SM Electrodes

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left, and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out to the right of the square. The full name of the agency is "U.S. Food & Drug Administration". March 26, 2019 Hong Qiangxing (Shen Zhen) Electronics Limited % Doris Dong Manager Shanghai CV Technology Co., Ltd. Room 903, No. 19 Dongbao Road, Songjiang Area Shanghai, 201613 China Re: K183154 Trade/Device Name: SM Electrodes Regulation Number: 21 CFR 882.1320 Regulation Name: Cutaneous Electrode Regulatory Class: Class II Product Code: GXY Dated: March 8, 2019 Received: March 21, 2019 Dear Doris Dong: 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. {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 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.html; 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). Sincerely, Vivek J. Pinto -S for 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) K183154 Device Name SM Electrodes Indications for Use (Describe) SM Electrodes are intended to transmit electrical current to patient skin for use with transcutaneous 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. | Type of Use (Select one or both, as applicable) | | |----------------------------------------------------------------------------------|--------------------------------------------------------------------------------| | <div> <span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> | বী। [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 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 [As required by 21 CFR 807.92] # 1. Submission Information: | 510(k) Number: | K183154 | |------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Date: | March 26, 2019 | | Type of 510(k) Submission: | Traditional | | Basis for 510(k) Submission: | New device | | Submitter/Manufacturer: | Hong Qiangxing(Shen Zhen) Electronics Limited<br>4F, Jingcheng Building, Xicheng Industrial Zone, Xixiang Road, Bao'an<br>District, Shenzhen City, Guangdong, China 518126 | | Contactor: | Doris Dong (Consultant)<br>Shanghai CV Technology Co., Ltd.<br>Rm. 903, No. 19 Dongbao Rd., Songjiang Area, Shanghai, 201613 China<br>E-mail: doris_d@126.com<br>Tel: 86 21-31261348 | # 2. Device Description: | Proprietary Name: | SM Electrodes | |----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Common Name: | Cutaneous electrode | | Classification Name: | Cutaneous electrode | | Product Code: | GXY | | Device Class: | II | | Regulation Number: | 21 CFR 882.1320 | | Review Panel: | Neurology | | Indications for use: | SM Electrodes are intended to transmit electrical current to patient skin for<br>use with transcutaneous electrical stimulation devices. Some common<br>types of the stimulation devices include, but are not limit to TENS<br>(Transcutaneous Electrical Nerve Stimulation) and EMS (Electrical<br>Muscular Stimulation). The electrode is for OTC (Over-The -Counter) or<br>Prescription use. | | Device Description: | SM Electrode pad is used as an accessory to the TENS or EMS device<br>unit, which transmits electrical current to patient skin. The electrical<br>current of electrode pad is first transmitted via the snap button then<br>transmitted to the conductive gel which is adhered to patient skin.<br><br>SM Electrode Pad is composed of a top cover material, connector snap<br>button, conductive carbon film, conductive hydrogel media, and a carrier<br>line.<br><br>It is non-sterile and intended for single adult patient multiple application<br>use. The SM Electrode has various shapes and sizes.<br><br>To connect with a nerve or muscle stimulator, this SM Electrode Pad has<br>male snap button. The electrical pad connecting two separated gels<br>together through a non-woven fabric has a pair of male snap button and the<br>diameter is 3mm. The electrical pad with only one male snap button are to | {4}------------------------------------------------ be used in pairs and the diameter of snap button is 4mm. When not in use, the hydrogel face is covered by a PET(polyethylene terephthalate) carrier line. ## 3. Predicate Device Identification K152648--Ennova Self-adhesive Electrode--January 12, 2016 K182111--DL Adhesive Electrode--January 17, 2019 ## 4. Non-Clinical Test Conclusion Bench tests were conducted on SM Electrodes to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards: - Shelf life testing per ASTM F1980:2016. - ANSI AAMI ISO 10993-5:2009/(R) 2014, Biological evaluation of medical devices -- Part 5: Tests for In Vitro Cytotoxicity. (Biocompatibility) - ISO 10993-10 Third Edition 2010-08-01, Biological evaluation of medical devices - Part 10: Tests for Irritation and Skin Sensitization. (Biocompatibility) - ANSI AAMI IEC 60601-2-2:2009, Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories Contact Impedance test per 201.15.101.6 Adhesion test per 201.15.101.7 ## 5. Substantial Equivalent Based on Assessment of Clinical Performance Data: Clinical data was not including in this submission. | 6. Substantially Equivalent Comparison Conclusion | | | | |---------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------| | | New Device | Predicate Device 1 | Predicate Device 2 | | 501(k) number | K183154 | K152648 | K182111 | | Trade Name: | SM Electrodes | Ennova Self-adhesive Electrode | DL Adhesive Electrode | | Common<br>Name: | Cutaneous electrode | Cutaneous electrode | Cutaneous electrode | | Classification<br>Name: | Cutaneous electrode | Cutaneous electrode | Cutaneous electrode | | Product Code: | GXY | GXY | GXY | | Regulation<br>Number: | 882.1320 | 882.1320 | 882.1320 | | Medical<br>Specialty: | Neurology | Neurology | Neurology | | Device Class: | II | II | II | | Indications for<br>use: | SM Electrodes are intended to<br>transmit electrical current to<br>patient skin for use with<br>transcutaneous electrical | Ennova Self-adhesive Electrode<br>is intended to transmit electrical<br>current to patient skin for use<br>with transcutaneous electrical | DL Adhesive Electrode is<br>intended to transmit electrical<br>current to patient skin for use<br>with transcutaneous electrical | ## 6. Substantially Equivalent Comparison Conclusion {5}------------------------------------------------ #### SM Electrodes; Hong Qiangxing(Shen Zhen) Electronics Limited | Hong Qiangxing(Shen Zhen) Electronics Limited | | | | | | | |-----------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------| | | | stimulation devices. Some<br>common types of the stimulation<br>devices include, but are not limit<br>to TENS (Transcutaneous<br>Electrical Nerve Stimulation) and<br>EMS (Electrical Muscular<br>Stimulation). The electrode is for<br>OTC (Over-The -Counter) or<br>Prescription use. | stimulation devices. Some<br>common types of the stimulation<br>devices include, but are not limit<br>to TENS (Transcutaneous<br>Electrical Nerve Stimulation) and<br>EMS (Electrical Muscular<br>Stimulation). The electrode is for<br>OTC (Over-The -Counter) or<br>Prescription use. | stimulation devices. Some<br>common types of the stimulation<br>devices include, but are not<br>limited to TENS<br>(Transcutaneous Electrical Nerve<br>Stimulation) and EMS<br>(Electrical Muscular<br>Stimulation). The electrode is for<br>OTC (Over-The -Counter) or<br>Prescription use. | | | | Target<br>population: | Single patient use and multiple<br>application | | Single patient use and multiple<br>application | | Single patient use and multiple<br>application | | | Prescription<br>use | OTC and Prescription use | | OTC and Prescription use | | OTC and Prescription use | | | Design (shape<br>& connection): | Round, rectangle, butterfly, oval,<br>according to customized<br>specification.<br>Snap button with male snap<br>connector | | Round, rectangle, oval, butterfly<br>according to customized<br>specification.<br>Lead wire with female socket, or<br>snap button with male snap<br>connector | | Round, rectangle, butterfly, oval,<br>according to customized<br>specification.<br>Lead wire with female socket, or<br>snap button with male snap<br>connector | | | Materials: | - Top cover material<br>- Electrically conductive carbon<br>cloth<br>- Biocompatible conductive<br>hydrogel<br>- Electrode carrier liner | | - Top cover material<br>- Electrically conductive carbon<br>cloth<br>- Biocompatible conductive<br>hydrogel<br>- Electrode carrier liner | | - Top cover material<br>- Electrically conductive carbon<br>cloth<br>- Biocompatible conductive<br>hydrogel<br>- Electrode carrier liner | | | Electrode Pad<br>Size | Round | Min.Ø20mm;<br>Max.Ø70mm | Round | Min.Ø32mm;<br>Max.Ø70mm | Round | Min.Ø18mm;<br>Max.Ø85mm | | | Rectangle | Min.50×50mm;<br>Max.170×100mm | Rectangle | Min.40×40mm;<br>Max.100×130mm | Rectangle | Min.40×40mm;<br>Max.40×350mm | | | Oval | Min.43×30mm;<br>Max.120×76mm | Oval | Min.50×120mm;<br>Max.100×240mm | Oval | 50×78mm | | | Butterfly | 165×79mm | Butterfly | Min.55×75mm;<br>Max.95×165mm | Butterfly | Min.93×150mm;<br>Max.110×150mm | | Connector retention force | | | | | | | | --Lead wire<br>with female<br>socket | NA | | 10.80N | | 10.85N | | | --snap button<br>with male snap<br>connector | 9.62N | | 9.60N | | 9.61N | | | Hydrogel<br>thickness | 1.0mm ± 0.2mm | | 1.0mm ± 0.2mm | | 1.0mm ± 0.2mm | | | Standards met: | 1. Impedance test, | | 1. Lead wires test per 8.5.2.3 of | | 1.Lead wires test per8.5.2.3 of | | | | Conformability test and Fluid | | | | | | {6}------------------------------------------------ #### SM Electrodes; Hong Qiangxing(Shen Zhen) Electronics Limited | | tolerance test per 201.15.101.6<br>and 201.15.101.7 of ANSI AAMI<br>IEC 60601-2-2:2009;<br>2. Impedance Test (Dispersion<br>Test) per FDA requirement;<br>3. Peel strength test according to<br>manufacturer's requirement;<br>4. Shelf life test per ASTM<br>F1980:2016; | 2. Impedance test,<br>Conformability test and Fluid<br>tolerance test per 201.15.101.6<br>and 201.15.101.7 of IEC<br>60601-2-2:2009<br>3. Impedance Test (Dispersion<br>Test) per FDA requirement;<br>4. Peel strength test according to<br>manufacturer's requirement;<br>5. Shelf life test per ASTM<br>F1980:2011; | 2.Impedance test, Conformability<br>test and Fluid tolerance test per<br>201.15.101.6 and 201.15.101.7<br>of ANSI AAMI IEC<br>60601-2-2:2017<br>3. Impedance Test (Dispersion<br>Test) per FDA requirement;<br>4. Peel strength test according to<br>manufacturer's requirement;<br>5.Shelf life test per ASTM<br>F1980:2016; | |----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Biocompatibili<br>ty | ISO10993-5:2009;<br>ISO10993-10:2010 | ISO10993-5:2009;<br>ISO10993-10:2010 | ISO10993-5:2009;<br>ISO10993-10:2010 | | Sterility<br>Status: | Non-sterile | Non-sterile | Non-sterile | | Electrical<br>safety | NA | Lead wire meets Clause 8.5.2.3<br>of AAMI/ANSI ES60601-1 | Lead wire meets Clause 8.5.2.3<br>of AAMI/ANSI ES60601-1 | | Other<br>Performance | Good electrical conductivity,<br>good adhesive property | Good electrical conductivity,<br>good adhesive property | Good electrical conductivity,<br>good adhesive property | # The Conclusions: Based on the successful biocompatibility testing, electrode current distribution test results, SM Electrodes are safe and effective when used as an interface between a user's skin and an approved nerve and muscle stimulation device. 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.