3M™ Attest™ Super Rapid Readout Biological Indicator 1493; 3M™ Attest™ Super Rapid Steam Gravity Clear Challenge Pack 1493PCDG; 3M™ Attest™ Auto-reader 490; 3M™ Attest™ Auto-reader 490H; 3M™ Attest™ Mini Auto-reader 490M

K242538 · 3M Company · FRC · Nov 25, 2024 · General Hospital

Device Facts

Record IDK242538
Device Name3M™ Attest™ Super Rapid Readout Biological Indicator 1493; 3M™ Attest™ Super Rapid Steam Gravity Clear Challenge Pack 1493PCDG; 3M™ Attest™ Auto-reader 490; 3M™ Attest™ Auto-reader 490H; 3M™ Attest™ Mini Auto-reader 490M
Applicant3M Company
Product CodeFRC · General Hospital
Decision DateNov 25, 2024
DecisionSESE
Submission TypeTraditional
Regulation21 CFR 880.2800
Device ClassClass 2

Intended Use

3M™ Attest™ Super Rapid Readout Biological Indicator 1493: Use the 3M™ Attest™ Super Rapid Readout Biological Indicator 1493 in conjunction with the 3M™ Attest™ Auto-reader 490 having software version 4.0.0 or greater, 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: Gravity Displacement 250°F (121°C) 30 minutes; Dynamic-air-removal (pre-vacuum and SFPP) 250°F (121°C) 15, 20, 30, or 35 minutes. 3M™ Attest™ Super Rapid Steam Gravity Clear Challenge Pack 1493PCDG: Use the 3M™ Attest™ Super Rapid Steam Gravity Clear Challenge Pack 1493PCDG in conjunction with the 3M™ Attest™ Auto-reader 490 having software version 4.0.0 or greater, 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: Gravity Displacement 250°F (121°C) 30 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 1493 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, and 3M™ Attest™ Super Rapid Readout Biological Indicators, catalog numbers 1491, 1492V, and 1493 at 60°C 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 1493, at 60°C for a final fluorescent result at 24 minutes.

Device Story

Device system includes self-contained biological indicators (BI) and process challenge devices (PCD) for steam sterilization monitoring. BI 1493 contains Geobacillus stearothermophilus spores and growth media in a plastic vial. PCD 1493PCDG consists of a clear plastic shell containing the BI and a chemical integrator. Used in healthcare facilities by staff to verify sterilization efficacy. BI is incubated in 3M Attest Auto-readers (490, 490H, 490M). Auto-reader detects fluorescence from enzymatic hydrolysis of a non-fluorescent substrate by active spores; fluorescence indicates sterilization failure. Results provided at 24 minutes. Chemical process indicator on BI cap provides visual confirmation of steam exposure. System ensures sterilization process adequacy, protecting patients from improperly sterilized instruments.

Clinical Evidence

No clinical data. Bench testing only. Performance verified via spore population counts, D-value, Z-value, survival/kill time, component inhibition, holding time, reduced incubation time validation, and simulated use testing per ISO 11138-1, 11138-3, and 11138-8.

Technological Characteristics

Materials: Plastic vial, crushable glass ampoule, foil lid. Sensing: Enzymatic fluorescence detection of Geobacillus stearothermophilus (ATCC 7953). Energy: 60°C incubation. Connectivity: Standalone Auto-reader. Standards: ISO 11138-1, 11138-3, 11138-8, ASTM F88, ASTM F2824.

Indications for Use

Indicated for healthcare facilities to qualify or monitor steam sterilization cycles (gravity displacement and dynamic-air-removal) at 250°F (121°C) using 3M Attest biological indicators and challenge packs in conjunction with specified 3M 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

Reference Devices

Related Devices

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. November 25, 2024 3M Company Michelle Larsen Principal RA Specialist 3M Center 2510 Conway Ave., Building 275-5W-06 St. Paul, Minnesota 55144 #### Re: K242538 Trade/Device Name: 3M™ Attest™ Super Rapid Readout Biological Indicator 1493; 3M™ Attest™ Super Rapid Steam Gravity Clear Challenge Pack 1493PCDG; 3MTM Attest™ Auto-reader 490; 3MTM Attest™ Auto-reader 490H; 3MTM Attest™ Mini Autoreader 490M Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: Class II Product Code: FRC Dated: August 26, 2024 Dear Michelle Larsen: Received: August 26, 2024 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/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. {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 (OS) 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. All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system. 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 medical devices and radiation-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-regulatory {2}------------------------------------------------ assistance/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. Digitally signed by Stephen A. Anisko -S Anisko -S Date: 2024.11.25 11:20:05 -05'00' for: Christopher Dugard Assistant Director DHT4C: Division of Infection Control Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ # Indications for Use Submission Number (if known) K242538 Device Name 3M™ Attest™ Super Rapid Readout Biological Indicator 1493; 3M™ Attest™ Super Rapid Steam Gravity Clear Challenge Pack 1493PCDG; 3M™ Attest™ Auto-reader 490; 3M™ Attest™ Auto-reader 490H; 3M™ Attest™ Mini Auto-reader 490M Indications for Use (Describe) 3M™ Attest™ Super Rapid Readout Biological Indicator 1493: Use the 3M™ Attest™ Super Rapid Readout Biological Indicator 1493 in conjunction with the 3M™ Attest™ Auto-reader 490 having software version 4.0.0 or greater, 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<br>Temperature | Exposure<br>Time | |-------------------------------------------|-------------------------|---------------------------| | Gravity Displacement | 250°F (121°C) | 30 minutes | | Dynamic-air-removal (pre-vacuum and SFPP) | 250°F (121°C) | 15, 20, 30, or 35 minutes | 3M™ Attest™ Super Rapid Steam Gravity Clear Challenge Pack 1493PCDG: Use the 3M™ Attest™ Super Rapid Steam Gravity Clear Challenge Pack 1493PCDG in conjunction with the 3M™ Attest™ Auto-reader 490 having software version 4.0.0 or greater, 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: | | Exposure | Exposure | |----------------------|---------------|------------| | Cycle Type | Temperature | Time | | Gravity Displacement | 250°F (121°C) | 30 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 1493 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, and 3M™ Attest™ Super Rapid Readout Biological Indicators, catalog numbers 1491, 1492V, and 1493 at 60°C 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 1493, 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) {4}------------------------------------------------ #### 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." {5}------------------------------------------------ Image /page/5/Picture/1 description: The image shows the 3M logo, which is a well-known brand. The logo consists of the number "3" and the letter "M" in a bold, sans-serif font. The color of the logo is a vibrant red, and the background is white, creating a strong contrast that makes the logo easily recognizable. # 510(k) Summary for 3MTM Attest™ Super Rapid Readout Biological Indicator 1493, 3MTM Attest™ Super Rapid Steam Gravity Clear Challenge Pack 1493PCDG. 3MTM Attest™ Auto-reader 490, 3MTM Attest™ Auto-reader 490H, 3MTM Attest™ Mini Auto-reader 490M K242538 #### Sponsor Information: 3M Company 3M Center 2510 Conway Ave., Bldg. 275-5W-06 St. Paul, MN 55144-1000, USA Contact: Michelle M. Larsen, Principal RA Specialist Phone Number: (651) 467-3991 Fax Number: (651) 737-5320 Email: mmlarsen@solventum.com Date of Summary: 19 November 2024 K242538 {6}------------------------------------------------ #### 1. Device Name and Classification: | Common or Usual Name: | Biological Indicator (BI) | |------------------------|---------------------------------------------------------------------------| | Proprietary Name: | 3MTM AttestTM Super Rapid Readout Biological Indicator<br>1493, | | | 3MTM AttestTM Super Rapid Steam Gravity Clear Challenge<br>Pack 1493PCDG, | | | 3MTM AttestTM Auto-reader 490, | | | 3MTM AttestTM Auto-reader 490H, | | | 3MTM AttestTM Mini Auto-reader 490M | | Classification Name: | Indicator, Biological Sterilization Process | | Device Classification: | Class II, 21 CFR 880.2800(a) | | Product Code: | FRC | #### 2. Predicate Device: 3M™ Attest™ Super Rapid Steam Biological Indicator 1592, 3M™ Attest™ Super Rapid Steam Challenge Pack 51582, 3MTM Attest™ Auto-reader 490, 3M™ Attest™ Auto-reader 490H, and 3MTM Attest™ Mini- Auto-reader 490M, K213809 ## 3. Description of Device: The 3MTM Attest™ Super Rapid Readout Biological Indicator (BI) 1493 is a self-contained biological indicator specifically designed for rapid and reliable qualification testing and routine monitoring of 121°C (250°F) dynamic-air-removal and gravity-displacement steam sterilization processes in healthcare facilities. The 1493 BI is used in conjunction with a 3M™ Attest™ Auto-reader 490 having software version 4.0.0 or greater, or a 3MTM Attest™ Auto-reader 490H having software version 4.0.0 or greater, or a 3M™ Attest™ Mini Auto-reader 490M. The 1493 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 1493 BI cap is a chemical process indicator that changes color from pink to light brown or darker when exposed to steam. The presence of fluorescence within the specified incubation time of the 1493 BI in the 490 Autoreader, the 490H Auto-reader, or the 490M Mini Auto-reader indicates a steam sterilization process failure. {7}------------------------------------------------ The 3M™ Attest™ Super Rapid Steam Gravity Clear Challenge Pack 1493PCDG is specifically designed to qualify and monitor gravity steam sterilization processes at 250°F (121°C) in healthcare facilities. The 1493PCDG Challenge Pack consists of a clear plastic shell with an opening to the cavity containing the monitoring products, all covered by a foil lid. The 1493PCDG is a single-use device. Each 1493PCDG Challenge Pack contains a 3M™ Attest™ Super Rapid Readout Biological Indicator (BI) 1493 and a 3M™ Attest™ Steam Chemical Integrator (CI) (Type 5 (Category i5) Integrating Indicator as categorized by ISO 11140-1:2014). The 3M™ Attest™ Steam Chemical Integrator offers an immediate ACCEPT or REJECT reading. A chemical process indicator is present on the cap of the 1493 BI and is visible through the clear plastic shell of the challenge pack. The process indicator on the BI cap turns color from pink to light brown or darker upon exposure to steam. 3M™ Attest™ 1493 BI controls are provided with the Challenge Pack. The 1493 BI is specifically designed for rapid and reliable qualification testing and routine monitoring of steam sterilization process when used in conjunction with the 3MM Attest™ Auto-reader 490 having software version 4.0.0 or greater, a 3M™ Attest™ Auto-reader 490H having software version 4.0.0 or greater, or a 3M™ Attest™ Mini Auto-reader 490M. The presence of fluorescence within the specified incubation time of the 1493 BI in the 490. 490H or 490M Auto-reader indicates a steam sterilization process failure. ## 4. Indications for Use 3MTM Attest™ Super Rapid Readout Biological Indicator 1493: Use the 3M™ Attest™ Super Rapid Readout Biological Indicator 1493 in conjunction with the 3M™ Attest™ Auto-reader 490 having software version 4.0.0 or greater, the 3MTM 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 | |----------------------------------------------|----------------------|---------------------------| | Gravity Displacement | 250°F (121°C) | 30 minutes | | Dynamic-air-removal<br>(pre-vacuum and SFPP) | 250°F (121°C) | 15, 20, 30, or 35 minutes | 3MTM Attest™ Super Rapid Steam Gravity Clear Challenge Pack 1493PCDG: Use the 3M™ Attest™ Super Rapid Steam Gravity Clear Challenge Pack 1493PCDG in conjunction with the 3MTM Attest™ Auto-reader 490 having software version 4.0.0 or {8}------------------------------------------------ greater, 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 cvcles: | Cycle Type | Exposure<br>Temperature | Exposure Time | |----------------------|-------------------------|---------------| | Gravity Displacement | 250°F (121°C) | 30 minutes | #### 3MTM AttestTM 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 1493 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, and 3MTM Attest™ Super Rapid Readout Biological Indicators, catalog numbers 1491, 1492V, and 1493 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 1493, at 60°C for a final fluorescent result at 24 minutes. The submission device, the 3M™ Attest™ Super Rapid Readout Biological Indicator (BI) 1493, has the same intended use as the predicate device, the 3M™ Attest™ Super Rapid Steam Biological Indicator 1592. 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. Both the submission and predicate BIs are intended to be used in conjunction with a 3MTM Attest™ Auto-reader 490, a 3MTM Attest™ Auto-reader 490H, or a 3MTM Attest™ Mini Auto-reader 490M to qualify or monitor gravity displacement and dynamic-air-removal (pre-vacuum and steam-flush pressure-pulse (SFPP)) steam sterilization cycles at 250°F (121°C). The predicate BI covers additional dynamic-air-removal steam sterilization cycles (270°F/132°C, 273°F/134°C and 275°F/135°C) compared to the submission BI. The differences in Indications for Use do not alter the fundamental Intended Use of these products as sterilization process monitors and do not raise new questions of safety and effectiveness. #### K242538 {9}------------------------------------------------ The submission device, the 3M™ Attest™ Super Rapid Steam Gravity Clear Challenge Pack 1493PCDG, has the same intended use as the predicate device, the 3M™ Attest™ Super Rapid Steam Challenge Pack 51582. Both the submission device and the predicate device are Single Use biological indicator process challenge devices that are intended to be used in healthcare facilities to accompany products being sterilized and to monitor adequacy of the sterilization process. Both the submission and predicate challenge packs are intended to be used in conjunction with a 3M™ Attest™ Auto-reader 490, a 3M™ Attest™ Auto-reader 490H, or a 3M™ Attest™ Mini Auto-reader 490M to qualify or monitor gravity displacement steam sterilization cycles at 250°F (121°C). The predicate challenge pack also covers dynamic-air-removal (pre-vacuum and steam-flush pressure-pulse (SFPP)) steam sterilization cycles (250°F/121°C, 270°F/132°C, 273°F/134°C and 275°F/135°C') compared to the submission challenge pack. The differences in Indications for Use do not alter the fundamental Intended Use of these products as biological indicator process challenge devices and do not raise new questions of safety and effectiveness. ## 5. Comparison of Technological Characteristics with the Predicate Device #### Biological Indicator The submission device, 3M™ Attest™ Super Rapid Readout Biological Indicator 1493, is the same design, materials, and construction as the previously cleared predicate device, 3M™ Attest™ Super Rapid Steam Biological Indicator 1592 (cleared per K213809). The only difference is the 1493 BI is claiming use with fewer cycles compared to the 1592 BI. Both the submission device and the predicate device utilize the same spores to accomplish their intended use as biological sterilization indicators. The submission and predicate device are intended to qualify or monitor gravity displacement and dynamic-air-removal (pre-vacuum and steam-flush pressure-pulse (SFPP)) steam sterilization cycles at 250°F (121°C) while the predicate device covers additional dynamic-air-removal steam sterilization cvcles at 270°F (132°C), 273°F (134°C) and 275°F (135°C). The Resistance Characteristics (D-Value, Survival/Kill Window) of the submission device and the predicate device both cover the monitoring of steam sterilization cycles at 250°F (121°C). The predicate device was cleared per K213809 for use with the 3M™ Attest™ Auto-reader 490, the 3MTM Attest™ Autoreader 490H, and the 3M™ Attest™ Mini-Auto-reader 490M. The accessories (Autoreaders) 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. {10}------------------------------------------------ The differences in technological characteristics between the submission and predicate biological indicators are illustrated in the Device Technological Characteristics Comparison Table - Biological Indicator (Table 1). | Feature | Submission Device:<br>(K242538)<br>3MTM AttestTM Super<br>Rapid Readout<br>Biological Indicator<br>1493, 3MTM AttestTM<br>Super Rapid Steam<br>Gravity Clear<br>Challenge Pack<br>1493PCDG<br>and<br>3MTM AttestTM Auto-<br>reader 490 and 490H<br>and 3MTM AttestTM<br>Mini Auto-reader 490M | Predicate Device:<br>(K213809)<br>3MTM AttestTM Super<br>Rapid Steam Biological<br>Indicator 1592, 3MTM<br>AttestTM Super Rapid<br>Steam Challenge Pack<br>51582<br>and<br>3MTM AttestTM Auto-<br>reader 490 and 490H<br>and 3MTM AttestTM<br>Mini Auto-reader 490M | Comparison | |---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended Use | Single Use sterilization<br>process indicator | Single Use sterilization<br>process indicator | Identical | | Indications for use | Use the 3MTM AttestTM<br>Super Rapid Readout<br>Biological Indicator 1493<br>in conjunction with the<br>3MTM AttestTM Auto-<br>reader 490 having<br>software version 4.0.0 or<br>greater, the 3MTM<br>AttestTM Auto-reader<br>490H having software<br>version 4.0.0 or greater,<br>or the 3MTM AttestTM<br>Mini Auto-reader 490M<br>to qualify or monitor the<br>following steam<br>sterilization cycles:<br>• Gravity<br>Displacement, 250°F<br>(121°C),<br>30 minutes<br>and Dynamic-air-removal | Use the 3MTM AttestTM<br>Super Rapid Steam<br>Biological Indicator 1592<br>in conjunction with the<br>3MTM AttestTM Auto-<br>reader 490 having<br>software version 4.0.0 or<br>greater, the 3MTM<br>AttestTM Auto-reader<br>490H having software<br>version 4.0.0 or greater,<br>or the 3MTM AttestTM<br>Mini Auto-reader 490M<br>to qualify or monitor the<br>following steam<br>sterilization cycles:<br>• Gravity<br>Displacement, 250°F<br>(121°C),<br>30 minutes<br>and Dynamic-air-removal | Both the predicate<br>and submission BIs<br>are indicated for<br>qualifying and<br>monitoring gravity<br>displacement and<br>dynamic-air-removal<br>steam sterilization<br>cycles at 250°F<br>(121°C). The<br>predicate BI is<br>indicated for<br>qualifying and<br>monitoring<br>additional dynamic-<br>air-removal steam<br>sterilization cycles<br>(270°F/132°C,<br>273°F/134°C and<br>275°F/135°C). | | | | Table 1: Device Technological Characteristics Comparison Table - Biological Indicator | |--|--|---------------------------------------------------------------------------------------| | | | | {11}------------------------------------------------ | Feature | Submission Device:<br>(K242538)<br>3MTM AttestTM Super<br>Rapid Readout<br>Biological Indicator<br>1493, 3MTM AttestTM<br>Super Rapid Steam<br>Gravity Clear<br>Challenge Pack<br>1493PCDG<br>and<br>3MTM AttestTM Auto-<br>reader 490 and 490H<br>and 3MTM AttestTM<br>Mini Auto-reader 490M | Predicate Device:<br>(K213809)<br>3MTM AttestTM Super<br>Rapid Steam Biological<br>Indicator 1592, 3MTM<br>AttestTM Super Rapid<br>Steam Challenge Pack<br>51582<br>and<br>3MTM AttestTM Auto-<br>reader 490 and 490H<br>and 3MTM AttestTM<br>Mini Auto-reader 490M | Comparison | |--------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | (pre-vacuum and<br>SFPP), 250°F<br>(121°C),<br>15, 20, 30, or 35<br>minutes | (pre-vacuum and<br>SFPP), 250°F<br>(121°C),<br>15, 20, 30, or 35<br>minutes<br>• Dynamic-air-removal<br>(pre-vacuum and<br>SFPP), 270°F<br>(132°C),<br>3, 3.5, 4, 5.5, or 6<br>minutes<br>• Dynamic-air-removal<br>(pre-vacuum and<br>SFPP), 273°F<br>(134°C),<br>3 or 4 minutes<br>• Dynamic-air-removal<br>(pre-vacuum and<br>SFPP), 275°F<br>(135°C), 3, 3.5, or 10<br>minutes | Both the predicate<br>and submission BIs<br>are intended to be<br>used in conjunction<br>with the same auto-<br>readers. | | General<br>Design/Construction | Plastic vial containing a<br>spore carrier and media<br>ampoule, enclosed with a<br>color-coded cap with<br>chemical process | Plastic vial containing a<br>spore carrier and media<br>ampoule, enclosed with a<br>color-coded cap with<br>chemical process | Identical | | Feature | Submission Device:<br>(K242538)<br>3MTM AttestTM Super<br>Rapid Readout<br>Biological Indicator<br>1493, 3MTM AttestTM<br>Super Rapid Steam<br>Gravity Clear<br>Challenge Pack<br>1493PCDG<br>and<br>3MTM AttestTM Auto-<br>reader 490 and 490H<br>and 3MTM AttestTM<br>Mini Auto-reader 490M | Predicate Device:<br>(K213809)<br>3MTM AttestTM Super<br>Rapid Steam Biological<br>Indicator 1592, 3MTM<br>AttestTM Super Rapid<br>Steam Challenge Pack<br>51582<br>and<br>3MTM AttestTM Auto-<br>reader 490 and 490H<br>and 3MTM AttestTM<br>Mini Auto-reader 490M | Comparison | | | indicator located on top<br>of cap. | indicator located on top<br>of cap. | | | Carrier Material | Plastic | Plastic | Identical | | Media Ampoule | Crushable glass ampoule<br>containing a growth<br>media and a fluorescence<br>indicator which is<br>correlated to an optional<br>use pH indicator. | Crushable glass ampoule<br>containing a growth<br>media and a fluorescence<br>indicator which is<br>correlated to an optional<br>use pH indicator. | Identical | | Chemical indicator | Turns from pink to light<br>brown or darker upon<br>steam exposure | Turns from pink to light<br>brown or darker upon<br>steam exposure | Identical | | Indicator Organism | Geobacillus<br>stearothermophilus<br>traceable to ATCCTM<br>7953 | Geobacillus<br>stearothermophilus<br>traceable to ATCCTM<br>7953 | Identical | | Viable spore<br>population | ≥ 1 x 106 | ≥ 1 x 106 | Identical | | Mechanism of Action | When the enzyme that is<br>naturally occurring in the<br>spore is in its active state,<br>it is detected by<br>measuring the<br>fluorescence produced by<br>the enzymatic hydrolysis<br>of a non-fluorescent<br>substrate. The resultant<br>fluorescent by-product is<br>detected by the Auto- | When the enzyme that is<br>naturally occurring in the<br>spore is in its active state,<br>it is detected by<br>measuring the<br>fluorescence produced by<br>the enzymatic hydrolysis<br>of a non-fluorescent<br>substrate. The resultant<br>fluorescent by-product is<br>detected by the Auto- | Identical | | Feature | Submission Device:<br>(K242538)<br>3MTM AttestTM Super<br>Rapid Readout<br>Biological Indicator<br>1493, 3MTM AttestTM<br>Super Rapid Steam<br>Gravity Clear<br>Challenge Pack<br>1493PCDG<br>and<br>3MTM AttestTM Auto-<br>reader 490 and 490H<br>and 3MTM AttestTM<br>Mini Auto-reader 490M | Predicate Device:<br>(K213809)<br>3MTM AttestTM Super<br>Rapid Steam Biological<br>Indicator 1592, 3MTM<br>AttestTM Super Rapid<br>Steam Challenge Pack<br>51582<br>and<br>3MTM AttestTM Auto-<br>reader 490 and 490H<br>and 3MTM AttestTM<br>Mini Auto-reader 490M | Comparison | | | fluorescence upon<br>incubation in the Auto-<br>reader indicates a<br>sterilization process<br>failure. | fluorescence upon<br>incubation in the Auto-<br>reader indicates a<br>sterilization process<br>failure. | | | • D-value | D-Value ≥ 1.5 min at<br>121°C | D-Value ≥ 1.5 min at<br>121°C<br>D-value ≥ 10 seconds at<br>132°C<br>D-value ≥ 8 seconds at<br>134°C, 135°C | Both the predicate<br>and submission BIs<br>are indicated for<br>qualifying and<br>monitoring gravity<br>displacement and<br>dynamic-air-removal<br>steam sterilization<br>cycles at 250°F<br>(121°C). The<br>predicate BI is<br>indicated for<br>qualifying and<br>monitoring<br>additional dynamic-<br>air-removal steam<br>sterilization cycles<br>(270°F/132°C,<br>273°F/134°C and<br>275°F/135°C). | | Survival Time | Meets the longer of FDA<br>and ISO 11138-1 and ISO<br>11138-3 requirements | Meets the longer of FDA<br>and ISO 11138-1 and ISO<br>11138-3 requirements | Identical | | Kill Time | Meets the ISO 11138-1 and<br>ISO 11138-3 requirements | Meets the ISO 11138-1 and<br>ISO 11138-3 requirements | Identical | | Feature | Submission Device:<br>(K242538)<br>3MTM AttestTM Super<br>Rapid Readout<br>Biological Indicator<br>1493, 3MTM AttestTM<br>Super Rapid Steam<br>Gravity Clear<br>Challenge Pack<br>1493PCDG<br>and<br>3MTM AttestTM Auto-<br>reader 490 and 490H<br>and 3MTM AttestTM<br>Mini Auto-reader 490M | Predicate Device:<br>(K213809)<br>3MTM AttestTM Super<br>Rapid Steam Biological<br>Indicator 1592, 3MTM<br>AttestTM Super Rapid<br>Steam Challenge Pack<br>51582<br>and<br>3MTM AttestTM Auto-<br>reader 490 and 490H<br>and 3MTM AttestTM<br>Mini Auto-reader 490M | Comparison | | Incubation temperature | 60 $\pm$ 2°C | 60 $\pm$ 2°C | Identical | | Readout time | 24 minute final<br>fluorescent result in:<br>The 490 Auto-reader<br>having software<br>version 4.0.0 or<br>greater or The 490H Auto-<br>reader having<br>software version<br>4.0.0 or greater or The 490M Mini<br>Auto-reader<br>Optional visual pH color<br>change result in 7 days. | 24 minute final<br>fluorescent result in:<br>The 490 Auto-reader<br>having software<br>version 4.0.0 or<br>greater or The 490H Auto-<br>reader having<br>software version<br>4.0.0 or greater or The 490M Mini<br>Auto-reader<br>Optional visual pH color<br>change result in 7 days. | Identical | | Shelf Life | 24 months | 24 months | Identical | | Accessories<br>(Auto-readers) | 3MTM AttestTM Auto-<br>reader 490 having<br>software version 4.0.0 or<br>greater, 3MTM AttestTM<br>Auto-reader, or 490H<br>having software version<br>4.0.0 or greater, or 3MTM<br>AttestTM Mini Auto-<br>reader 490M | 3MTM AttestTM Auto-<br>reader 490 having<br>software version 4.0.0 or<br>greater, 3MTM AttestTM<br>Auto-reader, or 490H<br>having software version<br>4.0.0 or greater, or 3MTM<br>AttestTM Mini Auto-<br>reader 490M | Identical | {12}------------------------------------------------ {13}------------------------------------------------ {14}------------------------------------------------ {15}------------------------------------------------ #### Challenge Pack The submission device, the 3M™ Attest™ Super Rapid Steam Gravity Clear Challenge Pack 1493PCDG, consists of a clear plastic shell with a cavity opening in the shell to the monitoring products, all heat sealed with a foil lid. The predicate device, the 3MIM Attest™ Super Rapid Steam Challenge Pack 51582, consists of layers of medical index cards, some of which are die-cut to contain indicators, overwrapped and secured with a label. Both the submission and predicate device are designed to increase the resistance beyond that measured with a standalone biological indicator and both represent a challenge to the sterilization process equivalent to the AAMI reference PCD. The predicate device utilizes the 3M™ Attest™ Super Rapid Steam Biological Indicator 1592 that was cleared per K213809. The submission device utilizes the 3M™ Attest Super Rapid Readout Biological Indicator 1493 which is the subject biological indicator of this submission. The submission BI (1493) is the same design, materials, and construction as the previously cleared predicate BI (1592). The only difference is the 1493 BI is claiming use with fewer cycles compared to the 1592 BI. Both the submission and predicate device utilize the same Chemical Integrator (CI), the 3M™ Attest™ Steam Chemical Integrator (cleared per K220942). The process indicator dot on the predicate device is present on the outer label of the overwrapped device whereas the process indicator on the submission device is present on the cap of the 1493 BI which is visible through the clear challenge pack. Both the submission and predicate device contain a visible process indicator that changes color upon steam exposure that is used by the customer to distinguish processed and unprocessed challenge packs. 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 challenge packs are illustrated in the Device Technological Characteristics Comparison Table - Challenge Pack (Table 2). {16}------------------------------------------------ | Feature | Submission Device:<br>(242538)<br>3M™ Attest™ Super<br>Rapid Readout<br>Biological Indicator<br>1493, 3M™ Attest™<br>Super Rapid Steam<br>Gravity Clear<br>Challenge Pack<br>1493PCDG<br>and<br>3M™ Attest™ Auto-<br>reader 490 and 490H<br>and 3M™ Attest™<br>Mini Auto-reader 490M | Predicate Device:<br>(K213809)<br>3M™ Attest™ Super<br>Rapid Steam Biological<br>Indicator 1592, 3M™<br>Attest™ Super Rapid<br>Steam Challenge Pack<br>51582<br>and<br>3M™ Attest™ Auto-<br>reader 490 and 490H<br>and 3M™ Attest™<br>Mini Auto-reader 490M | Comparison | | |---------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--| | Intended Use | Single Use biological<br>indicator process<br>challenge device | Single Use biological<br>indicator process<br>challenge device | Identical | | | Indications for use | Use the 3M™ Attest™<br>Super Rapid Steam<br>Gravity Clear Challenge<br>Pack 1493PCDG in<br>conjunction with the<br>3M™ Attest™ Auto-<br>reader 490 having<br>software version 4.0.0 or<br>greater, the 3M™<br>Attest™ Auto-reader<br>490H having software<br>version 4.0.0 or greater,<br>or the 3M™ Attest™<br>Mini Auto-reader 490M<br>to qualify or monitor the<br>following steam<br>sterilization cycles:<br>• Gravity<br>Displacement, 250°F<br>(121°C),<br>30 minutes | Use the 3M™ Attest™<br>Super Rapid Steam<br>Challenge Pack 51582 in<br>conjunction with the<br>3M™ Attest™ Auto-<br>reader 490 having<br>software version 4.0.0 or<br>greater, the 3M™<br>Attest™ Auto-reader<br>490H having software<br>version 4.0.0 or greater,<br>or the 3M™ Attest™<br>Mini Auto-reader 490M<br>to qualify or monitor the<br>following steam<br>sterilization cycles:<br>• Gravity<br>Displacement, 250°F<br>(121°C),<br>30 minutes<br>• Dynamic-air-removal<br>(pre-vacuum and<br>SFPP),<br>250°F (121°C),<br>30 minutes | Both the submission<br>and predicate<br>challenge packs are<br>indicated for<br>qualifying and<br>monitoring gravity<br>displacement steam<br>sterilization cycles at<br>250°F (121°C). The<br>predicate challenge<br>pack is also<br>indicated for<br>qualifying and<br>monitoring dynamic-<br>air-removal steam<br>sterilization cycles<br>(250°F/121°C,<br>270°F/132°C,<br>273°F/134°C, and<br>275°F/135°C).<br>The submission BI<br>(1493) that is<br>contained in the<br>submission PCD is | | | Feature | Submission Device:<br>(242538)<br><br>3M™ Attest™ Super<br>Rapid Readout<br>Biological Indicator<br>1493, 3M™ Attest™<br>Super Rapid Steam<br>Gravity Clear<br>Challenge Pack<br>1493PCDG<br>and<br>3M™ Attest™ Auto-<br>reader 490 and 490H<br>and 3M™ Attest™<br>Mini Auto-reader 490M | Predicate Device:<br>(K213809)<br><br>3M™ Attest™ Super<br>Rapid Steam Biological<br>Indicator 1592, 3M™<br>Attest™ Super Rapid<br>Steam Challenge Pack<br>51582<br>and<br>3M™ Attest™ Auto-<br>reader 490 and 490H<br>and 3M™ Attest™<br>Mini Auto-reader 490M | Comparison | | | | | Dynamic-air removal<br>(pre-vacuum and<br>SFPP), 270°F<br>(132°C),<br>4 minutes Dynamic-air removal<br>(pre-vacuum and<br>SFPP), 273°F<br>(134°C),<br>4 minutes Dynamic-air removal<br>(pre-vacuum and<br>SFPP), 275°F<br>(135°C), 3 minutes | the same design,<br>materials, and<br>construction as the<br>predicate BI (1592)<br>that is contained in<br>the predicate PCD<br>(51582). Both the<br>predicate and<br>submission BIs are<br>indicated for<br>qualifying and<br>monitoring gravity<br>displacement and<br>dynamic-air-removal<br>steam sterilization<br>cycles at 250°F<br>(121°C). The<br>predicate BI is<br>indicated for<br>qualifying and<br>monitoring<br>additional dynamic-<br>air-removal steam<br>sterilization cycles<br>(270°F/132°C,<br>273°F/134°C and<br>275°F/135°C).<br><br>Both the submission<br>and predicate | | | Feature | Submission Device:<br>(242538)<br>3M™ Attest™ Super<br>Rapid Readout<br>Biological Indicator<br>1493, 3M™ Attest™<br>Super Rapid Steam<br>Gravity Clear<br>Challenge Pack<br>1493PCDG<br>and<br>3M™ Attest™ Auto-<br>reader 490 and 490H<br>and 3M™ Attest™<br>Mini Auto-reader 490M | Predicate Device:<br>(K213809)<br>3M™ Attest™ Super<br>Rapid Steam Biological<br>Indicator 1592, 3M™<br>Attest™ Super Rapid<br>Steam Challenge Pack<br>51582<br>and<br>3M™ Attest™ Auto-<br>reader 490 and 490H<br>and 3M™ Attest™<br>Mini Auto-reader 490M | Comparison | | | | | | challenge packs<br>utilize the same<br>Chemical Integrator<br>(CI). The 1243R CI<br>is indicated for use<br>in 250°F (121°C)<br>gravity and 250°F<br>(121°C), 270°F<br>(132°C), 273°F<br>(134°C) and 275°F<br>(135°C) dynamic-<br>air-removal steam<br>sterilization cycles<br>(per K220942).<br>Both the predicate<br>and submission<br>challenge packs are<br>intended to be used<br>in conjunction with<br>the same auto-<br>readers. | | | General<br>Design/Construction | Clear plastic tray with a<br>cavity opening in the<br>shell to the indicators,<br>acting as a challenge to<br>limit air removal and<br>steam penetration, sealed<br>with a foil lid. | Layers of medical index<br>cards, some of which are<br>die-cut to contain<br>indicators, overwrapped<br>and secured with a label. | Both the submission<br>and predicate<br>challenge packs are<br>designed to increase<br>resistance beyond<br>that measured with a<br>standalone BI and<br>both represent a | | | Feature | Submission Device:<br>(242538)<br>3M™ Attest™ Super<br>Rapid Readout<br>Biological Indicator<br>1493, 3M™ Attest™<br>Super Rapid Steam<br>Gravity Clear<br>Challenge Pack<br>1493PCDG<br>and<br>3M™ Attest™ Auto-<br>reader 490 and 490H<br>and 3M™ Attest™<br>Mini Auto-reader 490M | Predicate Device:<br>(K213809)<br>3M™ Attest™ Super<br>Rapid Steam Biological<br>Indicator 1592, 3M™<br>Attest™ Super Rapid<br>Steam Challenge Pack<br>51582<br>and<br>3M™ Attest™ Auto-<br>reader 490 and 490H<br>and 3M™ Attest™<br>Mini Auto-reader 490M | Comparison | | | | | | challenge to the<br>sterilization process<br>equivalent to the<br>AAMI reference<br>PCD. | | | Biological Indicator | 3M™ Attest™ Super<br>Rapid Readout Biological<br>Indicator 1493 | 3M™ Attest™ Super<br>Rapid Steam Biological<br>Indicator 1592 | The predicate BI and<br>the submission BI<br>are the same design,<br>materials, and<br>construction. | | | Biological Indicator<br>Incubation<br>temperature | 60 ± 2°C | 60 ± 2°C | Identical | | | Biological Indicator<br>Readout time | 24 minute final<br>fluorescent result in:<br>• The 490 Auto-reader<br>having software<br>version 4.0.0 or<br>greater<br>or<br>• The 490H Auto-<br>reader having<br>software version<br>4.0.0 or greater<br>or<br>• The 490M Mini<br>Auto-reader | 24 minute final<br>fluorescent result in:<br>• The 490 Auto-reader<br>having software<br>version 4.0.0 or<br>greater<br>or<br>• The 490H Auto-<br>reader having<br>software version<br>4.0.0 or greater<br>or<br>• The 490M Mini<br>Auto-reader | Identical | | | Chemical Integrator | 3M™ Attest™ Steam<br>Chemical Integrator | 3M™ Attest™ Steam<br>Chemical Integrator | Identical…
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510(k) Summary
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