(130 days)
Not Found
No
The description focuses on a biological indicator and an auto-reader for sterilization monitoring, with no mention of AI or ML technologies.
No.
The device is a biological indicator used to monitor sterilization processes, not to treat a medical condition or disease.
No
This device is a biological indicator used to monitor the effectiveness of sterilization processes, not to diagnose a condition in a patient.
No
The device description clearly outlines a physical biological indicator (BI) and an auto-reader, both of which are hardware components. The software component, if any, is not the primary or sole component of the 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 a sterilization process (vaporized hydrogen peroxide sterilization) for medical devices. It does not involve testing a sample taken from the human body to provide information about a patient's health or condition.
- Device Description: The device contains a spore carrier and media, and its function is to indicate whether the sterilization process killed the spores. This is a quality control measure for the sterilization equipment, not a diagnostic test on a patient sample.
- Lack of Patient Information: There is no mention of patient samples, anatomical sites, or patient age ranges, which are typical characteristics of IVDs.
- No Clinical Data: The summary of performance studies explicitly states "No clinical data was included in this premarket application submission," which is consistent with a device that is not an IVD.
This device falls under the category of a sterilization process indicator, which is used to verify the effectiveness of sterilization cycles.
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 STERRAD® 100S, STERRAD® NX (Standard and Advanced cycles) and 100NX (Standard, Flex, Express and Duo cycles) systems.
Product codes (comma separated list FDA assigned to the subject device)
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 STERRAD® 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 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 Autoreader indicates a sterilization failure.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Applicable
Indicated Patient Age Range
Not Applicable
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
No clinical data was included in this premarket application submission.
Description of the test set, sample size, data source, and annotation protocol
No clinical data was included in this premarket application submission.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
No clinical data was included in this premarket application submission. The nonclinical testing demonstrates that the 3M™ Attest™ 1295 Biological Indicator is effective, and performs as well as the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol composed of three stylized human profiles facing to the right, with flowing lines beneath them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 1, 2015
3M Health Care Dr. Matt S. Mortensen, Ph.D., RAC Regulatory Affairs Specialist 3M Center, Bldg. 275-5W-06 St. Paul. MN 55144
Re: K152060
Trade/Device Name: 3M™ Attest™ Rapid Readout Biological Indicator 1295 Regulation Number: 21 CFR 880.2800(a) Regulation Name: Biological sterilization process indicator Regulatory Class: II Product Code: FRC Dated: October 20, 2015 Received: October 28, 2015
Dear Dr. Mortensen,
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.
1
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 devicerelated 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/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 yours,
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) K152060
Device Name
3MTM Attest™ Rapid Readout Biological Indicator 1295
Indications for Use (Describe)
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 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)
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FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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3
Premarket Notification (510(k)) Summary
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 logo is simple and recognizable, and it is often used to represent the 3M company.
Sponsor Information:
3M Health Care 3M Center, Bldg. 275-5W-06 St. Paul, MN 55144-1000
Contact Person: Matt S. Mortensen, Ph.D., RAC Regulatory Affairs Phone Number: (651) 737-2670 FAX Number: (651) 737-5320
Date of Summary: October 19, 2015
Device Name and Classification:
Common or Usual Name: Biological Indicator Proprietary Name: 3M™ 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:
- K140392 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 STERRAD® 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 1295 BI utilizes the same fundamental technology that exists in current 3M Attest™ Rapid Readout and Super Rapid
4
Readout BIs. The detection of fluorescence upon incubation of the 1295 BI in the 490H Autoreader indicates a sterilization failure.
Nonclinical Comparison to the Predicate Device
This submission is addressing clearance for use in an additional sterilizer. The 3M™ Attest™ Rapid Readout Biological Indicator 1295 is the same design as the previously cleared device of the same model number. There device has the same materials, performance specifications, and fundamental scientific technology.
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 STERRAD® 100S, STERRAD® NX (Standard and Advanced cycles) and 100NX (Standard, Flex, Express and Duo cycles) systems.
Comparison to Predicate Device
| Feature | Submission Device: 3M™
Attest™ 1295 Biological Indicator | Predicate Device (K140392):
3M™ Attest™ 1295 Biological
Indicator |
|--------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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 STERRAD® 100S,
STERRAD® NX (Standard and
Advanced cycles) and 100NX
(Standard, Flex, Express and Duo
cycles) systems. | 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
STERRAD® NX and 100NX
systems. |
| Organism | Geobacillus stearothermophilus
traceable to ATCC™ 7953 | Same |
| Viable spore
population | ≥1x106 | Same |
| Resistance
characteristics
• D-value | (Tested at 10 mg/L vaporized hydrogen
peroxide)
D10 mg/L ≥ 1 second
Survival Time > 5 seconds | Same |
5
| Survival/Kill
| Window | Kill Time = 7 minutes | |
|---|---|---|
| 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™ 1295 Biological Indicator is substantially equivalent to the predicate device in terms of their intended use, physical properties and technological characteristics. The nonclinical testing demonstrates that the 3M™ Attest™ 1295 Biological Indicator i effective, and performs as well as the predicate device.