(104 days)
Not Found
No
The description focuses on a biological indicator and an auto-reader that detects fluorescence, which is a chemical/biological process, not AI/ML. There is no mention of AI, ML, or related concepts in the text.
No
This device is a biological indicator used to monitor the effectiveness of sterilization processes, not to treat or diagnose a medical condition in a patient.
No
This device is a biological indicator used to monitor the effectiveness of sterilization processes, not to diagnose a medical condition in a patient.
No
The device description clearly states it is a "single-use device composed of a polycarbonate sleeve containing a spore carrier and media ampoule, enclosed with a color-coded cap." This describes a physical, hardware-based biological indicator, not a software-only device.
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. It does not involve testing a sample taken from a human body to diagnose a disease or condition.
- Device Description: The device contains spores and media to assess the sterilization process, not to analyze biological samples from a patient.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as analyzing blood, urine, tissue, or other bodily fluids. There is no mention of diagnosing, monitoring, or treating a patient's health status based on a biological sample.
This device falls under the category of a sterilization process indicator, which is a different type of medical device than an IVD.
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, and Flexible cycles), and in STERRAD® 100S, STERRAD® NX (Standard and Advanced cycles) and 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 to pink upon exposure to vaporized hydrogen peroxide is located on the top of the cap. The 1295 BI utilizes the same fundamental technology that exists in current 3M™ Attest™ Rapid Readout and Super Rapid Readout BIs. 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
Nonclinical Testing:
Test: Verification of performance in full cycles in the Amsco® V-PRO® maX Low Temperature Sterilization System (Lumen, Non Lumen, and Flexible cycles). Results: Passed.
Test: Growth promotion ability in the Amsco® V-PRO® maX Low Temperature Sterilization System (Lumen, Non Lumen, and Flexible cycles). Results: Passed.
Test: Verification of half cycles in the Amsco® V-PRO® maX Low Temperature Sterilization System (Lumen, Non Lumen, and Flexible cycles). Results: Passed.
Test: Verification of performance in fractional cycles in the Amsco® V-PRO® maX Low Temperature Sterilization System. Results: Passed.
Test: Verification of 4-hour fluorescent readout per FDA's Reduced Incubation Time protocol in the Amsco® V-PRO® maX Low Temperature Sterilization System. Results: Passed.
Test: Verification of population and resistance characteristics (D-value, survival, kill) at the end of shelf life in the Amsco® V-PRO® maX Low Temperature Sterilization System (Lumen, Non Lumen, and Flexible cycles). Results: Passed.
Summary of Clinical Testing:
No clinical data was included in this premarket application submission.
Key Metrics
Not Found
Predicate Device(s)
K152060 3M™ Attest™ Rapid Readout Biological Indicator 1295
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three human profiles incorporated into its design. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 9, 2016
3M Health Care Ms. Hilary B. Hovde 3M Health Care Regulatory Affairs Specialist 3M Center, Building 275-5W-06 St. Paul, Minnesota 55144
Re: K160546
Trade/Device Name: 3M™ Attest™ Rapid Readout Biological Indicator 1295 Regulation Number: 21 CFR 880.2800 Regulation Name: Indicator, Biological Sterilization Process Regulatory Class: Class II Product Code: FRC Dated: May 12, 2016 Received: May 17, 2016
Dear Hilary B. 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 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 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/Resourcesfor You/Industry/default.htm. 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 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 vours.
Tejashri Purohit-Sheth, M.D.
Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR
Erin I. Keith, M.S. Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K160546
Device Name
3MTM Attest™ Rapid Readout Biological Indicator 1295
Indications for Use (Describe)
Use the 3MM 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, and Flexible cycles), and in STERRAD® 100S, STERRAD® NX (Standard and Advanced cycles) and 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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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3
Premarket Notification (510(k)) Summary K160546
Image /page/3/Picture/1 description: The image shows the 3M logo. The logo is red and features the number 3 followed by the letter M. The font is bold and sans-serif.
Sponsor Information:
3M Health Care 3M Center, Bldg. 275-5W-06 St. Paul, MN 55144-1000
Contact Person: Hilary B. Hovde Regulatory Affairs Associate Phone Number: (651) 736-0364 FAX Number: (651) 737-5320
Date of Summary: June 7, 2016
Device Name and Classification:
Common or Usual Name: Biological Indicator Proprietary Name: 3MTM Attest™ Rapid Readout Biological Indicator 1295 Classification Name: Indicator, Biological Sterilization Process Device Classification: Class II, 21 CFR 880.2800(a) Product Code: FRC
Predicate Devices:
- K152060 3MTM Attest™ Rapid Readout Biological Indicator 1295 .
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 to pink upon exposure to vaporized hydrogen peroxide is located on the top of the cap. The 1295 BI utilizes the same fundamental technology that exists in current 3M™ Attest™ Rapid Readout and Super Rapid Readout BIs. The detection of fluorescence upon incubation of the 1295 BI in the 490H Auto-reader indicates a sterilization failure.
4
Nonclinical Comparison to the Predicate Device
This submission is addressing clearance for use in an additional sterilizer. The 3MIM 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, performance specifications, and fundamental scientific technology.
Summary of Nonclinical Testing
The effectiveness of the 3M™ Attest™ Rapid Readout Biological Indicator 1295 in the Amsco® V-PRO® maX Low Temperature Sterilization System (Lumen, Non Lumen, and Flexible cycles) is demonstrated in the following tests:
| Test | Results |
|---|---|
| Verification of performance in full cycles in the Amsco® V-PRO® maX Low | |
| Temperature Sterilization System (Lumen, Non Lumen, and Flexible cycles) | Passed |
| Growth promotion ability in the Amsco® V-PRO® maX Low Temperature | |
| Sterilization System (Lumen, Non Lumen, and Flexible cycles) | Passed |
| Verification of half cycles in the Amsco® V-PRO® maX Low Temperature | |
| Sterilization System (Lumen, Non Lumen, and Flexible cycles) | Passed |
| Verification of performance in fractional cycles in the Amsco® V-PRO® | |
| maX Low Temperature Sterilization System | Passed |
| Verification of 4-hour fluorescent readout per FDA's Reduced Incubation | |
| Time protocol in the Amsco® V-PRO® maX Low Temperature Sterilization | |
| System | Passed |
| Verification of population and resistance characteristics (D-value, survival, | |
| kill) at the end of shelf life in the Amsco® V-PRO® maX Low Temperature | |
| Sterilization System (Lumen, Non Lumen, and Flexible cycles) | 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 100NX (Standard, Flex, Express and Duo cycles) systems.
5
Comparison to Predicate Device
| Feature | Submission Device: 3MTM
AttestTM 1295 Biological Indicator | Predicate Device (K152060):
3MTM AttestTM 1295 Biological
Indicator |
|-------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for use | Use the 3MTM 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 100NX
(Standard, Flex, Express and Duo
cycles) systems. | Use the 3MTM 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
STERRAD® 100S, STERRAD®
NX (Standard and Advanced
cycles) and 100NX (Standard, Flex,
Express and Duo cycles) systems. |
| Organism | Geobacillus stearothermophilus
traceable to ATCCTM 7953 | Same |
| Viable spore
population | ≥1x106 | Same |
| Resistance
characteristics | (Tested at 10 mg/L vaporized hydrogen
peroxide)
D-value D10 mg/L ≥ 1 second Survival/Kill Survival Time ≥ 5 seconds Window Kill Time = 7 minutes | Same |
| Carrier material | Polyethylene terephthalate | Same |
| Incubation
temperature | 60 +/- 2 °C | Same |
| Readout time | 4 hour fluorescence result read on 3M
490H Auto-reader | Same |
| Chemical
indicator | H2O2 sensitive ink; appears blue until
processed, then appears pink | Same |
| Shelf-life | 18 months | Same |
Conclusion
The 3M™ Attest™ Rapid Readout Biological Indicator 1295 is substantially equivalent to the predicate device in terms of their intended use, physical properties and technological characteristics. The non-clinical testing demonstrates that the 1295 Biological Indicator is as safe, as effective, and performs as well as the predicate device.