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, STERRAD® 100S, STERRAD® NX (Standard and Advanced cycles), STERRAD® 100NX (Standard, Flex, Express and Duo cycles), STERRAD® NX with ALLClear™ Technology (Standard and Advanced cycles), STERRAD® 100NX with ALLClear™ Technology (Standard, Flex, Express and Duo cycles), AMSCO® V-PRO® 1 (Lumen cycle), AMSCO® V-PRO® 1 Plus (Lumen and Non Lumen cycles), AMSCO® V-PRO® maX, Low Temperature Sterilization System (Lumen, and Flexible cycles), AMSCO® V-PRO® 60 Low Temperature Sterilization System (Lumen, Non Lumen and Flexible cycles), and AMSCO® V-PRO™ maX 2 Low Temperature Sterilization System (Lumen and Flexible, and Fast Non Lumen cycles) sterilizers. The tape is suitable for use on non-woven disposable wraps and peel pouches. The chemical indicator stripes turn from blue toward pink after exposure to vaporized hydrogen peroxide.

Device Description

The 3M™ Comply™ Hydrogen Peroxide Indicator Tape 1228 consists of a noncellulosic plastic backing material with a pressure-sensitive adhesive on one side and chemical indicator stripes on the other side. The chemical indicator stripes turn from blue toward pink after exposure to vaporized hydrogen peroxide.

AI/ML Overview

The device is the 3M™ Comply™ Hydrogen Peroxide Indicator Tape 1228, a chemical indicator used to determine if items have been processed in specific hydrogen peroxide sterilization systems.

Here's a breakdown of the requested information:

1. A table of acceptance criteria and the reported device performance

Test	Purpose	Acceptance Criteria	Reported Device Performance
Color Change in Health Care Facility Cycle	To demonstrate the color change of the device when used in the AMSCO® V-PRO™ maX 2 Low Temperature Sterilization System	Color change from blue toward pink	Pass
Minimum Exposure Parameters	To determine the minimum time required for the color change of the device when used in the AMSCO® V-PRO™ maX 2 Low Temperature Sterilization System	Determination of the minimum time for color to change from blue toward pink	Pass
End Point Color Stability	To demonstrate the post-sterilization color stability of the device after use in the AMSCO® V-PRO™ maX 2 Low Temperature Sterilization System	No significant color change after exposure to fluorescent light for a minimum of twelve (12) months.	Pass

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not explicitly state the specific sample sizes for each test in Table 6.1. It describes the "Purpose" as demonstrating performance in specific sterilizers and cycles. The provenance of the data is not specified (e.g., country of origin, retrospective or prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This product is a chemical indicator, not an AI/medical imaging device. Therefore, the concept of "experts" establishing ground truth in the context of human interpretation of data (like radiologists for imaging) is not directly applicable. The "ground truth" for chemical indicators is determined by their physical and chemical response to specific sterilization conditions. The testing would be performed by qualified laboratory personnel following established protocols.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable for a chemical indicator. Adjudication methods are typically relevant for subjective interpretations, often in medical image analysis. The performance of a chemical indicator is based on observable color changes under controlled conditions.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is not an AI-assisted device or an imaging product that would involve human readers.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. This is a physical chemical indicator, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The ground truth for chemical indicators is the physical/chemical response of the indicator to controlled sterilization parameters (e.g., exposure to a specified concentration of hydrogen peroxide for a given time and temperature, resulting in a color change). The sterilization process itself, as defined by the sterilizer's validated cycles, serves as the "gold standard" or ground truth for whether sterilization conditions were met. The indicator is designed to react to these conditions.

8. The sample size for the training set

Not applicable. This product is a physical chemical indicator and does not involve AI or machine learning models that require a training set.

9. How the ground truth for the training set was established

Not applicable, as no training set is used for this type of device.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

October 28, 2019

3M Company Mary Fretland Senior Regulatory Affairs Associate 3M Center, Building 275-5W-06 St. Paul, Minnesota 55144

Re: K192673

Trade/Device Name: 3MTM ComplyTM Hydrogen Peroxide Indicator Tape 1228 Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: Class II Product Code: JOJ Dated: September 25, 2019 Received: September 30, 2019

Dear Mary Fretland:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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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 Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

For Elizabeth Claverie, M.S. Assistant Director for THT4B2 Acting Assistant Director for THT4B1 DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K192673

Device Name

3M™ ComplyTM Hydrogen Peroxide Indicator Tape 1228

Indications for Use (Describe)

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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510(k) Summary for 3M™ Comply™ Hydrogen Peroxide Indicator Tape 1228

K192673

Sponsor Information:

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

Contact: Mary Fretland Senior Regulatory Affairs Associate Phone Number: (651) 737-2296 Fax Number: (651) 737-5320

Date of Summary: October 26, 2019

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PREMARKET NOTIFICATION [510(k)] 3MTM ComplyTM Hydrogen Peroxide Indicator Tape 1228

1. Device Name and Classification:

Common or Usual Name:	Chemical Indicator
Proprietary Name:	3M TM Comply TM Hydrogen Peroxide Chemical Indicator1228
Classification Name:	Indicator, physical/chemical sterilization process
Device Classification:	Class II, 21 CFR § 880.2800
Product Code:	JOJ

2. Predicate Device:

K183209 3M™ Comply™ Hydrogen Peroxide Indicator Tape 1228

3. Description of Device:

4. Indications for Use

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, STERRAD® 100S, STERRAD® NX (Standard and Advanced cycles), STERRAD® 100NX (Standard, Flex, Express and Duo cycles), STERRAD® NX with ALLClear™ Technology (Standard and Advanced cycles), STERRAD® 100NX with ALLClear™ Technology (Standard, Flex, Express and Duo cycles), AMSCO® V-PRO® 1 (Lumen cycle), AMSCO® V-PRO® 1 Plus (Lumen and Non-Lumen cycles), AMSCO® V-PRO® maX, Low Temperature Sterilization System (Lumen, Non-Lumen, and Flexible cycles), AMSCO® V-PRO® 60 Low Temperature Sterilization System (Lumen, Non-Lumen and Flexible cycles), and AMSCO® V-PRO™ maX 2 Low Temperature Sterilization System (Lumen, Non-Lumen, Flexible, and Fast Non-Lumen cycles) sterilizers. The tape is suitable for use on non-woven disposable wraps and peel pouches. The chemical indicator stripes turn from blue toward pink after exposure to vaporized hydrogen peroxide.

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	Submission Device (K192673):	Predicate Device (K183209):
Feature	3M™ Comply™ Hydrogen PeroxideIndicator Tape 1228	3M™ Comply™ Hydrogen PeroxideIndicator Tape 1228
Indications for use	Use the 3M™ Comply™ HydrogenPeroxide Indicator Tape 1228 to securepacks and as an external pack processindicator to differentiate unprocessed itemsfrom items processed in the STERRAD®100, STERRAD® 100S, STERRAD® NX(Standard and Advanced cycles),STERRAD® 100NX (Standard, Flex,Express and Duo cycles), STERRAD® NXwith ALLClear™ Technology (Standardand Advanced cycles), STERRAD®100NX with ALLClear™ Technology(Standard, Flex, Express and Duo cycles),AMSCO® V-PRO® 1 (Lumen cycle),AMSCO® V-PRO® 1 Plus (Lumen andNon-Lumen cycles), AMSCO® V-PRO®maX, Low Temperature SterilizationSystem (Lumen, Non-Lumen, and Flexiblecycles), AMSCO® V-PRO® 60 LowTemperature Sterilization System (Lumen,Non-Lumen and Flexible cycles), andAMSCO® V-PRO™ maX 2 LowTemperature Sterilization System (Lumen,Non-Lumen, Flexible, and Fast Non-Lumencycles) sterilizers. The tape is suitable foruse on non-woven disposable wraps andpeel pouches. The chemical indicator stripesturn from blue toward pink after exposure tovaporized hydrogen peroxide.	Use the 3M™ Comply™ HydrogenPeroxide Indicator Tape 1228 to securepacks and as an external pack processindicator to differentiate unprocessed itemsfrom items processed in the STERRAD®100, STERRAD® 100S, STERRAD® NX(Standard and Advanced cycles),STERRAD® 100NX (Standard, Flex,Express and Duo cycles), STERRAD® NXwith ALLClear™ Technology (Standard andAdvanced cycles), STERRAD® 100NXwith ALLClear™ Technology (Standard,Flex, Express and Duo cycles), AMSCO®V-PRO® 1 (Lumen cycle), AMSCO® V-PRO® 1 Plus (Lumen and Non-Lumencycles), AMSCO® V-PRO® maX LowTemperature Sterilization System (Lumen,Non-Lumen, and Flexible cycles), andAMSCO® V-PRO® 60 Low TemperatureSterilization System (Lumen, Non-Lumenand Flexible cycles) sterilizers. The tape issuitable for use on non-woven disposablewraps and peel pouches. The chemicalindicator stripes turn from blue toward pinkafter exposure to vaporized hydrogenperoxide.
Sterilizers andSterilizationCycles	STERRAD® 100STERRAD® 100SSTERRAD® NX (Standard and Advancedcycles)STERRAD® NX with ALLClear™Technology (Standard and Advancedcycles)STERRAD® 100NX (Standard, Flex,Express, and Duo cycles)STERRAD® 100NX with ALLClear™Technology (Standard, Flex, Express, andDuo cycles)AMSCO® V-PRO™ 1 (Lumen cycle)AMSCO® V-PRO™ 1 Plus (Lumen andNon-Lumen cycles)AMSCO® V-PRO™ maX LowTemperature Sterilization System (Lumen,Non-Lumen and Flexible cycles)	STERRAD® 100STERRAD® 100SSTERRAD® NX (Standard and Advancedcycles)STERRAD® NX with ALLClear™Technology (Standard and Advanced cycles)STERRAD® 100NX (Standard, Flex,Express, and Duo cycles)STERRAD® 100NX with ALLClear™Technology (Standard, Flex, Express, andDuo cycles)AMSCO® V-PRO™ 1 (Lumen cycle)AMSCO® V-PRO™ 1 Plus (Lumen andNon-Lumen cycles)AMSCO® V-PRO™ maX Low TemperatureSterilization System (Lumen, Non-Lumenand Flexible cycles)
Feature	Submission Device (K192673):3M™ Comply™ Hydrogen PeroxideIndicator Tape 1228	Predicate Device (K183209):3M™ Comply™ Hydrogen PeroxideIndicator Tape 1228
	AMSCO® V-PRO™ 60 (Lumen, Non-Lumen and Flexible cycles)AMSCO® V-PRO™ maX 2 LowTemperature Sterilization System (Lumen,Non-Lumen, Flexible, and Fast Non-Lumencycles)
Substrate	Non-cellulosic plastic	Identical
Biocompatibility	The exposure to health care professionals isminimal and well below any identified toxicthresholds for the compounds.	Identical
Color Change	Blue toward pink	Identical
Detection	Hydrogen Peroxide	Identical
Stability of theendpoint reaction	Twelve (12) months	Identical
Shelf life	Eighteen (18) months	Identical

5. Technological Characteristic Comparison Table

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PREMARKET NOTIFICATION [510(k)] 3M™ ComplyTM Hydrogen Peroxide Indicator Tape 1228

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 (K183209). No changes have been made to the device materials or fundamental technology.

6. Summary of Non-clinical Testing

To demonstrate performance in the newly claimed sterilizer and cycles, nonclinical testing was performed in accordance with the FDA Guidance for Industry and Staff: Premarket Notification [510(k)] Submissions for Chemical Indicators, issued December 19, 2003. Reference Table 6.1 for testing completed in the AMSCO® V-PRO™ maX 2 Low Temperature Sterilization System (Lumen, Non-Lumen, Flexible, and Fast Non-Lumen cycles).

Test	Purpose	Acceptance Criteria	Result
Color Change inHealth CareFacility Cycle	To demonstrate the color change ofthe device when used in theAMSCO® V-PRO™ maX 2 LowTemperature Sterilization System	Color change from blue towardpink	Pass
MinimumExposureParameters	To determine the minimum timerequired for the color change of thedevice when used in the AMSCO®V-PRO™ maX 2 Low TemperatureSterilization System	Determination of the minimumtime for color to change fromblue toward pink	Pass
End Point ColorStability	To demonstrate the post-sterilization color stability of thedevice after use in the AMSCO® V-PRO™ maX 2 Low TemperatureSterilization System	No significant color changeafter exposure to fluorescentlight for a minimum of twelve(12) months.	Pass

Table 6.1 Summary of Nonclinical Testing

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7. Conclusion

Based on the non-clinical performance data, the 3MTM Comply™ Hydrogen Peroxide Indicator Tape 1228 is as safe, as effective, and performs as well as or better than the legally marketed predicate, 3M™ Comply™ Hydrogen Peroxide Indicator Tape 1228 cleared under K183209, Class II (21 CFR 880.2800), product code JOJ.

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).