3M Attest Rapid Readout Biological Indicator

K160546 · 3M Company · FRC · Jun 9, 2016 · General Hospital

Device Facts

• Record ID: K160546
• Device Name: 3M Attest Rapid Readout Biological Indicator
• Applicant: 3M Company
• Product Code: FRC · General Hospital
• Decision Date: Jun 9, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.2800
• Device Class: Class 2

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, and Flexible cycles), and in STERRAD® 100S, STERRAD® NX (Standard and Advanced cycles) and 100NX (Standard, Flex, Express and Duo cycles) systems.

Device Story

Self-contained biological indicator (BI) for monitoring vaporized hydrogen peroxide sterilization; consists of polycarbonate sleeve, spore carrier (Geobacillus stearothermophilus), and media ampoule. User places BI in sterilizer; after cycle, user incubates BI in 3M Attest Auto-reader 490H. Auto-reader detects fluorescence from spore metabolism; fluorescence indicates sterilization failure. Provides rapid 4-hour readout. Used in clinical settings by sterile processing staff to verify sterilization efficacy; ensures medical instruments are safe for patient use.

Clinical Evidence

No clinical data included. Effectiveness demonstrated via non-clinical bench testing, including verification of performance, growth promotion, and resistance characteristics (D-value, survival/kill) in the Amsco V-PRO maX system.

Technological Characteristics

Self-contained biological indicator; polycarbonate sleeve; polyethylene terephthalate carrier; Geobacillus stearothermophilus spores (≥1x10^6); H2O2-sensitive chemical indicator ink (blue to pink). Incubation at 60 +/- 2 °C. Fluorescence-based detection via 3M Attest Auto-reader 490H. 18-month shelf life.

Indications for Use

Indicated for routine monitoring of vaporized hydrogen peroxide sterilization processes in specified Amsco and STERRAD low-temperature sterilization systems. Used in conjunction with the 3M Attest Auto-reader 490H.

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 (K152060)

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

June 9, 2016

3M Health Care Ms. Hilary B. Hovde 3M Health Care Regulatory Affairs Specialist 3M Center, Building 275-5W-06 St. Paul, Minnesota 55144

Re: K160546

Trade/Device Name: 3M™ Attest™ Rapid Readout Biological Indicator 1295 Regulation Number: 21 CFR 880.2800 Regulation Name: Indicator, Biological Sterilization Process Regulatory Class: Class II Product Code: FRC Dated: May 12, 2016 Received: May 17, 2016

Dear Hilary B. 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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 vours.

*Tejashri Purohit-Sheth, M.D.*

Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR

Erin I. Keith, M.S. 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) K160546

Device Name

3MTM Attest™ Rapid Readout Biological Indicator 1295

#### Indications for Use (Describe)

Use the 3MM 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, and Flexible cycles), and in STERRAD® 100S, STERRAD® NX (Standard and Advanced cycles) and 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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Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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Premarket Notification (510(k)) Summary K160546

Image /page/3/Picture/1 description: The image shows the 3M logo. The logo is red and features the number 3 followed by the letter M. The font is bold and sans-serif.

### Sponsor Information:

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

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

### Date of Summary: June 7, 2016

#### Device Name and Classification:

Common or Usual Name: Biological Indicator Proprietary Name: 3MTM Attest™ Rapid Readout Biological Indicator 1295 Classification Name: Indicator, Biological Sterilization Process Device Classification: Class II, 21 CFR 880.2800(a) Product Code: FRC

### Predicate Devices:

- K152060 3MTM Attest™ Rapid Readout Biological Indicator 1295 .
### 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 to pink upon exposure to vaporized hydrogen peroxide is located on the top of the cap. The 1295 BI utilizes the same fundamental technology that exists in current 3M™ Attest™ Rapid Readout and Super Rapid Readout BIs. The detection of fluorescence upon incubation of the 1295 BI in the 490H Auto-reader indicates a sterilization failure.

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## Nonclinical Comparison to the Predicate Device

This submission is addressing clearance for use in an additional sterilizer. The 3MIM 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, performance specifications, and fundamental scientific technology.

## Summary of Nonclinical Testing

The effectiveness of the 3M™ Attest™ Rapid Readout Biological Indicator 1295 in the Amsco® V-PRO® maX Low Temperature Sterilization System (Lumen, Non Lumen, and Flexible cycles) is demonstrated in the following tests:

| Test | Results |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| Verification of performance in full cycles in the Amsco® V-PRO® maX Low<br>Temperature Sterilization System (Lumen, Non Lumen, and Flexible cycles) | Passed |
| Growth promotion ability in the Amsco® V-PRO® maX Low Temperature<br>Sterilization System (Lumen, Non Lumen, and Flexible cycles) | Passed |
| Verification of half cycles in the Amsco® V-PRO® maX Low Temperature<br>Sterilization System (Lumen, Non Lumen, and Flexible cycles) | Passed |
| Verification of performance in fractional cycles in the Amsco® V-PRO®<br>maX Low Temperature Sterilization System | Passed |
| Verification of 4-hour fluorescent readout per FDA's Reduced Incubation<br>Time protocol in the Amsco® V-PRO® maX Low Temperature Sterilization<br>System | Passed |
| Verification of population and resistance characteristics (D-value, survival,<br>kill) at the end of shelf life in the Amsco® V-PRO® maX Low Temperature<br>Sterilization System (Lumen, Non Lumen, and Flexible cycles) | 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 100NX (Standard, Flex, Express and Duo cycles) systems.

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# Comparison to Predicate Device

| Feature | Submission Device: 3MTM<br>AttestTM 1295 Biological Indicator | Predicate Device (K152060):<br>3MTM AttestTM 1295 Biological<br>Indicator |
|-------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for use | Use the 3MTM Attest™ Rapid Readout<br>Biological Indicator 1295 in<br>conjunction with the 3M Attest™ Auto<br>reader 490H as a standard method of<br>routine monitoring of vaporized<br>hydrogen peroxide sterilization<br>processes in the Amsco® V-PRO®<br>maX Low Temperature Sterilization<br>System (Lumen, Non Lumen, and<br>Flexible cycles), and in STERRAD®<br>100S, STERRAD® NX (Standard and<br>Advanced cycles) and 100NX<br>(Standard, Flex, Express and Duo<br>cycles) systems. | Use the 3MTM Attest™ Rapid<br>Readout Biological Indicator 1295<br>in conjunction with the 3M<br>Attest™ Auto-reader 490H as a<br>standard method of routine<br>monitoring of vaporized hydrogen<br>peroxide sterilization processes in<br>STERRAD® 100S, STERRAD®<br>NX (Standard and Advanced<br>cycles) and 100NX (Standard, Flex,<br>Express and Duo cycles) systems. |
| Organism | Geobacillus stearothermophilus<br>traceable to ATCCTM 7953 | Same |
| Viable spore<br>population | ≥1x106 | Same |
| Resistance<br>characteristics | (Tested at 10 mg/L vaporized hydrogen<br>peroxide)<br>D-value D10 mg/L ≥ 1 second Survival/Kill Survival Time ≥ 5 seconds Window Kill Time = 7 minutes | Same |
| Carrier material | Polyethylene terephthalate | Same |
| Incubation<br>temperature | 60 +/- 2 °C | Same |
| Readout time | 4 hour fluorescence result read on 3M<br>490H Auto-reader | Same |
| Chemical<br>indicator | H2O2 sensitive ink; appears blue until<br>processed, then appears pink | Same |
| Shelf-life | 18 months | Same |

## Conclusion

The 3M™ Attest™ Rapid Readout Biological Indicator 1295 is substantially equivalent to the predicate device in terms of their intended use, physical properties and technological characteristics. The non-clinical testing demonstrates that the 1295 Biological Indicator is as safe, as effective, and performs as well as the predicate device.