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® 100, 100S, NX® (Standard and Advanced cycles) and 100NX® (Standard, Flex, Express and Duo cycles) sterilization processes. The chemical indicator bar turns from blue to pink after exposure to vaporized hydrogen peroxide.

Device Description

The 3M™ Comply™ Hydrogen Peroxide Chemical Indicator 1248 consists of a non-cellulosic 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 a breakdown of the acceptance criteria and study information for the 3M™ Comply™ Hydrogen Peroxide Chemical Indicator 1248, based on the provided document:

Acceptance Criteria and Device Performance

Acceptance Criteria / Feature	Reported Device Performance
Color Change (STERRAD® 100)	Turned from blue to pink. Minimum time for all indicators to indicate a "pass" in relation to the color match was found to be between 10 and 15 minutes. (Demonstrated per original submission K013228).
Color Change (STERRAD® 100S)	Turned from blue to pink. Minimum time for all indicators to indicate a "pass" in relation to the color match was found to be between 4 and 8 minutes. (Demonstrated per original submission K013228).
Color Change (STERRAD® NX® - Standard & Advanced)	Turned from blue to pink. Minimum time required for all indicators to indicate a "pass" in relation to the color specification was found when exposed to these cycles.
Color Change (STERRAD® 100NX® - Standard, Flex, Express, Duo)	Turned from blue to pink. Minimum time required for all indicators to indicate a "pass" in relation to the color specification was found when exposed to these cycles.
Stability of the endpoint reaction	At least one month (4 weeks). Samples from four different lots were verified to be stable to storage under typical office lighting conditions for at least one month post-exposure in a Hydrogen Peroxide Health Care Facility Cycle.
Shelf life	Two (2) years.
Safety (Biocompatibility/Toxicity)	Components of the indicator ink were all of low general toxicity. Exposure to health care professional is minimal and below identified toxic thresholds. Indirect patient exposure is minimal and below identified toxic thresholds.

Study Details

The provided document describes a premarket notification [510(k)] submission for an expanded indication for use of an existing device, the 3M™ Comply™ Hydrogen Peroxide Chemical Indicator 1248. Crucially, the document states: "No clinical data was included in this premarket application submission." The focus of this specific submission is on nonclinical testing to demonstrate substantial equivalence for the expanded indications.

Therefore, the following details relate to the nonclinical studies conducted to support the expanded indications.

2. Sample size used for the test set and the data provenance:

Color Change in Health Care Facility Cycle: "Samples from six different lots" were verified.
Minimum Exposure Parameters to Affect the Change of the Indicator in Health Care Facility Cycle: "Samples from six different lots" were evaluated.
End Point Color Stability: "Samples from four different lots" were verified.
Data Provenance: The studies were conducted by 3M Health Care. Origin of data (e.g., country) is not specified but implied to be internal testing. The studies are prospective in nature, as they involve testing new lots of the device under controlled conditions to verify performance against pre-defined criteria.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not provided in the document. For chemical indicators, the ground truth is typically visual observation against a color match standard. The document mentions "color match" and "color specification," implying a pre-defined standard (the comparison color match printed on the product). The determination of "pass" or "fail" is based on whether the indicator sufficiently changes color to match this standard. It doesn't typically involve human expert interpretation in the same way as, for example, a medical imaging diagnosis.

4. Adjudication method for the test set:

This information is not explicitly stated. Given the nature of a chemical indicator changing color to a pre-defined standard, adjudication in a multi-rater sense is less common. The "pass" or "fail" is usually determined by direct comparison to the color target on the indicator. The mention of "all indicators" in relation to color change implies a quantitative or objective assessment rather than subjective expert consensus.

5. 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. Therefore, an MRMC study or assessment of human reader improvement with AI assistance is not applicable and was not performed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Yes, effectively. The device itself is a standalone chemical indicator designed to change color based on exposure. Its performance (color change, stability) is evaluated independently, without requiring human interpretation in a diagnostic loop that would alter or confirm its output in a clinical decision-making process. The "reading" of the indicator (e.g., "blue to pink") is an inherent property of the device itself.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

For the performance testing, the ground truth is established by physical measurement and visual comparison against a pre-defined color standard/specification. The actual exposure parameters within the sterilizer cycles (time, presence of vaporized hydrogen peroxide) serve as the objective truth for whether the indicator should change color. The "pass" or "fail" is determined by whether the observed color reaches the specified end-point color.

8. The sample size for the training set:

This device does not involve a "training set" in the context of an AI or machine learning algorithm. It is a chemical indicator that reacts based on chemical principles, not learned patterns.

9. How the ground truth for the training set was established:

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

Summary

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-000

September 29, 2015

3M Health Care, Ms. Hilary B. Hovde Regulatory Affairs 3M Center, Bldg. 275-5W-06 St. Paul, MN 55144

Re: K150622

Trade/Device Name: 3M™ Comply™ Hydrogen Peroxide Chemical Indicator 1248 Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: II Product Code: JOJ Dated: August 24, 2015 Received: August 27, 2015

Dear Ms. Hovde,

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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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 (reporting of medical device-related 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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Tejashri Purohit-Sheth, M.D.

Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR

Erin I. Keith, M.S. 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K150622

Device Name

3MTM ComplyTM Hydrogen Peroxide Chemical Indicator 1248

Indications for Use (Describe)

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® 100. 100S. NX® (Standard and Advanced cycles) and 100NX® (Standard, Flex, Express and Duo cycles) sterilization processes. The chemical indicator bar turns from blue to pink after exposure to vaporized hydrogen peroxide.

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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Premarket Notification [510(k)] Summary

Image /page/3/Picture/1 description: The image shows the 3M logo. The logo consists of the number "3" followed by the letter "M", both in a bold, sans-serif font. The color of the text is red, and the background is white.

Sponsor Information:

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

Contact Person: Hilary B. Hovde Regulatory Affairs Phone Number: (651) 736-0364 FAX Number: (651) 737-5320

Date of Summary: September 29, 2015

Device Name and Classification:

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

Predicate Device:

3M™ Comply™ 1248 Gas Plasma Chemical Indicator (K013228) .

Description of Device:

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Nonclinical Comparison to the Predicate Device

The 3M™ Comply™ Hydrogen Peroxide Chemical Indicator 1248 is the same design as the previously cleared device of the same model number (the predicate) which is sold under the tradename 3M™ Comply™ 1248 Gas Plasma Chemical Indicator (K013228). There has been no change to the device's materials, performance specifications, or fundamental scientific technology. The intent of this submission is to expand the indications for use to include use in the STERRAD® NX® and STERRAD® 100NX® sterilizers.

Summary of Clinical Testing

No clinical data was included in this premarket application submission.

Indications for Use

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Comparison to Predicate Device

Feature	Submission Device:3M™ Comply™ Hydrogen Peroxide Chemical Indicator 1248	Predicate Device (K013228):3M™ Comply™ 1248 GasPlasma Chemical Indicator
Indications foruse	Use the 3M™ Comply™ Hydrogen Peroxide Chemical Indicator 1248 asan internal pack process indicator to verify exposure to vaporizedhydrogen peroxide in the STERRAD® 100, 100S, NX® (Standard andAdvanced cycles) and 100NX® (Standard, Flex, Express and Duocycles) sterilization processes. The chemical indicator bar turns fromblue to pink after exposure to vaporized hydrogen peroxide.	The 3M™ Comply™ 1248 GasPlasma Chemical Indicator isindicated for use as an internalpack process indicator to verifyexposure to vapor hydrogenperoxide in the STERRAD® 100,STERRAD® 100S, andSTERRAD® 50 Sterilizationprocesses.
Sterilizers	STERRAD® 100STERRAD® 100SSTERRAD® NX® (Standard and Advanced cycles)STERRAD® 100NX® (Standard, Flex, Express, and Duo cycles)	STERRAD® 100STERRAD® 100SSTERRAD® 50
Indicator Agent	Alkali blue 6B dye	Identical
Cycle Conditionsfor Color Changein STERRAD®100	Testing verified that the 3M™ Comply™ Hydrogen Peroxide Chemical Indicators 1248 turned from blue topink when exposed to the STERRAD® 100 Sterilization cycle and the minimum time required for all indicatorsto indicate a "pass" in relation to the color match was found to be between 10 and 15 minutes.Demonstrated per original submission K013228.	Testing verified that the 3M™ Comply™ Hydrogen Peroxide Chemical Indicators 1248 turned from blue to pink when exposed to the STERRAD® 100 Sterilization cycle and the minimum time required for all indicators to indicate a "pass" in relation to the color match was found to be between 10 and 15 minutes.Demonstrated per original submission K013228.
for Color Changein STERRAD®100S	Testing verified that the 3M™ Comply™ Hydrogen Peroxide Chemical Indicators 1248 turned from blue topink when exposed to the STERRAD® 100S Sterilization cycle and the minimum time required for allindicators to indicate a "pass" in relation to the color match was found to be between 4 and 8 minutes.Demonstrated per original submission K013228.	Testing verified that the 3M™ Comply™ Hydrogen Peroxide Chemical Indicators 1248 turned from blue to pink when exposed to the STERRAD® 100S Sterilization cycle and the minimum time required for all indicators to indicate a "pass" in relation to the color match was found to be between 4 and 8 minutes.Demonstrated per original submission K013228.
Cycle Conditionsfor Color Changein STERRAD®50	Not Applicable.	Testing verified that the 3M™Comply™ Hydrogen PeroxideChemical Indicators 1248 turnedfrom blue to pink when exposed tothe STERRAD® 50 Sterilizationcycle and the minimum timerequired for all indicators toindicate a "pass" in relation to thecolor match was found to bebetween 0.25 and 2 minutes.Demonstrated per originalsubmission K013228.
Cycle Conditionsfor Color Changein STERRAD®NX®	Testing verified that the 3M™ Comply™ Hydrogen Peroxide ChemicalIndicators 1248 turned from blue to pink and the minimum time requiredfor all indicators to indicate a "pass" in relation to the color specificationwas found when exposed to the following STERRAD® NX®Sterilization Cycles:StandardAdvanced
Cycle Conditionsfor Color Changein STERRAD®100NX®	Testing verified that the 3M™ Comply™ Hydrogen Peroxide ChemicalIndicators 1248 turned from blue to pink and the minimum time requiredfor all indicators to indicate a "pass" in relation to the color specificationwas found when exposed to the following STERRAD® 100NX®Sterilization Cycles:StandardFlexExpressDuo
Stability of theendpoint reaction	At least one month (4 weeks)	Identical
Shelf life	Two (2) years	Identical

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Biocompatibility

The components of the indicator ink used on the 3M™ Comply™ Hydrogen Peroxide Chemical Indicator 1248 are all of low general toxicity. The exposure to the health care professional is minimal and well below any identified toxic thresholds for the compounds. There is no anticipated direct exposure to the patient. Indirect exposure to the patient via potential exposure to medical instruments with the indicator ink is minimal and well below any identified toxic thresholds for the compounds.

Effectiveness

The effectiveness of the 3M™ Comply™ Hydrogen Peroxide Chemical Indicator 1248 is demonstrated by the following tests:

Color Change in Health Care Facility Cycle Samples from six different lots were verified to meet the requirements for detectable color change in the STERRAD® NX® (Standard and Advanced cycles) and the STERRAD® 100NX® (Standard, Flex, Express, and Duo cycles) sterilizers.
Minimum Exposure Parameters to Affect the Change of the Indicator in Health Care Facility Cycle - Samples from six different lots were evaluated to determine the minimum time required for the color change of the indicator when used in the STERRAD® NX® (Standard and Advanced cycles) and the STERRAD® 100NX® (Standard, Flex, Express, and Duo cycles) sterilizers.
End Point Color Stability Samples from four different lots were verified to be stable to storage under typical office lighting conditions for at least one month post-exposure in a Hydrogen Peroxide Health Care Facility Cycle.

Conclusion

The composition, physical properties, specifications and technological characteristics of the 3M™ Comply" Hydrogen Peroxide Chemical Indicator 1248 remain the same as the predicate device.

Testing was conducted to confirm performance of the 3M™ Comply™ Hydrogen Peroxide Chemical Indicator 1248 in the STERRAD® NX® and the STERRAD® 100NX® per FDA's Premarket Notification [510(k)] Submissions for Chemical Indicators; Guidance for Industry and FDA Staff, December 19, 2003.

The 3M™ Comply " Hydrogen Peroxide Chemical Indicator 1248 is substantially equivalent to the predicate device. There are no new questions of safety or effectiveness.

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).