ATTEST RAPID READOUT BIOLOGICAL INDICATOR FOR EO, MODEL 1294; ATTEST RAPID READOUT BIOLOGICAL INDICATOR FOR EO TEST PACK

K031012 · 3M Company · FRC · Oct 16, 2003 · General Hospital

Device Facts

• Record ID: K031012
• Device Name: ATTEST RAPID READOUT BIOLOGICAL INDICATOR FOR EO, MODEL 1294; ATTEST RAPID READOUT BIOLOGICAL INDICATOR FOR EO TEST PACK
• Applicant: 3M Company
• Product Code: FRC · General Hospital
• Decision Date: Oct 16, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.2800
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

The 3M™ Attest™ 1294 Rapid Readout Biological Indicator for EO is used to monitor ethylene oxide sterilization cycles when used in conjunction with the 3M™ Attest™ 290G Auto-reader. The 3M™ Attest™ 1298 Rapid Readout Biological Indicator for EO Test Pack is a routine challenge pack used to monitor ethylene oxide sterilization cycles when used in conjunction with the 3M™ Attest™ 290G Auto-reader. The 3M™ Attest TM 290G Auto-reader is designed to incubate and automatically read the 3M™ Attest ™ 1294 Rapid Readout Biological Indicators (RRBI) for EO at 37℃ for a final negative fluorescence reading at 4 hours.

Device Story

Device consists of self-contained biological indicator (1294) containing Bacillus atrophaeus spores and 3M Attest 290G Auto-reader. Indicator monitors EO sterilization efficacy; detects enzyme beta-glucosidase produced by spores during germination. Auto-reader incubates indicator at 37°C; detects fluorescent byproduct from enzymatic substrate breakdown. Output is negative fluorescence reading at 4 hours, indicating successful sterilization. Failure to sterilize results in enzyme activity and fluorescence. 1298 Test Pack provides standardized challenge to EO process. Used in clinical settings to verify sterilization cycle performance; provides rapid results compared to traditional 7-day visual pH color change (green to yellow).

Clinical Evidence

Bench testing only. Evaluated resistance characteristics, spore population, species confirmation, media recovery, and 4-hour fluorescent readout reliability across multiple lots. 1298 Test Packs compared against ANSI/AAMI ST41 routine test pack standards.

Technological Characteristics

Self-contained biological indicator containing Bacillus atrophaeus spores (ATCC 9372). Employs enzymatic fluorescence detection (beta-glucosidase). 290G Auto-reader provides 37°C incubation. Complies with ANSI/AAMI ST21, ST41, ST44, ST59, and USP 25 standards.

Indications for Use

Indicated for monitoring ethylene oxide (EO) sterilization cycles in healthcare facilities using the 3M Attest 290G Auto-reader. Applicable for routine process monitoring via the 1294 indicator or 1298 test pack.

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

• Steris® Verify™
• 3M™ Attest™ 1292 Rapid Readout Biological Indicator for Steam

Submission Summary (Full Text)

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K031012

OCT 1 6 2003

- 510(k) Notification for the 3M™Attest™ 1294 Rapid Readout Biological Indicator for EO
# 15.0 Premarket Notification Summary

Image /page/0/Picture/6 description: The image shows a blurry black and white image of what appears to be a signature or some handwritten text. The characters are not easily discernible due to the image quality. The text is oriented vertically in the image.

# General Information

#### Sponsor

3M Company 3M Medical Division 3M Center Building 275-5W-06 St. Paul, MN 55144-1000

#### Contact

Cynthia Lamarucciola Phone: [phone] Fax: [phone] Email: [e-mail]

Prepared February 20, 2003

#### Device Name

Common or Usual Name: Biological Indicator

| Proprietary Name: | 3M™ Attest™ 1294 Rapid Readout Biological<br>Indicator for EO and 3M™ Attest™ 1298 Rapid<br>Readout Biological Indicator for EO Test Pack |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------|
| Classification Name: | Biological Sterilization Process Indicators<br>(21CFR§880.2800). |

#### Establishment Registration Number

The establishment registration number for 3M Company is 2110898.

The 3M™Attest™ 1294 Rapid Readout Biological Indicator for EO is manufactured and packaged at the following facility:

> 3M Brookings 601 22nd Avenue Brookings, SD 57006

Phone: [phone]

3M Confidential

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FAX: [phone] Establishment Number 1717046

The 3M™Attest™ 1298 Rapid Readout Biological Indicator for EO Test Pack is assembled and packaged at the following facility:

> 3M Flemington 500 Route 202 North Flemington, NJ 08822

Phone: [phone] FAX: [phone] Establishment Number 2222706

The 3M™ Attest™ 290G Auto-reader is manufactured and packaged at the following facility:

> 3M Company 1617 North Front Street New Ulm, MN 56073

Phone: [phone] Fax: [phone] Establishment Number 2183581

The through-put chemical indicator utilized on the label of the 3M™ 1294 Rapid Readout Biological Indicator for EO and the 3M™Attest™ 1298 Rapid Readout Biological Indicator for EO Test Pack is manufactured and released by:

> Propper Manufacturing Company, Inc. 36-04 Skillman Avenue Long Island, NY 11101 Establishment Number 2410251

### Device Classification

Class:

Class II

General Hospital (80) Classification Panel:

FRC Product Code:

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# Performance Standards

The FDA has developed no performance standards under Section 514 for biological indicators, reader/incubators or test packs. However, the following consensus standards and FDA draft guidance document were utilized to develop the test protocols outlined for the 3M™ Attest™ 1294 EO Rapid Readout Biological Indicator and the associated 3M™ Attest™ 1298 Test Pack, when used in conjunction with the 3M™ Attest™ Model 290G Auto-reader:

- ANSI/AAMI ST21:1986 Sterilization of Health Care Products-Biological . Indicators-Part 2: Biological Indicators for Ethylene Oxide Sterilization (reaffirmed 1994)
- ANSI/AAMI ST21:1999 Sterilization of Health Care Products-Biological . Indicators-Part 2: Biological Indicators for Ethylene Oxide Sterilization
- ANSI/AAMI ST41:1999 Good Hospital Practice: Ethylene Oxide . Sterilization and Sterility Assurance
- . ANSI/AAMI ST44:1992 BIER/EO Gas Vessels
- ANSI/AAMI ST59:1999 Sterilization of Health Care Products-Biological . Indicators-Part 1: General
- United States Pharmacopoeia (USP) 25, General Notices; Storage . Temperature and Monograph 1151, Stability, 2002
- . Premarket Notifications [510(k)] for Biological Indicators Intended to Monitor Sterilizers Used in Health Care Facilities; Draft Guidance for Industry and FDA Reviewers (Draft dated May 21, 2001)
- The Center for Devices and Radiological Health, FDA Guidance for . Validation of Biological Indicator Incubation Time

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# Indication for Use

The 3M™ Attest™ 1294 Rapid Readout Biological Indicator for EO is used to monitor ethylene oxide sterilization cycles when used in conjunction with the 3M™ Attest™ 290G Auto-reader.

The 3M™ Attest™ 1298 Rapid Readout Biological Indicator for EO Test Pack is used to monitor ethylene oxide sterilization cycles when used in conjunction with the 3M™ Attest™ 290G Auto-reader.

The 3M™ Attest ™ 290G Auto-reader is designed to incubate and automatically read the 3M™ Attest ™ 1294 Rapid Readout Biological Indicators (RRBI) for EO at 37℃ for a final neqative fluorescence reading at 4 hours.

# Device Description

The 3M™ Attest™ 1294 Rapid Readout Biological Indicator (RRBI) for EO (green cap) is a self contained device consisting of a standardized, viable population of Bacillus atrophaeus, (formerly Bacillus subtilis), spores specifically designed for the rapid, reliable monitoring of ethylene oxide (EO) sterilization processes when used in conjunction with the 3M™ Attest™ 290G Auto-reader.

The Attest 1294 RRBI for EO detects sterilization process failure through the activity of a naturally occurring enzyme, beta-glucosidase, produced by the organism during the germination and outgrowth process. The auto-reader detects the activity of this enzyme by reading a fluorescent product produced by the enzymatic breakdown of a substrate in the media. Presence of this enzyme indicates a sterilization process failure. The final negative biological indicator result, indicating an acceptable sterilization process, is made after 4 hours of incubation.

The Attest 1294 RRBI for EO may also be incubated for 7 days to obtain a visual pH color change. (The 7-dav incubation is not intended for routine use and may be used to validate of the fluorescent results.) The biochemical activity of viable Bacillus atrophaeus produces acid by-products that cause the media to change from green to yellow. This visual pH color change also indicates a sterilization process failure however, due to the high sensitivity of the 4-hour fluorescent results, there is no advantage to incubate the Attest 1294 RRBI beyond 4 hours.

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The 3M™ Attest™ 1298 Rapid Readout Biological Indicator (RRBI) for EO Test Pack is specifically designed to routinely challenge the ethylene oxide (EO) sterilization process when used in conjunction with the 3M™ Attest™ Model 290G Auto-reader.

This Test Pack is designed to present a challenge to the EO sterilization process comparable to the routine EO biological indicator pack recommended by ANSI/AAMI ST41 (1999).

## Substantial Equivalence

The 3M™ Attest™ 1294 Rapid Readout Biological Indicator for EO uses the identical Bacillus atrophaeus (formerly Bacillus subtilis var. niger) spore species (ATCC 9372) as the Steris® Verify™, and produces the identical fluorescent byproduct as the 3M™ Attest™ 1292 Rapid Readout Biological Indicator (for steam).

The 3M™ Attest™ 1298 Rapid Readout Biological Indicator for EO Test Pack functions in the same manner as the ANSI/AAMI routine test pack for EO.

## Description of Testing

Multiple lots of the Attest 1294 RRBI for EO were tested, and demonstrated performance, for: Resistance Characteristics, Spore Population and species confirmation, Media Recovery and 4-hour Fluorescent Readout Reliability.

Multiple lots of the Attest 1298 RRBI for EO Test Packs were tested for performance comparison to a routine test pack recommended by ANSI/AAMI ST 41.

Testing demonstrated that the Attest 1294 RRBI for EO is substantially equivalent to the named predicates, the Steris® Verify™ and the 3M™ Attest™ 1292 Rapid Readout Biological Indicator for Steam.

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Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular emblem with the words "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, with flowing lines suggesting movement or connection. The logo is black and white.

OCT 1 6 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

3M Company C/O Mr. Robert Mosenkis President Citech 5200 Butler Pike Plymouth Meeting, Pennsylvania 19462-1298

Re: K031012

Trade/Device Name: 3M™ Attest™ 1294 Rapid Readout Biological Indicator for EO. Model 1294 Regulation Number: 880.2800 (a) Regulation Name: Sterilization Process Indicator Regulatory Class: II Product Code: FRC Dated: October 10, 2003 Received: October 14, 2003

Dear Mr. Mosenkis:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 - Mr. Mosenkis

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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801). please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrh/dsma/dsmamain.html

Sincerely yours,

Susan Rinner fas

Chiu Lin, Ph.D. 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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610/10 Notification for the 3M ** Attest™ 1294 Rapid Readout Biological Indicator for EO

### 11.0 Indications for Use

1021012 510(k) Number (if known):

Device Name: 3M™Attest™ 1294 Rapid Readout Biological Indicator for EO

Indications for Use:

The 3M™ Attest™ 1294 Rapid Readout Biological Indicator for EO is used to monitor ethylene oxide sterilization cycles when used in conjunction with the 3MTM Attest™ 290G Auto-reader.

The 3M™ Attest™ 1298 Rapid Readout Biological Indicator for EO Test Pack is a routine challenge pack used to monitor ethylene oxide sterilization cycles when used in conjunction with the 3M™ Attest™ 290G Auto-reader.

The 3M™ Attest TM 290G Auto-reader is designed to incubate and automatically read the 3M™ Attest ™ 1294 Rapid Readout Biological Indicators (RRBI) for EO at 37℃ for a final negative fluorescence reading at 4 hours.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

ાર

Over-The-Counter-Use

3M CONFIDENTIAL

Patrician A.V. Anderson Branchi Arif
10/16/83

Page 11- 1

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

510(k) Number. K031012