3M™ Attest™ Rapid Readout Biological Indicator 1295 and 3M™ Attest™ Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square and the words "U.S. Food & Drug Administration". June 27, 2024 3M Company Heidi Wallis Regulatory Affairs Senior Associate 3M Center 2510 Conway Avenue, Building 275-5W-06 St. Paul, Minnesota 55144-1000 Re: K240717 Trade/Device Name: 3M™ Rapid Readout Biological Indicator 1295 and 3M™ Attest™ Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: Class II Product Code: FRC, QKM Dated: May 14, 2024 Received: May 29, 2024 Dear Heidi Wallis: 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. 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" {1}------------------------------------------------ (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 OS 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. # Christopher K. Dugard -S Christopher K. Dugard, M.S. Assistant Director DHT4B: Division of Infection Control and Plastic and Reconstructive Surgery Devices {2}------------------------------------------------ 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 510(k) Number (if known) K240717 Device Name 3M TM Attest TM Rapid Readout Biological Indicator 1295 Indications for Use (Describe) Use the 3M TM Attest TM Rapid Readout Biological Indicator 1295 in conjunction with the 3M TM Attest TM Auto-reader 490H or 490 Auto-reader having software version 4.0.0 or greater or 490M Auto-reader as a standard method of routine monitoring of vaporized hydrogen peroxide sterilization processes in the following systems: STERRAD 100S® Sterilization System STERRAD NX® Sterilization System (Standard and Advanced cycles) STERRAD 100NX® Sterilization System (Standard, Flex, Express and Duo cycles) STERRAD NX® with ALLClear® Technology Sterilization System (Standard and Advanced cycles) STERRAD 100NX® with ALLClear® Technology Sterilization System (Standard, Flex, Express and Duo cycles) V-PRO® 1 Low Temperature Sterilization System (Lumen cycle) V-PRO® 1 Plus Low Temperature Sterilization System (Lumen and Non Lumen cycles) V-PRO® maX Low Temperature Sterilization System (Lumen, and Flexible cycles) V-PRO® 60 Low Temperature Sterilization System (Lumen and Flexible cycles) V-PRO® maX 2 Low Temperature Sterilization System (Lumen, Non Lumen, Flexible, and Fast Non Lumen cvcles) V-PRO® &2 Low Temperature Sterilization System (Lumen, Flexible, and Fast cycles) STERIZONE® VP4 Sterilizer (Cycle 1) SteroScope® Sterilization System | 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}------------------------------------------------ # Indications for Use 510(k) Number (if known) K240717 Device Name 3M TM Attest TM Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E Indications for Use (Describe) Use the 3M IM Attest TM Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E for pack control monitoring of the following hydrogen peroxide sterilization sterilizers and cycles: STERRAD 100S® Sterilization System STERRAD NX® Sterilization System (Standard and Advanced cycles) STERRAD 100NX® Sterilization System (Standard, Flex, Express and Duo cycles) STERRAD NX® with ALLClear® Technology Sterilization System (Standard and Advanced cycles) STERRAD 100NX® with ALLClear® Technology Sterilization System (Standard, Flex, Express and Duo cycles) V-PRO® 1 Low Temperature Sterilization System (Lumen cycle) V-PRO® 1 Plus Low Temperature Sterilization System (Lumen and Non Lumen cycles) V-PRO® maXLow Temperature Sterilization System (Lumen, and Flexible cycles) V-PRO® 60 Low Temperature Sterilization System (Lumen and Flexible cycles) V-PRO® maX 2 Low Temperature Sterilization System (Lumen, Flexible, and Fast Non Lumen cycles) V-PRO® s2 Low Temperature Sterilization System (Lumen, Flexible, and Fast cycles) STERIZONE® VP4 Sterilizer (Cycle 1) SteroScope® Sterilization System | 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." {5}------------------------------------------------ Image /page/5/Picture/1 description: The image shows the 3M logo. The logo is red and consists of the number "3" and the letter "M" next to each other. The number "3" is on the left and the letter "M" is on the right. The logo is simple and recognizable. # 510(k) Summary for # 3M™ Attest™ Rapid Readout Biological Indicator 1295 and 3M™ Attest™ Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E Sponsor Information: 3M Health Care 3M Center, Bldg. 275-5W-06 St. Paul, MN 55144-1000 Contact: Heidi Wallis Regulatory Affairs Senior Associate Date of Summary: June 24, 2024 510(k) Reference: K240717 {6}------------------------------------------------ #### 3M™ Attest™ Rapid Readout Biological Indicator 1295 and #### MTM Attest™ Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E #### 1. Device Name and Classification: | Common or Usual Name: | Biological Indicator | |------------------------|-------------------------------------------------------| | Proprietary Name: | 3MTM AttestTM Rapid Readout Biological Indicator 1295 | | Classification Name: | Indicator, biological sterilization process | | Device Classification: | Class II, 21 CFR § 880.2800(a) | | Product Code: | FRC | | Common or Usual Name: | Chemical Indicator | |------------------------|-------------------------------------------------------------------------------------| | Proprietary Name: | 3M™ Attest™ Vaporized Hydrogen Peroxide Tri-Metric<br>Chemical Indicator 1348/1348E | | Classification Name: | Indicator, physical/chemical sterilization process | | Device Classification: | Class II, 21 CFR § 880.2800 | | Product Code: | QKM | #### 2. Predicate Device: K211705, 3M™ Attest™ Rapid Readout Biological Indicator 1295 K212022, 3M™ Attest™ Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E #### 3. Description of Device: 3MTM Attest™ Rapid Readout Biological Indicator 1295: The 3M™ Attest™ Rapid Readout Biological Indicator 1295 is a self-contained biological indicator specifically designed for rapid and reliable routine monitoring of vaporized hydrogen peroxide sterilization processes when used in conjunction with the 3MTM Attest™ Auto-reader 490H or the 3MTM Attest™ Auto-reader 490 having software version 4.0.0 or greater or a 3MTM Attest™ Mini Auto-reader 490M. The 1295 BI is a single-use device composed of a plastic sleeve containing a spore carrier and media ampoule, enclosed with a color-coded cap. A chemical process indicator printed with stripes which change from blue toward pink upon exposure to vaporized hydrogen peroxide is located on the top of the cap. The detection of fluorescence upon incubation of the 1295 BI in one of the designated Attest™ Auto-readers indicates a sterilization failure. 3M™ Attest™ Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E: The 3M™ Attest™ Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E is a chemical indicator consisting of a non-cellulose based coated indicator strip sensitive to vaporized hydrogen peroxide, contained in a film laminate. There has been no change to the product construction compared to the predicate submission, K212022. {7}------------------------------------------------ #### 3M™ Attest™ Rapid Readout Biological Indicator 1295 and #### 3M™ Attest™ Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E The 3M™ Attest™ CI 1348/1348E verifies that the stated values for the three critical parameters of exposure time, temperature, and concentration of vaporized hydrogen peroxide have been achieved within a package or containment device (i.e. wrapped trays, rigid containers, sterilization pouches, and other types of packs) and/or at a specific location within the load or empty chamber. Upon exposure to vaporized hydrogen peroxide, the color of the coated indicator strip progressively changes from blue toward pink along the strip. The progression of the blue to pink color change along the strip is visible through a window with marked "REJECT" and "ACCEPT" zones. The extent of the progression depends on exposure time, temperature, and concentration of vaporized hydrogen peroxide. #### 4. Indications for Use Use the 3M™ Attest™ Rapid Readout Biological Indicator 1295 in conjunction with the 3M™ Attest™ Auto-reader 490H or 490 Auto-reader having software version 4.0.0 or greater or 490M Auto-reader as a standard method of routine monitoring of vaporized hydrogen peroxide sterilization processes in the following systems: | STERRAD 100S® Sterilization System | |--------------------------------------------------------------------------------------------------------------| | STERRAD NX® Sterilization System (Standard and Advanced cycles) | | STERRAD 100NX® Sterilization System (Standard, Flex, Express and Duo cycles) | | STERRAD NX® with ALLClear® Technology Sterilization System (Standard and<br>Advanced cycles) | | STERRAD 100NX® with ALLClear® Technology Sterilization System (Standard, Flex,<br>Express and Duo cycles) | | V-PRO® 1 Low Temperature Sterilization System (Lumen cycle) | | V-PRO® 1 Plus Low Temperature Sterilization System (Lumen and Non Lumen cycles) | | V-PRO® maX Low Temperature Sterilization System (Lumen, Non Lumen, and Flexible<br>cycles) | | V-PRO® 60 Low Temperature Sterilization System (Lumen, Non Lumen and Flexible<br>cycles) | | V-PRO® maX 2 Low Temperature Sterilization System (Lumen, Non Lumen, Flexible,<br>and Fast Non Lumen cycles) | | V-PRO® s2 Low Temperature Sterilization System (Lumen, Non Lumen, Flexible, and<br>Fast cycles) | | STERIZONE® VP4 Sterilizer (Cycle 1) | | SteroScope® Sterilization System | {8}------------------------------------------------ #### PREMARKET NOTIFICATION [510(k)] 3M™ Attest™ Rapid Readout Biological Indicator 1295 and 3M™ Attest™ Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E Use the 3MTM Attest™ Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E for pack control monitoring of the following hydrogen peroxide sterilization sterilizers and cycles: | STERRAD 100S® Sterilization System | |-----------------------------------------------------------------------------------------------------------| | STERRAD NX® Sterilization System (Standard and Advanced cycles) | | STERRAD 100NX® Sterilization System (Standard, Flex, Express, and Duo cycles) | | STERRAD NX® with ALLClear® Technology Sterilization System (Standard and Advanced cycles) | | STERRAD 100NX® with ALLClear® Technology Sterilization System (Standard, Flex, Express, and Duo cycles) | | V-PRO® 1 Low Temperature Sterilization System (Lumen cycle) | | V-PRO® 1 Plus Low Temperature Sterilization System (Lumen and Non Lumen cycles) | | V-PRO® maX Low Temperature Sterilization System (Lumen, Non Lumen, and Flexible cycles) | | V-PRO® 60 Low Temperature Sterilization System (Lumen, Non Lumen, and Flexible cycles) | | V-PRO® maX 2 Low Temperature Sterilization System (Lumen, Non Lumen, Flexible, and Fast Non Lumen cycles) | | V-PRO® s2 Low Temperature Sterilization System (Lumen, Non Lumen, Flexible, and Fast cycles) | | STERIZONE® VP4 Sterilizer (Cycle 1) | | SteroScope® Sterilization System | ### Technological Characteristic Comparison Table | Feature | Submission Device:<br>3MTM Attest™ Rapid Readout<br>Biological Indicator | Predicate Device (K211705):<br>3MTM Attest™ Rapid Readout<br>Biological Indicator | Comparison | |-------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------| | Device Models | 1295 | 1295 | Identical | | Indications for use | Use the 3M™ Attest™ Rapid<br>Readout Biological Indicator 1295<br>in conjunction with the 3MTM<br>Attest™ Auto-reader 490H or 490<br>Auto-reader having software<br>version 4.0.0 or greater or 490M<br>Auto-reader as a standard method<br>of routine monitoring of vaporized<br>hydrogen peroxide sterilization<br>processes in the following systems:<br>STERRAD 100S® Sterilization<br>System | Use the 3M™ Attest™ Rapid<br>Readout Biological Indicator 1295<br>in conjunction with the 3MTM<br>Attest™ Auto-reader 490H or 490<br>Auto-reader having software version<br>4.0.0 or greater or 490M Auto-<br>reader as a standard method of<br>routine monitoring of vaporized<br>hydrogen peroxide sterilization<br>processes in the following systems:<br>STERRAD 100S® Sterilization<br>System | Addition of<br>SteroScope®<br>Sterilization<br>System | | | Submission Device:<br>3MTM Attest™ Rapid Readout<br>Biological Indicator | Predicate Device (K211705):<br>3MTM Attest™ Rapid Readout<br>Biological Indicator | Comparison | | Feature | STERRAD NX® Sterilization<br>System (Standard and<br>Advanced cycles) | STERRAD NX® Sterilization<br>System (Standard and Advanced<br>cycles) | | | | STERRAD 100NX®<br>Sterilization System (Standard,<br>Flex, Express and Duo cycles) | STERRAD 100NX®<br>Sterilization System (Standard,<br>Flex, Express and Duo cycles) | | | | STERRAD NX® with<br>ALLClear® Technology<br>Sterilization System (Standard<br>and Advanced cycles) | STERRAD NX® with<br>ALLClear® Technology<br>Sterilization System (Standard<br>and Advanced cycles) | | | | STERRAD 100NX® with<br>ALLClear® Technology<br>Sterilization System (Standard,<br>Flex, Express and Duo cycles) | STERRAD 100NX® with<br>ALLClear® Technology<br>Sterilization System (Standard,<br>Flex, Express and Duo cycles) | | | | V-PRO® 1 Low Temperature<br>Sterilization System (Lumen<br>cycle) | V-PRO® 1 Low Temperature<br>Sterilization System (Lumen<br>cycle) | | | | V-PRO® 1 Plus Low<br>Temperature Sterilization<br>System (Lumen and Non<br>Lumen cycles) | V-PRO® 1 Plus Low<br>Temperature Sterilization<br>System (Lumen and Non Lumen<br>cycles) | | | | V-PRO® maX Low<br>Temperature Sterilization<br>System (Lumen, Non Lumen,<br>and Flexible cycles) | V-PRO® maX Low Temperature<br>Sterilization System (Lumen,<br>Non Lumen, and Flexible<br>cycles) | | | | V-PRO® 60 Low Temperature<br>Sterilization System (Lumen,<br>Non Lumen and Flexible<br>cycles) | V-PRO® 60 Low Temperature<br>Sterilization System (Lumen,<br>Non Lumen and Flexible cycles) | | | | V-PRO® maX 2 Low<br>Temperature Sterilization<br>System (Lumen, Non Lumen,<br>Flexible, and Fast Non Lumen<br>cycles) | V-PRO® maX 2 Low<br>Temperature Sterilization<br>System (Lumen, Non Lumen,<br>Flexible, and Fast Non Lumen<br>cycles) | | | | V-PRO® s2 Low Temperature<br>Sterilization System (Lumen,<br>Non Lumen, Flexible, and Fast<br>cycles) | V-PRO® s2 Low Temperature<br>Sterilization System (Lumen,<br>Non Lumen, Flexible, and Fast<br>cycles) | | | | STERIZONE® VP4 Sterilizer<br>(Cycle 1) | STERIZONE® VP4 Sterilizer<br>(Cycle 1) | | | | SteroScope® Sterilization<br>System | | | | Organism | Geobacillus stearothermophilus<br>traceable to ATCC™ 7953 | Geobacillus stearothermophilus<br>traceable to ATCC™ 7953 | Identical | | Viable spore<br>population | $\ge$ 1x106 | >1x106 | Identical | | Resistance<br>characteristics | (Tested at 10 mg/L vaporized<br>hydrogen peroxide) | (Tested at 10 mg/L vaporized<br>hydrogen peroxide) | | | • D-value | D10 mg/L $\ge$ 1 second | D10 mg/L $\ge$ 1 second | Identical | | • Survival/Kill<br>Window | Survival Time $\ge$ 5 seconds<br>Kill Time = 7 minutes | Survival Time $\ge$ 5 seconds<br>Kill Time = 7 minutes | | | Feature | Submission Device:<br>3MTM Attest™ Rapid Readout<br>Biological Indicator | Predicate Device (K211705):<br>3MTM Attest™ Rapid Readout<br>Biological Indicator | Comparison | | Incubation<br>temperature | 60 ± 2℃ | 60 ± 2℃ | Identical | | Readout time | 24 minute fluorescence result read | 24 minute fluorescence result read | Identical | | Chemical<br>indicator | H2O2 sensitive ink; changes from<br>blue towards pink | H2O2 sensitive ink; changes from<br>blue towards pink | Identical | | Shelf life | Two (2) years | Two (2) years | Identical | {9}------------------------------------------------ ### 3M™ Attest™ Rapid Readout Biological Indicator 1295 and # 3M™ Attest™ Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E {10}------------------------------------------------ #### PREMARKET NOTIFICATION [510(k)] 3M™ Attest™ Rapid Readout Biological Indicator 1295 and | | 3M™ Attest™ Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E | |--|----------------------------------------------------------------------------------| | Feature | Submission Device:<br>3M™ Attest™ Vaporized Hydrogen<br>Peroxide Tri-Metric Chemical<br>Indicator | Predicate Device:<br>3M™ Attest™ Vaporized Hydrogen<br>Peroxide Tri-Metric Chemical<br>Indicator (K212022) | Comparis<br>on | |------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------| | Device<br>Models | 1348, 1348E | 1348, 1348E | Identical | | Indications<br>for Use | Use the 3M™ Attest™ Vaporized<br>Hydrogen Peroxide Tri-Metric Chemical<br>Indicator 1348/1348E for pack control<br>monitoring of the following hydrogencycles:<br>STERRAD 100S® Sterilization<br>System<br>STERRAD NX® Sterilization<br>System (Standard and Advanced<br>cycles)<br>STERRAD 100NX®<br>Sterilization System (Standard,<br>Flex, Express and Duo cycles)<br>STERRAD NX® with<br>ALLClear® Technology<br>Sterilization System (Standard<br>and Advanced cycles)<br>STERRAD 100NX® with<br>ALLClear® Technology<br>Sterilization System (Standard,<br>Flex, Express and Duo cycles)<br>V-PRO® 1 Low Temperature<br>Sterilization System (Lumen<br>cycle)<br>V-PRO® 1 Plus Low<br>Temperature Sterilization<br>System (Lumen and Non Lumen<br>cycles)<br>V-PRO® maX Low Temperature<br>Sterilization System (Lumen,<br>Non Lumen, and Flexible<br>cycles) | Use the 3M™ Attest™ Vaporized<br>Hydrogen Peroxide Tri-Metric Chemical<br>Indicator 1348/1348E for pack control<br>monitoring of the following hydrogen<br>peroxide sterilization sterilizers and<br>cycles:<br>STERRAD 100S® Sterilization<br>System<br>STERRAD NX® Sterilization<br>System (Standard and Advanced<br>cycles)<br>STERRAD 100NX®<br>Sterilization System (Standard,<br>Flex, Express and Duo cycles)<br>STERRAD NX® with<br>ALLClear® Technology<br>Sterilization System (Standard<br>and Advanced cycles)<br>STERRAD 100NX® with<br>ALLClear® Technology<br>Sterilization System (Standard,<br>Flex, Express and Duo cycles)<br>V-PRO® 1 Low Temperature<br>Sterilization System (Lumen<br>cycle)<br>V-PRO® 1 Plus Low<br>Temperature Sterilization<br>System (Lumen and Non Lumen<br>cycles)<br>V-PRO® maX Low Temperature<br>Sterilization System (Lumen,<br>Non Lumen, and Flexible<br>cycles) | Addition<br>of<br>SteroScop<br>e®<br>Sterilizatio<br>n System | {11}------------------------------------------------ 3M™ Attest™ Rapid Readout Biological Indicator 1295 and | Feature | Submission Device:<br>3MTM Attest™ Vaporized Hydrogen<br>Peroxide Tri-Metric Chemical<br>Indicator | Predicate Device:<br>3MTM Attest™ Vaporized Hydrogen<br>Peroxide Tri-Metric Chemical<br>Indicator (K212022) | Comparis<br>on | |-----------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------| | | V-PRO® 60 Low Temperature<br>Sterilization System (Lumen,<br>Non Lumen and Flexible cycles)<br>V-PRO® maX 2 Low<br>Temperature Sterilization<br>System (Lumen, Non Lumen,<br>Flexible, and Fast Non Lumen<br>cycles)<br>V-PRO® s2 Low Temperature<br>Sterilization System (Lumen,<br>Non Lumen, Flexible, and Fast<br>cycles)<br>STERIZONE® VP4 Sterilizer<br>(Cycle 1)<br>SteroScope® Sterilization<br>System | V-PRO® 60 Low Temperature<br>Sterilization System (Lumen,<br>Non Lumen and Flexible cycles)<br>V-PRO® maX 2 Low<br>Temperature Sterilization<br>System (Lumen, Non Lumen,<br>Flexible, and Fast Non Lumen<br>cycles)<br>V-PRO® s2 Low Temperature<br>Sterilization System (Lumen,<br>Non Lumen, Flexible, and Fast<br>cycles)<br>STERIZONE® VP4 Sterilizer<br>(Cycle 1) | | | Indicator<br>Agent | Proprietary | Proprietary | Identical | | Stability of<br>the<br>endpoint<br>reaction | At least six months | At least six months | Identical | | Shelf life | 24 months | 15 months | Similar,<br>shelf-life<br>extended<br>to 24<br>months | | Endpoint<br>Specificati<br>ons<br>(Minimum<br>Stated<br>Values) | VH2O2<br>Concentrati<br>on<br>5.1 mg/L<br> | VH2O2<br>Concentrati<br>on<br>5.1 mg/L | Identical | | | Exposu<br>re Time<br>1 | Exposu<br>re Time<br>1 | | | | Temperat<br>ure<br>50 degrees | Temperat<br>ure<br>50 degrees | | #### 3M™ Attest™ Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E {12}------------------------------------------------ #### 5. Nonclinical Comparison to the Predicate Device The 3M™ Attest™ Rapid Readout Biological Indicator 1295 has identical design, fundamental technology, and performance specifications to the predicate device under the same name. The key difference between the submission device and the predicate device is that the submission device adds an indication for pack control monitoring of the SteroScope® Sterilization System (last cleared under K211705) To demonstrate performance in the newly claimed sterilizer and cycles, nonclinical testing was performed in accordance with the FDA Guidance for Industry and FDA Staff: Biological Indicator (BI) Premarket Notification [510(k)] Submissions, issued October 04, 2007, and ANSI/AAMI/ISO 11138-1:2017 Sterilization of health care products- Biological Indicators-Part 1: General requirements (FDA Recognition Number 14-502). Reference Table 5.1 and 5.2 for testing completed in SteroScope® Sterilization System. | Test Name | Purpose | Acceptance Criteria | Result | |--------------------------------------------|----------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------|--------| | Full Cycle<br>Performance | Verify performance in each of the<br>full cycles in the SteroScope®<br>Sterilization System. | All biological indicators display a<br>negative fluorescent and negative<br>growth response. | Pass | | Fractional Cycle<br>Performance | Verify performance in fractional<br>cycles for each of the cycles<br>within the SteroScope®<br>Sterilization System. | All biological indicators display a<br>negative fluorescent and negative<br>growth response. | Pass | | Chemical<br>Indicator (CI)<br>Color Change | Demonstrate the color change of<br>the CI when exposed to the<br>SteroScope® Sterilization System. | Color change from blue toward<br>pink. | Pass | Table 5.1 Summary of Biological Indicator Nonclinical Testing 3M™ Attest™ Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E, has identical design, fundamental technology, and performance specifications to the predicate device under the same name. The key difference between the submission device and the predicate device is that the submission device adds an indication for pack control monitoring of the SteroScope® Sterilization System (last cleared under K212022). Given the addition of this indication for the SteroScope® Sterilization System, nonclinical testing was performed in accordance with the FDA Guidance for Industry and Staff: Premarket Notification [510(k)] Submissions for Chemical Indicators, issued December 19, 2003. Testing was conducted via simulated use testing of the SteroScope® Sterilization System.in a health care facility and all tests conducted passed. Table 5.1 Summary of Tri-Metric Chemical Indicator Nonclinical Testing | Test Name | Purpose | Acceptance Criteria | Result | |-----------------------------------------|---------------------------------------------------------|-----------------------------------------------------------------------------------------------|---------------------------| | Complete (Full)<br>Cycle<br>Performance | Verify performance in the<br>complete (full) cycle of a | Visual assessment of the chemical<br>indicator yields an ACCEPT result<br>with ≥ 95% accuracy | Pass,<br>100%<br>accuracy | {13}------------------------------------------------ # PREMARKET NOTIFICATION [510(k)] 3MTM Attest™ Rapid Readout Biological Indicator 1295 and | | loaded SteroScope®<br>Sterilization System. | At least 80% of the population of<br>indicators tested has a measured<br>color change value corresponding<br>to an ACCEPT result. | Pass,<br>>99.9%<br>population | |---------------------------------|--------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------|-------------------------------| | Fractional Cycle<br>Performance | Verify performance in an<br>incomplete cycle of a<br>loaded SteroScope®<br>Sterilization System. | Visual assessment of the chemical<br>indicator yields a REJECT result<br>with ≥ 95% accuracy | Pass,<br>100%<br>accuracy | | | | At least 80% of the population of<br>indicators tested has a measured<br>color change value corresponding<br>to a REJECT result. | Pass,<br>>99.9%<br>population | | 3M Attest Rapid Readout Biological Indicator 1295 and | |-----------------------------------------------------------------------------------| | 3MTM AttestTM Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348 | #### 6. Conclusion Based on the non-clinical performance data, the 3M™ Attest™ Rapid Readout Biological Indicator 1295 and 3M™ Attest™ Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E is as safe, as effective, and performs as well as the legally marketed predicate, the 3M™ Attest™ Rapid Readout Biological Indicator 1295 cleared under K211705, Class II (21 CFR 880.2800), product code FRC and 3M™ Attest™ Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E cleared under K212022, Class II (21 CFR 880.2800), product code QKM.