Self-adhesive Electrode

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. August 7, 2018 Dong Guan Ou Kang Electronics CO., LTD % Field Fu Consultant Shenzhen Joyantech Consulting Co., Ltd. Room 1122, International Mayors Communication Centre Shenzhen, 511470 Cn Re: K181234 Trade/Device Name: Self-adhesive Electrode Regulation Number: 21 CFR 882.1320 Regulation Name: Cutaneous Electrode Regulatory Class: Class II Product Code: GXY Dated: May 9, 2018 Received: May 9, 2018 Dear Field Fu: 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 {1}------------------------------------------------ requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). for # Sincerely, Michael J. Hoffmann -S Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) k181234 Device Name Self-adhesive electrode #### Indications for Use (Describe) Self-adhesive electrode is intended for single use, conductive adhesive interface between the patient's skin and the electrical stimulation devices. Some common types of the stimulation devices include, but are not limit to, TENS (Transcutaneous Electrical Nerve Stimulation) and EMS (Electrical Muscular Stimulation). The electrode is for OTC (Over-The -Counter) or Prescription use, for single patient use only. | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------| | <div> <span> <span style="text-decoration: overline;">X</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> <span style="text-decoration: overline;">X</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> | #### 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 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}------------------------------------------------ # 510(k) Summary Date of summary prepared: 08/06/2018 This summary of 510(K) safety and effectiveness information is submitted as required by requirements of SMDA and 21 CFR §807.92. ### 1. Administrative Information | Date of summary prepared | | |--------------------------|------------------------------------------------------| | Manufacturer information | Company title: Dong Guan Ou Kang Electronics CO.,LTD | | | Company address: 3rd floor, Xiqunli building, Shipai | | | road, Yanwo village, Shipai town, Dongguan | | | Phone: +86-0769-82686009 | | | Fax: +86-0769-82686009 | | | Contact person: Nianjun Liu | | | E-mail: nianjun_liu@sohu.com | | | | | Submission Correspondent | | | | Name: Shenzhen Joyantech Consulting Co., Ltd | | | Address: Room 1122, International Mayors | | | Communication Centre, NO. 55 Shizhou middle road , | | | Nanshan District, Shenzhen | | | Contact person: Field Fu; Summer Wu; Elly Xv | | | E-mail: summer@cefda.com; elly@cefda.com | ### 2. Device information | Type of 510(k) submission: | Traditional | |----------------------------|--------------------------------------------------| | Trade name: | Self-adhesive electrode | | Model: | Lead wire type electrode and snap type electrode | | Classification Name: | Electrode, Cutaneous | | Review panel: | Neurology | | Product Code: | GXY | | Device Class | II | | Regulation number: | 882.1320 | ### 3. Predicate Device Information | Sponsor: | Shenzhen Mailuokang Technology Co., Ltd. | |----------------|------------------------------------------| | Device: | Mailuokang Self-adhesive Electrode | | 510(k) number: | K152815 | {4}------------------------------------------------ ### 4. Device description ### 1) Intended use/indications for use Self-adhesive electrode is intended for single use, conductive adhesive interface between the patient's skin and the electrical stimulation devices. Some common types of the stimulation devices include, but are not limit to, TENS (Transcutaneous Electrical Nerve Stimulation) and EMS (Electrical Muscular Stimulation). The electrode is for OTC (Over-The -Counter) or Prescription use, for single patient use only. ### 2) Device specification The specification of self-adhesive electrode is listed below. | Model | Shape | Product Size(mm) | Connector<br>Size (hole<br>diameter)<br>(mm) | |---------------------------------------------|------------------------------------------------------|--------------------------------------------------------------------------------------|----------------------------------------------| | Non-woven<br>lead wire<br>type<br>electrode | Rectangular<br>and circular | Rectangular:<br>40×40;40×60;50×50;50×60;50×70;50×90;50×100;60×80;60×90;70×110;90×130 | 2.0, 2.5 | | | | | | | | | | | | | | | | | | | | | | | | Circular:<br>$Ф$ 30; $Ф$ 40; $Ф$ 50; $Ф$ 80 | | | | | | | | Non-woven<br>snap type<br>electrode | Rectangular<br>, circular,<br>oval and<br>hand shape | Rectangular:<br>40×40; 40×80; 50×50; 50×90; 50×100; 60×90 | 3.3, 3.6 | | | | Circular:<br>$Ф$ 30; $Ф$ 40; $Ф$ 50; $Ф$ 80 | | | | | | | | | | Oval:<br>43×30 | | | | | | | | | | Hand shape:<br>75×46 | | ### 3) Device design Non-woven lead wire type electrode and non-woven snap type electrode have different appearance and construction. See Figure 1 and Figure 2 for the structure picture of non-woven lead wire type electrode and non-woven snap type electrode. Image /page/4/Figure/10 description: The image shows a diagram of a layered structure with labels indicating the different components. The layers, from top to bottom, are: 1 Non-woven fabric, 2 Double sides adhesive tape, 3 Conducting film, 4 Hydrogel, and 5 Plastic film. A wire labeled as 6 Carbon fiber wire is connected to the side of the layered structure. Image /page/4/Figure/11 description: The image shows the text "Figure 1 The structure of non-woven lead wire type electrode". The text appears to be a figure caption. The caption describes the structure of a non-woven lead wire type electrode and is labeled as Figure 1. {5}------------------------------------------------ Proposed product: Self-adhesive electrode Image /page/5/Figure/3 description: The image shows a diagram of a layered structure, with labels indicating the different components. The layers, from top to bottom, are: 1 Non-woven fabric, 2 Double sides adhesive tape, 3 Conducting film, 4 Hydrogel, and 5 Plastic film. There is also a component labeled 6 Snap on the top layer. Figure 2 The structure of non-woven snap type electrode ### 4) Materials used Both non-woven lead wire type electrode and snap type electrode are composed of a non-woven fabric, a double side adhesive tape, conducting film, hydrogel and plastic film. The construction difference between non-woven lead wire electrode and non-woven snap electrode is lead wire and snap. ### 5) Physical and performance characteristics of the device Electrical impedance: less than 3KΩ. Current uniformity: the current deviation index of the electrode is less than 5%. Adhesive performance: 30 minutes maximum duration use. # 6) Principle of Operation Self-adhesive electrode functions as a passive device by carrying an electrical signal from a stimulation device through the device cable and electrode lead wire or snap to the user skin. Electrical signal from an electrical stimulator is conducted to the self-adhesive electrode through a lead wire or snap; which is dispersed across the conductive film, then transmitted through the conductive adhesive hydrogel to the surface of the patient's skin. | Component | Material | |------------------|---------------------------------------------------------------------------------------------------| | Non-woven fabric | 100% polypropylene in white | | Conducting film | Carbon paste | | Hydrogel | Cross linked acrylic resin, polyhydric alcohol, electrolytic salt, additives and de-ionized water | | Lead wire | PVC | | Snap | Nickel-clad copper | ### 7) Material of construction # 5. Technological characteristics of the subject device compared to the predicate device | Items | Predicate<br>(K152815) | Device | Subject Device | Comparison | |-----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------|------------| | General Characteristics | | | | | | ltems | Predicate<br>Device<br>(K152815) | Subject Device | Comparison | | | Classification<br>Name | Cutaneous Electrode | Cutaneous Electrode | Same. | | | Product Code | GXY | GXY | Same. | | | Regulation<br>Number | 882.1320 | 882.1320 | Same. | | | Device Class | Class II | Class II | Same. | | | Intended<br>Use/Indicatio<br>ns for Use | Mailuokang<br>Self-adhesive<br>Electrode is intended<br>for use as reusable,<br>conductive adhesive<br>interface between the<br>patient's skin and the<br>electrical stimulation<br>devices. Example<br>electrical stimulation<br>devices for current<br>applications of the<br>electrodes includes,<br>but are not limited to,<br>TENS<br>(Transcutaneous<br>Electrical Nerve<br>Stimulation) and EMS<br>(Electrical Muscle<br>Stimulation).<br>Mailuokang<br>Self-adhesive<br>Electrode is for<br>prescription use and<br>over-the-counter use,<br>for single patient use<br>only. | Self-adhesive<br>electrode is intended<br>for use as single<br>use, conductive<br>adhesive interface<br>between the<br>patient's skin and the<br>electrical stimulation<br>devices. Some<br>common types of the<br>stimulation devices<br>include, but are not<br>limit to, TENS<br>(Transcutaneous<br>Electrical Nerve<br>Stimulation) and<br>EMS (Electrical<br>Muscular<br>Stimulation). The<br>electrode is for OTC<br>(Over-The-Counter)<br>or Prescription use,<br>for single patient use<br>only. | Similar. (Note 1) | | | Intended<br>User/Patient<br>Population | No specified<br>population. | No specified<br>population. | Same. | | | Electrical<br>Connection | Lead wire or snap. | Lead wire or snap. | Same. | | | OTC or<br>prescription<br>use | OTC use and<br>prescription use. | OTC use and<br>prescription use. | Same. | | | Items | Predicate<br>Device<br>(K152815) | Subject Device | Comparison | | | Reusable | Yes | No. | Similar. (Note 1) | | | Single Patient<br>Use | Yes | Yes | Same. | | | Multiple<br>Applications | Yes | No. | Similar. (Note 1) | | | Sterility<br>Status | Non-sterile | Non-sterile | Same. | | | Technical Characteristics | | | | | | Electrode<br>dimensions(c<br>m) | For lead wire style<br>electrode:<br>Rectangular:<br>3×7;4×4;5×5;5×6;5×7;<br>6×9;8×12;8×13<br>For snap style<br>electrode:<br>Rectangular:<br>9×4<br>Circle:<br>Ф4; Ф5; Ф8.5<br>Oval:<br>4.5×3 | For<br>non-woven<br>lead-wire<br>type<br>electrode:<br>Rectangular:<br>4×4;4×6;5×5;5×6;5×<br>7;5×9;5×10;6×8;6×9;<br>7×11;9×13<br>Circular:<br>Ф3; Ф4; Ф5; Ф8<br>For non-woven snap<br>type electrode:<br>Rectangular:<br>4×4; 4×8; 5×5; 5×9;<br>5×10; 6×9<br>Circular:<br>Ф3; Ф4; Ф5; Ф8<br>Oval:<br>4.3×3<br>Hand shape:<br>7.5×4.6 | Similar. (Note 2) | | | Conductive<br>surface<br>area(cm2) | 12.56~104 | 7~117 | Similar. (Note 2) | | | Design<br>Features | Six basic components<br>for Lead Wire Style<br>Electrode:<br>• non-woven<br>fabrics;<br>• double sides<br>adhesive tape;<br>• conducting film;<br>• hydrogel;<br>• plastic film; | Six basic<br>components for Lead<br>Wire Style Electrode:<br>• non-woven<br>fabrics;<br>• double sides<br>adhesive tape;<br>• conducting film;<br>• hydrogel;<br>• plastic film; | Same. | | {6}------------------------------------------------ Proposed product: Self-adhesive electrode {7}------------------------------------------------ {8}------------------------------------------------ Proposed product: Self-adhesive electrode | Items | Predicate<br>(K152815) | Device | Subject Device | Comparison | | | | | | | | | | | | | | | | | | | |-----------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--------| | | • carbon fiber wire.<br>Six basic components<br>for Snap Style<br>Electrode:<br>• non-woven<br>fabrics;<br>• double sides<br>adhesive tape;<br>• conducting film;<br>• hydrogel;<br>• plastic film;<br>• snap. | | • carbon fiber wire.<br>Six basic<br>components for Snap<br>Style Electrode:<br>• non-woven<br>fabrics;<br>• double sides<br>adhesive tape;<br>• conducting film;<br>• hydrogel;<br>• plastic film;<br>• snap. | | | | | | | | | | | | | | | | | | | | | Hydrogel<br>Composition | Glyrol, Polyacrylic<br>acid, Water and Salt | | Crosslinked acrylic<br>resin, polyhydric<br>alcohol, electrolytic<br>salt, additives and<br>de-iconized water. | Similar.<br>(Note 43) | | | | | | | | | | | | | | | | | | | | Function and<br>concentration<br>of each<br>ingredient in<br>final<br>formulation | Not publicly available. | | Ingredient Concentration<br>(WT%) Function Crosslinked<br>acrylic resin 15-25 Cross-<br>linking<br>polymerization. polyhydric<br>alcohol 40-60 Buffer<br>and<br>humectant. electrolytic<br>salt 2-10 Ionic<br>conducting<br>media additives <0.5 Stabilization. de-iconized<br>water 20-40 Solution. | | | | | | | | | | | | | | | | | | | Note 3 | {9}------------------------------------------------ | Items | Predicate<br>Device<br>(K152815) | Subject Device | Comparison | |-----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------|----------------------| | pH<br>of<br>hydrogel | Not publicly available. | 6.5~7.5 | Note 4 | | Conductivity<br>of<br>hydrogel<br>(S/m) | Not publicly available. | 50 | Note 5 | | Resistivity<br>(Ωm) | Not publicly available. | 0.02 | Note 5 | | Volume<br>of<br>hydrogel<br>(cm³) | Not publicly available. | The<br>volume<br>of<br>hydrogel varies by<br>the shape of<br>electrodes, ranging<br>from 0.7 to 11.7. | Note 6 | | Maximum<br>duration<br>of<br>use | 30min. | 30min. | Same. | | Biocompatibi<br>lity | Mailuokang's hydrogel<br>has passed three<br>biocompatibility tests:<br>skin irritation,<br>sensitization and<br>cytotoxicity. | Self adhesive<br>electrode has passed<br>3 biocompatibility<br>tests: skin irritation,<br>sensitization and<br>cytotoxicity. | Same. | | Performance<br>Test | Measuring<br>the<br>electrode contact<br>impedance and<br>adhesion. | Size, electrical<br>impedance and<br>adhesion. | Same. | | Conductive<br>Surface<br>Shapes | Various shapes<br>(rectangular, oval,<br>circle) | Various shapes<br>(rectangular, oval,<br>circular, hand shape) | Similar.<br>(Note 2) | {10}------------------------------------------------ #### Discussion of the similarities and differences: #### Note 1: The difference between the subject device and the predicate device is that, the predicate device is intended for multiple uses, while the subject device is intended for single use. The difference does not adversely affect the safety and effectiveness of the device. #### Note 2: The electrode dimension and conductive surface of the predicate device is similar to the subject device. The difference does not adversely affect the safety and effectiveness of the device. ### Note 3: Both Mailuokang self-adhesive electrode and self-adhesive electrode have passed the biocompatibility test, electrode impedance test and adhesion test. Therefore, the difference in hydrogel composition will not raise any safety or efficacy issues. ### Note 4: The conductive gel is called hydrogel, it is pre-applied to the electrode. The hydrogel pH of the predicate device is unknown, as the subject device has pass the biocompatibility tests performed per ISO 10993 series standards, the difference does not adversely affect the safety and effectiveness of the device. #### Note 5: The conductivity and impedance of the hydrogel in the predicate device is unknown. As both the electrical impedance of the predicate device and the subject device are less than 3kΩ, the difference does not adversely affect the safety and effectiveness of the device. {11}------------------------------------------------ #### Note 6: The difference in volume of hydrogel does not adversely affect the safety and effectiveness of the device. ### 6. Brief discussion of the nonclinical tests Self-adhesive electrode has passed performance tests for size, electrical impedance, current uniformity test and adhesion test is performed according to IEC 60601-2-2:2009 Clause 201.15.101.7. Self-adhesive electrode has passed 3 biocompatibility tests: cytotoxicity, skin irritation and.skin sensitization. The biocompatibility tests are performed according to ISO 10993-1, 5 and 10. The shelf life of self-adhesive electrode is verified according to ASTM F 1980-07. ### 7. Brief discussion of clinical tests Not applicable. ### 8. Other information (such as required by FDA guidance) No other information. ### 9. Conclusions The subject device is substantially equivalent to Mailuokang Self-adhesive Electrode whose 510(k) number is K152815.