(90 days)
No
The description focuses on the biological and chemical processes of the indicator and the incubation/reading functions of the auto-readers, with no mention of AI or ML.
No.
This device is designed to monitor and qualify steam sterilization cycles, indicating whether sterilization has been successful. It does not directly treat or diagnose a medical condition.
No
The device is a biological indicator used to monitor steam sterilization cycles. It is not used to diagnose a medical condition in a patient.
No
The device description clearly outlines a physical biological indicator (BI) and associated hardware auto-readers. While the auto-readers utilize software, the core device being described is a physical, single-use biological indicator.
Based on the provided information, the 3M™ Attest™ Super Rapid Readout Biological Indicator 1492V is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to "qualify or monitor the following steam sterilization cycles." This means the device is used to assess the effectiveness of a sterilization process, not to diagnose a disease or condition in a patient.
- Device Description: The device is a biological indicator containing spores and media. It's designed to detect whether the sterilization process has killed the spores. This is a quality control measure for sterilization equipment, not a diagnostic test on a biological sample from a patient.
- Lack of IVD Characteristics: The description does not mention analyzing human biological samples (blood, urine, tissue, etc.) or providing information for the diagnosis, treatment, or prevention of disease.
Therefore, the 3M™ Attest™ Super Rapid Readout Biological Indicator 1492V falls under the category of a sterilization process indicator, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
3M™ Attest™ Super Rapid Readout Biological Indicator 1492V:
Use the 3M™ Attest™ Super Rapid Readout Biological Indicator 1492V in coniunction with the 3M™ Attest™ Auto-reader 490, the 3M™ Attest™ Auto-reader 490H having software version 4.0.0 or greater, or the 3M™ Attest™ Mini Auto-reader 490M to qualify or monitor the following steam sterilization cycles:
| Cycle Type | Exposure Temperature | Exposure Time |
|---|---|---|
| Dynamic-air-removal (pre-vacuum and SFPP) | 270°F (132°C) | 3, 3.5, 4, 5.5, or 6 minute |
| Dynamic-air-removal (pre-vacuum and SFPP) | 273°F (134°C) | 3 or 4 minutes |
| Dynamic-air-removal (pre-vacuum and SFPP) | 275°F (135°C) | 3, 3.5 or 10 minutes |
3M™ Attest™ Auto-reader 490:
The 3M™ Attest™ Auto-reader 490 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, 1492V, and 1592 at 60°C for a final fluorescent result at 24 minutes.
3M™ Attest™ Auto-reader 490H:
The 3M™ Attest™ Auto-reader 490H is designed to incubate and automatically read 3M™ Attest™ Rapid Readout Biological Indicators 1295, 3M™ Attest™ Super Rapid Readout Biological Indicators, catalog numbers 1491 and 1492V, and 3M™ Attest Super Rapid Steam Biological Indicators 1592 at 60℃ for a final fluorescent result at 24 minutes.
3M™ Attest™ Mini Auto-reader 490M:
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, 1492V and 1592, at 60°C for a final fluorescent result at 24 minutes.
Product codes
FRC
Device Description
The 3M™ Attest™ Super Rapid Readout Biological Indicator 1492V is a self-contained biological indicator (BI) specifically designed to be used with the 3M™ Attest™ Auto-reader 490, the 3M™ Attest™ Auto-reader 490H (having software version 4.0.0 or greater), or the 3M™ Attest™ Mini Auto-reader 490M to qualify or monitor dynamic-air-removal steam sterilization cycles at 132°C, 134°C and 135°C.
The 1492V BI is a single-use device composed of a plastic vial containing a spore carrier and media ampoule, enclosed with a color-coded cap. On each 1492V BI cap is a chemical process indicator that changes color from pink to light brown or darker when exposed to steam. The detection of fluorescence upon incubation of the 1492V BI in the 490 Autoreader, the 490H Auto-reader (software version 4.0.0 or greater), or the 490M Mini Autoreader indicates a sterilization failure.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The differences between the submission and predicate device have been evaluated through performance tests for the 3MTM Attest™ Super Rapid Readout Biological Indicator 1492V.
Three lots of 3M™ Attest™ Super Rapid Readout Biological Indicators 1492V were tested for Positive Control, D-Value, Survival, and Kill for 134°C (273°F) cycles. Testing was completed per the Guidance for Industry and FDA Staff, Biological Indicator Premarket Notification [510(k)] Submissions, October 4, 2007, ISO 11138-1:2017 Sterilization of Health Care Products-Biological Indicators-Part 1: General Requirements, and ISO 11138-3:2017 Sterilization of health care products – Biological indicators - Part 3: Biological indicators for moist heat sterilization processes.
Three lots of 3M™ Attest™ Super Rapid Readout Biological Indicators 1492V were tested for Reduced Incubation Time for 134°C (273°F) cycles. Testing was completed per the Guidance for Industry and FDA Staff, Biological Indicator Premarket Notification [510(k)] Submissions, October 4, 2007, ISO 11138-1:2017 Sterilization of Health Care Products-Biological Indicators-Part 1: General Requirements, and ISO 11138-8:2021 Sterilization of health care products – Biological indicators - Part 8: Method for validation of a reduced incubation time for a biological indicator.
One lot of 3M™ Attest™ Super Rapid Readout Biological Indicators 1492V was tested for a holding time assessment for 134°C (273°F) cycles. Testing was completed per the Guidance for Industry and FDA Staff, Biological Indicator Premarket Notification [510(k)] Submissions, October 4, 2007, ISO 11138-1:2017 Sterilization of Health Care Products-Biological Indicators-Part 1: General Requirements, and ISO 11138-3:2017 Sterilization of health care products – Biological indicators - Part 3: Biological indicators for moist heat sterilization processes.
Four lots of 3M™ Attest™ Super Rapid Readout Biological Indicators 1492V were evaluated for simulated use testing in the claimed cycles. Testing was completed per the Guidance for Industry and FDA Staff, Biological Indicator Premarket Notification [510(k)] Submissions, October 4, 2007.
Key results summary: All acceptance criteria were met for:
- Positive Control Test
- D-value for 134°C (273°F) cycles
- Survival for 134C° (273°F) cycles
- Kill for 134C° (273°F) cycles
- Reduced Incubation Time for 134°C (273°F) cycles
- Holding Time Assessment for 134°C (273°F) cycles
- Attest 1492V Simulated Use
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
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & 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.
September 12, 2024
3M Company Michelle M. Larsen Advanced Regulatory Affairs Specialist 3M Center 2510 Conway Ave., Building 275-5W-06 St. Paul, Minnesota 55144
Re: K241710
Trade/Device Name: 3MTM Attest™ Super Rapid Readout Biological Indicator 1492V; 3M™ Attest™ Auto-reader 490; 3MTM Attest™ Auto-reader 490H; 3MTM Attest™ Mini Autoreader 490M Regulation Number: 21 CFR 880.2800(a) Regulation Name: Biological Sterilization Process Indicator Regulatory Class: Class II Product Code: FRC Dated: June 13, 2024 Received: June 14, 2024
Dear Michelle Larsen:
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 (the 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 available at https://www.accessdata.fda.gov/scripts/cdrb/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.
1
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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, Stephen A. Anisko -S
Digitally signed by Stephen A. Anisko -S Date: 2024.09.12 15:23:32 -04'00
for: Christopher K. Dugard Assistant Director DHT4C: Division of Infection Control Devices OHT4: Office of Surgical and
2
Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K241710
Device Name
3MTM Attest™ Super Rapid Readout Biological Indicator 1492V; 3MTM AttestTM Auto-reader 490; 3MTM AttestTM Auto-reader 490H; 3MTM Attest™ Mini Auto-reader 490M
Indications for Use (Describe)
3M™ Attest™ Super Rapid Readout Biological Indicator 1492V:
Use the 3M™ Attest™ Super Rapid Readout Biological Indicator 1492V in coniunction with the 3M™ Attest™ Auto-reader 490, the 3M™ Attest™ Auto-reader 490H having software version 4.0.0 or greater, or the 3M™ Attest™ Mini Auto-reader 490M to qualify or monitor the following steam sterilization cycles:
| Cycle Type | Exposure Temperature | Exposure Time |
|---|---|---|
| Dynamic-air-removal (pre-vacuum and SFPP) | 270°F (132°C) | 3, 3.5, 4, 5.5, or 6 minute |
| Dynamic-air-removal (pre-vacuum and SFPP) | 273°F (134°C) | 3 or 4 minutes |
| Dynamic-air-removal (pre-vacuum and SFPP) | 275°F (135°C) | 3, 3.5 or 10 minutes |
3M™ Attest™ Auto-reader 490:
The 3M™ Attest™ Auto-reader 490 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, 1492V, and 1592 at 60°C for a final fluorescent result at 24 minutes.
3M™ Attest™ Auto-reader 490H:
The 3M™ Attest™ Auto-reader 490H is designed to incubate and automatically read 3M™ Attest™ Rapid Readout Biological Indicators 1295, 3M™ Attest™ Super Rapid Readout Biological Indicators, catalog numbers 1491 and 1492V, and 3M™ Attest Super Rapid Steam Biological Indicators 1592 at 60℃ for a final fluorescent result at 24 minutes.
3M™ Attest™ Mini Auto-reader 490M:
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, 1492V and 1592, at 60°C for a final fluorescent result at 24 minutes.
Type of Use (Select one or both, as applicable)Prescription Use (Part 21 CFR 801 Subpart D)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary (K241710) for 3M™ Attest™ Super Rapid Readout Biological Indicator 1492V, 3MTM Attest™ Auto-reader 490, 3MTM Attest™ Auto-reader 490H, 3MTM Attest™ Mini Auto-reader 490M
Sponsor Information:
3M Company 3M Center 2510 Conway Ave., Bldg. 275-5W-06 St. Paul, MN 55144-1000, USA
Contact: Michelle M. Larsen, Advanced Regulatory Affairs Specialist Phone Number: (651) 467-3991 Fax Number: (651) 737-5320 Email: mmlarsen@solventum.com
Date of Summary: 04, September 2024
1. Device Name and Classification:
Common or Usual Name: Sterilization Biological Indicator
3M™ Attest™ Super Rapid Readout Biological Indicator Proprietary Name: 1492V,
5
| Classification Name: | Indicator, Biological Sterilization Process |
|---|---|
| Device Classification: | Class II, 21 CFR 880.2800(a) |
| Product Code: | FRC |
2. Predicate Device:
Primary Predicate: 3MTM Attest™ Super Rapid Readout Biological Indicator 1492V, 3M™ Attest™ Auto-reader 490, 3MTM Attest™ Auto-reader 490H, K173437
3. Description of Device:
The 3M™ Attest™ Super Rapid Readout Biological Indicator 1492V is a self-contained biological indicator (BI) specifically designed to be used with the 3M™ Attest™ Auto-reader 490, the 3M™ Attest™ Auto-reader 490H (having software version 4.0.0 or greater), or the 3M™ Attest™ Mini Auto-reader 490M to qualify or monitor dynamic-air-removal steam sterilization cycles at 132°C, 134°C and 135°C.
The 1492V BI is a single-use device composed of a plastic vial containing a spore carrier and media ampoule, enclosed with a color-coded cap. On each 1492V BI cap is a chemical process indicator that changes color from pink to light brown or darker when exposed to steam. The detection of fluorescence upon incubation of the 1492V BI in the 490 Autoreader, the 490H Auto-reader (software version 4.0.0 or greater), or the 490M Mini Autoreader indicates a sterilization failure.
4. Indications for Use
3M™ Attest™ Super Rapid Readout Biological Indicator 1492V:
Use the 3M™ Attest™ Super Rapid Readout Biological Indicator 1492V in conjunction with the 3M™ Attest™ Auto-reader 490, the 3M™ Attest™ Auto-reader 490H having software version 4.0.0 or greater, or the 3MM Attest™ Mini Auto-reader 490M to qualify or monitor the following steam sterilization cycles:
| Cycle Type | Exposure Temperature | Exposure Time |
|---|---|---|
| Dynamic-air-removal | ||
| (pre-vacuum and SFPP) | 270°F (132°C) | 3, 3.5, 4, 5.5, or 6 minutes |
6
| Cycle Type | Exposure Temperature | Exposure Time |
|---|---|---|
| Dynamic-air-removal | ||
| (pre-vacuum and SFPP) | 273°F (134°C) | 3 or 4 minutes |
| Dynamic-air-removal | ||
| (pre-vacuum and SFPP) | 275°F (135°C) | 3, 3.5 or 10 minutes |
3MTM Attest™ Auto-reader 490:
The 3M™Attest™ Auto-reader 490 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, 1492V, and 1592 at 60°C for a final fluorescent result at 24 minutes.
3MTM Attest™ Auto-reader 490H:
The 3M™ Attest™ Auto-reader 490H is designed to incubate and automatically read 3M™ Attest™ Rapid Readout Biological Indicators 1295, 3M™ Attest™ Super Rapid Readout Biological Indicators, catalog numbers 1491 and 1492V, and 3M™ Attest Super Rapid Steam Biological Indicators 1592 at 60°C for a final fluorescent result at 24 minutes.
3MTM Attest™ Mini Auto-reader 490M:
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, 1492V and 1592, at 60°C for a final fluorescent result at 24 minutes.
The submission device, the 3M™ Attest™ Super Rapid Readout Biological Indicator 1492V, has the same intended use as the predicate device. Both the submission device and the predicate device are Single Use biological sterilization indicators that are intended to be used in healthcare facilities to accompany products being sterilized and to monitor adequacy of the sterilization process. The 3M™ Attest™ Super Rapid Readout Biological Indicator 1492V was cleared per K173437 for use with the 3M™ Attest™ Auto-reader 490, and the 3M™ Attest™ Auto-reader 490H and the 3M™ Attest™ Mini Auto-reader 490M was subsequently cleared for use with the 1492V BI per K200092. As a result, the Indications for Use for the currently marketed 3M™ Attest™ Super Rapid Readout Biological Indicator 1492V have been updated to include the 490M Mini Auto-reader. Both the predicate and submission BIs are indicated for use in dynamic-air-removal steam sterilization cycles. The submission device covers additional exposure temperatures and times for dynamic-airremoval steam sterilization cycles compared to the predicate device. The differences in Indications for Use do not alter the fundamental Intended Use of these products as sterilization process monitors.
7
5. Comparison of Technological Characteristics with the Predicate Device
The submission device, 3M™ Attest™ Super Rapid Readout Biological Indicator 1492V, is the same design as the previously cleared device of the same model number (the predicate K173437). Both the subject device and the predicate device utilize the same spores to accomplish their intended use as biological sterilization indicators. There have been no changes to the device's materials, technology, engineering or performance specifications since this clearance. The predicate device is indicated for qualifying and monitoring dynamic-air removal steam sterilization cycles at 132°C and 135°C. The submission device is indicated for qualifying and monitoring dynamic-air removal steam sterilization cycles at 132°C and 135°C plus steam sterilization cycles at 134°C. The Resistance Characteristics (D-Value. Survival/Kill Window) of the submission device have been updated to include the monitoring of steam sterilization cycles at 273°F (134°C). The 3MIM Attest™ Super Rapid Readout Biological Indicator 1492V was cleared for use with the 3M™ Attest™ Auto-reader 490, and the 3M™ Attest™ Auto-reader 490H, per K173437. The 3MTM Attest™ Mini Auto-reader 490M was cleared for use with the 1492V BI per K200092. There are no changes to the 3MTM Attest™ Auto-readers 490 and 490H, nor to the 490M Mini-Autoreader. The accessories (Auto-readers) are the same for both the submission and predicate device and the readout time or the time to a result is the same for both the submission and predicate device.
The differences in technological characteristics between the submission and predicate device are summarized in the Device Technological Characteristics Comparison Table (Table 1).
| Feature | Submission Device:
(K241710)
3M™ Attest™
Super Rapid Readout
Biological Indicator
1492V and
3M™ Attest™ Auto-
reader 490 and 490H
and 3M™ Attest™
Mini Auto-reader 490M | Predicate Device:
(K173437)
3M™ Attest™
Super Rapid Readout
Biological Indicator
1492V and
3M™ Attest™ Auto-
reader 490 and 490H | Comparison |
|-------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Single Use sterilization
process indicator | Single Use sterilization
process indicator | Identical |
| Indications for use | Use the 3M™ Attest™
Super Rapid Readout
Biological Indicator
1492V in conjunction | Use the 3M™ Attest™
Super Rapid Readout
Biological Indicator
1492V in conjunction | Both the predicate
and submission BIs
are indicated for use
in dynamic-air- |
| Feature | Submission Device:
(K241710)
3MTM AttestTM
Super Rapid Readout
Biological Indicator
1492V and
3MTM AttestTM Auto-
reader 490 and 490H
and 3MTM AttestTM
Mini Auto-reader 490M | Predicate Device:
(K173437)
3MTM AttestTM
Super Rapid Readout
Biological Indicator
1492V and
3MTM AttestTM Auto-
reader 490 and 490H | Comparison |
| | with the 3MTM AttestTM
Auto-reader 490, the
3MTM AttestTM Auto-
reader 490H having
software version 4.0.0 or
greater, or the 3MTM
AttestTM Mini Auto-
reader 490M to qualify or
monitor the following
steam sterilization cycles:
Dynamic-air-
removal (pre-
vacuum and
SFPP), 3, 3.5, 4,
5.5 or 6 minutes
at 270°F (132°C) Dynamic-air-
removal (pre-
vacuum and
SFPP), 3 or 4
minutes at 273°F
(134°C) Dynamic-air-
removal (pre-
vacuum and
SFPP), 3, 3.5 or
10 minutes at
275°F (135°C) | with both the 3MTM
AttestTM Auto-reader 490
or the AttestTM Auto-
reader 490H having
software version 4.0.0 or
greater to qualify or
monitor dynamic-air-
removal steam
sterilization cycles of:
3 or 4 minutes at
270°F (132°C) 3 minutes at
275°F (135°C) | removal steam
sterilization cycles.
The intent of this
submission is to
expand the
indications for use to
include additional
exposure
temperatures and
times compared to
the predicate device.
Both the predicate
and submission BIs
are intended to be
used in conjunction
with the 3MTM
AttestTM Auto-reader
490, the 3MTM
AttestTM Auto-reader
490H having
software version
4.0.0 or greater to
qualify or monitor
dynamic-air removal
steam sterilization
cycles. The 1492V
was cleared for use
with the 3MTM
AttestTM Mini Auto-
reader 490M per
K200092. |
| Organism | Geobacillus
stearothermophilus
traceable to ATCCTM
7953 | Geobacillus
stearothermophilus
traceable to ATCCTM
7953 | Identical |
| Feature | Submission Device:
(K241710)
3MTM AttestTM
Super Rapid Readout
Biological Indicator
1492V and
3MTM Attest™ Auto-
reader 490 and 490H
and 3MTM Attest™
Mini Auto-reader 490M | Predicate Device:
(K173437)
3MTM Attest™
Super Rapid Readout
Biological Indicator
1492V and
3MTM Attest™ Auto-
reader 490 and 490H | Comparison |
| Viable spore
population | ≥ 1 x 106 | ≥ 1 x 106 | Identical |
| Mechanism of Action | When the enzyme that is
naturally occurring in the
spore is in its active state,
it is detected by
measuring the
fluorescence produced by
the enzymatic hydrolysis
of a non-fluorescent
substrate. The resultant
fluorescent by-product is
detected by the Auto-
reader. The presence of
fluorescence upon
incubation in the Auto-
reader indicates a
sterilization process
failure. There is an
optional visual pH color
change which indicates a
steam sterilization
process failure. | When the enzyme that is
naturally occurring in the
spore is in its active state,
it is detected by
measuring the
fluorescence produced by
the enzymatic hydrolysis
of a non-fluorescent
substrate. The resultant
fluorescent by-product is
detected by the Auto-
reader. The presence of
fluorescence upon
incubation in the Auto-
reader indicates a
sterilization process
failure. There is an
optional visual pH color
change which indicates a
steam sterilization
process failure. | Identical |
| Resistance
characteristics
• D-value
• Survival/Kill
Window | D-value ≥ 10 seconds at
132°C
D-value ≥ 8 seconds at
134°C
D-value ≥ 8 seconds at
135°C
Survival Time =
Calculated survival time*
or 1 minute at 132°C and
40 seconds at 134°C and
135°C, whichever is
longer | D-value ≥ 10 seconds at
132°C
D-value ≥ 8 seconds at
135°C
Survival Time =
Calculated survival time*
or 1 minute at 132°C and
40 seconds at 135°C,
whichever is longer
Kill Time = Calculated
kill time* at 132°C and at
135°C | The predicate device
is indicated for
qualifying and
monitoring dynamic-
air removal steam
sterilization cycles at
132°C and 135°C.
The submission
device is indicated
for qualifying and
monitoring dynamic-
air removal steam
sterilization cycles at
132°C and 135°C |
| Feature | Submission Device:
(K241710)
3MTM AttestTM
Super Rapid Readout
Biological Indicator
1492V and
3MTM Attest™ Auto-
reader 490 and 490H
and 3MTM Attest™
Mini Auto-reader 490M | Predicate Device:
(K173437)
3MTM AttestTM
Super Rapid Readout
Biological Indicator
1492V and
3MTM Attest™ Auto-
reader 490 and 490H | Comparison |
| | Kill Time = Calculated
kill time* at 132°C,
134°C and at 135°C | | plus steam
sterilization cycles at
134°C. |
| Carrier material | Polypropylene | Polypropylene | Identical |
| Media Ampoule | Crushable glass ampoule
containing a liquid
growth media. | Crushable glass ampoule
containing a liquid
growth media. | Identical |
| Incubation
temperature | 60 ± 2°C | 60 ± 2°C | Identical |
| Readout time | 24 minute final
fluorescent result in both
the 490 and 490H Auto-
readers having software
version 4.0.0 or greater or
in a 490M Auto-reader.
1 hour final fluorescent
result in 490 Auto-
readers having software
versions less than 4.0.0.
Optional visual pH color
change result in 48 hours
for 490, 490H or 490M
Auto-readers. | 24 minute final
fluorescent result in both
the 490 and 490H Auto-
readers having software
version 4.0.0 or greater.
1 hour final fluorescent
result in 490 Auto-
readers having software
versions less than 4.0.0.
Optional visual pH color
change result in 48 hours
for 490 or 490H Auto-
readers. | Both the predicate
and submission BIs
are intended to be
used in conjunction
with the 3M™M
Attest™ Auto-reader
490, the 3M™M
Attest™ Auto-reader
490H having
software version
4.0.0 or greater to
qualify or monitor
dynamic-air removal
steam sterilization
cycles. The 1492V
was cleared for use
with the 3M™
Attest™ Mini Auto-
reader 490M per
K200092. |
| Chemical indicator | Turns from pink to light
brown or darker upon
steam exposure | Turns from pink to light
brown or darker upon
steam exposure | Identical |
| General
Design/Construction | Plastic vial containing a
spore carrier and media
ampoule, enclosed with a
color-coded cap with | Plastic vial containing a
spore carrier and media
ampoule, enclosed with a
color-coded cap with | Identical |
| Feature | Submission Device:
(K241710)
3M™ Attest™
Super Rapid Readout
Biological Indicator
1492V and
3M™ Attest™ Auto-
reader 490 and 490H
and 3M™ Attest™
Mini Auto-reader 490M
indicator located on top
of cap. | Predicate Device:
(K173437)
3M™ Attest™
Super Rapid Readout
Biological Indicator
1492V and
3M™ Attest™ Auto-
reader 490 and 490H
indicator located on top
of cap. | Comparison |
| Shelf-life | 21 months | 21 months | Identical |
| Accessories
(Auto-readers) | 3M™ Attest™ Auto-
reader 490 or the 3M™
Attest™ Auto-reader
490H or the 3M™
Attest™ Mini Auto-
reader 490M | 3M™ Attest™ Auto-
reader 490 or the 3M™
Attest™ Auto-reader
490H | Both the predicate
and submission BIs
are intended to be
used in conjunction
with the 3M™
Attest™ Auto-reader
490, the 3M™
Attest™ Auto-reader
490H having
software version
4.0.0 or greater to
qualify or monitor
dynamic-air removal
steam sterilization
cycles. The 1492V
was cleared for use
with the 3M™
Attest™ Mini Auto-
reader 490M per
K200092 |
Table 1: Device Technological Characteristics Comparison Table
8
9
10
11
- per ISO 11138-1:2017, Annex E
12
6. Nonclinical Comparison to the Predicate Device
The differences between the submission and predicate device have been evaluated through performance tests for the 3MTM Attest™ Super Rapid Readout Biological Indicator 1492V.
Three lots of 3M™ Attest™ Super Rapid Readout Biological Indicators 1492V were tested for Positive Control, D-Value, Survival, and Kill for 134°C (273°F) cycles. Testing was completed per the Guidance for Industry and FDA Staff, Biological Indicator Premarket Notification [510(k)] Submissions, October 4, 2007, ISO 11138-1:2017 Sterilization of Health Care Products-Biological Indicators-Part 1: General Requirements, and ISO 11138-3:2017 Sterilization of health care products – Biological indicators - Part 3: Biological indicators for moist heat sterilization processes.
Three lots of 3M™ Attest™ Super Rapid Readout Biological Indicators 1492V were tested for Reduced Incubation Time for 134°C (273°F) cycles. Testing was completed per the Guidance for Industry and FDA Staff, Biological Indicator Premarket Notification [510(k)] Submissions, October 4, 2007, ISO 11138-1:2017 Sterilization of Health Care Products-Biological Indicators-Part 1: General Requirements, and ISO 11138-8:2021 Sterilization of health care products – Biological indicators - Part 8: Method for validation of a reduced incubation time for a biological indicator.
One lot of 3M™ Attest™ Super Rapid Readout Biological Indicators 1492V was tested for a holding time assessment for 134°C (273°F) cycles. Testing was completed per the Guidance for Industry and FDA Staff, Biological Indicator Premarket Notification [510(k)] Submissions, October 4, 2007, ISO 11138-1:2017 Sterilization of Health Care Products-Biological Indicators-Part 1: General Requirements, and ISO 11138-3:2017 Sterilization of health care products – Biological indicators - Part 3: Biological indicators for moist heat sterilization processes.
Four lots of 3M™ Attest™ Super Rapid Readout Biological Indicators 1492V were evaluated for simulated use testing in the claimed cycles. Testing was completed per the Guidance for Industry and FDA Staff, Biological Indicator Premarket Notification [510(k)] Submissions, October 4, 2007.
| Test
Performed | Device
Description | Applicable
Standards | Purpose | Acceptance
Criteria | Results |
|-----------------------------------------------------------------|-----------------------|----------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------|
| Positive
Control Test | 1492V BI | FDA Guidance¹,
ISO 11138-1:2017
and ISO 11138-
3:2017 | To evaluate
performance of BI
without steam
exposure | All BIs must be
fluorescent
positive at 24
minutes and
visual pH color
change positive
(yellow) at 48
hours | Acceptance
criteria met |
| Test
Performed | Device
Description | Applicable
Standards | Purpose | Acceptance
Criteria | Results |
| D-value for
134°C
(273°F)
cycles | 1492V BI | FDA Guidance¹,
ISO 11138-1:2017
and ISO 11138-
3:2017 | | D-value must be
≥ 8 seconds | Acceptance
criteria met |
| Survival for
134C°
(273°F)
cycles | 1492V BI | FDA Guidance¹,
ISO 11138-1:2017
and ISO 11138-
3:2017 | To evaluate the
resistance
characteristics of
the BI | Meets the
requirements for
Calculated
survival time* or
40 seconds,
whichever is
longer.
- ISO 11138-
1:2017 | Acceptance
criteria met |
| Kill for
134C°
(273°F)
cycles | 1492V BI | FDA Guidance¹,
ISO 11138-1:2017
and ISO 11138-
3:2017 | | Meets the
requirements for
Calculated kill
time* - ISO 11138-
1:2017 | Acceptance
criteria met |
| Reduced
Incubation
Time for
134°C
(273°F)
cycles | 1492V BI | FDA Guidance¹,
ISO 11138-1:2017
and ISO 11138-
8:2021 | To validate the
reduction in
incubation time
from 7 days (visual
color change) to 24
minutes
(fluorescent
readout) and 48
hours (visual pH
color change) | Meets FDA's
requirements for
Reduced
Incubation Time
with > 97%
alignment with
the conventional
incubation time
of 7 days for the
following
readout times:
• Fluorescent
result in 24
minutes
• Visual pH
color change
result in 48
hours | Acceptance
criteria met |
| Holding
Time
Assessment
for 134°C
(273°F)
cycles | 1492V BI | FDA Guidance¹,
ISO 11138-1:2017
and ISO 11138-
3:2017 | To evaluate the
effect of the
labeled holding
time on the D-
value | D-value must be
within +/- 20%
of the initial D-
value calculated
per ISO 11138-
1:2017 | Acceptance
criteria met |
| Attest
1492V
Simulated
Use | 1492V BI | FDA Guidance¹ | Verification of
performance in
claimed cycles | BI performs as
intended in
claimed cycles | Acceptance
criteria met |
Performance of the 1492V Biological Indicator (BI) was verified through the following tests:
13
1 FDA Guidance for Industry and FDA Staff, Biological Indicator (BI) Premarket Notification [510(k)] Submissions, October 4, 2007
14
7. Clinical Comparison to the Predicate Device
Clinical testing was not required or completed for the submission device.
8. Conclusion
Based on the intended use, technological characteristics, and non-clinical performance data, the submission device, the 3M™ Attest™ Super Rapid Readout Biological Indicator 1492V, the 3MTM Attest™ Auto-reader 490, the 3M™ Attest™ Auto-reader 490H, and the 3MTM Attest™ Mini Auto-reader 490M with expanded Indications for Use to cover additional exposure temperatures and times for dynamic-air-removal steam sterilization cycles, is as safe, as effective and performs as well as or better than the legally marketed predicate device, the 3M™ Attest™ Super Rapid Readout Biological Indicator 1492V, the 3M™ Attest™ Auto-reader 490, the 3MTM Attest™ Auto-reader 490H (cleared under K173437).