Use the 3M™ Attest™ Rapid Readout Biological Indicator 1295 in conjunction with the 3M Attest™ Auto reader 490H as a standard method of routine monitoring of vaporized hydrogen peroxide sterilization processes in the Amsco® V-PRO® maX Low Temperature Sterilization System (Lumen, and Flexible cycles), and in STERRAD® 100S, STERRAD® NX (Standard and Advanced cycles) and 100NX (Standard, Flex, Express and Duo cycles) systems.

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 3M™ Attest™ Auto-reader 490H. The 1295 BI is a single-use device composed of a polycarbonate 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 to pink upon exposure to vaporized hydrogen peroxide is located on the top of the cap. The 1295 BI utilizes the same fundamental technology that exists in current 3M™ Attest™ Rapid Readout and Super Rapid Readout BIs. The detection of fluorescence upon incubation of the 1295 BI in the 490H Auto-reader indicates a sterilization failure.

AI/ML Overview

This document is a 510(k) Premarket Notification for the 3M™ Attest™ Rapid Readout Biological Indicator 1295. Its purpose is to demonstrate substantial equivalence to a legally marketed predicate device. Therefore, the information provided focuses on the device's technical specifications and performance when used in specific sterilization systems, rather than a clinical study of diagnostic accuracy typically associated with AI/ML-driven medical devices.

Despite the fact the question doesn't align with the content, I will extract relevant information that resembles the structure requested.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are not explicitly stated in a quantitative table format suitable for diagnostic performance metrics (e.g., sensitivity, specificity). Instead, they are implied through "Pass/Fail" results of various verification tests. The "performance" is the device's ability to demonstrate effective sterilization or sterilization failure.

Test	Acceptance Criteria (Implied)	Reported Device Performance
Verification of performance in full cycles in the Amsco® V-PRO® maX Low Temperature Sterilization System (Lumen, Non Lumen, and Flexible cycles)	BI must correctly indicate sterilization or failure	Passed
Growth promotion ability in the Amsco® V-PRO® maX Low Temperature Sterilization System (Lumen, Non Lumen, and Flexible cycles)	BI must promote growth of viable spores	Passed
Verification of half cycles in the Amsco® V-PRO® maX Low Temperature Sterilization System (Lumen, Non Lumen, and Flexible cycles)	BI must correctly indicate sterilization failure in partial cycles	Passed
Verification of performance in fractional cycles in the Amsco® V-PRO® maX Low Temperature Sterilization System	BI must correctly indicate sterilization failure in fractional cycles	Passed
Verification of 4-hour fluorescent readout per FDA's Reduced Incubation Time protocol in the Amsco® V-PRO® maX Low Temperature Sterilization System	BI must provide accurate fluorescent readout within 4 hours	Passed
Verification of population and resistance characteristics (D-value, survival, kill) at the end of shelf life in the Amsco® V-PRO® maX Low Temperature Sterilization System (Lumen, Non Lumen, and Flexible cycles)	BI must maintain specified D-value, survival, and kill characteristics	Passed

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

The document does not explicitly state the sample sizes (number of biological indicators or sterilization cycles) used for each individual test. The term "test set" is not directly applicable in the context of this device as it refers to a validation process for an AI/ML model. Instead, these are non-clinical verification tests of a biological indicator.
The data provenance is not specified by country of origin, but the testing was conducted to prove the effectiveness of the BI in the Amsco® V-PRO® maX Low Temperature Sterilization System. The studies are non-clinical and likely performed in a laboratory setting. These are prospective tests of the device's performance, not retrospective analysis of existing data.

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

This information is not applicable. The device is a biological indicator designed to detect sterilization failure based on the growth of Geobacillus stearothermophilus spores. The "ground truth" for these tests relates to microbiologic viability and efficacy of sterilization, not expert interpretation of medical images or clinical data. The assessment of "Pass/Failed" for the tests would be based on established scientific protocols for biological indicator evaluation, not expert consensus in the diagnostic sense.

4. Adjudication Method for the Test Set

This information is not applicable. Adjudication methods like 2+1 or 3+1 are typically used for resolving discrepancies in expert interpretations of diagnostic data. The "tests" performed for this biological indicator involve standardized laboratory procedures with objective endpoints (e.g., spore growth/no growth, fluorescence detection).

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

This information is not applicable, as the device is not an AI-assisted diagnostic tool for human readers. It is a biological indicator for monitoring sterilization processes. Therefore, no MRMC study was conducted, and there is no "human reader improvement with AI" to report.

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

This information is not applicable in the context of an "algorithm only" performance. The device itself (the 3M™ Attest™ Rapid Readout Biological Indicator 1295 in conjunction with the 3M Attest™ Auto-reader 490H) operates autonomously to detect sterilization failure. Its performance is evaluated directly through the non-clinical tests listed. There is no human involved in the interpretation of the biological indicator's direct result (fluorescence as detected by the auto-reader).

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The ground truth for the in vitro performance tests is based on microbiological and physical measurements related to sterilization efficacy. This includes:

The known viability and resistance characteristics of Geobacillus stearothermophilus spores.
The controlled conditions of the sterilization cycles (full, half, fractional).
The ability of the indicator to show growth when viable spores are present (lack of sterilization) and no growth when spores are killed (successful sterilization).
Objective measurements of fluorescence and color change.

8. The Sample Size for the Training Set

This information is not applicable, as the device is not an AI/ML model that requires a "training set." It is a physical biological indicator.

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

This information is not applicable as there is no training set for this type of device.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

June 9, 2016

3M Health Care Ms. Hilary B. Hovde 3M Health Care Regulatory Affairs Specialist 3M Center, Building 275-5W-06 St. Paul, Minnesota 55144

Re: K160546

Trade/Device Name: 3M™ Attest™ Rapid Readout Biological Indicator 1295 Regulation Number: 21 CFR 880.2800 Regulation Name: Indicator, Biological Sterilization Process Regulatory Class: Class II Product Code: FRC Dated: May 12, 2016 Received: May 17, 2016

Dear Hilary B. Hovde:

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 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

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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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

Tejashri Purohit-Sheth, M.D.

Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR

Erin I. Keith, M.S. Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K160546

Device Name

3MTM Attest™ Rapid Readout Biological Indicator 1295

Indications for Use (Describe)

Use the 3MM Attest™ Rapid Readout Biological Indicator 1295 in conjunction with the 3M Attest™ Auto reader 490H as a standard method of routine monitoring of vaporized hydrogen peroxide sterilization processes in the Amsco® V-PRO® maX Low Temperature Sterilization System (Lumen, and Flexible cycles), and in STERRAD® 100S, STERRAD® NX (Standard and Advanced cycles) and 100NX (Standard, Flex, Express and Duo cycles) systems.

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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FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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Premarket Notification (510(k)) Summary K160546

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Sponsor Information:

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

Contact Person: Hilary B. Hovde Regulatory Affairs Associate Phone Number: (651) 736-0364 FAX Number: (651) 737-5320

Date of Summary: June 7, 2016

Device Name and Classification:

Common or Usual Name: Biological Indicator Proprietary Name: 3MTM Attest™ Rapid Readout Biological Indicator 1295 Classification Name: Indicator, Biological Sterilization Process Device Classification: Class II, 21 CFR 880.2800(a) Product Code: FRC

Predicate Devices:

K152060 3MTM Attest™ Rapid Readout Biological Indicator 1295 .

Description of Device:

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Nonclinical Comparison to the Predicate Device

This submission is addressing clearance for use in an additional sterilizer. The 3MIM Attest™ Rapid Readout Biological Indicator 1295 is the same design as the previously cleared device of the same model number. The device has the same materials, performance specifications, and fundamental scientific technology.

Summary of Nonclinical Testing

The effectiveness of the 3M™ Attest™ Rapid Readout Biological Indicator 1295 in the Amsco® V-PRO® maX Low Temperature Sterilization System (Lumen, Non Lumen, and Flexible cycles) is demonstrated in the following tests:

Test	Results
Verification of performance in full cycles in the Amsco® V-PRO® maX LowTemperature Sterilization System (Lumen, Non Lumen, and Flexible cycles)	Passed
Growth promotion ability in the Amsco® V-PRO® maX Low TemperatureSterilization System (Lumen, Non Lumen, and Flexible cycles)	Passed
Verification of half cycles in the Amsco® V-PRO® maX Low TemperatureSterilization System (Lumen, Non Lumen, and Flexible cycles)	Passed
Verification of performance in fractional cycles in the Amsco® V-PRO®maX Low Temperature Sterilization System	Passed
Verification of 4-hour fluorescent readout per FDA's Reduced IncubationTime protocol in the Amsco® V-PRO® maX Low Temperature SterilizationSystem	Passed
Verification of population and resistance characteristics (D-value, survival,kill) at the end of shelf life in the Amsco® V-PRO® maX Low TemperatureSterilization System (Lumen, Non Lumen, and Flexible cycles)	Passed

Summary of Clinical Testing

No clinical data was included in this premarket application submission.

Indications for Use

Use the 3M™ Attest™ Rapid Readout Biological Indicator 1295 in conjunction with the 3M Attest™ Auto reader 490H as a standard method of routine monitoring of vaporized hydrogen peroxide sterilization processes in the AMSCO® V-PRO® maX Low Temperature Sterilization System (Lumen, Non Lumen, and Flexible cycles), and in STERRAD® 100S, STERRAD® NX (Standard and Advanced cycles) and 100NX (Standard, Flex, Express and Duo cycles) systems.

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Comparison to Predicate Device

Feature	Submission Device: 3MTMAttestTM 1295 Biological Indicator	Predicate Device (K152060):3MTM AttestTM 1295 BiologicalIndicator
Indications for use	Use the 3MTM Attest™ Rapid ReadoutBiological Indicator 1295 inconjunction with the 3M Attest™ Autoreader 490H as a standard method ofroutine monitoring of vaporizedhydrogen peroxide sterilizationprocesses in the Amsco® V-PRO®maX Low Temperature SterilizationSystem (Lumen, Non Lumen, andFlexible cycles), and in STERRAD®100S, STERRAD® NX (Standard andAdvanced cycles) and 100NX(Standard, Flex, Express and Duocycles) systems.	Use the 3MTM Attest™ RapidReadout Biological Indicator 1295in conjunction with the 3MAttest™ Auto-reader 490H as astandard method of routinemonitoring of vaporized hydrogenperoxide sterilization processes inSTERRAD® 100S, STERRAD®NX (Standard and Advancedcycles) and 100NX (Standard, Flex,Express and Duo cycles) systems.
Organism	Geobacillus stearothermophilustraceable to ATCCTM 7953	Same
Viable sporepopulation	≥1x106	Same
Resistancecharacteristics	(Tested at 10 mg/L vaporized hydrogenperoxide)D-value D10 mg/L ≥ 1 second Survival/Kill Survival Time ≥ 5 seconds Window Kill Time = 7 minutes	Same
Carrier material	Polyethylene terephthalate	Same
Incubationtemperature	60 +/- 2 °C	Same
Readout time	4 hour fluorescence result read on 3M490H Auto-reader	Same
Chemicalindicator	H2O2 sensitive ink; appears blue untilprocessed, then appears pink	Same
Shelf-life	18 months	Same

Conclusion

The 3M™ Attest™ Rapid Readout Biological Indicator 1295 is substantially equivalent to the predicate device in terms of their intended use, physical properties and technological characteristics. The non-clinical testing demonstrates that the 1295 Biological Indicator is as safe, as effective, and performs as well as the predicate device.

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).