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 following sterilizers:

STERRAD 100® Sterilization System
STERRAD 100S® Sterilization System
STERRAD NX® Sterilization System (Standard and Advanced cycles)
STERRAD 100NX® Sterilization System (Standard, Flex, Express and Duo cycles)
STERRAD NX® with ALLClear® Technology Sterilization System (Standard and Advanced cycles)
STERRAD 100NX® with ALLClear® Technology Sterilization System (Standard, Flex, Express and Duo cycles)
V-PRO® 1 Low Temperature Sterilization System (Lumen cycle)
V-PRO® 1 Plus Low Temperature Sterilization System (Lumen and Non Lumen cycles)
V-PRO® maX Low Temperature Sterilization System (Lumen, Non Lumen, and Flexible cycles)
V-PRO® 60 Low Temperature Sterilization System (Lumen, Non Lumen and Flexible cycles)
V-PRO® maX 2 Low Temperature Sterilization System (Lumen, Non Lumen, Flexible, and Fast Non Lumen cycles)
V-PRO® s2 Low Temperature Sterilization System (Lumen, Non Lumen, Flexible, and Fast cycles)
STERIZONE® VP4 Sterilizer (Cycle 1)

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

Here's a breakdown of the acceptance criteria and the study information regarding the 3M™ Comply™ Hydrogen Peroxide Indicator Tape 1228, based on the provided text:

1. Table of Acceptance Criteria and 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 STERIZONE® VP4 Sterilizer (Cycle 1)	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 STERIZONE® VP4 Sterilizer (Cycle 1)	Determination of the minimum time for color to change from blue toward pink	Pass

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

The document does not explicitly state the specific number of samples (e.g., indicator tapes) used for the non-clinical testing. It only mentions the purpose of the tests and the acceptance criteria. The data provenance is "non-clinical testing" conducted to demonstrate performance in the newly claimed sterilizer and cycles. It does not provide details on the country of origin or whether it was retrospective or prospective, although typically such performance testing for medical devices is prospective.

3. Number of Experts Used to Establish Ground Truth and Their Qualifications

This information is not provided. The study focuses on the chemical indicator's color change in response to sterilization, which is a physical/chemical property rather than an interpretation requiring human expert analysis of complex data.

4. Adjudication Method for the Test Set

This information is not provided. Given the nature of the "Pass" result for color change, it's likely a direct observation rather than a multi-reader adjudication process.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is typically used for diagnostic devices that involve human interpretation of images or other data, where AI might assist or replace human readers. The 3M™ Comply™ Hydrogen Peroxide Indicator Tape 1228 is a chemical indicator that shows a direct color change, not a system involving a human reader interpreting AI output.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, in a sense, a standalone performance was evaluated. The device itself (the chemical indicator tape) is designed to perform its function (color change) independently of human interpretation beyond observing the color. The tests conducted (Color Change in Health Care Facility Cycle and Minimum Exposure Parameters) directly assess the performance of the device without human intervention as a variable in the outcome.

7. The Type of Ground Truth Used

The ground truth for this device is the observable physical color change of the chemical indicator from blue towards pink, confirming exposure to vaporized hydrogen peroxide. This is an objective chemical reaction, not a subjective interpretation.

8. The Sample Size for the Training Set

The document refers to non-clinical testing for the newly claimed sterilizer and cycles. It does not describe a training set in the context of machine learning (AI). This device is a chemical indicator, not an AI or algorithm-based device that typically requires a training set.

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

As explained above, this device does not utilize a training set in the AI sense. The performance is based on direct chemical reaction and observable color change, not on an algorithm trained on data.

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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

September 5, 2021

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

Re: K212081

Trade/Device Name: 3M1M Comply 100 Hydrogen Peroxide Indicator Tape 1228 Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: Class II Product Code: JOJ Dated: August 6, 2021 Received: August 9, 2021

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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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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 (OS) 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 mediation-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 Clarence W. Murray, III, PhD Assistant Director 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)

K212081

Device Name 3M™ ComplyTM Hydrogen Peroxide Indicator Tape 1228

Indications for Use (Describe)

STERRAD 100® Sterilization System STERRAD 100S® Sterilization System STERRAD NX® Sterilization System (Standard and Advanced cycles) STERRAD 100NX® Sterilization System (Standard, Flex, Express and Duo cycles) STERRAD NX® with ALLClear® Technology Sterilization System (Standard and Advanced cycles) STERRAD 100NX® with ALLClear® Technology Sterilization System (Standard, Flex, Express and Duo cycles) V-PRO® 1 Low Temperature Sterilization System (Lumen cycle) V-PRO® 1 Plus Low Temperature Sterilization System (Lumen and Non Lumen cycles) V-PRO® maX Low Temperature Sterilization System (Lumen, and Flexible cycles) V-PRO® 60 Low Temperature Sterilization System (Lumen, Non Lumen and Flexible cycles) V-PRO® maX 2 Low Temperature Sterilization System (Lumen, Flexible, and Fast Non Lumen cycles) V-PRO® s2 Low Temperature Sterilization System (Lumen, Flexible, and Fast cycles) STERIZONE® VP4 Sterilizer (Cycle 1)

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.

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)

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

K212081

Sponsor Information:

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

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

Date of Summary: August 02, 2021

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

1. 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
Device Classification:	Class II, 21 CFR § 880.2800
Product Code:	JOJ

2. Predicate Device:

K203285 3M™ Comply™ Hydrogen Peroxide Indicator Tape 1228

3. Description of Device:

The 3MTM 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.

4. Indications for Use

STERRAD 100® Sterilization System
STERRAD 100S® Sterilization System
STERRAD NX® Sterilization System (Standard and Advanced cycles)
STERRAD 100NX® Sterilization System (Standard, Flex, Express and Duo cycles)
STERRAD NX® with ALLClear® Technology Sterilization System (Standard and Advanced cycles)
STERRAD 100NX® with ALLClear® Technology Sterilization System (Standard, Flex, Express and Duo cycles)
V-PRO® 1 Low Temperature Sterilization System (Lumen cycle)
V-PRO® 1 Plus Low Temperature Sterilization System (Lumen and Non Lumen cycles)
V-PRO® maX Low Temperature Sterilization System (Lumen, Non Lumen, and Flexible cycles)
V-PRO® 60 Low Temperature Sterilization System (Lumen, Non Lumen and Flexible cycles)
V-PRO® maX 2 Low Temperature Sterilization System (Lumen, Non Lumen, Flexible, and Fast Non Lumen cycles)
V-PRO® s2 Low Temperature Sterilization System (Lumen, Non Lumen, Flexible, and Fast cycles)
STERIZONE® VP4 Sterilizer (Cycle 1)

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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5. Technological Characteristic Comparison Table

Feature	Submission Device:3MTM Comply™ HydrogenPeroxide Indicator Tape 1228	Predicate Device (K203285):3MTM ComplyTM HydrogenPeroxide Indicator Tape 1228	Comparison
Indications forUse	Use the 3M™ ComplyTMHydrogen Peroxide Indicator Tape1228 to secure packs and as anexternal pack process indicator todifferentiate unprocessed itemsfrom items processed in thefollowing sterilizers:STERRAD 100® SterilizationSystemSTERRAD 100S® SterilizationSystemSTERRAD NX® SterilizationSystem (Standard andAdvanced cycles)STERRAD 100NX®Sterilization System (Standard,Flex, Express and Duo cycles)STERRAD NX® withALLClear® TechnologySterilization System (Standardand Advanced cycles)STERRAD 100NX® withALLClear® TechnologySterilization System (Standard,Flex, Express and Duo cycles)V-PRO® 1 Low TemperatureSterilization System (Lumencycle)V-PRO® 1 Plus LowTemperature SterilizationSystem (Lumen and NonLumen cycles)V-PRO® maX LowTemperature SterilizationSystem (Lumen, Non Lumen,and Flexible cycles)V-PRO® 60 Low TemperatureSterilization System (Lumen,Non Lumen and Flexiblecycles)V-PRO® maX 2 LowTemperature SterilizationSystem (Lumen, Non Lumen,Flexible, and Fast Non Lumencycles)V-PRO® s2 Low TemperatureSterilization System (Lumen,Non Lumen, Flexible, and Fastcycles)	Use the 3M™ ComplyTMHydrogen Peroxide Indicator Tape1228 to secure packs and as anexternal pack process indicator todifferentiate unprocessed itemsfrom items processed in thefollowing sterilizers:STERRAD 100® SterilizationSystemSTERRAD 100S® SterilizationSystemSTERRAD NX® SterilizationSystem (Standard andAdvanced cycles)STERRAD 100NX®Sterilization System (Standard,Flex, Express and Duo cycles)STERRAD NX® withALLClear® TechnologySterilization System (Standardand Advanced cycles)STERRAD 100NX® withALLClear® TechnologySterilization System (Standard,Flex, Express and Duo cycles)V-PRO® 1 Low TemperatureSterilization System (Lumencycle)V-PRO® 1 Plus LowTemperature SterilizationSystem (Lumen and NonLumen cycles)V-PRO® maX LowTemperature SterilizationSystem (Lumen, Non Lumen,and Flexible cycles)V-PRO® 60 Low TemperatureSterilization System (Lumen,Non Lumen and Flexiblecycles)V-PRO® maX 2 LowTemperature SterilizationSystem (Lumen, Non Lumen,Flexible, and Fast Non Lumencycles)V-PRO® s2 Low TemperatureSterilization System (Lumen,Non Lumen, Flexible, and Fastcycles)	Similar. Thesubmissiondevice adds theSTERIZONE®VP4 Sterilizer(Cycle 1) to theIndications forUse.
Feature	Submission Device:3M™ Comply™ HydrogenPeroxide Indicator Tape 1228	Predicate Device (K203285):3M™ Comply™ HydrogenPeroxide Indicator Tape 1228	Comparison
	STERIZONE® VP4 Sterilizer(Cycle 1)The tape is suitable for use on non-woven disposable wraps and peelpouches. The chemical indicatorstripes turn from blue toward pinkafter exposure to vaporizedhydrogen peroxide.	The tape is suitable for use on non-woven disposable wraps and peelpouches. The chemical indicatorstripes turn from blue toward pinkafter exposure to vaporizedhydrogen peroxide.
Substrate	Non-cellulosic plastic	Identical
Biocompatibility	The exposure to health careprofessionals is minimal and wellbelow any identified toxicthresholds for the compounds.	Identical
Color Change	Blue toward pink	Identical
Detection	Hydrogen Peroxide	Identical
Stability of theendpoint reaction	Six (6) months	Twelve (12) months	Alignment ofclaim withsimilar 3Mproducts.
Shelf life	Eighteen (18) months	Identical

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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 (K203285). 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 STERIZONE® VP4 Sterilizer (Cycle 1).

Table 6.1 Summary of Nonclinical Testing

Test	Purpose	Acceptance Criteria	Result
Color Change inHealth CareFacility Cycle	To demonstrate the color change ofthe device when used in theSTERIZONE® VP4 Sterilizer(Cycle 1)	Color change from blue towardpink	Pass
MinimumExposureParameters	To determine the minimum timerequired for the color change of thedevice when used in theSTERIZONE® VP4 Sterilizer(Cycle 1)	Determination of the minimumtime for color to change fromblue toward pink	Pass

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7. Conclusion

Based on the non-clinical performance data, the 3M™ Comply™ Hydrogen Peroxide Indicator Tape 1228 is as safe, as effective, and performs as well as or better than the legally marketed predicate device, 3M™ Comply™ Hydrogen Peroxide Indicator Tape 1228 cleared under K203285, 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).