Use the 3M™ Comply™ Hydrogen Peroxide Chemical Indicator 1248 as an internal pack process indicator to verify exposure to vaporized hydrogen peroxide in the STERRAD® 100S, STERRAD® NX (Standard and Advanced cycles), STERRAD® 100NX (Standard, Flex, Express and Duo cycles), STERRAD® NX with ALLClear™ Technology (Standard and Advanced cycles), STERRAD® 100NX with ALLClear™ Technology (Standard, Flex, Express and Duo cycles), AMSCO® V PRO® 1 (Lumen cycle), AMSCO® V PRO® 1 Plus (Lumen and Non Lumen cycles), AMSCO® V PRO® maX Low Temperature Sterilization System (Lumen, and Flexible cycles) and AMSCO® V-PRO® 60 Low Temperature Sterilization System (Lumen and Flexible cycles) sterilizers. The chemical indicator bar turns from blue toward pink after exposure to vaporized hydrogen peroxide.

Device Description

The 3M™ Comply™ Hydrogen Peroxide Chemical Indicator 1248 consists of a noncellulosic plastic material onto which a chemical indicator bar is printed. A comparison color match is also printed on the product to aid in color interpretation.

AI/ML Overview

Here's an analysis of the provided text in the context of acceptance criteria and a study proving device performance, focusing on the information given.

It's important to note that the provided document is an FDA 510(k) clearance letter and a 510(k) Summary for a medical device (a chemical indicator for sterilization). This type of document is for pre-market notification and demonstrates substantial equivalence to a predicate device, not necessarily a comprehensive clinical study report for an AI/ML device. Therefore, many of the requested categories for AI/ML device studies will not be directly applicable or detailed in this document.

The document describes the 3M™ Comply™ Hydrogen Peroxide Chemical Indicator 1248, a chemical indicator that turns from blue to pink when exposed to vaporized hydrogen peroxide during sterilization cycles.

Acceptance Criteria and Device Performance Study Analysis

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a quantitative, pass/fail table as one might see for an AI/ML diagnostic device's performance metrics (e.g., sensitivity, specificity thresholds). Instead, the performance is demonstrated by the chemical indicator's ability to "Pass" the relevant non-clinical tests.

Acceptance Criteria (Inferred)	Reported Device Performance
Color Change in Health Care Facility Cycle: The indicator must visibly change from blue toward pink after exposure to required sterilization conditions in the specified cycles.	Pass
Minimum Exposure Parameters to Affect the Change of the Indicator in Health Care Facility Cycle: The indicator must react appropriately to a defined minimum exposure of vaporized hydrogen peroxide.	Pass
End Point Color Stability: The final color (pink) must remain stable for at least one month (4 weeks) after exposure.	Pass

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

Test Set Sample Size: The document does not specify the exact number of chemical indicators tested in the non-clinical studies. It refers to "nonclinical testing" without providing specific counts of units or repetitions.
Data Provenance: The tests were "nonclinical testing," meaning controlled laboratory experiments. The document doesn't specify the country of origin for the data collection, but given it's a 3M product undergoing FDA clearance, it's likely conducted in the US or under US-equivalent standards. It is retrospective in the sense that the device was fully developed prior to these tests, but the tests themselves would be prospective controlled experiments.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This category is not applicable for this type of device. The "ground truth" for a chemical indicator is its physical reaction to chemical exposure, not a subjective interpretation by human experts. The "ground truth" is defined by the physical or chemical parameters of the sterilization cycle itself (e.g., concentration of hydrogen peroxide, temperature, time).

4. Adjudication Method for the Test Set

Not applicable. There's no human interpretation or "adjudication" necessary for the chemical indicator's performance in these non-clinical tests. The color change is a physical phenomenon observed and assessed against a pre-defined standard (blue to pink).

5. MRMC Comparative Effectiveness Study

Not applicable. This is not an AI/ML diagnostic device where human readers interact with AI. This is a physical chemical indicator.

6. Standalone Performance (Algorithm Only)

The device itself is a "standalone" chemical indicator; there is no embedded algorithm. Its performance is evaluated directly through the physical and chemical tests mentioned.

7. Type of Ground Truth Used

The ground truth for this device's performance is based on physical and chemical parameters of the sterilization cycles (e.g., validated STERRAD® and AMSCO® V-PRO® sterilizer cycles' hydrogen peroxide exposure, temperature, and time). The expectation is that the indicator will change color when exposed to these validated sterilization conditions and not change color inappropriately under non-sterilizing conditions.

8. Sample Size for the Training Set

Not applicable. This is not an AI/ML device that requires a training set. The device is a physical chemical indicator with inherent chemical properties.

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

Not applicable, as there's no training set for this type of device.

Summary of the Study Proving Device Meets Acceptance Criteria:

The study described is non-clinical testing focusing on the chemical indicator's performance in various vaporized hydrogen peroxide sterilization cycles. The core of the study is a series of controlled laboratory tests to ensure the indicator performs as expected:

Objective: To demonstrate that the 3M™ Comply™ Hydrogen Peroxide Chemical Indicator 1248 functions correctly (changes color from blue to pink) when exposed to specific, validated sterilization cycles in various sterilizers (STERRAD® and AMSCO® V-PRO® models, including newer variants).
Methodology: The tests were conducted according to the FDA Guidance for Industry and Staff: Premarket Notification [510(k)] Submissions for Chemical Indicators, issued December 19, 2003. This guidance outlines the required testing for chemical indicators. The document lists three specific non-clinical tests performed:
1. Color Change in Health Care Facility Cycle: Verified that the indicator changes color as intended under actual or simulated sterilization conditions.
2. Minimum Exposure Parameters to Affect the Change of the Indicator in Health Care Facility Cycle: Confirmed that the indicator visibly reacts when exposed to the minimum effective parameters of the sterilization process.
3. End Point Color Stability: Assessed that the final color change remains stable for at least one month.
Results: All tests were reported as "Pass."
Rationale for Equivalence: The submission emphasizes that the device is identical in materials, performance specifications, and fundamental technology to a previously cleared device (K170321). The non-clinical testing specifically addressed performance in newly claimed sterilizers and cycles (e.g., STERRAD® NX with ALLClear™ Technology, STERRAD® 100NX with ALLClear™ Technology, AMSCO® V-PRO® 60).
Conclusion: Based on these non-clinical performance data, the manufacturer concluded that the device is "as safe, as effective, and performs as well as or better than the legally marketed device."

This "study" is typical for demonstrating substantial equivalence for a Class II medical device like a chemical indicator, where the primary concern is its physical/chemical performance under specified conditions, rather than a diagnostic or therapeutic effect that requires clinical trials or complex AI/ML evaluation.

Summary

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February 26, 2019

3M Company Nadia Battah Regulatory Affairs Associate 3m Center Building 275-5w-06 St.paul. Minnesota 55144

Re: K183211

Trade/Device Name: 3M Comply Hydrogen Peroxide Chemical Indicator 1248 Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: Class II Product Code: JOJ Dated: February 8, 2019 Received: February 11, 2019

Dear Nadia Battah:

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 mav, 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 avare 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/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 lii III -S

For Tina Kiang, Ph.D. Acting 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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Indications for Use

510(k) Number (if known) K183211

Device Name

3MTM ComplyTM Hydrogen Peroxide Chemical Indicator 1248

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
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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 3M™ ComplyTM Hydrogen Peroxide Chemical Indicator 1248

K183211

Sponsor Information:

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

Contact: Nadia Battah Senior Regulatory Affairs Associate Phone Number: (651) 733-0929 Fax Number: (651) 737-5320

Date of Summary: February 22, 2019

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1. Device Name and Classification:

Common or Usual Name:	Chemical Indicator
Proprietary Name:	3MTM ComplyTM Hydrogen Peroxide Chemical Indicator1248
Classification Name:	Indicator, physical/chemical sterilization process
Device Classification:	Class II, 21 CFR § 880.2800
Product Code:	JOJ

2. Predicate Device:

K170321 3M™ Comply™ Hydrogen Peroxide Chemical Indicator 1248

3. Description of Device:

4. Indications for Use

Use the 3MTM ComplyTM Hydrogen Peroxide Chemical Indicator 1248 as an internal pack process indicator to verify exposure to vaporized hydrogen peroxide in the STERRAD® 100, STERRAD® 100S, STERRAD® NX (Standard and Advanced cycles), STERRAD® 100NX (Standard, Flex, Express and Duo cycles), STERRAD® NX with ALLClear™ Technology (Standard and Advanced cycles), STERRAD® 100NX with ALLClear™ Technology (Standard, Flex, Express and Duo cycles), AMSCO® V-PRO® 1 (Lumen cycle), AMSCO® V-PRO® 1 Plus (Lumen and Non Lumen cycles), AMSCO® V-PRO® maX Low Temperature Sterilization System (Lumen, Non Lumen, 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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	Submission Device: K183211:	Predicate Device (K170321):
Feature	3M™ Comply™ Hydrogen Peroxide Chemical	3M™ Comply™ Hydrogen PeroxideChemical Indicator 1248
	Indicator 1248
Indications for use	Use the 3M™ Comply™ Hydrogen PeroxideChemical Indicator 1248 as an internal pack processindicator to verify exposure to vaporized hydrogenperoxide in the STERRAD® 100, STERRAD®100S, STERRAD® NX (Standard and Advancedcycles), STERRAD® 100NX (Standard, Flex,Express and Duo cycles), STERRAD® NX withALLClear™ Technology (Standard and Advancedcycles), STERRAD® 100NX with ALLClear™Technology (Standard, Flex, Express and Duocycles), AMSCO® V-PRO® 1 (Lumen cycle),AMSCO® V-PRO® 1 Plus (Lumen and NonLumen cycles), AMSCO® V-PRO® maX LowTemperature Sterilization System (Lumen, NonLumen, and Flexible cycles) and AMSCO® V-PRO® 60 Low Temperature Sterilization System(Lumen, Non Lumen and Flexible cycles)sterilizers. The chemical indicator bar turns fromblue toward pink after exposure to vaporizedhydrogen peroxide.	Use the 3M™ Comply™ HydrogenPeroxide Chemical Indicator 1248 as aninternal pack process indicator to verifyexposure to vaporized hydrogen peroxidein the STERRAD® 100, 100S, NX®(Standard and Advanced cycles),100NX® (Standard, Flex, Express andDuo cycles), AMSCO® V-PRO™ 1(Lumen cycle), AMSCO® V-PRO™ 1Plus (Lumen and Non Lumen cycles), andAMSCO® V-PRO™ maX LowTemperature Sterilization System(Lumen, Non Lumen, and Flexiblecycles) sterilizers. The chemical indicatorbar turns from blue to pink after exposureto vaporized hydrogen peroxide.
Sterilizers andSterilizationCycles	STERRAD® 100STERRAD® 100SSTERRAD® NX (Standard and Advanced cycles)STERRAD® NX with ALLClear™ Technology(Standard and Advanced cycles)STERRAD® 100NX (Standard, Flex, Express, andDuo cycles)STERRAD® 100NX with ALLClear™ Technology(Standard, Flex, Express, and Duo cycles)AMSCO® V-PRO™ 1 (Lumen cycle)AMSCO® V-PRO™ 1 Plus (Lumen and NonLumen cycles)AMSCO® V-PRO™ maX Low TemperatureSterilization System (Lumen, Non Lumen andFlexible cycles)AMSCO® V-PRO™ 60 (Lumen, Non Lumen andFlexible cycles)	STERRAD® 100STERRAD® 100SSTERRAD® NX (Standard and Advancedcycles)STERRAD® 100NX (Standard, Flex,Express, and Duo cycles)AMSCO® V-PRO™ 1 (Lumen cycle)AMSCO® V-PRO™ 1 Plus (Lumen andNon Lumen cycles)AMSCO® V-PRO™ maX LowTemperature Sterilization System(Lumen, Non Lumen and Flexible cycles)
Substrate	Polyethylene	Identical
Biocompatibility	The exposure to health care professional is minimaland well below any identified toxic thresholds forthe compounds.	Identical
Color Change	Blue toward pink	Identical
Detection	Hydrogen Peroxide	Identical
Stability of theendpoint reaction	At least one month (4 weeks)	Identical
Shelf life	Two (2) years	Identical

5. Summary of Technological Characteristics compared to Predicate Device

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6. Summary of Non-Clinical Testing

The 3M™ Comply™ Hydrogen Peroxide Chemical Indicator 1248 is identical to the previously cleared device of the same model number (the predicate) which is sold under the tradename 3M™ Comply™ Hydrogen Peroxide Chemical Indicator 1248 (K170321). As no change has been made to the device materials, performance specifications, or fundamental technology, the biocompatibility and nonclinical testing provided in K170321 was referenced in this submission to support performance of the device in the claimed sterilizers.

To demonstrate performance in the newly claimed sterilizers and cycles, 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. Reference Table 6.1 for testing completed in the AMSCO® V-PRO™ 60 Low Temperature Sterilization System (Lumen, Non-Lumen and Flexible cycles), STERRAD® NX with ALLClear™ Technology (Standard and Advanced cycles), and STERRAD® 100NX with ALLClear™ Technology (Standard, Flex and Express cycles) sterilizer.

Table 6.1 Summary of Nonclinical Testing

Test	Result
Color Change in Health Care Facility Cycle	Pass
Minimum Exposure Parameters to Affect the Change of the Indicator inHealth Care Facility Cycle	Pass
End Point Color Stability	Pass

7. Conclusion

Based on the intended uses, technological characteristics and non-clinical performance data, the 3MTM ComplyTM Hydrogen Peroxide Chemical Indicator 1248 is as safe, as effective, and performs as well as or better than the legally marketed device, the 3MTM Comply™ Hydrogen Peroxide Chemical Indicator 1248 cleared under K170321, Class II (21 CFR 880.2800), product code JOJ.

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).