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 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 STERRAD® 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 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 Autoreader indicates a sterilization failure.

AI/ML Overview

This document describes a premarket notification (510(k)) for the 3M™ Attest™ Rapid Readout Biological Indicator 1295.

Here's an analysis of the provided text in relation to your request:

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

The document does not explicitly state "acceptance criteria" for the entire device as one might expect for a diagnostic or imaging AI. Instead, it presents a comparison to a predicate device, focusing on specific performance characteristics of the biological indicator (BI). The assumption is that the new device's performance matching the predicate device, especially for the additional sterilizer, meets the regulatory requirements.

Here's a table derived from the "Comparison to Predicate Device" section, identifying the characteristics (which serve as performance metrics for this type of device) and their reported values. The "acceptance criteria" here are implicitly that the device performs the same as the predicate device for these characteristics.

Acceptance Criteria (Implicit: Same as Predicate)	Reported Device Performance (3M™ Attest™ 1295 Biological Indicator)
Organism: Geobacillus stearothermophilus traceable to ATCC™ 7953	Geobacillus stearothermophilus traceable to ATCC™ 7953
Viable spore population: ≥1x10^6	≥1x10^6
Resistance characteristics:
• D-value: (Tested at 10 mg/L vaporized hydrogen peroxide) D10 mg/L ≥ 1 second	(Tested at 10 mg/L vaporized hydrogen peroxide) D10 mg/L ≥ 1 second
• Survival Time: > 5 seconds	Survival Time > 5 seconds
• Kill Time: = 7 minutes	Kill Time = 7 minutes
Carrier material: Polyethylene terephthalate	Polyethylene terephthalate
Incubation temperature: 60 +/- 2 °C	60 +/- 2 °C
Readout time: 4 hour fluorescence result read on 3M 490H Auto-reader	4 hour fluorescence result read on 3M 490H Auto-reader
Chemical indicator: H2O2 sensitive ink; appears blue until processed, then appears pink	H2O2 sensitive ink; appears blue until processed, then appears pink
Shelf-life: 18 months	18 months

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 states: "No clinical data was included in this premarket application submission." This implies that testing was nonclinical. For biological indicators, this typically involves laboratory testing under controlled conditions rather than human patient data.

Sample size for test set: Not explicitly stated in terms of number of biological indicators tested, but implied to be sufficient for nonclinical testing.
Data provenance: Not explicitly stated, but the nature of the device (biological indicator) suggests lab-based, controlled experiments rather than clinical data from a specific country or retrospective/prospective collection related to human subjects.

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)

Not applicable. For a biological indicator, the "ground truth" is typically established by physical/chemical properties and microbiological testing (e.g., presence or absence of viable spores after sterilization, fluorescence detection) rather than expert human interpretation.

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

Not applicable, as no human expert interpretation or adjudication is mentioned for establishing the ground truth or evaluating performance.

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

Not applicable. This device is a biological indicator for sterilization processes, not an AI or imaging device that would involve human readers or MRMC studies.

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

This concept is not directly applicable to a biological indicator. The "device" in this context is the BI itself, which functions by a chemical and biological reaction detected by an auto-reader. The performance described is inherent to the BI and its interaction with the sterilization process and the auto-reader, without a "human-in-the-loop" in the diagnostic sense. The comparison provided is for the BI's performance alone against its predicate.

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

The "ground truth" for a biological indicator is based on:

Microbiological viability testing: Determining the presence or absence of viable Geobacillus stearothermophilus spores after exposure to sterilization conditions.
Physical/chemical properties: Verifying D-value, survival time, kill time, and chemical indicator color change.
The effectiveness of the sterilization process itself, often validated against established standards.

8. The sample size for the training set

Not applicable. This device is a biological indicator, not an AI/machine learning algorithm that requires a "training set."

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

Not applicable. No training set is involved.

Summary

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

December 1, 2015

3M Health Care Dr. Matt S. Mortensen, Ph.D., RAC Regulatory Affairs Specialist 3M Center, Bldg. 275-5W-06 St. Paul. MN 55144

Re: K152060

Trade/Device Name: 3M™ Attest™ Rapid Readout Biological Indicator 1295 Regulation Number: 21 CFR 880.2800(a) Regulation Name: Biological sterilization process indicator Regulatory Class: II Product Code: FRC Dated: October 20, 2015 Received: October 28, 2015

Dear Dr. Mortensen,

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.

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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 devicerelated 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/ResourcesforYou/Industry/default.htm. 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

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 yours,

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) K152060

Device Name

3MTM Attest™ Rapid Readout Biological Indicator 1295

Indications for Use (Describe)

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)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

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

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Premarket Notification (510(k)) Summary

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Sponsor Information:

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

Contact Person: Matt S. Mortensen, Ph.D., RAC Regulatory Affairs Phone Number: (651) 737-2670 FAX Number: (651) 737-5320

Date of Summary: October 19, 2015

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

Predicate Devices:

K140392 3MTM Attest™ Rapid Readout Biological Indicator 1295 .

Description of Device:

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Readout BIs. The detection of fluorescence upon incubation of the 1295 BI in the 490H Autoreader indicates a sterilization failure.

Nonclinical Comparison to the Predicate Device

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

Summary of Clinical Testing

No clinical data was included in this premarket application submission.

Indications for Use

Comparison to Predicate Device

Feature	Submission Device: 3M™Attest™ 1295 Biological Indicator	Predicate Device (K140392):3M™ Attest™ 1295 BiologicalIndicator
Indications for use	Use the 3M™ Attest™ Rapid ReadoutBiological Indicator 1295 inconjunction with the 3M Attest™Auto-reader 490H as a standard methodof routine monitoring of vaporizedhydrogen peroxide sterilizationprocesses in STERRAD® 100S,STERRAD® NX (Standard andAdvanced cycles) and 100NX(Standard, Flex, Express and Duocycles) systems.	Use the 3M Attest™ RapidReadout Biological Indicator1295 in conjunction with the 3MAttest™ Auto-reader 490H as astandard method of routinemonitoring of vaporized hydrogenperoxide sterilization processes inSTERRAD® NX and 100NXsystems.
Organism	Geobacillus stearothermophilustraceable to ATCC™ 7953	Same
Viable sporepopulation	≥1x106	Same
Resistancecharacteristics• D-value	(Tested at 10 mg/L vaporized hydrogenperoxide)D10 mg/L ≥ 1 secondSurvival Time > 5 seconds	Same

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Survival/KillWindow	Kill Time = 7 minutes
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™ 1295 Biological Indicator is substantially equivalent to the predicate device in terms of their intended use, physical properties and technological characteristics. The nonclinical testing demonstrates that the 3M™ Attest™ 1295 Biological Indicator i 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).