(136 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 performance metrics are related to the biological indicator's ability to detect sterilization failure, not complex data analysis or pattern recognition typically associated with AI/ML.
No.
The device is a biological indicator used to monitor the effectiveness of sterilization cycles, not to provide therapy or treatment to a patient.
No
Explanation: This device is a biological indicator used to monitor the effectiveness of steam sterilization cycles, not to diagnose a disease or condition in a patient. It determines if sterilization was successful, not if a patient has a particular illness.
No
The device description clearly states it is a "self-contained biological indicator (BI)" which is a physical, single-use device composed of a polycarbonate sleeve, spore carrier, media ampoule, and cap with a chemical process indicator. While it is used in conjunction with an auto-reader (which contains software), the device itself is a hardware component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "qualify or monitor dynamic-air-removal steam sterilization cycles." This is a quality control function for a sterilization process, 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. Its function is to determine if a sterilization process was effective by checking if the spores were killed. This is a test of the sterilization equipment/process, not a test of a patient sample.
- Lack of IVD Characteristics: The description does not mention analyzing human biological samples (blood, urine, tissue, etc.), diagnosing a disease, or providing information about a patient's health status.
The device is a quality control tool for sterilization equipment in a healthcare setting.
N/A
Intended Use / Indications for Use
Use the 3M™ Attest™ Super Rapid Readout Biological Indicator 1492V in conjunction with both the 3M™ Attest™ Auto-reader 490 or the Attest™ Auto-reader 490H having software version 4.0.0 or greater to qualify or monitor dynamic-air-removal steam sterilization cycles of:
- · 3 minutes at 270°F (132°C)
- · 4 minutes at 270°F (132°C)
- · 3 minutes at 275°F (135°C)
Product codes
FRC
Device Description
The 3M™ Attest™ Super Rapid Readout Biological Indicator 1492V is a self-contained biological indicator (BI) specifically designed to be used with the 3M™ Attest™ Auto-reader 490 or the 3M™ Attest™ Auto-reader 490H (software version 4.0.0 or greater) to qualify or routinely challenge dynamic-air-removal steam sterilization cycles at 132°C and 135°C.
The 1492V BI is a single-use device composed of a polycarbonate sleeve containing a spore carrier and media ampoule, enclosed with a cap. On each 1492V 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 the 1492V 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)
Nonclinical 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 (R)2015 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
Key Results:
- Positive Control: Passed
- Survival Time: Passed (132°C ≥ 2.07 minutes, 135°C ≥ 1.82 minutes)
- Kill Time: Passed (132°C ≤ 5.07 minutes, 135°C ≤ 4.45 minutes)
- Reduced Incubation Time: Passed (Meets FDA's requirements for Reduced Incubation Time with > 97% alignment with the conventional incubation time of 7 days for fluorescent result in 24 minutes and optional visual pH color change result in 48 hours)
- D-Value: Passed (D132°C ≥ 24 seconds, D135°C ≥ 21 seconds)
- Population (Total Viable Spore Count): Passed (≥ 10 spores)
- Component Inhibition Studies: Passed (Components have no impact on the recovery of 10-100 organisms)
- Hold Time Assessment: Passed (D-value does not change when activated 7 days post sterilization)
- Simulated Use: Passed (Verification of performance in claimed cycles)
- Auto-reader Maintenance of Incubation Temperature: Passed (Maintain 60 ± 2°C over a period of 7 days)
The results showed that the 3M™ Attest™ Super Rapid Readout Biological Indicator 1492V, when used with the 3M™ 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 Attest™ Auto-readers 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
- 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
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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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 19, 2018
3M Health Care Ms. Hilary B. Hovde Regulatory Affairs Associate 3M Center, Bldg. 275-5W-06 St. Paul, MN 55144-1000
Re: K173437
Trade/Device Name: 3MTM Attest™ Super Rapid Readout Biological Indicator 1492V 3MTM Attest™ Auto-reader 490 3MTM Attest™ Auto-reader 490H Regulation Number: 21 CFR 880.2800 Biological Sterilization Process Indicator Regulation Name: Regulatory Class: Class II Product Code: FRC Dated: February 12, 2018 Received: February 14, 2018
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 or any Federal statutes and regulations administered by other Federal agencies. You must comply
1
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,
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) K173437
Device Name
3M™ Attest™ Super Rapid Readout Biological Indicator 1492V, 3M™ Attest™ Auto-reader 490, and 3M™ Attest™ Auto-reader 490H
Indications for Use (Describe)
Use the 3M™ Attest™ Super Rapid Readout Biological Indicator 1492V in conjunction with both the 3M™ Attest™ Auto-reader 490 or the Attest™ Auto-reader 490H having software version 4.0.0 or greater to qualify or monitor dynamic-air-removal steam sterilization cycles of:
- · 3 minutes at 270°F (132°C)
- · 4 minutes at 270°F (132°C)
- · 3 minutes at 275°F (135°C)
| 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 3MTM Attest™ Super Rapid Readout Biological Indicator 1492V, 3MTM Attest™ Auto-reader 490, and 3MTM 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: March 16, 2018
4
Device Name and Classification:
| Common or Usual Name: | Biological Indicator |
|---|---|
| Proprietary Name: | 3M™ Attest™ Super Rapid Readout Biological Indicator 1492V |
| 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 1492V and 3MTM Attest™ Auto-reader 490, K121484
Reference Device:
- 3MTM Attest™ Auto-reader 490H, K171003 . (490 Auto-reader will be shown to be identical to the 490H Auto-reader)
Indications for Use
Use the 3M™ Attest™ Super Rapid Readout Biological Indicator 1492V in conjunction with both the 3M™ Attest™ Auto-reader 490 or the Attest™ Auto-reader 490H having software version 4.0.0 or greater to qualify or monitor dynamic-air-removal steam sterilization cycles of:
- 3 minutes at 270°F (132°C) .
- 4 minutes at 270°F (132°C) ●
- 3 minutes at 275°F (135°C) .
Description of Device:
The 3M™ Attest™ Super Rapid Readout Biological Indicator 1492V is a self-contained biological indicator (BI) specifically designed to be used with the 3M™ Attest™ Auto-reader 490 or the 3M™ Attest™ Auto-reader 490H (software version 4.0.0 or greater) to qualify or routinely challenge dynamic-air-removal steam sterilization cycles at 132°C and 135°C.
The 1492V BI is a single-use device composed of a polycarbonate sleeve containing a spore carrier and media ampoule, enclosed with a cap. On each 1492V 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 the 1492V BI in the 490 Auto-reader or the 490H Auto-reader (software version 4.0.0 or greater) indicates a sterilization failure.
5
Nonclinical Comparison to the Predicate Device
This submission is addressing an expansion to the indications for use to include qualifying or monitoring dynamic-air-removal steam sterilization cycles of 3 minutes at 270°F (132°C), a software change to the 3M™ Attest™ Auto-reader 490 to reduce the final fluorescent readout for the 1492V BI from 1 hour to 24 minutes, and to change the incubation temperature from 56°C to 60°C. The Model 490 Auto-reader is now identical to the Model 490H Auto-reader (software version 4.0.0 or greater) as it incubates at the same temperature and uses the same software. The 3M™ Attest™ Super Rapid Readout Biological Indicator 1492V is the same design as the previously cleared device of the same model number. The device has the same materials and fundamental scientific technology.
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 (R)2015 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™ Super Attest™ Rapid Readout Biological Indicator 1492V in conjunction with the 3M™ Attest™ Auto-reader 490 with a final fluorescent readout of 24 minutes and an incubation temperature of 60°C (i.e., identical to the Model 490H Auto-reader having software version 4.0.0 or greater) is demonstrated in the following tests:
6
| 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 | Passed |
| 132°C ≥ 2.07 minutes | |
| 135°C ≥ 1.82 minutes | |
| Kill Time = Calculated kill time* at 132°C and at 135°C |
- ISO 11138-1:2017, Annex E | Passed
132°C ≤ 5.07 minutes
135°C ≤ 4.45 minutes |
| 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 48 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
D132°C ≥ 24 seconds
D135°C ≥ 21 seconds |
| 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 |
| Hold Time Assessment
D-value does not change when activated 7 days post sterilization | Passed |
| Simulated Use
Verification of performance in claimed cycles | Passed |
| Auto-reader Maintenance of Incubation Temperature
Maintain 60 ± 2°C over a period of 7 days | Passed |
The results of these evaluations showed that the 3M™ Attest™ Super Rapid Readout Biological Indicator 1492V, when used with the 3M™ 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 Attest™ Auto-readers 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
7
Summary of Clinical Testing
No clinical data was included in this premarket application submission.
| | Submission Device: | Predicate Device
(K121484): | Reference Device
(K171003): |
|-----------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Feature | 3MTM AttestTM
Super Rapid Readout
Biological Indicator
1492V and
3MTM AttestTM Auto-
reader 490 and 490H | 3MTM AttestTM
Super Rapid Readout
Biological Indicator
1492V and
3MTM AttestTM Auto-
reader 490 | 3MTM AttestTM
Auto-reader 490H |
| Indications for use | Use the 3MTM AttestTM
Super Rapid Readout
Biological Indicator
1492V 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 qualify or
monitor dynamic-air-
removal steam
sterilization cycles of:
• 3 minutes at
270°F (132°C)
• 4 minutes at
270°F (132°C)
• 3 minutes at
275°F (135°C) | Use the 3MTM AttestTM
Super Rapid Readout
Biological Indicator
1492V in conjunction
with the 3MTM AttestTM
Auto-reader 490 to
qualify or monitor
dynamic-air-removal
(pre-vacuum) steam
sterilization cycles of 4
minutes at 270°F (132°C)
and 3 minutes at 275°F
(135°C).
The 3MTM AttestTM 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. | 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.
- Reference Device is 3MTM
AttestTM Auto-reader 490H
Only. |
| Organism | Geobacillus stearothermophilus
traceable to ATCCTM
7953 | Identical | N/A- Reference Device is
3MTM AttestTM Auto-reader
490H Only |
| Viable spore
population | ≥ 1 x 106 | Identical | N/A- Reference Device is
3MTM AttestTM Auto-reader
490H Only |
| Resistance
characteristics | | Identical | N/A- Reference Device is
3MTM AttestTM Auto-reader
490H Only |
| • D-value
• Survival/Kill
Window | | | |
| | D-value ≥ 10 seconds at
132°C
D-value ≥ 8 seconds at
135°C
Survival Time =
Calculated survival time*
or 1 minute at 132°C and
40 seconds at 135°C,
whichever is longer | | |
| Feature | Submission Device:
3MTM AttestTM
Super Rapid Readout
Biological Indicator
1492V and
3MTM AttestTM Auto-
reader 490 and 490H | Predicate Device
(K121484): | Reference Device
(K171003):
3MTM AttestTM
Auto-reader 490H |
| | Kill Time = Calculated
kill time* at 132°C and at
135°C | | |
| Carrier material | polypropylene | Identical | N/A- Reference Device is
3MTM AttestTM Auto-reader
490H Only |
| Incubation
temperature | 60 ± 2°C | 56 ± 2°C | 60 ± 2°C |
| Readout time | 24 minute final
fluorescent result in both
the 490 and 490H Auto-
readers having software
version 4.0.0 or greater.
1 hour final fluorescent
result in 490 Auto-readers
having software versions
less than 4.0.0.
Optional visual pH color
change result in 48 hours | 1 hour final fluorescent
result in 490 Auto-
readers.
Identical | 24 minute fluorescence result
of 3MTM AttestTM 1295 BI read
in the 3MTM AttestTM Auto-
reader 490H. |
| Chemical indicator | Turns from pink to light
brown or darker upon
steam exposure | Identical | N/A- Reference Device is
3MTM AttestTM Auto-reader
490H Only |
| Shelf-life | 21 months | Identical | N/A- Reference Device is
3MTM AttestTM Auto-reader
490H Only |
| Design Function | Submission Device: | Reference Device: | Predicate Device |
| or | 3MTM AttestTM | (K171003) 3MTM AttestTM | (K121484): 3MTM AttestTM |
| Characteristic | Auto-reader 490 | Auto-reader 490H | Auto-reader 490 |
| Statement of
Intended Use | The 3MTM AttestTM 490
Auto-reader is designed to
incubate and automatically
read the 3MTM AttestTM
Super Rapid Readout
Biological Indicator 1492V
at 60°C for a final
fluorescent result at 24
minutes. | The 3MTM AttestTM 490H
Auto-reader is designed to
incubate and automatically
read the 3MTM AttestTM
Rapid Readout Biological
Indicator 1295 at 60°C for a
final fluorescent result at 24
minutes. | The 3MTM AttestTM 490
Auto-reader is designed to
incubate and automatically
read the 3MTM AttestTM
Super Rapid Readout
Biological Indicator 1492V at
56°C for a final fluorescent
result at 1 hour. |
| Incubation
temperature | 60 ± 2°C | Identical to Submission
Device | 56 ± 2°C |
| Rapid Readout
Capability | Yes | Identical | Identical |
| Basis of Rapid
Readout | Fluorescence of biological
medium | Identical | Identical |
| Use with
Biological
Indicators | 3MTM AttestTM Super
Rapid Readout Biological
Indicator 1492V. | 3MTM AttestTM Rapid
Readout Biological Indicator
-
| Identical to Submission
Device |
| Method of
Fluorescence
Detection | UV LED, optical filters,
with sensing by photo
diode | Identical | Identical |
| Identification of
(+) Result | Fluorescence measurement
and 24 minute readout
algorithm | Fluorescence measurement
and 24 minute readout
algorithm | Fluorescence measurement
and 1 hour readout algorithm |
| Visual Indicator
of Adequate
Sterilization
Cycle | (-) on LCD Display | Identical | Identical |
| Visual Indicator
of Possible
Sterilization
Cycle Failure | (+) on LCD Display | Identical | Identical |
| Audible
Indicator of
Possible
Sterilization
Cycle Failure | Audible Alarm | Identical | Identical |
| Number of
Incubation Wells | 10 incubation wells/reader | Identical | Identical |
| Voltage Range | 100-240 Volts AC (12 Volt
DC conversion for internal
circuitry) | Identical | Identical |
| Calibration | No calibration.
Fluorescent baseline
measured independently
for each BI placed in well. | Identical | Identical |
| Design Function
or | Submission Device:
3MTM Attest™
Auto-reader 490 | Reference Device:
(K171003) 3MTM Attest™
Auto-reader 490H | Predicate Device
(K121484): 3MTM Attest™
Auto-reader 490 |
| Characteristic | | | |
| | Software monitors
incubation duration | Identical | Identical |
| | Software performs reading
of BI | Identical | Identical |
| System
Operation | Software allows user to
view status remotely via
Ethernet | Identical | Identical |
| | Software allows 100 most
recent results to be stored
electronically in the reader | Identical | Identical |
| Product Safety | UL/IEC 61010-1 | Identical | Identical |
| EMC
Compliance | FCC Part 15, Subpart B,
Class A | Identical | Identical |
| Preventative
Maintenance | None | Identical | Identical |
Comparison to Predicate and Reference Devices
8
- per ISO 11138-1:2017, Annex E
9
3M™ Attest™ Auto-reader Comparison to Predicate and Reference Auto-readers
10
Conclusion
Based on the intended use, technological characteristics, performance data, and non-clinical tests performed, the subject device is substantially equivalent to, and is as safe and as effective as the legally marketed predicate devices, the 3M™ Attest™ Super Rapid Readout Biological Indicator 1492V and the 3M™ Attest™ Auto-reader 490 cleared under K121484, Class II (21 CFR 880.2800), product code FRC.