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® NX and 100NX systems.

Device Description

The 3M Attest™ 1295 Rapid Readout Biological Indicator for Vaporized Hydrogen Peroxide Sterilization (pink cap, referred to hereinafter as the 1295 BI) 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 (hereinafter referred to as the 490H Auto-reader). The 1295 BI is a single-use device.

The Attest™ 1295 BI is 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. All Attest™ Rapid Readout and Super Rapid Readout BIs for steam utilize the a-glucosidase enzyme system, which is generated naturally within growing Geobacillus stearothermophilus organisms. The a-glucosidase enzyme in its active state is detected by measuring the fluorescence produced by the enzymatic hydrolysis of a non-fluorescent substrate. The resultant fluorescent by-product is detected in the 3M Attest™ 490H Auto-reader. The detection of fluorescence upon incubation of the 1295 BI in the 490H Auto-reader indicates a sterilization failure.

The 1295 BI is similar in design to the 3M Attest™ 1492V Super Rapid Readout Biological Indicator for Steam cleared as K121484 for dynamic-air-removal (prevacuum) steam sterilization cycles. Minor modifications were made to 1492V that resulted in the 1295 BI for STERRAD® vaporized hydrogen peroxide sterilization cycles.

The Attest™ Auto-reader 490H is similar in design to the Attest™ Auto-reader 490 that has been cleared for use with the Attest™ 1491 Super Rapid Readout Biological Indicator under K103277 and Attest™ 1492V Super Rapid Readout Biological Indicator under K121484.

The Attest™ Auto-reader 490H is designed to incubate at 60°C and automatically read the Attest™ 1295 BI for a fluorescent result within 4 hours. The fluorescent readout at 4 hours met the FDA's requirement of > 97% alignment with the result after the conventional incubation time of 7 days. The Auto-reader 490H is also designed to allow further incubation of the 1295 BI for an optional visual pH color change result of the growth media at 7 days.

AI/ML Overview

The provided document describes the 3M Attest™ Rapid Readout Biological Indicator 1295 (BI) and 3M Attest™ Auto-reader 490H. The primary study presented is a substantial equivalence comparison to predicate devices, rather than a direct study demonstrating absolute performance against highly specific, quantitative acceptance criteria for all aspects of a typical diagnostic device. However, some performance characteristics are outlined, particularly in comparison to the predicate.

Here's an analysis based on the document:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" for the new device as a set of a priori thresholds. Instead, it demonstrates substantial equivalence by comparing its characteristics and performance to legally marketed predicate devices, and against the FDA's Guidance for Industry and FDA Staff, Biological Indicator (BI) Premarket Notification [510(k)] Submissions.

The table below summarizes the key performance characteristics mentioned for the Attest™ 1295 BI compared to its "Intended Use Predicate," the STERRAD® CycleSure® 24 BI (K123017).

Characteristic	Acceptance Criteria (Predicate Performance / Guidance)	Reported Device Performance (Attest™ 1295 BI)
Intended Use	Monitoring vaporized hydrogen peroxide sterilization processes (e.g., STERRAD® NX, 100NX).	Same as predicate.
Organism (Species, Strain)	Geobacillus stearothermophilus traceable to ATCC™ 7953.	Same as predicate.
Viable Spore Population	≥ 10^6^	Same as predicate.
D-value (Resistance)	D_2.5 mg/L_ ≥ 1 second (for predicate at 2.5 mg/L H2O2)	D_10 mg/L_ ≥ 1 second (at 10 mg/L H2O2).
Survival Time	≥ 5 seconds	≥ 5 seconds
Kill Time	= 60 seconds (for predicate at 2.5 mg/L H2O2)	= 7 minutes (at 10 mg/L H2O2) - Note: Much longer due to higher challenge.
Reduced Incubation Time (Fluorescent Result)	>97% correlation to 7-day visual pH color change (for predicate: 24 hours visual pH).	Fluorescent result in 4 hours (>97% correlation to 7-day visual pH color change not explicitly stated for 1295, but inferred by meeting FDA guidance).
Chemical Process Indicator	Changes from red to golden yellow or bronze.	Changes from blue to pink.
Incubation Temperature	55-60°C	60 +/- 2 °C
Shelf-life	6 months	6 months (with plans for extension).

Note for Auto-reader 490H: The document states the fluorescent readout at 4 hours met the FDA's requirement of > 97% alignment with the result after the conventional incubation time of 7 days. This is a key "acceptance criterion" for the rapid readout functionality, implying the accuracy of the 4-hour fluorescent result vs. the traditional 7-day visual result.

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

Test Set Sample Size: The document states, "Multiple lots of Attest™ 1295 BIs were evaluated for performance." However, it does not provide a specific number or breakdown of the sample size (e.g., number of BIs, number of sterilization cycles, replicates) used for the resistance testing or reduced incubation time validation.
Data Provenance: Not explicitly stated. Given it's a 510(k) submission, the studies would likely be conducted in a controlled laboratory setting (e.g., 3M's R&D facilities) in the country of origin of the manufacturer (USA, St. Paul, MN). The data would be prospective as it involves controlled testing of the new device's performance against defined parameters.

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

This type of device (biological indicator) relies on a biological process (spore inactivation) and a chemical reaction for ground truth, rather than expert review of images or clinical assessments.
Ground Truth Establishment: The ground truth for the BI performance studies is based on established microbiological methods for assessing spore viability (e.g., lack of growth after incubation for positive control, confirmed kill for negative control) and comparison to the predicate device's known performance characteristics. No human "experts" in the sense of clinicians or radiologists are involved in establishing the ground truth for this device's function.

4. Adjudication Method

Not applicable in the conventional sense. The "ground truth" for a biological indicator is determined by the growth or non-growth of spores, and the optical detection of fluorescence by the auto-reader. This is a direct, objective measurement, not subject to human interpretation or adjudication in the study itself.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human reader performance is being evaluated, often with or without AI assistance. The 3M Attest system is a standalone biological sterilization indicator and auto-reader, not a diagnostic device involving human interpretation of complex medical cases.

6. Standalone Performance Study

Yes, a standalone performance evaluation of the algorithm (or device's intrinsic function) was performed.
- The "Reduced Incubation Time" validation demonstrates standalone performance, showing the 4-hour fluorescent readout reliably predicts the 7-day visual pH color change. This is the core "algorithm" of the rapid readout auto-reader.
- The resistance characteristics (D-value, Survival/Kill Time) are also standalone performance metrics for the BI itself.
- The comparison to the predicate device is also a form of standalone evaluation against a known standard.

7. Type of Ground Truth Used

The ground truth used for performance evaluation is microbiological growth/non-growth of spores (indicating sterilization efficacy), and chemical pH change in growth media (for the traditional 7-day visual result).
For the rapid readout function, the fluorescent signal's correlation to the 7-day visual pH change is the key ground truth.

8. Sample Size for the Training Set

The document does not explicitly mention a training set in the context of an AI/ML algorithm development. This device uses a physiological detection mechanism (enzyme activity leading to fluorescence) rather than a machine learning model that would typically require a training set. The "development of a test cycle" and "evaluating multiple lots" suggests R&D and validation efforts, but not a distinct training set for an AI model.

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

Not applicable, as a conventional AI/ML training set is not described or implied for this device. The development process would involve standard microbiology and engineering principles to ensure the BI and auto-reader accurately detect spore viability and fluorescence, respectively.

Summary

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

Auqust 13, 2014

3M Health Care Dr. Suzanne Leung, Ph.D., RAC Regulatory Affairs Manager 3M Center, Bldg. 275-5W-06 St. Paul, MN 55144

Re: K140392

Trade/Device Name: 3M Attest™ Rapid Readout Biological Indicator 1295 and 3M Attest™ Auto- reader 490H Regulation Number: 21 CFR 880.2800(a) Regulation Name: Biological sterilization process Indicator Regulatory Class: II Product Code: FRC Dated: July 14, 2014 Received: July 17, 2014

Dear Dr. Leung:

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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Page 2 - Dr. Leung

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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 Small Manufacturers, International and Consumer Assistance 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,

Mary S. Runner -S

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

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K140392

Device Name

3M Attest™ Rapid Readout Biological Indicator 1295 and 3M Attest™ Auto-reader 490H

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

K140392

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Sponsor Information:

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

Contact Person:	Suzanne Leung, Ph.D., RACRegulatory Affairs Manager
Phone Number:FAX Number:	(651) 575-8052(651) 737-5320
Date of Summary:	August 11, 2014

Device Name and Classification:

Common or Usual Name:	Sterilization Biological Indicator
Proprietary Name:	3M Attest™ Rapid Readout Biological Indicator 12953M Attest™ Auto-reader 490H
Classification Name:	Indicator, Biological Sterilization Process(21 CFR § 880.2800(a))
Product Code:	FRC
Product Class:	Class II

Predicate Devices:

New Device	Predicate
Attest™ 1295 RapidReadout BI	'Intended Use Predicate' – shares same Intended Use asSTERRAD® CycleSure® 24 BI, K123017
	'Design Predicate' – shares same BI design asAttest™ 1492V Super Rapid Readout BI, K121484
3M Attest™ Auto-reader 490H	3M Attest™ Auto-reader 490, K121484

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Description of Device:

Attest™1295 BI

Attest™ Auto-reader 490H

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Indications for Use:

Substantial Equivalence of Attest™ 1295 Rapid Readout BI to 'Intended Use' Predicate Device STERRAD® CycleSure® 24 BI:

The Attest™ 1295 Rapid Readout BI has the same Intended Use as the predicate device, the STERRAD® CycleSure® 24 BI. cleared under K123017. Both the 1295 Rapid Readout BI and the predicate are biological indicators that are intended to be used in healthcare facilities to monitor the adequacy of hydrogen peroxide sterilization processes. This is accomplished through the biological challenge of Geobacillus stearothermophilus spores. Growth of the spores within the biological indicator after processing, indicates a failure of the hydrogen peroxide sterilization process.

Testing was conducted on the Attest™ 1295 BI following the FDA's Guidance for Industry and FDA Staff, Biological Indicator (BI) Premarket Notification [510(k)] Submissions; October 4, 2007. Multiple lots of Attest™ 1295 BIs were evaluated for performance when used with the Attest™ 490H Auto-reader.

A test cycle was developed for resistance testing utilizing a 10 mg/L hydrogen peroxide concentration, which is much more challenging than that used for evaluation of the predicate device. Despite using a higher hydrogen peroxide concentration, the Kill time for the Attest™ 1295 BI at 7 minutes is still much longer than the CycleSure® BI, reflecting its higher resistance. The greater resistance of the 1295 BI imparts a superior challenge to the sterilization process and provides a larger margin of sterility assurance.

An additional benefit of the Attest™ 1295 BI is the faster time to result. Through the use of the Attest™ Rapid Readout technology, the Reduced Incubation Time, performed according to FDA's guidance for biological indicators, has been validated at 4 hours. The more rapid time to result for the Attest™ 1295 BI over the CycleSure® BI allows for increased patient safety as the faster answer will reduce the number of patients affected should there be a sterilization failure.

The results of these evaluations showed that the new Attest™ 1295 Biological Indicator, when used with the Attest™ 490H Auto-reader, complies with the FDA's Guidance for Biological Indicators and is substantially equivalent to the predicate device, the STERRAD® CycleSure® 24 BI for the intended use with STERRAD® NX and 100NX cycles.

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DEVICECHARACTERISTIC	'INTENDED USEPREDICATE'STERRAD® CycleSure® BIK123017	NEW DEVICEAttest™ 1295 BI
Intended Use• Method of sterilization	Vaporized hydrogen peroxide	Same as predicate
Indications for Use	The STERRAD® CycleSure® 24BI is intended to be used as astandard method for frequentmonitoring of the followingSTERRAD® SterilizationSystems:• STERRAD 100S• STERRAD 50• STERRAD 200• STERRAD NX• STERRAD 100NX• For STERRAD 100NX DUOCycle in the United States, theSTERRAD CYCLESURE 24Biological Indicator should onlybe used in a test packconfiguration.	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• Spore, Species, Strain	Geobacillus stearothermophilustraceable to ATCC™ 7953	Same as predicate
Viable Spore Population	≥ 106	Same as predicate
Carrier Material	Glass Fiber	PET (Polyethylene terephthalate)
Resistance Characteristics:	Tested at 2.5 mg/L vaporizedhydrogen peroxide	Tested at 10 mg/L vaporizedhydrogen peroxide
• D-value• Survival/KillWindow	D2.5 mg/L ≥ 1 secondSurvival Time ≥ 5 secondsKill Time = 60 seconds	D10 mg/L ≥ 1 secondSurvival Time ≥ 5 secondsKill Time = 7 minutes
Incubation Temperature	55-60°C	60 +/- 2 °C
Reduced Incubation Time(>97% correlation to the 7-day visual pH color changeresult)	Visual pH color change result in24 hours	Fluorescent result in 4 hours
Chemical Process Indicator	Turns from red to golden yellowor bronze	Chemical indicator on the BI capchanges from blue to pink
Shelf-life	6 months	6 months, will be extended withavailable real time aging data

A summary of the testing and predicate comparison is provided below.

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Substantial Equivalence of Attest™ Auto-reader 490H with Auto-reader 490:

Both the new Auto-reader 490H and the predicate Auto-reader 490 share the same Intended Use. These devices incubate and read Attest™ Rapid Readout biological indicators to determine a positive or negative result based on a fluorescence signal. The difference between the devices is in their Indications for Use. The Auto-reader 490H is intended for use with the Attest™ 1295 BI for hydrogen peroxide while the predicate Attest™ Auto-reader 490 is intended for use with the Attest™ Super Rapid Readout 1491 and 1492V Biological Indicators for steam. The difference in biological indicators being incubated leads to a difference of target incubation temperatures and time to result between the 490H and the 490.

The Attest™ Auto-reader 490H was tested for safety by Underwriters Laboratory to verify compliance to applicable electrical safety standards including IEC 61010-1 (2001) Second Edition and IEC 61010-2-010 (2003) Second Edition. In addition, the Attest™ Auto-reader 490H has been tested by a certified Testing Laboratory to verify electromagnetic compatibility per USA Title 47, Code of Federal Regulations (2009) for Radiated Emissions (FCC Part 15, Subpart B, Class A) and Conducted Emissions (FCC Part 15. Subpart B. Class A).

Device Function or	PREDICATE	NEW DEVICE
Characteristic	3M Attest™ 490 Auto-Reader	3M Attest™ 490H Auto-
	K121484	Reader
Statement of Intended Use	The 3M Attest™ 490 Auto-reader	The 3M Attest™ 490H Auto-
	is designed to incubate and	reader is designed to incubate and
	automatically read the 3M Attest™	automatically read the 3M
	Super Rapid Readout Biological	Attest™ 1295 Rapid Readout
	Indicators at 56°C for a final	Biological Indicator at 60°C for a
	fluorescent result at 30 minutes for	final fluorescent result at 4 hour.
	1491 and 1 hour for 1492V.
Incubation Temperature	56°C + 2°C	60°C ± 2°C
Basis of Rapid Readout	Fluorescence of biological	Same
	indicator medium
Use with Biological	3M Attest™ Super Rapid Readout	3M Attest™ Rapid Readout
Indicators	Biological Indicators 1492V, 1491	Biological Indicator 1295
Color-coded configuration	Blue (1491 BI), Brown (1492V BI), or	Pink (1295 BI)
indicator (racetrack around	Blue and Brown (both 1491 and
incubation wells)	1492V)
Method of FluorescenceDetection	UV LED, optical filters, with	Same
	sensing by photo diode
Indicator of Adequate	(-) on LCD Display	Same
Sterilization Cycle
Indicators of Possible	(+) on LCD Display	Same
Sterilization Cycle Failure	Audible Alarm
Incubation Wells	10 - reader/incubation wells	Same
Voltage Range	100-240 Volts AC (12 Volt DCconversion for internal circuitry)	Same
Product Safety	UL/IEC 61010-1	Same
EMC Compliance	FCC Part 15, Subpart B, Class A	Same

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Conclusion

The 3M Attest™ 1295 Rapid Readout Biological Indicator and the 3M Attest™ Autoreader 490H meet all applicable performance standards and are substantially equivalent to their predicate devices in terms of their intended use, physical properties and technological characteristics. There are no new questions of safety or effectiveness.

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).