3M Attest Rapid Readout Biological Indicator, 3M Attest Auto-reader

K171003 · 3M Company · FRC · Jul 21, 2017 · General Hospital

Device Facts

• Record ID: K171003
• Device Name: 3M Attest Rapid Readout Biological Indicator, 3M Attest Auto-reader
• Applicant: 3M Company
• Product Code: FRC · General Hospital
• Decision Date: Jul 21, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.2800
• Device Class: Class 2

Intended Use

Use the 3M™ Attest™ Rapid Readout Biological Indicator in conjunction with the 3M™ Attest™ Auto reader 490H as a standard method of routine monitoring of vaporized hydrogen peroxide sterilization processes in the Amsco® V-PRO® maX Low Temperature Sterilization System (Lumen, Non Lumen, and Flexible cycles), and in STERRAD® 100S, STERRAD® NX® (Standard and Advanced cycles) and STERRAD® 100NX® (Standard, Flex, Express, and Duo cycles) systems.

Device Story

System comprises 3M Attest Rapid Readout Biological Indicator 1295 (self-contained BI) and 3M Attest Auto-reader 490H. BI contains Geobacillus stearothermophilus spores and media ampoule in polycarbonate sleeve; cap features chemical process indicator (blue-to-pink). User places BI in sterilizer; post-cycle, BI is activated and inserted into Auto-reader. Auto-reader incubates BI at 60°C; detects fluorescence via enzymatic activity. Fluorescence indicates sterilization failure. Software update reduces final readout time from 4 hours to 24 minutes. Used in clinical settings for sterilization quality assurance; provides rapid feedback to healthcare staff regarding sterilization efficacy; ensures patient safety by confirming successful sterilization of instruments.

Clinical Evidence

No clinical data included. Effectiveness demonstrated via bench testing: positive control, survival/kill time (survival ≥ 5s, kill = 7 min), and reduced incubation time validation (24-minute readout vs 7-day conventional).

Technological Characteristics

Self-contained BI: polycarbonate sleeve, polyethylene terephthalate spore carrier, Geobacillus stearothermophilus spores (≥ 1x10^6). Chemical indicator: H2O2-sensitive ink. Auto-reader: 60±2°C incubation, fluorescence detection. Software-based readout.

Indications for Use

Indicated for routine monitoring of vaporized hydrogen peroxide sterilization processes in specified Amsco and STERRAD low-temperature sterilization systems.

Regulatory Classification

Identification

Biological sterilization process indicator: A device intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor adequacy of sterilization. The device consists of a known number of microorganisms, of known resistance to the mode of sterilization, in or on a carrier and enclosed in a protective package. Subsequent growth or failure of the microorganisms to grow under suitable conditions indicates the adequacy of sterilization. Physical/chemical sterilization process indicator: A device intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor one or more parameters of the sterilization process. The adequacy of the sterilization conditions as measured by these parameters is indicated by a visible change in the device.

Predicate Devices

• 3M™ Attest™ Rapid Readout Biological Indicator 1295 (K160546)
• 3M™ Attest™ Auto-reader 490H (K140392)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

July 21, 2017

3M Company c/0 Hilary Hovde Regulatory Affairs Associate 3M Center, Building 275-5W-06 St. Paul, Minnesota 55144

Re: K171003

Trade/Device Name: 3M Attest Rapid Readout Biological Indicator 1295, 3M Attest Autoreader 490H Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: Class II Product Code: FRC Dated: June 29, 2017 Received: June 30, 2017

Dear Hilary Hovde:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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

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or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely.

# Tara A. Ryan -S

for Lori Wiggins Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) K171003

Device Name

3M™ Attest™ Rapid Readout Biological Indicator 1295 and 3M™ Attest™ Auto-reader 490H

Indications for Use (Describe)

Use the 3M™ Attest™ Rapid Readout Biological Indicator in conjunction with the 3M™ Attest™ Auto reader 490H as a standard method of routine monitoring of vaporized hydrogen peroxide sterilization processes in the Amsco® V-PRO® maX Low Temperature Sterilization System (Lumen, Non Lumen, and Flexible cycles), and in STERRAD® 100S, STERRAD® NX® (Standard and Advanced cycles) and STERRAD® 100NX® (Standard, Flex, Express, and Duo cycles) systems.

Type of Use (Select one or both, as applicable)

- Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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# 510(k) Summary for 3M™ Attest™ Rapid Readout Biological Indicator 1295 and 3M™ Attest™ Auto-reader 490H

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

> Contact: Hilary B. Hovde Regulatory Affairs Associate Phone Number: [phone] FAX Number: [phone]

Submission Date: July 20, 2017

K171003

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#### TRADITIONAL PREMARKET NOTIFICATION [510(k)] 3MTM Attest™ Rapid Readout Biological Indicator 1295 and 3MTM Attest™ Auto-reader 490H

#### Device Name and Classification:

| Common or Usual Name: | Biological Indicator |
|------------------------|-------------------------------------------------------------------------------------|
| Proprietary Name: | 3M™ Attest™ Rapid Readout Biological Indicator 1295<br>3M™ Attest™ Auto-Reader 490H |
| Classification Name: | Indicator, Biological Sterilization Process<br>(21 CFR § 880.2800(a)) |
| Device Classification: | Class II |
| Product Code: | FRC |

#### Predicate Device:

- Intended use Predicate for system K160546 3M™ Attest™ Rapid Readout . Biological Indicator 1295
- . 3MTM AttestTM Auto-reader 490H, K140392

#### Description of Device:

The 3M™ 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 3M™ Attest™ Auto-reader 490H. The 1295 BI is a single-use device composed of a polycarbonate 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 the 490H Auto-reader indicates a sterilization failure.

#### Nonclinical Comparison to the Predicate Device

This submission is addressing a software change to the 3MTM Attest™ Auto-reader 490H to reduce the final fluorescent readout from 4 hours to 24 minutes. The 3M™ Attest™ Rapid Readout Biological Indicator 1295 is the same design as the previously cleared device of the same model number. The device has the same materials and fundamental scientific technology. The only change to the performance specifications is the change in final fluorescent readout from 4 hours to 24 minutes.

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#### TRADITIONAL PREMARKET NOTIFICATION [510(k)] 3M™ Attest™ Rapid Readout Biological Indicator 1295 and 3M™ Attest™ Auto-reader 490H

#### Summary of Nonclinical Testing

The effectiveness of the 3M™ Attest™ Rapid Readout Biological Indicator 1295 in conjunction with the 3M™ Attest™ Auto-reader 490H with a final fluorescent readout of 24 minutes is demonstrated in the following tests:

| Test | Results |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| Positive Control | Passed |
| Survival Time = 5 seconds<br>Kill Time = 7 minutes | Passed |
| Reduced Incubation Time<br>Meets FDA's requirements for Reduced Incubation Time with > 97%<br>alignment with the conventional incubation time of 7 days for the<br>following readout time:<br>• 24 minutes | Passed |

## Summary of Clinical Testing

No clinical data was included in this premarket application submission.

## Indications for Use

Use the 3M™ Attest™ Rapid Readout Biological Indicator 1295 in conjunction with the 3M™ Attest™ Auto-reader 490H as a standard method of routine monitoring of vaporized hydrogen peroxide sterilization processes in the AMSCO® V-PRO® maX Low Temperature Sterilization System (Lumen, Non Lumen, and Flexible cycles), and in STERRAD® 100S, STERRAD® NX® (Standard and Advanced cycles) and STERRAD® 100NX® (Standard, Flex, Express and Duo cycles) systems.

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## Comparison to Predicate Device

| Feature | Submission Device:<br>3MTM AttestTM Rapid Readout<br>Biological Indicator 1295 and<br>3MTM AttestTM Auto-reader 490H | Predicate Device (K160546):<br>3MTM AttestTM Rapid Readout<br>Biological Indicator 1295 and<br>3MTM AttestTM Auto-reader 490H |
|----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------|
| Indications for use | Use the 3MTM AttestTM Rapid Readout<br>Biological Indicator 1295 in conjunction<br>with the 3MTM AttestTM Auto-reader<br>490H as a standard method of routine<br>monitoring of vaporized hydrogen<br>peroxide sterilization processes in the<br>Amsco® V-PRO® maX Low<br>Temperature Sterilization System<br>(Lumen, Non Lumen, and Flexible<br>cycles), and in STERRAD® 100S,<br>STERRAD® NX® (Standard and<br>Advanced cycles) and STERRAD®<br>100NX® (Standard, Flex, Express and<br>Duo cycles) systems. | Identical |
| Organism | Geobacillus stearothermophilus<br>traceable to ATCCTM 7953 | Identical |
| Viable spore<br>population | ≥ 1 x 106 | Identical |
| Resistance<br>characteristics | (Tested at 10 mg/L vaporized hydrogen<br>peroxide)<br>D-value<br>Survival/Kill Window<br> | Identical |
| • D-value<br>• Survival/Kill<br>Window | $D_{10 mg/L} ≥ 1 second$<br>Survival Time ≥ 5 seconds<br>Kill Time = 7 minutes | Identical |
| Carrier material | polyethylene terephthalate | Identical |
| Incubation<br>temperature | 60 ± 2°C | Identical |
| Readout time | 24 minute fluorescence result read in the<br>3MTM AttestTM Auto-reader 490H | 4 hour fluorescence result read in the<br>3MTM AttestTM Auto-reader 490H |
| Chemical<br>indicator | H2O2 sensitive ink; changes from blue<br>towards pink | Identical |
| Shelf-life | 24 months | Identical |

## Conclusion

The 3M™ Attest™ Rapid Readout Biological Indicator 1295 and the 3MTM Attest™ Autoreader 490H meet all applicable standards and are substantially equivalent to their predicate devices in terms of their intended use, physical properties and technological characteristics.