Use the 3M Attest™ Super Rapid Readout Steam Challenge Pack 1496V and the 3M Attest™ Super Rapid 5 Steam-Plus Challenge Pack 41482V in conjunction with the 3M Attest™ Auto-reader 490 to qualify or monitor dynamic-air-removal (pre-vacuum) steam sterilization cycles of 270°F (132°C) at 4 minutes and 275°F (135°C) at 3 minutes.

The 3M Attest™ Super Rapid Readout Biological Indicator 1492V contained in the challenge pack provides a final fluorescent result in 1 hour. An optional visual pH color change result is observed in 48 hours.

Device Description

The 3M Attest™ 1496V Super Rapid Readout Steam and 41482V Super Rapid 5 Steam-Plus Challenge Packs are specifically designed to qualify or routinely challenge 270°F (132°C) and 275°F (135°C) dynamic-air-removal (pre-vacuum) steam sterilization cycles in healthcare facilities. The packs consist of multiple layers of medical index cards, some of which are die-cut to contain monitoring products. The packs are overwrapped and secured with a label. The Challenge Packs and the predicate device all contain a biological indicator. The 41482V Challenge Pack and the predicate device also contain a SteriGage™ chemical integrator. Each Challenge Pack has a chemical process indicator on the outside of the device that changes from yellow to brown or darker when exposed to steam.

AI/ML Overview

Here's an analysis of the provided text, outlining the acceptance criteria and study details for the 3M Attest™ 1496V and 41482V Super Rapid Readout Steam Challenge Packs:

Acceptance Criteria and Device Performance

Challenge Pack Testing	Acceptance Criteria	Reported Device Performance
Resistance of the Challenge Pack as compared to AAMI towel pack	Challenge Pack is at least as resistant as the biological indicator AAMI towel pack recommended by ANSI/AAMI ST-79: 2010, A1:2010 and A2:2011	Pass
Resistance of the Pack as compared to the Biological Indicator or Chemical Integrator alone	Pack provides a greater resistance than the Biological Indicator or Chemical Integrator alone	Pass
Chemical Process Indicator	Chemical Process Indicator on the Challenge Pack label changes from yellow to brown or darker upon exposure to steam	Pass
Characteristics of Biological Indicator	Challenge Packs contain a biological indicator with Geobacillus stearothermophilus (ATCCTM 7953) at a population ≥ 10^6 spores that complies with 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 and ANSI/AAMI/ISO 11138-3: 2006/(R)2010	Pass
Characteristics of Chemical Integrator (41482V only)	Challenge Packs contain a chemical integrator that complies with FDA's Guidance for Chemical Indicators FDA's Premarket Notification [510(k)] Submissions for Chemical Indicators: Guidance for Industry and FDA Staff, December 19, 2003 and ANSI/AAMI/ISO 11140-1:2005/(R)2010. Class 5	Pass

Study Details:

Sample sizes used for the test set and data provenance:
- Test Set Sample Size: "Multiple lots of 3M Attest™ Super Rapid Challenge Packs were prepared containing multiple lots of 1492V Super Rapid BIs and SteriGage™ chemical integrators." While "multiple lots" indicates more than one, a specific numerical sample size (e.g., number of individual challenge packs tested, number of BIs, number of CIs) is not provided.
- Data Provenance: The document does not specify the country of origin for the data. The study appears to be retrospective in the sense that it's based on pre-market testing to demonstrate compliance with standards, rather than a prospective clinical trial.
Number of experts used to establish the ground truth for the test set and qualifications of those experts:
- This type of device (biological and chemical indicators for sterilization) does not typically involve human expert interpretation for establishing ground truth in the same way a diagnostic imaging device would. The "ground truth" is established by adherence to predefined scientific and regulatory standards (e.g., spore population, color changes, resistance compared to AAMI towel pack). Therefore, information on "experts" for ground truth in this context is not applicable and not provided.
Adjudication method for the test set:
- Adjudication methods like 2+1 or 3+1 are typically used for studies involving human interpretation (e.g., image reading). For this device, the "adjudication" is based on objective measurements and comparison against established scientific and regulatory standards. Therefore, an adjudication method in this sense is not applicable and not provided.
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 type of study is relevant for diagnostic devices where human readers (e.g., radiologists) interpret results, potentially with AI assistance. The 3M Attest™ Challenge Packs are sterilization indicators, and their function relies on chemical and biological reactions, not human interpretation in the context of reading an image or clinical case.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- This is a standalone performance assessment of the physical device (challenge pack, biological indicator, chemical integrator). The "algorithm" in this context refers to the biological and chemical processes the device undergoes and the auto-reader's ability to detect the fluorescent result. The testing described focuses on the inherent performance of the device without a human-in-the-loop interacting with an AI system. The 3M Attest™ 490 Auto-reader is a key component for interpreting the fluorescent result, so it operates as a "standalone" system in conjunction with the indicators.
The type of ground truth used:
- The ground truth is established by adherence to predefined scientific and regulatory standards. These standards dictate:
  - The minimum resistance required (compared to AAMI towel pack).
  - The expected resistance relative to its components (BI or CI alone).
  - The observable color change of the chemical process indicator.
  - The characteristics of the biological indicator (specific organism, spore population, compliance with ISO standards).
  - The characteristics of the chemical integrator (compliance with FDA guidance and ISO standards, Class 5).
The sample size for the training set:
- This document describes performance testing for a finished medical device. It is not a machine learning model, so there is no concept of a "training set" in the traditional AI sense. The development and manufacturing of such devices involve extensive internal testing and quality control, but these are not referred to as "training sets."
How the ground truth for the training set was established:
- As there is no training set mentioned or applicable for this type of device, this question is not applicable.

Summary

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Premarket Notification (510(k)) Summary

ЗМ

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:	(651) 575-8052
FAX Number:	(651) 737-5320

Date of Summary: March 14, 2013

Device Name and Classification:

Common or Usual Name:	Sterilization Biological Indicator
Proprietary Name:	3M Attest™ 1496V Super Rapid Readout SteamChallenge Pack3M Attest™ 41482V Super Rapid 5 Steam-Plus ChallengePack
Classification Name:	Indicator, Biological Sterilization Process(21 CFR § 880.2800(a))
Product Code:	FRC
Product Class:	Class II

Predicate Devices:

3M Attest™ Steam-Plus Pack, formerly AT1® Disposable Biological-Plus Test Pack cleared under K925496, acquired by 3M

3M Attest™ 1492V Super Rapid Readout Biological Indicator for Steam and 3M Attest™ 490 Auto-reader (K121484)

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Description of Device:

Similarities to the predicate device

The 1496V and 41482V Challenge Packs are similar in design to the predicate device the 3M Attest™ Steam-Plus Pack. The packs consist of multiple layers of medical index cards, some of which are die-cut to contain monitoring products. The packs are overwrapped and secured with a label. The Challenge Packs and the predicate device all contain a biological indicator. The 41482V Challenge Pack and the predicate device also contain a SteriGage™ chemical integrator. The SteriGage™ integrator offers an immediate Accept/Reject reading that allows for implant load early release in emergency situations as defined in AAMI ST-79. Each Challenge Pack has a chemical process indicator on the outside of the device that changes from yellow to brown or darker when exposed to steam.

Differences from the predicate device

Each 1496V test pack contains an Attest™ 1492V Super Rapid Biological Indicator (1492V SRBI) while the 41482V Super Rapid 5 Steam-Plus Challenge Pack contains a 1492V SRBI and a SteriGage™ steam chemical integrator. The predicate device contains an Attes1™ 1262 Biological Indicator with a visual pH color change result at 48 hours and a SteriGage™ steam chemical integrator. The 1492V SRBI is specifically designed for a rapid fluorescent result when used in conjunction with the 3M Attest™ 490 Auto-reader. A fluorescence change indicates a steam sterilization process failure. Attest™ 1492V SRBI controls are provided with the Challenge Packs.

	Predicate DeviceAttest™ Steam-Plus Pack	Attest™ 1496VChallenge Pack	Attest™ 41482VChallenge Pack
General Design	Layers of medical index cards,some of which are die-cut tocontain indicators, overwrappedand secured with a label.	Same as Predicate	Same as Predicate
BiologicalIndicator	Attest™ 1262 BiologicalIndicator (48 hr visual pH colorchange result)	Attest™ 1492VBiological Indicator(1 hour fluorescentresult)	Attest™ 1492VBiological Indicator (1hour fluorescent result)
ChemicalIntegrator	SteriGage™ Chemical Integrator	No ChemicalIntegrator	SteriGage™ ChemicalIntegrator
ExternalChemicalProcessIndicator	Yellow to brown color changewhen exposed to steam	Same as Predicate	Same as Predicate

Similarities and Differences between Challenge Packs and Predicate Device

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Indications for Use:

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

Testing was conducted on the indicators and the challenge packs 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
FDA's Premarket Notification [510(k)] Submissions for Chemical Indicators: . Guidance for Industry and FDA Staff, December 19, 2003
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 11140-1:2005/(R)2010 Sterilization of health care products -Chemical indicators, Part 1: General requirements
ANSI/AAMI/ISO 18472:2006 Sterilization of health care products Biological and . chemical indicators: Test equipment
United States Pharmacopeia, Chapter <1035> Biological Indicators for Sterilization and ● Chapter <55> Biological Indicators - Resistance Performance Tests.

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. ANSI/AAMI ST-79:2010, A1:2010 and A2:2011, Comprehensive guide to steam sterilization & sterility assurance in health care facilities

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Multiple lots of 3M Attest™ Super Rapid Challenge Packs were prepared containing multiple lots of 1492V Super Rapid Bls and SteriGage™ chemical integrators. The Challenge Packs were evaluated against performance requirements below.

Summary of Nonclinical Testing

Challenge Pack Testing	Acceptance Criteria	Result
Resistance of the ChallengePack as compared to AAMItowel pack	Challenge Pack is at least as resistant as the biological indicatorAAMI towel pack recommended by ANSI/AAMI ST-79: 2010,A1:2010 and A2:2011	Pass
Resistance of the Pack ascompared to the BiologicalIndicator or ChemicalIntegrator alone	Pack provides a greater resistance than the Biological Indicatoror Chemical Integrator alone	Pass
Chemical Process Indicator	Chemical Process Indicator on the Challenge Pack label changesfrom yellow to brown or darker upon exposure to steam	Pass
Characteristics of BiologicalIndicator	Challenge Packs contain a biological indicator with Geobacillusstearothermophilus (ATCCTM 7953) at a population ≥ 10^6spores that complies with FDA's Guidance for Industry andFDA Staff, Biological Indicator (BI) Premarket Notification[510(k)] Submissions; October 4, 2007,ANSI/AAMI/ISO 11138-1:2006/(R)2010 and ANSI/AAMI/ISO11138-3: 2006/(R)2010	Pass
Characteristics of ChemicalIntegrator (41482V only)	Challenge Packs contain a chemical integrator that complieswith FDA's Guidance for Chemical Indicators FDA'sPremarket Notification [510(k)] Submissions for ChemicalIndicators: Guidance for Industry and FDA Staff, December19, 2003 and ANSI/AAMI/ISO 11140-1:2005/(R)2010. Class 5	Pass

The results of these evaluations showed that the 3M Attest™ 1496V and 41482V Super Rapid Challenge Packs present a challenge to the sterilization process equivalent to the biological indicator AAMI towel pack recommended by ANSI/AAMI ST-79 Comprehensive guide to steam sterilization & sterility assurance in health care facilities.

Conclusion

The 3M Attest™ 1496V and 41482V Super Rapid Challenge Packs and the 3M Attest™ 490 Auto-reader meet all applicable voluntary performance standards and are substantially equivalent to the predicate device in terms of their intended use, physical properties and technological characteristics. There are no new questions of safety or effectiveness.

141

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-00002

March 15, 2013

Suzanne Leung, Ph.D., RAC Regulatory Affairs Manager 3M Company 3M Center, Building 275-5W-06 ST. PAUL MN 55144-1000

Re: K121593

Trade/Device Name: 3M Attest™ 1496V Super Rapid Readout Steam Challenge Pack 3M Attest™ 41482V Super Rapid 5 Steam-Plus Challenge Pack Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: II Product Code: FRC Dated: March 1, 2013 Received: March 4, 2013

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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/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.

Anthony D. Watson, B.S., M.S., M.B.A. 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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K121593 510(k) Number:

Device Name:

3M Attest™ 1496V Super Rapid Readout Steam Challenge Pack 3M Attest™ 41482V Super Rapid 5 Steam-Plus Challenge Pack

Indications for Use:

Use the 3M Attest™ Super Rapid Readout Steam Challenge Pack 1496V and the 3M Attest™ Super Rapid 5 Steam-Plus Steam Challenge Pack 41482V in conjunction with the 3M Attest™ Auto-reader 490 to qualify or monitor dynamic-air-removal (pre-vacuum) steam sterilization cycles of 270°F (132°C) at 4 minutes and 275°F (135°C) at 3 minutes.

Prescription Use

AND/OR

Over-The-Counter Use X

(Part 21 CFR 801 Subpart D)

(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)

Elizabeth 2013.03.12

(Division Sign-Off) mesthestology, General Hospital Infection Control, Den

510(k) Number: K121593

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).