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), 100NX® (Standard, Flex, Express and Duo cycles), AMSCO® V-PRO™ 1 (Lumen cycle), AMSCO® V-PRO™ 1 Plus (Lumen and Non Lumen cycles), and AMSCO® V-PRO™ maX Low Temperature Sterilization System (Lumen, Non Lumen, and Flexible cycles) sterilizers. 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 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

This document is a 510(k) premarket notification for a chemical indicator used in sterilization processes. It concerns the 3M™ Comply™ Hydrogen Peroxide Chemical Indicator 1248. The primary purpose of this 510(k) is to expand the indications for use of an already cleared device to include additional sterilizers (AMSCO® V-PRO™ 1, AMSCO® V-PRO™ 1 Plus, and AMSCO® V-PRO™ maX).

Here's an analysis based on the provided text:

Nature of the Device and Study:
This device is a chemical indicator, not an AI/ML powered medical device for diagnostic imaging or similar applications. It physically changes color (blue to pink) upon exposure to vaporized hydrogen peroxide during sterilization cycles to indicate successful processing. Therefore, many of the typical acceptance criteria and study methodologies asked for in AI/ML performance evaluations (like MRMC studies, standalone AI performance, large expert panels for ground truth of complex data, etc.) are not applicable to this type of device.

The "study" here refers to non-clinical testing to demonstrate the physical performance of the chemical indicator under specified sterilization conditions.

Acceptance Criteria and Device Performance Table:

Given the nature of the device, the acceptance criteria are based on the indicator's physical color change within specific sterilization cycle parameters. The document primarily focuses on demonstrating that the indicator performs identically to its predicate and successfully changes color within the new sterilizer cycles.

Acceptance Criteria (What the device should do)	Reported Device Performance (What the device did)
Color Change after Exposure to VHP (Predicate Sterilizers):Indicator turns from blue to pink when exposed to complete cycles in STERRAD® 100, 100S, NX (Standard & Advanced), and 100NX (Standard, Flex, Express, Duo).	Demonstrated for Predicate Sterilizers:- STERRAD® 100: Color change within 10-15 minutes (per K013228).- STERRAD® 100S: Color change within 4-8 minutes (per K013228).- STERRAD® NX (Standard/Advanced): Standard cycle: 5.25-7 minutes; Advanced cycle: 11.25-15 minutes (per K150622).- STERRAD® 100NX (Standard/Flex/Express/Duo): Flex: 12.75-17 minutes; Express: 4.5-6 minutes; Duo: 10 seconds-8 minutes (per K150622).Finding: Testing had previously verified this performance with the predicate device, which is identical in design.
Color Change after Exposure to VHP (New Sterilizers):Indicator turns from blue to pink when exposed to complete cycles in AMSCO® V-PRO™ 1 (Lumen), AMSCO® V-PRO™ 1 Plus (Lumen & Non Lumen), and AMSCO® V-PRO™ maX (Lumen, Non Lumen, & Flexible).	Demonstrated for New Sterilizers:Testing verified that the indicator turned from blue to pink, indicating a "pass" in relation to the color match, under complete cycles in the AMSCO® V-PRO™ maX Low Temperature Sterilization System:- Lumen cycle: Between 7 seconds and 8 minutes.- Non Lumen cycle: Between 6 minutes and 9 minutes.- Flexible cycle: Between 9 minutes and 12 minutes.Note: While V-PRO 1/1 Plus cycles are mentioned in the IFU, the detailed performance data specifically for AMSCO® V-PRO™ maX is provided in the comparison table regarding "Cycle Conditions for Color Change." The statement "Samples from six different lots were verified to meet the requirements for detectable color change in the AMSCO® V-PRO™ maX Low Temperature Sterilization System" implies successful color change for these specific cycles.
Minimum Exposure Parameters to Affect Change:Determine the minimum time required for the color change within the new sterilizer cycles.	Samples from six different lots were evaluated. The minimum times are reported above for the AMSCO® V-PRO™ maX cycles.
Endpoint Color Stability:The "pass" color (pink) remains stable for a specified period after exposure.	The color was verified to be stable to storage under typical office lighting conditions for at least one month (4 weeks) post-exposure in a Hydrogen Peroxide Health Care Facility Cycle. (Identical to predicate).
Shelf Life:	Two (2) years. (Identical to predicate).

Since this is a simple chemical indicator and not an AI/ML software, many of the requested detailed points are not applicable or the information is not provided because it's not relevant to this type of device submission.

Sample sizes used for the test set and the data provenance:
- Test Set Sample Size: For the new sterilizer (AMSCO® V-PRO™ maX), "Samples from six different lots" were used for both "Color Change" and "Minimum Exposure Parameters" testing. Specific numbers of indicators per lot or per test run are not detailed in this summary.
- Data Provenance: The data is from manufacturer testing ("Nonclinical Testing"). The country of origin is not explicitly stated, but the company (3M) is based in the USA, and the submission is to the FDA. This is considered prospective testing, specifically designed to demonstrate the device's performance under controlled conditions.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- This is not applicable. The "ground truth" for a chemical indicator is its observable color change, verified against a printed color match. This is a physical, objective observation, not a subjective interpretation requiring expert consensus in the typical sense of medical image analysis. No human "experts" in the clinical sense were used to "establish ground truth" for the indicator's performance. The "ground truth" for whether the sterilizer cycle was appropriate comes from established sterilization parameters and validated equipment (which the indicator is designed to verify exposure to).
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. This is not a study requiring reader adjudication. The color change is a direct physical property.
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:
- Not applicable. This is not an AI/ML device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an AI/ML device. It is a passive chemical indicator.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" is the physical state of the chemical indicator (color change from blue to pink, validated against a color match on the product) and its performance under controlled and validated sterilization cycle conditions. It's an objective physical/chemical reaction.
The sample size for the training set:
- Not applicable. This device does not involve machine learning or a "training set."
How the ground truth for the training set was established:
- Not applicable.

Summary

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August 14, 2017

3M Company Nadia Battah Regulatory Affairs Associate 3M Health Center 3M Center, Building 275-5W-06 St Paul. Minnesota 55144-1000

Re: K170321

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: July 12, 2017 Received: July 13, 2017

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 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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 Industry and Consumer Education 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. 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 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 Industry and Consumer Education 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,

Michael J. Ryan -S

for Lori Wiggins 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)

K170321

Device Name

3MTM ComplyTM Hydrogen Peroxide Chemical Indicator 1248

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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Premarket Notification [510(k)] Summary

Sponsor Information:

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

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

Date of Summary: July 31, 2017

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 (21CFR §880.2800)
Device Classification:	Class II
Product Code:	JOJ

Predicate Device:

3M™ Comply™ Hydrogen Peroxide Chemical Indicator 1248 (K150622)

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 3MTM ComplyTM Hydrogen Peroxide Chemical Indicator 1248 (K150622). 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 AMSCO® V-PRO™ 1 (Lumen cycle), AMSCO® V-PRO™ 1 Plus (Lumen and Non Lumen cycles), and AMSCO® V-PRO™ maX Low Temperature Sterilization System (Lumen, Non Lumen, and Flexible cycles) sterilizers.

Summary of Clinical Testing

No clinical data was included in this premarket application submission.

Indications for Use

Use the 3M™ ComplyTM 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), 100NX® (Standard, Flex, Express and Duo cycles), AMSCO® V-PRO™ 1 (Lumen cycle), AMSCO® V-PRO™ 1 Plus (Lumen and Non Lumen cycles), and AMSCO® V-PRO™ maX Low Temperature Sterilization System (Lumen, Non Lumen, and Flexible cycles) sterilizers. The chemical indicator bar turns from blue to pink after exposure to vaporized hydrogen peroxide.

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Comparison to Predicate Device

Feature	Submission Device:3M™ Comply™ Hydrogen PeroxideChemical Indicator 1248	Predicate Device (K150622):3M™ Comply™ Hydrogen PeroxideChemical Indicator 1248
Indications for use	Use the 3MTM ComplyTM Hydrogen PeroxideChemical Indicator 1248 as an internal packprocess indicator to verify exposure tovaporized hydrogen peroxide in theSTERRAD® 100, 100S, NX® (Standard andAdvanced cycles), 100NX® (Standard, Flex,Express and Duo cycles), AMSCO® V-PROTM 1 (Lumen cycle), AMSCO® V-PROTM 1 Plus (Lumen and Non Lumencycles), and AMSCO® V-PRO™ maX LowTemperature Sterilization System (Lumen,Non Lumen, and Flexible cycles) sterilizers.The chemical indicator bar turns from blue topink after exposure to vaporized hydrogenperoxide.	Use the 3MTM ComplyTM Hydrogen PeroxideChemical Indicator 1248 as an internal packprocess indicator to verify exposure tovaporized hydrogen peroxide in theSTERRAD® 100, 100S, NX® (Standard andAdvanced cycles) and 100NX® (Standard,Flex, Express and Duo cycles) sterilizationprocesses. The chemical indicator bar turnsfrom blue to pink after exposure to vaporizedhydrogen peroxide.
Sterilizers	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 and NonLumen cycles)AMSCO® V-PRO™ maX Low TemperatureSterilization System (Lumen, Non Lumen andFlexible cycles)	STERRAD® 100STERRAD® 100SSTERRAD® NX (Standard and Advancedcycles)STERRAD® 100NX (Standard, Flex,Express, and Duo cycles)
Indicator Agent	Alkali blue 6B dye	Identical
Cycle Conditionsfor Color Change inSTERRAD® 100	Testing verified that the 3MTM Comply™ Hydrogen Peroxide Chemical Indicators 1248 turnedfrom blue to pink when exposed to the STERRAD® 100 Sterilization cycle and the minimumtime required for all indicators to indicate a "pass" in relation to the color match was found tobe between 10 and 15 minutes.Demonstrated per submission K013228.
Cycle Conditionsfor Color Change inSTERRAD® 100S	Testing verified that the 3MTM Comply™ Hydrogen Peroxide Chemical Indicators 1248 turnedfrom blue to pink when exposed to the STERRAD® 100S Sterilization cycle and the minimumtime required for all indicators to indicate a "pass" in relation to the color match was found tobe between 4 and 8 minutes.Demonstrated per submission K013228.
Cycle Conditionsfor Color Change inSTERRAD® NX(Standard andAdvanced cycles)	Testing verified that the 3M™ Comply™ Hydrogen Peroxide Chemical Indicator 1248 turnsfrom blue to pink to indicate a "pass" in relation to the device color match printed on theindicator when exposed to complete Standard and Advanced cycles in the STERRAD® NX®sterilizer. The minimum time required for all samples to indicate a "pass" in these cycles islisted below:Standard cycle: Between 5.25 minutes and 7 minutesAdvanced cycle: Between 11.25 minutes and 15 minutesDemonstrated per submission K150622.
Cycle Conditionsfor Color Change inSTERRAD®100NX (Standard,Flex Express andDuo cycles)	Testing verified that the 3M™ Comply™ Hydrogen Peroxide Chemical Indicator 1248 turnsfrom blue to pink to indicate a "pass" in relation to the device color match printed on theindicator when exposed to complete Standard, Flex, Express, and Duo cycles in theSTERRAD® 100NX® sterilizer. The minimum time required for all samples to indicate a"pass" in these cycles is listed below:
	Flex cycle: Between 12.75 minutes and 17 minutes
	Express cycle: Between 4.5 and 6 minutes
	Duo cycle. Between 10 seconds and 8 minutes
	Demonstrated per submission K150622.
Cycle Conditionsfor Color Change inAMSCO® V-PROTM 1 (Lumencycle), AMSCO®V-PROTM 1 Plus(Lumen and NonLumen cycles), andAMSCO® V-PROTM maX LowTemperatureSterilization System(Lumen, NonLumen, andFlexible cycles)sterilizers	Testing verified that the 3MTM ComplyTMHydrogen Peroxide Chemical Indicator 1248turns from blue to pink to indicate a “pass” inrelation to the color match when exposed to acomplete Lumen, Non Lumen or Flexiblecycle in an AMSCO® V-PROTM maX LowTemperature Sterilization System. Theminimum time required for all samples toindicate a “pass” in these cycles is listedbelow:
	Lumen cycle: Between 7 seconds and 8minutes
	Non Lumen cycle: Between 6 minutes and 9minutes.
	Flexible cycle: Between 9 minutes and 12minutes.





Stability of theendpoint reaction	At least four (4) weeks (28 days)	Identical
Shelf life	Two (2) years	Identical

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Biocompatibility

The components of the indicator ink used on the 3MTM 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.

Summary of Nonclinical Testing

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 AMSCO® V-PRO™ maX Low Temperature Sterilization System (Lumen, Non Lumen and Flexible cycles) sterilizer.
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 AMSCO® V-PROTM maX Low Temperature Sterilization System (Lumen, Non Lumen and Flexible cycles).

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End Point Color Stability Samples from six different lots were verified to be stable to storage under typical office lighting conditions for at least one month (4 weeks) post-exposure in a Hydrogen Peroxide Health Care Facility Cycle.

Conclusion

The 3M™ Comply™ Hydrogen Peroxide Chemical Indicator 1248 is as safe, as effective, and performs as well as the predicate, K150622, 3M™ Comply™ Hydrogen Peroxide Chemical Indicator 1248.

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).