(90 days)
No
The description focuses on incubation, fluorescence measurement, and basic analysis of fluorescent by-product, with no mention of AI or ML algorithms for interpretation or decision-making.
No
The device is used to incubate and read biological indicators to monitor sterilization equipment, not to directly treat a patient or disease.
No
Explanation: This device is used to monitor the effectiveness of sterilization processes by interpreting biological indicators. It does not provide information about a patient's health status or diagnose any disease or condition.
No
The device description clearly states it is a compact, 4-well incubator, which is a hardware component. It also mentions an LED array on the front panel and USB connectivity, further indicating it is not software-only.
Based on the provided text, the 3M™ Attest™ Mini Auto-reader 490M is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The device is intended to incubate and read biological indicators (BIs) used to monitor the effectiveness of sterilization processes (steam and vaporized hydrogen peroxide). This is a quality control function for sterilization equipment, not a diagnostic test performed on a biological sample from a patient to diagnose a disease or condition.
- Device Description: The description reinforces its function as an incubator and reader for BIs, analyzing fluorescent by-products of spore growth. This process is related to assessing the sterility of instruments or materials, not diagnosing a patient.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.) from a patient.
- Providing information for the diagnosis, treatment, or prevention of disease.
- Measuring analytes in a biological sample.
The device is clearly intended for use in a healthcare setting, but its purpose is to ensure the effectiveness of sterilization, which is a critical part of infection control, not patient diagnosis.
N/A
Intended Use / Indications for 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.
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 3M™ 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.
Product codes
FRC
Device Description
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 BIs 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 60 degrees C. 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 3M™ Attest™ Mimi Auto-reader 490M is indicated to work as a system with the 1491, 1492V, and is not compatible with other BIs.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 BIs in both auto-readers under positive control conditions, lethal sterilizer conditions (kill cycle), sub-lethal sterilizer conditions (survive cycle), and reduced incubation time.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 880.2800 Sterilization process indicator.
(a)
Biological sterilization process indicator —(1)Identification. A biological sterilization process indicator is a device intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor adequacy of sterilization. The device consists of a known number of microorganisms, of known resistance to the mode of sterilization, in or on a carrier and enclosed in a protective package. Subsequent growth or failure of the microorganisms to grow under suitable conditions indicates the adequacy of sterilization.(2)
Classification. Class II (performance standards).(b)
Physical/chemical sterilization process indicator —(1)Identification. A physical/chemical sterilization process indicator is a device intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor one or more parameters of the sterilization process. The adequacy of the sterilization conditions as measured by these parameters is indicated by a visible change in the device.(2)
Classification. Class II (performance standards).
0
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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
1
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
2
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: (651) 733-9209 Fax Number: (651) 737-5320 Email: acwingen@mmm.com
Date of Summary: 14 January 2020
4
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.
5
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.
6
5. Technical Characteristic Comparison Table
| Device
Identity | Proposed Device:
3M™ Attest™ Mini
Auto-reader / 3M™
Attest™ Super Rapid
Readout Biological
Indicators 1491 and
1492V, 3M™
Attest™ Rapid
Readout Biological
Indicator 1295 | Predicate: 3M™
Attest™ Super Rapid
Readout Biological
Indicator 1492V / 3M™
Attest™ 490/490H
Auto-reader (K173437) | Reference: 3M™
Attest™ Super
Rapid Readout
Biological
Indicator 1491 /
3M™ Attest™
490/490H Auto-
reader (K173584) | Reference: 3M™ Attest™
Rapid Readout Biological
Indicator 1295 / 3M™
Attest™ 490H Auto-reader
(K173435) | Comments |
|------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|
| Intended Use | The 3M™ Attest™
Mini Auto-reader is
designed to incubate
and 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 3M™ Attest™
490/490H Auto-reader is
designed to incubate and
automatically read the
3M™ Attest™ Super
Rapid Readout Biological
Indicator 1492V at 60°C
for a final fluorescent
result at 24 minutes. | The 3M™ Attest™
490/490H Auto-
reader is designed to
incubate and
automatically read
the 3M™ Attest™
Super Rapid
Readout Biological
Indicator 1491 at
60°C for a final
fluorescent result at
24 minutes. | The 3M™ Attest™ 490H
Auto-reader is designed to
incubate and automatically
read the 3M™ Attest™ Rapid
Readout Biological Indicator
1295 at 60°C for a final
fluorescent result at 24
minutes. | Identical |
| Indications for
Use | The 3M™ Attest™
Mini Auto-reader | Use the 3M™ Attest™
Super Rapid Readout
Biological Indicator
1492V in conjunction
with both the 3M™ | Use the 3M™
Attest™ Super
Rapid Readout
Biological Indicator
1491 in conjunction | Use the 3M™ Attest™ Rapid
Readout Biological Indicator
1295 in conjunction with the
3M™ Attest™ Auto reader
490H as a standard method of | Similar |
7
| 490M is designed to
incubate and
automatically read
3MTM AttestTM Rapid
Readout Biological
Indicators 1295 and
3MTM Attest™ Super
Rapid Readout
Biological Indicators,
catalog numbers 1491
and 1492V, at 60°C
for a final fluorescent
result at 24 minutes.
The indications for use
for Attest™ Biological
Indicators are
provided in the
product's
Instructions for Use. | Attest™ Auto-reader 490
or the AttestTM Auto-
reader 490H having
software version 4.0.0 or
greater to qualify or
monitor dynamic-air-
removal steam
sterilization cycles of:
3 minutes at 270°F
(132°C)
4 minutes at 270°F
(132°C)
3 minutes at 275°F
(135°C) | with the 3MTM
AttestTM 490/490H
Auto-reader 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) | routine monitoring of
vaporized hydrogen peroxide
sterilization processes in the
following systems:
AMSCO® V-PROTM 1 Low
Temperature Sterilization
System (Lumen cycle),
AMSCO® V-PROTM 1
Plus Low Temperature
Sterilization System (Lumen
and Non Lumen cycles),
AMSCO® V-PROTM maX
Low Temperature
Sterilization System (Lumen,
Non Lumen, and Flexible
cycles), AMSCO® V-PROTM
60 Low Temperature
Sterilization System (Lumen,
Non 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
ALLClearTM Technology
(Standard and Advanced
cycles) and STERRAD®
100NX with ALLClear™
Technology (Standard, Flex,
Express and Duo cycles) |
| -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
|---|
8
| Method of
Fluorescence
Detection | UV LED, photo diode
with embedded optical
filters | UV LED, optical filters,
with sensing by photo
diode | UV LED, optical
filters, with sensing
by photo diode | UV LED, optical filters, with
sensing by photo diode | Similar |
|----------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|-----------|
| Number of
Incubation
Wells | 4 incubation
wells/reader | 10 incubation
wells/reader | 10 incubation
wells/reader | 10 incubation wells/reader | Different |
| Incubation
Temperature | 60 ± 2º C | 60 ± 2º C | 60 ± 2º C | 60 ± 2º C | Identical |
| Readout Time | 24 minute final
fluorescent result | 24 minute final
fluorescent result | 24 minute final
fluorescent result | 24 minute final fluorescent
result | Identical |
| | Optional visual pH
color change result as
follows:
1492V: 48 hours
1491: 24 hours
1295: 7 days | Optional visual pH color
change result in 48 hours | Optional visual pH
color change result
in 24 hours | Optional visual pH color
change result in 7 days | |
| Chemical
Indicator | 1491, 1492V - Turns
from pink to light
brown
or darker upon steam
exposure
1295 - Turns from
blue
towards pink upon | 1492V - Turns from pink
to light brown or darker
upon steam exposure | 1491 - Turns from
pink to light brown
or darker upon
steam exposure | 1295 - Turns from blue
towards pink upon vaporized
hydrogen
peroxide exposure | Identical |
| | vaporized hydrogen
peroxide exposure | | | | |
| Visual
Indicator of
Adequate
Sterilization
Cycle | (-) on dot matrix LED
display | (-) on LCD display | (-) on LCD display | (-) on LCD display | Similar |
| Visual
Indicator of
Possible
Sterilization
Cycle Failure | (+) on dot matrix LED
display | (+) on LCD display | (+) on LCD display | (+) on LCD display | Similar |
| Alarm
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 -
fluorescent baseline
measured
independently for each
BI placed in a well | No calibration -
fluorescent baseline
measured independently
for each BI placed in a
well | No calibration -
fluorescent baseline
measured
independently for
each BI placed in a
well | No calibration - fluorescent
baseline measured
independently for each BI
placed in a well | Identical |
| System
Operation | Software monitors
incubation duration
Software performs
reading of BI
Software allows
results to be stored | Software monitors
incubation duration | Software monitors
incubation duration | Software monitors incubation
duration | Similar |
9
10
| | electronically in the
reader | | | | |
|------------------------------------------|--------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|-------------------------------------------------------------------------------|-----------|
| Software
Application | Software allows user
to view status
remotely via USB
connection and PC
application | Software allows user to
view status remotely via
ethernet | Software allows user
to view status
remotely via
ethernet | Software allows user to view
status remotely via ethernet | Similar |
| Cloud Server
Connection | Enabled via the USB
connection to the PC.
Facilitates software
application and
firmware updates. | Not present | Not present | Not present | Different |
| BI Insertion
Detection | Detected by white
LED and detector | Detected by photo-
interrupter sensor | Detected by photo-
interrupter sensor | Detected by photo-interrupter
sensor | 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 |
| EMC
Compliance | Title 47 CFR 15,
Subclass B, for Class
A type devices
IEC 61326-1 | Title 47 CFR 15,
Subclass B, for Class A
type devices
IEC 61326-1 | Title 47 CFR 15,
Subclass B, for
Class A type devices
IEC 61326-1 | Title 47 CFR 15, Subclass B,
for Class A type devices
IEC 61326-1 | Identical |
| Preventative
Maintenance | Area outside of wells
can be cleaned. Full
instructions in user
manual. | Area outside of wells can
be cleaned. Full
instructions in user
manual. | Area outside of
wells can be
cleaned. Full
instructions in user
manual. | Area outside of wells can be
cleaned. Full instructions in
user manual. | Identical |
| Biological
Indicator
Compatibility | 1491, 1492V, 1295 | 1492V | 1491 | 1295 | Identical |
11
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.