3M Comply Hydrogen Peroxide Indicator Tape 1228

{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. December 10, 2020 3M Company Mary Fretland Senior Regulatory Affairs Associate 3M Center. Building 275-5W-06 St. Pauk, Minnesota 55144 Re: K203285 Trade/Device Name: 3M Comply Hydrogen Peroxide Indicator Tape 1228 Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: Class II Product Code: JOJ Dated: November 6, 2020 Received: November 9, 2020 Dear Mary Fretland: 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 (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 located 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. 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 {1}------------------------------------------------ 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 803) for devices or postmarketing safety reporting (21 CFR 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 (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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, Clarence W. Murray, III, PhD Acting Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K203285 Device Name 3M™ ComplyTM Hydrogen Peroxide Indicator Tape 1228 Indications for Use (Describe) Use the 3M™ Comply™ Hydrogen Peroxide Indicator Tape 1228 to secure packs and as an external pack process indicator to differentiate unprocessed items from items processed in the following sterilizers: STERRAD 100® Sterilization System 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, Flexible, and Fast Non Lumen cycles) V-PRO® s2 Low Temperature Sterilization System (Lumen, Flexible, and Fast cycles) The tape is suitable for use on non-woven disposable wraps and peel pouches. The chemical indicator stripes turn from blue toward pink after exposure to vaporized hydrogen peroxide. | Type of Use (Select one or both, as applicable) | | |----------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------| | <div style="display:flex; align-items:center;"><input type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</div> | <div style="display:flex; align-items:center;"><input checked="" type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</div> | #### 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." {3}------------------------------------------------ Image /page/3/Picture/1 description: The image shows the 3M logo. The logo is red and features the number 3 followed by the letter M. The font is bold and sans-serif. # 510(k) Summary for 3M™ ComplyTM Hydrogen Peroxide Indicator Tape 1228 #### Sponsor Information: 3M Company 3M Center, Bldg. 275-5W-06 St. Paul, MN 55144-1000 Contact: Mary Fretland Senior Regulatory Affairs Associate Phone Number: (651) 737-2296 Fax Number: (651) 737-5320 Date of Summary: November 06, 2020 {4}------------------------------------------------ #### PREMARKET NOTIFICATION [510(k)] 3M™ ComplyTM Hydrogen Peroxide Indicator Tape 1228 #### 1. Device Name and Classification: | Common or Usual Name: | Chemical Indicator | |------------------------|-----------------------------------------------------| | Proprietary Name: | 3M™™ Comply™™ Hydrogen Peroxide Indicator Tape 1228 | | Classification Name: | Indicator, physical/chemical sterilization process | | Device Classification: | Class II, 21 CFR § 880.2800 | | Product Code: | JOJ | #### 2. Predicate Device: K192673 3M™ Comply™ Hydrogen Peroxide Indicator Tape 1228 #### 3. Description of Device: The 3MTM ComplyTM Hydrogen Peroxide Indicator Tape 1228 consists of a noncellulosic plastic backing material with a pressure-sensitive adhesive on one side and chemical indicator stripes on the other side. The chemical indicator stripes turn from blue toward pink after exposure to vaporized hydrogen peroxide. #### 4. Indications for Use Use the 3M™ Comply™ Hydrogen Peroxide Indicator Tape 1228 to secure packs and as an external pack process indicator to differentiate unprocessed items from items processed in the following sterilizers: | STERRAD 100® Sterilization System | |-----------------------------------------------------------------------------------------------------------| | 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) | The tape is suitable for use on non-woven disposable wraps and peel pouches. The chemical indicator stripes turn from blue toward pink after exposure to vaporized hydrogen peroxide. {5}------------------------------------------------ ## PREMARKET NOTIFICATION [510(k)] 3MTM ComplyTM Hydrogen Peroxide Indicator Tape 1228 | Feature | Submission Device:<br>3MTM Comply™ Hydrogen Peroxide<br>Indicator Tape 1228 | Predicate Device (K192673):<br>3MTM Comply™ Hydrogen Peroxide<br>Indicator Tape 1228 | |--------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Indications for use | Use the 3MTM Comply™ Hydrogen<br>Peroxide Indicator Tape 1228 to secure<br>packs and as an external pack process<br>indicator to differentiate unprocessed items<br>from items processed in the following<br>sterilizers:<br>STERRAD 100® Sterilization System<br>STERRAD 100S® Sterilization System<br>STERRAD NX® Sterilization System<br>(Standard and Advanced cycles)<br>STERRAD 100NX® Sterilization System<br>(Standard, Flex, Express and Duo cycles)<br>STERRAD NX® with ALLClear®<br>Technology Sterilization System<br>(Standard and Advanced cycles)<br>STERRAD 100NX® with ALLClear®<br>Technology Sterilization System<br>(Standard, Flex, Express and Duo cycles)<br>V-PRO® 1 Low Temperature<br>Sterilization System (Lumen cycle)<br>V-PRO® 1 Plus Low Temperature<br>Sterilization System (Lumen and Non<br>Lumen cycles)<br>V-PRO® maX Low Temperature<br>Sterilization System (Lumen, Non<br>Lumen, and Flexible cycles)<br>V-PRO® 60 Low Temperature<br>Sterilization System (Lumen, Non<br>Lumen and Flexible cycles)<br>V-PRO® maX 2 Low Temperature<br>Sterilization System (Lumen, Non<br>Lumen, Flexible, and Fast Non Lumen<br>cycles)<br>V-PRO® s2 Low Temperature<br>Sterilization System (Lumen, Non<br>Lumen, Flexible, and Fast cycles)<br>The tape is suitable for use on non-woven<br>disposable wraps and peel pouches. The<br>chemical indicator stripes turn from blue<br>toward pink after exposure to vaporized<br>hydrogen peroxide. | Use the 3MTM Comply™ Hydrogen<br>Peroxide Indicator Tape 1228 to secure<br>packs and as an external pack process<br>indicator to differentiate unprocessed items<br>from items processed in the STERRAD®<br>100, STERRAD® 100S, STERRAD® NX<br>(Standard and Advanced cycles),<br>STERRAD® 100NX (Standard, Flex,<br>Express and Duo cycles), STERRAD® NX<br>with ALLClear™ Technology (Standard and<br>Advanced cycles), STERRAD® 100NX<br>with ALLClear™ Technology (Standard,<br>Flex, Express and Duo cycles), AMSCO®<br>V-PRO® 1 (Lumen cycle), AMSCO® V-<br>PRO® 1 Plus (Lumen and Non-Lumen<br>cycles), AMSCO® V-PRO® maX, Low<br>Temperature Sterilization System (Lumen,<br>Non-Lumen, and Flexible cycles),<br>AMSCO® V-PRO® 60 Low Temperature<br>Sterilization System (Lumen, Non-Lumen<br>and Flexible cycles), and AMSCO® V-<br>PRO™ maX 2 Low Temperature<br>Sterilization System (Lumen, Non-Lumen,<br>Flexible, and Fast Non-Lumen cycles)<br>sterilizers. The tape is suitable for use on<br>non-woven disposable wraps and peel<br>pouches. The chemical indicator stripes turn<br>from blue toward pink after exposure to<br>vaporized hydrogen peroxide. | | Sterilizers and<br>Sterilization<br>Cycles | STERRAD 100® Sterilization System<br>STERRAD 100S® Sterilization System<br>STERRAD NX® Sterilization System<br>(Standard and Advanced cycles)<br>STERRAD 100NX® Sterilization System | STERRAD 100® Sterilization System<br>STERRAD 100S® Sterilization System<br>STERRAD NX® Sterilization System<br>(Standard and Advanced cycles)<br>STERRAD 100NX® Sterilization System | | Feature | Submission Device:<br>3MTM Comply™ Hydrogen Peroxide<br>Indicator Tape 1228 | Predicate Device (K192673):<br>3MTM Comply™ Hydrogen Peroxide<br>Indicator Tape 1228 | | | STERRAD NX® with ALLClear®<br>Technology Sterilization System<br>(Standard and Advanced cycles)<br>STERRAD 100NX® with ALLClear®<br>Technology Sterilization System<br>(Standard, Flex, Express and Duo cycles)<br>V-PRO® 1 Low Temperature<br>Sterilization System (Lumen cycle)<br>V-PRO® 1 Plus Low Temperature<br>Sterilization System (Lumen and Non<br>Lumen cycles)<br>V-PRO® maX Low Temperature<br>Sterilization System (Lumen, Non<br>Lumen, and Flexible cycles)<br>V-PRO® 60 Low Temperature<br>Sterilization System (Lumen, Non<br>Lumen and Flexible cycles)<br>V-PRO® maX 2 Low Temperature<br>Sterilization System (Lumen, Non<br>Lumen, Flexible, and Fast Non Lumen<br>cycles) | STERRAD NX® with ALLClear®<br>Technology Sterilization System<br>(Standard and Advanced cycles)<br>STERRAD 100NX® with ALLClear®<br>Technology Sterilization System<br>(Standard, Flex, Express and Duo cycles)<br>V-PRO® 1 Low Temperature Sterilization<br>System (Lumen cycle)<br>V-PRO® 1 Plus Low Temperature<br>Sterilization System (Lumen and Non<br>Lumen cycles)<br>V-PRO® maX Low Temperature<br>Sterilization System (Lumen, Non<br>Lumen, and Flexible cycles)<br>V-PRO® 60 Low Temperature<br>Sterilization System (Lumen, Non Lumen<br>and Flexible cycles)<br>V-PRO® maX 2 Low Temperature<br>Sterilization System (Lumen, Non<br>Lumen, Flexible, and Fast Non Lumen<br>cycles) | | | V-PRO® s2 Low Temperature<br>Sterilization System (Lumen, Non<br>Lumen, Flexible, and Fast cycles) | | | Substrate | Non-cellulosic plastic | Identical | | Biocompatibility | The exposure to health care professionals is<br>minimal and well below any identified toxic<br>thresholds for the compounds. | Identical | | Color Change | Blue toward pink | Identical | | Detection | Hydrogen Peroxide | Identical | | Stability of the<br>endpoint reaction | Twelve (12) months | Identical | | Shelf life | Eighteen (18) months | Identical | ## 5. Technological Characteristic Comparison Table {6}------------------------------------------------ #### PREMARKET NOTIFICATION [510(k)] 3M™ ComplyTM Hydrogen Peroxide Indicator Tape 1228 The 3M™ Comply™ Hydrogen Peroxide Indicator Tape 1228 is the same design as the previously cleared device of the same model number (the predicate) which is sold under the tradename 3M™ Comply™ Hydrogen Peroxide Indicator Tape 1228 (K192673). No changes have been made to the device materials or fundamental technology. ### 6. Summary of Non-clinical Testing To demonstrate performance in the newly claimed sterilizer and cycles, 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. Reference Table 6.1 for testing completed in the V-PRO® s2 Low Temperature Sterilization System (Lumen, Non-Lumen, Flexible, and Fast cycles). {7}------------------------------------------------ | Test | Purpose | Acceptance Criteria | Result | |--------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------|--------| | Color Change in<br>Health Care<br>Facility Cycle | To demonstrate the color change of<br>the device when used in the<br>V-PRO® s2 Low Temperature<br>Sterilization System | Color change from blue toward<br>pink | Pass | | Minimum<br>Exposure<br>Parameters | To determine the minimum time<br>required for the color change of the<br>device when used in the V-PRO®<br>s2 Low Temperature Sterilization<br>System | Determination of the minimum<br>time for color to change from<br>blue toward pink | Pass | | End Point Color<br>Stability | To demonstrate the post-<br>sterilization color stability of the<br>device after use in the V-PRO® s2<br>Low Temperature Sterilization<br>System | No significant color change<br>after exposure to fluorescent<br>light for a minimum of twelve<br>(12) months. | Pass | # Table 6.1 Summary of Nonclinical Testing #### 7. Conclusion Based on the non-clinical performance data, the 3M™ Comply™ Hydrogen Peroxide Indicator Tape 1228 is as safe, as effective, and performs as well as or better than the legally marketed predicate device, 3M™ Comply™ Hydrogen Peroxide Indicator Tape 1228 cleared under K192673, Class II (21 CFR 880.2800), product code JOJ.