The 3M™ Comply™ 1228 Gas Plasma Indicator Tape is indicated for use to secure packs and as an external pack process indicator to differentiate processed from unprocessed items when exposed to vapor hydrogen peroxide in the STERRAD® 100, STERRAD® 100S, and STERRAD® 50 Sterillization processes.

Device Description

The 3M Comply™ 1228 Gas Plasma Indicator Tape is a sterilization process indicator and is comprised of non-cellulosic plastic backing material with a pressure sensitive adhesive on one side and indicator stripes on the other side. A color match is printed in the Comply 1228 Technical Information Sheet. The chemical indicator stripes turn from blue to pink after exposure to vapor hydrogen peroxide in the STERRAD® 100, STERRAD® 100S and the STERRAD® 50 Sterilization processes.

AI/ML Overview

Here's an analysis of the provided text regarding the 3M™ Comply™ 1228 Gas Plasma Indicator Tape, structured to address your specific questions.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria / Test	Reported Device Performance and Acceptance
Color Change after Exposure to Sterrad Cycles (100)	Acceptance: Indicator tape turns from blue to pink. Performance: Testing verified that the 3M Comply™ 1228 Gas Plasma Indicator Tape samples turned from blue to pink when exposed to the STERRAD 100 Sterilization cycle. The minimum time required for all indicator tape samples to indicate a "pass" in relation to the color match was found.
Color Change after Exposure to Sterrad Cycles (100S)	Acceptance: Indicator tape turns from blue to pink. Performance: Testing verified that the 3M Comply™ 1228 Gas Plasma Indicator Tape samples turned from blue to pink when exposed to the STERRAD 100S Sterilization cycle. The minimum time required for all indicator tape samples to indicate a "pass" in relation to the color match was found.
Color Change after Exposure to Sterrad Cycles (50)	Acceptance: Indicator tape turns from blue to pink. Performance: Testing verified that the 3M Comply™ 1228 Gas Plasma Indicator Tape samples turned from blue to pink when exposed to the STERRAD 50 Sterilization cycle. The minimum time required for all indicator tape samples to indicate a "pass" in relation to the color match was found.
Eighteen-Month Color Change Stability	Acceptance: Indicator tape continues to turn from blue to pink when exposed to complete STERRAD 100S cycles over 18 months. Performance: Six-month interim results verified that all indicator tape turned from blue to pink when exposed to the complete STERRAD 100S Sterilization cycles, thereby confirming the continued stability of the 3M Comply™ 1228 Gas Plasma Chemical Indicator to date. (18-month testing ongoing)
Eighteen-Month Adhesive Stability	Acceptance: No significant degradation in peel force, and wrap security maintained over 18 months. Performance: Six-month interim results found no initial trends in the peel force over time for both unprocessed tape and processed tape when removed from Kimberly-Clark Spungard One-Step wrap. Six-month interim results verified wrap security. (18-month testing ongoing)
Light Stability (Unprocessed & Processed Colors)	Acceptance: No significant color change after 4 weeks of fluorescent light exposure. Performance: Testing verified that the colors of the processed and unprocessed 3M Comply™ 1228 Gas Plasma Indicator Tape samples did not change significantly after four (4) weeks of exposure to fluorescent light.
Performance After Exposure to Light (Post-Exposure)	Acceptance: Indicator tape continues to meet the color match after 4 weeks of fluorescent light exposure and then exposure to STERRAD 100S cycles. Performance: Testing verified that all indicator tape samples continued to meet the color match when exposed to both the complete STERRAD 100S Sterilization cycles, thereby confirming the stability of the 3M Comply™ 1228 Gas Plasma Indicator Tape samples following four (4) weeks of exposure to fluorescent light.
Effect of Absence of Hydrogen Peroxide	Acceptance: No color change when exposed to a cycle without hydrogen peroxide. Performance: Testing verified that the 3M Comply™ 1228 Gas Plasma Indicator Tape samples did not exhibit any color change following exposure to a cycle containing deionized water instead of hydrogen peroxide.
Effects of Steam and Ethylene Oxide Sterilization	Acceptance: Unaffected by steam or ethylene oxide (with a precaution not to use for these cycles). Performance: Testing verified that the 3M Comply™ 1228 Gas Plasma Indicator Tape samples were found to be unaffected by the steam or ethylene oxide sterilization process. (A precaution is included in the Instructions For Use).
Effects of Acid and Base	Acceptance: Not sensitive to acid or base resulting in a "processed" color change (pink) when unprocessed. Performance: Testing verified that the 3M Comply™ 1228 Gas Plasma Indicator Tape samples were not sensitive to the presence of an acidic or basic (alkaline) environment, meaning they did not turn pink. The unprocessed color was found to be sensitive to acid/base, but this did not result in a "processed" color. (A precaution is included for storage).

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

The document does not explicitly state the numerical sample size used for the test set for each test. It refers to "samples" and "all indicator tape samples" without providing specific counts.

The data provenance is from the manufacturer, 3M Company, and appears to be prospective testing conducted specifically for this 510(k) submission. There is no information about the country of origin of the data beyond "3M Company 3M Medical Division... St. Paul, MN."

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

The document does not mention the use of experts or their qualifications for establishing the ground truth of the test set. For a chemical indicator, the "ground truth" is typically the objective color change (blue to pink) as defined by the manufacturer's color match and the known exposure to the sterilant.

4. Adjudication Method for the Test Set

No explicit adjudication method (e.g., 2+1, 3+1) is mentioned or implied. The determination of "pass" (color change from blue to pink in relation to the color match) for the indicator tapes appears to be a direct, objective observation of the chemical reaction.

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

No. This type of study is not applicable to a chemical indicator device like this. MRMC studies are typically used for diagnostic devices where human interpretation of medical images or data is involved and the goal is to evaluate reader performance with and without AI assistance. The 3M Comply™ 1228 Gas Plasma Indicator Tape is a passive, objective chemical indicator.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, in a way. The "performance" of the device is its standalone chemical reaction. The tests describe the device's inherent behavior (color change, stability, etc.) under various conditions, independent of human interpretation or intervention beyond initial observation. There isn't an "algorithm" in the typical AI sense, but the device's function is purely automatic chemical response.

7. The Type of Ground Truth Used

The ground truth used is based on objective physical/chemical properties and observations:

Color change: The visual transformation from blue to pink, referenced against a defined "color match" in the technical information sheet (though the sheet itself isn't provided here).
Presence/absence of sterilant: Knowing whether the indicator was exposed to the STERRAD sterilization process (vapor hydrogen peroxide) or not.
Physical stability: Measurement of properties like peel force for adhesive stability.
Environmental conditions: Controlled exposure to light, acid, base, steam, ethylene oxide.

This is fundamentally a chemical/physical property ground truth.

8. The Sample Size for the Training Set

This device is a chemical indicator, not an AI/machine learning algorithm. Therefore, there is no training set in the typical sense. The "training" of such a device is its manufacturing process to ensure consistent chemical composition and reaction.

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

As there is no training set for an AI algorithm, this question is not applicable. The performance of the chemical indicator is based on its inherent chemical formulation and manufacturing quality control, rather than learning from data.

Summary

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3M™ Comply™ 1228 Gas Plasma Indicator Tape 510(k) Notification

K020589
Page 92

APPENDIX G: Premarket Notification (510 (k)) Summary

Manufacturer:

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

Regulatory Affairs Contact:

Joann L. Huehn Advanced Regulatory Affairs Associate 3M Company Tel: 651-733-9209 FAX: 651-737-5320

Date

February 21, 2002

Summary Prepared:

Device Trade Name:	3MTM ComplyTM 1228 Gas Plasma Indicator Tape
Common or UsualName:	Chemical Indicator Tape

Classification: Physical/Chemical Sterilization Process Indicator [21CFR 880.2800(b)]

Device Description:

Intended Use: The 3M Comply™ 1228 Gas Plasma Indicator Tape is indicated for use to secure packs and as an external pack process indicator to differentiate processed from unprocessed items when exposed to vapor hydrogen peroxide in the STERRAD® 100, STERRAD® 100S, and STERRAD® 50 Sterillization processes.

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Substantial Equivalence: The 3M Comply™ 1228 Gas Plasma. Indicator Tape is comparable in performance to the Advanced Sterilization Products (ASP) STERRAD® Gas Plasma Indicator Tape (K945190). The 3M Comply 1228 Gas Plasma Indicator Tape and the predicate device share the same intended use to secure packs and as external pack indicators to differentiate processed from unprocessed items when exposed to vapor hydrogen peroxide in the STERRAD 100, STERRAD 100S, and the STERRAD 50 sterilization processes. In addition, the 3M Comply™ 1228 Gas Plasma Indicator Tape and the predicate device share similar design and appearance.

Testing Summary:

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Cycle Conditions Required for Color Change in a STERRAD 100 Sterilizer

Cycle Conditions Required for Color Change Using the STERRAD 100S Cycle

Cycle Conditions Required for Color Change in a STERRAD 50 Sterilizer

Eighteen-Month Color Change Stability Study

Eighteen-Month Adhesive Stability Study

Testing verified that the 3M Comply™ 1228 Gas Plasma Indicator Tape samples turned from blue to pink when exposed to the STERRAD 100 Sterilization cycle and the minimum time required for all indicator tape samples to indicate a "pass" in relation to the color match was found.

Testing verified that the 3M Comply™ 1228 Gas Plasma Indicator Tape samples turned from blue to pink when exposed to the STERRAD 100S Sterilization cycle and the minimum time required for all indicator tape samples to indicate a "pass" in relation to the color match was found.

Testing verified that the 3M Comply™ 1228 Gas Plasma Indicator Tape samples turned from blue to pink when exposed to the STERRAD 50 Sterilization cycle and the minimum time required for all indicator tape samples to indicate a "pass" in relation to the color match was found.

Six-month interim results verified that all indicator tape turned from blue to pink when exposed to the complete STERRAD 100S Sterilization cycles, thereby confirming the continued stability of the 3M ComplyTM 1228 Gas Plasma Chemical Indicator to date. Eighteen-Month color change stability testing is ongoing.

Six-month interim results have found no initial trends in the peel force over time for both unprocessed tape and processed tape when removed from Kimberly-Clark Spungard One-Step wrap. Six-month interim results have verified wrap security. Eighteen-Month adhesive stability testing is ongoing.

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Testing verified that the colors of the processed and Light Stability unprocessed 3M Comply™ 1228 Gas Plasma Indicator Tape Testing samples did not change significantly after four (4) weeks of exposure to fluorescent light.

Testing verified that all indicator tape samples continued to Performance After meet the color match when exposed to both the complete Exposure to Light STERRAD 100S Sterilization cycles, thereby confirming the stability of the 3M Comply™ 1228 Gas Plasma Indicator Tape samples following four (4) weeks of exposure to fluorescent light.

Effect of the Absence of Hydrogen Peroxide on the Color Change

Effects of Steam and Ethylene Oxide Sterilization

Effects of Acid and Base

Testing verified that the 3M Comply™ 1228 Gas Plasma Indicator Tape samples did not exhibit any color change following exposure to a cycle containing deionized water instead of hydrogen peroxide.

Testing verified that the 3M Comply™ 1228 Gas Plasma Indicator Tape samples were found to be unaffected by the steam or ethylene oxide sterilization process. The Instructions For Use includes a Precaution not to use the indicator tape to monitor steam or ethylene oxide sterilization cycles.

Testing verified that the 3M Comply™ 1228 Gas Plasma Indicator Tape samples were not sensitive to the presence of an acidic or basic (alkaline) environment. The unprocessed color of the 3M Comply 1228 Gas Plasma Indicator Tape samples was found to be sensitive to the presence of an acidic and basic (alkaline) environment, but does not change to pink, the processed color. The Instructions For Use includes a Precaution to store the indicator tape away from hydrogen peroxide and alkaline chemicals.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

PR 2 2 2002

Ms. Joann L. Huehn 3M Company Medical Division 3M Center, Building 275-5W-06 Saint Paul, Minnesota 55144-1000

Re: K020589

Trade/Device Name: 3M™ ComplyTM 1228 Gas Plasma Indicator Tape Regulation Number: 880.2800 (b) Regulation Name: Sterilization Process Indicator Regulatory Class: II Product Code: JOJ Dated: February 21, 2002 Received: February 22, 2002

Dear Ms. Huehn:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.

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You must comply with all the Act's requirements, including, but not limited to: registration r od listing (21 CFR Part 807); labeling (21 CFR Part 801); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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APPENDIX C: INDICATIONS FOR USE STATEMENT

510(k) Number:

. TBD

Device Name:

Indications For Use:

The 3M™ Comply™ 1228 Gas Plasma Indicator Tape is indicated for use to secure packs and as an external pack indicator to differentiate processed from unprocessed items when exposure to vapor hydrogen peroxide in the STERRAD® sterilization processes (100, 100S, 50). The 3M Comply 1228 is suitable for use on non-woven disposable wraps and peel pouches. The diagonal stripes of chemical indicator ink turn from blue to pink after exposure to vapor hydrogen peroxide in

3M™ Comply™ 1228 Gas Plasma Indicator Tape

Chin S. Lim

these sterilization processes.

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number

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).