Use the 3M™ Attest™ Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E for pack control monitoring of the following hydrogen peroxide sterilization sterilizers and cycles: STERRAD® 100S System, STERRAD® NX® System (Standard and Advanced cycles), STERRAD® NX® System with AllClear™ Technology (Standard and Advanced cycles), STERRAD® 100NX® System (Standard, Flex, Express and Duo cycles) STERRAD® 100NX® System with AllClear™ Technology (Standard, Flex, Express and Duo cycles) vaporized hydrogen peroxide sterilizers and STERIS® V-PRO® 1 (Lumen cycle), STERIS ® V-PRO® 1 Plus (Lumen and Non-Lumen cycles) and STERIS ® V-PRO® maX Low Temperature Sterilization System (Lumen, Non-Lumen and Flexible cycles), STERIS® V-PRO® 60 Temperature Sterilization System (Lumen, Non-Lumen and Flexible cycles), STERIS® V-PRO® maX 2 Temperature Sterilization System (Lumen, Non-Lumen, Flexible, and Fast Non-Lumen cycles), and the STERIS® V-PRO® s2 Low Temperature Sterilization System (Lumen, Non-Lumen, Flexible, and Fast cycles).

Device Description

The 3M™ Attest™ Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E is a chemical indicator consisting of a non-cellulose based coated indicator strip sensitive to vaporized hydrogen peroxide, contained in a film laminate.

The 3M™ Attest™ CI 1348/1348E verifies that the stated values for the three critical parameters of exposure time, temperature, and amount of vaporized hydrogen peroxide have been achieved within a package or containment device (i.e. wrapped trays, rigid containers, sterilization pouches, and other types of packs) and/or at a specific location within the load or empty chamber.

Upon exposure to vaporized hydrogen peroxide, the color of the coated indicator strip progressively changes from blue toward pink along the strip. The progression of the blue to pink color change along the strip is visible through a window with marked "REJECT" and "ACCEPT" zones. The extent of the progression depends on exposure time, temperature, and amount of vaporized hydrogen peroxide.

AI/ML Overview

Here's an analysis of the acceptance criteria and study proving device performance based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Test Method	Purpose	Acceptance Criteria	Reported Device Performance
Health Care Facility Simulated Use Testing on STERIS V-PRO s2 sterilizer	Assess color change of indicator after exposure to representative complete and incomplete cycles for the STERIS V-PRO s2 sterilizer	Complete Cycles (PASS): The 3M Tri-Metric CI turns from blue toward pink in the ACCEPT region of the indicator window to indicate a "PASS" (reaches endpoint) when exposed to a complete Lumen, Non-Lumen, Flexible, or Fast Cycle in the STERIS V-PRO s2 Low Temperature Sterilization System. Incomplete Cycles (FAIL): The 3M Tri-Metric CI turns from blue toward pink only within the REJECT region of the indicator window to indicate a "FAIL" (does not reach endpoint) when exposed to an incomplete Lumen, Non-Lumen, Flexible, or Fast Cycle in the STERIS V-PRO s2 Low Temperature Sterilization System.	All Tri-Metric CIs tested met acceptance criteria.

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

The provided text does not explicitly state the sample size used for the simulated use testing. It mentions "All Tri-Metric CIs tested," but the specific number is not given.

The data provenance is prospective as it describes testing conducted for the purpose of demonstrating performance of the device in new sterilizer cycles (specifically the STERIS V-PRO s2). The country of origin of the data is not specified, but the applicant (3M Company) is based in St. Paul, Minnesota, USA.

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

The document does not specify the number of experts or their qualifications used to establish the ground truth for the test set. However, for a chemical indicator (CI), the "ground truth" is typically the objective color change against a predefined standard (e.g., a "REJECT" or "ACCEPT" zone on the indicator itself), rather than subjective expert interpretation. The acceptance criteria clearly define what constitutes a "PASS" or "FAIL" based on the visible color change within specific regions of the indicator.

4. Adjudication Method for the Test Set:

The document does not describe an adjudication method in the traditional sense (e.g., 2+1, 3+1). For this type of device (chemical indicator), the assessment of "PASS" or "FAIL" is based on the objective color change relative to the marked "REJECT" and "ACCEPT" zones on the indicator, as defined in the acceptance criteria. It is implied that the assessment is a direct comparison to these internal standards.

5. If a Multi-Reader, Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, a multi-reader, multi-case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for diagnostic devices where human interpretation needs to be evaluated. The 3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator is an objective chemical indicator, not a device requiring human interpretation for its primary function. The evaluation focuses on the chemical reaction and color change.

6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

This is effectively a standalone study in the context of a chemical indicator. The "device performance" refers to the intrinsic chemical reaction and color change of the indicator itself when exposed to the sterilization conditions. There is no "human-in-the-loop performance" being evaluated in terms of a diagnostic interpretation, and no AI algorithm is involved. The indicator functions mechanically/chemically to provide a visual result.

7. The Type of Ground Truth Used:

The ground truth used is based on defined physical/chemical properties and objective observation of color change against established reference points (the "REJECT" and "ACCEPT" regions on the indicator). This is directly tied to the efficacy of the sterilization cycle itself as the true determinant of whether the conditions were met. The indicator is designed to reflect this physical reality.

8. The Sample Size for the Training Set:

The provided document does not mention a training set as this device is a chemical indicator and does not employ machine learning or AI algorithms that would require a training set. The performance is based on the chemical formulation and design of the indicator.

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

As there is no training set for this chemical indicator device, this question is not applicable.

Summary

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Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

December 7, 2020

3M Company Andrew Wingen Regulatory Affairs Commercialization Strategy Lead 2510 Conway Ave, Bldg 275-5W-06 St. Paul, Minnesota 55144-1000

Re: K203284

Trade/Device Name: 3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: Class II Product Code: QKM Dated: November 6, 2020 Received: November 9, 2020

Dear Andrew Wingen:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Clarence W. Murray, III, PhD Acting Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K203284

Device Name

3M™ Attest™ Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator (1348/1348E)

Indications for Use (Describe)

Use the 3M™ Attest™ Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E for pack control monitoring of the following hydrogen peroxide sterilization sterilizers and cycles: STERRAD® 100S System, STERRAD® NX® System (Standard and Advanced cycles), STERRAD® NX® System with AllClear™ Technology (Standard and Advanced cycles), STERRAD® 100NX® System (Standard, Flex, Express and Duo cycles) STERRAD® 100NX® System with AllClear™ Technology (Standard, Flex, Express and Duo cycles) vaporized hydrogen peroxide sterilizers and STERIS® V-PRO® 1 (Lumen cycle), STERIS ® V-PRO® 1 Plus (Lumen and Non-Lumen cycles) and STERIS ® V-PRO® maX Low Temperature Sterilization System (Lumen and Flexible cycles), STERIS® V-PRO® 60 Temperature Sterilization System (Lumen and Flexible cycles), STERIS® V-PRO® maX 2 Temperature Sterilization System (Lumen, Flexible, and Fast Non-Lumen cycles), and the STERIS® V-PRO® s2 Low Temperature Sterilization System (Lumen, Flexible, and Fast cycles).

Type of Use (Select one or both, as applicable)| | Prescription Use (Part 21 CFR 801 Subpart D)

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

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Image /page/3/Picture/1 description: The image shows the 3M logo. The logo is red and consists of the number "3" and the letter "M". The number and letter are in a bold, sans-serif font. The logo is simple and recognizable.

Special 510(k) Summary for 3MTM Attest™ Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E K203284

Sponsor Information:

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

Contact: Andrew Wingen Regulatory Affairs Commercialization Strategy Lead Phone Number: (651) 733-0929 Fax Number: (651) 737-5320

Date of Summary: 4 December 2020

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1. Device Name and Classification:

Common or Usual Name:	Chemical Indicator
Proprietary Name:	3MTM AttestTM Vaporized Hydrogen Peroxide Tri-MetricChemical Indicator 1348/1348E
Classification Name:	Indicator, physical/chemical sterilization process
Device Classification:	Class II, 21 CFR § 880.2800
Product Code:	QKM

2. Predicate Device:

K193110, 3M™ Attest™ Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E

3. Description of Device:

4. Indications for Use

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PREMARKET NOTIFICATION [Special 510(k)] 3MTM Attest™ Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E

(Standard, Flex, Express and Duo cycles) vaporized hydrogen peroxide sterilizers and STERIS® V-PRO® 1 (Lumen cycle), STERIS ® V-PRO® 1 Plus (Lumen and Non-Lumen cycles) and STERIS ® V-PRO® maX Low Temperature Sterilization System (Lumen, Non-Lumen and Flexible cycles), STERIS® V-PRO® 60 Temperature Sterilization System (Lumen, Non-Lumen and Flexible cycles), STERIS® V-PRO® maX 2 Temperature Sterilization System (Lumen, Non-Lumen, Flexible, and Fast Non-Lumen cycles), and the STERIS® V-PRO® s2 Low Temperature Sterilization System (Lumen, Non-Lumen, Flexible, and Fast cycles).

Feature	Submission Device: 3MTM AttestTMVaporized Hydrogen Peroxide Tri-Metric Chemical Indicator	Predicate Device:3MTM Attest™ Vaporized HydrogenPeroxide Tri-Metric ChemicalIndicator (K193110)	Comparison
DeviceModels	1348, 1348E	1348, 1348E	Identical
DeviceDesign	The 3MTM Attest™ VaporizedHydrogen Peroxide Tri-MetricChemical Indicator 1348/1348E is achemical indicator consisting of a non-cellulose based coated indicator stripsensitive to vaporized hydrogenperoxide, contained in a film laminate.The 3M™ Attest™ CI 1348/1348Everifies that the stated values for thethree critical parameters of exposuretime, temperature, and concentration ofvaporized hydrogen peroxide have beenachieved within a package orcontainment device (i.e. wrapped trays,rigid containers, sterilization pouches,and other types of packs) and/or at aspecific location within the load orempty chamber.Upon exposure to vaporized hydrogenperoxide, the color of the coatedindicator strip progressively changesfrom blue toward pink along the strip.The progression of the blue to pinkcolor change along the strip is visiblethrough a window with marked"REJECT" and "ACCEPT" zones. Theextent of the progression depends onexposure time, temperature, andconcentration of vaporized hydrogenperoxide.	The 3MTM Attest™ VaporizedHydrogen Peroxide Tri-MetricChemical Indicator 1348/1348E is achemical indicator consisting of a non-cellulose based coated indicator stripsensitive to vaporized hydrogenperoxide, contained in a film laminate.The 3MTM Attest™ CI 1348/1348Everifies that the stated values for thethree critical parameters of exposuretime, temperature, and concentration ofvaporized hydrogen peroxide have beenachieved within a package orcontainment device (i.e. wrapped trays,rigid containers, sterilization pouches,and other types of packs) and/or at aspecific location within the load orempty chamber.Upon exposure to vaporized hydrogenperoxide, the color of the coatedindicator strip progressively changesfrom blue toward pink along the strip.The progression of the blue to pinkcolor change along the strip is visiblethrough a window with marked"REJECT" and "ACCEPT" zones. Theextent of the progression depends onexposure time, temperature, andconcentration of vaporized hydrogenperoxide.	Identical
Sterilizers inwhich Color	STERRAD® 100SSTERRAD® NX (Standard and	STERRAD® 100SSTERRAD® NX (Standard and	Similar. Thesubmission
Change	Advanced cycles)	Advanced cycles)	device adds

Performance wasDemonstrated(Blue toward Pink)	STERRAD® NX with ALLClear™Technology (Standard and Advancedcycles)STERRAD® 100NX (Standard, Flex,Express, and Duo cycles)STERRAD® 100NX with ALLClear™Technology (Standard, Flex, Express,and Duo cycles)STERIS® V-PRO® maX (Lumen,Non-Lumen, and Flexible cycles)STERIS® V-PRO® maX2 (Lumen,Non-Lumen, Flexible, and Fast Non-Lumen cycles)STERIS® V-PRO® 60 (Lumen, Non-Lumen, and Flexible cycles)STERIS® V-PRO® s2 (Lumen, Non-Lumen, Flexible, and Fast cycles)Use the 3MTM Attest™ VaporizedHydrogen Peroxide Tri-MetricChemical Indicator 1348/1348E forpack control monitoring of thefollowing hydrogen peroxidesterilization sterilizers and cycles:STERRAD® 100S System,STERRAD® NX® System (Standardand Advanced cycles), STERRAD®NX® System with AllClear™Technology (Standard and Advancedcycles), STERRAD® 100NX® System(Standard, Flex, Express and Duocycles) STERRAD® 100NX® Systemwith AllClear™ Technology (Standard,Flex, Express and Duo cycles)	STERRAD® NX with ALLClear™Technology (Standard and Advancedcycles)STERRAD® 100NX (Standard, Flex,Express, and Duo cycles)STERRAD® 100NX with ALLClear™Technology (Standard, Flex, Express,and Duo cycles)STERIS® V-PRO® maX (Lumen,Non-Lumen, and Flexible cycles)STERIS® V-PRO® maX2 (Lumen,Non-Lumen, Flexible, and Fast Non-Lumen cycles)STERIS® V-PRO® 60 (Lumen, Non-Lumen, and Flexible cycles)Use the 3MTM Attest™ VaporizedHydrogen Peroxide Tri-MetricChemical Indicator 1348/1348E forpack control monitoring of thefollowing hydrogen peroxidesterilization sterilizers and cycles:STERRAD® 100S System,STERRAD® NX® System (Standardand Advanced cycles), STERRAD®NX® System with AllClear™Technology (Standard and Advancedcycles), STERRAD® 100NX® System(Standard, Flex, Express and Duocycles) STERRAD® 100NX® Systemwith AllClear™ Technology (Standard,Flex, Express and Duo cycles)	theSTERIS®V-PRO® s2sterilizer totheindicationsfor use andtesting wasconducted todemonstratecolor changeperformance.
Indicationsfor Use	vaporized hydrogen peroxide sterilizersand STERIS® V-PRO® 1 (Lumencycle), STERIS ® V-PRO® 1 Plus(Lumen and Non-Lumen cycles) andSTERIS ® V-PRO® maX LowTemperature Sterilization System(Lumen, Non-Lumen and Flexiblecycles), STERIS® V-PRO® 60Temperature Sterilization System(Lumen, Non-Lumen and Flexiblecycles), STERIS® V-PRO® maX 2Temperature Sterilization System(Lumen, Non-Lumen, Flexible, andFast Non-lumen cycles), STERIS® V-PRO® s2 Low TemperatureSterilization System (Lumen, Non-Lumen, Flexible, and Fast cycles).	vaporized hydrogen peroxide sterilizersand STERIS® V-PRO® 1 (Lumencycle), STERIS ® V-PRO® 1 Plus(Lumen and Non-Lumen cycles) andSTERIS ® V-PRO® maX LowTemperature Sterilization System(Lumen, Non-Lumen and Flexiblecycles), STERIS® V-PRO® 60Temperature Sterilization System(Lumen, Non-Lumen and Flexiblecycles), and STERIS® V-PRO® maX 2Temperature Sterilization System(Lumen, Non-Lumen, Flexible, andFast Non-lumen cycles).	Similar. Thesubmissiondevice addstheSTERIS®V-PRO® s2sterilizer totheindicationsfor use.
IndicatorAgent	Proprietary	Proprietary	Identical
Stability ofthe endpointreaction	At least one month (4 weeks)	At least one month (4 weeks)	Identical

5. Summary of Technological Characteristics compared to Predicate Device

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PREMARKET NOTIFICATION [Special 510(k)] 3M™ Attest™ Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E

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PREMARKET NOTIFICATION [Special 510(k)] 3MTM Attest™ Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E

Shelf life	15 months			6 months			Similar. 15month shelflife data hasbeengenerated forthesubmissiondevice usingthe sameprotocolused in thepredicatesubmission.
EndpointSpecifications(MinimumStatedValues)	VH2O2Concentration	ExposureTime	Temperature	VH2O2Concentration	ExposureTime	Temperature	Identical
	5.1 mg/L	1minute	50 degreesC	5.1 mg/L	1minute	50 degreesC

6. Summary of Nonclinical Testing

Provided below are the non-clinical test methodologies performed to demonstrate the Tri-Metric CI met the acceptance criteria of the standard.

Test Method	Purpose	Acceptance Criteria	Results
Health CareFacilitySimulatedUse Testingon STERISV-PRO s2sterilizer	Assess colorchange ofindicator afterexposure torepresentativecomplete andincompletecycles for theSTERIS V-PRO s2sterilizer	The 3M Tri-Metric CI turns from bluetoward pink in the ACCEPT region ofthe indicator window to indicate a"PASS" (reaches endpoint) whenexposed to a complete Lumen, Non-Lumen, Flexible, or Fast Cycle in theSTERIS V-PRO s2 Low TemperatureSterilization System.The 3M Tri-Metric CI turns from bluetoward pink only within the REJECTregion of the indicator window toindicate a "FAIL" (does not reachendpoint) when exposed to anincomplete Lumen, Non-Lumen,Flexible, or Fast Cycle in the STERISV-PRO s2 Low TemperatureSterilization System.	All Tri-Metric CIstested metacceptancecriteria.All Tri-Metric CIstested metacceptancecriteria.

7. Conclusion

Based on the non-clinical performance data, the submission device 3MTM Attest™ Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E is as safe, as effective, and performs as well as or better than the predicate of the same name (K193110), Class II (21 CFR 880.2800), product code QKM.

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).