(136 days)
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)
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.
The provided text describes the 3M™ Attest™ Super Rapid Readout Biological Indicator 1492V, 3M™ Attest™ Auto-reader 490, and 3M™ Attest™ Auto-reader 490H. This is a Class II medical device used for monitoring steam sterilization cycles.
Here's an analysis of the acceptance criteria and the study proving the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (from text) | Reported Device Performance (from text) |
|---|---|
| Biological Indicator 1492V Performance: | |
| Positive Control Test | Passed |
| Survival Time (132°C) | ≥ 2.07 minutes |
| Survival Time (135°C) | ≥ 1.82 minutes |
| Kill Time (132°C) calculated per ISO 11138-1:2017, Annex E | ≤ 5.07 minutes |
| Kill Time (135°C) calculated per ISO 11138-1:2017, Annex E | ≤ 4.45 minutes |
| Reduced Incubation Time (>97% alignment with 7-day conventional incubation) - Fluorescent result in 24 minutes | Passed |
| Reduced Incubation Time (>97% alignment with 7-day conventional incubation) - Optional visual pH color change result in 48 hours | Passed |
| D-Value (at 132°C) | ≥ 24 seconds (Acceptance criteria: ≥ 10 seconds) |
| D-Value (at 135°C) | ≥ 21 seconds (Acceptance criteria: ≥ 8 seconds) |
| Population (Total Viable Spore Count) | ≥ 10^6 spores (Acceptance criteria: ≥ 10^6 spores) |
| Component Inhibition Studies (no impact on 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 490/490H Performance: | |
| Incubation Temperature Maintenance (60 ± 2°C over 7 days) | Passed |
| Compliance to IEC 61010-1 (2010), IEC 61010-2-010 (2014) | Verified by Underwriters Laboratory |
| Compliance to FCC Part 15, Subpart B, Class A | Passed |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state a specific "test set" sample size in terms of number of biological indicators or cycles tested for all the non-clinical tests. However, it indicates that testing was conducted following FDA guidance and relevant ISO/ANSI standards, which typically specify minimum sample sizes for such evaluations.
Regarding data provenance: The studies are non-clinical bench and laboratory tests, meaning the data was generated in a controlled testing environment, not from patient populations. There is no information about country of origin of the data provided, but the submission is to the U.S. FDA by 3M Health Care, St. Paul, MN, USA. The data is prospective in the sense that it was generated specifically for this submission to demonstrate compliance with performance and safety standards.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
This information is not applicable as the device is a biological indicator system, not an AI or diagnostic device that relies on expert human interpretation for establishing ground truth for test sets. The "ground truth" for these tests is based on objective, quantifiable biological and physical parameters (e.g., spore kill, fluorescence detection, temperature stability) governed by established international standards like ISO 11138-1 and ISO 11138-3.
4. Adjudication Method for the Test Set:
This is not applicable for the reasons stated above. The tests performed are objective and do not involve human interpretation requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
This is not applicable. The device is an automated biological indicator system, not a device intended for interpretation by human readers, nor does it incorporate AI for diagnostic or interpretive purposes in the context of human "reading." Therefore, no MRMC study was performed or is relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
The device (3M™ Attest™ Auto-reader 490/490H) is inherently a standalone automated system for reading the biological indicators. The "algorithm" (software version 4.0.0 or greater) in the auto-reader automatically detects fluorescence and provides a result (positive/negative) at 24 minutes without human intervention in the reading process itself. The non-clinical tests described demonstrate the performance of this system (biological indicator + auto-reader) in a standalone capacity.
7. The Type of Ground Truth Used:
The ground truth used for proving the device performance relies on:
- Biological Viability: The presence or absence of viable Geobacillus stearothermophilus spores after exposure to sterilization cycles, as determined by growth and metabolic activity leading to fluorescence. This is the fundamental "ground truth" for biological indicators.
- Physical Measurements: Precisely controlled temperature and time exposures during resistance testing to establish D-values, survival times, and kill times according to ISO standards.
- Established Standards: Adherence to defined parameters and methodologies dictated by ISO 11138 series, USP chapters, and FDA guidance for biological indicators.
8. The Sample Size for the Training Set:
This information is not explicitly provided in the document. However, "training set" is typically a term used for machine learning or AI models. Given that this device is a biological indicator system and auto-reader, its underlying principles are based on biological and chemical reactions and established parameters, not on machine learning requiring a training set in the conventional sense. The "training" of the system would be its design and calibration based on known biological and chemical properties of Geobacillus stearothermophilus and its interaction with the growth medium and the auto-reader's detection mechanism.
9. How the Ground Truth for the Training Set Was Established:
As mentioned above, the concept of a "training set" in the context of AI/ML is not directly applicable here. The "ground truth" for the development and validation of the biological indicator and auto-reader system would be established through extensive foundational research in microbiology, sterilization science, and optical detection technology. This would involve:
- Microbiological Standards: Using certified strains of Geobacillus stearothermophilus (traceable to ATCC™ 7953) with known resistance characteristics.
- Controlled Sterilization Cycles: Running precisely controlled steam sterilization cycles with varying conditions to determine spore survival and kill rates.
- Fluorescence Detection Principles: Understanding the biochemical reactions that lead to fluorescence in the presence of viable spores and designing the auto-reader's optics to reliably detect this signal.
- Calibration: Calibrating the auto-reader's detection threshold and timing based on these established biological and chemical principles to accurately differentiate between sterile and non-sterile conditions.
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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
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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
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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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Image /page/3/Picture/1 description: The image shows the 3M logo. The logo is in red and features the number 3 followed by the letter M. The number 3 is larger than the letter M. The logo is simple and recognizable.
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
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Device Name and Classification:
| Common or Usual Name: | Biological Indicator |
|---|---|
| Proprietary Name: | 3M™ Attest™ Super Rapid Readout Biological Indicator 1492V3M™ Attest™ Auto-reader 4903M™ 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.
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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 <1035> Biological Indicators for Sterilization and Chapter <55> 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:
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| 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 | Passed132°C ≥ 2.07 minutes135°C ≥ 1.82 minutes |
| Kill Time = Calculated kill time* at 132°C and at 135°C* ISO 11138-1:2017, Annex E | Passed132°C ≤ 5.07 minutes135°C ≤ 4.45 minutes |
| Reduced Incubation TimeMeets 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-ValueGreater than or equal to 10 seconds at 132°CGreater than or equal to 8 seconds at 135°C | PassedD132°C ≥ 24 secondsD135°C ≥ 21 seconds |
| Population (Total Viable Spore Count)Greater than or equal to 106 spores | Passed |
| Component Inhibition StudiesComponents have no impact on the recovery of 10-100 organisms | Passed |
| Hold Time AssessmentD-value does not change when activated 7 days post sterilization | Passed |
| Simulated UseVerification of performance in claimed cycles | Passed |
| Auto-reader Maintenance of Incubation TemperatureMaintain 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
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Summary of Clinical Testing
No clinical data was included in this premarket application submission.
| Submission Device: | Predicate Device(K121484): | Reference Device(K171003): | |
|---|---|---|---|
| Feature | 3MTM AttestTMSuper Rapid ReadoutBiological Indicator1492V and3MTM AttestTM Auto-reader 490 and 490H | 3MTM AttestTMSuper Rapid ReadoutBiological Indicator1492V and3MTM AttestTM Auto-reader 490 | 3MTM AttestTMAuto-reader 490H |
| Indications for use | Use the 3MTM AttestTMSuper Rapid ReadoutBiological Indicator1492V in conjunctionwith both the 3MTMAttestTM Auto-reader 490or the AttestTM Auto-reader 490H havingsoftware version 4.0.0 orgreater to qualify ormonitor dynamic-air-removal steamsterilization cycles of:• 3 minutes at270°F (132°C)• 4 minutes at270°F (132°C)• 3 minutes at275°F (135°C) | Use the 3MTM AttestTMSuper Rapid ReadoutBiological Indicator1492V in conjunctionwith the 3MTM AttestTMAuto-reader 490 toqualify or monitordynamic-air-removal(pre-vacuum) steamsterilization cycles of 4minutes at 270°F (132°C)and 3 minutes at 275°F(135°C).The 3MTM AttestTM SuperRapid Readout BiologicalIndicator 1492V providesa final fluorescent resultin 1 hour. An optionalvisual pH color changeresult is observed in 48hours. | Use the 3MTM AttestTM RapidReadout Biological Indicator1295 in conjunction with the3MTM AttestTM Auto-reader490H* as a standard method ofroutine monitoring of vaporizedhydrogen peroxide sterilizationprocesses in the Amsco® V-PRO® maX Low TemperatureSterilization System (Lumen,Non Lumen, and Flexiblecycles), and in STERRAD®100S, STERRAD® NX®(Standard and Advancedcycles) and STERRAD®100NX® (Standard, Flex,Express and Duo cycles)systems.* Reference Device is 3MTMAttestTM Auto-reader 490HOnly. |
| Organism | Geobacillus stearothermophilustraceable to ATCCTM7953 | Identical | N/A- Reference Device is3MTM AttestTM Auto-reader490H Only |
| Viable sporepopulation | ≥ 1 x 106 | Identical | N/A- Reference Device is3MTM AttestTM Auto-reader490H Only |
| Resistancecharacteristics | Identical | N/A- Reference Device is3MTM AttestTM Auto-reader490H Only | |
| • D-value• Survival/KillWindow | |||
| D-value ≥ 10 seconds at132°CD-value ≥ 8 seconds at135°CSurvival Time =Calculated survival time*or 1 minute at 132°C and40 seconds at 135°C,whichever is longer | |||
| Feature | Submission Device:3MTM AttestTMSuper Rapid ReadoutBiological Indicator1492V and3MTM AttestTM Auto-reader 490 and 490H | Predicate Device(K121484): | Reference Device(K171003):3MTM AttestTMAuto-reader 490H |
| Kill Time = Calculatedkill time* at 132°C and at135°C | |||
| Carrier material | polypropylene | Identical | N/A- Reference Device is3MTM AttestTM Auto-reader490H Only |
| Incubationtemperature | 60 ± 2°C | 56 ± 2°C | 60 ± 2°C |
| Readout time | 24 minute finalfluorescent result in boththe 490 and 490H Auto-readers having softwareversion 4.0.0 or greater.1 hour final fluorescentresult in 490 Auto-readershaving software versionsless than 4.0.0.Optional visual pH colorchange result in 48 hours | 1 hour final fluorescentresult in 490 Auto-readers.Identical | 24 minute fluorescence resultof 3MTM AttestTM 1295 BI readin the 3MTM AttestTM Auto-reader 490H. |
| Chemical indicator | Turns from pink to lightbrown or darker uponsteam exposure | Identical | N/A- Reference Device is3MTM AttestTM Auto-reader490H Only |
| Shelf-life | 21 months | Identical | N/A- Reference Device is3MTM AttestTM Auto-reader490H 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 ofIntended Use | The 3MTM AttestTM 490Auto-reader is designed toincubate and automaticallyread the 3MTM AttestTMSuper Rapid ReadoutBiological Indicator 1492Vat 60°C for a finalfluorescent result at 24minutes. | The 3MTM AttestTM 490HAuto-reader is designed toincubate and automaticallyread the 3MTM AttestTMRapid Readout BiologicalIndicator 1295 at 60°C for afinal fluorescent result at 24minutes. | The 3MTM AttestTM 490Auto-reader is designed toincubate and automaticallyread the 3MTM AttestTMSuper Rapid ReadoutBiological Indicator 1492V at56°C for a final fluorescentresult at 1 hour. |
| Incubationtemperature | 60 ± 2°C | Identical to SubmissionDevice | 56 ± 2°C |
| Rapid ReadoutCapability | Yes | Identical | Identical |
| Basis of RapidReadout | Fluorescence of biologicalmedium | Identical | Identical |
| Use withBiologicalIndicators | 3MTM AttestTM SuperRapid Readout BiologicalIndicator 1492V. | 3MTM AttestTM RapidReadout Biological Indicator1295. | Identical to SubmissionDevice |
| Method ofFluorescenceDetection | UV LED, optical filters,with sensing by photodiode | Identical | Identical |
| Identification of(+) Result | Fluorescence measurementand 24 minute readoutalgorithm | Fluorescence measurementand 24 minute readoutalgorithm | Fluorescence measurementand 1 hour readout algorithm |
| Visual Indicatorof AdequateSterilizationCycle | (-) on LCD Display | Identical | Identical |
| Visual Indicatorof PossibleSterilizationCycle Failure | (+) on LCD Display | Identical | Identical |
| AudibleIndicator ofPossibleSterilizationCycle Failure | Audible Alarm | Identical | Identical |
| Number ofIncubation Wells | 10 incubation wells/reader | Identical | Identical |
| Voltage Range | 100-240 Volts AC (12 VoltDC conversion for internalcircuitry) | Identical | Identical |
| Calibration | No calibration.Fluorescent baselinemeasured independentlyfor each BI placed in well. | Identical | Identical |
| Design Functionor | 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 monitorsincubation duration | Identical | Identical | |
| Software performs readingof BI | Identical | Identical | |
| SystemOperation | Software allows user toview status remotely viaEthernet | Identical | Identical |
| Software allows 100 mostrecent results to be storedelectronically in the reader | Identical | Identical | |
| Product Safety | UL/IEC 61010-1 | Identical | Identical |
| EMCCompliance | FCC Part 15, Subpart B,Class A | Identical | Identical |
| PreventativeMaintenance | None | Identical | Identical |
Comparison to Predicate and Reference Devices
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- per ISO 11138-1:2017, Annex E
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3M™ Attest™ Auto-reader Comparison to Predicate and Reference Auto-readers
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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.
§ 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).