Sterilization Type	Temperature	Time
Gravity Displacement	270°F (132°C)	3 minutes
Immediate Use SteamSterilization Cycle(Flash)	270°F (132°C)	10 minutes
	275°F (135°C)	3 minutes
	275°F (135°C)	10 minutes

The 3M™ Attest™ 1491 Super Rapid Readout Biological Indicator provides a final fluorescent result in 30 minutes. An optional visual pH color change result is observed in 24 hours.

Device Description

The 3M™ Attest™ 1491 Super Rapid Readout Biological Indicator (hereafter referred to as the 1491 Bl) is a self-contained biological indicator designed to be used with the 3M™ Attest™ 490 Auto-reader (hereafter referred to as the 490 Auto-reader) to routinely challenge 270°F (132°C) and 275°F (135°C) gravity-displacement steam sterilization cycles having exposure times > 3 minutes in length.

The 1491 BI is composed of a polycarbonate sleeve containing a spore carrier and media ampoule, enclosed with a blue cap. On each 1491 BI is a chemical process indicator that changes color from rose to brown when exposed to steam.

The 1491 Bl is a further improvement over the current 3M Attest Rapid Readout technology. Both the Attest Rapid Readout BIs and the Attest Super Rapid Readout Bls utlize the a-glucosidase enzyme system, which is generated naturally within growing G. stearothermophilus spores. 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 490 Auto-reader. The detection of fluorescence upon incubation of the 1491 BI in the 490 Auto-reader indicates steam sterilization failure.

The 490 Auto-reader is designed to incubate at 56°C and automatically read the 1491 BI for a fluorescent result within 30 minutes. The 490 Auto-reader is also designed to allow further incubation of the 1491 BI for an optional visual pH color change of the growth media at 24 hours. Both the fluorescent readout at 30 minutes and the optional visual color readout at 24 hours met the FDA's requirement of > 97% alignment with the result after the conventional incubation time of 7 days.

AI/ML Overview

The 3M™ Attest™ 1491 Super Rapid Readout Biological Indicator and 3M™ Attest™ 490 Auto-reader are designed to monitor steam sterilization cycles. The study provided assesses the performance of both components against established standards and FDA guidance.

1. Table of Acceptance Criteria and Reported Device Performance:

Test	Acceptance Criteria	Reported Device Performance
Characterization of spores	> 90% Genetic similarity to Geobacillus stearothermophilus to ATCC™ 7953	Pass
D-Value	≥ 10 seconds at 132°C; ≥ 8 seconds at 135°C	Pass
Population (Total Viable Spore Count)	≥ 10^6 spores	Pass
Survival/Kill Times	Survival Time = 1 min at 132°C or calculated survival time (whichever is greater); Survival Time = 40 seconds at 135°C or calculated survival time (whichever is greater); Kill time is calculated kill time at 132°C and at 135°C (per ANSI/AAMI/ISO 11138-1:2006, Annex E)	Pass
Reduced Incubation Time	Meets FDA's requirements for Reduced Incubation Time with > 97% alignment with the conventional incubation time of 7 days for the following readout times: Fluorescent result in 30 minutes; Optional visual color change result in 24 hours	Pass
Hold Time Assessment	D-value does not change when activated 7 days post-sterilization	Pass
Recovery Media Study	Ability to recover 10-100 organisms	Pass
Component Inhibition Studies	No impact of components on recovery of 10-100 organisms	Pass
Chemical Process Indicator	Chemical Process Indicator on the BI changes from rose to brown upon exposure to steam	Pass
Auto-reader Maintenance of Incubation Temperature	Must maintain 56 +/- 2°C over a period of 24 hrs	Pass
Auto-reader Safety Standards	Compliance to IEC 61010-1 (2001), IEC 61010-2-010 (2003), and IEC 60825-1 (1993) with amendments	Verified by Underwriters Laboratory
Auto-reader Electromagnetic Compatibility	Compliance to 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), and IEC 61326	Verified by a certified Testing Laboratory

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

Test Set Sample Size: "Multiple lots" of 3M™ Attest™ 1491 Super Rapid Readout Biological Indicators were evaluated. Specific numbers are not provided for each test, but the product's performance refers to adherence to international and US standards for biological indicators.
Data Provenance: The document does not explicitly state the country of origin for the data or whether it was retrospective or prospective. However, the testing was conducted in accordance with FDA guidance and international standards (ANSI/AAMI/ISO, USP), implying a controlled laboratory setting for these performance tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not provided in the document. The ground truth for biological indicators is typically established through direct microbiological analysis (e.g., confirming spore viability and count, measuring D-values). Expert consensus in the human interpretation sense (like in image diagnostics) is not directly applicable here. The "experts" would be the scientists and microbiologists performing the tests and validating against the established standards.

4. Adjudication method for the test set:

Adjudication methods (like 2+1 or 3+1 for human readers) are not applicable to this type of device testing. The device's performance is objectively measured against predefined scientific and engineering specifications (e.g., spore count, D-value, temperature control, fluorescent detection, chemical indicator color change).

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:

No, an MRMC comparative effectiveness study was not done. This device is a biological indicator and an auto-reader, not an AI-assisted diagnostic tool that relies on human interpretation. The "reader" in this context is the auto-reader detecting a fluorescent signal.

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

Yes, a standalone performance assessment was done. The entire set of tests described in the "Comparative Data" section evaluates the performance of the 3M™ Attest™ 1491 BI (biological component) and the 3M™ Attest™ 490 Auto-reader (the automated reading device/algorithm) either individually or as a system. For example, the auto-reader's ability to "automatically read the 1491 BI for a fluorescent result within 30 minutes" and maintain incubation temperature is a standalone performance measure. The "Reduced Incubation Time" test specifically compares the device's automated fluorescent result to the "conventional incubation time of 7 days," which serves as a gold standard for a biological indicator's performance.

7. The type of ground truth used:

The ground truth employed for the various tests includes:
- Microbiological Standards: For spore characterization, D-value, population count, survival/kill times, recovery media, and component inhibition, the ground truth is established by recognized microbiological culturing and enumeration techniques, adhering to standards like ANSI/AAMI/ISO 11138-1 and -3, and United States Pharmacopeia (USP) chapters.
- Physical/Chemical Standards: For the chemical process indicator, the ground truth is the expected color change upon steam exposure. For the auto-reader's temperature maintenance, the ground truth is a precisely calibrated temperature range (56 +/- 2°C).
- Reference Standard (Conventional Incubation): For the "Reduced Incubation Time," the ground truth is the result obtained after the "conventional incubation time of 7 days," which is the established method for determining biological indicator failure/pass.

8. The sample size for the training set:

The document does not mention a "training set" or "training data" in the context of machine learning. This device does not appear to be an AI/ML-based system that requires a distinct training phase. The system relies on enzyme detection and physical measurements, calibrated and validated against established standards.

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

As a training set for an AI/ML algorithm is not discussed or implied for this device, this question is not applicable. The device's operational parameters and performance were likely developed and validated through iterative engineering and experimental testing based on scientific principles of microbial inactivation and enzyme activity, guided by the aforementioned industry standards.

Summary

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K103277

Premarket Notification (510(k)) Summary

Image /page/0/Picture/2 description: The image shows the logo for 3M. The logo is in black and white. The number 3 is next to the letter M.

APR 1 9 2011

Sponsor Information:

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

Contact Person:	Suzanne Leung
	Regulatory Affairs
Phone Number:	(651) 575-8052
FAX Number:	(651) 737-5320

Date of Summary: April 18, 2011

Device Name and Classification:

Common or Usual Name:	Sterilization Biological Indicator
Proprietary Name:	3MTM Attest™ 1491 Super Rapid ReadoutBiological Indicator3MTM Attest™ 490 Auto-reader
Classification Name:	Indicator, Biological Sterilization Process

Predicate Devices:

3M™ Attest™ 1291 Rapid Readout Biological Indicator for Steam .
(21 CFR § 880.2800(a))
3MTM Attest™ 290 Auto-reader .

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Description of Device:

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Indications for Use:

Use the 3MTM Attest™ 1491 Super Rapid Readout Biological Indicator in conjunction with the 3M™ Attest™ 490 Auto-reader to monitor the cycles below.

Sterilization Type	Temperature	Time
Gravity DisplacementImmediate Use SteamSterilization Cycle(Flash)	270°F (132°C)	3 minutes
	270°F (132°C)	10 minutes
	275°F (135°C)	3 minutes
	275°F (135°C)	10 minutes

The 3M™ Attest™ 1491 Super Rapid Readout Biological Indicator provides a final fluorescent result in 30 minutes. An optional visual pH color change result is observed in 24 hours.

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Comparative Data for Determining Substantial Equivalence of New Device to Predicate Device:

Testing was conducted following the FDA guidance and standards below:

. FDA's Guidance for Industry and FDA Staff, Biological Indicator (BI) Premarket Notification [510(k)] Submissions; October 4, 2007
ANSI/AAMI/ISO 11138-1:2006/(R)2010 Sterilization of health care products . Biological indicators - Part 1: General Requirements
. ANSI/AAMI/ISO 11138-3: 2006/(R)2010 Sterilization of health care products -Biological indicators – Part 3: Biological indicators for moist heat sterilization processes
. ANSI/AAMI/ISO 18472:2006 Sterilization of Health Care Product-Biological and Chemical Indicators: Test Equipment
United States Pharmacopeia, Chapter <1035> Biological Indicators for Sterilization and . Chapter <55> Biological Indicators - Resistance Performance Tests.

Multiple lots of 3MTM Attest™ 1491 Super Rapid Readout Biological Indicators were evaluated for performance when used with the 3MTM Attest™ 490 Auto-reader. A Summary of the nonclinical testing is shown below.

Test	Acceptance Criteria	Result
Characterization of spores	> 90% Genetic similarity to Geobacillusstearothermophilus to ATCCTM 7953	Pass
D-Value	Greater than or equal to 10 seconds at 132°CGreater than or equal to 8 seconds at 135°C	Pass
Population (Total ViableSpore Count)	Greater than or equal to 10^6 spores	Pass
Survival/Kill Times	Survival Time = 1 min at 132°C or calculated survivetime, whichever is greaterSurvival Time = 40 seconds at 135°C or calculatedsurvive time, whichever is greaterKill time is calculated kill time* at 132°C and at 135°C*ANSI/AAMI/ISO 11138-1:2006, Annex E	Pass
Reduced Incubation Time	Meets FDA's requirements for Reduced Incubation Timewith > 97% alignment with the conventional incubationtime of 7 days for the following readout times:Fluorescent result in 30 minutesOptional visual color change result in 24 hours	Pass
Hold Time Assessment	D-value does not change when activated 7 days post-sterilization	Pass
Recovery Media Study	Ability to recover 10-100 organisms	Pass
Component InhibitionStudies	No impact of components on recovery of 10-100organisms	Pass
Chemical ProcessIndicator	Chemical Process Indicator on the BI changes from roseto brown upon exposure to steam	Pass
Auto-reader Maintenanceof Incubation Temperature	Must maintain 56+/- 2°C over a period of 24 hrs	Pass

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The results of these evaluations showed that the new 3M™ Attest™ 1491 Rapid Readout Biological Indicator, when used with the 3M™ Attest™ 490 Auto-reader, complies with ANSI/AAMI/ISO 11138-1:2006/(R)2010 and ANSI/AAMI/ISO 11138-3:2006/(R)2010. the USP requirements for biological indicators, as well as the FDA's Guidance for Biological Indicators.

The 490 Auto-reader was tested for safety by Underwriters Laboratory to verify compliance to:

IEC 61010-1(2001) Second Edition; Safety requirements for electrical equipment . for measurement, control, and laboratory use – Part 1: General requirements,
- IEC 61010-2-010 (2003) Second Edition: Safety requirements for electrical . equipment for measurement, control, and laboratory use - Part 2-010: Particular requirements for laboratory equipment for the heating of materials, and
- IEC 60825-1 (1993) First Edition with Am. 111997) and Am. 2 (2001): Standard for safety of laser products - Part 1: Equipment classification and requirements.

In addition, the 490 Auto-reader has been tested by a certified Testing Laboratory to verify electromagnetic compatibility per:

· USA Title 47, Code of Federal Regulations (2009) for:
- O Radiated Emissions (FCC Part 15, Subpart B. Class A)
- Conducted Emissions (FCC Part 15, Subpart B. Class A), and
IEC 61326: Electrical Equipment for Measurement. Control and Laboratorv Use-EMC Requirements.

Conclusion

The 3M™ Attest™ 1491 Super Rapid Readout Biological Indicator and the 3MTM Attest™ 490 Auto-reader are substantially equivalent to the predicate devices, the 3MTM Attest™ 1291 Rapid Readout Biological Indicator for Steam, cleared under K900771, and 3MTM Attest™ 290 Auto-reader, cleared under K004009, in terms of their intended use, physical properties and technological characteristics. There are no new questions of safety or effectiveness.

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Image /page/5/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 three stripes extending from its wing, representing the department's mission to protect the health of all Americans and provide essential human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.

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

Suzanne Leung Ph.D. Manager, Regulatory Affairs 3M Company-3M Healthcare 3M Center, Building 275-5W-06 St. Paul, Minnesota 55133-1006

APR 1 9 2011

Re: K103277

Trade/Device Name: 3M™ Attest™ 1491 Super Rapied Readout, Biological Indicator for Steam, 3MTM Attest 490 Auto-reader Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: II Product Code: FRC Dated: March 14, 2011 Received: March 25, 2011 ·

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 111 (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 (OS) 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

for Z

Anthony D. Watson, B.S., M.S., M.B.A. 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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Indications for Use

510(k) Number (if known):	K103277
Device Name:	3M™ Attest™ 1491 Super Rapid ReadoutBiological Indicator for Steam3M™ Attest™ 490 Auto-reader

Indications For Use:

Use the 3M™ Attest™ 1491 Super Rapid Readout Biological Indicator in conjunction with the 3M™ Attest™ 490 Auto-reader to monitor the cycles below.

Sterilization Type	Temperature	Time
Gravity Displacement	270°F (132°C)	3 minutes
Immediate Use SteamSterilization Cycle(Flash)	270°F (132°C)	10 minutes
	275°F (135°C)	3 minutes
	275°F (135°C)	10 minutes

The 3M™ Attest™ 1491 Super Rapid Readout Biological Indicator provides a final fluorescent result in 30 minutes. An optional visual pH color change result is observed in 24 hours.

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

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Eldgett $. Clamie-Will

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

510(k) Number:________________________________________________________________________________________________________________________________________________________________

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).