Revital-Ox RESERT Solution Test Strip

{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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with the profiles overlapping each other. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 April 14, 2015 STERIS Corporation Anthony Piotrkowski Senior Manager, Regulatory Affairs 5960 Heisley Road Mentor, Ohio 44060-1834 Re: K143333 Trade/Device Name: Revital-OxTM RESERT™ R60 Solution Test Strip Regulation Number: 21 CFR 880.2800 Regulation Name: Chemical Indicator/Physical/Chemical sterilization process indicator Regulatory Class: II Product Code: JOJ Dated: March 16, 2015 Received: March 17, 2015 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. {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 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/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 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) K143333 ### Device Name Revital-Ox™ RESERT™ R60 Solution Test Strip Indications for Use (Describe) The Revital-Ox™ RESERT™ R60 Solution Test Strip is a high level disinfectant concentration monitor dedicated for use with Revital-Ox™ RESERT™ High Level Disinfectant. The purpose of the Revital-Ox™ RESERT™ R60 Solution Test Strip is to determine whether the concentration of hydrogen peroxide, the active ingredient in Revital-Ox™ RESERT™ High Level Disinfectant, is above the minimum recommentration (MRC) of 1.5%. 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) 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}------------------------------------------------ # STERIS® # 510(k) Summary For Revital-Ox™ RESERT™ R60 Solution Test Strip K143333 # Sponsor: STERIS Corporation 5960 Heisley Road Mentor, OH 44060 Phone: (440) 354-2600 Fax No: (440) 357-9198 # Manufacturer: Albert Browne, Ltd. Chancery House 190 Waterside Rd. Hamilton Industrial Park Leicester United Kingdom LE5 1QZ Contact: Anthony Piotrkowski Regulatory Affairs Manager Telephone: (440) 392-7473 Fax No: (440) 357-9198 E-mail: tpiotrko@steris.com April 8, 2015 Summary Date: STERIS Corporation ■ 5960 Heisley Road ■ Mentor. OH 44060-1834 USA ■ 440-354-2600 {4}------------------------------------------------ ### 1. Device Name | Trade Name: | Revital-Ox™ RESERT™ R60 Solution Test Strip | |----------------------|----------------------------------------------------------------------------------------------| | Common/usual Name: | Chemical Indicator | | Device Class: | Class II | | Classification Name: | Physical/chemical sterilization process indicator<br>(21 CFR 880.2800 (b), Product Code JOJ) | ### 2. Predicate Device K102296 Verify® Chemical Monitoring Strip for Resert™ Solution - This predicate has not been subject to a design-related recall. ● ### 3. Description of Device The Revital-Ox™ RESERT™ R60 Solution Test Strip is a chemical indicator strip consisting of an absorbent paper pad impregnated with reactive chemicals that is adhesively bonded to one end of a polymer film. The polymer strip has a window to facilitate viewing of the color change. The Revital-OxTM RESERT™ R60 Solution Test Strip has been developed to monitor Revital-Ox™ RESERT™ High Level Disinfectant solution (originally cleared as Resert XL HLD High Level Disinfectant) that has a minimum recommended concentration (MRC) of 1.5%. The Revital-Ox™ RESERTIM R60 Solution Test Strip is dipped into a working solution of Revital-Ox™ RESERT™ High Level Disinfectant and the resultant color reaction is viewed through the window to determine if the solution is above the MRC and thus still suitable for use. ### 4. Intended Use The Revital-Ox™ RESERT™ R60 Solution Test Strip is a high level disinfectant concentration monitor dedicated for use with Revital-Ox™ RESERT™ High Level Disinfectant. The purpose of the Revital-OxTM RESERT™ R60 Solution Test Strip is to determine whether the concentration of hydrogen peroxide, the active ingredient in Revital-OxTM RESERT™ High Level Disinfectant, is above the minimum recommended concentration (MRC) of 1.5%. {5}------------------------------------------------ | Proposed | Predicate K102296 | Comparison | |-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Revital-Ox™ RESERT™ R60<br>Solution Test Strip | Verify® Chemical Monitoring Strip<br>for Resert Solutions Version 2 | | | The Revital-Ox™ RESERT™ R60<br>Solution Test Strip is a high level<br>disinfectant concentration monitor<br>dedicated for use with Revital-Ox™<br>RESERT™ High Level Disinfectant.<br>The purpose of the Revital-Ox™<br>RESERT™ R60 Solution Test Strip is to<br>determine whether the concentration<br>of hydrogen peroxide, the active<br>ingredient in Revital-Ox™ RESERT™<br>High Level Disinfectant, is above the<br>minimum recommended<br>concentration (MRC) of 1.5%. | The Verify® Chemical Monitoring Strip<br>for Resert Solutions Version 2 is a high<br>level disinfectant concentration<br>monitor dedicated for use with Resert®<br>XL HLD High-Level Disinfectant. The<br>purpose of the Verify® Chemical<br>Monitoring Strip for Resert Solutions<br>Version 2 is to determine whether the<br>concentration of a Resert® XL HLD<br>High-Level Disinfectant solution is<br>above the minimum recommended<br>concentration (MRC) of 1.5%. | Change in intended<br>use is limited to a<br>name change to<br>reflect the<br>brand/name change<br>of Resert® XL<br>HLD High-Level<br>Disinfectant to<br>Revital-Ox™<br>RESERT™ High<br>Level Disinfectant<br>and to specify that<br>the strips monitors<br>the active<br>ingredient in the<br>disinfectant<br>solution. | # Table 5-1. Indications for Use Comparison Bolded text is identical between predicate and proposed devices ### 5. Description of Safety and Substantial Equivalence The proposed and predicate devices are single use chemical indicator strips that monitor the hydrogen peroxide concentration in Revital-Ox™ RESERT™ High Level Disinfectant solution. The purpose of this submission is to clear design changes to the Revital-OxTM RESERT™ R60 Solution Test Strip for ease of read and longer shelf life. Table 5-2 summarizes the comparison between the proposed device, Revital-OxTM RESERT™ Solution Test Strip, and the predicate. | | Proposed | Predicate | Comparison | |-------------------------|-------------------------------------------|----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Substrate | Absorbent Paper | Absorbent Paper | Same | | Indicator /<br>reaction | Colorimetric sulfite<br>pH-based reaction | Colorimetric<br>starch/iodide reaction | The strip does not contact<br>patients. Impact of the<br>difference in reactive<br>chemistry on safety was<br>evaluated through literature<br>review.<br>Efficacy of the proposed<br>strip is summarized in<br>Table 5.3 below | | Backing | Polypropylene | Polypropylene | Same | Table 5-2. Technological Comparison to Predicate {6}------------------------------------------------ | | Proposed | Predicate | Comparison | |-----------------------------|-------------------------------------------|----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Color change | Yellow to blue/purple | Blue to black | Blinded testing<br>demonstrated proper<br>interpretation of strips. | | Detection | greater than 1.5%<br>hydrogen peroxide | greater than 1.5%<br>hydrogen peroxide | Same | | Use<br>temperature<br>range | 20 °C minimum | 20 -24 °C | Efficacy of the proposed<br>strip at or above 20 °C was<br>demonstrated through<br>testing under simulated<br>use, testing with<br>contaminants, testing after<br>exposure to aggressive<br>chemicals and blind<br>interpretation of exposed<br>strips. | | Viewing | Viewing window, paper<br>on back of strip | Paper on front of strip | Blinded testing<br>demonstrated proper<br>interpretation of strips. | | Shelf-life,<br>unopened | 1 year | 6 months | Testing was performed to<br>support increased | | Shelf-life,<br>opened | 11 days to date | 180 days | unopened bottle shelf life. | Table 5-3 summarizes the verification activities that were performed, with their respective acceptance criteria and results, to demonstrate that the Revital-OxTM RESERT™ R60 Solution Test Strip is substantially equivalent to the claimed predicate device when used according to its instructions for use. The product effectively determines whether or not the concentration of the use solution of Revital-Ox™ RESERT™ High Level Disinfectant is greater than 1.5% hydrogen peroxide. These studies confirm that the device's performance meets the requirements of its pre-defined acceptance criteria and intended uses. {7}------------------------------------------------ | Test | Acceptance Criteria | Comparision | |----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Performance | Equivalent performance to the predicate in pass and fail conditions for simulated use. | Equivalent | | Specificity | Incomplete color change when exposed to tap water only or to Revital-Ox™ RESERT™ High Level Disinfectant solution with peroxide below MRC or no peroxide | The proposed strip does not change when exposed to the active ingredient (hydrogen peroxide) alone as the predicate does. The proposed strip requires the active ingredient of the disinfectant to be in its final form thus demonstrating greater specificity to the disinfectant solution than the predicate. The proposed strip performs equivalently to the predicate in water alone or in disinfectant without the active ingredient. | | Contaminants | Equivalent performance to the predicate in pass and fail conditions in the presence of organic and inorganic contaminants in the test solution | Equivalent | | Exposure to aggressive chemicals | Equivalent performance to the predicate in pass and fail conditions | The proposed strip demonstrated failing results under pass conditions after exposure to aggressive chemicals. The product labeling includes a warning to store away from aggressive chemicals. This same warning is in the labeling of the predicate device. | | Blind study testing | Equivalent performance to the predicate in pass and fail conditions | Equivalent | | Shelf life | Meet performance specifications at each time point after storage in different environments | Performance testing of the proposed device out to one year was performed. | | In-use (open bottle) | Meet performance specifications at each time point after storage in different environments | Performance testing of the proposed device up to 11 days was performed. | Table 5-3 Performance Test Summary {8}------------------------------------------------ ### 6. Conclusion The Revital-Ox™ RESERT™ R60 Solution Test Strip intended for use with Revital-Ox™ RESERT™ High Level Disinfectant is substantially equivalent to the predicate device, Verify® Chemical Monitoring Strip for Resert™ Solution. Based on the nonclinical tests performed the subject device is as safe, as effective and performs at least as safely and effectively as the legally marketed predicate devices, Class II (21 CFR 880.2800, Product code JOJ).