3M Attest Rapid Readout Biological Indicator, 1295

K211705 · 3M Company · FRC · Jun 28, 2022 · General Hospital

Device Facts

• Record ID: K211705
• Device Name: 3M Attest Rapid Readout Biological Indicator, 1295
• Applicant: 3M Company
• Product Code: FRC · General Hospital
• Decision Date: Jun 28, 2022
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.2800
• Device Class: Class 2

Intended Use

Use the 3M™ Attest™ Rapid Readout Biological Indicator 1295 in conjunction with the 3MTM Attest™ Auto-reader 490H or 490 Auto-reader having software version 4.0.0 or greater or 490M Auto-reader as a standard method of routine monitoring of vaporized hydrogen peroxide sterilization processes in the following systems: 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

Self-contained biological indicator (BI) for monitoring vaporized hydrogen peroxide sterilization. Device consists of plastic sleeve, spore carrier (Geobacillus stearothermophilus), and media ampoule. Chemical process indicator on cap changes color (blue to pink) upon exposure to sterilant. After sterilization, BI is incubated in 3M Attest Auto-reader (490H, 490, or 490M). Auto-reader detects fluorescence from enzymatic activity; fluorescence indicates sterilization failure. Used in clinical settings to verify sterilization efficacy. Provides rapid (24-minute) readout to inform clinical decision-making regarding instrument sterility and patient safety.

Clinical Evidence

Bench testing only. Performance verified in STERIZONE VP4 Sterilizer (Cycle 1) via full and fractional cycle testing. All BIs showed negative fluorescent and visual responses in full cycles and expected responses in fractional cycles. Chemical indicator color change confirmed.

Technological Characteristics

Self-contained BI; polyethylene terephthalate carrier; Geobacillus stearothermophilus spores (≥1x10^6); H2O2-sensitive ink; 60±2°C incubation; 24-minute fluorescence readout. Complies with ANSI/AAMI/ISO 11138-1:2017.

Indications for Use

Indicated for routine monitoring of vaporized hydrogen peroxide sterilization processes in specified STERRAD, V-PRO, and STERIZONE sterilization systems. Used by healthcare personnel in clinical settings.

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 Rapid Readout Biological Indicator 1295 (K210277)

Submission Summary (Full Text)

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June 28, 2022

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

Re: K211705

Trade/Device Name: 3M Attest Rapid Readout Biological Indicator, 1295 Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: Class II Product Code: FRC Dated: June 7, 2022 Received: June 8, 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 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 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, Ph.D. 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) K211705

Device Name

3M™ Attest™ Rapid Readout Biological Indicator 1295

Indications for Use (Describe)

Use the 3M™ Attest™ Rapid Readout Biological Indicator 1295 in conjunction with the 3MTM Attest™ Auto-reader 490H or 490 Auto-reader having software version 4.0.0 or greater or 490M Auto-reader as a standard method of routine monitoring of vaporized hydrogen peroxide sterilization processes in the following systems:

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) | |
|----------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------|
| <div style="display:flex; align-items:center;"><input type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</div> | <div style="display:flex; align-items:center;"><input checked="" type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</div> |

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# K211705 510(k) Summary for 3M™ Attest™ Rapid Readout Biological Indicator 1295

# Sponsor Information:

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: June 08, 2022

510(k) Reference: K211705

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#### PREMARKET NOTIFICATION [510(k) 3MTM Attest™ Rapid Readout Biological Indicator 1295

#### 1. Device Name and Classification:

| Common or Usual Name: | Biological Indicator |
|------------------------|-----------------------------------------------------|
| Proprietary Name: | 3M™ Attest™ Rapid Readout Biological Indicator 1295 |
| Classification Name: | Indicator, biological sterilization process |
| Device Classification: | Class II, 21 CFR § 880.2800(a) |
| Product Code: | FRC |

# 2. Predicate Device:

K210277 3MTM Attest™ Rapid Readout Biological Indicator 1295

# 3. Description of Device:

The 3MTM Attest™ Rapid Readout Biological Indicator 1295 is a self-contained biological indicator specifically designed for rapid and reliable routine monitoring of vaporized hydrogen peroxide sterilization processes when used in conjunction with the 3MTM Attest™ Auto-reader 490H or the 3M™ Attest™ Auto-reader 490 having software version 4.0.0 or greater or a 3M™ Attest™ Mini Auto-reader 490M. The 1295 BI is a single-use device composed of a plastic sleeve containing a spore carrier and media ampoule, enclosed with a color-coded cap. A chemical process indicator printed with stripes which change from blue toward pink upon exposure to vaporized hydrogen peroxide is located on the top of the cap. The detection of fluorescence upon incubation of the 1295 BI in one of the designated Attest™ Auto-readers indicates a sterilization failure.

# 4. Indications for Use

Use the 3M™ Attest™ Rapid Readout Biological Indicator 1295 in conjunction with the 3M™ Attest™ Auto-reader 490H or 490 Auto-reader having software version 4.0.0 or greater or 490M Auto-reader as a standard method of routine monitoring of vaporized hydrogen peroxide sterilization processes in the following systems:

| 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, Non Lumen, and Flexible cycles) |

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#### PREMARKET NOTIFICATION [510(k)] 3MTM Attest™ Rapid Readout Biological Indicator 1295

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

# Technological Characteristic Comparison Table

| Feature | Submission Device:<br>3M™ Attest™ Rapid Readout<br>Biological Indicator 1295 | Predicate Device (K210277):<br>3M™ Attest™ Rapid Readout<br>Biological Indicator 1295 | Comparison |
|------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------|
| Indications for<br>use | Use the 3M™ Attest™ Rapid<br>Readout Biological Indicator 1295<br>in conjunction with the 3M™<br>Attest™ Auto-reader 490H or 490<br>Auto-reader having software<br>version 4.0.0 or greater or 490M<br>Auto-reader as a standard method of<br>routine monitoring of vaporized<br>hydrogen peroxide sterilization<br>processes in the following systems:<br>STERRAD 100S® Sterilization<br>System<br>STERRAD NX® Sterilization<br>System (Standard and Advanced<br>cycles)<br>STERRAD 100NX®<br>Sterilization System (Standard,<br>Flex, Express and Duo cycles)<br>STERRAD NX® with<br>ALLClear® Technology<br>Sterilization System (Standard<br>and Advanced cycles)<br>STERRAD 100NX® with<br>ALLClear® Technology<br>Sterilization System (Standard,<br>Flex, Express and Duo cycles)<br>V-PRO® 1 Low Temperature<br>Sterilization System (Lumen<br>cycle)<br>V-PRO® 1 Plus Low<br>Temperature Sterilization<br>System (Lumen and Non Lumen<br>cycles)<br>V-PRO® maX Low Temperature<br>Sterilization System (Lumen,<br>Non Lumen, and Flexible<br>cycles)<br>V-PRO® 60 Low Temperature<br>Sterilization System (Lumen,<br>Non Lumen and Flexible cycles) | Use the 3M™ Attest™ Rapid<br>Readout Biological Indicator 1295<br>in conjunction with the 3M™<br>Attest™ Auto-reader 490H or 490<br>Auto-reader having software<br>version 4.0.0 or greater or 490M<br>Auto-reader as a standard method of<br>routine monitoring of vaporized<br>hydrogen peroxide sterilization<br>processes in the following systems:<br>STERRAD 100S® Sterilization<br>System<br>STERRAD NX® Sterilization<br>System (Standard and Advanced<br>cycles)<br>STERRAD 100NX®<br>Sterilization System (Standard,<br>Flex, Express and Duo cycles)<br>STERRAD NX® with<br>ALLClear® Technology<br>Sterilization System (Standard<br>and Advanced cycles)<br>STERRAD 100NX® with<br>ALLClear® Technology<br>Sterilization System (Standard,<br>Flex, Express and Duo cycles)<br>V-PRO® 1 Low Temperature<br>Sterilization System (Lumen<br>cycle)<br>V-PRO® 1 Plus Low<br>Temperature Sterilization<br>System (Lumen and Non Lumen<br>cycles)<br>V-PRO® maX Low Temperature<br>Sterilization System (Lumen,<br>Non Lumen, and Flexible<br>cycles)<br>V-PRO® 60 Low Temperature<br>Sterilization System (Lumen,<br>Non Lumen and Flexible cycles) | Addition of<br>the<br>STERIZONE®<br>VP4 Sterilizer<br>(Cycle 1) |

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| Feature | Submission Device:<br>3MTM Attest™ Rapid Readout<br>Biological Indicator 1295 | Predicate Device (K210277)<br>3MTM Attest™ Rapid Readout<br>Biological Indicator 1295 |
|---------|------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------|
| | V-PRO® maX 2 Low<br>Temperature Sterilization<br>System (Lumen, Non Lumen,<br>Flexible, and Fast Non Lumen | V-PRO® maX 2 Low<br>Temperature Sterilization<br>System (Lumen, Non Lumen,<br>Flexible, and Fast Non Lumen |

| Feature | Submission Device:<br>3MTM Attest™ Rapid Readout<br>Biological Indicator 1295 | Predicate Device (K210277):<br>3MTM Attest™ Rapid Readout<br>Biological Indicator 1295 | Comparison |
|-------------------------------|-----------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------|------------|
| | V-PRO® maX 2 Low<br>Temperature Sterilization<br>System (Lumen, Non Lumen,<br>Flexible, and Fast Non Lumen<br>cycles) | V-PRO® maX 2 Low<br>Temperature Sterilization<br>System (Lumen, Non Lumen,<br>Flexible, and Fast Non Lumen<br>cycles) | |
| | V-PRO® s2 Low Temperature<br>Sterilization System (Lumen,<br>Non Lumen, Flexible, and Fast<br>cycles) | V-PRO® s2 Low Temperature<br>Sterilization System (Lumen,<br>Non Lumen, Flexible, and Fast<br>cycles) | |
| | STERIZONE® VP4 Sterilizer<br>(Cycle 1) | | |
| Organism | Geobacillus stearothermophilus<br>traceable to ATCCTM 7953 | Geobacillus stearothermophilus<br>traceable to ATCCTM 7953 | Identical |
| Viable spore<br>population | ≥1x106 | ≥1x106 | Identical |
| Resistance<br>characteristics | (Tested at 10 mg/L vaporized<br>hydrogen peroxide) | (Tested at 10 mg/L vaporized<br>hydrogen peroxide) | |
| • D-value | D10 mg/L ≥ 1 second | D10 mg/L ≥ 1 second | Identical |
| • Survival/Kill<br>Window | Survival Time ≥ 5 seconds<br>Kill Time = 7 minutes | Survival Time ≥ 5 seconds<br>Kill Time = 7 minutes | |
| Carrier material | Polyethylene terephthalate | Polyethylene terephthalate | Identical |
| Incubation<br>temperature | 60 ± 2°C | 60 ± 2°C | Identical |
| Readout time | 24 minute fluorescence result read | 24 minute fluorescence result read | Identical |
| Chemical<br>indicator | H2O2 sensitive ink; changes from<br>blue towards pink | H2O2 sensitive ink; changes from<br>blue towards pink | Identical |
| Shelf life | Two (2) years | Two (2) years | Identical |

# 5. Nonclinical Comparison to the Predicate Device

The 3MTM Attest™ Rapid Readout Biological Indicator 1295 is identical to the previously cleared device of the same model number (the predicate) which is sold under the same tradename and cleared via K210277.

To demonstrate performance in the newly claimed sterilizer and cycles, nonclinical testing was performed in accordance with the FDA Guidance for Industry and FDA Staff: Biological Indicator (BI) Premarket Notification [510(k)] Submissions, and ANSI/AAMI/ISO 11138-1:2017 Sterilization of health care products- Biological Indicators- Part 1: General requirements (FDA Recognition Number 14-502).

Reference Table 5.1 for testing completed in the STERIZONE® VP4 Sterilizer (Cycle 1).

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#### PREMARKET NOTIFICATION [510(k)] 3MTM Attest™ Rapid Readout Biological Indicator 1295

| Test Name | Purpose | Acceptance Criteria | Result |
|--------------------------------------------|-------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------|--------|
| Full Cycle<br>Performance | Verify performance in each of the<br>full cycles in the STERIZONE®<br>VP4 Sterilizer (Cycle 1). | All biological indicators display a<br>negative fluorescent and negative<br>visual response. | Pass |
| Fractional Cycle<br>Performance | Verify performance in fractional<br>cycles for each of the cycles<br>within the STERIZONE® VP4<br>Sterilizer (Cycle 1). | All biological indicators display a<br>negative fluorescent and negative<br>visual response. | Pass |
| Chemical<br>Indicator (CI)<br>Color Change | Demonstrate the color change of<br>the CI when exposed to the<br>STERIZONE® VP4 Sterilizer<br>(Cycle 1). | Color change from blue toward<br>pink. | Pass |

# Table 5.1 Summary of Nonclinical Testing

#### 6. Conclusion

Based on the non-clinical performance data, the 3M™ Attest™ Rapid Readout Biological Indicator 1295 is as safe, as effective, and performs as well as or better than the legally marketed predicate, the 3M™ Attest™ Rapid Readout Biological Indicator 1295 cleared under K210277, Class II (21 CFR 880.2800), product code FRC.