3M Comply Hydrogen Peroxide Chemical Indicator 1248

K170321 · 3M Company · JOJ · Aug 14, 2017 · General Hospital

Device Facts

• Record ID: K170321
• Device Name: 3M Comply Hydrogen Peroxide Chemical Indicator 1248
• Applicant: 3M Company
• Product Code: JOJ · General Hospital
• Decision Date: Aug 14, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.2800
• Device Class: Class 2

Intended Use

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 Story

Chemical indicator for vaporized hydrogen peroxide sterilization; consists of noncellulosic plastic strip with printed chemical indicator bar and reference color match; used as internal pack process indicator in healthcare facilities; indicator bar changes from blue to pink upon exposure to hydrogen peroxide vapor; provides visual confirmation of sterilization cycle exposure; aids healthcare personnel in verifying sterilization process; no direct patient contact; indirect patient exposure via sterilized instruments deemed minimal.

Clinical Evidence

Bench testing only. No clinical data included. Performance verified through color change testing across six lots in AMSCO V-PRO maX cycles (Lumen, Non Lumen, Flexible) and stability testing under office lighting for 4 weeks.

Technological Characteristics

Noncellulosic plastic substrate; alkali blue 6B dye indicator; visual color change (blue to pink); 2-year shelf life; 4-week post-exposure endpoint stability; passive chemical indicator; no energy source or software.

Indications for Use

Indicated for use as an internal pack process indicator to verify exposure to vaporized hydrogen peroxide in specified STERRAD and AMSCO V-PRO low-temperature sterilization systems.

Regulatory Classification

Identification

Biological sterilization process indicator: 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. Physical/chemical sterilization process indicator: 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.

Predicate Devices

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

Reference Devices

• K013228

Submission Summary (Full Text)

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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 [phone] or [phone] 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 [phone] or [phone] 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)

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.

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: [phone] FAX Number: [phone]

#### Date of Summary: July 31, 2017

#### Device Name and Classification:

| Common or Usual Name: | Chemical Indicator |
|------------------------|--------------------------------------------------------------------------|
| Proprietary Name: | 3M™ Comply™ Hydrogen Peroxide Chemical Indicator<br>1248 |
| Classification Name: | Indicator, physical/chemical sterilization process (21<br>CFR §880.2800) |
| Device Classification: | Class II |
| Product Code: | JOJ |

#### Predicate Device:

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

#### Description of Device:

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.

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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:<br>3M™ Comply™ Hydrogen Peroxide<br>Chemical Indicator 1248 | Predicate Device (K150622):<br>3M™ Comply™ Hydrogen Peroxide<br>Chemical Indicator 1248 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for use | Use the 3MTM ComplyTM Hydrogen Peroxide<br>Chemical Indicator 1248 as an internal pack<br>process indicator to verify exposure to<br>vaporized hydrogen peroxide in the<br>STERRAD® 100, 100S, NX® (Standard and<br>Advanced cycles), 100NX® (Standard, Flex,<br>Express and Duo cycles), AMSCO® V-<br>PROTM 1 (Lumen cycle), AMSCO® V-<br>PROTM 1 Plus (Lumen and Non Lumen<br>cycles), and AMSCO® V-PRO™ maX Low<br>Temperature Sterilization System (Lumen,<br>Non Lumen, and Flexible cycles) sterilizers.<br>The chemical indicator bar turns from blue to<br>pink after exposure to vaporized hydrogen<br>peroxide. | Use the 3MTM ComplyTM Hydrogen Peroxide<br>Chemical Indicator 1248 as an internal pack<br>process indicator to verify exposure to<br>vaporized hydrogen peroxide in the<br>STERRAD® 100, 100S, NX® (Standard and<br>Advanced cycles) and 100NX® (Standard,<br>Flex, Express and Duo cycles) sterilization<br>processes. The chemical indicator bar turns<br>from blue to pink after exposure to vaporized<br>hydrogen peroxide. |
| Sterilizers | STERRAD® 100<br>STERRAD® 100S<br>STERRAD® NX (Standard and Advanced<br>cycles)<br>STERRAD® 100NX (Standard, Flex, Express,<br>and Duo cycles)<br>AMSCO® V-PRO™ 1 (Lumen cycle)<br>AMSCO® V-PRO™ 1 Plus (Lumen and Non<br>Lumen cycles)<br>AMSCO® V-PRO™ maX Low Temperature<br>Sterilization System (Lumen, Non Lumen and<br>Flexible cycles) | STERRAD® 100<br>STERRAD® 100S<br>STERRAD® NX (Standard and Advanced<br>cycles)<br>STERRAD® 100NX (Standard, Flex,<br>Express, and Duo cycles) |
| Indicator Agent | Alkali blue 6B dye | Identical |
| Cycle Conditions<br>for Color Change in<br>STERRAD® 100 | Testing verified that the 3MTM Comply™ Hydrogen Peroxide Chemical Indicators 1248 turned<br>from blue to pink when exposed to the STERRAD® 100 Sterilization cycle and the minimum<br>time required for all indicators to indicate a "pass" in relation to the color match was found to<br>be between 10 and 15 minutes.<br>Demonstrated per submission K013228. | |
| Cycle Conditions<br>for Color Change in<br>STERRAD® 100S | Testing verified that the 3MTM Comply™ Hydrogen Peroxide Chemical Indicators 1248 turned<br>from blue to pink when exposed to the STERRAD® 100S Sterilization cycle and the minimum<br>time required for all indicators to indicate a "pass" in relation to the color match was found to<br>be between 4 and 8 minutes.<br>Demonstrated per submission K013228. | |
| Cycle Conditions<br>for Color Change in<br>STERRAD® NX<br>(Standard and<br>Advanced cycles) | Testing verified that the 3M™ Comply™ Hydrogen Peroxide Chemical Indicator 1248 turns<br>from blue to pink to indicate a "pass" in relation to the device color match printed on the<br>indicator when exposed to complete Standard and Advanced cycles in the STERRAD® NX®<br>sterilizer. The minimum time required for all samples to indicate a "pass" in these cycles is<br>listed below:<br>Standard cycle: Between 5.25 minutes and 7 minutes<br>Advanced cycle: Between 11.25 minutes and 15 minutes<br>Demonstrated per submission K150622. | |
| Cycle Conditions<br>for Color Change in<br>STERRAD®<br>100NX (Standard,<br>Flex Express and<br>Duo cycles) | Testing verified that the 3M™ Comply™ Hydrogen Peroxide Chemical Indicator 1248 turns<br>from blue to pink to indicate a "pass" in relation to the device color match printed on the<br>indicator when exposed to complete Standard, Flex, Express, and Duo cycles in the<br>STERRAD® 100NX® sterilizer. The minimum time required for all samples to indicate a<br>"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 Conditions<br>for Color Change in<br>AMSCO® V-<br>PROTM 1 (Lumen<br>cycle), AMSCO®<br>V-PROTM 1 Plus<br>(Lumen and Non<br>Lumen cycles), and<br>AMSCO® V-<br>PROTM maX Low<br>Temperature<br>Sterilization System<br>(Lumen, Non<br>Lumen, and<br>Flexible cycles)<br>sterilizers | Testing verified that the 3MTM ComplyTM<br>Hydrogen Peroxide Chemical Indicator 1248<br>turns from blue to pink to indicate a “pass” in<br>relation to the color match when exposed to a<br>complete Lumen, Non Lumen or Flexible<br>cycle in an AMSCO® V-PROTM maX Low<br>Temperature Sterilization System. The<br>minimum time required for all samples to<br>indicate a “pass” in these cycles is listed<br>below: | |
| | Lumen cycle: Between 7 seconds and 8<br>minutes | |
| | Non Lumen cycle: Between 6 minutes and 9<br>minutes. | |
| | Flexible cycle: Between 9 minutes and 12<br>minutes. | |
| | | |
| | | |
| | | |
| | | |
| | | |
| Stability of the<br>endpoint 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.