subpart C)

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Premarket Notification [510(k)] Summary K170563

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Sponsor Information:

3M Health Care 3M Center, Bldg. 275-5W-06 St. Paul, MN 55144-1000

Contact Person: Nadia Battah Regulatory Affairs Phone Number: (651) 733-0929 FAX Number: (651) 737-5320

Date of Summary: July 26, 2017

Device Name and Classification:

Common or Usual Name:	Chemical Indicator
Proprietary Name:	3M™ Comply™ Hydrogen Peroxide Indicator Tape 1228
Classification Name:	Indicator, physical/chemical sterilization process (21 CFR §880.2800)
Device Classification:	Class II
Product Code:	JOJ

Predicate Device:

3MTM Comply™ Hydrogen Peroxide Indicator Tape 1228 (K150694) .

Description of Device:

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Nonclinical Comparison to the Predicate Device

The 3M™ Comply™ Hydrogen Peroxide Indicator Tape 1228 is the same design as the previously cleared device of the same model number (the predicate) which is sold under the tradename 3M™ Comply™ Hydrogen Peroxide Indicator Tape 1228 (K150694). There has been no change to the device's materials, performance specifications, or fundamental scientific technology. The intent of this submission is to expand the indications for use to include use in the AMSCO® V-PRO™ 1 (Lumen cycle), AMSCO® V-PRO™ 1 Plus (Lumen and Non Lumen cycles), and AMSCO® V-PRO™ maX Low Temperature Sterilization System (Lumen, Non Lumen, and Flexible cycles) sterilizers.

Summary of Clinical Testing

No clinical data was included in this premarket application submission.

Indications for Use

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Comparison to Predicate Device

Feature	Submission Device:3MTM Comply™ Hydrogen PeroxideIndicator 1228	Predicate Device (K150694):3M™ Comply™ Hydrogen PeroxideIndicator Tape 1228
Indications for use	Use the 3MTM Comply™ Hydrogen PeroxideIndicator Tape 1228 to secure packs and as anexternal pack process indicator to differentiateunprocessed items from items processed in theSTERRAD® 100, 100S, NX® (Standard andAdvanced cycles) and 100NX® (Standard, Flex,Express and Duo cycles) sterilization processesand AMSCO® V-PROTM 1 (Lumen cycle),AMSCO® V-PROTM 1 Plus (Lumen and NonLumen cycles), and AMSCO® V-PROT™ maXLow Temperature Sterilization System (Lumen,Non Lumen, and Flexible cycles) sterilizers. Thetape is suitable for use on non-woven disposablewraps and peel pouches. The chemical indicatorstripes turn from blue to pink after exposure tovaporized hydrogen peroxide.	Use the 3MTM Comply™ HydrogenPeroxide Indicator Tape 1228 to securepacks and as an external pack processindicator to differentiate unprocessed itemsfrom items processed in the STERRAD®100, 100S, NX® (Standard and Advancedcycles) and 100NX® (Standard, Flex,Express and Duo cycles) sterilizationprocesses. The tape is suitable for use onnon-woven disposable wraps and peelpouches. The chemical indicator from blueto pink after exposure to vaporizedhydrogen peroxide.
Sterilizers	STERRAD® 100STERRAD® 100SSTERRAD® NX (Standard and Advancedcycles)STERRAD® 100NX (Standard, Flex, Express,and Duo cycles)AMSCO® V-PROTM 1 (Lumen cycle)AMSCO® V-PROTM 1 Plus (Lumen and NonLumen cycles)AMSCO® V-PROTM maX Low TemperatureSterilization System (Lumen, Non Lumen andFlexible cycles)	STERRAD® 100STERRAD® 100SSTERRAD® NX (Standard and Advancedcycles)STERRAD® 100NX (Standard, Flex,Express, and Duo cycles)
Indicator Agent	Alkali blue 6B dye	Identical
Cycle Conditionsfor Color Change inSTERRAD® 100	Testing verified that the 3MTM Complyтм Hydrogen Peroxide Indicator Tape 1228 samplesturned from blue to pink when exposed to the STERRAD® 100 Sterilization cycle and theminimum time required for all indicator tape samples to indicate a "pass" in relation to the colormatch was found.Demonstrated per submission K020589.
Cycle Conditionsfor Color Change inSTERRAD® 100S	Testing verified that the 3MTM Complyтм Hydrogen Peroxide Indicator Tape 1228 samplesturned from blue to pink when exposed to the STERRAD® 100S Sterilization cycle and theminimum time required for all indicator tape samples to indicate a "pass" in relation to the colormatch was found.Demonstrated per submission K020589.
Cycle Conditionsfor Color Change inSTERRAD® NX(Standard andAdvanced cycles)	Testing verified that the 3MTM Complyтм Hydrogen Peroxide Indicator Tape 1228 samplesturned from blue to pink and the minimum time required for all indicator tape samples toindicate a "pass" in relation to the color specification was found when exposed to the followingSTERRAD® NX® Sterilization Cycles:StandardAdvancedDemonstrated per submission K150694.
Cycle Conditionsfor Color Change inSTERRAD®100NX (Standard,Flex Express andDuo cycles)	Testing verified that the 3M™ Complyт™ Hydrogen Peroxide Indicator Tape 1228 samplesturned from blue to pink and the minimum time required for all indicator tape samples toindicate a "pass" in relation to the color specification was found when exposed to the followingSTERRAD® 100NX® Sterilization Cycles:Standard
ExpressDuoDemonstrated per submission K150694.
Cycle Conditionsfor Color Change inAMSCO® V-PRO™ 1 (Lumencycle), AMSCO®V-PRO™ 1 Plus(Lumen and NonLumen cycles), andAMSCO® V-PRO™ maX LowTemperatureSterilization System(Lumen, NonLumen, andFlexible cycles)sterilizers	Testing verified that the 3M™ Comply™Hydrogen Peroxide Indicator Tape 1228 turnedfrom blue to pink and the minimum timerequired for all indicator tape samples to indicatea “pass” in relation to the color specification wasfound when exposed to the following AMSCO®V-PRO™ maX Low Temperature SterilizationSystem Cycles:LumenNon LumenFlexible
Stability of theendpoint reaction	Twelve (12) months	Identical
Shelf life	Eighteen (18) months	Identical

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Biocompatibility

The components of the indicator ink used on the 3M™ Comply™ Hydrogen Peroxide Indicator Tape 1228 are all of low general toxicity. The exposure to the health care professional is minimal and well below any identified toxic thresholds for the compounds. There is no anticipated direct exposure to medical instruments with the ink, nor the patient.

Summary of Non-Clinical Testing

The non-clinical testing of the 3MIM ComplyTM Hydrogen Peroxide Indicator Tape 1228 is demonstrated by the following tests:

Color Change in Health Care Facility Cycle Samples from six different lots were verified to meet the requirements for detectable color change in the AMSCO® V-PRO™ maX Low Temperature Sterilization System (Lumen, Non Lumen and Flexible cycles) sterilizer.
Minimum Exposure Parameters to Affect the Change of the Indicator in Health Care Facility Cycle - Samples from six different lots were evaluated to determine the minimum time required for the color change of the indicator when used in the AMSCO® V-PRO™ maX Low Temperature Sterilization System (Lumen, Non Lumen and Flexible cycles).
End Point Color Stability Samples from six different lots were verified to be stable to storage under typical office lighting conditions for at least twelve months post-exposure in a Hydrogen Peroxide Health Care Facility Cycle.

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Conclusion

The 3M™ Comply™ Hydrogen Peroxide Indicator Tape 1228 is substantially equivalent to the predicate device.

Regulation Number and Section

§ 880.2800 Sterilization process indicator.

(a)
Biological sterilization process indicator —(1)Identification. A biological sterilization process indicator is a device intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor adequacy of sterilization. The device consists of a known number of microorganisms, of known resistance to the mode of sterilization, in or on a carrier and enclosed in a protective package. Subsequent growth or failure of the microorganisms to grow under suitable conditions indicates the adequacy of sterilization.(2)
Classification. Class II (performance standards).(b)
Physical/chemical sterilization process indicator —(1)Identification. A physical/chemical sterilization process indicator is a device intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor one or more parameters of the sterilization process. The adequacy of the sterilization conditions as measured by these parameters is indicated by a visible change in the device.(2)
Classification. Class II (performance standards).