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:

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)

Device Description

The 3M™ Attest™ 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

The provided text describes the 3M™ Attest™ Rapid Readout Biological Indicator 1295 and its performance in a non-clinical study to demonstrate its effectiveness in additional sterilization cycles.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and the Reported Device Performance:

Test Name	Purpose	Acceptance Criteria	Reported Device Performance
Full Cycle Performance	Verify performance in each of the full cycles in the V-PRO® s2 Low Temperature Sterilization System (Lumen, Non Lumen, Flexible, and Fast cycles).	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 V-PRO® s2 Low Temperature Sterilization System (Lumen, Non Lumen, Flexible, and Fast 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 V-PRO® s2 Low Temperature Sterilization System (Lumen, Non Lumen, Flexible, and Fast cycles).	Color change from blue toward pink.	Pass

2. Sample size used for the test set and the data provenance:

Sample Size: The document does not explicitly state the exact sample size (number of biological indicators) used for each test. However, it indicates tests were conducted in "each of the full cycles" and "fractional cycles" within the V-PRO® s2 system, implying multiple indicators were used per cycle type.
Data Provenance: The study was a non-clinical testing performed by the device sponsor (3M Health Care) to support a premarket notification (510(k)). The data provenance is from internal testing conducted by the manufacturer. The country of origin of the data is not specified, but the sponsor is located in St. Paul, Minnesota, USA. The study is a prospective test designed to evaluate the device's performance under specified conditions.

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. The ground truth (i.e., whether sterilization was successful or not) is determined by the biological indicator's response (negative fluorescent and negative growth response for sterility) and the chemical indicator's color change, not by expert interpretation of complex data.

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

This information is not applicable. The outcome of the biological indicator (fluorescence and growth response) and the chemical indicator (color change) are objective readings, not subject to subjective adjudication by multiple readers.

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. The device is a biological indicator, not an AI software intended for interpretation by human readers. It functions as a standalone indicator to confirm sterilization.

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

Yes, the study described is a standalone performance evaluation of the biological indicator. Its function is to independently indicate sterilization success or failure based on its biological and chemical responses, which are then read by a compatible auto-reader. The auto-reader (3M™ Attest™ Auto-reader 490H, 490 with software version 4.0.0+, or 490M) performs the "reading" of the biological indicator without human interpretation of raw data.

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

The ground truth is derived from the biological response of Geobacillus stearothermophilus spores on the indicator and the chemical reaction of the indicator.

For the full and fractional cycle performance, the ground truth for successful sterilization is a "negative fluorescent and negative growth response" from the biological indicator, meaning the sterilization process successfully killed the spores.
For the chemical indicator, the ground truth for successful exposure to the sterilant is a "color change from blue toward pink."

This is based on the principle that if the spores are killed and the chemical indicator changes color, the sterilization cycle has been effective.

8. The sample size for the training set:

This information is not applicable as this is a biological indicator, not an AI/machine learning device that requires a training set. The device's function is mechanistic based on biological and chemical reactions, not learned from data.

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

This information is not applicable for the same reason as point 8.

Summary

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March 3, 2021

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

Re: K210277

Trade/Device Name: 3M Attest Rapid Readout Biological Indicator, 1295 Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: Class II Product Code: FRC Dated: January 28, 2021 Received: February 1, 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 and Part 809); 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)

K210277

Device Name

3M™ Attest™ Rapid Readout Biological Indicator 1295

Indications for Use (Describe)

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)

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™ Attest™ Rapid Readout Biological Indicator 1295

Sponsor Information:

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

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

Date of Summary: January 28, 2021

510(k) References: K210277

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PREMARKET NOTIFICATION [510(k)] 3M™ 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:

K200996 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:

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

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, Flexible, and Fast cycles)

Technological Characteristic Comparison Table

Feature	Submission Device:3MTM Attest™ Rapid ReadoutBiological Indicator 1295	Predicate Device (K200996):3MTM Attest™ Rapid ReadoutBiological Indicator 1295	Comparison
Indications for use	Use the 3MTM Attest™ RapidReadout Biological Indicator 1295in conjunction with the 3MTMAttest™ Auto-reader 490H or 490Auto-reader having software version4.0.0 or greater or 490M Auto-reader as a standard method ofroutine monitoring of vaporizedhydrogen peroxide sterilizationprocesses in the following systems:STERRAD 100S® SterilizationSystem	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 AllClear™Technology (Standard andAdvanced cycles) and STERRAD®100NX with AllClear™Technology (Standard, Flex,Express and Duo cycles).	Addition ofthe V-PRO®s2 LowTemperatureSterilizationSystem(Lumen, NonLumen,Flexible, andFast cycles)
	STERRAD NX® SterilizationSystem (Standard and Advancedcycles)
	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 Non Lumencycles)
	V-PRO® maX Low TemperatureSterilization System (Lumen,Non Lumen, and Flexiblecycles)
	V-PRO® 60 Low TemperatureSterilization System (Lumen,Non Lumen and Flexible cycles)
	V-PRO® maX 2 LowTemperature SterilizationSystem (Lumen, Non Lumen,

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

Feature	Submission Device:3MTM Attest™ Rapid ReadoutBiological Indicator 1295	Predicate Device (K200996):3MTM Attest™ Rapid ReadoutBiological Indicator 1295	Comparison
	Flexible, and Fast Non Lumencycles)V-PRO® s2 Low TemperatureSterilization System (Lumen,Non Lumen, Flexible, and Fastcycles)
Organism	Geobacillus stearothermophilustraceable to ATCCTM 7953	Geobacillus stearothermophilustraceable to ATCCTM 7953	Identical
Viable sporepopulation	≥1x106	≥1x106	Identical
Resistancecharacteristics	(Tested at 10 mg/L vaporizedhydrogen peroxide)	(Tested at 10 mg/L vaporizedhydrogen peroxide)
• D-value	D10 mg/L≥ 1 second	D10 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
Readout time	24 minute fluorescence result read	24 minute fluorescence result read	Identical
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. Nonclinical Comparison to the Predicate Device

The 3M™ 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 K200996.

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 5.1 for testing completed in V-PRO® s2 Low Temperature Sterilization System (Lumen, Non Lumen, Flexible, and Fast cycles)

Test Name	Purpose	Acceptance Criteria	Result
Full CyclePerformance	Verify performance in each of thefull cycles in the V-PRO® s2 LowTemperature Sterilization System(Lumen, Non Lumen, Flexible,and Fast cycles).	All biological indicators display anegative fluorescent and negativegrowth response.	Pass

Table 5.1 Summary of Nonclinical Testing

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

Fractional CyclePerformance	Verify performance in fractionalcycles for each of the cycleswithin the V-PRO® s2 LowTemperature Sterilization System(Lumen, Non Lumen, Flexible,and Fast cycles).	All biological indicators display anegative fluorescent and negativegrowth response.	Pass
ChemicalIndicator (CI)Color Change	Demonstrate the color change ofthe CI when exposed to the V-PRO® s2 Low TemperatureSterilization System (Lumen, NonLumen, Flexible, and Fast cycles).	Color change from blue towardpink.	Pass

6. 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 or better than the legally marketed predicate, the 3M™ Attest™ Rapid Readout Biological Indicator 1295 cleared under K200996, 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).