(154 days)
No
The device description focuses on the biological and chemical processes for detecting sterilization failure and the auto-reader's function is described as incubation and detection of fluorescence, not involving AI/ML for analysis or interpretation.
No
The device is a biological indicator used to monitor the effectiveness of sterilization cycles, not to treat or diagnose a disease or condition in a patient.
Yes
Explanation: The device, specifically the 3M™ Attest™ Super Rapid Readout Biological Indicator 1492V in conjunction with the 3M™ Attest™ Auto-reader 490, is used to determine the efficacy of sterilization cycles. It essentially "diagnoses" whether the sterilization process has successfully killed microorganisms by detecting the presence or absence of enzymes produced by spores. The detection of fluorescence indicates a steam sterilization failure, which is a diagnostic outcome.
No
The device description clearly outlines physical components (biological indicator with spore carrier, media ampoule, cap, chemical process indicator) and a hardware auto-reader (3M Attest™ 490 Auto-reader) that are integral to the device's function. While software likely exists within the auto-reader, the device as a whole is not software-only.
Based on the provided text, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is to "qualify or monitor dynamic-air-removal (prevacuum) 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 is a biological indicator containing spores and media. It's used to assess the effectiveness of a sterilization process by checking if the spores are killed. This is a test of the sterilization equipment's performance, not a test of a patient's health.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing a biological sample (blood, urine, tissue, etc.) from a patient.
- Providing information for the diagnosis, treatment, or prevention of a disease or condition in a patient.
- Measuring analytes in a biological sample.
The device is clearly designed to evaluate the efficacy of a sterilization process, which falls under the category of a sterilization process indicator or quality control device, not an IVD.
N/A
Intended Use / Indications for Use
Use the 3M™ Attest™ Super Rapid Readout Biological Indicator 1492V in conjunction with the 3M™ Attest™ Auto-reader 490 to qualify or monitor dynamic-air-removal (prevacuum) steam sterilization cycles of 4 minutes at 270°F (132°C) and 3 minutes at 275°F (135°C).
The 3M™ Attest™ Super Rapid Readout Biological Indicator 1492V provides a final fluorescent result in 1 hour. An optional visual pH color change result is observed in 48 hours.
Product codes
FRC
Device Description
The 3M AttestTM 1492V Super Rapid Readout Biological Indicator (SRBI) is a selfcontained biological indicator designed to be used with the 3M AttestTM 490 Auto-reader to qualify or routinely challenge dynamic-air-removal (prevacuum) steam sterilization cycles at 270°F (132°C) and at 275°F (135°C).
The AttestTM 1492V SRBI is composed of a polycarbonate sleeve containing a spore carrier and media ampoule, enclosed with a color-coded cap. On each 1492V SRBI cap is a chemical process indicator that changes color from pink to light brown when exposed to steam.
The 1,492V SRBI is a further improvement over the current 3M AttestTM Rapid Readout technology. Both the AttestTM Rapid Readout BIs and the AttestTM Super Rapid Readout BIs utilize the a-glucosidase enzyme system, which is generated naturally within growing G. 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 AttestTM 490 Autoreader. The detection of fluorescence upon incubation of the 1492V SRBI in the 490 Autoreader indicates a steam sterilization failure.
The 1492V SRBI is similar in design to the 3M AttestTM 1491 Super Rapid Readout Biological Indicator for Steam cleared as K 103277 for gravity displacement steam sterilization cvcles. Minor modifications were made to 1491 that resulted in the 1492V SRBI for dynamic-air-removal (prevacuum) steam sterilization cycles.
The AttestTM 490 Auto-reader has been cleared for use with the AttestTM 1491 Super Rapid Readout Biological Indicator for Steam under K103277. The current submission extends the use of the 490 Auto-reader to the 1492V SRBI.
The AttestTM 490 Auto-reader is designed to incubate at 56°C and automatically read the AttestTM 1492V SRBI for a fluorescent result within 1 hour. The 490 Auto-reader is also designed to allow further incubation of the 1492V SRBI for an optional visual pH color change of the growth media at 48 hours. Both the fluorescent readout at 1 hour and the optional visual readout at 48 hours met the FDA's requirement of > 97% alignment with the result after the conventional incubation time of 7 days.
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)
Testing was conducted on the biological indicator following the FDA guidance and standards below:
- FDA's Guidance for Industry and FDA Staff, Biological Indicator (BI) Premarket Notification [510(k)] Submissions; October 4, 2007
- ANSI/AAMI/ISO 11138-1:2006/(R)2010 Sterilization of health care products Biological indicators – Part 1: General Requirements
- ANSI/AAMI/ISO 11138-3:2006/(R)2010 Sterilization of health care products Biological indicators - Part 3: Biological indicators for moist heat sterilization processes
- ANSI/AAMI/ISO 18472:2006 Sterilization of Health Care Product-Biological and Chemical Indicators: Test Equipment
- United States Pharmacopeia, Chapter Biological Indicators for Sterilization and Chapter Biological Indicators - Resistance Performance Tests.
Multiple lots of 3M Attest™ 1492V SRBIs were evaluated for performance when used with the 3M Attest™ 490 Auto-reader.
Summary of Nonclinical Testing:
| Biological Indicator Test | Acceptance Criteria | Result |
|---|---|---|
| Characterization of spores | > 90% Genetic similarity to Geobacillus stearothermophilus ATCC™ 7953 | Pass |
| D-Value | Greater than or equal to 10 seconds at 132°C Greater than or equal to 8 seconds at 135°C | Pass |
| Population (Total Viable Spore Count) | Greater than or equal to 10^6 spores | Pass |
| Survival/Kill Times | Survival Time = Calculated survival time* or 1 minute at 132°C and 40 seconds at 135°C, whichever is longer; Kill time = Calculated kill time* at 132°C and at 135°C *ANSI/AAMI/ISO 11138-1:2006/(R) 2010, Annex E | Pass |
| Reduced Incubation Time | Meets FDA's requirements for Reduced Incubation Time with > 97% alignment with the conventional incubation time of 7 days for the following readout times: Fluorescent result in 1 hour Optional visual pH color change at 48 hours | Pass |
| Hold Time Assessment | D-value does not change when activated 7 days post- sterilization | Pass |
| Component Inhibition Studies | Components have no impact on the recovery of 10-100 organisms | Pass |
| Chemical Process Indicator | Chemical Process Indicator on the BI changes from pink to light brown upon exposure to steam | Pass |
| Auto-reader Maintenance of Incubation Temperature | Maintain 56+/- 2°C over a period of 7 days | Pass |
Key results: The results of these evaluations showed that the new Attest™ 1492V Rapid Readout Biological Indicator, when used with the Attest™ 490 Auto-reader, complies with ANSI/AAMI/ISO 11138-1:2006/(R)2010 and ANSI/AAMI/ISO 11138-3:2006/(R)2010, the USP requirements for biological indicators, as well as the FDA's Guidance for Biological Indicators.
The Attest™ 490 Auto-reader was tested for safety by Underwriters Laboratory to verify compliance to:
- IEC 61010-1 (2001) Second Edition; Safety requirements for electrical equipment for measurement, control, and laboratory use -- Part 1: General requirements,
- IEC 61010-2-010 (2003) Second Edition; Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-010: Particular requirements for laboratory equipment for the heating of materials, and
- IEC 60825-1 (1993) First Edition with Am. 1(1997) and Am. 2 (2001); Standard for safety of laser products - Part 1: Equipment classification and requirements.
In addition, the Attest™ 490 Auto-reader has been tested by a certified Testing Laboratory to verify electromagnetic compatibility per:
- USA Title 47, Code of Federal Regulations (2009) for:
- 0 Radiated Emissions (FCC Part 15, Subpart B, Class A)
- O Conducted Emissions (FCC Part 15, Subpart B, Class A), and
- IEC 61326: Electrical Equipment for Measurement, Control and Laboratory Use-. EMC Requirements.
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
Premarket Notification 510(k) Summary
OCT 1 9 2012
ЗМ
Sponsor Information:
3M Health Care
3M Center, Bldg. 275-5W-06 St. Paul, MN 55144-1000
| Contact Person: | |
|---|---|
| ----------------- | -- |
Phone Number:
FAX Number:
Suzanne Leung, Ph.D., RAC Regulatory Affairs (651) 575-8052 (651) 737-5320
Date of Summary: October 4, 2012
Device Name and Classification:
| Common or Usual Name: | Sterilization Biological Indicator |
|---|---|
| Proprietary Name: | 3M Attest™ 1492V Super Rapid Readout |
| Biological Indicator for Steam | |
| 3M Attest™ 490 Auto-reader | |
| Classification Name: | Indicator, Biological Sterilization Process |
| (21 CFR § 880.2800(a)) |
Predicate Devices:
- 'Intended Use Predicate' for 1492V 3M Attest™ 1292 Rapid Readout Biological . Indicator for Steam, K090569, K926364
- 'Design Predicate' for 1492V 3M Attest™ 1491 Super Rapid Readout Biological . Indicator for Steam, K103277
- 3M Attest™ 490 Auto-reader, K103277 ●
1
Description of Device:
1492V
The 3M Attest™ 1492V Super Rapid Readout Biological Indicator (SRBI) is a selfcontained biological indicator designed to be used with the 3M Attest™ 490 Auto-reader to qualify or routinely challenge dynamic-air-removal (prevacuum) steam sterilization cycles at 270°F (132°C) and at 275°F (135°C).
The Attest™ 1492V SRBI is composed of a polycarbonate sleeve containing a spore carrier and media ampoule, enclosed with a color-coded cap. On each 1492V SRBI cap is a chemical process indicator that changes color from pink to light brown when exposed to steam.
The 1,492V SRBI is a further improvement over the current 3M Attest™ Rapid Readout technology. Both the Attest™ Rapid Readout BIs and the Attest™ Super Rapid Readout BIs utilize the a-glucosidase enzyme system, which is generated naturally within growing G. 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™ 490 Autoreader. The detection of fluorescence upon incubation of the 1492V SRBI in the 490 Autoreader indicates a steam sterilization failure.
The 1492V SRBI is similar in design to the 3M Attest™ 1491 Super Rapid Readout Biological Indicator for Steam cleared as K 103277 for gravity displacement steam sterilization cvcles. Minor modifications were made to 1491 that resulted in the 1492V SRBI for dynamic-air-removal (prevacuum) steam sterilization cycles.
490 Auto-reader
The Attest™ 490 Auto-reader has been cleared for use with the Attest™ 1491 Super Rapid Readout Biological Indicator for Steam under K103277. The current submission extends the use of the 490 Auto-reader to the 1492V SRBI.
The Attest™ 490 Auto-reader is designed to incubate at 56°C and automatically read the Attest™ 1492V SRBI for a fluorescent result within 1 hour. The 490 Auto-reader is also designed to allow further incubation of the 1492V SRBI for an optional visual pH color change of the growth media at 48 hours. Both the fluorescent readout at 1 hour and the optional visual readout at 48 hours met the FDA's requirement of > 97% alignment with the result after the conventional incubation time of 7 days.
2
Indications for Use:
Use the 3M™ Attest™ Super Rapid Readout Biological Indicator 1492V in conjunction with the 3M™ Attest™ Auto-reader 490 to qualify or monitor dynamic-air-removal (prevacuum) steam sterilization cycles of 4 minutes at 270°F (132°C) and 3 minutes at 275°F (135°C).
The 3M™ Attest™ Super Rapid Readout Biological Indicator 1492V provides a final fluorescent result in 1 hour. An optional visual pH color change result is observed in 48 hours.
Comparative Data for Determining Substantial Equivalence of New Device to Predicate Device:
Testing was conducted on the biological indicator following the FDA guidance and standards below:
- FDA's Guidance for Industry and FDA Staff, Biological Indicator (BI) Premarket . Notification [510(k)] Submissions; October 4, 2007
- ANSI/AAMI/ISO 11138-1:2006/(R)2010 Sterilization of health care products Biological . indicators – Part 1: General Requirements
- ANSI/AAMI/ISO 11138-3:2006/(R)2010 Sterilization of health care products Biological . indicators - Part 3: Biological indicators for moist heat sterilization processes
- ANSI/AAMI/ISO 18472:2006 Sterilization of Health Care Product-Biological and ● Chemical Indicators: Test Equipment
- United States Pharmacopeia, Chapter Biological Indicators for Sterilization and . Chapter Biological Indicators - Resistance Performance Tests.
Multiple lots of 3M Attest™ 1492V SRBIs were evaluated for performance when used with the 3M Attest™ 490 Auto-reader. A Summary of the Nonclinical Testing is shown on the following page.
3
Summary of Nonclinical Testing
| Biological Indicator Test | Acceptance Criteria | Result |
|---|---|---|
| Characterization of spores | > 90% Genetic similarity to Geobacillus | |
| stearothermophilus ATCC™ 7953 | Pass | |
| D-Value | Greater than or equal to 10 seconds at 132°C | |
| Greater than or equal to 8 seconds at 135°C | Pass | |
| Population (Total Viable | ||
| Spore Count) | Greater than or equal to $10^6$ spores | Pass |
| Survival/Kill Times | Survival Time = Calculated survival time* or 1 minute at | |
| 132°C and 40 seconds at 135°C, whichever is longer; | ||
| Kill time = Calculated kill time* at 132°C and at 135°C | ||
| *ANSI/AAMI/ISO 11138-1:2006/(R) 2010, Annex E | Pass | |
| Reduced Incubation Time | Meets FDA's requirements for Reduced Incubation Time | |
| with > 97% alignment with the conventional incubation | ||
| time of 7 days for the following readout times: | ||
| Fluorescent result in 1 hour | ||
| Optional visual pH color change at 48 hours | Pass | |
| Hold Time Assessment | D-value does not change when activated 7 days post- | |
| sterilization | Pass | |
| Component Inhibition | ||
| Studies | Components have no impact on the recovery of 10-100 | |
| organisms | Pass | |
| Chemical Process | ||
| Indicator | Chemical Process Indicator on the BI changes from pink | |
| to light brown upon exposure to steam | Pass | |
| Auto-reader Maintenance | ||
| of Incubation Temperature | Maintain 56+/- 2°C over a period of 7 days | Pass |
The results of these evaluations showed that the new Attest™ 1492V Rapid Readout Biological Indicator, when used with the Attest™ 490 Auto-reader, complies with ANSI/AAMI/ISO 11138-1:2006/(R)2010 and ANSI/AAMI/ISO 11138-3:2006/(R)2010, the USP requirements for biological indicators, as well as the FDA's Guidance for Biological Indicators.
The Attest™ 490 Auto-reader was tested for safety by Underwriters Laboratory to verify compliance to:
- IEC 61010-1 (2001) Second Edition; Safety requirements for electrical equipment . for measurement, control, and laboratory use -- Part 1: General requirements,
- IEC 61010-2-010 (2003) Second Edition; Safety requirements for electrical . equipment for measurement, control, and laboratory use - Part 2-010: Particular requirements for laboratory equipment for the heating of materials, and
- IEC 60825-1 (1993) First Edition with Am. 1(1997) and Am. 2 (2001); Standard for ﻟﺪ safety of laser products - Part 1: Equipment classification and requirements.
4
In addition, the Attest™ 490 Auto-reader has been tested by a certified Testing Laboratory to verify electromagnetic compatibility per:
- USA Title 47, Code of Federal Regulations (2009) for: .
- 0 Radiated Emissions (FCC Part 15, Subpart B, Class A)
- O Conducted Emissions (FCC Part 15, Subpart B, Class A), and
- IEC 61326: Electrical Equipment for Measurement, Control and Laboratory Use-. EMC Requirements.
Conclusion
The 3M Attest™ 1492V Super Rapid Readout Biological Indicator and the 3M Attest™ 490 Auto-reader 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.
5
Image /page/5/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized eagle or bird-like symbol with three distinct, curved lines representing the body and wings.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
3M Health Care
C/O Suzanne Leung, Ph.D., RAC
Regulatory Affairs
3M Center Bldg. 275-5W-06
St. Paul, Minnesota 55144
OCT
19 2012
Re: K121484
Trade/Device Name: 3M Attest™ 1492V Super Rapid Readout Biological Indicator for Steam, 3M Attest™ 490 Auto Reader Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: II Product Code: FRC Dated: October 17, 2012 Received: October 18, 2012
Dear Ms. 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.
6
Page 2 - Ms. 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 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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
hh for
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
7
510(k) Number:
K121484
Device Name:
3M Attest™ 1492V Super Rapid Readout Biological Indicator for Steam 3M Attest™ 490 Auto-reader
Indications for Use:
Use the 3M™ Attest™ Super Rapid Readout Biological Indicator 1492V in conjunction with the 3MTM Attest™ Auto-reader 490 to qualify or monitor dynamic-air-removal (prevacuum) steam sterilization cycles of 4 minutes at 270°F (132°C) and 3 minutes at 275°F (135°C).
The 3M™ Attest™ Super Rapid Readout Biological Indicator 1492V provides a final fluorescent result in 1 hour. An optional visual pH color change result is observed in 48 hours.
Prescription Use
AND/OR
Over-The-Counter Use X
(Part 21 CFR 801 Subpart D)
(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)
Nikhil Gangulur
ision Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K121484