3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E

K212022 · 3M Company · QKM · Apr 20, 2022 · General Hospital

Device Facts

• Record ID: K212022
• Device Name: 3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E
• Applicant: 3M Company
• Product Code: QKM · General Hospital
• Decision Date: Apr 20, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.2800
• Device Class: Class 2

Intended Use

Use the 3M™ Attest™ Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E for pack control monitoring of the following sterilizers and cycles: - 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) - STERIZONE® VP4 Sterilizer (Cycle 1)

Device Story

Chemical indicator strip for monitoring sterilization cycles; consists of non-cellulose coated strip in film laminate. Input: exposure to vaporized hydrogen peroxide/ozone during sterilization. Operation: color changes from blue to pink based on time, temperature, and sterilant concentration. Output: visual color progression in 'REJECT' or 'ACCEPT' window. Used in healthcare facilities for pack control monitoring; interpreted by sterile processing staff. Benefits: verifies sterilization parameters achieved within packs/containers; ensures sterilization efficacy.

Clinical Evidence

Bench testing only. Simulated use testing conducted in a healthcare facility to assess indicator color change performance in the STERIZONE® VP4 Sterilizer (Cycle 1). All indicators met acceptance criteria for distinguishing between complete and incomplete cycles.

Technological Characteristics

Non-cellulose coated indicator strip in film laminate. Sensing principle: chemical color change (blue to pink) responsive to VH2O2 concentration (5.1 mg/L), temperature (50°C), and exposure time (1 minute). Shelf life: 15 months. Stability: 6 months.

Indications for Use

Indicated for pack control monitoring of specific vaporized hydrogen peroxide and dual sterilant (hydrogen peroxide/ozone) sterilization systems and cycles in healthcare facilities.

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™ Attest™ Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E (K203284)

Submission Summary (Full Text)

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April 20, 2022

3M Company Mary Fretland Regulatory Affairs Specialist 3M Center, Building 275-5W-06 St. Paul, Minnesota 55144

Re: K212022

Trade/Device Name: 3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: Class II Product Code: QKM Dated: March 24, 2022 Received: March 25, 2022

Dear Mary Fretland:

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

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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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-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, PhD Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K212022

Device Name

Attest™ Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E

Indications for Use (Describe)

Use the 3M™ Attest™ Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E for pack control monitoring of the following sterilizers and cycles:

- 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)
- STERIZONE® VP4 Sterilizer (Cycle 1)

| 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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# 510(k) Summary for 3MTM Attest™ Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E

### Sponsor Information:

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

Contact: Mary Fretland Regulatory Affairs Specialist Phone Number: [phone]

Date of Summary: 19 April 2022

510(k): K212022

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## PREMARKET NOTIFICATION [510(k)] 3M™ Attest™ Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E

#### Device Name and Classification:

| Common or Usual Name: | Chemical Indicator |
|------------------------|---------------------------------------------------------------------------------------|
| Proprietary Name: | 3MTM AttestTM Vaporized Hydrogen Peroxide Tri-Metric<br>Chemical Indicator 1348/1348E |
| Classification Name: | Indicator, physical/chemical sterilization process |
| Device Classification: | Class II, 21 CFR § 880.2800 |
| Product Code: | QKM |

### 1. Predicate Device:

K203284, 3M™ Attest™ Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E

### 2. Description of Device:

The 3MTM Attest™ Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E is a chemical indicator consisting of a non-cellulose based coated indicator strip sensitive to vaporized hydrogen peroxide, contained in a film laminate.

The 3M™ Attest™ CI 1348/1348E verifies that the stated values for the three critical parameters of exposure time, temperature, and amount of vaporized hydrogen peroxide have been achieved within a package or containment device (i.e. wrapped trays, rigid containers, sterilization pouches, and other types of packs) and/or at a specific location within the load or empty chamber.

Upon exposure to vaporized hydrogen peroxide, the color of the coated indicator strip progressively changes from blue to pink along the strip. The progression of the blue to pink color change along the strip is visible through a window with marked "REJECT" and "ACCEPT" zones. The extent of the progression depends on exposure time, temperature, and amount of vaporized hydrogen peroxide.

#### 3. Indications for Use

Use the 3MTM Attest™ Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E for pack control monitoring of the following sterilizers and cycles:

| 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) |

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## PREMARKET NOTIFICATION [510(k)] 3M™ Attest™ Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E

| 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, Non 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, Non Lumen, Flexible, and Fast Non Lumen cycles) |
| V-PRO® s2 Low Temperature Sterilization System (Lumen, Non Lumen, Flexible, and Fast cycles) |
| STERIZONE® VP4 Sterilizer (Cycle 1) |

## 4. Summary of Technological Characteristics compared to Predicate Device

| Feature | Submission Device: 3MTM AttestTM<br>Vaporized Hydrogen Peroxide Tri-<br>Metric Chemical Indicator | Predicate Device:<br>3MTM Attest™ Vaporized Hydrogen<br>Peroxide Tri-Metric Chemical<br>Indicator (K203284) | Comparison |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device<br>Models | 1348, 1348E | 1348, 1348E | Identical |
| Indications<br>for Use | Use the 3MTM Attest™ Vaporized<br>Hydrogen Peroxide Tri-Metric<br>Chemical Indicator 1348/1348E for<br>pack control monitoring of the<br>following sterilizers and cycles:<br>STERRAD 100S® Sterilization<br>System<br>STERRAD NX® Sterilization<br>System (Standard and Advanced<br>cycles)<br>STERRAD 100NX® Sterilization<br>System (Standard, Flex, Express and<br>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 and<br>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) | Use the 3MTM Attest™ Vaporized<br>Hydrogen Peroxide Tri-Metric<br>Chemical Indicator 1348/1348E for<br>pack control monitoring of the<br>following hydrogen peroxide<br>sterilization sterilizers and cycles:<br>STERRAD 100S® Sterilization<br>System<br>STERRAD NX® Sterilization<br>System (Standard and Advanced<br>cycles)<br>STERRAD 100NX® Sterilization<br>System (Standard, Flex, Express and<br>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 and<br>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 | Similar. The<br>submission<br>device adds the<br>STERIZONE®<br>VP4 Sterilizer<br>(Cycle 1) to the<br>indications for<br>use and<br>removes the<br>"hydrogen<br>peroxide<br>sterilization" as<br>a descriptor for<br>the list of<br>sterilizers. The<br>list now<br>includes both<br>hydrogen<br>peroxide and a<br>dual sterilant<br>(hydrogen<br>peroxide/ozone)<br>sterilizer. |

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## PREMARKET NOTIFICATION [510(k)] 3M™ Attest™ Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E

| | V-PRO® s2 Low Temperature<br>Sterilization System (Lumen, Non<br>Lumen, Flexible, and Fast cycles)<br>STERIZONE® VP4 Sterilizer<br>(Cycle 1) | | 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) | | |
|-------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|
| Indicator<br>Agent | Proprietary | Proprietary | Identical | | |
| Stability of<br>the endpoint<br>reaction | At least six months | At least six months | Identical | | |
| Shelf life | 15 months | 15 months | Identical | | |
| Endpoint<br>Specifications<br>(Minimum<br>Stated<br>Values) | VH2O2<br>Concentration<br>5.1 mg/L<br>Exposure<br>Time<br>1 minute<br>Temperature<br>50 degrees<br>C | VH2O2<br>Concentration<br>5.1 mg/L<br>Exposure<br>Time<br>1 minute<br>Temperature<br>50 degrees<br>C | Identical | | |

### 5. Nonclinical Comparison to the Predicate Device

The submission device, 3M™ Attest™ Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E, has identical design, fundamental technology, and performance specifications to the predicate device under the same name. The key difference between the submission device and the predicate device is that the submission device adds an indication for pack control monitoring of the exposure time, temperature, and amount of vaporized hydrogen peroxide of the dual sterilant vaporized hydrogen peroxide/ozone STERIZONE® VP4 Sterilizer (Cycle 1), last cleared under K203284.

Given the addition of this indication for the STERIZONE® VP4 Sterilizer, 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. Testing was conducted via simulated use testing of the STERIZONE® VP4 Sterilizer in a health care facility and all tests conducted passed.

| Test Name | Purpose | Acceptance Criteria | Result |
|---------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------|
| Health Care<br>Facility<br>Simulated Use<br>Testing on<br>STERIONE<br>VP4 Sterilizer<br>(Cycle 1) | Assess color change of<br>indicator after exposure<br>to representative<br>complete and incomplete<br>cycles for the<br>STERIONE VP4<br>Sterilizer (Cycle 1) | The 3MTM Tri-Metric CI turns from blue<br>toward pink in the ACCEPT region of<br>the indicator window to indicate a<br>"PASS" (reaches endpoint) when<br>exposed to a complete cycle in the<br>STERIONE VP4 Sterilizer (Cycle 1).<br><br>The 3MTM Tri-Metric CI turns from blue<br>toward pink only within the REJECT<br>region of the indicator window to<br>indicate a "FAIL" (does not reach<br>endpoint) when exposed to an<br>incomplete cycle in the STERIONE VP4<br>Sterilizer (Cycle 1). | All Tri-Metric<br>CIs tested met<br>acceptance<br>criteria.<br><br>All Tri-Metric<br>CIs tested met<br>acceptance<br>criteria. |

Summary of Nonclinical Testing

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# 6. Conclusion

The conclusions drawn from the non-clinical performance data demonstrate that the submission device, 3M™ Attest™ Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/13485, is as safe, as effective, and performs as well or better than the legally marketed predicate of the same name (K203284), Class II (21 CFR 880.2800), product code QKM.