Use the 3M™ Attest™ Rapid Readout Biological Indicator 1295 in conjunction with the 3MTM Attest™ Auto-reader 490H or 490 Auto-reader having software version 4.0.0 or greater or 490M Auto-reader as a standard method of routine monitoring of vaporized hydrogen peroxide sterilization processes in the following systems: AMSCO® V-PRO® I Low Temperature Sterilization System (Lumen cycle), AMSCO® V-PRO® 1 Plus Low Temperature Sterilization System (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 and Flexible cycles), STERIS® V-PRO® maX 2 Low Temperature Sterilization System (Fast Non Lumen, Non Lumen, and Flexible cycles) and in STERRAD® NX (Standard and Advanced cycles), STERRAD® 100NX (Standard, Flex, Express and Duo cycles) systems, STERRAD® NX with AllClear™ Technology (Standard and Advanced cycles) and STERRAD® 100NX with AllClear™ Technology (Standard, Flex, Express and Duo cycles),

Device Description

The 3MTM AttestTM Rapid Readout Biological Indicator 1295 is a self-contained biological indicator specifically designed for rapid and reliable routine monitoring of vaporized hydrogen peroxide sterilization processes when used in conjunction with the 3MTM Attest™ Auto-reader 490H or the 3M™ Attest™ Auto-reader 490 having software version 4.0.0 or greater or a 3M™ Attest™ Mini Auto-reader 490M. The 1295 BI is a single-use device composed of a plastic sleeve containing a spore carrier and media ampoule, enclosed with a color-coded cap. A chemical process indicator printed with stripes which change from blue toward pink upon exposure to vaporized hydrogen peroxide is located on the top of the cap. The detection of fluorescence upon incubation of the 1295 BI in one of the designated Attest™ Auto-readers indicates a sterilization failure.

AI/ML Overview

This document describes regulatory approval for a Biological Indicator (a type of sterilization process indicator) and as such does not contain information on an AI/ML device. Therefore, it is impossible to answer the questions as formulated because the provided text is about a hardware device, not software/AI.

However, based on the provided text, here's a breakdown of the acceptance criteria and study that demonstrates the device meets these criteria for the 3M™ Attest™ Rapid Readout Biological Indicator 1295:

1. Table of Acceptance Criteria and Reported Device Performance

Test Name	Purpose	Acceptance Criteria	Result
Full Cycle Performance	Verify performance in each of the full cycles in the AMSCO® V-PRO™ maX 2 Low Temperature Sterilization System (Lumen, Non-Lumen, Flexible, and Fast Non-Lumen cycles) sterilizer.	All biological indicators display a negative fluorescent and negative growth response.	Pass
Fractional Cycle Performance	Verify performance in fractional cycles for each of the cycles within the AMSCO® V-PRO™ maX 2 Low Temperature Sterilization System (Lumen, Non-Lumen, Flexible, and Fast Non-Lumen cycles).	All biological indicators display a negative fluorescent and negative growth response.	Pass
Chemical Indicator (CI) Color Change	Demonstrate the color change of the CI when exposed to the AMSCO® V-PRO™ maX 2 Low Temperature Sterilization System (Lumen, Non-Lumen, Flexible, and Fast Non-Lumen cycles).	Color change from blue toward pink.	Pass

2. Sample size used for the test set and data provenance:
The document does not specify the exact sample sizes (number of biological indicators) used for each test. The study was a nonclinical performance test conducted to demonstrate performance in a newly claimed sterilizer and its cycles. As such, the provenance is likely from laboratory testing rather than human clinical data (e.g., country of origin, retrospective/prospective). While not explicitly stated, such tests are typically conducted in a controlled lab environment.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable as the device is a biological indicator for sterilization processes. Its performance is measured by biological and chemical responses (fluorescence, growth, color change), not by human interpretation or diagnosis requiring expert ground truth.

4. Adjudication method for the test set:
This information is not applicable for the same reason as point 3. The outcomes are objective measurements of biological and chemical changes.

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 information is not applicable as the device is a biological indicator for sterilization processes, not an AI/ML diagnostic tool for human readers.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This information is not applicable as the device is a biological indicator, not an algorithm or AI. Its "performance" is inherently "standalone" in the sense that it reacts biologically/chemically to sterilization conditions, and then the auto-reader interprets that reaction. There isn't a human-in-the-loop interpretation phase in the same way there would be for an AI diagnostic.

7. The type of ground truth used:
The ground truth is based on the biological viability of Geobacillus stearothermophilus spores and the chemical reaction of the indicator ink.

For Full Cycle and Fractional Cycle Performance: The ground truth is the presence or absence of spore growth, determined by fluorescence and growth response. A "negative" result in a properly sterilized cycle indicates successful killing of spores, which is the desired outcome.
For Chemical Indicator Color Change: The ground truth is the expected color change of the indicator upon exposure to hydrogen peroxide.

8. The sample size for the training set:
This information is not applicable as the device is a biological indicator and not an AI/ML algorithm that requires a training set. The device itself is designed and validated; it does not "learn" from data.

9. How the ground truth for the training set was established:
This information is not applicable as the device is not an AI/ML algorithm and therefore does not have a "training set" or "ground truth for a training set" in the context of机器学习. Its performance is based on its inherent biological and chemical properties, validated through laboratory testing as detailed in point 7.

Summary

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December 11, 2020

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

Re: K200996

Trade/Device Name: 3M™ Attest™ Rapid Readout Biological Indicator Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: Class II Product Code: FRC Dated: November 13, 2020 Received: November 16, 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, Ph.D. 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) K200996

Device Name

3M™ Attest™ Rapid Readout Biological Indicator 1295

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
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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™ Rapid Readout Biological Indicator 1295 K200996

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: December 09, 2020

510(k) Reference: K200996

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PREMARKET NOTIFICATION [510(k)] 3MTM Attest™ Rapid Readout Biological Indicator 1295

1. Device Name and Classification:

Common or Usual Name:	Biological Indicator
Proprietary Name:	3M™ Attest™ Rapid Readout Biological Indicator 1295
Classification Name:	Indicator, biological sterilization process
Device Classification:	Class II, 21 CFR § 880.2800(a)
Product Code:	FRC

2. Predicate Device:

K173435 3M™ Attest™ Rapid Readout Biological Indicator 1295

3. Description of Device:

4. Indications for Use

Use the 3M™ Attest™ Rapid Readout Biological Indicator 1295 in conjunction with the 3M™ Attest™ Auto-reader 490H or 490 Auto-reader having software version 4.0.0 or greater or 490M Auto-reader as a standard method of routine monitoring of vaporized hydrogen peroxide sterilization processes in the following systems: AMSCO® V-PRO® 1 Low Temperature Sterilization System (Lumen cycle), AMSCO® V-PRO® 1 Plus Low Temperature Sterilization System (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), STERIS® V-PRO® maX 2 Low Temperature Sterilization System (Fast Non Lumen, Lumen, Non Lumen, and Flexible cycles) and in STERRAD® 100S, STERRAD® NX (Standard and Advanced cycles), STERRAD® 100NX (Standard, Flex, Express and Duo cycles) systems, STERRAD® NX with AllClear™ Technology (Standard and Advanced cycles) and STERRAD® 100NX with AllClear™ Technology (Standard, Flex, Express and Duo cycles).

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PREMARKET NOTIFICATION [510(k)] 3MTM Attest™ Rapid Readout Biological Indicator 1295

	Submission Device:3MTM AttestTM Rapid ReadoutBiological Indicator 1295	Predicate Device (K173435):3MTM AttestTM Rapid ReadoutBiological Indicator 1295	Comparison
Feature	Use the 3MTM Attest™ RapidReadout Biological Indicator 1295in conjunction with the 3MTMAttest™ Auto-reader 490H or 490Auto-reader having softwareversion 4.0.0 or greater or 490MAuto-reader as a standard method ofroutine monitoring of vaporizedhydrogen peroxide sterilizationprocesses in the following systems:AMSCO® V-PRO® 1 LowTemperature Sterilization System(Lumen cycle), AMSCO® V-PRO® 1 Plus Low TemperatureSterilization System (Lumen andNon Lumen cycles), AMSCO® V-PRO® maX Low TemperatureSterilization System (Lumen, NonLumen, and Flexible cycles),AMSCO® V-PRO® 60 LowTemperature Sterilization System(Lumen, Non Lumen and Flexiblecycles), STERIS® V-PRO® maX 2Low Temperature SterilizationSystem (Fast Non Lumen, Lumen,Non Lumen, and Flexible cycles)and in STERRAD® 100S,STERRAD® NX (Standard andAdvanced cycles), STERRAD®100NX (Standard, Flex, Expressand Duo cycles) systems,STERRAD® NX with AllClearTMTechnology (Standard andAdvanced cycles) and STERRAD®100NX with AllClearTMTechnology (Standard, Flex,Express and Duo cycles).	Use the 3MTM Attest™ RapidReadout Biological Indicator 1295in conjunction with the 3MTMAttest™ Auto reader 490H as astandard method of routinemonitoring of vaporized hydrogenperoxide sterilization processes inthe following systems: AMSCO®V-PROTM 1 Low TemperatureSterilization System (Lumen cycle),AMSCO® V-PROTM 1 Plus LowTemperature Sterilization System(Lumen and Non Lumen cycles),AMSCO® V-PROTM maX LowTemperature Sterilization System(Lumen, Non Lumen, and Flexiblecycles), AMSCO® V-PROTм 60Low Temperature SterilizationSystem (Lumen, Non Lumen andFlexible cycles) and in STERRAD®100S, STERRAD® NX (Standardand Advanced cycles), STERRAD®100NX (Standard, Flex, Expressand Duo cycles) systems,STERRAD® NX with ALLClearTMTechnology (Standard andAdvanced cycles) and STERRAD®100NX with ALLClear™Technology (Standard, Flex,Express and Duo cycles).	Addition ofthe 490 and490M Auto-readersandAddition oftheSTERIS®V-PRO®max 2 LowTemperatureSterilizationSystem(Fast NonLumen,Lumen, NonLumen, andFlexiblecycles)sterilizer
Indications for use
Organism	Geobacillus stearothermophilustraceable to ATCCTM 7953	Geobacillus stearothermophilustraceable to ATCCTM 7953	Identical
Viable sporepopulation	$≥1x10^6$	$≥1x10^6$	Identical
Resistancecharacteristics	(Tested at 10 mg/L vaporizedhydrogen peroxide)	(Tested at 10 mg/L vaporizedhydrogen peroxide)
• D-value	$D_{10 mg/L} ≥ 1 second$	$D_{10 mg/L} ≥ 1 second$	Identical
• Survival/KillWindow	Survival Time ≥ 5 secondsKill Time = 7 minutes	Survival Time ≥ 5 secondsKill Time = 7 minutes
Carrier material	Polyethylene terephthalate	Polyethylene terephthalate	Identical
Incubationtemperature	60 ± 2°C	60 ± 2°C	Identical
Feature	Submission Device:3MTM AttestTM Rapid ReadoutBiological Indicator 1295	Predicate Device (K173435):3MTM AttestTM Rapid ReadoutBiological Indicator 1295	Comparison
Chemicalindicator	H2O2 sensitive ink; changes fromblue towards pink	H2O2 sensitive ink; changes fromblue towards pink	Identical
Shelf life	Two (2) years	Two (2) years	Identical

5. Technological Characteristic Comparison Table

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PREMARKET NOTIFICATION [510(k)] 3M™ Attest™ Rapid Readout Biological Indicator 1295

6. Nonclinical Comparison to the Predicate Device

The 3MTM Attest™ Rapid Readout Biological Indicator 1295 is identical to the previously cleared device of the same model number (the predicate) which is sold under the same tradename and cleared via K173435.

To demonstrate performance in the newly claimed sterilizer and cycles, nonclinical testing was performed in accordance with the FDA Guidance for Industry and FDA Staff: Biological Indicator (BI) Premarket Notification [510(k)] Submissions, and ANSI/AAMI/ISO 11138-1:2017 Sterilization of health care products- Biological Indicators- Part 1: General requirements (FDA Recognition Number 14-502).

Reference Table 6.1 for testing completed in AMSCO® V-PRO™ maX 2 Low Temperature Sterilization System (Lumen, Non-Lumen, Flexible, and Fast Non-Lumen cycles).

Test Name	Purpose	Acceptance Criteria	Result
Full CyclePerformance	Verify performance in each of thefull cycles in the AMSCO® V-PRO™ maX 2 Low TemperatureSterilization System (Lumen, Non-Lumen, Flexible, and Fast Non-Lumen cycles) sterilizer.	All biological indicators display anegative fluorescent and negativegrowth response.	Pass
Fractional CyclePerformance	Verify performance in fractionalcycles for each of the cycleswithin the AMSCO® V-PRO™maX 2 Low TemperatureSterilization System (Lumen, Non-Lumen, Flexible, and Fast Non-Lumen cycles).	All biological indicators display anegative fluorescent and negativegrowth response.	Pass
ChemicalIndicator (CI)Color Change	Demonstrate the color change ofthe CI when exposed to theAMSCO® V-PRO™ maX 2 LowTemperature Sterilization System(Lumen, Non-Lumen, Flexible,and Fast Non-Lumen cycles).	Color change from blue towardpink.	Pass

Table 6.1 Summary of Nonclinical Testing

Addition of 3M™ Attest™ Auto-reader 490 having software version 4.0.0 or ● greater per K173437 and K173584.
Addition of 3MTM Attest™ Mini Auto-reader 490M per K200092. ●

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7. Conclusion

Based on the non-clinical performance data, the 3M™ Attest™ Rapid Readout Biological Indicator 1295 is as safe, as effective, and performs as well as or better than the legally marketed predicate, the 3M™ Attest™ Rapid Readout Biological Indicator 1295 cleared under K173435, 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).