(90 days)
The 3M™ Attest™ Mini Auto-reader 490M is designed to incubate and automatically read 3MM Attest™ Rapid Readout Biological Indicators 1295 and 3M™ Attest™ Super Rapid Readout Biological Indicators, catalog numbers 1491 and 1492V, at 60°C for a final fluorescent result at 24 minutes.
The following Indications for Use are proposed for the 3M™ Attest™ Super Rapid Readout Biological Indicators 1491 and 1492V, as well as the vaporized hydrogen peroxide biological indicator, 3M™ Attest™ Rapid Readout Biological Indicator 1295. The only change to the previously cleared indications for the Mini Auto-reader 490M as being able to be used in conjunction with each of the BIs:
Use the 3M™ Attest™ Super Rapid Readout Biological Indicator 1491 in conjunction with the 3M™ Attest™ 490/490H Auto-reader or 3M™ Attest™ Mini Auto-reader 490M to monitor gravity displacement steam sterilization cycles of 3 minutes at 270°F (132°C), 10 minutes at 270°F (132°C), 3 minutes at 275°F (135°C) and 10 minutes at 275°F (135°C). An optional visual pH color change result is observed in 24 hours.
Use the 3M™ Attest™ Super Rapid Readout Biological Indicator 1492V in conjunction with the 3MTM Attest™ 490/490H Auto-reader or 3M™ Attest™ Mini Auto-reader 490M to qualify or monitor dynamic-air-removal (prevacuum) steam sterilization cycles of 4 minutes at 270°F (132°C) and 3 minutes at 275°C). An optional visual pH color change result is observed in 48 hours.
Use 3M™ Attest™ Rapid Readout Biological Indicator 1295 in conjunction with the 3M™ Attest™ 490/490H Autoreader or 3M™ Attest™ Mini Auto-reader 490M as a standard method of routine monitoring of vaporized hydrogen peroxide sterilization processes in the following systems: AMSCO® V-PRO™ 1 Low Temperature Sterilization System (Lumen cycle), AMSCO® V-PRO™ 1 Plus Low Temperature Sterilization System (Lumen and Non Lumen cycles), AMSCO® V-PRO™ maX Low Temperature Sterilization System (Lumen, and Flexible cycles), AMSCO® VPRO™ 60 Low Temperature Sterilization System (Lumen and Flexible cycles) and in STERRAD® 100S, STERRAD® NX (Standard and Advanced cycles), STERRAD® 100NX (Standard, Flex, Express and Duo cycles) systems, STERRAD® NX with ALLClear™ Technology (Standard and Advanced cycles) and STERRAD® 100NX with ALLClear™ Technology (Standard, Flex, Express and Duo cycles). An optional visual pH color change result is observed in 7 days.
The 3M™ Attest™ Mini Auto-reader 490M is a compact, 4-well incubator for processing the steam biological indicators 3M™ Attest™ Super Rapid Readout Biological Indicators 1491 and 1492V, as well as the vaporized hydrogen peroxide biological indicator, 3M™ Attest™ Rapid Readout Biological Indicator 1295. These biological indicators (BIs) are used to monitor sterilization processing equipment. After a sterilization cycle is complete, the Bls are removed from the sterilizer, cooled as needed, activated, and placed into any available well in the Mini Auto-reader 490M. Incubation starts automatically, UV fluorescence, measured during each interval, is analyzed by measuring fluorescent by-product of enzyme that occurs naturally during biological growth of the spore. The maximum time-to-result is 24 minutes at 600C. An LED array on the front panel will display the time remaining for each BI, the result (positive or negative), and any error codes that occur. The device includes USB connectivity for in-field firmware updates, downloading data, and communicating to third party instrument tracking systems.
The 3MM Attest™ Mimi Auto-reader 490M is indicated to work as a system with the 1491, 1492V, and is not compatible with other BIs.
Here's a breakdown of the acceptance criteria and study information for the 3M™ Attest™ Mini Auto-reader 490M, based on the provided FDA 510(k) summary:
Acceptance Criteria and Device Performance
The core acceptance criteria for the 3M™ Attest™ Mini Auto-reader 490M are based on its ability to accurately incubate and read specific 3M™ Attest™ Biological Indicators (BIs) to provide fluorescent results within a specified timeframe. The device's performance is compared against a predicate device (3M™ Attest™ 490/490H Auto-reader) and established safety and electromagnetic compatibility standards.
Table of Acceptance Criteria and Reported Device Performance:
| Feature/Criterion | Acceptance Criteria (Implied / Predicate Performance) | Reported Device Performance (3M™ Attest™ Mini Auto-reader 490M) |
|---|---|---|
| Intended Use | Designed to incubate and automatically read 3M™ Attest™ Super Rapid Readout Biological Indicator 1492V (for predicate) at 60°C for a final fluorescent result at 24 minutes. (Similar for 1491 and 1295 for other reference devices). | Designed to incubate and automatically read 3M™ Attest™ Rapid Readout Biological Indicators 1295 and 3M™ Attest™ Super Rapid Readout Biological Indicators 1491 and 1492V at 60°C for a final fluorescent result at 24 minutes. |
| Incubation Temperature | 60 ± 2º C | 60 ± 2º C |
| Readout Time | 24 minute final fluorescent result | 24 minute final fluorescent result |
| Fluorescence Detection | UV LED, optical filters, with sensing by photo diode | UV LED, photo diode with embedded optical filters |
| BI Compatibility | Each predicate/reference device was compatible with specific BIs (e.g., 1492V for K173437, 1491 for K173584, 1295 for K173435). | Compatible with 1491, 1492V, 1295. |
| Visual Indicator (Adequate Sterilization) | (-) on LCD display (for predicate) | (-) on dot matrix LED display (similar with different display technology) |
| Visual Indicator (Possible Sterilization Failure) | (+) on LCD display (for predicate) | (+) on dot matrix LED display (similar with different display technology) |
| Product Safety | Compliance to IEC 61010-1 (3rd Ed.) and IEC 61010-2-010 (3rd Ed.), IEC 62471 (2008) | Complies to IEC 61010-1 (2010) 3rd Edition; IEC 61010-2-010 (2014) 3rd Edition; IEC 62471 (2008). |
| EMC Compliance | Compliance to Title 47 CFR 15, Subclass B, for Class A type devices and IEC 61326-1 (2013) | Complies to Class A digital device pursuant to Part 15 of the FCC rules, and IEC 61326-1 (2013). |
| Comparative BI Performance | Predicate devices demonstrated adequate performance in positive control conditions, lethal sterilizer conditions (kill cycle), sub-lethal sterilizer conditions (survive cycle), and reduced incubation time. (Implied by substantial equivalence to predicate) | Demonstrated comparable performance to predicate: "Comparative BI performance was comprised of testing the 1491, 1492V, and 1295 BIs in both auto-readers under positive control conditions, lethal sterilizer conditions (kill cycle), sub-lethal sterilizer conditions (survive cycle), and reduced incubation time." |
| Analytical Sensitivity | Adequate analytical sensitivity using standard curves of reference dye solutions (Implied by substantial equivalence to predicate) | Tested using standard curves of reference dye solutions. |
| Signal-to-Noise Ratio | Adequate signal-to-noise measurements of fluorescent standards during incubation (Implied by substantial equivalence to predicate) | Tested using signal-to-noise measurements of fluorescent standards during incubation. |
| Fluorescence Background | Acceptable fluorescence background measurements (Implied by substantial equivalence to predicate) | Analysis of the fluorescence background measurements of both readers was performed. |
Study Details for Device Performance
The provided document doesn't detail a single, comprehensive "study" with specific sample sizes for test and training sets in a typical AI/software context. Instead, it describes nonclinical comparison testing to demonstrate substantial equivalence to a predicate device.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Test Set Sample Size: Not explicitly stated as a numerical sample size. The testing involved "testing the 1491, 1492V, and 1295 BIs in both auto-readers." This implies multiple BIs of each type were tested. The specific number of BIs and repetitions is not provided.
- Data Provenance: Not specified. The manufacturer (3M Company) is based in St. Paul, Minnesota, USA, suggesting the testing likely occurred in the USA or a controlled laboratory environment.
- Retrospective or Prospective: The nonclinical comparison testing described appears to be prospective testing, specifically designed to evaluate the new device against the predicate under controlled laboratory conditions.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This is not applicable to this type of device and study. The "ground truth" for a biological indicator reader is based on the known biological response of the biological indicator to sterilization conditions. Experts would be involved in designing the test protocols for sterilization cycles and interpreting the results, but not in establishing a subjective "ground truth" like in image interpretation tasks. Sterilization efficacy is objectively measured.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are typically used when subjective interpretations (like medical image diagnosis) require a consensus among multiple human readers. For this device, the "reading" is an automated fluorescent measurement.
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
Not applicable. This is not an AI-assisted diagnostic device that involves human readers. It is an automated reader for biological indicators.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, the described nonclinical comparison is a standalone (algorithm only) performance evaluation. The device (the auto-reader) automatically interprets the fluorescent signal from the biological indicators without human intervention in the reading process itself to determine a pass/fail result. Human users only activate the BI and place it into the reader, then read the final result displayed by the device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for the biological indicator testing is established by:
- Known Biological Response: The expected growth or no-growth of the Geobacillus stearothermophilus spores within the biological indicators under specific sterilization conditions.
- Controlled Sterilization Cycles: The tests involved "positive control conditions," "lethal sterilizer conditions (kill cycle)," and "sub-lethal sterilizer conditions (survive cycle)." These cycles are precisely controlled to known sterilization outcomes (i.e., complete kill or partial inactivation/survival leading to growth). The "ground truth" is therefore derived from the physical and biological conditions applied, not from human interpretation.
8. The sample size for the training set
Not applicable. This device is an auto-reader that performs fluorescent detection and signal processing based on a biological mechanism, not a machine learning or AI model that requires a "training set" in the conventional sense. The "training" for such a system would involve engineering and calibration against known fluorescent standards and biological responses.
9. How the ground truth for the training set was established
Not applicable, as there isn't a "training set" in the conventional machine learning sense. The device's "knowledge" is built into its hardware and firmware, based on established scientific principles of bioluminescence/fluorescence and the known growth characteristics of the biological indicator organisms. This involves:
- Biochemical principles: Understanding the enzyme activity and fluorescent byproduct generation.
- Sterilization science: Knowledge of how sterilization processes affect microorganisms.
- Calibration: Using known standards (e.g., reference dye solutions) to calibrate the fluorescent detection system.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
April 15, 2020
3m Andrew Wingen Regulatory Affairs Commercialization Strategy Lead 2510 Conway Ave, Bldg 275-5W-06 St. Paul, Minnesota 55144-1000
Re: K200092
Trade/Device Name: 3MTM Attest™ Mini Auto-reader 490M Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: Class II Product Code: FRC Dated: January 15, 2020 Received: January 16, 2020
Dear Andrew Wingen:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
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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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For Christopher K. Dugard, M.S. Acting Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K200092
Device Name
3MTM AttestTM Mini Auto-reader 490M
Indications for Use (Describe)
The 3M™ Attest™ Mini Auto-reader 490M is designed to incubate and automatically read 3MM Attest™ Rapid Readout Biological Indicators 1295 and 3M™ Attest™ Super Rapid Readout Biological Indicators, catalog numbers 1491 and 1492V, at 60°C for a final fluorescent result at 24 minutes.
The following Indications for Use are proposed for the 3M™ Attest™ Super Rapid Readout Biological Indicators 1491 and 1492V, as well as the vaporized hydrogen peroxide biological indicator, 3M™ Attest™ Rapid Readout Biological Indicator 1295. The only change to the previously cleared indications for the Mini Auto-reader 490M as being able to be used in conjunction with each of the BIs:
Use the 3M™ Attest™ Super Rapid Readout Biological Indicator 1491 in conjunction with the 3M™ Attest™ 490/490H Auto-reader or 3M™ Attest™ Mini Auto-reader 490M to monitor gravity displacement steam sterilization cycles of 3 minutes at 270°F (132°C), 10 minutes at 270°F (132°C), 3 minutes at 275°F (135°C) and 10 minutes at 275°F (135°C). An optional visual pH color change result is observed in 24 hours.
Use the 3M™ Attest™ Super Rapid Readout Biological Indicator 1492V in conjunction with the 3MTM Attest™ 490/490H Auto-reader or 3M™ Attest™ Mini Auto-reader 490M to qualify or monitor dynamic-air-removal (prevacuum) steam sterilization cycles of 4 minutes at 270°F (132°C) and 3 minutes at 275°C). An optional visual pH color change result is observed in 48 hours.
Use 3M™ Attest™ Rapid Readout Biological Indicator 1295 in conjunction with the 3M™ Attest™ 490/490H Autoreader or 3M™ Attest™ Mini Auto-reader 490M as a standard method of routine monitoring of vaporized hydrogen peroxide sterilization processes in the following systems: AMSCO® V-PRO™ 1 Low Temperature Sterilization System (Lumen cycle), AMSCO® V-PRO™ 1 Plus Low Temperature Sterilization System (Lumen and Non Lumen cycles), AMSCO® V-PRO™ maX Low Temperature Sterilization System (Lumen, and Flexible cycles), AMSCO® VPRO™ 60 Low Temperature Sterilization System (Lumen and Flexible cycles) and in STERRAD® 100S, STERRAD® NX (Standard and Advanced cycles), STERRAD® 100NX (Standard, Flex, Express and Duo cycles) systems, STERRAD® NX with ALLClear™ Technology (Standard and Advanced cycles) and STERRAD® 100NX with ALLClear™ Technology (Standard, Flex, Express and Duo cycles). An optional visual pH color change result is observed in 7 days.
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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Image /page/3/Picture/1 description: The image shows the 3M logo. The logo is red and consists of the number "3" and the letter "M" next to each other. The number "3" is larger than the letter "M". The logo is simple and recognizable.
510(k) Summary for 3M™ Attest™ Mini Auto-reader 490M K200092
Sponsor Information:
3M Company 3M Center, Bldg. 275-5W-06 St. Paul, MN 55144-1000
Contact: Andrew Wingen Regulatory Affairs Commercialization Strategy Lead Phone Number: (651) 733-9209 Fax Number: (651) 737-5320 Email: acwingen@mmm.com
Date of Summary: 14 January 2020
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1. Device Name and Classification:
| Common or Usual Name: | Biological Indicator Reader/Incubator |
|---|---|
| Proprietary Name: | 3MTM AttestTM Mini Auto-reader |
| Classification Name: | Accessory to Biological Sterilization Process Indicator |
| Device Classification: | Class II, 21 CFR § 880.2800(a) |
| Product Code: | FRC (Accessory) |
2. Predicate Device:
K173437 3M™ Attest™ 490/490H Auto-reader / 3MTM Attest™ Super Rapid Readout Biological Indicator 1492V
3. Description of Device:
The 3M™ Attest™ Mini Auto-reader 490M is a compact, 4-well incubator for processing the steam biological indicators 3M™ Attest™ Super Rapid Readout Biological Indicators 1491 and 1492V, as well as the vaporized hydrogen peroxide biological indicator, 3M™ Attest™ Rapid Readout Biological Indicator 1295. These biological indicators (BIs) are used to monitor sterilization processing equipment. After a sterilization cycle is complete, the Bls are removed from the sterilizer, cooled as needed, activated, and placed into any available well in the Mini Auto-reader 490M. Incubation starts automatically, UV fluorescence, measured during each interval, is analyzed by measuring fluorescent by-product of enzyme that occurs naturally during biological growth of the spore. The maximum time-to-result is 24 minutes at 600C. An LED array on the front panel will display the time remaining for each BI, the result (positive or negative), and any error codes that occur. The device includes USB connectivity for in-field firmware updates, downloading data, and communicating to third party instrument tracking systems.
The 3MM Attest™ Mimi Auto-reader 490M is indicated to work as a system with the 1491, 1492V, and is not compatible with other BIs.
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4. Indications for Use
The following Indications for Use are proposed for the Mini Auto-reader:
The 3M™ Attest™ Mini Auto-reader 490M is designed to incubate and automatically read 3MM Attest™ Rapid Readout Biological Indicators 1295 and 3M™ Attest™ Super Rapid Readout Biological Indicators, catalog numbers 1491 and 1492V, at 60°C for a final fluorescent result at 24 minutes.
The following Indications for Use are proposed for the 3M™ Attest™ Super Rapid Readout Biological Indicators 1491 and 1492V, as well as the vaporized hydrogen peroxide biological indicator, 3M™ Attest™ Rapid Readout Biological Indicator 1295. The only change to the previously cleared indications for these Bls is the addition of the Mini Auto-reader 490M as being able to be used in conjunction with each of the BIs:
Use the 3MM Attest™ Super Rapid Readout Biological Indicator 1491 in conjunction with the 3M™ Attest™ 490/490H Auto-reader or 3M™ Attest™ Mini Auto-reader 490M to monitor gravity displacement steam sterilization cycles of 3 minutes at 270°F (132°C), 10 minutes at 270°F (132°C), 3 minutes at 275°F (135°C) and 10 minutes at 275°F (135°C), An optional visual pH color change result is observed in 24 hours.
Use the 3MM Attest™ Super Rapid Readout Biological Indicator 1492V in conjunction with the 3M™ Attest™ 490/490H Auto-reader or 3M™ Attest™ Mini Auto-reader 490M to qualify or monitor dynamic-air-removal (pre-vacum) steam sterilization cycles of 4 minutes at 270°F (132°C) and 3 minutes at 275°F (135°C). An optional visual pH color change result is observed in 48 hours.
Use 3M™ Attest™ Rapid Readout Biological Indicator 1295 in conjunction with the 3M™ Attest™ 490/490H Autoreader or 3MTM Attest™ Mini Auto-reader 490M as a standard method of routine monitoring of vaporized hydrogen peroxide sterilization processes in the following systems: AMSCO® V-PRO™ 1 Low Temperature Sterilization System (Lumen cycle). AMSCO® V-PRO™ 1 Plus Low Temperature Sterilization System (Lumen cycles). AMSCO® V-PRO™ maX Low Temperature Sterilization System (Lumen, and Flexible cycles), AMSCO® VPRO™ 60 Low Temperature Sterilization System (Lumen and Flexible cycles) and in STERRAD® 100S, STERRAD® NX (Standard and Advanced cycles), STERRAD® 100NX (Standard, Flex, Express and Duo cycles) systems, STERRAD® NX with ALLClear™ Technology (Standard and Advanced cycles) and STERRAD® 100NX with ALLClear™ Technology (Standard, Flex, Express and Duo cycles). An optional visual pH color change result is observed in 7 days.
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5. Technical Characteristic Comparison Table
| DeviceIdentity | Proposed Device:3M™ Attest™ MiniAuto-reader / 3M™Attest™ Super RapidReadout BiologicalIndicators 1491 and1492V, 3M™Attest™ RapidReadout BiologicalIndicator 1295 | Predicate: 3M™Attest™ Super RapidReadout BiologicalIndicator 1492V / 3M™Attest™ 490/490HAuto-reader (K173437) | Reference: 3M™Attest™ SuperRapid ReadoutBiologicalIndicator 1491 /3M™ Attest™490/490H Auto-reader (K173584) | Reference: 3M™ Attest™Rapid Readout BiologicalIndicator 1295 / 3M™Attest™ 490H Auto-reader(K173435) | Comments |
|---|---|---|---|---|---|
| Intended Use | The 3M™ Attest™Mini Auto-reader isdesigned to incubateand automatically readthe 3M™ Attest™Super Rapid ReadoutBiological Indicators1491 and 1492V, aswell as 3M™ Attest™Rapid ReadoutBiological Indicator1295, at 60°C for afinal fluorescent resultat 24 minutes. | The 3M™ Attest™490/490H Auto-reader isdesigned to incubate andautomatically read the3M™ Attest™ SuperRapid Readout BiologicalIndicator 1492V at 60°Cfor a final fluorescentresult at 24 minutes. | The 3M™ Attest™490/490H Auto-reader is designed toincubate andautomatically readthe 3M™ Attest™Super RapidReadout BiologicalIndicator 1491 at60°C for a finalfluorescent result at24 minutes. | The 3M™ Attest™ 490HAuto-reader is designed toincubate and automaticallyread the 3M™ Attest™ RapidReadout Biological Indicator1295 at 60°C for a finalfluorescent result at 24minutes. | Identical |
| Indications forUse | The 3M™ Attest™Mini Auto-reader | Use the 3M™ Attest™Super Rapid ReadoutBiological Indicator1492V in conjunctionwith both the 3M™ | Use the 3M™Attest™ SuperRapid ReadoutBiological Indicator1491 in conjunction | Use the 3M™ Attest™ RapidReadout Biological Indicator1295 in conjunction with the3M™ Attest™ Auto reader490H as a standard method of | Similar |
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| 490M is designed toincubate andautomatically read3MTM AttestTM RapidReadout BiologicalIndicators 1295 and3MTM Attest™ SuperRapid ReadoutBiological Indicators,catalog numbers 1491and 1492V, at 60°Cfor a final fluorescentresult at 24 minutes.The indications for usefor Attest™ BiologicalIndicators areprovided in theproduct'sInstructions for Use. | Attest™ 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 at 270°F(132°C)4 minutes at 270°F(132°C)3 minutes at 275°F(135°C) | with the 3MTMAttestTM 490/490HAuto-reader tomonitor gravitydisplacement steamsterilization cyclesof 3 minutes at270°F (132°C), 10minutes at 270°F(132°C), 3 minutesat 275°F (135°C)and 10 minutes at275°F (135°C) | routine monitoring ofvaporized hydrogen peroxidesterilization processes in thefollowing systems:AMSCO® V-PROTM 1 LowTemperature SterilizationSystem (Lumen cycle),AMSCO® V-PROTM 1Plus Low TemperatureSterilization System (Lumenand Non Lumen cycles),AMSCO® V-PROTM maXLow TemperatureSterilization System (Lumen,Non Lumen, and Flexiblecycles), AMSCO® V-PROTM60 Low TemperatureSterilization System (Lumen,Non Lumen and Flexiblecycles) and in STERRAD®100S, STERRAD® NX(Standard and Advancedcycles),STERRAD® 100NX(Standard, Flex, Express andDuo cycles) systems,STERRAD® NX withALLClearTM Technology(Standard and Advancedcycles) and STERRAD®100NX with ALLClear™Technology (Standard, Flex,Express and Duo cycles) |
|---|---|---|---|
| -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
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| Method ofFluorescenceDetection | UV LED, photo diodewith embedded opticalfilters | UV LED, optical filters,with sensing by photodiode | UV LED, opticalfilters, with sensingby photo diode | UV LED, optical filters, withsensing by photo diode | Similar |
|---|---|---|---|---|---|
| Number ofIncubationWells | 4 incubationwells/reader | 10 incubationwells/reader | 10 incubationwells/reader | 10 incubation wells/reader | Different |
| IncubationTemperature | 60 ± 2º C | 60 ± 2º C | 60 ± 2º C | 60 ± 2º C | Identical |
| Readout Time | 24 minute finalfluorescent result | 24 minute finalfluorescent result | 24 minute finalfluorescent result | 24 minute final fluorescentresult | Identical |
| Optional visual pHcolor change result asfollows:1492V: 48 hours1491: 24 hours1295: 7 days | Optional visual pH colorchange result in 48 hours | Optional visual pHcolor change resultin 24 hours | Optional visual pH colorchange result in 7 days | ||
| ChemicalIndicator | 1491, 1492V - Turnsfrom pink to lightbrownor darker upon steamexposure1295 - Turns frombluetowards pink upon | 1492V - Turns from pinkto light brown or darkerupon steam exposure | 1491 - Turns frompink to light brownor darker uponsteam exposure | 1295 - Turns from bluetowards pink upon vaporizedhydrogenperoxide exposure | Identical |
| vaporized hydrogenperoxide exposure | |||||
| VisualIndicator ofAdequateSterilizationCycle | (-) on dot matrix LEDdisplay | (-) on LCD display | (-) on LCD display | (-) on LCD display | Similar |
| VisualIndicator ofPossibleSterilizationCycle Failure | (+) on dot matrix LEDdisplay | (+) on LCD display | (+) on LCD display | (+) on LCD display | Similar |
| AlarmFunction | Audible Alarm | Audible Alarm | Audible Alarm | Audible Alarm | Identical |
| Voltage Range | 100-240 Volts AC | 100-240 Volts AC | 100-240 Volts AC | 100-240 Volts AC | Identical |
| Calibration | No calibration -fluorescent baselinemeasuredindependently for eachBI placed in a well | No calibration -fluorescent baselinemeasured independentlyfor each BI placed in awell | No calibration -fluorescent baselinemeasuredindependently foreach BI placed in awell | No calibration - fluorescentbaseline measuredindependently for each BIplaced in a well | Identical |
| SystemOperation | Software monitorsincubation durationSoftware performsreading of BISoftware allowsresults to be stored | Software monitorsincubation duration | Software monitorsincubation duration | Software monitors incubationduration | Similar |
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| electronically in thereader | |||||
|---|---|---|---|---|---|
| SoftwareApplication | Software allows userto view statusremotely via USBconnection and PCapplication | Software allows user toview status remotely viaethernet | Software allows userto view statusremotely viaethernet | Software allows user to viewstatus remotely via ethernet | Similar |
| Cloud ServerConnection | Enabled via the USBconnection to the PC.Facilitates softwareapplication andfirmware updates. | Not present | Not present | Not present | Different |
| BI InsertionDetection | Detected by whiteLED and detector | Detected by photo-interrupter sensor | Detected by photo-interrupter sensor | Detected by photo-interruptersensor | Similar |
| Product Safety | IEC 61010-1,IEC 61010-2-010 | IEC 61010-1,IEC 61010-2-010 | IEC 61010-1,IEC 61010-2-010 | IEC 61010-1,IEC 61010-2-010 | Identical |
| EMCCompliance | Title 47 CFR 15,Subclass B, for ClassA type devicesIEC 61326-1 | Title 47 CFR 15,Subclass B, for Class Atype devicesIEC 61326-1 | Title 47 CFR 15,Subclass B, forClass A type devicesIEC 61326-1 | Title 47 CFR 15, Subclass B,for Class A type devicesIEC 61326-1 | Identical |
| PreventativeMaintenance | Area outside of wellscan be cleaned. Fullinstructions in usermanual. | Area outside of wells canbe cleaned. Fullinstructions in usermanual. | Area outside ofwells can becleaned. Fullinstructions in usermanual. | Area outside of wells can becleaned. Full instructions inuser manual. | Identical |
| BiologicalIndicatorCompatibility | 1491, 1492V, 1295 | 1492V | 1491 | 1295 | Identical |
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6. Nonclinical Comparison to the Predicate Device
The 3M™ Attest™ Mini Auto-reader 490M, like the predicate 3M™ Attest™ 490/490H Auto-reader, is designed to automatically read the 3M™ Attest™ Super Rapid Readout Biological Indicators 1491 and 1492V, as well as 3M™ Attest™ Rapid Readout Biological Indicator 1295, at 60°C for a final fluorescent result at 24 minutes. The hardware and firmware utilized by the Attest™ Mini Auto-reader 490M is similar to the predicate Attest™ 490/490H Auto-reader.
The 3M™ Attest™ Mini Auto-reader 490M has additional software functionality and cloud services functionality via the PC App, 3MTM Attest™ Connect, compared to the predicate 490/490H Auto-reader.
The functional areas of comparison of the submission and predicate auto-readers comprised of temperature testing, analytical sensitivity using standard curves of reference dye solutions, signal-to-noise measurements of fluorescent standards during incubation, and analysis of the fluorescence background measurements of both readers. Comparative BI performance was comprised of testing the 1491, 1492V, and 1295 Bls in both auto-readers under positive control conditions, lethal sterlizer conditions (kill cycle), sub-lethal sterilizer conditions (survive cycle), and reduced incubation time.
The Mini Auto-reader 490M was also tested for safety by Underwriters Laboratory and complies 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 the heating of materials.
- IEC 62471 (2008); Photobiological safety of lamps and lamp systems
The Mini Auto-reader 490M was tested for electromagnetic compatibility and complies to:
- Class A digital device pursuant to Part 15 of the FCC rules, and .
- IEC 61326-1 (2013); Electrical equipment for measurement, control and laboratory use EMC requirements. .
7. Conclusion
Based on the intended use, technological characteristics and non-clinical performance data, the 3MTM Autoreader 490M is as safe, as effective, and performs at least as well as or better than the predicate, the 3M™ Attest™ Autoreader 490/490H cleared under K173437, 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).