3M ATTEST RAPID READOUT BIOLOGICAL INDICATOR / 3M ATTEST AUTO-READER

K140392 · 3M Company · FRC · Aug 13, 2014 · General Hospital

Device Facts

• Record ID: K140392
• Device Name: 3M ATTEST RAPID READOUT BIOLOGICAL INDICATOR / 3M ATTEST AUTO-READER
• Applicant: 3M Company
• Product Code: FRC · General Hospital
• Decision Date: Aug 13, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.2800
• Device Class: Class 2

Intended 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 STERRAD® NX and 100NX systems.

Device Story

The 3M Attest™ 1295 Rapid Readout Biological Indicator (BI) is a self-contained, single-use device containing Geobacillus stearothermophilus spores and an α-glucosidase enzyme system. It is used to monitor vaporized hydrogen peroxide sterilization cycles. After processing, the BI is placed in the 3M Attest™ Auto-reader 490H, which incubates the sample at 60°C. The reader uses UV LEDs and optical filters to detect fluorescence generated by the enzymatic hydrolysis of a non-fluorescent substrate, indicating spore viability. A fluorescent result within 4 hours signifies a sterilization failure. The system provides a rapid readout compared to conventional 7-day visual pH color change methods, allowing for faster identification of sterilization failures and improved patient safety. The Auto-reader displays results on an LCD and provides an audible alarm for failures. It is intended for use in healthcare facilities.

Clinical Evidence

Bench testing only. Performance evaluated per FDA Guidance for Industry and FDA Staff, Biological Indicator (BI) Premarket Notification [510(k)] Submissions. Testing confirmed >97% alignment between the 4-hour fluorescent readout and the 7-day visual pH color change result. Resistance testing at 10 mg/L H2O2 demonstrated a kill time of 7 minutes, confirming the device provides a robust challenge to the sterilization process.

Technological Characteristics

BI: Polycarbonate sleeve, PET spore carrier, α-glucosidase enzyme system. Auto-reader: 60°C incubation, UV LED/photodiode fluorescence detection, 10 incubation wells. Electrical: 100-240V AC input, 12V DC internal conversion. Compliance: IEC 61010-1, IEC 61010-2-010, FCC Part 15 Subpart B Class A.

Indications for Use

Indicated for routine monitoring of vaporized hydrogen peroxide sterilization processes in STERRAD® NX and 100NX systems in healthcare facilities. Used by healthcare personnel to verify sterilization adequacy via Geobacillus stearothermophilus spore challenge.

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

• STERRAD® CycleSure® 24 BI (K123017)
• Attest™ 1492V Super Rapid Readout BI (K121484)
• 3M Attest™ Auto-reader 490 (K121484)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

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

Auqust 13, 2014

3M Health Care Dr. Suzanne Leung, Ph.D., RAC Regulatory Affairs Manager 3M Center, Bldg. 275-5W-06 St. Paul, MN 55144

Re: K140392

Trade/Device Name: 3M Attest™ Rapid Readout Biological Indicator 1295 and 3M Attest™ Auto- reader 490H Regulation Number: 21 CFR 880.2800(a) Regulation Name: Biological sterilization process Indicator Regulatory Class: II Product Code: FRC Dated: July 14, 2014 Received: July 17, 2014

Dear Dr. Leung:

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.

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Page 2 - Dr. Leung

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 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 Small Manufacturers, International and Consumer Assistance at its tollfree 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Mary S. Runner -S

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

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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

510(k) Number (if known) K140392

#### 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 1295 in conjunction with the 3M Attest™ Auto-reader 490H as a standard method of routine monitoring of vaporized hydrogen peroxide sterilization processes in STERRAD® NX and 100NX 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)

#### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

#### FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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# Premarket Notification (510(k)) Summary

K140392

Image /page/4/Picture/2 description: The image shows the 3M logo. The logo consists of the number "3" and the letter "M" in a bold, sans-serif font. The color of the text is red, and the background is white.

## Sponsor Information:

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

| Contact Person: | Suzanne Leung, Ph.D., RAC<br>Regulatory Affairs Manager |
|------------------------------|---------------------------------------------------------|
| Phone Number:<br>FAX Number: | [phone]<br>[phone] |
| Date of Summary: | August 11, 2014 |

# Device Name and Classification:

| Common or Usual Name: | Sterilization 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)) |
| Product Code: | FRC |
| Product Class: | Class II |

## Predicate Devices:

| New Device | Predicate |
|----------------------------------|------------------------------------------------------------------------------------------------|
| Attest™ 1295 Rapid<br>Readout BI | 'Intended Use Predicate' – shares same Intended Use as<br>STERRAD® CycleSure® 24 BI, K123017 |
| | 'Design Predicate' – shares same BI design as<br>Attest™ 1492V Super Rapid Readout BI, K121484 |
| 3M Attest™ Auto-<br>reader 490H | 3M Attest™ Auto-reader 490, K121484 |

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### Description of Device:

### Attest™1295 BI

The 3M Attest™ 1295 Rapid Readout Biological Indicator for Vaporized Hydrogen Peroxide Sterilization (pink cap, referred to hereinafter as the 1295 BI) is a self-contained biological indicator specifically designed for rapid and reliable routine monitoring of STERRAD® vaporized hydrogen peroxide sterilization processes when used in conjunction with the 3M Attest™ Auto-reader 490H (hereinafter referred to as the 490H Auto-reader). The 1295 BI is a single-use device.

The Attest™ 1295 BI is 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. All Attest™ Rapid Readout and Super Rapid Readout BIs for steam utilize the a-glucosidase enzyme system, which is generated naturally within growing Geobacillus stearothermophilus organisms. The a-glucosidase enzyme in its active state is detected by measuring the fluorescence produced by the enzymatic hydrolysis of a non-fluorescent substrate. The resultant fluorescent by-product is detected in the 3M Attest™ 490H Auto-reader. The detection of fluorescence upon incubation of the 1295 BI in the 490H Auto-reader indicates a sterilization failure.

The 1295 BI is similar in design to the 3M Attest™ 1492V Super Rapid Readout Biological Indicator for Steam cleared as K121484 for dynamic-air-removal (prevacuum) steam sterilization cycles. Minor modifications were made to 1492V that resulted in the 1295 BI for STERRAD® vaporized hydrogen peroxide sterilization cycles.

### Attest™ Auto-reader 490H

The Attest™ Auto-reader 490H is similar in design to the Attest™ Auto-reader 490 that has been cleared for use with the Attest™ 1491 Super Rapid Readout Biological Indicator under K103277 and Attest™ 1492V Super Rapid Readout Biological Indicator under K121484.

The Attest™ Auto-reader 490H is designed to incubate at 60°C and automatically read the Attest™ 1295 BI for a fluorescent result within 4 hours. The fluorescent readout at 4 hours met the FDA's requirement of > 97% alignment with the result after the conventional incubation time of 7 days. The Auto-reader 490H is also designed to allow further incubation of the 1295 BI for an optional visual pH color change result of the growth media at 7 days.

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### 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 STERRAD® NX and 100NX systems.

## Substantial Equivalence of Attest™ 1295 Rapid Readout BI to 'Intended Use' Predicate Device STERRAD® CycleSure® 24 BI:

The Attest™ 1295 Rapid Readout BI has the same Intended Use as the predicate device, the STERRAD® CycleSure® 24 BI. cleared under K123017. Both the 1295 Rapid Readout BI and the predicate are biological indicators that are intended to be used in healthcare facilities to monitor the adequacy of hydrogen peroxide sterilization processes. This is accomplished through the biological challenge of Geobacillus stearothermophilus spores. Growth of the spores within the biological indicator after processing, indicates a failure of the hydrogen peroxide sterilization process.

Testing was conducted on the Attest™ 1295 BI following the FDA's Guidance for Industry and FDA Staff, Biological Indicator (BI) Premarket Notification [510(k)] Submissions; October 4, 2007. Multiple lots of Attest™ 1295 BIs were evaluated for performance when used with the Attest™ 490H Auto-reader.

A test cycle was developed for resistance testing utilizing a 10 mg/L hydrogen peroxide concentration, which is much more challenging than that used for evaluation of the predicate device. Despite using a higher hydrogen peroxide concentration, the Kill time for the Attest™ 1295 BI at 7 minutes is still much longer than the CycleSure® BI, reflecting its higher resistance. The greater resistance of the 1295 BI imparts a superior challenge to the sterilization process and provides a larger margin of sterility assurance.

An additional benefit of the Attest™ 1295 BI is the faster time to result. Through the use of the Attest™ Rapid Readout technology, the Reduced Incubation Time, performed according to FDA's guidance for biological indicators, has been validated at 4 hours. The more rapid time to result for the Attest™ 1295 BI over the CycleSure® BI allows for increased patient safety as the faster answer will reduce the number of patients affected should there be a sterilization failure.

The results of these evaluations showed that the new Attest™ 1295 Biological Indicator, when used with the Attest™ 490H Auto-reader, complies with the FDA's Guidance for Biological Indicators and is substantially equivalent to the predicate device, the STERRAD® CycleSure® 24 BI for the intended use with STERRAD® NX and 100NX cycles.

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| DEVICE<br>CHARACTERISTIC | 'INTENDED USE<br>PREDICATE'<br>STERRAD® CycleSure® BI<br>K123017 | NEW DEVICE<br>Attest™ 1295 BI |
|-------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use<br>• Method of sterilization | Vaporized hydrogen peroxide | Same as predicate |
| Indications for Use | The STERRAD® CycleSure® 24<br>BI is intended to be used as a<br>standard method for frequent<br>monitoring of the following<br>STERRAD® Sterilization<br>Systems:<br>• STERRAD 100S<br>• STERRAD 50<br>• STERRAD 200<br>• STERRAD NX<br>• STERRAD 100NX<br>• For STERRAD 100NX DUO<br>Cycle in the United States, the<br>STERRAD CYCLESURE 24<br>Biological Indicator should only<br>be used in a test pack<br>configuration. | Use the 3M Attest™ Rapid<br>Readout Biological Indicator<br>1295 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® NX and 100NX<br>systems. |
| Organism<br>• Spore, Species, Strain | Geobacillus stearothermophilus<br>traceable to ATCC™ 7953 | Same as predicate |
| Viable Spore Population | ≥ 106 | Same as predicate |
| Carrier Material | Glass Fiber | PET (Polyethylene terephthalate) |
| Resistance Characteristics: | Tested at 2.5 mg/L vaporized<br>hydrogen peroxide | Tested at 10 mg/L vaporized<br>hydrogen peroxide |
| • D-value<br>• Survival/Kill<br>Window | D2.5 mg/L ≥ 1 second<br>Survival Time ≥ 5 seconds<br>Kill Time = 60 seconds | D10 mg/L ≥ 1 second<br>Survival Time ≥ 5 seconds<br>Kill Time = 7 minutes |
| Incubation Temperature | 55-60°C | 60 +/- 2 °C |
| Reduced Incubation Time<br>(>97% correlation to the 7-<br>day visual pH color change<br>result) | Visual pH color change result in<br>24 hours | Fluorescent result in 4 hours |
| Chemical Process Indicator | Turns from red to golden yellow<br>or bronze | Chemical indicator on the BI cap<br>changes from blue to pink |
| Shelf-life | 6 months | 6 months, will be extended with<br>available real time aging data |

A summary of the testing and predicate comparison is provided below.

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### Substantial Equivalence of Attest™ Auto-reader 490H with Auto-reader 490:

Both the new Auto-reader 490H and the predicate Auto-reader 490 share the same Intended Use. These devices incubate and read Attest™ Rapid Readout biological indicators to determine a positive or negative result based on a fluorescence signal. The difference between the devices is in their Indications for Use. The Auto-reader 490H is intended for use with the Attest™ 1295 BI for hydrogen peroxide while the predicate Attest™ Auto-reader 490 is intended for use with the Attest™ Super Rapid Readout 1491 and 1492V Biological Indicators for steam. The difference in biological indicators being incubated leads to a difference of target incubation temperatures and time to result between the 490H and the 490.

The Attest™ Auto-reader 490H was tested for safety by Underwriters Laboratory to verify compliance to applicable electrical safety standards including IEC 61010-1 (2001) Second Edition and IEC 61010-2-010 (2003) Second Edition. In addition, the Attest™ Auto-reader 490H has been tested by a certified Testing Laboratory to verify electromagnetic compatibility per USA Title 47, Code of Federal Regulations (2009) for Radiated Emissions (FCC Part 15, Subpart B, Class A) and Conducted Emissions (FCC Part 15. Subpart B. Class A).

| Device Function or | PREDICATE | NEW DEVICE |
|-------------------------------------|--------------------------------------------------------------------|-------------------------------------|
| Characteristic | 3M Attest™ 490 Auto-Reader | 3M Attest™ 490H Auto- |
| | K121484 | Reader |
| Statement of Intended Use | The 3M Attest™ 490 Auto-reader | The 3M Attest™ 490H Auto- |
| | is designed to incubate and | reader is designed to incubate and |
| | automatically read the 3M Attest™ | automatically read the 3M |
| | Super Rapid Readout Biological | Attest™ 1295 Rapid Readout |
| | Indicators at 56°C for a final | Biological Indicator at 60°C for a |
| | fluorescent result at 30 minutes for | final fluorescent result at 4 hour. |
| | 1491 and 1 hour for 1492V. | |
| Incubation Temperature | 56°C + 2°C | 60°C ± 2°C |
| Basis of Rapid Readout | Fluorescence of biological | Same |
| | indicator medium | |
| Use with Biological | 3M Attest™ Super Rapid Readout | 3M Attest™ Rapid Readout |
| Indicators | Biological Indicators 1492V, 1491 | Biological Indicator 1295 |
| Color-coded configuration | Blue (1491 BI), Brown (1492V BI), or | Pink (1295 BI) |
| indicator (racetrack around | Blue and Brown (both 1491 and | |
| incubation wells) | 1492V) | |
| Method of Fluorescence<br>Detection | UV LED, optical filters, with | Same |
| | sensing by photo diode | |
| Indicator of Adequate | (-) on LCD Display | Same |
| Sterilization Cycle | | |
| Indicators of Possible | (+) on LCD Display | Same |
| Sterilization Cycle Failure | Audible Alarm | |
| Incubation Wells | 10 - reader/incubation wells | Same |
| Voltage Range | 100-240 Volts AC (12 Volt DC<br>conversion for internal circuitry) | Same |
| Product Safety | UL/IEC 61010-1 | Same |
| EMC Compliance | FCC Part 15, Subpart B, Class A | Same |

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## Conclusion

The 3M Attest™ 1295 Rapid Readout Biological Indicator and the 3M Attest™ Autoreader 490H meet all applicable performance standards and are substantially equivalent to their predicate devices in terms of their intended use, physical properties and technological characteristics. There are no new questions of safety or effectiveness.