Use the Attest 1292 RRBI to monitor: 1. 250°F (121°C) gravity steam sterilization cycles. 2. 270°F (132°C) vacuum assisted steam sterilization cycles.

Device Description

The 3M™ Attest™ 1292 Rapid Readout Biological Indicator, RRBI, is a dual readout biological indicator system specifically designed for rapid and reliable monitoring of steam sterilization process when used in conjunction with the 3M™ Attest™ 190/290 Auto-readers. The Attest 1292 RRBI detects the presence of Geobacillus stearothermophilus, (formerly known as Bacillus stearothermophilus), by detecting the activity of alpha-glucosidase, an enzyme present within the organism. The presence of the enzyme is detected by reading fluorescence produced by the enzymatic breakdown of a non-fluorescent substrate. This creates a fluorescence change, which is detected by the Attest 290 Autoreader. A fluorescence change indicates a steam sterilization process failure, The Attest 1292 RRBI also detects the presence of G. stearothermophilus organisms by a visual color change reaction. Biochemical activity of the G. stearothermophilus organism produces acid by-products that cause the media to change color from purple to yellow. A visual pH color change also indicates a steam sterilization process failure. The 3M™ Attest™ Rapid Read-Out Biological Indicator is identical in design and performance specifications (with exception of the calculation of survival/kill) to the predicate device.

AI/ML Overview

The provided text does not contain detailed information regarding the acceptance criteria, specific study results, sample sizes, expert qualifications, or adjudication methods typically found in a clinical or performance study report for an AI/ML medical device. The document is a 510(k) summary for a biological indicator (3M Attest Rapid Read-Out Biological Indicator #1292), which is a device used to monitor sterilization processes, not an AI/ML algorithm.

Therefore, most of the requested information regarding acceptance criteria and study details for an AI/ML device cannot be extracted from this document.

However, I can provide what little information is available from the document about the device and its claimed performance, even though it's not in the context of AI/ML evaluation.

Here's a response based only on the provided text, heavily indicating the lack of information for AI/ML specific questions:

1. Table of Acceptance Criteria and Reported Device Performance

The document describes the device's function and a modification. It does not provide explicit "acceptance criteria" in the format typically seen for AI/ML performance, nor detailed performance metrics beyond its intended use.

Acceptance Criteria (Implied)	Reported Device Performance (Implied)
Detect presence of Geobacillus stearothermophilus via alpha-glucosidase activity	Detects enzyme activity by reading fluorescence produced by enzymatic breakdown of a non-fluorescent substrate. A fluorescence change indicates failure.
Detect presence of G. stearothermophilus via visual color change reaction	Biochemical activity produces acid by-products, causing media to change color from purple to yellow. A visual pH color change indicates failure.
Functionality with 3M™ Attest™ 190/290 Auto-readers	Specifically designed for use with these auto-readers.
Monitoring 250°F (121°C) gravity steam sterilization cycles	Indicated for this use.
Monitoring 270°F (132°C) vacuum assisted steam sterilization cycles	Indicated for this use.
Performance identical to predicate device (K926364)	Claims to be identical in design and performance specifications (with exception of the calculation of survival/kill).
Ability to calculate survival/kill on a lot-by-lot basis (modification)	The purpose of the 510(k) filing is to move to this calculated method.

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

This information is not provided in the 510(k) summary. The document is for a biological indicator, not an AI/ML device where "test set" and "data provenance" are typically discussed in the context of training and validation of a model. The modification described is related to the method of calculating survival/kill for the biological indicator.

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 and not provided in the 510(k) summary for this type of device. There is no mention of expert review or ground truth establishment in the context of diagnostic interpretation by AI/ML.

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

This information is not applicable and not provided in the 510(k) summary for this type of device.

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 and not provided. The device is a biological indicator for sterilization, not an AI-assisted diagnostic tool.

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

This information is not applicable. The device is a biological indicator; it does not involve algorithms or human-in-the-loop performance in the AI/ML sense. It interacts with an auto-reader, but this is a chemical-biological sensor system, not an AI system.

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

For a biological indicator, the "ground truth" would typically be defined by established microbiological standards for sterilization efficacy (e.g., complete kill of Geobacillus stearothermophilus after a specific sterilization cycle). The document implies this by stating the device detects the presence of the organism and indicates sterilization failure. However, the specific methodology for establishing this "ground truth" in their testing is not detailed.

8. The sample size for the training set

This information is not applicable and not provided. The device is not an AI/ML model that undergoes "training."

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

This information is not applicable. As stated, the device is not an AI/ML model and therefore does not have a "training set" in that context.

Summary

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4.0 510(k) Summary

K090569
p 1 of 2

3M™ Attest™ Rapid Read-Out Biological Indicator (#1292)

1. Sponsor:

3M Infection Prevention Division 3M Center, Bldg 275-5W-06 St. Paul, MN 55144

APR 9 9 2009

Contact Person: Bryan Becker Regulatory Affairs Specialist Infection Prevention Division 3M Center, Bldg 275-5W-06 St. Paul, MN 55144 Phone: 651-733-3373 651-737-5320 Fax: email: bbecker@mmm.com

2. Device Name

a. Proprietary Name: 3M™ Attest™ Rapid Read-Out Biological Indicator (#1292)

b. Device Common/Usual Name: Biological indicator

c. Device Classification Name: Biological Sterilization Process Indicators

3. Identification of Predicate Device:

3M™ Attest™ Rapid Read-Out Biological Indicator (#1292), K926364

4. Device Description:

The Attest 1292 RRBI detects the presence of Geobacillus stearothermophilus, (formerly known as Bacillus stearothermophilus), by detecting the activity of alpha-glucosidase, an enzyme present within the organism. The presence of the enzyme is detected by reading fluorescence produced by the enzymatic breakdown of a non-fluorescent substrate. This creates a fluorescence change, which is detected by the Attest 290 Autoreader. A fluorescence change indicates a steam sterilization process failure, The Attest 1292 RRBI also detects the presence of G. stearothermophilus organisms by a visual color change reaction. Biochemical activity of the G. stearothermophilus organism produces acid by-products that cause the media

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p. 2 of 2

to change color from purple to yellow. A visual pH color change also indicates a steam sterilization process failure. The 3M™ Attest™ Rapid Read-Out Biological Indicator is identical in design and performance specifications (with exception of the calculation of survival/kill) to the predicate device.

5. Indication For Use:

Use the Attest 1292 RRBI to monitor:

1. 250°F (121°C) gravity steam sterilization cycles.
1. 270°F (132°C) vacuum assisted steam sterilization cycles.

6. Description of Modification

The purpose of this filing is to move from a survival tested at 5 minutes and a kill tested at 15 minutes to a calculated survival/kill testing on a lot-by-lot basis.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Bryan Becker Regulatory Affairs Specialist 3M Company 3M Center, Building 275-5W-06 Saint Paul, Minnesota 55133-3275

APR 2 9 2009

Re: K090569

Trade/Device Name: 3MTM Attest™ Rapid Read -Out Biological Indicator (#1292) Regulation Number: 880.2800 Regulatory Class: Il Product Code: FRC Dated: April 22, 2009 Received: April 23, 2009

Dear Mr. Becker:

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.

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 (reporting of medical device-related adverse events) (21 CFR 803); 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.

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Page 2 Mr. Becker

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0100. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Anithony V. Walton for

Susan Runner, D.D.S., M.A. Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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1.0 Indications for Use

510(k) Number (if known): K090569

Device Name: 3M™ Attest™ Rapid Read-Out Biological Indicator (#1292)

Indications For Use:

Use the Attest 1292 RRBI to monitor: 1. 250°F (121°C) gravity steam sterilization cycles. 2. 270°F (132°C) vacuum assisted steam sterilization cycles.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use X (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IFNEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Shule B. Murphy, ans

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K990529

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).