3M Comply Hydrogen Peroxide Chemical Indicator 1248

K203458 · 3M Company · JOJ · Dec 11, 2020 · General Hospital

Device Facts

• Record ID: K203458
• Device Name: 3M Comply Hydrogen Peroxide Chemical Indicator 1248
• Applicant: 3M Company
• Product Code: JOJ · General Hospital
• Decision Date: Dec 11, 2020
• Decision: SESE
• Submission Type: Special
• 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 hyrdogen peroxide in the following sterilizers and cycles. STERRAD 100® Sterilization System STERRAD 100S® Sterilization System STERRAD NX® Sterilization System (Standard and Advanced cycles) STERRAD 100NX® Sterilization System (Standard, Flex, Express, and Duo cycles) STERRAD NX® with ALLClear® Technology Sterilization System (Standard and Advanced cycles) STERRAD 100NX® with ALLClear® Technology Sterilization System (Standard, Flex, Express, and Duo cycles) V-PRO® 1 Low Temperature Sterilization System (Lumen cycle) V-PRO® 1 Plus Low Temperature Sterilization System (Lumen and Non Lumen cycles) V-PRO® maX Low Temperature Sterilization System (Lumen, and Flexible cycles) V-PRO® 60 Low Temperature Sterilization System (Lumen, Non Lumen, and Flexible cycles) V-PRO® maX 2 Low Temperature Sterilization System (Lumen, Flexible, and Fast Non Lumen cycles) V-PRO® s2 Low Temperature Sterilization System (Lumen, Flexible, and Fast cycles) The chemical indicator bar turns from blue toward pink after exposure to vaporized hydrogen peroxide.

Device Story

Internal pack process indicator; verifies exposure to vaporized hydrogen peroxide during sterilization. Device consists of noncellulosic plastic substrate with printed chemical indicator bar and comparison color reference. Used in healthcare facilities; placed inside sterilization packs. Upon exposure to vaporized hydrogen peroxide, indicator bar undergoes irreversible color change from blue to pink. Provides visual confirmation to healthcare personnel that the pack was exposed to the sterilization process; does not indicate sterility. Simple, passive chemical device; no electronic components or software.

Clinical Evidence

Bench testing only. Performance verified via color change, minimum exposure parameters, and endpoint color stability testing in the V-PRO s2 Low Temperature Sterilization System. All tests passed.

Technological Characteristics

Noncellulosic plastic substrate; printed chemical indicator bar; blue-to-pink color change mechanism; passive chemical indicator; no energy source; no software; shelf life of two years; endpoint stability of at least four weeks.

Indications for Use

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

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 (K192937)

Submission Summary (Full Text)

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December 11, 2020

3M Company Yumi Wackerfuss Senior Regulatory Affairs Associate 3M Center, Building 275-5W-06 St. Paul, Minnesota 55144

Re: K203458

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: November 20, 2020 Received: November 24, 2020

Dear Yumi Wackerfuss:

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 medical devices and radiation-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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Clarence W. Murray, III, 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) K203458

Device Name

3M Comply 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 hyrdogen peroxide in the following sterilizers and cycles.

STERRAD 100® Sterilization System

STERRAD 100S® Sterilization System

STERRAD NX® Sterilization System (Standard and Advanced cycles)

STERRAD 100NX® Sterilization System (Standard, Flex, Express, and Duo cycles)

STERRAD NX® with ALLClear® Technology Sterilization System (Standard and Advanced cycles)

STERRAD 100NX® with ALLClear® Technology Sterilization System (Standard, Flex, Express, and Duo cycles)

V-PRO® 1 Low Temperature Sterilization System (Lumen cycle)

V-PRO® 1 Plus Low Temperature Sterilization System (Lumen and Non Lumen cycles)

V-PRO® maX Low Temperature Sterilization System (Lumen, and Flexible cycles)

V-PRO® 60 Low Temperature Sterilization System (Lumen, Non Lumen, and Flexible cycles)

V-PRO® maX 2 Low Temperature Sterilization System (Lumen, Flexible, and Fast Non Lumen cycles)

V-PRO® s2 Low Temperature Sterilization System (Lumen, Flexible, and Fast cycles)

The chemical indicator bar turns from blue toward pink after exposure to vaporized hydrogen peroxide.

| Type of Use (Select one or both, as applicable) | |
|-----------------------------------------------------------------------|---------------------------------------------------------------------------------|
| <input type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) | <input checked="" type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) |

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Image /page/3/Picture/1 description: The image shows the 3M logo, which is a well-known corporate symbol. The logo consists of the number "3" followed by the letter "M", both rendered in a bold, sans-serif typeface. The color of the text is a vibrant red, which stands out against the white background. The overall design is simple, clean, and easily recognizable.

# K203458 510(k) Summary for 3M™ Comply™ Hydrogen Peroxide Chemical Indicator 1248

## Sponsor Information:

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

Contact: Yumi Wackerfuss Senior Regulatory Affairs Associate Phone Number: [phone] Fax Number: [phone]

Date of Summary: November 20, 2020

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## PREMARKET NOTIFICATION [510(k)] 3MTM ComplyTM Hydrogen Peroxide Chemical Indicator 1248

## 1. Device Name and Classification:

| Common Name: | Chemical Indicators |
|------------------------|-------------------------------------------------------|
| Proprietary Name: | 3M™ Comply™ Hydrogen Peroxide Chemical Indicator 1248 |
| Classification Name: | Physical/chemical sterilization process indicators |
| Device Classification: | Class II, 21 CFR 880.2800(b) |
| Product Code: | JOJ |

## 2. Predicate Device:

K192937, 3MTM ComplyTM Hydrogen Peroxide Chemical Indicator 1248

## 3. Description of Device:

The 3MTM 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.

## 4. Indications for Use

Proposed indication for use for this submission is:

Use the 3M™ Comply™ Hydrogen Peroxide Chemical Indicator 1248 as an internal pack process indicator to verify exposure to vaporized hydrogen peroxide in the following sterilizers and cycles:

STERRAD 100® Sterilization System

STERRAD 100S® Sterilization System

STERRAD NX® Sterilization System (Standard and Advanced cycles)

STERRAD 100NX® Sterilization System (Standard, Flex, Express, and Duo cycles)

STERRAD NX® with ALLClear® Technology Sterilization System (Standard and Advanced cycles)

STERRAD 100NX® with ALLClear® Technology Sterilization System (Standard, Flex, Express, and Duo cycles)

V-PRO® 1 Low Temperature Sterilization System (Lumen cycle)

V-PRO® 1 Plus Low Temperature Sterilization System (Lumen and Non Lumen cycles)

V-PRO® maX Low Temperature Sterilization System (Lumen, and Flexible cycles)

V-PRO® 60 Low Temperature Sterilization System (Lumen, and Flexible cycles)

V-PRO® maX 2 Low Temperature Sterilization System (Lumen, Flexible, and Fast Non Lumen cycles)

V-PRO® s2 Low Temperature Sterilization System (Lumen, Flexible, and Fast cycles)

The chemical indicator bar turns from blue toward pink after exposure to vaporized hydrogen peroxide.

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## PREMARKET NOTIFICATION [510(k)] 3M™ ComplyTM Hydrogen Peroxide Chemical Indicator 1248

## 5. Technological Characteristic Comparison

The 3M™ Comply ™ Hydrogen Peroxide Chemical Indicator 1248 is the same design as the previously cleared device of same model number (predicate device: K192937). No change has been made to the device materials, performance specifications, or fundamental technology.

| Items | Predicate Device (K192937) | Proposed device (this submission) |
|--------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | 3MTM Comply™ Hydrogen<br>Peroxide Chemical Indicator 1248 | 3MTM Comply™ Hydrogen Peroxide<br>Chemical Indicator 1248 |
| Indications for<br>use | Use the 3M™ Comply™ Hydrogen<br>Peroxide Chemical Indicator 1248 as<br>an internal pack process indicator to<br>verify exposure to vaporized<br>hydrogen peroxide in the<br>STERRAD® 100, STERRAD®<br>100S, STERRAD® NX (Standard<br>and Advanced cycles), STERRAD®<br>100NX (Standard, Flex, Express and<br>Duo cycles), STERRAD® NX with<br>ALLClear™ Technology (Standard<br>and Advanced cycles), STERRAD®<br>100NX with ALLClear™<br>Technology (Standard, Flex, Express<br>and Duo cycles), AMSCO® V-<br>PRO® 1 (Lumen cycle), AMSCO®<br>V-PRO® 1 Plus (Lumen and Non<br>Lumen cycles), AMSCO® V-PRO®<br>maX Low Temperature Sterilization<br>System (Lumen, Non Lumen, and<br>Flexible cycles), AMSCO® V-PRO®<br>60 Low Temperature Sterilization<br>System (Lumen, Non Lumen and<br>Flexible cycles) and AMSCO® V-<br>PRO™ maX 2 Low Temperature<br>Sterilization System (Lumen, Non<br>Lumen, Flexible, and Fast Non<br>Lumen cycles) sterilizers. The<br>chemical indicator bar turns from<br>blue toward pink after exposure to<br>vaporized hydrogen peroxide. | Use the 3M™ Comply™ Hydrogen<br>Peroxide Chemical Indicator 1248 as<br>an internal pack process indicator to<br>verify exposure to vaporized hydrogen<br>peroxide in the following sterilizers<br>and cycles:<br>STERRAD® 100 Sterilization<br>System<br>STERRAD® 100SSterilization<br>System<br>STERRAD® NX Sterilization<br>System (Standard and Advanced<br>cycles)<br>STERRAD® 100NX Sterilization<br>System (Standard, Flex, Express,<br>and Duo cycles)<br>STERRAD® NX with ALLClear®<br>Technology Sterilization System<br>(Standard and Advanced cycles)<br>STERRAD® 100NX with<br>ALLClear® Technology Sterilization<br>System (Standard, Flex, Express,<br>and Duo cycles)<br>V-PRO® 1 Low Temperature<br>Sterilization System (Lumen cycle)<br>V-PRO® 1 Plus Low Temperature<br>Sterilization System (Lumen and<br>Non Lumen cycles)<br>V-PRO® maX Low Temperature<br>Sterilization System (Lumen, Non<br>Lumen, and Flexible cycles)<br>V-PRO® 60 Low Temperature<br>Sterilization System (Lumen, Non<br>Lumen, and Flexible cycles)<br>V-PRO® maX 2 Low Temperature<br>Sterilization System (Lumen, Non<br>Lumen, Flexible, and Fast Non<br>Lumen cycles)<br>V-PRO® s2 Low Temperature<br>Sterilization System (Lumen, Non<br>Lumen, Flexible, and Fast cycles) |
| Items | Predicate Device (K192937) | Proposed device (this submission) |
| | 3M™ Comply™ Hydrogen Peroxide Chemical Indicator 1248 | 3M™ Comply™ Hydrogen Peroxide Chemical Indicator 1248 |
| | | The chemical indicator bar turns from blue toward pink after exposure to vaporized hydrogen peroxide. |
| Sterilizers and Sterilization Cycles | (1) STERRAD® 100 | (1) STERRAD® 100 |
| | (2) STERRAD® 100S | (2) STERRAD® 100S |
| | (3) STERRAD® NX (Standard and Advanced cycles) | (3) STERRAD® NX (Standard and Advanced cycles) |
| | (4) STERRAD® NX with ALLClear™ Technology (Standard and Advanced cycles) | (4) STERRAD® NX with ALLClear™ Technology (Standard and Advanced cycles) |
| | (5) STERRAD® 100NX (Standard, Flex, Express, and Duo cycles) | (5) STERRAD® 100NX (Standard, Flex, Express, and Duo cycles) |
| | (6) STERRAD® 100NX with ALLClear™ Technology (Standard, Flex, Express, and Duo cycles) | (6) STERRAD® 100NX with ALLClear™ Technology (Standard, Flex, Express, and Duo cycles) |
| | (7) AMSCO® V-PRO™ 1 (Lumen cycle) | (7) V-PRO™ 1 (Lumen cycle) |
| | (8) AMSCO® V-PRO™ 1 Plus (Lumen and NonLumen cycles) | (8) V-PRO™ 1 Plus (Lumen and NonLumen cycles) |
| | (9) AMSCO® V-PRO™ maX Low Temperature Sterilization System (Lumen, Non Lumen and Flexible cycles) | (9) V-PRO™ maX Low Temperature Sterilization System (Lumen, Non Lumen and Flexible cycles) |
| | (10) AMSCO® V-PRO™ 60 (Lumen, Non Lumen and Flexible cycles) | (10) V-PRO™ 60 (Lumen, Non Lumen and Flexible cycles) |
| | (11) AMSCO® V-PRO™ maX 2 Low Temperature Sterilization System (Lumen, Non-Lumen, Flexible, and Fast Non-Lumen cycles) | (11) V-PRO™ maX 2 Low Temperature Sterilization System (Lumen, Non-Lumen, Flexible, and Fast Non-Lumen cycles) |
| | | (12) V-PRO™ s2 Low Temperature Sterilization System (Lumen, Non Lumen, Flexible, and Fast cycles) |
| Substrate | Polyethylene | Identical |
| Biocompatibility | The exposure to health care professionals is minimal and well below any identified toxic thresholds for the compounds. | Identical |
| Color Change | Blue toward pink | Identical |
| Detection | Hydrogen Peroxide | Identical |
| Stability of the endpoint reaction | At least one month (4 weeks) | Identical |
| Shelf life | Two (2) years | Identical |

### Table 6.1: Technological Characteristic Comparison Table

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## PREMARKET NOTIFICATION [510(k)] 3M™ ComplyTM Hydrogen Peroxide Chemical Indicator 1248

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## PREMARKET NOTIFICATION [510(k)] 3M™ ComplyTM Hydrogen Peroxide Chemical Indicator 1248

## 6. Nonclinical Comparison to the Predicate Device

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 (K192937). As no change has been made to the device materials, performance specifications, or fundamental technology, the biocompatibility and nonclinical testing provided in K192937 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 for the V-PRO® s2 Low Temperature Sterilization System (Lumen, Non Lumen, Flexible, and Fast 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 6.2 for testing completed in V-PRO® s2 Low Temperature Sterilization System (Lumen, Non Lumen, Flexible, and Fast cycles) sterilizer and the tests were resulted passed.

#### Table 6.2 Summarv of Nonclinical Testing

| Test Method/Name | Result |
|----------------------------------------------------------------------------------------------------|--------|
| Color Change in Health Care Facility Cycle | Pass |
| Minimum Exposure Parameters to Affect the Change of the Indicator in Health Care<br>Facility Cycle | Pass |
| End Point Color Stability | Pass |

## 7. Conclusion

Based on the non-clinical testing performance data, the 3M™ ComplyTM Hydrogen Peroxide Chemical Indicator 1248 is as safe, as effective, and performs as well as or better than the legally marketed predicate device, the 3MTM Comply™ Hydrogen Peroxide Chemical Indicator 1248 cleared under K192937, Class II (21 CFR 880.2800), product code JOJ.