3M Comply Indicator Tape for Ethylene Oxide (EO) Sterilization

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's symbol, which is a stylized representation of a human figure with three faces in profile, stacked on top of each other. The symbol is enclosed within a circular border, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is written around the border of the circle. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 July 2, 2015 3M Health Care Matt Mortensen, PhD, RAC Regulatory Affairs Lead 3M Center Building 275-5W-06 St. Paul. MN 55144 Re: K150477 Trade/Device Name: 3M Comply™ 1224 Indicator Tape for Ethylene Oxide (EO) Sterilization Regulation Number: 21 CFR 880.2800 Regulation Name: Physical/chemical sterilization process indicator Regulatory Class: II Product Code: JOJ Dated: June 4, 2015 Received: June 5, 2015 Dear Dr. Mortensen: 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. 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}------------------------------------------------ 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours, *Tejashri Purohit-Sheth, M.D.* Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health {2}------------------------------------------------ # Indications for Use #### 510(k) Number (if known) K150477 #### Device Name 3M Comply 1224 Indicator Tape for Ethylene Oxide (EO) Sterilization #### Indications for Use (Describe) The tape is designed to secure packs wrapped with untreated woven (i.e., reusable 100% cotton and cotton/poly blends) and disposable non-woven, paper/plastic, and spunbond polyolefin/plastic wraps. ### United States Use the EO indicator tape to demonstrate that packs have been exposed to one of the EO sterilization processes in the table below and to distinguish between processed and unprocessed packs. | EO Gas Concentration | Exposure Time | Temperature | Relative Humidity % | |----------------------|---------------|-------------|---------------------| | 736 mg/L | 4.5 hours | 38°C | 40 - 80 % | | 736 mg/L | 1 hour | 55°C | 40 - 80 % | | 759 mg/L | 4.5 hours | 38°C | 40 - 80 % | | 759 mg/L | 1 hour | 55°C | 40 - 80 % | | 736 mg/L | 1 hour | 54°C | >35% | | 736 mg/L | 4.5 hours | 38°C | >35% | | 736 mg/L | 1 hour | 55°C | >35% | | 736 mg/L | 3 hours | 37°C | >35% | | 759 mg/L | 1 hour | 55°C | >35% | | 759 mg/L | 3 hours | 37°C | >35% | Type of Use (Select one or both, as applicable) _ Prescription Use (Part 21 CFR 801 Subpart D) > Over-The-Counter Use (21 CFR 801 Subpart C) ### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED. ### FOR FDA USE ONLY Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) {3}------------------------------------------------ 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}------------------------------------------------ # Premarket Notification (510(k)) Summary Image /page/4/Picture/1 description: The image shows the 3M logo. The logo is in red and features the number "3" followed by the letter "M". The logo is simple and recognizable, and it is often used to represent the company 3M. ## Sponsor Information: 3M Health Care 3M Center, Bldg. 275-5W-06 St. Paul, MN 55144-1000 Contact Person: Matt S. Mortensen, Ph.D., RAC Regulatory Affairs Phone Number: (651) 737-2670 FAX Number: (651) 737-5320 # Date of Summary: June 15, 2015 ### Device Name and Classification: Common or Usual Name: EO Process Indicator Tape Proprietary Name: 3M Comply™ 1224 Indicator Tape for Ethylene Oxide (EO) Sterilization Classification Name: Indicator, physical/chemical sterilization process (21 CFR § 880.2800) Device Classification: Class II Product Code: JOJ ### Predicate Devices: - . Indox Ethylene Oxide Indicator Tape - pre-amendment # Description of Device: The 3M Comply 10 1224 Indicator Tape for Ethylene Oxide (EO) Sterilization is a green, pressure sensitive adhesive tape with yellow stripes that can be used to secure packages for EO sterilization. Post-sterilization the yellow stripes turn to red-maroon. {5}------------------------------------------------ # Nonclinical Comparison to the Predicate Device The 3M Comply™ 1224 Indicator Tape for Ethylene Oxide (EO) Sterilization is similar in design to the previous generation of this product (the predicate) which was sold under the tradename Indox Ethylene Oxide Indicator Tape. In 2012 this previous version was determined by the Agency to meet the definition of a pre-amendment device. The product has been reformulated to lessen the environmental impact of solvents used in the manufacturing process. The new tape has the same intended use as the predicate. # Summary of Clinical Testing No clinical data was included in this premarket application submission. # Indications for Use The tape is designed to secure packs wrapped with untreated woven (i.e., reusable 100% cotton and cotton/poly blends) and disposable non-woven, paper, paper/plastic, and spunbond polyolefin/plastic wraps. # United States Use the EO indicator tape to demonstrate that packs have been exposed to one of the EO sterilization processes in the table below and to distinguish between processed and unprocessed packs. | EO Gas<br>Concentration | Exposure<br>Time | Temperature | Relative<br>Humidity % | |-------------------------|------------------|-------------|------------------------| | 736 mg/L | 4.5 hours | 38°C | 40 - 80 % | | 736 mg/L | 1 hour | 55°C | 40 - 80 % | | 759 mg/L | 4.5 hours | 38°C | 40 - 80 % | | 759 mg/L | 1 hour | 55°C | 40 - 80 % | | 736 mg/L | 1 hour | 54°C | >35% | | 736 mg/L | 4.5 hours | 38°C | >35% | | 736 mg/L | 1 hour | 55°C | >35% | | 736 mg/L | 3 hours | 37°C | >35% | | 759 mg/L | 1 hour | 55°C | >35% | | 759 mg/L | 3 hours | 37°C | >35% | # Comparison to Predicate Devices | Feature | Submission Device: 3M Comply 1224 Indicator Tape for Ethylene Oxide (EO) Sterilization | Predicate Device (Pre- | |---------|----------------------------------------------------------------------------------------|------------------------| |---------|----------------------------------------------------------------------------------------|------------------------| {6}------------------------------------------------ | amendment):<br>Indox Ethylene<br>Oxide Indicator<br>Tape | | | | | | |-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------|------------------|-------------|------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | The tape is designed to secure packs wrapped with untreated<br>woven (i.e., reusable 100% cotton and cotton/poly blends) and<br>disposable non-woven, paper, paper/plastic, and spunbond<br>polyolefin/plastic wraps.<br>United States<br>Use the EO indicator tape to demonstrate that packs have been<br>exposed to one of the EO sterilization processes in the table below<br>and to distinguish between processed and unprocessed packs. | | | | | Use the EO<br>indicator tape to<br>demonstrate that<br>packs have been<br>exposed to the<br>sterilization<br>process and to<br>distinguish<br>between processed<br>and unprocessed<br>packs. The tape is<br>designed to secure<br>packs wrapped<br>with treated and<br>untreated woven,<br>with treated and<br>untreated non-<br>woven, paper,<br>paper/plastic, and<br>Tyvek®/plastic<br>wraps. | | Indications<br>for use | EO Gas<br>Concentration | Exposure<br>Time | Temperature | Relative<br>Humidity % | | | | 736 mg/L | 4.5 hours | 38°C | 40 - 80 % | | | | 736 mg/L | 1 hour | 55°C | 40 - 80 % | | | | 759 mg/L | 4.5 hours | 38°C | 40 - 80 % | | | | 759 mg/L | 1 hour | 55°C | 40 - 80 % | | | | 736 mg/L | 1 hour | 54°C | >35% | | | | 736 mg/L | 4.5 hours | 38°C | >35% | | | | 736 mg/L | 1 hour | 55°C | >35% | | | | 736 mg/L | 3 hours | 37° | >35% | | | | 759 mg/L | 1 hour | 55°C | >35% | | | | 759 mg/L | 3 hours | 37° | >35% | | | Indicator<br>Agent | Phenol red | | | | 1,8-<br>dihydroxyanthroquinone | | Minimum<br>exposure to<br>critical<br>parameters<br>for color<br>change | Designed to meet ISO 11140-1 Class 1 EO process indicator<br>requirements | | | | Identical | | Recommended storage | Best stored at normal room temperature conditions, 15-30°C (59-<br>86°F) and <50% relative humidity. Store away from direct | | | | Identical | {7}------------------------------------------------ | | as cleaning/disinfecting agents. Store away from all chemical<br>sterilants (e.g., hydrogen peroxide). | | |---------------------------------------------|--------------------------------------------------------------------------------------------------------|-----------| | Stability of<br>the<br>endpoint<br>reaction | 6 months | Identical | | Shelf life | Will be based on results of completed testing at time of marketing. | 18 months | # Effectiveness The effectiveness of the 3M ComplyTM 1224 Indicator Tape for Ethylene Oxide (EO) Sterilization is demonstrated by the application of testing described in the Recognized Consensus Standard: ISO 11140-1:2005/R2010; Sterilization of Health Care Products - Chemical Indicators -Part 1: General Requirements, - Color Change in Resistometer Samples from 3 different lots were verified to meet the requirements for detectable color change post-exposure to ISO conditions in a resistometer. - Color Change in Health Care Facility Cycle Samples from 3 different lots were verified to meet the requirements for detectable color change post-exposure in an FDA cleared 3M Steri-Vac 5XL sterilizer cycle. - End-point Color Stability Samples from 3 different lots were verified to be stable to storage under typical office lighting conditions up to 6 months post-exposure in an FDA cleared 3M Steri-Vac 5XL sterilizer cycle. # Conclusion The 3M ComplyTM 1224 Indicator Tape for Ethylene Oxide (EO) Sterilization meets the performance standards of ISO 11140-1 and are substantially equivalent to the predicate device in terms of their intended use, physical properties and technological characteristics. The nonclinical testing demonstrates that the 3M ComplyTM 1224 Indicator Tape for Ethylene Oxide (EO) Sterilization is as safe, as effective, and performs as well as the predicate device, Indox Ethylene Oxide Indicator Tape.