VERIFY VH2O2 Indicator Tape

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus, with three human profiles forming the staff and a wing-like shape above them. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 June 1, 2016 Steris Corporation Anthony Piotrkowski Senior Manager, Regulatory Affairs 5960 Heisley Road Mentor, Ohio 44060 Re: K160485 Trade/Device Name: VERIFY™ VH2O2 Indicator Tape Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: Class II Product Code: JOJ Dated: April 29, 2016 Received: May 2, 2016 Dear Mr. Piotrkowski: 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. 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 devicerelated 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. {1}------------------------------------------------ If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education 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. 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 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 Industry and Consumer Education 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 Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K160485 Device Name VERIFY™ VH2O2 Indicator Tape Indications for Use (Describe) The VERIFY™ VH2O2 Indicator Tape is intended to secure items wrapped in synthetic wrap materials until used and to distinguish between processed and unprocessed units through a color change from the start color (pink) to peach, yellow or lighter. The tape may be used in the following sterilization cycles: - · Non Lumen, Flexible and Lumen Cycles of the V-PRO 1, 1 Plus, maX and 60 Low Temperature Sterilizers - · Standard Cycle of the STERRAD® 100S Sterilizer - · Standard and Advanced Cycles of the STERRAD® NX Sterilizer - · Express, Flex Scope, Duo and Standard Cycles of the STERRAD® 100 NX Sterilizer | 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. 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The logo is simple and abstract, with no text or other elements present. # 510(k) Summary for VERIFY™ VH2O2 Indicator Tape STERIS Corporation 5960 Heisley Road Mentor, OH 44060 Phone: (216) 354-2600 Fax No: (216) 639-4459 Anthony Piotrkowski Contact: Sr. Manager, Regulatory Affairs Telephone: (440) 392-7437 Fax No: (440) 357-9198 E-mail: tpiotrko@steris.com > Submission Date: May 28, 2016 K160485 STERIS Corporation ■ 5960 Heisley Road ■ Mentor, OH 44060-1834 USA ■ 440-354-2600 {4}------------------------------------------------ ## TRADITIONAL PREMARKET NOTIFICATION [510(k)] VERIFY™ VH2O2 Indicator Tape #### Device Name 1. | Trade Name: | VERIFYTM <span style="border: 1px solid black;">VH2O2</span> Indicator Tape | |----------------------|-----------------------------------------------------------------------------| | Common/Usual Name: | Chemical Sterilization Process Indicator | | Classification Name: | Sterilization Process Indicator<br>(21 CFR 880.2800, JOJ) | #### 2. Predicate Device STERRAD® Sealsure™ Chemical Indicator Tape (K111519) #### Description of Device 3. The VERIFY VH2O2 Indicator Tape consists of a special coated crepe paper with diagonal lines of a chemical indicator specific for hydrogen peroxide sterilization. It meets the performance specifications for a Type 1 process indicator as defined in ANSI/AAMI/ISO 11140-1:2014. The VERIFY | VH2O2 Indicator Tape and its packaging are manufactured in the absence of lead, heavy metals, natural rubber latex and dry natural rubber. #### 4. Intended Use/ Indications for Use The VERIFY™ VH2O2 Indicator Tape is intended to secure items wrapped in synthetic wrap materials until used and to distinguish between processed and unprocessed units through a color change from the start color (pink) to peach, vellow or lighter. The tape may be used in the following sterilization cycles: - . Non Lumen, Flexible and Lumen Cycles of the V-PRO 1, 1 Plus, maX and 60 Low Temperature Sterilizers - Standard Cycle of the STERRAD® 100S Sterilizer ● - Standard and Advanced Cycles of the STERRAD® NX Sterilizer ● - Express, Flex Scope, Duo and Standard Cycles of the STERRAD® 100 NX ● Sterilizer {5}------------------------------------------------ ## TRADITIONAL PREMARKET NOTIFICATION [510(k)] VERIFY™ VH2O2 Indicator Tape | Proposed | Predicate (K111519) STERRAD<br>SEALSURE Chemical Indicator Tape | Comparison | |---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | VERIFY VH2O2 Indicator Tape | | | | The VERIFY VH2O2 Indicator Tape<br>is intended to secure items wrapped<br>in synthetic wrap materials until used<br>and to distinguish between processed<br>and unprocessed units through a<br>color change from the start color<br>(pink) to peach, yellow or lighter.<br>The tape may be used in the<br>following sterilization cycles:<br>• Non Lumen, Flexible and Lumen<br>Cycles of the V-PRO 1, 1 Plus,<br>maX and 60 Low Temperature<br>Sterilizers<br>• Standard Cycle of the<br>STERRAD® 100S Sterilizer<br>• Standard and Advanced Cycles of<br>the STERRAD® NX Sterilizer<br>• Express, Flex Scope, Duo and<br>Standard Cycles of the | STERRAD SEALSURE Chemical<br>Indicator Tape (PN 14202) is a process<br>indicator (ISO 11140-1:2205) intended<br>for use by healthcare providers to secure<br>non-woven sterilization packs and wraps<br>to be sterilized in the STERRAD<br>Sterilization Systems.<br>• Standard Cycle of STERRAD 100S<br>• Standard Cycle of STERRAD 50<br>• Standard Cycle of STERRAD 200<br>• Standard and Advanced Cycles of<br>STERRAD NX<br>• Standard, Flex, DUO and EXPRESS<br>Cycles of STERRAD 100NX<br>The color of the STERRAD SEALSURE<br>Chemical Indicator Tape changes from<br>red to gold (or lighter) when exposed to<br>hydrogen peroxide and is intended to<br>differentiate between processed and<br>unprocessed loads. | Both devices are<br>chemical indicator<br>tapes used to secure<br>packs for<br>sterilization in<br>hydrogen peroxide<br>sterilizers and to<br>indicate through a<br>color change that the<br>packs have been<br>exposed to hydrogen<br>peroxide. Testing is<br>included in this<br>submission to<br>demonstrate safe and<br>effective<br>performance of the<br>proposed device in<br>the indicated cycles. | #### 5. Description of Safety and Substantial Equivalence The VERIFY VH2O2 Indicator Tape has equivalent characteristics as compared to its predicate device, STERRAD® Sealsure™ Chemical Indicator Tape. Table 5.2 compares the proposed device's design to the predicate. | Characteristic | Proposed | Predicate | Comparison | |-----------------------|------------------------------------------------------------------------------------|-------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------| | Substrate | Crepe Paper | Crepe Paper | Same | | Indicator | Proprietary - conforms<br>with ISO 11140-1:2014<br>Type 1 requirements | Proprietary - conforms<br>with ISO 11140-1:2005<br>Class 1 requirements | Testing included in this<br>submission demonstrating<br>performance (See Table<br>5.3). | | Adhesive | Proprietary | Proprietary | Testing included in this<br>submission demonstrating<br>performance (See Table<br>5.3). | | Color Change | Pink to Peach/Yellow | Red to Gold | Similar start and endpoint<br>colors | | Detection | hydrogen peroxide dose | hydrogen peroxide dose | Same | | Shelf-life | 3 months to be<br>extended as real time<br>data allows to a<br>projected 24 months | 22 months | Testing included in this<br>submission to support<br>proposed device's shelf life<br>when stored under labeled<br>conditions (See Table 5.3). | | Storage<br>Conditions | 16 - 24°C,<br>30 - 60% RH | 15 - 30°C,<br>Dry Conditions | | Table 5.2 Device Comparison {6}------------------------------------------------ ### TRADITIONAL PREMARKET NOTIFICATION [510(k)] VERIFY™ VH2O2 Indicator Tape The VERIFY VH2O2 Indicator Tape was tested in nonclinical testing. Performance of the chemical indicator, CI, was demonstrated by testing in an ANSI/AAMI/ISO 18472:2006-conforming resistometer according to the vapor-phased hydrogen peroxide, Type 1 chemical indicator requirements in ANSI/AAMI/ISO 11140-1:2014. CI performance was also tested in hydrogen peroxide sterilizers (V-Pro and STERRAD) with loads under simulated use conditions under pass and fail conditions. Endpoint stability was tested by evaluating the color of processed tape at various time points when stored at room temperature. Light stability was demonstrated by evaluating the tape after storage outside its packaging before exposure to peroxide sterilization. Tape adhesion was evaluated using ASTM adhesion standard and under simulated use conditions on wrapped loads processed through the sterilizer. Biocompatibility was demonstrated by testing peroxide residual levels of processed tape samples and Off-set testing per ANSI/AAMI/ISO 11140-1:2014. Shelf-life testing evaluated CI performance per ANSI/AAMI/ISO 11140-1:2014 and tape adhesion after various times of storage within the labeled storage conditions. Table 5.3 summarizes the testing performed to demonstrate substantial equivalence. | Test | Result | |-------------------------------------------------------------------------------------------------|--------| | ANSI/AAMI/ISO 11140-1:2014 Vaporized Hydrogen Peroxide Process<br>Indicator Performance Testing | Pass | | Simulated Use: Pass Performance Testing | Pass | | Simulated Use: Fail Performance Testing | Pass | | Endpoint Stability | Pass | | Light Stability after Removal from Packaging | Pass | | Adhesion Evaluation | Pass | | Shelf Life Evaluation | Pass | | Hydrogen Peroxide Residual Testing | Pass | | Off-set (transference) Performance Testing | Pass | | | | Table 5.3 Summary of Nonclinical Tests: | | |--|--|-----------------------------------------|--| |--|--|-----------------------------------------|--| #### 6. Conclusion The VERIFY | VH2O2 Indicator Tape is substantially equivalent to the predicate device, STERRAD® Sealsure™ Chemical Indicator Tape. Based on the performance testing provided in this submission and summarized above, the subject device is as safe and as effective as the legally marketed, claimed predicate device.