3M ATTEST RAPID READOUT STEAM PROCESS CHALLENGE DEVICE, MODEL 1296V, 3M ATTEST RAPID READOUT STEAM-PLUS

K101910 · 3M Company · FRC · Dec 8, 2010 · General Hospital

Device Facts

• Record ID: K101910
• Device Name: 3M ATTEST RAPID READOUT STEAM PROCESS CHALLENGE DEVICE, MODEL 1296V, 3M ATTEST RAPID READOUT STEAM-PLUS
• Applicant: 3M Company
• Product Code: FRC · General Hospital
• Decision Date: Dec 8, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.2800
• Device Class: Class 2

Intended Use

Use the Attest 1296V Rapid Readout Steam and 41382V Rapid Readout Steam-Plus Process Challenge Devices to monitor 132°C (270°F) dynamic-air-removal (prevacuum) steam sterilization cycles with exposure time of 4 minutes.

Device Story

Process Challenge Devices (PCDs) used in healthcare facilities to monitor prevacuum steam sterilization cycles; consists of medical index cards, absorbent pad, and vented film pouch to regulate air removal/steam penetration. 1296V includes 1292 Rapid Readout biological indicator (BI) containing Geobacillus stearothermophilus spores; 41382V includes 1292 BI and SteriGage chemical integrator. External chemical process indicator changes color (yellow to dark brown/black) upon steam exposure. BI utilizes fluorescence readout via 3M Attest Auto-reader to detect sterilization failure; fluorescence change indicates failure. Provides healthcare providers with objective sterility assurance data; ensures sterilization cycle efficacy; protects patients from non-sterile instruments.

Clinical Evidence

Bench testing only. Resistance performance evaluated against AAMI towel pack and predicate 41380 Steam-Plus Test Pack in 4-minute, 132°C (270°F) cycles. Results confirmed PCD resistance greater than or equal to AAMI towel pack and predicate; all PCDs killed in specified cycle. Compliance with ANSI/AAMI/ISO 11138-1:2006/(R)2010, 11138-3:2006/(R)2010, and 11140-1:2005 demonstrated.

Technological Characteristics

PCD construction: medical index cards, absorbent pad, vented film pouch. BI: Geobacillus stearothermophilus spores. Chemical indicator: yellow-to-black color change. Fluorescence-based readout via 3M Attest Auto-reader. Complies with ANSI/AAMI/ISO 11138-1, 11138-3, and 11140-1 standards.

Indications for Use

Indicated for monitoring 132°C (270°F) dynamic-air-removal (prevacuum) steam sterilization cycles with 4-minute exposure times in healthcare facilities.

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

• 3MTM Attest™ Steam-Plus Test Pack (formerly ATI Disposable Biological-Plus Test Pack)
• 3MTM Attest™ Rapid Readout 1292 Biological Indicator
• 3M™ Attest™ 41380 Steam-Plus Test Pack (K925496)

Submission Summary (Full Text)

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### play 4 K101910

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510(k) Summary

DEC - 8 2010

Image /page/0/Picture/3 description: The image shows the 3M logo. The logo is in black and white. The letters '3M' are in a bold, sans-serif font.

Sponsor Information:

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

| Contact Person: | Suzanne Leung |
|-----------------|--------------------|
| | Regulatory Affairs |
| | Phone Number: |
| FAX Number: | [phone] |

Date of Summary: November 30, 2010

# Device Name and Classification:

| Common or Usual Name: | Sterilization Biological Indicator |
|------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|
| Proprietary Name: | 3MTM AttestTM 1296V Rapid Readout Steam Process<br>Challenge Device<br>3MTM AttestTM 41382V Rapid Readout Steam-Plus Process<br>Challenge Device |
| Classification Name: | Indicator, Biological Sterilization Process<br>(21 CFR § 880.2800(a)) |
| Performance Standards: | N/A |

## Predicate Devices:

- 3MTM Attest™ Steam-Plus Test Pack (formerly ATI Disposable Biological-Plus . Test Pack)
- 3MTM Attest™ Rapid Readout 1292 Biological Indicator ●

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### Description of Device:

The 3M™ Attest™ 1296V Rapid Readout Steam and 41382V Rapid Readout Steam-Plus Process Challenge Devices (PCDs) are specifically designed to be used in healthcare facilities to routinely challenge 270°F (132°C) dynamic-air-removal (prevacuum) steam sterilization cycles with exposure time of 4 minutes. The changes from the predicate device include an optimization of the PCD for prevacuum steam cycles and a replacement of the biological indicator (BI) from one based on a visual color change growth readout to one based on a fluorescence readout.

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The PCD consists of multiple layers of medical index cards, some of which are die-cut to contain monitoring products. The pack is overwrapped and secured with a label. A sheet of moisture absorbent material (absorbent pad) is placed over the wrapped PCD pack, and then the PCD pack is placed in a vented film pouch as the fully-assembled PCD sold to the customer. This construction regulates air removal and steam penetration and presents a challenge to better monitor multiple pulse vacuum-assisted steam cycles.

Each Attest 1296V Rapid Readout Steam PCD is supplied with a 1292 Rapid Readout biological indicator, which contain bacterial endospores of Geobacillus stearothermophilus. The Attest 41382V Rapid Readout Steam-Plus PCD is supplied with a 1292 Rapid Readout biological indicator and one SteriGage chemical integrator.

Each PCD has a chemical process indicator on the outside of the PCD that changes from vellow to dark brown/black when exposed to steam. In addition, there is a chemical process indicator on the Attest BI that changes color from rose to brown when exposed to steam. The Attest Rapid Readout biological indicator is specifically designed for a rapid fluorescent readout when used in conjunction with the 3MTM Attest™ Auto-reader. A fluorescence change indicates a steam sterilization process failure. Attest Rapid Readout biological indicator controls are provided with the PCD.

### Indications for Use:

Use the Attest 1296V Rapid Readout Steam and 41382V Rapid Readout Steam-Plus Process Challenge Devices to monitor 132°C (270°F) dynamic-air-removal (prevacuum) steam sterilization cycles with exposure time of 4 minutes.

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# Comparative Data for Determining Substantial Equivalence of New Device to Predicate Device:

Multiple lots of 3M™ Attest™ Rapid Readout Steam and Rapid Readout Steam-Plus Process Challenge Devices were evaluated following applicable FDA guidance and standards.

- FDA's Guidance for Industry and FDA Staff, Biological Indicator (BI) Premarket Notification [510(k)] Submissions; October 4, 2007
- ANSI/AAMI ST79: 2006, A1:2008, A2:2009 Comprehensive guide to steam . sterilization and sterility assurance in health care facilities

A Summary of the nonclinical testing is shown.

| Test | Acceptance Criteria | Result |
|--------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|
| Resistance Performance:<br>• 1296V Rapid Readout Steam<br>PCD vs. AAMI Towel Pack in<br>a 4 minute, 132°C (270°F)<br>cycle | • 1296V PCD has resistance greater than or equal<br>to the AAMI Towel Pack<br>• All PCDs are killed in a 4 minute, 132°C<br>(270°F) cycle | Pass |
| Resistance Performance:<br>• 41382V Rapid Readout Steam-<br>Plus PCD vs. AAMI Towel<br>Pack in a 4 minute, 132°C<br>(270°F) cycle | • 41382V PCD has resistance greater than or<br>equal to the AAMI Towel Pack<br>• All PCDs are killed in a 4 minute, 132°C<br>(270°F) cycle | Pass |
| Resistance Performance:<br>• 1296V Rapid Readout Steam<br>PCD vs. predicate 41380<br>Steam-Plus Test Pack in a 4<br>minute, 132°C (270°F) cycle | • 1296V PCD has resistance greater than or equal<br>to the predicate 41380 Steam-Plus Test Pack<br>• All PCDs are killed in a 4 minutes, 132°C<br>(270°F) cycle | Pass |
| Resistance Performance:<br>• 41382V Rapid Readout Steam-<br>Plus PCD vs. predicate 41380<br>Steam-Plus Test Pack in a 4<br>minute, 132°C (270°F) cycle | • 41382V PCD has resistance greater than or<br>equal to the predicate 41380 Steam-Plus Test<br>Pack<br>• All PCDs are killed in a 4 minutes, 132°C<br>(270°F) cycle | Pass |

The results of these evaluations showed that the new 3M™ Attest™ 1296V Rapid Readout Steam and 41382V Rapid Readout Steam-Plus Process Challenge Devices are substantially equivalent to the predicate device, the 3M™ Attest™ 41380 Steam-Plus Test Pack (formerly ATI Disposable Biological-Plus Test Pack) cleared under K925496, in terms of its intended use, physical properties and technological characteristics. There are no new questions of safety or effectiveness.

The disposable 3M™ Attest™ Rapid Readout Steam and Rapid Readout Steam-Plus Process Challenge Devices present a challenge to the sterilization process equivalent to the biological indicator AAMI towel pack recommended by ANSI/AAMI ST79: 2006,

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K101910

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K101910

A1:2008, A2:2009. The biological indicator contained within complies with ANSI/AAMI/ISO 11138-1:2006/(R)2010 and ANSVAAMI/ISO 11138-3:2006/(R)2010. The chemical integrator complies with the performance requirements of the FDA for chemical integrators as well as the international voluntary standard ANSI/AAMI/ISO 11140-1:2005.

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Image /page/4/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an emblem that resembles an eagle with its wings spread, with three lines representing the feathers. The emblem is black, and the text is also black.

#### Public Health Service

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

Dr. Suzanne Leung Regulatory Affairs 3M Company 3M Center, Building 275-5W-06 St. Paul, Minnesota 55133-3275

DEC - 8 2010

### Re: K101910

Trade/Device Name: 3M Attest 1296V Rapid Readout Steam Process Challenge Device 3M Attest 41382V Rapid Readout Steam-Plus Process Challenge Device Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: II Product Code: JOJ, FRC Dated: December 1, 2010 Received: December 2, 2010

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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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 go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

funs
f

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

### Enclosure.

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### Indications for Use

DEC - 8 2010

510(k) Number (if known):

K101910

Device Name:

3MTM Attest™ 1296V Rapid Readout Steam Process Challenge Device 3MTM Attest™ 41382V Rapid Readout Steam-Plus Process Challenge Device

### Indications For Use:

Use the Attest 1296V Rapid Readout Steam and 41382V Rapid Readout Steam-Plus Process Challenge Devices to monitor 132°C (270°F) dynamic-air-removal (prevacuum) steam sterilization cycles with exposure time of 4 minutes.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

S.M. Murphy, D.D.S. E. Charisse Williams

(Division Sign-Off) vision of Anesthesiology, General Hospital ection Control, Dental Devices

- 10(k) Number: K/0/9/0