SPSmedical VH202 External Indicator (Container Cards), SPSmedical VH202 External Indicator (Label)

{0}------------------------------------------------ Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 June 9, 2015 Crosstex SPSmedical Division Mr. Michael Nolan Research and Development Coordinator 6789 West Henrietta Road Rush, NY 14543 Re: K143520 Trade/Device Name: SPSmedical VH2O2 External Indicators Regulation Number: 21 CFR 880.2800(b) Regulation Name: Physical/chemical sterilization process indicator Regulatory Class: II Product Code: JOJ Dated: May 8, 2015 Received: May 12, 2015 Dear Mr. Nolan: 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}------------------------------------------------ Page 2 - Mr. Nolan 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 Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K143520 Device Name SPSmedical VH2O2 External Indicators Indications for Use (Describe) A chemical indicator for monitoring all cycles within the STERIS® V-PRO™ 60 (Flexible, Lumen & The VH2O2 Indicators are intended to be used by health care providers with Non-lumen). sterilization wraps, containers, cassettes, or pouches to distinguish between processed and unprocessed units. Colors other than blue such as yellow/green should be treated as a process failure. > CATALOG NUMBER GPL-2000R 5093 PRODUCT NAME Indicator Label Indicator Card 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 I he buroen time for this collection of information to rees, gather and maintain the data needed and complete time to review instruction. 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." Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below. {3}------------------------------------------------ #### SUBMITTER INFORMATION | SPSmedical Supply Corp.<br>a division of Crosstex International | | Contact: | Michael G. Nolan<br>Research and Development Coordinator | |-----------------------------------------------------------------|--------------|----------|----------------------------------------------------------| | 6789 West Henrietta Road | | Phone: | (800) 722-1529 x 120 | | Rush, NY 14543 U.S.A. | | Fax: | (585) 359-0167 | | Date of Summary: | May 26, 2015 | | | ## DEVICE NAME AND CLASSIFICATION | Device Trade Name: | SPSmedical VH2O2 External Indicators | |----------------------|------------------------------------------------------------------------| | Common Name: | Vaporized Hydrogen Peroxide Chemical Indicators | | Classification Name: | Physical/chemical sterilization process indicator 21 CFR § 880.2800(b) | | Review Panel: | General Hospital | | Product Code: | JOJ | | Device Class: | II | ## PREDICATE DEVICE: SPSmedical VH2O2 Indicators K140566. ## DEVICE DESCRIPTION: The SPSmedical VH2O2 External Indicators are single use process indicators, intended for use in verifying exposure to all vaporized hydrogen peroxide cycles in the STERRAD® 100S, 200, 100NX, NX, STERIS® V-PRO® 1, V-PRO® 1 Plus, V-PRO® maX and Sterilucent™ PSD-85 sterilizers. For purposes of this submission testing has been performed to validate the SPSmedical VH2O2 External Indicators for use in the Steris® V-PRO® 60 sterilizer. Indicators will identify if an item has seen vaporized hydrogen peroxide during the Steris® V-PRO® 60 sterilization processes by changing from a pink to a blue signal color. They provide a visual indication to help distinguish between processed and unprocessed items. Physical Properties: The SPSmedical VH2O2 External Indicators consist of two (2) devices, an indicator label and an indicator card. These devices have minor physical differences. The label has an adhesive backing while the card does not. They use the same manufacturing process and are printed on the same substrate. Technical Characteristics: The chemical indicator ink utilized on the SPSmedical VH2O2 External Indicators has been formulated to meet the performance requirements ANSVAAMI/ISO 11140-1 for Process Indicators. Functional Characteristics: The SPSmedical VH2O2 External Indicators are designed to monitor sterilization cycles in low temperature vaporized hydrogen peroxide sterilizers. They are a reliable tool used for the monitoring of vaporized hydrogen peroxide sterilization processes and provide a visual indication that hydrogen peroxide (H2O2), an essential ingredient in the vaporized hydrogen peroxide sterilization process has been introduced into the sterilizer's chamber. Indicators will identify if an item has seen H2O2 during the sterilization process. Indicators change from an initial color of pink to a final signal color of blue. ## INTENDED USE: The SPSmedical VH3O2 External Indicators are intended to be used by health care providers with articles such as sterilization wraps, containers, cassettes, or pouches to distinguish between processed and unprocessed items. Indicators change to a signal color of blue after exposure to vapor hydrogen peroxide. {4}------------------------------------------------ #### BIOCOMPATIBILITY SPSmedical VH2O2 External Indicators are manufactured using nontoxic inks and substrates that will not alter the chemical composition of the products being sterilized and are safe for human contact. SPSmedical VH2O2 External Indicators can be disposed in general waste receptacles. #### STORAGE CONDITIONS: Store the SPSmedical VH2O2 External Indicators in a cool, dry place (15-30°C), and away from any alkaline chemicals, acids and sources of light. #### NON-CLINICAL TESTING: Since the SPSmedical VH2O2 External Indicators are a legally market device only the new Steris® V-PRO® 60 sterilization cycles were validated for use through simulated use testing. Three (3) lots of product were used which were all at or beyond their real time shelf life expiration of twenty four (24) months. Simulated Use Testing: Consisted of verifying SPSmedical VH2O2 External Indicators turned blue in a half cycle with end of shelf life sterilant with a fully loaded chamber at Steris® by Steris® technicians. All testing was performed in triplicate in lumen and flexible cycles of the Steris® V-PRO® 60 sterilizer. Shelf Life: When properly stored the SPSmedical VH2O2 External Indicators maintain a shelf life of up to two (2) years from the date of manufacture. The expiration date is located on every pack. Post processing indicator stability has been verified to maintain color change results for a minimum of six (6) months when properly stored. All other concerns with the SPSmedical VH2O2 External Indicators have been previously validated. There have been no changes to the product since the predicate filing under K140566. #### COMPONENTS: Indicators are composed of commercially existing materials of synthetic paper or label stock (e.g. Tyvek ", polypropylene, polystyrene etc ... ). The indicator ink is a nontoxic sterilization indicator ink that changes from an initial color of pink to a blue signal color when exposed to the stated vaporized hydrogen peroxide sterilization process described within this submission. #### SUBSTANTIAL EQUIVALENCE DISCUSSION: The predicate and subject devices are the exact same device. The predicate and subject devices are substantially equivalent in terms of their intended use, functional and technical characteristics within the vaporized hydrogen peroxide sterilization processes described within this submission. #### PREDICATE I.D. | Trade Name: | SPSmedical VH2O2 Indicators | | |-------------|-----------------------------|-----------------| | Model No.: | GPS-250R | Indicator Strip | | | GPS-250Y | Indicator Strip | | | GPL-2000R | Indicator Label | | | GPL-2000Y | Indicator Label | | | HT-048 | Indicator Tape | | | HT-036 | Indicator Tape | | | 5093 | Indicator Card | {5}------------------------------------------------ | Submitter/holder: | SPSmedical Supply Corp.<br>a division of Crosstex International<br>6789 West Henrietta Road<br>Rush, NY 14543 U.S.A.<br>Phone: (585) 359-0130<br>Fax: (585) 359-0167 | |-------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 510(k) No: | K140566 | #### COMPARISON OF INDICATIONS FOR USE (IFU): Predicate IFU-A chemical indicator for monitoring all cycles within the STERRAD® 100S (Standard & Long), 200, 100NX (Standard, Flex & Express), NX (Standard & Advanced), STERIS® V-PRO™ 1, V-PRO™ 1 Plus (Lumen & Non-lumen), V-PRO® maX (Flexible, Lumen & Non-lumen) and Sterilucent" PSD-85 (Lumen & Non-lumen). The VH2O2 Indicators are intended to be used by health care providers with sterilization wraps, containers, cassettes, or pouches to distinguish between processed and unprocessed units. Colors other than blue such as yellow/green should be treated as a process failure. Subject IFU-A chemical indicator for monitoring all cycles within the STERIS® V-PRO® 60 (Flexible, Lumen & Non-lumen). The VH2O2 Indicators are intended to be used by health care providers with sterilization wraps, containers, cassettes, or pouches to distinguish between processed and unprocessed units. Colors other than blue such as yellow/green should be treated as a process failure. | CATALOG NUMBER | PRODUCT NAME | |----------------|-----------------| | GPL-2000R | Indicator Label | | 5093 | Indicator Card | Discussion—The Predicate Device and the Subject Device have the same IFU with the exception of cycles other than the cycles which are the principle of this 510(k) remain on the Subject IFU. #### DESIGN DIFFERENCES PREDICATE VS. SUBJECT DEVICE: The predicate and subject devices are the exact same device. The subject device seeks the Indication for Use within the Steris® V-PRO® 60. ### SUBSTANTIAL EQUIVALENCE CONCLUSIONS The subject device has the same intended use, technical characteristics and functional characteristics as the predicate device. Both provide a visual indication that the indicator has been exposed to the vaporized hydrogen peroxide sterilization process. Both are made of the exact same materials and exact same manufacturing processes. The non-clinical testing has been performed by and directed by Steris® Corporation and found to meet predetermined acceptance criteria. {6}------------------------------------------------ #### SUBSTANTIAL EQUIVALENCE COMPARISON TABLE | ELEMENT | SUBJECT DEVICE<br>(K143520) | PREDICATE<br>(K140566) | |--------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended Use | Equivalent | Process Indicator | | Indications for Use | A chemical<br>indicator for<br>monitoring all cycles within the<br>STERIS® V-PRO™ 60 (Flexible,<br>Lumen & Non-lumen).<br>The<br>VH2O2 Indicators are intended to<br>be used by health care providers<br>with sterilization<br>wraps,<br>containers, cassettes, or pouches to<br>distinguish between processed and<br>unprocessed units. Colors other<br>than blue such as yellow/green<br>should be treated as a process<br>failure.<br>Catalog Number Product Name<br>GPL-2000R Indicator Label<br>5093 Indicator Card | A chemical indicator for<br>monitoring all cycles within the<br>STERRAD® 100S (Standard &<br>Long), 200, 100NX (Standard,<br>Flex & Express), NX (Standard<br>& Advanced), STERIS® V-<br>PRO™ 1, V-PRO™ 1 Plus<br>(Lumen & Non-lumen), V-<br>PRO® maX (Flexible, Lumen &<br>Non-lumen) and Sterilucent<br>PSD-85 (Lumen & Non-lumen).<br>The VH2O2 Indicators are<br>intended to be used by health<br>care providers with sterilization<br>wraps, containers, cassettes, or<br>pouches to distinguish between<br>processed and unprocessed<br>units. Colors other than blue<br>such as yellow/green should be<br>treated as a process failure. | | Device Design | Card, Label | Strip, Label, Tape, Card etc. | | Endpoint Color | Equivalent | Signal Color of Blue | | Indicator Agent | Equivalent | H2O2 Indicator Ink | | Sterilization Method | Equivalent | Vaporized Hydrogen Peroxide | | Device Materials | Equivalent | Synthetic Substrate | | Performance-ISO 11140-1<br>Complete reaction cycle | Equivalent | Indicators turn to a complete<br>reaction color of blue | | Performance-ISO 11140-1<br>Incomplete reaction cycle | Equivalent | Indicators do not turn blue and<br>are markedly different than the<br>color achieved under the<br>complete reaction cycle testing. | | Biocompatibility | Equivalent | Non-toxic | | Non-clinical Performance-<br>Steris® V-PRO® 60<br>(Flexible, Lumen & Non-<br>Lumen cycles) | Equivalent | Turns blue in a half cycle under<br>worst case conditions. | | Shelf-life | Equivalent | Up to 2 years | #### CONCLUSION: Since the predicate device and the subject device are the exact same device, they have the same intended use, the same functional and technical characteristics; they are comprised of the same materials and performance. Non-clinical testing performed at Steris® by Steris® technicians in the Steris® V-PRO® 60 documents that based on the results from the nonclinical testing performed there are no concerns with the safety or effectiveness of the SPSmedical VH2O2 External Indicators. Based on these facts and the nonclinical tests performed the subject device is as safe, as effective, and performs as well as the predicate device [SPSmedical Hydrogen Peroxide Chemical Indicators (K140566)].