(108 days)
No
The description focuses on a biological indicator and an auto-reader that detects fluorescence, with no mention of AI or ML technologies.
No.
The device is a biological indicator used to monitor the effectiveness of sterilization processes, not to treat a disease or condition in a patient.
No
The device is used for routine monitoring of sterilization processes, not for diagnosing medical conditions in patients. The output ("sterilization failure") is related to the effectiveness of sterilization, not to a diagnosis of a disease or condition in a patient.
No
The device description clearly outlines physical components (polycarbonate sleeve, spore carrier, media ampoule, cap, chemical process indicator) and relies on a separate hardware device (3M™ Attest™ Auto-reader 490H) for its function.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is to monitor the effectiveness of sterilization processes for medical devices using vaporized hydrogen peroxide. This is a quality control measure for the sterilization equipment and process, not a test performed on a biological sample from a patient to diagnose a condition or provide information about their health.
- Device Description: The device is a biological indicator containing spores and media. It is used to assess whether the sterilization process has successfully killed the spores. This is a test of the sterilization process itself, not a test of a patient sample.
- No mention of biological samples: The description does not mention the use of any biological samples from a patient (e.g., blood, urine, tissue).
IVDs are typically used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
Use the 3M™ Attest™ Rapid Readout Biological Indicator 1295 in conjunction with the 3M™ Attest™ Auto-reader 490H as a standard method of routine monitoring of vaporized hydrogen peroxide sterilization processes in the Amsco® V-PRO® maX Low Temperature Sterilization System (Lumen, Non Lumen, and Flexible cycles), and in STERRAD® 100S, STERRAD® NX® (Standard and Advanced cycles) and STERRAD® 100NX® (Standard, Flex, Express, and Duo cycles) systems.
Product codes
FRC
Device Description
The 3M™ Attest™ Rapid Readout Biological Indicator 1295 is a self-contained biological indicator specifically designed for rapid and reliable routine monitoring of vaporized hydrogen peroxide sterilization processes when used in conjunction with the 3M™ Attest™ Auto-reader 490H. The 1295 BI is a single-use device composed of a polycarbonate sleeve containing a spore carrier and media ampoule, enclosed with a color-coded cap. A chemical process indicator printed with stripes which change from blue toward pink upon exposure to vaporized hydrogen peroxide is located on the top of the cap. The detection of fluorescence upon incubation of the 1295 BI in the 490H Auto-reader indicates a sterilization failure.
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
The effectiveness of the 3M™ Attest™ Rapid Readout Biological Indicator 1295 in conjunction with the 3M™ Attest™ Auto-reader 490H with a final fluorescent readout of 24 minutes is demonstrated in the following tests:
- Positive Control: Passed
- Survival Time = 5 seconds; Kill Time = 7 minutes: Passed
- 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 time: • 24 minutes: Passed
Key Metrics
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).
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 21, 2017
3M Company c/0 Hilary Hovde Regulatory Affairs Associate 3M Center, Building 275-5W-06 St. Paul, Minnesota 55144
Re: K171003
Trade/Device Name: 3M Attest Rapid Readout Biological Indicator 1295, 3M Attest Autoreader 490H Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: Class II Product Code: FRC Dated: June 29, 2017 Received: June 30, 2017
Dear Hilary Hovde:
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.
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
1
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 devicerelated adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely.
Tara A. Ryan -S
for Lori Wiggins Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K171003
Device Name
3M™ Attest™ Rapid Readout Biological Indicator 1295 and 3M™ Attest™ Auto-reader 490H
Indications for Use (Describe)
Use the 3M™ Attest™ Rapid Readout Biological Indicator in conjunction with the 3M™ Attest™ Auto reader 490H as a standard method of routine monitoring of vaporized hydrogen peroxide sterilization processes in the Amsco® V-PRO® maX Low Temperature Sterilization System (Lumen, Non Lumen, and Flexible cycles), and in STERRAD® 100S, STERRAD® NX® (Standard and Advanced cycles) and STERRAD® 100NX® (Standard, Flex, Express, and Duo cycles) systems.
Type of Use (Select one or both, as applicable)
- Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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510(k) Summary for 3M™ Attest™ Rapid Readout Biological Indicator 1295 and 3M™ Attest™ Auto-reader 490H
3M Health Care 3M Center, Bldg. 275-5W-06 St. Paul, MN 55144-1000
Contact: Hilary B. Hovde Regulatory Affairs Associate Phone Number: (651) 736-0364 FAX Number: (651) 737-5320
Submission Date: July 20, 2017
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TRADITIONAL PREMARKET NOTIFICATION [510(k)] 3MTM Attest™ Rapid Readout Biological Indicator 1295 and 3MTM Attest™ Auto-reader 490H
Device Name and Classification:
| Common or Usual Name: | Biological Indicator |
|---|---|
| Proprietary Name: | 3M™ Attest™ Rapid Readout Biological Indicator 1295 |
| 3M™ Attest™ Auto-Reader 490H | |
| Classification Name: | Indicator, Biological Sterilization Process |
| (21 CFR § 880.2800(a)) | |
| Device Classification: | Class II |
| Product Code: | FRC |
Predicate Device:
- Intended use Predicate for system K160546 3M™ Attest™ Rapid Readout . Biological Indicator 1295
- . 3MTM AttestTM Auto-reader 490H, K140392
Description of Device:
The 3M™ Attest™ Rapid Readout Biological Indicator 1295 is a self-contained biological indicator specifically designed for rapid and reliable routine monitoring of vaporized hydrogen peroxide sterilization processes when used in conjunction with the 3M™ Attest™ Auto-reader 490H. The 1295 BI is a single-use device composed of a polycarbonate sleeve containing a spore carrier and media ampoule, enclosed with a color-coded cap. A chemical process indicator printed with stripes which change from blue toward pink upon exposure to vaporized hydrogen peroxide is located on the top of the cap. The detection of fluorescence upon incubation of the 1295 BI in the 490H Auto-reader indicates a sterilization failure.
Nonclinical Comparison to the Predicate Device
This submission is addressing a software change to the 3MTM Attest™ Auto-reader 490H to reduce the final fluorescent readout from 4 hours to 24 minutes. The 3M™ Attest™ Rapid Readout Biological Indicator 1295 is the same design as the previously cleared device of the same model number. The device has the same materials and fundamental scientific technology. The only change to the performance specifications is the change in final fluorescent readout from 4 hours to 24 minutes.
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TRADITIONAL PREMARKET NOTIFICATION [510(k)] 3M™ Attest™ Rapid Readout Biological Indicator 1295 and 3M™ Attest™ Auto-reader 490H
Summary of Nonclinical Testing
The effectiveness of the 3M™ Attest™ Rapid Readout Biological Indicator 1295 in conjunction with the 3M™ Attest™ Auto-reader 490H with a final fluorescent readout of 24 minutes is demonstrated in the following tests:
| Test | Results |
|---|---|
| Positive Control | Passed |
| Survival Time = 5 seconds | |
| Kill Time = 7 minutes | Passed |
| 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 time: | |
| • 24 minutes | Passed |
Summary of Clinical Testing
No clinical data was included in this premarket application submission.
Indications for Use
Use the 3M™ Attest™ Rapid Readout Biological Indicator 1295 in conjunction with the 3M™ Attest™ Auto-reader 490H as a standard method of routine monitoring of vaporized hydrogen peroxide sterilization processes in the AMSCO® V-PRO® maX Low Temperature Sterilization System (Lumen, Non Lumen, and Flexible cycles), and in STERRAD® 100S, STERRAD® NX® (Standard and Advanced cycles) and STERRAD® 100NX® (Standard, Flex, Express and Duo cycles) systems.
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Comparison to Predicate Device
| Feature | Submission Device:
3MTM AttestTM Rapid Readout
Biological Indicator 1295 and
3MTM AttestTM Auto-reader 490H | Predicate Device (K160546):
3MTM AttestTM Rapid Readout
Biological Indicator 1295 and
3MTM AttestTM Auto-reader 490H |
|----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------|
| Indications for use | Use the 3MTM AttestTM Rapid Readout
Biological Indicator 1295 in conjunction
with the 3MTM AttestTM Auto-reader
490H as a standard method of routine
monitoring of vaporized hydrogen
peroxide sterilization processes in the
Amsco® V-PRO® maX Low
Temperature Sterilization System
(Lumen, Non Lumen, and Flexible
cycles), and in STERRAD® 100S,
STERRAD® NX® (Standard and
Advanced cycles) and STERRAD®
100NX® (Standard, Flex, Express and
Duo cycles) systems. | Identical |
| Organism | Geobacillus stearothermophilus
traceable to ATCCTM 7953 | Identical |
| Viable spore
population | ≥ 1 x 106 | Identical |
| Resistance
characteristics | (Tested at 10 mg/L vaporized hydrogen
peroxide)
D-value
Survival/Kill Window
| Identical |
| • D-value
• Survival/Kill
Window | $D_{10 mg/L} ≥ 1 second$
Survival Time ≥ 5 seconds
Kill Time = 7 minutes | Identical |
| Carrier material | polyethylene terephthalate | Identical |
| Incubation
temperature | 60 ± 2°C | Identical |
| Readout time | 24 minute fluorescence result read in the
3MTM AttestTM Auto-reader 490H | 4 hour fluorescence result read in the
3MTM AttestTM Auto-reader 490H |
| Chemical
indicator | H2O2 sensitive ink; changes from blue
towards pink | Identical |
| Shelf-life | 24 months | Identical |
Conclusion
The 3M™ Attest™ Rapid Readout Biological Indicator 1295 and the 3MTM Attest™ Autoreader 490H meet all applicable standards and are substantially equivalent to their predicate devices in terms of their intended use, physical properties and technological characteristics.