(58 days)
Not Found
No
The device description focuses on a biological and enzymatic detection method, not AI/ML. There are no mentions of AI, ML, or related concepts in the provided text.
No
This device is designed to monitor sterilization cycles for medical instruments, not to diagnose, treat, or prevent disease in a patient.
No
The device is used to monitor the effectiveness of steam sterilization cycles by detecting the presence of specific microorganisms, indicating a sterilization process failure, rather than diagnosing a disease or medical condition in a patient.
No
The device description clearly outlines a physical biological indicator (RRBI) and an associated hardware auto-reader (Attest 190/290) that detects fluorescence and color changes. This involves hardware components and biological materials, not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to monitor steam sterilization cycles. This is a quality control process for sterilization equipment, not a diagnostic test performed on a biological sample from a patient to diagnose a disease or condition.
- Device Description: The device detects the presence of a specific microorganism (Geobacillus stearothermophilus) to assess the effectiveness of a sterilization process. It does not analyze human biological samples (like blood, urine, tissue, etc.) for diagnostic purposes.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing human biological samples.
- Providing information for the diagnosis, treatment, or prevention of disease.
- Being used in a clinical laboratory setting for patient testing.
The device is a biological indicator used to validate the efficacy of a sterilization process, which is a critical step in preventing the spread of infection, but it is not a diagnostic tool for patients.
N/A
Intended Use / Indications for Use
Use the Attest 1292 RRBI to monitor:
-
- 250°F (121°C) gravity steam sterilization cycles.
-
- 270°F (132°C) vacuum assisted steam sterilization cycles.
Product codes
FRC
Device Description
The 3M™ Attest™ 1292 Rapid Readout Biological Indicator, RRBI, is a dual readout biological indicator system specifically designed for rapid and reliable monitoring of steam sterilization process when used in conjunction with the 3M™ Attest™ 190/290 Auto-readers.
The Attest 1292 RRBI detects the presence of Geobacillus stearothermophilus, (formerly known as Bacillus stearothermophilus), by detecting the activity of alpha-glucosidase, an enzyme present within the organism. The presence of the enzyme is detected by reading fluorescence produced by the enzymatic breakdown of a non-fluorescent substrate. This creates a fluorescence change, which is detected by the Attest 290 Autoreader. A fluorescence change indicates a steam sterilization process failure, The Attest 1292 RRBI also detects the presence of G. stearothermophilus organisms by a visual color change reaction. Biochemical activity of the G. stearothermophilus organism produces acid by-products that cause the media to change color from purple to yellow. A visual pH color change also indicates a steam sterilization process failure. The 3M™ Attest™ Rapid Read-Out Biological Indicator is identical in design and performance specifications (with exception of the calculation of survival/kill) to the predicate device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 880.2800 Sterilization process indicator.
(a)
Biological sterilization process indicator —(1)Identification. A biological sterilization process indicator is 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.(2)
Classification. Class II (performance standards).(b)
Physical/chemical sterilization process indicator —(1)Identification. A physical/chemical sterilization process indicator is 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.(2)
Classification. Class II (performance standards).
0
4.0 510(k) Summary
K090569
p 1 of 2
3M™ Attest™ Rapid Read-Out Biological Indicator (#1292)
1. Sponsor:
3M Infection Prevention Division 3M Center, Bldg 275-5W-06 St. Paul, MN 55144
APR 9 9 2009
Contact Person: Bryan Becker Regulatory Affairs Specialist Infection Prevention Division 3M Center, Bldg 275-5W-06 St. Paul, MN 55144 Phone: 651-733-3373 651-737-5320 Fax: email: bbecker@mmm.com
2. Device Name
a. Proprietary Name: 3M™ Attest™ Rapid Read-Out Biological Indicator (#1292)
b. Device Common/Usual Name: Biological indicator
c. Device Classification Name: Biological Sterilization Process Indicators
3. Identification of Predicate Device:
3M™ Attest™ Rapid Read-Out Biological Indicator (#1292), K926364
4. Device Description:
The 3M™ Attest™ 1292 Rapid Readout Biological Indicator, RRBI, is a dual readout biological indicator system specifically designed for rapid and reliable monitoring of steam sterilization process when used in conjunction with the 3M™ Attest™ 190/290 Auto-readers.
The Attest 1292 RRBI detects the presence of Geobacillus stearothermophilus, (formerly known as Bacillus stearothermophilus), by detecting the activity of alpha-glucosidase, an enzyme present within the organism. The presence of the enzyme is detected by reading fluorescence produced by the enzymatic breakdown of a non-fluorescent substrate. This creates a fluorescence change, which is detected by the Attest 290 Autoreader. A fluorescence change indicates a steam sterilization process failure, The Attest 1292 RRBI also detects the presence of G. stearothermophilus organisms by a visual color change reaction. Biochemical activity of the G. stearothermophilus organism produces acid by-products that cause the media
1
p. 2 of 2
to change color from purple to yellow. A visual pH color change also indicates a steam sterilization process failure. The 3M™ Attest™ Rapid Read-Out Biological Indicator is identical in design and performance specifications (with exception of the calculation of survival/kill) to the predicate device.
5. Indication For Use:
Use the Attest 1292 RRBI to monitor:
-
- 250°F (121°C) gravity steam sterilization cycles.
-
- 270°F (132°C) vacuum assisted steam sterilization cycles.
6. Description of Modification
The purpose of this filing is to move from a survival tested at 5 minutes and a kill tested at 15 minutes to a calculated survival/kill testing on a lot-by-lot basis.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Bryan Becker Regulatory Affairs Specialist 3M Company 3M Center, Building 275-5W-06 Saint Paul, Minnesota 55133-3275
APR 2 9 2009
Re: K090569
Trade/Device Name: 3MTM Attest™ Rapid Read -Out Biological Indicator (#1292) Regulation Number: 880.2800 Regulatory Class: Il Product Code: FRC Dated: April 22, 2009 Received: April 23, 2009
Dear Mr. Becker:
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 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.
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Page 2 Mr. Becker
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0100. 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 contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
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 (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Anithony V. Walton for
Susan Runner, D.D.S., M.A. Acting 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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1.0 Indications for Use
510(k) Number (if known): K090569
Device Name: 3M™ Attest™ Rapid Read-Out Biological Indicator (#1292)
Indications For Use:
Use the Attest 1292 RRBI to monitor: 1. 250°F (121°C) gravity steam sterilization cycles. 2. 270°F (132°C) vacuum assisted steam sterilization cycles.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use X (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IFNEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Shule B. Murphy, ans
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K990529