3MTM AttestTM Mini Auto-reader 490M

K200092 · 3M · FRC · Apr 15, 2020 · General Hospital

Device Facts

• Record ID: K200092
• Device Name: 3MTM AttestTM Mini Auto-reader 490M
• Applicant: 3M
• Product Code: FRC · General Hospital
• Decision Date: Apr 15, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.2800
• Device Class: Class 2

Intended Use

The 3M™ Attest™ Mini Auto-reader 490M is designed to incubate and automatically read 3M™ 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.

Device Story

Compact 4-well incubator for 3M Attest biological indicators (BIs). Processes BIs post-sterilization; user activates BI and inserts into well. Device automatically incubates at 60°C; monitors UV fluorescence via photo diode to detect enzymatic by-products of spore growth. Provides final result (positive/negative) at 24 minutes via LED display. Includes audible alarm for failures. Connects via USB to PC for data download, firmware updates, and integration with third-party tracking systems. Used in clinical settings to verify sterilization cycle efficacy; helps ensure patient safety by confirming sterilization of instruments.

Clinical Evidence

Bench testing only. Performance validated through analytical sensitivity testing using standard dye curves, signal-to-noise measurements of fluorescent standards, and fluorescence background analysis. Comparative BI performance testing conducted using 1491, 1492V, and 1295 indicators under positive control, lethal (kill), and sub-lethal (survive) sterilizer conditions. Safety and EMC compliance verified per IEC 61010-1, IEC 61010-2-010, IEC 62471, and IEC 61326-1.

Technological Characteristics

4-well incubator; UV LED and photo diode sensing with optical filters; 60°C incubation temperature; 100-240V AC power; USB connectivity for PC/cloud integration. Complies with IEC 61010-1, IEC 61010-2-010, IEC 62471, and IEC 61326-1. No calibration required; fluorescent baseline measured independently per well.

Indications for Use

Indicated for use with 3M™ Attest™ Rapid Readout Biological Indicators 1295, 1491, and 1492V to monitor steam (gravity displacement and dynamic-air-removal) and vaporized hydrogen peroxide sterilization cycles. Used by healthcare personnel to qualify or monitor sterilization equipment performance.

Regulatory Classification

Identification

Biological sterilization process indicator: 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. Physical/chemical sterilization process indicator: 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.

Predicate Devices

• 3M™ Attest™ 490/490H Auto-reader (K173437)

Reference Devices

• 3M™ Attest™ Super Rapid Readout Biological Indicator 1491 / 3M™ Attest™ 490/490H Auto-reader (K173584)
• 3M™ Attest™ Rapid Readout Biological Indicator 1295 / 3M™ Attest™ 490H Auto-reader (K173435)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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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# 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: [phone] Fax Number: [phone] Email: [e-mail]

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

| Device<br>Identity | Proposed Device:<br>3M™ Attest™ Mini<br>Auto-reader / 3M™<br>Attest™ Super Rapid<br>Readout Biological<br>Indicators 1491 and<br>1492V, 3M™<br>Attest™ Rapid<br>Readout Biological<br>Indicator 1295 | Predicate: 3M™<br>Attest™ Super Rapid<br>Readout Biological<br>Indicator 1492V / 3M™<br>Attest™ 490/490H<br>Auto-reader (K173437) | Reference: 3M™<br>Attest™ Super<br>Rapid Readout<br>Biological<br>Indicator 1491 /<br>3M™ Attest™<br>490/490H Auto-<br>reader (K173584) | Reference: 3M™ Attest™<br>Rapid Readout Biological<br>Indicator 1295 / 3M™<br>Attest™ 490H Auto-reader<br>(K173435) | Comments |
|------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|
| Intended Use | The 3M™ Attest™<br>Mini Auto-reader is<br>designed to incubate<br>and automatically read<br>the 3M™ Attest™<br>Super Rapid Readout<br>Biological Indicators<br>1491 and 1492V, as<br>well as 3M™ Attest™<br>Rapid Readout<br>Biological Indicator<br>1295, at 60°C for a<br>final fluorescent result<br>at 24 minutes. | The 3M™ Attest™<br>490/490H Auto-reader is<br>designed to incubate and<br>automatically read the<br>3M™ Attest™ Super<br>Rapid Readout Biological<br>Indicator 1492V at 60°C<br>for a final fluorescent<br>result at 24 minutes. | The 3M™ Attest™<br>490/490H Auto-<br>reader is designed to<br>incubate and<br>automatically read<br>the 3M™ Attest™<br>Super Rapid<br>Readout Biological<br>Indicator 1491 at<br>60°C for a final<br>fluorescent result at<br>24 minutes. | The 3M™ Attest™ 490H<br>Auto-reader is designed to<br>incubate and automatically<br>read the 3M™ Attest™ Rapid<br>Readout Biological Indicator<br>1295 at 60°C for a final<br>fluorescent result at 24<br>minutes. | Identical |
| Indications for<br>Use | The 3M™ Attest™<br>Mini Auto-reader | Use the 3M™ Attest™<br>Super Rapid Readout<br>Biological Indicator<br>1492V in conjunction<br>with both the 3M™ | Use the 3M™<br>Attest™ Super<br>Rapid Readout<br>Biological Indicator<br>1491 in conjunction | Use the 3M™ Attest™ Rapid<br>Readout Biological Indicator<br>1295 in conjunction with the<br>3M™ Attest™ Auto reader<br>490H as a standard method of | Similar |

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| 490M is designed to<br>incubate and<br>automatically read<br>3MTM AttestTM Rapid<br>Readout Biological<br>Indicators 1295 and<br>3MTM Attest™ Super<br>Rapid Readout<br>Biological Indicators,<br>catalog numbers 1491<br>and 1492V, at 60°C<br>for a final fluorescent<br>result at 24 minutes.<br><br>The indications for use<br>for Attest™ Biological<br>Indicators are<br>provided in the<br>product's<br>Instructions for Use. | Attest™ Auto-reader 490<br>or the AttestTM Auto-<br>reader 490H having<br>software version 4.0.0 or<br>greater to qualify or<br>monitor dynamic-air-<br>removal steam<br>sterilization cycles of:<br>3 minutes at 270°F<br>(132°C)<br>4 minutes at 270°F<br>(132°C)<br>3 minutes at 275°F<br>(135°C) | with the 3MTM<br>AttestTM 490/490H<br>Auto-reader to<br>monitor gravity<br>displacement steam<br>sterilization cycles<br>of 3 minutes at<br>270°F (132°C), 10<br>minutes at 270°F<br>(132°C), 3 minutes<br>at 275°F (135°C)<br>and 10 minutes at<br>275°F (135°C) | routine monitoring of<br>vaporized hydrogen peroxide<br>sterilization processes in the<br>following systems:<br>AMSCO® V-PROTM 1 Low<br>Temperature Sterilization<br>System (Lumen cycle),<br>AMSCO® V-PROTM 1<br>Plus Low Temperature<br>Sterilization System (Lumen<br>and Non Lumen cycles),<br>AMSCO® V-PROTM maX<br>Low Temperature<br>Sterilization System (Lumen,<br>Non Lumen, and Flexible<br>cycles), AMSCO® V-PROTM<br>60 Low Temperature<br>Sterilization System (Lumen,<br>Non Lumen and Flexible<br>cycles) and in STERRAD®<br>100S, STERRAD® NX<br>(Standard and Advanced<br>cycles),<br>STERRAD® 100NX<br>(Standard, Flex, Express and<br>Duo cycles) systems,<br>STERRAD® NX with<br>ALLClearTM Technology<br>(Standard and Advanced<br>cycles) and STERRAD®<br>100NX with ALLClear™<br>Technology (Standard, Flex,<br>Express and Duo cycles) |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

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| Method of<br>Fluorescence<br>Detection | UV LED, photo diode<br>with embedded optical<br>filters | UV LED, optical filters,<br>with sensing by photo<br>diode | UV LED, optical<br>filters, with sensing<br>by photo diode | UV LED, optical filters, with<br>sensing by photo diode | Similar |
|----------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|-----------|
| Number of<br>Incubation<br>Wells | 4 incubation<br>wells/reader | 10 incubation<br>wells/reader | 10 incubation<br>wells/reader | 10 incubation wells/reader | Different |
| Incubation<br>Temperature | 60 ± 2º C | 60 ± 2º C | 60 ± 2º C | 60 ± 2º C | Identical |
| Readout Time | 24 minute final<br>fluorescent result | 24 minute final<br>fluorescent result | 24 minute final<br>fluorescent result | 24 minute final fluorescent<br>result | Identical |
| | Optional visual pH<br>color change result as<br>follows:<br>1492V: 48 hours<br>1491: 24 hours<br>1295: 7 days | Optional visual pH color<br>change result in 48 hours | Optional visual pH<br>color change result<br>in 24 hours | Optional visual pH color<br>change result in 7 days | |
| Chemical<br>Indicator | 1491, 1492V - Turns<br>from pink to light<br>brown<br>or darker upon steam<br>exposure<br>1295 - Turns from<br>blue<br>towards pink upon | 1492V - Turns from pink<br>to light brown or darker<br>upon steam exposure | 1491 - Turns from<br>pink to light brown<br>or darker upon<br>steam exposure | 1295 - Turns from blue<br>towards pink upon vaporized<br>hydrogen<br>peroxide exposure | Identical |
| | vaporized hydrogen<br>peroxide exposure | | | | |
| Visual<br>Indicator of<br>Adequate<br>Sterilization<br>Cycle | (-) on dot matrix LED<br>display | (-) on LCD display | (-) on LCD display | (-) on LCD display | Similar |
| Visual<br>Indicator of<br>Possible<br>Sterilization<br>Cycle Failure | (+) on dot matrix LED<br>display | (+) on LCD display | (+) on LCD display | (+) on LCD display | Similar |
| Alarm<br>Function | 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 -<br>fluorescent baseline<br>measured<br>independently for each<br>BI placed in a well | No calibration -<br>fluorescent baseline<br>measured independently<br>for each BI placed in a<br>well | No calibration -<br>fluorescent baseline<br>measured<br>independently for<br>each BI placed in a<br>well | No calibration - fluorescent<br>baseline measured<br>independently for each BI<br>placed in a well | Identical |
| System<br>Operation | Software monitors<br>incubation duration<br>Software performs<br>reading of BI<br>Software allows<br>results to be stored | Software monitors<br>incubation duration | Software monitors<br>incubation duration | Software monitors incubation<br>duration | Similar |

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| | electronically in the<br>reader | | | | |
|------------------------------------------|--------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|-------------------------------------------------------------------------------|-----------|
| Software<br>Application | Software allows user<br>to view status<br>remotely via USB<br>connection and PC<br>application | Software allows user to<br>view status remotely via<br>ethernet | Software allows user<br>to view status<br>remotely via<br>ethernet | Software allows user to view<br>status remotely via ethernet | Similar |
| Cloud Server<br>Connection | Enabled via the USB<br>connection to the PC.<br>Facilitates software<br>application and<br>firmware updates. | Not present | Not present | Not present | Different |
| BI Insertion<br>Detection | Detected by white<br>LED and detector | Detected by photo-<br>interrupter sensor | Detected by photo-<br>interrupter sensor | Detected by photo-interrupter<br>sensor | Similar |
| Product Safety | IEC 61010-1,<br>IEC 61010-2-010 | IEC 61010-1,<br>IEC 61010-2-010 | IEC 61010-1,<br>IEC 61010-2-010 | IEC 61010-1,<br>IEC 61010-2-010 | Identical |
| EMC<br>Compliance | Title 47 CFR 15,<br>Subclass B, for Class<br>A type devices<br>IEC 61326-1 | Title 47 CFR 15,<br>Subclass B, for Class A<br>type devices<br>IEC 61326-1 | Title 47 CFR 15,<br>Subclass B, for<br>Class A type devices<br>IEC 61326-1 | Title 47 CFR 15, Subclass B,<br>for Class A type devices<br>IEC 61326-1 | Identical |
| Preventative<br>Maintenance | Area outside of wells<br>can be cleaned. Full<br>instructions in user<br>manual. | Area outside of wells can<br>be cleaned. Full<br>instructions in user<br>manual. | Area outside of<br>wells can be<br>cleaned. Full<br>instructions in user<br>manual. | Area outside of wells can be<br>cleaned. Full instructions in<br>user manual. | Identical |
| Biological<br>Indicator<br>Compatibility | 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.