3M ATTEST 293 AUTO-READER, 3M ATTEST 293G AUTO-READER

K052128 · 3M Company · FRC · Aug 16, 2005 · General Hospital

Device Facts

• Record ID: K052128
• Device Name: 3M ATTEST 293 AUTO-READER, 3M ATTEST 293G AUTO-READER
• Applicant: 3M Company
• Product Code: FRC · General Hospital
• Decision Date: Aug 16, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.2800
• Device Class: Class 2

Intended Use

The 3M™ Attest™ 293 Auto-reader is designed to incubate and automatically read the 3M™ Attest™ 1291 and/or 3M™ Attest™ 1292 Rapid Readout Biological Indicators for Steam, at 60°C for a final negative fluorescence reading at 1 hour for Attest 1291 or 3 hours for Attest 1292. The 3M™ Attest™ 293 Auto-reader is also designed to allow for further incubation of the Attest 1291 and/or Attest 1292 Rapid Readout Biological Indicators for Steam, for a final negative, visual pH color change of the growth media at 24 hours for Attest 1291 and 48 hours for Attest 1292. The 3M™ Attest™ 293G Auto-reader is designed to incubate and automatically read the 3M™ Attest™ 1294 Rapid Readout Biological Indicators (RRBI) for EO, at 37°C for a final negative fluorescence reading at 4 hours.

Device Story

The 3M Attest 293/293G Auto-readers are incubation and reading systems for biological indicators (BI) used to monitor sterilization cycle efficacy. The 293 model houses three 290 units for steam sterilization monitoring (1291/1292 BIs); the 293G model houses three 290G units for ethylene oxide (EO) monitoring (1294 BIs). The device accepts BIs as input, incubating them at 60°C (steam) or 37°C (EO). The system automatically detects fluorescence as a rapid indicator of sterilization failure; it also supports visual pH color change observation for final confirmation. Used in clinical settings, the device provides automated output to healthcare personnel, enabling rapid assessment of sterilization cycle success or failure, thereby ensuring patient safety by preventing the use of improperly sterilized instruments.

Clinical Evidence

No clinical data provided; substantial equivalence is based on bench testing and design similarity to previously cleared predicate devices.

Technological Characteristics

The device consists of three integrated 290 or 290G units in a single housing. It functions as an incubator and automated fluorescence reader. It operates at 60°C for steam indicators and 37°C for EO indicators. The system utilizes automated fluorescence detection and visual pH color change observation.

Indications for Use

Indicated for use in healthcare facilities to incubate and automatically read Rapid Readout Biological Indicators (RRBI) to assess the efficacy of steam (Attest 1291/1292) or ethylene oxide (Attest 1294) sterilization cycles.

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 290 Auto-reader (K004009)
• 3M Attest 290G Auto-reader (K031012)

Reference Devices

• Attest 1291 (K900771)
• Attest 1292 (K926364)

Submission Summary (Full Text)

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# AUG 1 6 2005

# Premarket Notification (510(k)) Summary

#### General Information

K052128

#### 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]

August 4, 2005 Prepared

## Device Name

Common or Usual Name: Auto-reader

| Proprietary Name: | 3MTM AttestTM 293 Auto-reader<br>3MTM AttestTM 293G Auto-reader |
|----------------------|---------------------------------------------------------------------------|
| Classification Name: | Biological Sterilization Process Indicators accessories (21CFR§880.2800). |

#### Establishment Registration Number

The establishment registration number for 3M Company is 2110898.

The 3M™ Attest™ 293/293G Auto-readers are manufactured and packaged at the following facility:

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

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

3M Confidential

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## Device Classification

Class: Classification Panel: Product Code:

Class II General Hospital (80) FRC (accessory)

## Indications for Use

The 3MTM Attest ™ 293 Auto-reader is designed to incubate and automatically The SM Attest read the SM - Allest - - TEO Parfinal negative fluorescence reading at 1 hour for 1291 or 3 hours for 1292.

The 3M™ Attest ™ 293 Auto-reader is also designed to allow for further The SM - Attest 1291 and/or the Attest 1292 Rapid Readout Biological Indicators for a final negative, visual pH color change of the growth media at 24 hours for 1291 and 48 hours for 1292.

The 3M™ Attest ™ 293G Auto-reader is designed to incubate and automatically The SM - Attest - 2300 Auto Todor 16 Cougical Indicators (RRBI) for EO at 37℃ for a final negative fluorescence reading at 4 hours.

#### Device Description

Device Desorripati The own Attoot 2007 late reas (BI), which are incubated at 60 °C. The initial Bls in this series to receive market clearance were the 1291 (K900771) and 1292 (K926364).

The purpose of these Bls is to assess whether a potential failure of a steam sterilization cycle has occurred. Please note that both of these initial premarket sterfilizations (K900771) and (K926364) listed the 3M Attest 190 Auto-reader as houncations (13007 17 and (102000 1) 1102000 1) 1100 Auto-reader was cleared (K004009) for use with these Bls and serves as the predicate device for the new Model 293 Auto-reader.

The Attest 293 is comprised of three (3) Attest 290 units within a single case.

The 3M Attest 293G Auto-reader is an accessory to the 3M Attest 1294 Rapid Readout EO Biological Indicator (RRBI) which is to be incubated at 37 °C.

The purpose of these Bls is to assess whether a potential failure of an ethylene oxide sterilization cycle has occurred. The model 290G was cleared (K031012) with the Attest 1294 Bl and serves as the predicate for the 293G.

The Attest 293G is comprised of three (3) Attest 290G units within a single case.

3M Confidential

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# Substantial Equivalence

The Attest 293 and 293G Auto-readers are substantially equivalent to the predicate Attest 290 and 290G Auto-readers in that they use the same product 7 litted. Loo and Leane software, have the same indications for use land the same intended use. They are in fact a "three units within one case" configuration of the predicate.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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AUG 1 6 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Cynthia Lamanrucciola Senior Regulatory Affairs Associate 3M Company 3M Center, Bldg. 275-5W-06 St. Paul Minnesota 55144-1000

Re: K052128

Trade/Device Name: 3M™ ATTEST™ 293 Auto-Reader Regulation Number: 21 CFR 880.2800 Regulation Name: Biological sterilization process indicator Regulatory Class: II Product Code: FRC Dated: August 4, 2005 Received: August 30, 2005

Dear Ms. Lamanrucciola:

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 for associated in 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 –Ms. Lamanrucciola

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 that I Drines Internates and regulations administered by other Federal agencies. You must or any I vith 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 Of It Fur 607), adoling 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. product raction of one begin marketing your device as described in your Section 510(k) I mis lotter notification. The FDA finding of substantial equivalence of your device to a legally premaince nevice 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/industry/support/index.html.

Sincerely yours,

Clus

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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# 510(k) Notification for the 3M™Attest™ 293/293G Autoreader

# Indications for Use Statement

510(k) Number (if known): K052128

3M™ Attest™ 293 Auto-reader Device Name:

Indications for Use:

The 3M™ Attest™ 293 Auto-reader is designed to incubate and automatically The SM - Attest™ 1291 and/or 3M™ Attest™1292 Rapid Readout read the Uni- All.com, at 60°C for a final negative fluorescence reading at 1 hour for Attest 1291 or 3 hours for Attest 1292.

The 3M™ Attest™ 293 Auto-reader is also designed to allow for further incubation of the Attest 1291 and/or Attest 1292 Rapid Readout Biological Indicators for Steam, for a final negative, visual pH color change of the growth media at 24 hours for Attest 1291 and 48 hours for Attest 1292.

3M™ Attest™ 293G Auto-reader Device Name:

Indications for Use:

The 3M™ Attest™ 293G Auto-reader is designed to incubate and automatically The UNI - MTM Attest™ 1294 Rapid Readout Brological Indicators (RRBI) for EO, at 37°C for a final negative fluorescence reading at 4 hours.

Over the Counter X OR Prescription Use

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

Shal Condliffe, at CDRH, Office of Device Evaluation (ODE)

Division of nergi Hoself Infection Control. Dantal

510(k) Number: K0521

3M Confidential