3M™ Attest™ Steam Chemical Integrator Test Pack 41360 is specifically designed to routinely challenge the steam sterilization process in healthcare facilities. This convenient disposable process challenge device presents a challenge to the sterilization process equivalent to the 16towel process challenge device (PCD) recommended by the Associate for the Advancement of Medical Instrumentation (AAMI). Each test pack contains a process indicator on the outside that changes from yellow to brown or darker when steam processed.

Each pack contains a 3M™ Attest™ Steam Chemical Integrator and a record keeping sheet. The 3MTM Attest™ Steam Chemical Integrator consists of a paper wick and a steam and temperature sensitive chemical pellet contained in a paper/film/foil laminate. When exposed to steam sterilization conditions, the chemical pellet melts and migrates as a dark color along the paper wick. The migration is visible through a window marked REJECT or ACCEPT. The extent of migration depends on steam, time, and temperature.

AI/ML Overview

The provided document describes the 3M™ Attest™ Steam Chemical Integrator Test Pack 41360. Based on the information, here's a breakdown of the acceptance criteria and the study that proves the device meets them:

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

Test	Purpose	Acceptance Criteria	Reported Device Performance
Comparison to AAMI 16 Towel PCD	Determine the resistance of the Challenge Pack as compared to an AAMI 16 Towel PCD	Challenge Pack is at least as resistant as the biological indicator AAMI 16 Towel Process Challenge Device (PCD) described in ANSI/AAMI ST79: 2017	Passed
Comparison to Biological Indicator	Determine the resistance of the Challenge Pack as compared to the Biological Indicator alone	Challenge Pack provides a greater resistance than the Biological Indicator alone	Passed

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 specify the exact sample size for the test set. It only states that "Performance testing to demonstrate substantial equivalence to the predicate device has been completed." The data provenance is not explicitly mentioned but is implied to be from 3M Company's internal testing as part of their premarket notification for the FDA. This would generally be considered prospective testing in a controlled laboratory environment.

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 is not applicable to the device described. The device is a chemical indicator for steam sterilization. Its performance is evaluated against established physical and chemical standards (like AAMI ST79) and other devices, rather than being assessed by human experts interpreting results.

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

This is not applicable. The performance testing involves objective measures of resistance to sterilization conditions, not subjective interpretations requiring adjudication.

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

This is not applicable. The device is a physical chemical indicator, not an AI or imaging diagnostic tool.

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

This is not applicable. The device is a physical chemical indicator. Its performance is inherent to its design and chemical properties.

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

The ground truth for the performance testing is based on established industry standards for steam sterilization and chemical indicators, specifically:

ANSI/AAMI ST79:2017, Comprehensive guide to steam sterilization and sterility assurance in health care facilities
ISO 11140-1:2014 Sterilization of health care products – Chemical indicators, Part 1: General Requirements

The ground truth for "resistance" is defined by these standards and the behavior of the AAMI 16 Towel Process Challenge Device (PCD) and a Biological Indicator.

8. The sample size for the training set

This is not applicable. The device is not an AI or machine learning model that requires a training set. The development of such physical indicators involves engineering, chemistry, and iterative testing, not "training" in the AI sense.

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

This is not applicable for the reasons stated above.

Summary

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July 2, 2020

3M Center Mary Fretland Senior Regulatory Affairs Associate 2510 Conway Avenue, Building 275-5W-06 St. Paul, MN 55144

Re: K200766

Trade/Device Name: 3M™ Attest™ Steam Chemical Integrator Test Pack 41360 Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: Class II Product Code: JOJ Dated: June 03, 2020 Received: June 04, 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 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

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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 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,

Christopher K. Dugard, M.S. 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) K200766

Device Name

3MTM Attest™ Steam Chemical Integrator Test Pack 41360

Indications for Use (Describe)

Use the 3MTM Attest™ Steam Chemical Integrator Test Pack 41360 to monitor:
· 121°C (250°F) gravity displacement steam sterilization cycle at 30 minutes
· 132°C (270°F) dynamic-air-removal steam sterilization cycle at 4 minutes
· 135°C (275°F) dynamic-air-removal steam sterilization cycle at 3 minutes

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

3MTM Attest™ Steam Chemical Integrator Test Pack 41360

K200766

3M Company, 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: July 02, 2020

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TRADITIONAL PREMARKET NOTIFICATION [510(k)] 3MTM Attest™ Steam Chemical Integrator Test Pack 41360

Device Names and Classification:

Trade Name:	3MTM AttestTM Steam Chemical Integrator TestPack 41360
Common/Usual Name:	Chemical Indicator (CI) Challenge Pack
Device Classification:	Class II
Classification Name:	Indicator, Biological Sterilization Process[21 CFR § 880.2800(b), FRC]

Predicate Device:

3MTM Attest™ Super Rapid 5 Steam-Plus Challenge Pack 41482V, K193154

Indications for Use:

3MTM Attest™ Steam Chemical Integrator Test Pack 41360:

Use the 3M™ Attest™ Steam Chemical Integrator Test Pack 41360 to monitor:

121°C (250°F) gravity displacement steam sterilization cycle at 30 minutes .
132°C (270°F) dynamic-air-removal steam sterilization cvcle at 4 minutes .
135°C (275°F) dynamic-air-removal steam sterilization cycle at 3 minutes ●

Description of Device:

Nonclinical Comparison to the Predicate Device

This submission is addressing a change to the 3M™ Attest™ Steam Chemical Integrator contained within the 3MTM Attest™ Steam Chemical Integrator Test Pack 41360. The design, fundamental technology and performance specifications for 3M™ Attest™ Steam Chemical Integrators are similar to the previously cleared device which is sold under the tradename 3MTM ComplyTM SteriGage™ Steam Chemical Integrator Test Pack (K894399).

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TRADITIONAL PREMARKET NOTIFICATION [510(k)] 3MTM Attest™ Steam Chemical Integrator Test Pack 41360

There have been no changes to the integrator's performance specifications or fundamental scientific technology. The changes to the integrator included an expansion of the indications for use, re-branding of the device, and a modification to the materials used to construct the device. Test Packs have the same intended use as the previously marketed devices and make use of the same fundamental scientific technology.

	Subject Device(K200766):	Predicate Device(K193154):
Feature	3M™ Attest™ SteamChemical Integrator Test Pack41360	3M™ Attest™ Super Rapid 5Steam-Plus Challenge Pack41482V	Comparison
Indications for use	Use the 3M™ Attest™ SteamChemical Integrator Test Pack41360 to monitor:• 121°C (250°F) gravitydisplacement steam sterilizationcycle at 30 minutes• 132°C (270°F) dynamic-air-removal steam sterilization cycleat 4 minutes• 135°C (275°F) dynamic-air-removal steam sterilization cycleat 3 minutes	Use the 3M™ Attest™ SuperRapid 5 Steam-Plus ChallengePack 41482V in conjunction withthe 3M™ Attest™ Auto-reader490 or 3M™ Attest™ Auto-reader490H having software version4.0.0 or greater to qualify ormonitor:dynamic-air-removal steamsterilization cycles of 4 minutes at270°F (132°C) and 3 minutes at275°F (135°C).	Two sharedcycles withpredicatedevice, oneunique cycle.
General Design	Layers of medical index cards,some of which are die-cut tocontain indicators, overwrappedand secured with a label.	Layers of medical index cards,some of which are die-cut tocontain indicators, overwrappedand secured with a label.	Identical
Biological Indicator	NA	3M™ Attest™ Super RapidReadout Biological Indicator1492V(cleared via K173437)	Subject devicedoes notcontain a BI.
Biological IndicatorIncubation temperature	NA	60 ± 2°C	Subject devicedoes notcontain a BI.
Biological IndicatorReadout time	NA	24-minute final fluorescent resultin both the 490 and 490H Auto-readers having software versions4.0.0 or greater.1-hour final fluorescent result in490 Auto-readers having softwareversions less than 4.0.0.	Subject devicedoes notcontain a BI.
Resistance Comparisonto the AAMI ST7916 Towel PCD	Equivalent in resistance to theAAMI ST7916 Towel PCD	Equivalent in resistance to theAAMI ST7916 Towel PCD	Identical
Chemical Integrator	3M™ Attest™ Steam ChemicalIntegrator (cleared via K191236)	3M™ Attest™ Steam ChemicalIntegrator (cleared via K191236)	Identical
Shelf life	Two (2) years	21 months	Similar

Technical Characteristics Comparison Table

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TRADITIONAL PREMARKET NOTIFICATION [510(k)]

3MTM Attest™ Steam Chemical Integrator Test Pack 41360

Summary of Non-clinical Testing

Testing was conducted on the Test Pack following the FDA guidance and the standards below:

Guidance for Industry and FDA Staff, Biological Indicator Premarket Notification ● [510(k)] Submissions, October 4, 2007
Premarket Notification [510(k)] Submission for Chemical Indicators: Guidance for ● Industry and FDA Staff, December 19, 2003
. ANSI/AAMI ST79:2017, Comprehensive guide to steam sterilization and sterility assurance in health care facilities
ISO 11140-1:2014 Sterilization of health care products – Chemical indicators, Part 1: General Requirements

Performance testing to demonstrate substantial equivalence to the predicate device has been completed and is summarized below:

Test	Purpose	Acceptance Criteria	Results
Comparison toAAMI 16 TowelPCD	Determine the resistance ofthe Challenge Pack ascompared to an AAMI 16Towel PCD	Challenge Pack is at least asresistant as the biologicalindicator AAMI 16 TowelProcess Challenge Device(PCD) described inANSI/AAMI ST79: 2017	Passed
Comparison toBiological Indicator	Determine the resistance ofthe Challenge Pack ascompared to the BiologicalIndicator alone	Challenge Pack provides agreater resistance than theBiological Indicator alone	Passed

Conclusion

The conclusion drawn from the non-clinical tests performed demonstrates that the subject device is as safe, as effective and perform as well as or better than the legally marketed predicate device, the 3M™ Attest™ Super Rapid 5 Steam-Plus Challenge Pack 41482V (cleared under K193154), Class II (21 CFR 880.2800), product code FRC.

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).