Medical Disposable Sterile Needle Electrode

{0}------------------------------------------------ December 4, 2023 Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath. Suzhou Haishen Medical Device Associates Co., Ltd % Jie Gao Consultant Sinow Medical AS Høyteknologisenteret Thormøhlens Gate 55 Bergen, 5008 Norway Re: K232581 Trade/Device Name: Medical Disposable Sterile Needle Electrode Regulation Number: 21 CFR 882.1350 Regulation Name: Needle Electrode Regulatory Class: Class II Product Code: GXZ Dated: August 23, 2023 Received: August 25, 2023 Dear Jie Gao: 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 (the 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 available 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. Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" {1}------------------------------------------------ (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). 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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely. Image /page/1/Picture/8 description: The image shows the name "Patrick Antkowiak -S" in black text. The name "Patrick" is on the first line, and "Antkowiak -S" is on the second line. To the left of the name is a faded FDA logo. for Jay Gupta Assistant Director DHT5A: Division of Neurosurgical, {2}------------------------------------------------ Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ # Indications for Use 510(k) Number (if known) Device Name Medical Disposable Sterile Needle Electrode Indications for Use (Describe) This product is intended for use with recording, monitoring equipment for the recording of bioelectrical signals, such as electromyograph (EMG). The electrodes are sterile and for single patient use only. X Prescription Use (Part 21 CFR 801 Subpart D) | 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." {4}------------------------------------------------ # 510(k) Summary #### I. SUBMITTER Submitter: Suzhou Haishen United Medical Device Associates Co., Ltd Address: 3F, 4F 401, 4F 402, 5F, Building 10, No. 168 Majian Road, Suzhou, Jiangsu Province, China Telephone: +86 18921623557 Email: 785445240@qq.com Contact Person: Leyi Dai Date Prepared: 01.07.2023 II. Consultant Company: Sinow Medical AS Address: Høyteknologisenteret Thormøhlens Gate 55, Bergen, Norway Contact Person: Jie Gao Telephone: +47 99127913 Email: gao@bergemed.com III. DEVICE Trade Name: Medical Disposable Sterile Needle Electrode Classification Name: Needle Electrode Regulatory Class: II Product Code: GXZ IV. PREDICATE DEVICE Product Name: Subdermal Needle Electrodes 510(k) Number: K072276 Product Code: GXZ Manufacture: Xian Friendship Electronics Co., Ltd. V. DEVICE DESCRIPTION Medical disposable sterile needle electrodes are sterile, single use products that penetrate the skin and directly contact the extracellular fluid during use, forming a good electrolyte interface. The pointed part of the needle electrode makes contact with the nerves, muscles, or {5}------------------------------------------------ other tissues under examination to collect and transmit the corresponding bioelectrical signals (myoelectric currents) to the electromyography (EMG) recorder. Needle electrodes are used in conjunction with EMG diagnostic instruments and serve as accessories to the EMG machine for detecting myoelectric potentials. Medical disposable sterile needle electrodes are invasive since they are positioned subcutaneously and are used under the supervision of a licensed physician. The subject device, available in configurations with and wires, which encompasses subdermal, monopolar, spiral, and concentric designs. The subject device's configurations of monopolar and concentric needles correspond to those without lead wires, while the configurations involving spiral and subdermal designs include lead wires. ### VI. INDICATIONS FOR USE This product is intended for use with recording, monitoring equipment for the recording of bioelectrical signals, such as electromyograph (EMG). The electrodes are sterile and for single patient use only. ## VII. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICES The technological characteristics comparing to the predicate device are outlined in the Substantial Equivalent table. | Attribute | Medical Disposable<br>Sterile Needle Electrodes<br>(Subject Device) | Friendship Subdermal<br>Needle Electrodes<br>(Predicate device<br>K072276) | Comment | |---------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------| | Regulation<br>Number | 21 CFR 882.1350 | 21 CFR 882.1350 | SE | | Regulation Name | Needle Electrode | Needle Electrode | SE | | Regulatory Class | Class II | Class II | SE | | Product Code | GXZ | GXZ | SE | | Indications for<br>Use | This product is intended for<br>use with recording,<br>monitoring equipment for<br>the recording of<br>bioelectrical signals, such<br>as electromyograph<br>(EMG). The electrodes are<br>sterile and for single patient<br>use only. | Subdermal Needle<br>Electrodes are intended for<br>use with recording,<br>monitoring and<br>stimulation/recording<br>equipment for the recording<br>of biopotential signals<br>including<br>electroencephalograph<br>(EEG), electromyograph<br>(EMG) and nerve potential<br>signals and for stimulation<br>during the intraoperative<br>diagnosis of acute<br>dysfunction in corticospinal | Subject<br>Device<br>without<br>stimulation<br>function;<br>Subject<br>Device only<br>records in<br>EMG | | | | axonal conduction. The<br>electrodes are sterile and for<br>single patient use only. | | | Environment of<br>Use | Hospital | Hospital | SE | | Provided Sterile | Yes | Yes | SE | | Method of<br>Sterilization | Ethylene Oxide | Ethylene Oxide | SE | | Sterility<br>assurance level<br>(SAL) | $10^{-6}$ | $10^{-6}$ | SE | | Single Use,<br>Disposable | Yes | Yes | SE | | Basic Principle | A needle electrode is an<br>electrode that requires<br>penetration through the<br>skin to directly contact<br>extracellular fluid. It forms<br>a good electrode-electrolyte<br>interface and is used in<br>conjunction with<br>electromyography (EMG)<br>diagnostic instruments as<br>an electrode for detecting<br>muscle electrical activity. | A needle electrode is an<br>electrode that requires<br>penetration through the skin<br>to directly contact<br>extracellular fluid. It forms<br>a good electrode-electrolyte<br>interface and is used in<br>conjunction with recording,<br>monitoring and<br>stimulation/recording<br>equipment for the recording<br>of biopotential signals<br>including<br>electroencephalograph<br>(EEG), electromyograph<br>(EMG) and nerve potential<br>signals and for stimulation<br>during the intraoperative<br>diagnosis of acute<br>dysfunction in corticospinal<br>axonal conduction. | Same basic<br>principle but<br>Subject<br>Device has<br>less clinical<br>usage than<br>Predicate<br>Device | | Target Population | Adults, children and infants | Adults, children and infants | SE | | Anatomical Sites | Subdermal, muscle tissue | Subdermal, nerve or muscle<br>tissue | Subject<br>Device has<br>less<br>Anatomical<br>Sites | | Needle material | Stainless steel | Stainless steel | SE | | Needle length | Spiral needle:<br>$20 \pm 1.5mm$<br>Concentric needle:<br>$(20 - 75) \pm 1.5mm$<br>Subdermal needle: | Spiral needle:<br>NA<br>Concentric needle:<br>20 - 75mm<br>Subdermal needle: | Equivalent | | | | | | | | (6, 7, 13, 19, 20, 22) ±<br>1.5mm | 7, 13, 17, 23mm | | | | Monopolar needle:<br>(20, 25, 30, 37, 50, 75) ±<br>1.5mm | Monopolar needle:<br>20, 25, 30, 38, 50, 75mm | | | Needle diameter | Spiral needle:<br>0.60 ± 0.15mm | Spiral needle:<br>0.60 mm | Equivalent | | | Concentric needle:<br>(0.25 - 0.65) ± 0.15mm | Concentric needle:<br>0.25 - 0.65mm | | | | Subdermal needle:<br>(0.35, 0.40, 0.45) ±<br>0.15mm | Subdermal needle:<br>0.35, 0.40, 0.45mm | | | | Monopolar needle:<br>(0.25, 0.30, 0.35, 0.40,<br>0.45, 0.50, 0.65) ± 0.15mm | Monopolar needle:<br>0.25, 0.30, 0.35, 0.40, 0.45,<br>0.50, 0.65mm | | | Lead wire<br>material | PVC insulated tin plated<br>with copper | PVC insulated tin plated<br>with copper | SE | | Lead wire length | (1000 - 2500) ± 25mm | 1200 - 2500mm | Equivalent | {6}------------------------------------------------ {7}------------------------------------------------ #### VIII. NON-CLINCAL TESTING Suzhou Haishen United Medical Device Associates Co., Ltd has performed the following nonclinical laboratory testing to determine substantial equivalence. | Test | Result | |-------------------------------------------------|--------| | Surface quality | Pass | | Sharpness index | Pass | | Toughness | Pass | | Connection strength | Pass | | Electrical conductivity | Pass | | Conductive terminals and needle body insulation | Pass | | Sterility testing | Pass | ## IX. BIOCOMPATIBILITY TESTING The contact classification for the Medical Disposable Sterile Needle Electrode component of the subject device is a subdermal communicating device with muscle. The biocompatibility evaluation for the subject device was conducted in accordance with ISO 10993-1:2018 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process and in accordance with FDA guidance Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk {8}------------------------------------------------ management process", Guidance for Industry and Food and Drug Administration Staff. The results of biocompatibility testing included in the table below demonstrate that the device meets biological safety requirements per ISO 10993-1 for subdermal communicating devices with muscle. | Test | Standard | Result | |---------------------------|--------------|-----------------------------| | In vitro cytotoxicity | ISO 10993-5 | Non-cytotoxic | | Skin sensitization | ISO 10993-10 | Non-sensitive | | Intracutaneous reactivity | ISO 10993-23 | Non- irritation | | Acute systemic toxicity | ISO 10993-11 | Non-acute systemic toxicity | | Pyrogen | ISO 10993-11 | Non-pyrogenic | ## X. STERILIZATION AND SHELF-LIFE TESTING The subject device is sterilized using Ethylene Oxide. The sterilization validation has been performed in accordance with the principles of ISO 11135:2014 Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices. A sterility assurance level (SAL) of 100 has been demonstrated. The device meets EO residuals per ISO 10993-7. A shelf-life of 3 years has been established based on accelerated and real-time aging. #### XI. CONCLUSIONS The subject and predicate device share intended use - for temporary use with recording and monitoring equipment for the recording and monitoring of bioelectrical signals from the corresponding muscle parts of the human body, such as electromyography (EMG). The subject device does not have stimulation function as the predicate device. The differences in technological characteristics do not raise different questions of safety and effectiveness, and the nonclinical performance data submitted in the 510(k) demonstrate that the subject device is as safe, as effective, and performs as well as the predicate device.