Use the 3M™ Attest™ Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E for pack control monitoring of the following hydrogen peroxide sterilizers and cycles: STERRAD® 100S System, STERRAD® NX® System (Standard and Advanced cycles), STERRAD® NX® System with AllClear™ Technology (Standard and Advanced cycles), STERRAD® 100NXº 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), and STERIS® V-PRO® maX 2 Temperature Sterilization System (Lumen, Non-Lumen, Flexible, and Fast Non-Lumen 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 a breakdown of the acceptance criteria and study information for the 3M™ Attest™ Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E, based on the provided document:

Acceptance Criteria and Device Performance

Acceptance Criteria / Test	Reported Device Performance
Health Care Facility Simulated Use Testing: Color change of the indicator was assessed after exposure to representative complete and incomplete cycles for various STERRAD® and STERIS® V-PRO® sterilizers.	Pass
Worst Case Sterilant Exposure Testing: Ensured color change in overexposure conditions was similar to color change observed for in-pack monitoring of the same cycle.	Pass
Endpoint Color Stability: After VH2O2 processing, chemical indicator samples were placed in a shelf life study to confirm the chemical indicator samples conserved their color change reading over time.	Pass
Shelf Life Testing: 6 months of shelf life testing assessing endpoint and non-endpoint conditions.	Pass

Note on "Acceptance Criteria": The document lists "Stated Values" for the chemical indicator, which represent the minimum conditions at which the indicator is designed to reach its endpoint (change color to "ACCEPT"). These are:

VH2O2: 5.1 mg/L
Exposure Time: 1 minute
Temperature: 50°C

The general acceptance criteria for the nonclinical testing seem to be 'Pass' for each test, indicating that the device performed as expected under the tested conditions.

Study Details

Sample size used for the test set and the data provenance:
- The document does not specify the exact sample size for the test set (e.g., how many individual indicators were tested for each sterilizer type or condition). It mentions "chemical indicator samples" for endpoint color stability and shelf life testing.
- Data Provenance: The document implies the testing was conducted by the manufacturer, 3M Company, as part of their premarket notification. The location of the testing is not explicitly stated (e.g., country of origin), but it's likely internal to 3M's development and validation processes. The study is prospective as it's part of the premarket submission for a new device.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document does not mention the use of human experts to establish ground truth for reading the chemical indicator's color change. Chemical indicators are typically designed for objective visual interpretation, where the "ground truth" is defined by the physical/chemical properties of the indicator and its response to specific sterilization parameters, as determined by laboratory measurements of those parameters.
- Therefore, this question is not directly applicable in the context of this device and study.
Adjudication method for the test set:
- None specified. As mentioned above, the assessment of a chemical indicator's color change against defined "ACCEPT" or "REJECT" zones is generally a direct visual interpretation, not requiring expert adjudication in the same way, for example, a medical imaging diagnosis might. The endpoint specifications are based on the physical chemistry of the indicator.
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. This is a chemical indicator, not an AI-powered diagnostic device or a system requiring human interpretation with or without AI assistance. Therefore, an MRMC study is not relevant to this submission.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical chemical indicator, not an algorithm. Its performance is inherent in its physical and chemical interaction with the sterilant.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth for this device is based on the defined physical/chemical parameters of the sterilization process (VH2O2 concentration, exposure time, and temperature) and the indicator's designed response to these parameters. The "Stated Values" (SV) in Table 1 define the minimum conditions for a successful ("ACCEPT") outcome. The "Health Care Facility Simulated Use Testing" and "Worst Case Sterilant Exposure Testing" would have used calibrated sterilization equipment to establish these ground truth conditions.
The sample size for the training set:
- Not applicable. This device is a passive chemical indicator, not a machine learning model, so there is no "training set." Its design and performance are based on chemical engineering and empirical testing rather than iterative learning from data.
How the ground truth for the training set was established:
- Not applicable. As there is no training set, this question is not relevant.

Summary

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March 13, 2020

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

Re: K193110

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: February 13, 2020 Received: February 14, 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

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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 (QS) 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,

For Sreekanth Gutala, Ph.D. 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)

K193110

Device Name

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

Indications for Use (Describe)

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: Andrew Wingen Regulatory Affairs Commercialization Strategy Lead Phone Number: (651) 733-9209 Fax Number: (651) 737-5320

Date of Summary: 9 March 2020

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1. Device Name and Classification:

Common or Usual Name:	Chemical Indicator
Proprietary Name:	3M™ Attest™ 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:

K183211 3M™ Comply™ Hydrogen Peroxide Chemical Indicator 1248

3. Description of Device:

4. Indications for Use

Use the 3MTM 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 cvcles) STERRAD® 100NX® System with AllClear™ Technology (Standard, Flex, Express and Duo cycles) vaporized hydrogen peroxide sterilizers and

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

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), and STERIS® V-PRO® maX 2 Temperature Sterilization System (Lumen, Flexible, and Fast Nonlumen cycles).

Stated Values (SV)

Stated values of a critical process variable are values at which the indicator is designed to reach its endpoint as defined by the manufacturer. The critical process variables measured by the 3M™ Attest™ CI 1348/1348E are exposure time, temperature, and concentration of vaporized hydrogen peroxide. The stated critical values for the 3MTM Attest™ CI 1348/1348E are contained in Table 1.

Table 1: Stated Values of 3M™ Attest™ CI 1348/1348E

Attribute	Measurement
VH2O2	5.1 mg/L
Exposure Time	1 minute
Temperature	50 C

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5. Summary of Technological Characteristics compared to Predicate Device

	Submission Device: 3MTM AttestTMVaporized Hydrogen Peroxide Tri-	Predicate Device:3MTM ComplyTM
Feature	Metric Chemical Indicator (K193110)	Hydrogen PeroxideChemical Indicator1248 (K183211)	Comparison
DeviceModels	1348, 1348E	1248	Different
Device Design	The 3MTM AttestTM Vaporized HydrogenPeroxide Tri-Metric Chemical Indicator1348/1348E is a chemical indicator consistingof a non-cellulose based coated indicator stripsensitive to vaporized hydrogen peroxide,contained in a film laminate.The 3MTM AttestTM CI 1348/1348E verifies thatthe three critical parameters of exposure time,temperature, and concentration of vaporizedhydrogen peroxide have been achieved within apackage or containment device (i.e. wrappedtrays, rigid containers, sterilization pouches,and other types of packs) and/or at a specificlocation within the load or empty chamber.Upon exposure to vaporized hydrogenperoxide, the color of the coated indicator stripprogressively changes from blue toward pinkalong the strip. The progression of the blue topink color change along the strip is visiblethrough a window with marked “REJECT” and"ACCEPT" zones. The extent of theprogression depends on exposure time,temperature, and concentration of vaporizedhydrogen peroxide.	The 3MTM ComplyTMHydrogen PeroxideChemical Indicator1248 consists of anon-cellulosic plasticmaterial onto which achemical indicatorbar is printed. Acomparison colormatch is also printedon the product to aidin colorinterpretation.Upon exposure tovaporized hydrogenperoxide, thechemical indicatorbar turns from bluetoward pink.	Similar
Sterilizers inwhich ColorChangePerformancewasDemonstrated(Blue towardPink)	STERRAD® 100SSTERRAD® NX (Standard and Advancedcycles)STERRAD® NX with ALLClearTM Technology(Standard and Advanced cycles)STERRAD® 100NX (Standard, Flex, Express,and Duo cycles)STERRAD® 100NX with ALLClearTMTechnology (Standard, Flex, Express, and Duocycles)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)	STERRAD® 100STERRAD® 100SSTERRAD® NX(Standard andAdvanced cycles)STERRAD® NX withALLClearTMTechnology(Standard andAdvanced cycles)STERRAD® 100NX(Standard, Flex,Express, and Duocycles)STERRAD® 100NXwith ALLClearTMTechnology(Standard, Flex,	Similar. The Tri-Metric CI is notindicated to be usedwith theSTERRAD® 100sterilizer. Testingwith the STERIS®V-PRO® maX isequivalent to V-PRO® 1 and V-PRO® 1 Pluscycles.

Table 2: Comparison of Submission Device and Predicate Device

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

			IndicatorAgent
	Express, and Duocycles)			Proprietary		Identical
	AMSCO® V-PRO™1 (Lumen cycle)		Stability of theendpointreaction	At least one month (4 weeks)	At least one month (4 weeks)	Identical
	AMSCO® V-PRO™1 Plus (Lumen andNon Lumen cycles)		Shelf life	6 months	Two (2) years	Similar
	AMSCO® V-PRO™maX LowTemperatureSterilization System(Lumen, Non Lumenand Flexible cycles)		EndpointSpecifications(MinimumStated Values)	VH2O2Concentration	ExposureTime	Temperature
	AMSCO® V-PRO™60 (Lumen, NonLumen and Flexiblecycles)			5.1 mg/L	1 minute	50 degrees C
Indications foruse	Use the 3M™ Attest™ Vaporized HydrogenPeroxide Tri-Metric Chemical Indicator1348/1348E for pack control monitoring of thefollowing hydrogen peroxide sterilizationsterilizers and cycles: STERRAD® 100SSystem, STERRAD® NX® System (Standardand Advanced cycles), STERRAD® NX®System with AllClear™ Technology (Standardand Advanced cycles), STERRAD® 100NX®System (Standard, Flex, Express and Duocycles) STERRAD® 100NX® System withAllClear™ Technology (Standard, Flex,Express and Duo cycles) vaporized hydrogenperoxide sterilizers and STERIS® V-PRO® 1(Lumen cycle), STERIS ® V-PRO® 1 Plus(Lumen and Non-Lumen cycles) and STERIS® V-PRO® maX Low TemperatureSterilization System (Lumen, Non-Lumen andFlexible cycles), STERIS® V-PRO® 60Temperature Sterilization System (Lumen,Non-Lumen and Flexible cycles), andSTERIS® V-PRO® maX 2 TemperatureSterilization System (Lumen, Non-Lumen,Flexible, and Fast Non-lumen cycles).		Use the 3M™Comply™ HydrogenPeroxide ChemicalIndicator 1248 as aninternal pack processindicator to verifyexposure tovaporized hydrogenperoxide in theSTERRAD® 100,STERRAD® 100S,STERRAD® NX(Standard andAdvanced cycles),STERRAD® 100NX(Standard, Flex,Express and Duocycles), STERRAD®NX withALLClear™Technology(Standard andAdvanced cycles),STERRAD® 100NXwith ALLClear™Technology(Standard, Flex,Express and Duocycles), AMSCO®V-PRO® 1 (Lumencycle), AMSCO® V-PRO® 1 Plus(Lumen and NonLumen cycles),AMSCO® V-PRO®maX LowTemperatureSterilization System(Lumen, Non Lumenand Flexible cycles)AMSCO® V-PRO®60 (Lumen, NonLumen and Flexiblecycles)	Sterilization System(Lumen, Non Lumen,	Similar. Tri-MetricremovesSTERRAD® 100and updates brandnames associatedwith the formerAMSCO® V-PROsterilizers. Tri-Metric notes colorchange in the devicedescription portionof the instructionsfor use rather thanin the indicationsfor use portion ofthe instructions foruse.		Different. The predicate is sensitive to VH2O2 exposure only, while the submission device is sensitive to VH2O2 concentration, exposure time, and temperature.
						Not applicable. The CI turns from blue toward pink after exposure to vaporized hydrogen peroxide.
		and Flexible cycles)and AMSCO® V-PRO® 60 Low Temperature Sterilization System (Lumen, Non Lumen and Flexible cycles) sterilizers. The chemical indicator bar turns from blue toward pink after exposure to vaporized hydrogen peroxide.

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

6. Nonclinical Comparison to the Predicate Device

The 3M™ Attest™ Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E has similar design, fundamental technology, and performance specification to the predicate device sold under the tradename 3M™ Comply™ Hydrogen Peroxide Chemical Indicator 1248 (K183211). The key difference between the Tri-Metric CI 1348/1348E and the Hydrogen Peroxide CI 1248 is that Tri-Metric is sensitive to three critical process variables (sterilant exposure duration, concentration, and temperature), while the predicate is sensitive to sterilant exposure.

Given differences in device construction and performance specifications between the predicate and new device, 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.

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Table 3: Summary of Nonclinical Testing

Test	Result
Health Care Facility Simulated Use Testing:Color change of the indicator was assessed after exposure torepresentative complete and incomplete cycles for the STERRAD® 100S,STERRAD® NX® (Standard and Advanced cycles), STERRAD® NX®with AllClear™ (Standard and Advanced cycles), STERRAD® 100NX®(Standard, Flex, Express and Duo cycles) STERRAD® 100NX® Systemwith AllClear™ (Standard, Flex, Express and Duo cycles), STERIS ® V-PRO® maX (Lumen, Non-Lumen and Flexible cycles), STERIS® V-PRO® maX 2 (Lumen, Non-Lumen, Flexible, and Fast Non-lumencycles), and STERIS® V-PRO® 60 (Lumen, Non-Lumen, Flexible andFast Non-Lumen cycles) sterilizers.	Pass
Worst Case Sterilant Exposure Testing:Testing was conducted using overexposure conditions in a commercialsterilizer to ensure color change in overexposure conditions was similar tocolor change observed for in-pack monitoring of the same cycle.	Pass
Endpoint Color Stability:Following VH2O2 processing, chemical indicator samples were placed ina shelf life study to confirm the chemical indicator samples conservedtheir color change reading over time.	Pass
Shelf Life Testing:6 months of shelf life testing assessing endpoint and non-endpointconditions was conducted.	Pass

7. Conclusion

Based on the intended uses, technological characteristics and non-clinical performance data, the 3M™ Attest™ Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E is as safe, as effective, and performs as well as or better than the legally marketed predicate device, the 3M™ Comply™ Hydrogen Peroxide Chemical Indicator 1248, cleared under K183211.

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).