HIVOX SELF ADHESIVE ELECTRODE GEL PADS

{0}------------------------------------------------ ### HIVOX #### НІУОХ ВІОТЕК INC. 5F., No. 123. Shingde Road. Sanchong District, New Taipei City, Taiwan Phone: +886 2 8511 2668 Fax: +886 2 8511 2669 | | | JUL 2 5 2014 | |-------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------| | | 510(K) SUMMARY<br>(Per 21 CFR 807.92.) | K131720 | | Submission Date: | July 22, 2014 | | | Submitter: | HIVOX BIOTEK INC.<br>5F, No.123, Shingde Road, Sanchong Dist.,<br>New Taipei City, 24158, TAIWAN, R.O.C.<br>Tel: +886-2-85112668<br>Fax:+886-2-85112669 | | | Establishment<br>Registration No .: | 9611558 | | | Official Contact: | Dr. Jen, Ke-Min<br>Tel: 886-2-85112668<br>Fax:886-3-5209783<br>Email: ceirs.jen@msa.hinet.net | | | Common /<br>Usual Name: | Electrode, Cutaneous | | | Trade Name: | HIVOX self-adhesive electrode gel pads. | | | 510(k) Number: | K131720 | | | Classification<br>Code: | GXY, Class II, 882.1320 | | | Intended Use: | HIVOX self-adhesive electrode gel pads are intended for use as<br>disposable, conductive adhesive interface between the patient's<br>skin and the electrical stimulator. The device is a gel pad for use<br>with an electrode and not an electrode itself. | | | Predicated<br>Devices: | 1) K070612, Top-Rank Adhesive Electrodes<br>Top-Rank Health Care Equipment Co., Ltd.<br>2) K132588, Top-Rank Adhesive Electrodes<br>Top-Rank Health Care Equipment Co., Ltd.<br>3) K000947, Ultrastim Electrode<br>Axelgaard Mfg. Co., Ltd. | | | Device Description: | HIVOX self-adhesive electrode gel pads are series of cutaneous<br>electrodes with various shapes and sizes, which use the same<br>materials from the predicate suppliers, i.e. K070612 (Top-Rank<br>Health Care Equipment Co., Ltd. ) and K000947 (Axelgaard Mfg.<br>Co., Ltd.). HIVOX self-adhesive electrode gel pads are non-sterile,<br>self-adhesive, for single patient use only, and to be disposable. | | : {1}------------------------------------------------ ### HIVO #### HIVOX BIOTEK INC. 5F., No. 123, Shingde Road. Sanchong District, New Taipei City. Taiwan Phone: +886 2 8511 2668 Fax: +886 2 8511 2669 #### Specifications: HIVOX self-adhesive electrode gel pads have the following possible dimensions and shapes. Image /page/1/Figure/5 description: The image is an exploded view diagram of a device, possibly a PennyPad Anatomical device body assembly, showing its components and their arrangement. The diagram includes numbered parts such as a Silicon Cover (1), ABS Top Cover (2), Moder Board (3), PET Button Cover (4), Right, Left touch Spring (5), ABS Bottom Cover (6), CR2025 Battery (7), and Battery Cover (8). The diagram also includes a table with the item numbers and corresponding part names. Scientific Concept: When we put the battery into the stimulator device, and the device will enable to transmit the electric pulse to the device's electrode area. The self-adhesive electrode gel pads should be placed onto the bottom of PET cover to enable to stick on the user's skin and conduct the electric pulse fully around the self-adhesive electrode gel pads. Function and . HIVOX self-adhesive electrode gel pads are non-sterile, Characteristics: self-adhesive, for single patient use only, and to be disposable. · The subject device is designed for Hivox device use only. · HIVOX self-adhesive electrode gel pads are series of cutaneous electrodes with various shapes and sizes, which use the same material as K070612 (Top-Rank Health Care Equipment Co., Ltd. ) and K000947 (Axelgaard Mfg. Co., Ltd.). Performance Tests: Biocompatibility Tests: · ISO 10993-5:2009, Biological evaluation of medical devices -Part 5: Tests for in vitro cytotoxicity. · ISO 10993-10:2010, Biological evaluation of medical devices -Part 10: Tests for in irritation and skin sensitization. NONE Clinical Tests: {2}------------------------------------------------ # HIVOX電子 #### HIVOX BIOTEK INC. 5F., No. 123, Shingde Road, Sanchong District, New Taipei City, Taiwan Phone: +886 2 8511 2668 Fax: +886 2 8511 2669 | Comparison table | | | | | |------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Items | Predicate device | Predicate device | Predicate device | Subject Device | | Trade Name | Top-Rank Adhesive<br>Electrode | Top-Rank Adhesive<br>Electrode | ULTRASTIM<br>ELECTRODE,<br>MODEL US4040 | HIVOX<br>self-adhesive<br>electrode gel pads. | | Manufacturer | Top Rank | Top Rank | Axelgaard | Top Rank,<br>Axelgaard | | 510(k) Number | K070612 | K132588 | K000947 | K131720 | | Intended Use | Top-Rank Adhesive<br>Electrodes are<br>intended for use as<br>the disposable,<br>conductive adhesive<br>interface between<br>the patient's skin<br>and the Electrical<br>Stimulator.<br>Top-Rank Adhesive<br>Electrodes are<br>intended to be used<br>with marketed,<br>Electrical<br>Stimulators i.e.<br>TENS<br>(Transcutaneous<br>Electrical Nerve<br>Stimulation) and<br>EMS (Electrical<br>Muscular<br>Stimulation).<br>These electrodes<br>will include the<br>precaution<br>statement: Federal<br>Law restricts<br>the device to sale<br>by or on the order<br>of a licensed<br>practitioner or<br>therapist. | Adhesive electrodes<br>are intended for use<br>as the disposable,<br>conductive adhesive<br>interface between<br>the patient's skin<br>and the Electrical<br>Stimulator.<br>Top-Rank Adhesive<br>Electrodes are<br>intended to be used<br>with marketed,<br>Electrical<br>Stimulators i.e.<br>TENS<br>(Transcutaneous<br>Electrical Nerve<br>Stimulation) and<br>EMS (Electrical<br>Muscular<br>Stimulation). | UltraStim<br>Electrodes are<br>intended for use<br>with a<br>garment/wrap<br>designed with a<br>snap connection for<br>distributing<br>electrical impulses<br>from transcutaneous<br>neurostimulation<br>devices to<br>UltraStim<br>electrodes placed on<br>the skin.<br>Transcutaneous<br>neurostimulation<br>electrodes are<br>passive devices<br>serving as an<br>interface between a<br>patient's skin and a<br>neurostimulation<br>device. | HIVOX Self<br>Adhesive<br>Electrodes are<br>intended for use as<br>disposable,<br>conductive adhesive<br>interface between<br>the patient's skin<br>and the electrical<br>stimulator. The<br>device is a gel pad<br>for use with an<br>electrode and not an<br>electrode itself. | | Prescription<br>Use | Prescription use | OTC | Prescription use | Prescription use &<br>OTC | | Classification<br>Name | Cutaneous<br>Electrode | Cutaneous<br>Electrode | Cutaneous<br>Electrode | Cutaneous<br>Electrode | {3}------------------------------------------------ ## HIVO #### HIVOX BIOTEK INC. 5F., No. 123, Shingdc Road, Sanchong District, New Taipei City, Taiwan Phone: +886 2 8511 2668 Fax: +886 2 8511 2669 | Product Code | GXY 882.1320 | GXY 882.1320 | GXY 882.1320 | GXY 882.1320 | |------------------------------|--------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------| | Single-Patient<br>Use | Yes | Yes | Yes | Yes | | Multiple<br>Applications | Yes | Yes | Yes | Yes | | Sterility Status | Non-sterile | Non-sterile | Non-sterile | Non-sterile | | Biocompatibility<br>Test | Meets Triparties<br>Biocompatibility<br>Guidance for<br>Medical Devices<br>&<br>ISO 10993-5.<br>ISO 10993-10 | Meets Triparties<br>Biocompatibility<br>Guidance for<br>Medical Devices &<br>ISO 10993-5,<br>ISO 10993-10 | Meets Triparties<br>Biocompatibility<br>Guidance for<br>Medical Devices &<br>ISO 10993-5,<br>ISO 10993-10 | Meets Triparties<br>Biocompatibility<br>Guidance for<br>Medical Devices &<br>ISO 10993-5,<br>ISO 10993-10 | | Conductive<br>Surface Shapes | Various shapes<br>(rectangular,<br>circle, oval) | Various shapes<br>(rectangular, circle,<br>oval) | Various shapes<br>(rectangular, circle,<br>oval) | Various shapes<br>(rectangular, circle,<br>oval) | Predicated Technological Characteristics Comparison: The subject device, HIVOX self-adhesive electrode gel pads, uses the same materials from the suppliers, predicate devices' manufacturers. And the suppliers, Top Rank and Axelgaard will provide all components materials of the HIVOX self-adhesive electrode gel pads. The differences between the subject device and K000947 are prescription use and OTC use. The subject device has OTC use but K000947 hasn't OTC use. But we have added a predicate device K132588 with OTC use, the OTC use of the safety and effectiveness of our device are ensured. The subject device and predicate device (K000947) have the minor different intended use and use the same gel ingredients and the conductive films; thus the effects of impedance levels for the intended situations are the same for both of the devices. We notice there are different wording of the intended uses between the subject device and the predicate device K000947. But the key sentences for K000947 : serving as an interface between a patient's skin and a neurostimulation device, and the key sentences for the subject device : interface between the patient's skin and the electrical stimulator are similar. Thus they have similar intended use. Both of them have the same safety and effectiveness. {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the word "HIVOX" in a bold, sans-serif font. To the right of the word is a symbol that looks like four squares connected by curved lines. The symbol is black and white, and it is slightly smaller than the word "HIVOX". The overall image is simple and clean, with a focus on the text and symbol. #### HIVOX BIOTEK INC. 5F., No. 123. Shingde Road, Sanchong District. New Taipei City, Taiwan Phone: +886 2 8511 2668 Fax: +886 2 8511 2669 And all of four devices had passed the Tripartite Biocompatibility Guidance for Medical Devices and the ISO 10993 relevant requirements for skin contact. Thus the subject device and predicate devices have the same safety and effectiveness. The subject device and the predicate devices have the same physical and technological characteristics, which are intended to be used with marketed Electrical Stimulators, including: TENS(Transcutaneous Electrical Nerve Stimulator), EMS (Electrical Muscular Stimulator), and IF (Interferential Stimulator). And all of the devices are for gel pads use with an electrode and not an electrode itself. #### Conclusion: The conclusions drawn from the non-clinical tests demonstrate that the device is as safe, as effective, and performs as well as the legally marketed devices identified in the submission. Thus the subject device is substantially equivalent to the predicate devices. {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the symbol. The text is in all caps and is in a circular format. #### DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 July 25, 2014 HIVOX BIOTEK, Inc. Dr. Jen. Ke-Min 5 F No. 123 Shinde Road Sanchong District New Taipei City 24158 TAIWAN, ROC Re: K131720 Trade/Device Name: HIVOX Self-Adhesive Electrode Gel Pads Regulation Number: 21 CFR 882.1320 Regulation Name: Cutaneous Electrodes Regulatory Class: Class II Product Code: GXY, GYB Dated: June 18, 2014 Received: June 25, 2014 Dear Dr. Jen, Ke-Min, 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 or any reathards and the Act's requirements, including, but not limited to: registration and listing (21 {6}------------------------------------------------ Page 2 - Dr. Jen, Ke-Min CFR Part 807): labeling (21 CFR Part 801); medical device 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/ResourcesforYou/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/Reportal/roblem/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, Felipe Aquel -S Carlos Pena, PhD, MS for Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {7}------------------------------------------------ #### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration #### Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below. 510(k) Number (if known) K131720 #### Device Name HIVOX Self-Adhesive Electrode Gel Pads Indications for Use (Describe) HIVOX self-adhesive electrode gel pads are intended for use as disposable, conductive adhesive interface between the patient's skin and the electrical stimulator. The device is a gel pad for use with an electrode itself. 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) ### - Date: 2014.07.25 17:34:13 04'00' 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."