3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator

K203284 · 3M Company · QKM · Dec 7, 2020 · General Hospital

Device Facts

• Record ID: K203284
• Device Name: 3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator
• Applicant: 3M Company
• Product Code: QKM · General Hospital
• Decision Date: Dec 7, 2020
• Decision: SESE
• Submission Type: Special
• 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 hydrogen peroxide sterilization sterilizers and cycles: STERRAD® 100S System, STERRAD® NX® System (Standard and Advanced cycles), STERRAD® NX® System with AllClear™ Technology (Standard and Advanced cycles), STERRAD® 100NX® System (Standard, Flex, Express and Duo cycles) STERRAD® 100NX® System with AllClear™ Technology (Standard, Flex, Express and Duo cycles) vaporized hydrogen peroxide sterilizers and STERIS® V-PRO® 1 (Lumen cycle), STERIS ® V-PRO® 1 Plus (Lumen and Non-Lumen cycles) and STERIS ® V-PRO® maX Low Temperature Sterilization System (Lumen and Flexible cycles), STERIS® V-PRO® 60 Temperature Sterilization System (Lumen and Flexible cycles), STERIS® V-PRO® maX 2 Temperature Sterilization System (Lumen, Flexible, and Fast Non-Lumen cycles), and the STERIS® V-PRO® s2 Low Temperature Sterilization System (Lumen, Flexible, and Fast cycles).

Device Story

Chemical indicator strip for vaporized hydrogen peroxide sterilization monitoring; non-cellulose coated strip in film laminate. Input: exposure to vaporized hydrogen peroxide (time, temperature, concentration). Operation: color changes from blue to pink along strip; progression visible through window with 'REJECT' and 'ACCEPT' zones. Used in healthcare facilities for pack control monitoring within wrapped trays, rigid containers, or pouches. Output: visual colorimetric indicator of sterilization cycle completion. Healthcare providers use output to verify sterilization parameters were achieved; ensures sterility assurance of processed items; benefits patient by confirming effective sterilization of surgical instruments.

Clinical Evidence

Bench testing only. Simulated use testing performed in the STERIS V-PRO s2 sterilizer across Lumen, Non-Lumen, Flexible, and Fast cycles. Results confirmed the indicator correctly transitions to 'ACCEPT' in complete cycles and remains in 'REJECT' for incomplete cycles.

Technological Characteristics

Non-cellulose based coated indicator strip in film laminate. Colorimetric sensing principle (blue to pink). Shelf life: 15 months. Endpoint specs: 5.1 mg/L concentration, 1 minute exposure, 50°C temperature.

Indications for Use

Indicated for pack control monitoring of hydrogen peroxide sterilization cycles in specified STERRAD and STERIS V-PRO systems. No specific patient population or contraindications defined.

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 (K193110)

Submission Summary (Full Text)

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December 7, 2020

3M Company Andrew Wingen Regulatory Affairs Commercialization Strategy Lead 2510 Conway Ave, Bldg 275-5W-06 St. Paul, Minnesota 55144-1000

Re: K203284

Trade/Device Name: 3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: Class II Product Code: QKM Dated: November 6, 2020 Received: November 9, 2020

Dear Andrew Wingen:

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 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) K203284

#### Device Name

3M™ 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 hydrogen peroxide sterilization sterilizers and cycles: STERRAD® 100S System, STERRAD® NX® System (Standard and Advanced cycles), STERRAD® NX® System with AllClear™ Technology (Standard and Advanced cycles), STERRAD® 100NX® System (Standard, Flex, Express and Duo cycles) STERRAD® 100NX® System with AllClear™ Technology (Standard, Flex, Express and Duo cycles) vaporized hydrogen peroxide sterilizers and STERIS® V-PRO® 1 (Lumen cycle), STERIS ® V-PRO® 1 Plus (Lumen and Non-Lumen cycles) and STERIS ® V-PRO® maX Low Temperature Sterilization System (Lumen and Flexible cycles), STERIS® V-PRO® 60 Temperature Sterilization System (Lumen and Flexible cycles), STERIS® V-PRO® maX 2 Temperature Sterilization System (Lumen, Flexible, and Fast Non-Lumen cycles), and the STERIS® V-PRO® s2 Low Temperature Sterilization System (Lumen, Flexible, and Fast cycles).

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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# Special 510(k) Summary for 3MTM Attest™ Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E K203284

Sponsor Information:

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

Contact: Andrew Wingen Regulatory Affairs Commercialization Strategy Lead Phone Number: [phone] Fax Number: [phone]

Date of Summary: 4 December 2020

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#### 1. 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 |

#### 2. Predicate Device:

K193110, 3M™ Attest™ Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E

## 3. Description of Device:

The 3M™ 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 toward 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.

## 4. Indications for Use

Use the 3M™ Attest™ Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E for pack control monitoring of the following hydrogen peroxide sterilization sterilizers and cycles: STERRAD® 100S System, STERRAD® NX® System (Standard and Advanced cycles), STERRAD® NX® System with AllClear™ Technology (Standard and Advanced cycles), STERRAD® 100NX® System (Standard, Flex, Express and Duo cycles) STERRAD® 100NX® System with AllClear™ Technology

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

(Standard, Flex, Express and Duo cycles) vaporized hydrogen peroxide sterilizers and STERIS® V-PRO® 1 (Lumen cycle), STERIS ® V-PRO® 1 Plus (Lumen and Non-Lumen cycles) and STERIS ® V-PRO® maX Low Temperature Sterilization System (Lumen, Non-Lumen and Flexible cycles), STERIS® V-PRO® 60 Temperature Sterilization System (Lumen, Non-Lumen and Flexible cycles), STERIS® V-PRO® maX 2 Temperature Sterilization System (Lumen, Non-Lumen, Flexible, and Fast Non-Lumen cycles), and the STERIS® V-PRO® s2 Low Temperature Sterilization System (Lumen, Non-Lumen, Flexible, and Fast cycles).

| 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 (K193110) | Comparison |
|-------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device<br>Models | 1348, 1348E | 1348, 1348E | Identical |
| Device<br>Design | The 3MTM Attest™ Vaporized<br>Hydrogen Peroxide Tri-Metric<br>Chemical Indicator 1348/1348E is a<br>chemical indicator consisting of a non-<br>cellulose based coated indicator strip<br>sensitive to vaporized hydrogen<br>peroxide, contained in a film laminate.<br>The 3M™ Attest™ CI 1348/1348E<br>verifies that the stated values for the<br>three critical parameters of exposure<br>time, temperature, and concentration of<br>vaporized hydrogen peroxide have been<br>achieved within a package or<br>containment device (i.e. wrapped trays,<br>rigid containers, sterilization pouches,<br>and other types of packs) and/or at a<br>specific location within the load or<br>empty chamber.<br>Upon exposure to vaporized hydrogen<br>peroxide, the color of the coated<br>indicator strip progressively changes<br>from blue toward pink along the strip.<br>The progression of the blue to pink<br>color change along the strip is visible<br>through a window with marked<br>"REJECT" and "ACCEPT" zones. The<br>extent of the progression depends on<br>exposure time, temperature, and<br>concentration of vaporized hydrogen<br>peroxide. | The 3MTM Attest™ Vaporized<br>Hydrogen Peroxide Tri-Metric<br>Chemical Indicator 1348/1348E is a<br>chemical indicator consisting of a non-<br>cellulose based coated indicator strip<br>sensitive to vaporized hydrogen<br>peroxide, contained in a film laminate.<br>The 3MTM Attest™ CI 1348/1348E<br>verifies that the stated values for the<br>three critical parameters of exposure<br>time, temperature, and concentration of<br>vaporized hydrogen peroxide have been<br>achieved within a package or<br>containment device (i.e. wrapped trays,<br>rigid containers, sterilization pouches,<br>and other types of packs) and/or at a<br>specific location within the load or<br>empty chamber.<br>Upon exposure to vaporized hydrogen<br>peroxide, the color of the coated<br>indicator strip progressively changes<br>from blue toward pink along the strip.<br>The progression of the blue to pink<br>color change along the strip is visible<br>through a window with marked<br>"REJECT" and "ACCEPT" zones. The<br>extent of the progression depends on<br>exposure time, temperature, and<br>concentration of vaporized hydrogen<br>peroxide. | Identical |
| Sterilizers in<br>which Color | STERRAD® 100S<br>STERRAD® NX (Standard and | STERRAD® 100S<br>STERRAD® NX (Standard and | Similar. The<br>submission |
| Change | Advanced cycles) | Advanced cycles) | device adds |
| | | | |
| Performance was<br>Demonstrated<br>(Blue toward Pink) | STERRAD® NX with ALLClear™<br>Technology (Standard and Advanced<br>cycles)<br>STERRAD® 100NX (Standard, Flex,<br>Express, and Duo cycles)<br>STERRAD® 100NX with ALLClear™<br>Technology (Standard, Flex, Express,<br>and Duo cycles)<br>STERIS® V-PRO® maX (Lumen,<br>Non-Lumen, and Flexible cycles)<br>STERIS® V-PRO® maX2 (Lumen,<br>Non-Lumen, Flexible, and Fast Non-<br>Lumen cycles)<br>STERIS® V-PRO® 60 (Lumen, Non-<br>Lumen, and Flexible cycles)<br>STERIS® V-PRO® s2 (Lumen, Non-<br>Lumen, Flexible, and Fast cycles)<br>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 System,<br>STERRAD® NX® System (Standard<br>and Advanced cycles), STERRAD®<br>NX® System with AllClear™<br>Technology (Standard and Advanced<br>cycles), STERRAD® 100NX® System<br>(Standard, Flex, Express and Duo<br>cycles) STERRAD® 100NX® System<br>with AllClear™ Technology (Standard,<br>Flex, Express and Duo cycles) | STERRAD® NX with ALLClear™<br>Technology (Standard and Advanced<br>cycles)<br>STERRAD® 100NX (Standard, Flex,<br>Express, and Duo cycles)<br>STERRAD® 100NX with ALLClear™<br>Technology (Standard, Flex, Express,<br>and Duo cycles)<br>STERIS® V-PRO® maX (Lumen,<br>Non-Lumen, and Flexible cycles)<br>STERIS® V-PRO® maX2 (Lumen,<br>Non-Lumen, Flexible, and Fast Non-<br>Lumen cycles)<br>STERIS® V-PRO® 60 (Lumen, Non-<br>Lumen, and Flexible cycles)<br>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 System,<br>STERRAD® NX® System (Standard<br>and Advanced cycles), STERRAD®<br>NX® System with AllClear™<br>Technology (Standard and Advanced<br>cycles), STERRAD® 100NX® System<br>(Standard, Flex, Express and Duo<br>cycles) STERRAD® 100NX® System<br>with AllClear™ Technology (Standard,<br>Flex, Express and Duo cycles) | the<br>STERIS®<br>V-PRO® s2<br>sterilizer to<br>the<br>indications<br>for use and<br>testing was<br>conducted to<br>demonstrate<br>color change<br>performance. |
| Indications<br>for Use | vaporized hydrogen peroxide sterilizers<br>and STERIS® V-PRO® 1 (Lumen<br>cycle), STERIS ® V-PRO® 1 Plus<br>(Lumen and Non-Lumen cycles) and<br>STERIS ® V-PRO® maX Low<br>Temperature Sterilization System<br>(Lumen, Non-Lumen and Flexible<br>cycles), STERIS® V-PRO® 60<br>Temperature Sterilization System<br>(Lumen, Non-Lumen and Flexible<br>cycles), STERIS® V-PRO® maX 2<br>Temperature Sterilization System<br>(Lumen, Non-Lumen, Flexible, and<br>Fast Non-lumen cycles), STERIS® V-<br>PRO® s2 Low Temperature<br>Sterilization System (Lumen, Non-<br>Lumen, Flexible, and Fast cycles). | vaporized hydrogen peroxide sterilizers<br>and STERIS® V-PRO® 1 (Lumen<br>cycle), STERIS ® V-PRO® 1 Plus<br>(Lumen and Non-Lumen cycles) and<br>STERIS ® V-PRO® maX Low<br>Temperature Sterilization System<br>(Lumen, Non-Lumen and Flexible<br>cycles), STERIS® V-PRO® 60<br>Temperature Sterilization System<br>(Lumen, Non-Lumen and Flexible<br>cycles), and STERIS® V-PRO® maX 2<br>Temperature Sterilization System<br>(Lumen, Non-Lumen, Flexible, and<br>Fast Non-lumen cycles). | Similar. The<br>submission<br>device adds<br>the<br>STERIS®<br>V-PRO® s2<br>sterilizer to<br>the<br>indications<br>for use. |
| Indicator<br>Agent | Proprietary | Proprietary | Identical |
| Stability of<br>the endpoint<br>reaction | At least one month (4 weeks) | At least one month (4 weeks) | Identical |

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

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

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

| Shelf life | 15 months | | | 6 months | | | Similar. 15<br>month shelf<br>life data has<br>been<br>generated for<br>the<br>submission<br>device using<br>the same<br>protocol<br>used in the<br>predicate<br>submission. |
|-------------------------------------------------------------|------------------------|------------------|-----------------|------------------------|------------------|-----------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Endpoint<br>Specifications<br>(Minimum<br>Stated<br>Values) | VH2O2<br>Concentration | Exposure<br>Time | Temperature | VH2O2<br>Concentration | Exposure<br>Time | Temperature | Identical |
| | 5.1 mg/L | 1<br>minute | 50 degrees<br>C | 5.1 mg/L | 1<br>minute | 50 degrees<br>C | |

## 6. Summary of Nonclinical Testing

Provided below are the non-clinical test methodologies performed to demonstrate the Tri-Metric CI met the acceptance criteria of the standard.

| Test Method | Purpose | Acceptance Criteria | Results |
|--------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------|
| Health Care<br>Facility<br>Simulated<br>Use Testing<br>on STERIS<br>V-PRO s2<br>sterilizer | Assess color<br>change of<br>indicator after<br>exposure to<br>representative<br>complete and<br>incomplete<br>cycles for the<br>STERIS V-<br>PRO s2<br>sterilizer | The 3M 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 Lumen, Non-<br>Lumen, Flexible, or Fast Cycle in the<br>STERIS V-PRO s2 Low Temperature<br>Sterilization System.<br>The 3M 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 Lumen, Non-Lumen,<br>Flexible, or Fast Cycle in the STERIS<br>V-PRO s2 Low Temperature<br>Sterilization System. | All Tri-<br>Metric CIs<br>tested met<br>acceptance<br>criteria.<br>All Tri-<br>Metric CIs<br>tested met<br>acceptance<br>criteria. |

## 7. Conclusion

Based on the non-clinical performance data, the submission device 3MTM Attest™ Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E is as safe, as effective, and performs as well as or better than the predicate of the same name (K193110), Class II (21 CFR 880.2800), product code QKM.