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, and Flexible cycles)

V-PRO® 60 Low Temperature Sterilization System (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)

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 3MTM ComplyTM 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

This document describes the 3M™ Comply™ Hydrogen Peroxide Indicator Tape 1228, a chemical indicator for sterilization processes. The acceptance criteria and the study proving the device meets these criteria are detailed, primarily for its use with the V-PRO® s2 Low Temperature Sterilization System.

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance:

Test	Purpose	Acceptance Criteria	Result
Color Change in Health Care Facility Cycle	To demonstrate the color change of the device when used in the V-PRO® s2 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 V-PRO® s2 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 V-PRO® s2 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:

The document does not explicitly state the specific sample sizes used for each test (Color Change, Minimum Exposure Parameters, End Point Color Stability) within the test set. It mentions "nonclinical testing was performed," but quantitative details on the number of tapes tested or the number of cycles run are not provided.

The data provenance is from non-clinical testing conducted specifically for this submission, focusing on the newly claimed sterilizer and cycles (V-PRO® s2 Low Temperature Sterilization System). The document does not specify the country of origin, but given it's an FDA submission for a US-based company (3M Company, St. Paul, Minnesota), the testing was likely conducted in the US. The testing appears to be prospective as it was done to demonstrate performance for new claims.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not provided in the document. For a chemical indicator like this, the "ground truth" is typically the physical-chemical reaction (color change) itself under specified conditions, rather than expert interpretation of complex clinical imagery. The "Pass" results suggest that the required color change was observed consistently.

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

The document does not mention any adjudication method. For the type of device (chemical indicator with a clear visual color change), a formal adjudication process involving multiple human observers is typically not necessary if the color change is unambiguous and measurable by standardized methods. The "Pass" results imply a straightforward assessment against the defined visual criteria.

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 device is a chemical indicator, not an AI-assisted diagnostic tool. Therefore, an MRMC study or an assessment of human reader improvement with AI assistance is not relevant to its functionality.

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

Not applicable. This device is a physical chemical indicator, not a software algorithm. Its performance is directly observed through a color change, which is a "human-in-the-loop" observation in that a human visually checks the tape. There is no automated algorithmic assessment.

7. The type of ground truth used:

The ground truth for this device is the physical-chemical reaction of the indicator within the specified sterilization environments. Specifically, it's the expected color change from blue toward pink upon exposure to vaporized hydrogen peroxide under effective sterilization conditions, and the stability of that color change over time.

8. The sample size for the training set:

Not applicable. This device is a pre-manufactured chemical indicator, not a machine learning model that requires a training set.

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

Not applicable. As explained above, there is no training set for this device.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & 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.

December 10, 2020

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

Re: K203285

Trade/Device Name: 3M Comply Hydrogen Peroxide Indicator Tape 1228 Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: Class II Product Code: JOJ Dated: November 6, 2020 Received: November 9, 2020

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,

Clarence W. Murray, III, PhD Acting 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)

K203285

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 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)

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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Image /page/3/Picture/1 description: The image shows the 3M logo. The logo is red and features the number 3 followed by the letter M. The font is bold and sans-serif.

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

Sponsor Information:

3M Company 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: November 06, 2020

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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:

K192673 3M™ Comply™ Hydrogen Peroxide Indicator Tape 1228

3. Description of Device:

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)

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

Feature	Submission Device:3MTM Comply™ Hydrogen PeroxideIndicator Tape 1228	Predicate Device (K192673):3MTM Comply™ Hydrogen PeroxideIndicator Tape 1228
Indications for use	Use the 3MTM Comply™ HydrogenPeroxide Indicator Tape 1228 to securepacks and as an external pack processindicator to differentiate unprocessed itemsfrom items processed in the followingsterilizers:STERRAD 100® Sterilization SystemSTERRAD 100S® Sterilization SystemSTERRAD 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 TemperatureSterilization System (Lumen cycle)V-PRO® 1 Plus Low TemperatureSterilization System (Lumen and NonLumen cycles)V-PRO® maX Low TemperatureSterilization System (Lumen, NonLumen, and Flexible cycles)V-PRO® 60 Low TemperatureSterilization System (Lumen, NonLumen and Flexible cycles)V-PRO® maX 2 Low TemperatureSterilization System (Lumen, NonLumen, Flexible, and Fast Non Lumencycles)V-PRO® s2 Low TemperatureSterilization System (Lumen, NonLumen, Flexible, and Fast cycles)The tape is suitable for use on non-wovendisposable wraps and peel pouches. Thechemical indicator stripes turn from bluetoward pink after exposure to vaporizedhydrogen 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, 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),AMSCO® V-PRO® 60 Low TemperatureSterilization System (Lumen, Non-Lumenand Flexible cycles), and AMSCO® V-PRO™ maX 2 Low TemperatureSterilization System (Lumen, Non-Lumen,Flexible, and Fast Non-Lumen cycles)sterilizers. The tape is suitable for use onnon-woven disposable wraps and peelpouches. The chemical indicator stripes turnfrom blue toward pink after exposure tovaporized hydrogen peroxide.
Sterilizers andSterilizationCycles	STERRAD 100® Sterilization SystemSTERRAD 100S® Sterilization SystemSTERRAD NX® Sterilization System(Standard and Advanced cycles)STERRAD 100NX® Sterilization System	STERRAD 100® Sterilization SystemSTERRAD 100S® Sterilization SystemSTERRAD NX® Sterilization System(Standard and Advanced cycles)STERRAD 100NX® Sterilization System
Feature	Submission Device:3MTM Comply™ Hydrogen PeroxideIndicator Tape 1228	Predicate Device (K192673):3MTM Comply™ Hydrogen PeroxideIndicator Tape 1228
	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 TemperatureSterilization System (Lumen cycle)V-PRO® 1 Plus Low TemperatureSterilization System (Lumen and NonLumen cycles)V-PRO® maX Low TemperatureSterilization System (Lumen, NonLumen, and Flexible cycles)V-PRO® 60 Low TemperatureSterilization System (Lumen, NonLumen and Flexible cycles)V-PRO® maX 2 Low TemperatureSterilization System (Lumen, NonLumen, Flexible, and Fast Non Lumencycles)	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 SterilizationSystem (Lumen cycle)V-PRO® 1 Plus Low TemperatureSterilization System (Lumen and NonLumen cycles)V-PRO® maX Low TemperatureSterilization System (Lumen, NonLumen, and Flexible cycles)V-PRO® 60 Low TemperatureSterilization System (Lumen, Non Lumenand Flexible cycles)V-PRO® maX 2 Low TemperatureSterilization System (Lumen, NonLumen, Flexible, and Fast Non Lumencycles)
	V-PRO® s2 Low TemperatureSterilization System (Lumen, NonLumen, Flexible, and Fast cycles)
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 (K192673). 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 V-PRO® s2 Low Temperature Sterilization System (Lumen, Non-Lumen, Flexible, and Fast cycles).

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Test	Purpose	Acceptance Criteria	Result
Color Change inHealth CareFacility Cycle	To demonstrate the color change ofthe device when used in theV-PRO® s2 Low TemperatureSterilization System	Color change from blue towardpink	Pass
MinimumExposureParameters	To determine the minimum timerequired for the color change of thedevice when used in the V-PRO®s2 Low Temperature SterilizationSystem	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 V-PRO® s2Low Temperature SterilizationSystem	No significant color changeafter exposure to fluorescentlight for a minimum of twelve(12) months.	Pass

Table 6.1 Summary of Nonclinical Testing

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 K192673, 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).