Use the 3M™ Attest™ Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E for pack control monitoring of the following sterilizers and cycles:

STERRAD 100S® Sterilization System
STERRAD NX® Sterilization System (Standard and Advanced cycles)
STERRAD 100NX® Sterilization System (Standard, Flex, Express and Duo cycles)
STERRAD NX® with ALLClear® Technology Sterilization System (Standard and Advanced cycles)
STERRAD 100NX® with ALLClear® Technology Sterilization System (Standard, Flex, Express and Duo cycles)
V-PRO® 1 Low Temperature Sterilization System (Lumen cycle)
V-PRO® 1 Plus Low Temperature Sterilization System (Lumen and Non Lumen cycles)
V-PRO® maX Low Temperature Sterilization System (Lumen, and Flexible cycles)
V-PRO® 60 Low Temperature Sterilization System (Lumen, Non Lumen and Flexible cycles)
V-PRO® maX 2 Low Temperature Sterilization System (Lumen, Flexible, and Fast Non Lumen cycles)
V-PRO® s2 Low Temperature Sterilization System (Lumen, Flexible, and Fast cycles)
STERIZONE® VP4 Sterilizer (Cycle 1)

Device Description

The 3MTM 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 to 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 a summary of the acceptance criteria and study information for the 3M™ Attest™ Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E:

1. Table of Acceptance Criteria and Reported Device Performance

Test Name	Purpose	Acceptance Criteria	Reported Device Performance
Health Care Facility Simulated Use Testing on STERIZONE® VP4 Sterilizer (Cycle 1)	Assess color change of indicator after exposure to representative complete and incomplete cycles for the STERIZONE® VP4 Sterilizer (Cycle 1)	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 cycle in the STERIZONE® VP4 Sterilizer (Cycle 1). 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 cycle in the STERIZONE® VP4 Sterilizer (Cycle 1).	All Tri-Metric CIs tested met acceptance criteria.

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

The document does not explicitly state the specific sample size (i.e., number of indicators) used for the sterile and incomplete cycles during the "Health Care Facility Simulated Use Testing." It broadly states "All Tri-Metric CIs tested met acceptance criteria," implying multiple indicators were used.

The data provenance is prospective, as the testing was conducted to evaluate the device's performance in a healthcare facility setting, specifically for the STERIZONE® VP4 Sterilizer (Cycle 1). The country of origin for the data is not specified, but the submission is from a US-based company to the FDA.

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

The document does not provide information on the number of experts used or their qualifications for establishing the ground truth for reading the chemical indicators. However, for a chemical indicator, the "ground truth" performance is typically based on the objective visual change of the indicator after exposure to defined sterilization conditions (complete vs. incomplete cycles). The acceptance criteria detail very specific visual outcomes ("blue toward pink in the ACCEPT region" for pass, and "blue toward pink only within the REJECT region" for fail), implying a relatively objective assessment rather than subjective expert interpretation, though standard operating procedures would likely be in place for reading.

4. Adjudication Method for the Test Set

The document does not specify an adjudication method like 2+1 or 3+1. Given the objective nature of chemical indicator color change and defined "ACCEPT" and "REJECT" zones, it's likely that a single trained observer could determine the outcome, or multiple observers could independently read and have their results compared, without a formal adjudication process being explicitly detailed in this type of submission.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The device is a chemical indicator, which is a standalone device that provides a visual reading, not an AI or diagnostic tool that assists human readers in interpreting complex data. Therefore, the concept of human readers improving with AI vs. without AI assistance does not apply here.

6. Standalone Performance Study

Yes, a standalone study was done. The "Health Care Facility Simulated Use Testing on STERIZONE® VP4 Sterilizer (Cycle 1)" was a standalone performance study. The chemical indicators were subjected to complete and incomplete sterilization cycles, and their performance (color change) was evaluated independently of any human intervention beyond the initial setup and final visual assessment. The results directly demonstrate the algorithm-only performance (e.g., the indicator's intrinsic ability to react to the sterilization process).

7. Type of Ground Truth Used

The ground truth used was based on the objective conditions of the sterilization cycles. This means:

Complete Cycle: The indicator was exposed to the full, verified sterilization parameters (time, temperature, vaporized hydrogen peroxide concentration) of a successful STERIZONE® VP4 Cycle 1.
Incomplete Cycle: The indicator was exposed to conditions known to be insufficient for sterilization (e.g., shorter time, lower temperature, insufficient sterilant).

The color change of the indicator was then compared against these known conditions.

8. Sample Size for the Training Set

This product is a chemical indicator, not a machine learning or AI-driven device. Therefore, there is no training set in the context of AI or machine learning algorithms. The device's performance is based on its chemical reaction properties, which are inherent to its design and manufacturing.

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

As explained above, there is no training set for this type of device. The chemical indicator's design and manufacturing are developed based on established scientific principles of chemical reactions to sterilants, rather than being "trained" on data.

Summary

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April 20, 2022

3M Company Mary Fretland Regulatory Affairs Specialist 3M Center, Building 275-5W-06 St. Paul, Minnesota 55144

Re: K212022

Trade/Device Name: 3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: Class II Product Code: QKM Dated: March 24, 2022 Received: March 25, 2022

Dear Mary Fretland:

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 Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K212022

Device Name

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 sterilizers and cycles:

STERRAD 100S® Sterilization System
STERRAD NX® Sterilization System (Standard and Advanced cycles)
STERRAD 100NX® Sterilization System (Standard, Flex, Express and Duo cycles)
STERRAD NX® with ALLClear® Technology Sterilization System (Standard and Advanced cycles)
STERRAD 100NX® with ALLClear® Technology Sterilization System (Standard, Flex, Express and Duo cycles)
V-PRO® 1 Low Temperature Sterilization System (Lumen cycle)
V-PRO® 1 Plus Low Temperature Sterilization System (Lumen and Non Lumen cycles)
V-PRO® maX Low Temperature Sterilization System (Lumen, and Flexible cycles)
V-PRO® 60 Low Temperature Sterilization System (Lumen, Non Lumen and Flexible cycles)
V-PRO® maX 2 Low Temperature Sterilization System (Lumen, Flexible, and Fast Non Lumen cycles)
V-PRO® s2 Low Temperature Sterilization System (Lumen, Flexible, and Fast cycles)
STERIZONE® VP4 Sterilizer (Cycle 1)

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

Sponsor Information:

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

Contact: Mary Fretland Regulatory Affairs Specialist Phone Number: (651) 461-2734

Date of Summary: 19 April 2022

510(k): K212022

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

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

1. Predicate Device:

K203284, 3M™ Attest™ Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E

2. Description of Device:

3. Indications for Use

Use the 3MTM Attest™ Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E for pack control monitoring of the following sterilizers and cycles:

STERRAD 100S® Sterilization System
STERRAD NX® Sterilization System (Standard and Advanced cycles)
STERRAD 100NX® Sterilization System (Standard, Flex, Express and Duo cycles)
STERRAD NX® with ALLClear® Technology Sterilization System (Standard and Advanced cycles)

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

STERRAD 100NX® with ALLClear® Technology Sterilization System (Standard, Flex, Express and Duo cycles)
V-PRO® 1 Low Temperature Sterilization System (Lumen cycle)
V-PRO® 1 Plus Low Temperature Sterilization System (Lumen and Non Lumen cycles)
V-PRO® maX Low Temperature Sterilization System (Lumen, Non Lumen, and Flexible cycles)
V-PRO® 60 Low Temperature Sterilization System (Lumen, Non Lumen and Flexible cycles)
V-PRO® maX 2 Low Temperature Sterilization System (Lumen, Non Lumen, Flexible, and Fast Non Lumen cycles)
V-PRO® s2 Low Temperature Sterilization System (Lumen, Non Lumen, Flexible, and Fast cycles)
STERIZONE® VP4 Sterilizer (Cycle 1)

4. Summary of Technological Characteristics compared to Predicate Device

Feature	Submission Device: 3MTM AttestTMVaporized Hydrogen Peroxide Tri-Metric Chemical Indicator	Predicate Device:3MTM Attest™ Vaporized HydrogenPeroxide Tri-Metric ChemicalIndicator (K203284)	Comparison
DeviceModels	1348, 1348E	1348, 1348E	Identical
Indicationsfor Use	Use the 3MTM Attest™ VaporizedHydrogen Peroxide Tri-MetricChemical Indicator 1348/1348E forpack control monitoring of thefollowing sterilizers and cycles:STERRAD 100S® SterilizationSystemSTERRAD NX® SterilizationSystem (Standard and Advancedcycles)STERRAD 100NX® SterilizationSystem (Standard, Flex, Express andDuo cycles)STERRAD NX® with ALLClear®Technology Sterilization System(Standard and Advanced cycles)STERRAD 100NX® withALLClear® Technology SterilizationSystem (Standard, Flex, Express andDuo cycles)V-PRO® 1 Low TemperatureSterilization System (Lumen cycle)V-PRO® 1 Plus Low TemperatureSterilization System (Lumen andNon Lumen cycles)V-PRO® maX Low TemperatureSterilization System (Lumen, NonLumen, and Flexible cycles)V-PRO® 60 Low TemperatureSterilization System (Lumen, NonLumen and Flexible cycles)V-PRO® maX 2 Low TemperatureSterilization System (Lumen, NonLumen, Flexible, and Fast NonLumen cycles)	Use the 3MTM Attest™ VaporizedHydrogen Peroxide Tri-MetricChemical Indicator 1348/1348E forpack control monitoring of thefollowing hydrogen peroxidesterilization sterilizers and cycles:STERRAD 100S® SterilizationSystemSTERRAD NX® SterilizationSystem (Standard and Advancedcycles)STERRAD 100NX® SterilizationSystem (Standard, Flex, Express andDuo cycles)STERRAD NX® with ALLClear®Technology Sterilization System(Standard and Advanced cycles)STERRAD 100NX® withALLClear® Technology SterilizationSystem (Standard, Flex, Express andDuo cycles)V-PRO® 1 Low TemperatureSterilization System (Lumen cycle)V-PRO® 1 Plus Low TemperatureSterilization System (Lumen andNon Lumen cycles)V-PRO® maX Low TemperatureSterilization System (Lumen, NonLumen, and Flexible cycles)V-PRO® 60 Low TemperatureSterilization System (Lumen, NonLumen and Flexible cycles)V-PRO® maX 2 Low TemperatureSterilization System (Lumen, Non	Similar. Thesubmissiondevice adds theSTERIZONE®VP4 Sterilizer(Cycle 1) to theindications foruse andremoves the"hydrogenperoxidesterilization" asa descriptor forthe list ofsterilizers. Thelist nowincludes bothhydrogenperoxide and adual sterilant(hydrogenperoxide/ozone)sterilizer.

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

	V-PRO® s2 Low TemperatureSterilization System (Lumen, NonLumen, Flexible, and Fast cycles)STERIZONE® VP4 Sterilizer(Cycle 1)		Lumen, Flexible, and Fast NonLumen cycles)V-PRO® s2 Low TemperatureSterilization System (Lumen, NonLumen, Flexible, and Fast cycles)
IndicatorAgent	Proprietary	Proprietary	Identical
Stability ofthe endpointreaction	At least six months	At least six months	Identical
Shelf life	15 months	15 months	Identical
EndpointSpecifications(MinimumStatedValues)	VH2O2Concentration5.1 mg/LExposureTime1 minuteTemperature50 degreesC	VH2O2Concentration5.1 mg/LExposureTime1 minuteTemperature50 degreesC	Identical

5. Nonclinical Comparison to the Predicate Device

The submission device, 3M™ Attest™ Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E, has identical design, fundamental technology, and performance specifications to the predicate device under the same name. The key difference between the submission device and the predicate device is that the submission device adds an indication for pack control monitoring of the exposure time, temperature, and amount of vaporized hydrogen peroxide of the dual sterilant vaporized hydrogen peroxide/ozone STERIZONE® VP4 Sterilizer (Cycle 1), last cleared under K203284.

Given the addition of this indication for the STERIZONE® VP4 Sterilizer, nonclinical testing was performed in accordance with the FDA Guidance for Industry and Staff: Premarket Notification [510(k)] Submissions for Chemical Indicators, issued December 19, 2003. Testing was conducted via simulated use testing of the STERIZONE® VP4 Sterilizer in a health care facility and all tests conducted passed.

Test Name	Purpose	Acceptance Criteria	Result
Health CareFacilitySimulated UseTesting onSTERIONEVP4 Sterilizer(Cycle 1)	Assess color change ofindicator after exposureto representativecomplete and incompletecycles for theSTERIONE VP4Sterilizer (Cycle 1)	The 3MTM Tri-Metric CI turns from bluetoward pink in the ACCEPT region ofthe indicator window to indicate a"PASS" (reaches endpoint) whenexposed to a complete cycle in theSTERIONE VP4 Sterilizer (Cycle 1).The 3MTM 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 cycle in the STERIONE VP4Sterilizer (Cycle 1).	All Tri-MetricCIs tested metacceptancecriteria.All Tri-MetricCIs tested metacceptancecriteria.

Summary of Nonclinical Testing

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6. Conclusion

The conclusions drawn from the non-clinical performance data demonstrate that the submission device, 3M™ Attest™ Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/13485, is as safe, as effective, and performs as well or better than the legally marketed predicate of the same name (K203284), 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).