3M Attest Super Rapid Readout Biological Indicator 1492V; 3M Attest Auto-reader 490; 3M Attest Auto-reader 490H; 3M Attest Mini Auto-reader 490M

Q: Who is the manufacturer of 3M Attest Super Rapid Readout Biological Indicator 1492V; 3M Attest Auto-reader 490; 3M Attest Auto-reader 490H; 3M Attest Mini Auto-reader 490M?

3M Company filed the 510(k) submission for 3M Attest Super Rapid Readout Biological Indicator 1492V; 3M Attest Auto-reader 490; 3M Attest Auto-reader 490H; 3M Attest Mini Auto-reader 490M (K241710).

Q: What is the FDA product code for 3M Attest Super Rapid Readout Biological Indicator 1492V; 3M Attest Auto-reader 490; 3M Attest Auto-reader 490H; 3M Attest Mini Auto-reader 490M?

FRC. It is classified under 21 CFR 880.2800 as a Class 2 device in the General Hospital panel.

Q: What is the regulatory pathway for 3M Attest Super Rapid Readout Biological Indicator 1492V; 3M Attest Auto-reader 490; 3M Attest Auto-reader 490H; 3M Attest Mini Auto-reader 490M?

510(k) clearance (submission type: Traditional).

Q: Who can help prepare an FDA 510(k) submission like 3M Attest Super Rapid Readout Biological Indicator 1492V; 3M Attest Auto-reader 490; 3M Attest Auto-reader 490H; 3M Attest Mini Auto-reader 490M?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

K241710 · 3M Company · FRC · Sep 12, 2024 · General Hospital

Device Facts

Record ID	K241710
Device Name	3M Attest Super Rapid Readout Biological Indicator 1492V; 3M Attest Auto-reader 490; 3M Attest Auto-reader 490H; 3M Attest Mini Auto-reader 490M
Applicant	3M Company
Product Code	FRC · General Hospital
Decision Date	Sep 12, 2024
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 880.2800
Device Class	Class 2

Intended Use

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

Device Story

Self-contained biological indicator (BI) for monitoring steam sterilization efficacy. Input: Geobacillus stearothermophilus spores on carrier within plastic vial. Operation: BI placed in sterilizer; post-exposure, user crushes internal media ampoule and incubates in 3M Attest Auto-reader (490, 490H, or 490M) at 60°C. Auto-reader detects fluorescence from enzymatic hydrolysis of non-fluorescent substrate; presence of fluorescence indicates sterilization failure. Optional visual pH color change (yellow) indicates failure at 48 hours. Output: Fluorescent result at 24 minutes; visual color change at 48 hours. Used in healthcare facilities by sterile processing staff. Results inform clinical decision-making regarding release of sterilized medical devices.

Clinical Evidence

No clinical data. Bench testing only. Performance verified per ISO 11138-1:2017, ISO 11138-3:2017, and ISO 11138-8:2021. Testing included positive control, D-value, survival/kill, reduced incubation time, and holding time assessment for 134°C cycles. All acceptance criteria met.

Technological Characteristics

Single-use biological indicator; polypropylene vial; Geobacillus stearothermophilus spores (traceable to ATCC 7953); crushable glass media ampoule; chemical process indicator (pink to light brown). Incubation at 60±2°C. Fluorescence detection via enzymatic hydrolysis. Connectivity: Standalone auto-reader units. Software version 4.0.0+ required for 490H.

Indications for Use

Indicated for healthcare facilities to qualify or monitor dynamic-air-removal steam sterilization cycles (pre-vacuum and SFPP) at 132°C, 134°C, and 135°C using 3M Attest Super Rapid Readout Biological Indicator 1492V in conjunction with specified 3M Attest Auto-readers.

Regulatory Classification

Identification

Biological sterilization process indicator: A device intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor adequacy of sterilization. The device consists of a known number of microorganisms, of known resistance to the mode of sterilization, in or on a carrier and enclosed in a protective package. Subsequent growth or failure of the microorganisms to grow under suitable conditions indicates the adequacy of sterilization. Physical/chemical sterilization process indicator: A device intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor one or more parameters of the sterilization process. The adequacy of the sterilization conditions as measured by these parameters is indicated by a visible change in the device.

Predicate Devices

3M™ Attest™ Super Rapid Readout Biological Indicator 1492V, 3M™ Attest™ Auto-reader 490, 3M™ Attest™ Auto-reader 490H (K173437)

Reference Devices

3M™ Attest™ Mini Auto-reader 490M (K200092)

Related Devices

K103277 — 3M ATTEST 1491 SUPER RAPID READOUT BIOLOGICAL INDICATOR; 3M ATTEST 490 AUTO-READER · 3M Company-3M Health Care · Apr 19, 2011
K173584 — 3M Attest Super Rapid Readout Biological Indicator, 3M Attest Auto-reader, 3M Attest Auto-reader · 3M Company · Jan 22, 2018
K121484 — 3M ATTEST(TM) SUPER RAPID READOUT BIOLOGICAL INDICATOR, 3M ATTEST(TM) AUTO-READER · 3M Company · Oct 19, 2012
K172432 — SporView Rapid Read Biological Indicator · Crosstex/Spsmedical, A Division of Cantel Medical · Dec 12, 2017
K211705 — 3M Attest Rapid Readout Biological Indicator, 1295 · 3M Company · Jun 28, 2022

Submission Summary (Full Text)

{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) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW!* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {4}------------------------------------------------ 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, {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).