(90 days)
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 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.
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.
The provided text describes the acceptance criteria and study results for the 3M™ Attest™ Super Rapid Readout Biological Indicator 1492V and associated auto-readers (490, 490H, 490M). This is for a 510(k) submission (K241710) to expand the indications for use to include additional exposure temperatures and times for dynamic-air-removal steam sterilization cycles.
Here's a breakdown of the requested information based on the document:
1. A table of acceptance criteria and the reported device performance
| Test Performed | Device Description | Applicable Standards | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|---|---|
| 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 |
| D-value for 134°C (273°F) cycles | 1492V BI | FDA Guidance¹, ISO 11138-1:2017 and ISO 11138-3:2017 | Not explicitly stated for D-value alone; part of evaluating resistance characteristics | D-value must be ≥ 8 seconds | Acceptance criteria met |
| Survival for 134°C (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 134°C (273°F) cycles | 1492V BI | FDA Guidance¹, ISO 11138-1:2017 and ISO 11138-3:2017 | Not explicitly stated for Kill alone; part of evaluating resistance characteristics | 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 |
Note: The source document refers to "FDA Guidance for Industry and FDA Staff, Biological Indicator (BI) Premarket Notification [510(k)] Submissions, October 4, 2007" as "FDA Guidance¹".
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
-
Sample Size for Test Set:
- Positive Control, D-Value, Survival, and Kill for 134°C cycles: Three lots of 3M™ Attest™ Super Rapid Readout Biological Indicators 1492V were tested. The specific number of BIs per lot for testing isn't explicitly stated but would be determined by the referenced ISO standards (ISO 11138-1:2017 and ISO 11138-3:2017).
- Reduced Incubation Time for 134°C cycles: Three lots of 3M™ Attest™ Super Rapid Readout Biological Indicators 1492V were tested. (Specific number of BIs per lot determined by ISO 11138-8:2021).
- Holding Time Assessment for 134°C cycles: One lot of 3M™ Attest™ Super Rapid Readout Biological Indicators 1492V was tested. (Specific number of BIs per lot determined by ISO 11138-1:2017 and ISO 11138-3:2017).
- Simulated Use Testing: Four lots of 3M™ Attest™ Super Rapid Readout Biological Indicators 1492V were evaluated. (Specific number of BIs per lot determined by FDA Guidance¹).
-
Data Provenance: The document does not explicitly state the country of origin of the data or whether it was retrospective or prospective. Given it's a 510(k) submission by a U.S. company (3M Company, St. Paul, MN), it can be inferred the testing was likely conducted in a controlled laboratory environment aligned with U.S. regulatory requirements and standards, implying a prospective testing approach for these performance studies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- This type of device (biological indicator for sterilization) does not involve human expert interpretation of images or other subjective data for ground truth establishment. The ground truth is objective, based on the growth or non-growth of microorganisms (fluorescence and visual pH change), and measured by an auto-reader and laboratory methods (plating for D-value, survival, and kill). Therefore, experts in the sense of radiologists providing interpretations are not applicable here. The "experts" would be the laboratory personnel performing the sterility testing and enumeration, governed by the specified ISO standards and FDA guidance. Their qualifications are inherent in following these validated procedures.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication methods like 2+1 or 3+1 are typically used for subjective assessments where human consensus is needed (e.g., image interpretation). This is a biological and physical performance study with objective endpoints (fluorescence, pH change, microbial growth counts). Therefore, no human adjudication method was employed or necessary. The "adjudication" is inherent in the quantitative and qualitative results generated by the auto-readers and laboratory microbiological techniques according to the established standards.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No, an MRMC comparative effectiveness study was not done. This device is a biological indicator for sterilization monitoring, not an AI-assisted diagnostic tool that requires human reader interpretation. The performance is assessed based on the BI's ability to accurately indicate sterilization success or failure.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Yes, in a sense. The core of the device's function is the biological indicator itself and the auto-reader's algorithmic interpretation of the fluorescence. The performance evaluation metrics (D-value, survival, kill, reduced incubation time, holding time assessment) are "standalone" in that they assess the intrinsic performance of the BI and auto-reader system without a human repeatedly making the final decision based on their output. The auto-reader's "algorithm" automatically reads the fluorescent result. The final visual pH change is a secondary, optional, human-observable check, but the primary rapid readout is automated.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The ground truth for this biological indicator is established by microbiological methods and physical-chemical principles as defined by the referenced ISO standards (ISO 11138-1, ISO 11138-3, ISO 11138-8) and FDA guidance specific to biological indicators.
- For D-value, survival, and kill times, the ground truth is determined by the actual microbial load reduction after exposure to various sterilization conditions. This involves traditional microbiology techniques like plate counting to determine the number of viable spores remaining after exposure.
- For the auto-reader's performance (fluorescence and pH change), the ground truth is the presence or absence of viable (germinated and metabolically active) spores, confirmed by the microbiological culture. A positive result (fluorescence/pH change) indicates spore survival, meaning sterilization failure; a negative result indicates spore death, meaning sterilization success.
8. The sample size for the training set
- The document describes a 510(k) submission for an expanded indication for use of an existing device. It discusses non-clinical performance testing (verification and validation) for the updated indications. It does not mention a "training set" in the context of an AI/ML model, as this is a traditional medical device (biological indicator and auto-reader) whose function is based on biological and chemical reactions, not adaptive algorithms trained on large datasets. Therefore, the concept of a "training set" in this context is not applicable.
9. How the ground truth for the training set was established
- As explained above, the concept of a "training set" is not applicable to this submission, as it's not an AI/ML device being developed and trained. The document focuses on demonstrating the device's performance against established standards and its equivalence to a predicate device.
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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.
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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
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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) 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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Image /page/4/Picture/1 description: The image shows the 3M logo. The logo is red and consists of the number "3" followed by the letter "M". The logo is simple and recognizable.
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,
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| 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 |
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| 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.
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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 ReadoutBiological Indicator1492V and3M™ Attest™ Auto-reader 490 and 490Hand 3M™ Attest™Mini Auto-reader 490M | Predicate Device:(K173437)3M™ Attest™Super Rapid ReadoutBiological Indicator1492V and3M™ Attest™ Auto-reader 490 and 490H | Comparison |
|---|---|---|---|
| Intended Use | Single Use sterilizationprocess indicator | Single Use sterilizationprocess indicator | Identical |
| Indications for use | Use the 3M™ Attest™Super Rapid ReadoutBiological Indicator1492V in conjunction | Use the 3M™ Attest™Super Rapid ReadoutBiological Indicator1492V in conjunction | Both the predicateand submission BIsare indicated for usein dynamic-air- |
| Feature | Submission Device:(K241710)3MTM AttestTMSuper Rapid ReadoutBiological Indicator1492V and3MTM AttestTM Auto-reader 490 and 490Hand 3MTM AttestTMMini Auto-reader 490M | Predicate Device:(K173437)3MTM AttestTMSuper Rapid ReadoutBiological Indicator1492V and3MTM AttestTM Auto-reader 490 and 490H | Comparison |
| with the 3MTM AttestTMAuto-reader 490, the3MTM AttestTM Auto-reader 490H havingsoftware version 4.0.0 orgreater, or the 3MTMAttestTM Mini Auto-reader 490M to qualify ormonitor the followingsteam sterilization cycles:Dynamic-air-removal (pre-vacuum andSFPP), 3, 3.5, 4,5.5 or 6 minutesat 270°F (132°C) Dynamic-air-removal (pre-vacuum andSFPP), 3 or 4minutes at 273°F(134°C) Dynamic-air-removal (pre-vacuum andSFPP), 3, 3.5 or10 minutes at275°F (135°C) | with both the 3MTMAttestTM Auto-reader 490or the AttestTM Auto-reader 490H havingsoftware version 4.0.0 orgreater to qualify ormonitor dynamic-air-removal steamsterilization cycles of:3 or 4 minutes at270°F (132°C) 3 minutes at275°F (135°C) | removal steamsterilization cycles.The intent of thissubmission is toexpand theindications for use toinclude additionalexposuretemperatures andtimes compared tothe predicate device.Both the predicateand submission BIsare intended to beused in conjunctionwith the 3MTMAttestTM Auto-reader490, the 3MTMAttestTM Auto-reader490H havingsoftware version4.0.0 or greater toqualify or monitordynamic-air removalsteam sterilizationcycles. The 1492Vwas cleared for usewith the 3MTMAttestTM Mini Auto-reader 490M perK200092. | |
| Organism | Geobacillusstearothermophilustraceable to ATCCTM7953 | Geobacillusstearothermophilustraceable to ATCCTM7953 | Identical |
| Feature | Submission Device:(K241710)3MTM AttestTMSuper Rapid ReadoutBiological Indicator1492V and3MTM Attest™ Auto-reader 490 and 490Hand 3MTM Attest™Mini Auto-reader 490M | Predicate Device:(K173437)3MTM Attest™Super Rapid ReadoutBiological Indicator1492V and3MTM Attest™ Auto-reader 490 and 490H | Comparison |
| Viable sporepopulation | ≥ 1 x 106 | ≥ 1 x 106 | Identical |
| Mechanism of Action | When the enzyme that isnaturally occurring in thespore is in its active state,it is detected bymeasuring thefluorescence produced bythe enzymatic hydrolysisof a non-fluorescentsubstrate. The resultantfluorescent by-product isdetected by the Auto-reader. The presence offluorescence uponincubation in the Auto-reader indicates asterilization processfailure. There is anoptional visual pH colorchange which indicates asteam sterilizationprocess failure. | When the enzyme that isnaturally occurring in thespore is in its active state,it is detected bymeasuring thefluorescence produced bythe enzymatic hydrolysisof a non-fluorescentsubstrate. The resultantfluorescent by-product isdetected by the Auto-reader. The presence offluorescence uponincubation in the Auto-reader indicates asterilization processfailure. There is anoptional visual pH colorchange which indicates asteam sterilizationprocess failure. | Identical |
| Resistancecharacteristics• D-value• Survival/KillWindow | D-value ≥ 10 seconds at132°CD-value ≥ 8 seconds at134°CD-value ≥ 8 seconds at135°CSurvival Time =Calculated survival time*or 1 minute at 132°C and40 seconds at 134°C and135°C, whichever islonger | D-value ≥ 10 seconds at132°CD-value ≥ 8 seconds at135°CSurvival Time =Calculated survival time*or 1 minute at 132°C and40 seconds at 135°C,whichever is longerKill Time = Calculatedkill time* at 132°C and at135°C | The predicate deviceis indicated forqualifying andmonitoring dynamic-air removal steamsterilization cycles at132°C and 135°C.The submissiondevice is indicatedfor qualifying andmonitoring dynamic-air removal steamsterilization cycles at132°C and 135°C |
| Feature | Submission Device:(K241710)3MTM AttestTMSuper Rapid ReadoutBiological Indicator1492V and3MTM Attest™ Auto-reader 490 and 490Hand 3MTM Attest™Mini Auto-reader 490M | Predicate Device:(K173437)3MTM AttestTMSuper Rapid ReadoutBiological Indicator1492V and3MTM Attest™ Auto-reader 490 and 490H | Comparison |
| Kill Time = Calculatedkill time* at 132°C,134°C and at 135°C | plus steamsterilization cycles at134°C. | ||
| Carrier material | Polypropylene | Polypropylene | Identical |
| Media Ampoule | Crushable glass ampoulecontaining a liquidgrowth media. | Crushable glass ampoulecontaining a liquidgrowth media. | Identical |
| Incubationtemperature | 60 ± 2°C | 60 ± 2°C | Identical |
| Readout time | 24 minute finalfluorescent result in boththe 490 and 490H Auto-readers having softwareversion 4.0.0 or greater orin a 490M Auto-reader.1 hour final fluorescentresult in 490 Auto-readers having softwareversions less than 4.0.0.Optional visual pH colorchange result in 48 hoursfor 490, 490H or 490MAuto-readers. | 24 minute finalfluorescent result in boththe 490 and 490H Auto-readers having softwareversion 4.0.0 or greater.1 hour final fluorescentresult in 490 Auto-readers having softwareversions less than 4.0.0.Optional visual pH colorchange result in 48 hoursfor 490 or 490H Auto-readers. | Both the predicateand submission BIsare intended to beused in conjunctionwith the 3M™MAttest™ Auto-reader490, the 3M™MAttest™ Auto-reader490H havingsoftware version4.0.0 or greater toqualify or monitordynamic-air removalsteam sterilizationcycles. The 1492Vwas cleared for usewith the 3M™Attest™ Mini Auto-reader 490M perK200092. |
| Chemical indicator | Turns from pink to lightbrown or darker uponsteam exposure | Turns from pink to lightbrown or darker uponsteam exposure | Identical |
| GeneralDesign/Construction | Plastic vial containing aspore carrier and mediaampoule, enclosed with acolor-coded cap with | Plastic vial containing aspore carrier and mediaampoule, enclosed with acolor-coded cap with | Identical |
| Feature | Submission Device:(K241710)3M™ Attest™Super Rapid ReadoutBiological Indicator1492V and3M™ Attest™ Auto-reader 490 and 490Hand 3M™ Attest™Mini Auto-reader 490Mindicator located on topof cap. | Predicate Device:(K173437)3M™ Attest™Super Rapid ReadoutBiological Indicator1492V and3M™ Attest™ Auto-reader 490 and 490Hindicator located on topof cap. | Comparison |
| Shelf-life | 21 months | 21 months | Identical |
| Accessories(Auto-readers) | 3M™ Attest™ Auto-reader 490 or the 3M™Attest™ Auto-reader490H or the 3M™Attest™ Mini Auto-reader 490M | 3M™ Attest™ Auto-reader 490 or the 3M™Attest™ Auto-reader490H | Both the predicateand submission BIsare intended to beused in conjunctionwith the 3M™Attest™ Auto-reader490, the 3M™Attest™ Auto-reader490H havingsoftware version4.0.0 or greater toqualify or monitordynamic-air removalsteam sterilizationcycles. The 1492Vwas cleared for usewith the 3M™Attest™ Mini Auto-reader 490M perK200092 |
Table 1: Device Technological Characteristics Comparison Table
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- per ISO 11138-1:2017, Annex E
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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.
| TestPerformed | DeviceDescription | ApplicableStandards | Purpose | AcceptanceCriteria | Results |
|---|---|---|---|---|---|
| PositiveControl Test | 1492V BI | FDA Guidance¹,ISO 11138-1:2017and ISO 11138-3:2017 | To evaluateperformance of BIwithout steamexposure | All BIs must befluorescentpositive at 24minutes andvisual pH colorchange positive(yellow) at 48hours | Acceptancecriteria met |
| TestPerformed | DeviceDescription | ApplicableStandards | Purpose | AcceptanceCriteria | Results |
| D-value for134°C(273°F)cycles | 1492V BI | FDA Guidance¹,ISO 11138-1:2017and ISO 11138-3:2017 | D-value must be≥ 8 seconds | Acceptancecriteria met | |
| Survival for134C°(273°F)cycles | 1492V BI | FDA Guidance¹,ISO 11138-1:2017and ISO 11138-3:2017 | To evaluate theresistancecharacteristics ofthe BI | Meets therequirements forCalculatedsurvival time* or40 seconds,whichever islonger.* ISO 11138-1:2017 | Acceptancecriteria met |
| Kill for134C°(273°F)cycles | 1492V BI | FDA Guidance¹,ISO 11138-1:2017and ISO 11138-3:2017 | Meets therequirements forCalculated killtime** ISO 11138-1:2017 | Acceptancecriteria met | |
| ReducedIncubationTime for134°C(273°F)cycles | 1492V BI | FDA Guidance¹,ISO 11138-1:2017and ISO 11138-8:2021 | To validate thereduction inincubation timefrom 7 days (visualcolor change) to 24minutes(fluorescentreadout) and 48hours (visual pHcolor change) | Meets FDA'srequirements forReducedIncubation Timewith > 97%alignment withthe conventionalincubation timeof 7 days for thefollowingreadout times:• Fluorescentresult in 24minutes• Visual pHcolor changeresult in 48hours | Acceptancecriteria met |
| HoldingTimeAssessmentfor 134°C(273°F)cycles | 1492V BI | FDA Guidance¹,ISO 11138-1:2017and ISO 11138-3:2017 | To evaluate theeffect of thelabeled holdingtime on the D-value | D-value must bewithin +/- 20%of the initial D-value calculatedper ISO 11138-1:2017 | Acceptancecriteria met |
| Attest1492VSimulatedUse | 1492V BI | FDA Guidance¹ | Verification ofperformance inclaimed cycles | BI performs asintended inclaimed cycles | Acceptancecriteria met |
Performance of the 1492V Biological Indicator (BI) was verified through the following tests:
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1 FDA Guidance for Industry and FDA Staff, Biological Indicator (BI) Premarket Notification [510(k)] Submissions, October 4, 2007
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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).
§ 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).