(63 days)
No
The summary describes a biological indicator and an auto-reader that detects fluorescence. There is no mention of AI or ML in the device description, intended use, or performance studies. The technology appears to be based on standard biological and optical detection methods.
No.
This device is a biological indicator used to monitor sterilization cycles for medical devices, not to treat or diagnose patients.
No
Explanation: The device is a biological indicator used to monitor the effectiveness of sterilization cycles, 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 cap," which are physical components, not software. The submission also includes performance testing for the biological indicator itself and safety/EMC testing for the associated hardware auto-readers.
Based on the provided text, the 3M™ Attest™ Super Rapid Readout Biological Indicator 1491 is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to "monitor the cycles below" which are steam sterilization cycles. This is a quality control measure for a sterilization process, not a diagnostic test performed on a biological sample from a human or animal to diagnose a condition.
- Device Description: The device is a biological indicator containing spores and media. It's designed to be exposed to a sterilization process and then incubated to see if the spores are killed. This is a test of the sterilization equipment's effectiveness, not a test of a patient sample.
- No mention of patient samples or diagnosis: The entire document focuses on the performance of the biological indicator in relation to sterilization cycles and auto-readers. There is no mention of analyzing patient samples, diagnosing diseases, or providing information about a patient's health status.
- Intended User / Care Setting: While it mentions "Over-The-Counter Use," this likely refers to the availability of the product for use in healthcare settings (like clinics or hospitals) for monitoring their sterilization equipment, not for direct use by patients for self-diagnosis.
- Performance Studies: The performance studies focus on the biological indicator's resistance to sterilization, spore count, and compatibility with the auto-reader. These are all related to evaluating the effectiveness of the sterilization process, not the accuracy of a diagnostic test.
In summary, the 3M™ Attest™ Super Rapid Readout Biological Indicator 1491 is a device used for monitoring the effectiveness of sterilization equipment, which falls under the category of quality control or process monitoring, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
Use the 3M™ Attest™ Super Rapid Readout Biological Indicator 1491 in conjunction with the 3M™ Autoreader 490 or 3MTM Attest™ Auto-reader 490H having software version 4.0.0 or greater to monitor the cycles below.
| Sterilization Type | Temperature | Time |
|---|---|---|
| Gravity Displacement Steam Sterilization Cycle | 270°F (132°C) | 3 minutes |
| 270°F (132°C) | 10 minutes | |
| 275°F (135°C) | 3 minutes | |
| 275°F (135°C) | 10 minutes |
Product codes
FRC
Device Description
The 3M™ Attest™ Super Rapid Readout Biological Indicator 1491 is a self-contained biological indicator (BI) specifically designed to be used with the 3MTM Attest™ Auto-reader 490 or the 3MTM Attest™ Auto-reader 490H (software version 4.0.0 or greater) to routinely monitor gravity displacement steam sterilization cycles at 132°C and 135°C.
The 1491 BI is a single-use device composed of a polycarbonate sleeve containing a spore carrier and media ampoule, enclosed with a cap. On each 1491 BI cap is a chemical process indicator that changes color from pink to light brown or darker when exposed to steam. The detection of fluorescence upon incubation of a processed 1491 BI in the 490 Auto-reader or the 490H Auto-reader (software version 4.0.0 or greater) 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Summary of Nonclinical Testing
Testing was conducted on the biological indicator following the FDA guidance and the standards below:
- Guidance for Industry and FDA Staff, Biological Indicator Premarket Notification [510(k)] Submissions, October 4, 2007
- ISO 11138-1:2017 Sterilization of health care products Biological indicators, Part 1: ● General Requirements
- ISO 11138-3:2017 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 Products – Biological and Chemical Indicators: Test Equipment
- United States Pharmacopeia, Chapter Biological Indicators for Sterilization and ● Chapter Biological Indicators - Resistance Performance Tests
The effectiveness of the 3M™ Attest™ Super Rapid Readout Biological Indicator 1491 in conjunction with the 3M™ Attest™ Auto-reader 490 with a final fluorescent readout of 24 minutes and an incubation temperature of 60°C is demonstrated in the following tests:
| Test | Results |
|---|---|
| Positive Control | Passed |
| 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 * ISO 11138-1:2017, Annex E | 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 times: • Fluorescent result in 24 minutes • Optional visual pH color change result in 24 hours | Passed |
| D-Value Greater than or equal to 10 seconds at 132°C Greater than or equal to 8 seconds at 135°C | Passed |
| Population (Total Viable Spore Count) Greater than or equal to 106 spores | Passed |
| Component Inhibition Studies Components have no impact on the recovery of 10-100 organisms | Passed |
| Holding Time Assessment D-value does not change when activated 7 days post sterilization | Passed |
| Auto-reader Maintenance of Incubation Temperature Maintain 60 ± 2°C over a period of 24 hours | Passed |
The results of these evaluations showed that the 3M™ Super Attest™ Rapid Readout Biological Indicator 1491, when used with the 3MTM Attest™ Auto-reader 490 or Attest™ Auto-reader 490H having software version 4.0.0 or greater, complies with ISO 11138-1:2017 and ISO 11138-3:2017, the USP requirements for biological indicators, as well as the FDA's Guidance for Biological Indicators.
The 3M™ Attest™ Auto-readers 490 and 490H were tested for safety by Underwriters Laboratory to verify compliance to:
- IEC 61010-1 (2010) 3rd Edition; Safety requirements for electrical equipment for measurement, control, and laboratory use – Part 1: General requirements, and
- IEC 61010-2-010 (2014) 3rd 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
In addition the 3MTM Attest™ Auto-readers 490 and 490H have been tested by a certified Testing Laboratory to verify electromagnetic compatibility per:
- USA Title 47, Code of Federal Regulations for:
- Radiated Emissions (FCC Part 15, Subpart B, Class A) O
- Conducted Emissions (FCC Part 15, Subpart B, Class A), and O
- IEC 61326-1:2012 Electrical Equipment for Measurement, Control, and Laboratory Use – EMC Requirements
Summary of Clinical Testing
No clinical data was included in this premarket application submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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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January 22, 2018
3M Company Hilary Hovde Regulatory Affairs Associate 3M Center, Building 275-5W-06 St. Paul, Minnesota 55144
Re: K173584
Trade/Device Name: 3M Attest Super Rapid Readout Biological Indicator, 3M Attest Auto-reader 490, 3M Attest Auto-reader 490H Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: Class II Product Code: FRC Dated: November 16, 2017 Received: November 20, 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 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 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);
1
and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Michael J. Ryan -S
for Tina Kiang, Ph.D. Acting 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) K173584
Device Name
3M™ Attest™ Super Rapid Readout Biological Indicator 1491 and 3M™ Attest™ Auto-reader 490 and 490H
Indications for Use (Describe)
Use the 3M™ Attest™ Super Rapid Readout Biological Indicator 1491 in conjunction with the 3M™ Autoreader 490 or 3MTM Attest™ Auto-reader 490H having software version 4.0.0 or greater to monitor the cycles below.
| Sterilization Type | Temperature | Time |
|---|---|---|
| 270°F (132°C) | 3 minutes | |
| Gravity Displacement | 270°F (132°C) | 10 minutes |
| Steam Sterilization Cycle | 275°F (135°C) | 3 minutes |
| 275°F (135°C) | 10 minutes |
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
| | Prescription Use (Part 21 CFR 801 Subpart D)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
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3
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510(k) Summary for K173584 3MTM Attest™ Super Rapid Readout Biological Indicator 1491, 3MTM Attest™ Auto-reader 490, and 3M™ Attest™ Auto-reader 490H (software version 4.0.0 or greater)
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: November 16, 2017
4
Device Name and Classification:
Common or Usual Name: Biological Indicator
| Proprietary Name: | 3M™ Attest™ Super Rapid Readout Biological Indicator 1491
3M™ Attest™ Auto-reader 490
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:
- 3MTM Attest™ Super Rapid Readout Biological Indicator 1491 and . 3MTM Attest™ Auto-reader 490, K103277
Reference Device:
- 3MTM AttestTM Auto-reader 490H, K171003 . (490 Auto-reader will be shown to be identical to the 490H Auto-reader)
Description of Device:
The 3M™ Attest™ Super Rapid Readout Biological Indicator 1491 is a self-contained biological indicator (BI) specifically designed to be used with the 3MTM Attest™ Auto-reader 490 or the 3MTM Attest™ Auto-reader 490H (software version 4.0.0 or greater) to routinely monitor gravity displacement steam sterilization cycles at 132°C and 135°C.
The 1491 BI is a single-use device composed of a polycarbonate sleeve containing a spore carrier and media ampoule, enclosed with a cap. On each 1491 BI cap is a chemical process indicator that changes color from pink to light brown or darker when exposed to steam. The detection of fluorescence upon incubation of a processed 1491 BI in the 490 Auto-reader or the 490H Auto-reader (software version 4.0.0 or greater) indicates a sterilization failure.
Nonclinical Comparison to the Predicate Device
This submission is addressing a software change to the 3MTM Attest™ Auto-reader 490 to reduce the final fluorescent readout for the 1491 BI from 30 minutes to 24 minutes, and to change the incubation temperature from 56°C to 60°C making the 490 Auto-reader identical to the 490H Auto-reader (software version 4.0.0 or greater). The 3M™ Attest™ Super Rapid Readout Biological Indicator 1491 is the same design as the previously cleared device of the same model number. The device has the same materials and fundamental scientific technology.
5
TRADITIONAL PREMARKET NOTIFICATION [510(k)] 3MTM Attest™ Super Rapid Readout Biological Indicator 1491 and 3M™ Attest™ Auto-reader 490/490H
Summary of Nonclinical Testing
Testing was conducted on the biological indicator following the FDA guidance and the standards below:
- Guidance for Industry and FDA Staff, Biological Indicator Premarket Notification [510(k)] Submissions, October 4, 2007
- ISO 11138-1:2017 Sterilization of health care products Biological indicators, Part 1: ● General Requirements
- ISO 11138-3:2017 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 Products – Biological and Chemical Indicators: Test Equipment
- United States Pharmacopeia, Chapter Biological Indicators for Sterilization and ● Chapter Biological Indicators - Resistance Performance Tests
The effectiveness of the 3M™ Attest™ Super Rapid Readout Biological Indicator 1491 in conjunction with the 3M™ Attest™ Auto-reader 490 with a final fluorescent readout of 24 minutes and an incubation temperature of 60°C is demonstrated in the following tests:
| Test | Results |
|---|---|
| Positive Control | Passed |
| 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 |
- ISO 11138-1:2017, Annex E | 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 times:
• Fluorescent result in 24 minutes
• Optional visual pH color change result in 24 hours | Passed |
| D-Value
Greater than or equal to 10 seconds at 132°C
Greater than or equal to 8 seconds at 135°C | Passed |
| Population (Total Viable Spore Count)
Greater than or equal to 106 spores | Passed |
| Component Inhibition Studies
Components have no impact on the recovery of 10-100 organisms | Passed |
| Holding Time Assessment
D-value does not change when activated 7 days post sterilization | Passed |
| Auto-reader Maintenance of Incubation Temperature
Maintain 60 ± 2°C over a period of 24 hours | Passed |
The results of these evaluations showed that the 3M™ Super Attest™ Rapid Readout Biological Indicator 1491, when used with the 3MTM Attest™ Auto-reader 490 or Attest™ Auto-reader 490H having software version 4.0.0 or greater, complies with ISO 11138-1:2017 and ISO 11138
6
3:2017, the USP requirements for biological indicators, as well as the FDA's Guidance for Biological Indicators.
The 3M™ Attest™ Auto-readers 490 and 490H were tested for safety by Underwriters Laboratory to verify compliance to:
- IEC 61010-1 (2010) 3rd Edition; Safety requirements for electrical equipment for . measurement, control, and laboratory use – Part 1: General requirements, and
- IEC 61010-2-010 (2014) 3rd 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
In addition the 3MTM Attest™ Auto-readers 490 and 490H have been tested by a certified Testing Laboratory to verify electromagnetic compatibility per:
- USA Title 47, Code of Federal Regulations for:
- Radiated Emissions (FCC Part 15, Subpart B, Class A) O
- Conducted Emissions (FCC Part 15, Subpart B, Class A), and O
- IEC 61326-1:2012 Electrical Equipment for Measurement, Control, and Laboratory Use – EMC Requirements
Summary of Clinical Testing
No clinical data was included in this premarket application submission.
Indications for Use
Use the 3M™ Attest™ Super Rapid Readout Biological Indicator 1491 in conjunction with the 3M™ Attest™ Auto-reader 490 or 3M™ Attest™ Auto-reader 490H having software version 4.0.0 or greater to monitor the cycles below.
| Sterilization Type | Temperature | Time |
|---|---|---|
| Gravity Displacement | ||
| Steam Sterilization Cycle | 270°F (132°C) | 3 minutes |
| 270°F (132°C) | 10 minutes | |
| 275°F (135°C) | 3 minutes | |
| 275°F (135°C) | 10 minutes |
7
TRADITIONAL PREMARKET NOTIFICATION [510(k)] 3M™ Attest™ Super Rapid Readout Biological Indicator 1491 and 3M™ Attest™ Auto-reader 490/490H
| Feature | Submission Device:
3MTM AttestTM
Super Rapid Readout
Biological Indicator 1491 and
3MTM AttestTM Auto-reader 490 | Predicate Device (K103277):
3MTM AttestTM
Super Rapid Readout
Biological Indicator 1491 and
3MTM AttestTM Auto-reader 490 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
|--------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|--|--|--|--|--|--|--|--|--|--|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|
| Indications for use | Use the 3MTM Attest™ Super Rapid
Readout Biological Indicator 1491 in
conjunction with both the 3MTM AttestTM
Auto-reader 490 or the AttestTM Auto-
reader 490H having software version 4.0.0
or greater to monitor the cycles below.
Sterilization Type Temperature Time Gravity
Displacement 270°F
(132°C) 3 minutes Steam
Sterilization
Cycle 270°F
(132°C) 10 minutes 275°F
(135°C) 3 minutes 275°F
(135°C) 10 minutes | | | | | | | | | | | | | | | | Use the 3MTM Attest™ 1491 Super Rapid
Readout Biological Indicator in conjunction
with the 3MTM AttestTM 490 Auto-reader to
monitor the cycles below.
Sterilization Type Temperature Time Gravity
Displacement 270°F
(132°C) 3 minutes Immediate
Use Steam 270°F
(132°C) 10 minutes Sterilization
Cycle (Flash) 275°F
(135°C) 3 minutes 275°F
(135°C) 10 minutes The 3MTM Attest™ 1491 Super Rapid Readout
Biological Indicator provides a final
fluorescent result in 30 minutes. An optional
visual pH color change result is observed in 24
hours. | | | | | | | | | | | | | | | |
| Organism | Geobacillus stearothermophilus
traceable to ATCCTM 7953 | Identical | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Viable spore
population | $\ge$ 1 x 106 | Identical | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Resistance
characteristics
• D-value | D-value $\ge$ 10 seconds at 132°C
D-value $\ge$ 8 seconds at 135°C | Identical | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| • Survival/Kill
Window | 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 | Identical | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Carrier material | Polypropylene | Identical | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Incubation
temperature | 60 ± 2°C | 56 ± 2°C | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Readout time | 24 minute final fluorescent result in both
the 490 and 490H Auto-readers having
software versions 4.0.0 or greater.
30 minute final fluorescent result in 490
Auto-readers having software versions
less than 4.0.0. | 30 minute final fluorescent result in 490 Auto-
readers. | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Chemical indicator | Optional visual pH color change result in
24 hours | Identical | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | Turns from pink to light brown or darker
upon steam exposure | Identical | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
Comparison to Predicate Device
8
- per ISO 11138-1:2017, Annex E
Conclusion
The conclusions drawn from the nonclinical tests demonstrate that the 3MTM Attest™ Super Rapid Readout Biological Indicator 1491, the 3MTM Attest™ Auto-reader 490, and the 3M™ Attest™ Auto-reader 490H is as safe, as effective, and performs as well as or better than the 3M™ Attest™ Super Rapid Readout Biological Indicator 1491 and 3M™ Attest™ Autoreader 490 (K103277).