Disposable Laryngeal Electrodes

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December 21, 2023 Suzhou Haishen Medical Device Associates Co., Ltd % Xiaoqing Xue Registration Engineer Sinow Medical AS Høyteknologisenteret Thormøhlens Gate 55 Bergen, 5008 Norway Re: K232888 Trade/Device Name: Disposable Laryngeal Electrodes Regulation Number: 21 CFR 874.1820 Regulation Name: Surgical Nerve Stimulator/Locator Regulatory Class: Class II Product Code: ETN Dated: November 24, 2023 Received: November 24, 2023 Dear Xiaoqing Xue: 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" (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). {1}------------------------------------------------ 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 medical devices and radiation-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, Shuchen Peng -S Shu-Chen Peng, Ph.D. Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K232888 Device Name Disposable Laryngeal Electrode Indications for Use (Describe) The disposable laryngeal electrodes are intended to be used as a disposable, self-adhesive electrodes attached to an endotracheal tube and positioned for continuous EMG monitoring of the larynx during surgical procedures. Type of Use (Select one or both, as applicable) | <label><input checked="true" type="checkbox"/><span>For activities under 21 CFR 312.2, Sponsor-Investigator</span></label> | <label><input type="checkbox"/><span>Compassionate Use, including Treatment Use</span></label> | |----------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------| |----------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------| 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." {3}------------------------------------------------ # 510(K) Summary # K232888 #### 1. 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@gq.com Contact Person: Leyi Dai Date Prepared: Dec.15, 2023 #### 2. Designated Submission Correspondent Company: Sinow Medical AS Address: Vestre Fantoftåsen 44, 5072, Bergen, Norway Contact Person: Xiaoqing Xue Telephone: +86 15161196032 Email: xue(@bergemed.com ## 3. Subject Device Trade name: Disposable Laryngeal Electrodes 510(K) number: K232888 Regulatory Class: II Regulation Number: 21 CFR 874.1820 Product Codes: ETN Classification Panel: Ear Nose & Throat Classification Name: Stimulator, Nerve ## 4. Primary Predicate Device Manufacturer: Inomed Medizintechnik GmbH Trade name: Inomed Adhesive Laryngeal Electrode 510(K) Number: K091874 Regulation Number: 21 CFR 874.1820 Product Codes: ETN Classification Panel: Ear Nose & Throat Classification Name: Stimulator, Nerve ## 5. Device Description The Disposable Laryngeal Electrodes are single used electrodes constructed from an medical-grade ink with a conductive polymer film covered by an insulating coating, a connector made of polypropylene and a cable assembly. The electrodes are designed to monitor the recurrent nerve during thyroid, anterior cervical, carotid endartecrectomy surgery and vagus nerve monitoring during brain surgery. The monitoring is performed with a surface electrode that is attached to an endotracheal tube placed on the vocal cord. A neutral adhesive electrode is placed on the patient's {4}------------------------------------------------ shoulder. Both adhesive electrodes are connected to a reusable recording cable and to the nerve monitor. # 6. Intended Use/Indications for Use The Disposable Laryngeal Electrodes are intended to be used as a disposable, self-adhesive electrode attached to an endotracheal tube and positioned for continuous EMG monitoring of the larynx during surgical procedures. | Attribute | Disposable Laryngeal<br>Electrode (Subject<br>Device) | Inomed Adhesive<br>Laryngeal Electrode<br>(Predicate device<br>K091874) | Comment | |-------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------| | Regulation<br>Number | 21 CFR 874.1820 | 21 CFR 874.1820 | Same | | Regulation Name | Surgical nerve<br>stimulator/locator | Surgical nerve<br>stimulator/locator | Same | | Regulatory Class | Class II | Class II | Same | | Product Code | ETN | ETN | Same | | Indications for<br>Use | The Disposable Laryngeal<br>Electrodes are intended to<br>be used as a disposable,<br>self-adhesive electrode<br>attached to an endotracheal<br>tube and positioned for<br>continuous EMG<br>monitoring of the larynx<br>during surgical procedures. | The Inomed Adhesive<br>Laryngeal Electrodes are<br>intended to be used as a<br>disposable, self-adhesive<br>electrode attached to an<br>endotracheal tube and<br>positioned for continuous<br>EMG monitoring of the<br>larynx during surgical<br>procedures. | Same | | Monitoring site | Trachea/larynx | Trachea/larynx | Same | | Monitoring type | Continuous EMG<br>monitoring | Continuous EMG<br>monitoring | Same | | May be used with<br>all commercial<br>EMG units | Yes | Yes | Same | | Method of<br>electrode<br>attachment | Attached to the surface of<br>the endotracheal tube | Attached to the surface of<br>the endotracheal tube | Same | | Number of<br>electrodes<br>utilized | 2 | 2 | Same | | Number of<br>channels | 2, 4 | 2 | Different 1 | | Device design | -Medical grade inks<br>suspended in a polyester<br>substrate | -Medical grade inks<br>suspended in a polyester<br>substrate | Same | | | -polypropylene connector<br>-cable assembly | -polypropylene connector<br>-cable assembly | | | Electrical<br>insulation | Electrical insulation on all<br>surfaces until the head of<br>the electrode | Electrical insulation on all<br>surfaces until the head of<br>the electrode | Same | | Single use only | Yes | Yes | Same | | Safety<br>characteristics | Non-invasive | Non-invasive | Same | | Sterilization | ETO | ETO | Same | # 7. Comparison of Technological Characteristics {5}------------------------------------------------ Discussion of difference !: The subject device included two and four channels type.The predicate device only have two channels type. Although differences between numbers of channel, the subject two and four channel device have the same design, materials and intended performance, only increasing two identical channels. Furthermore, the four channel device is selected as representative sample to performed electrical safety testing according to IEC 60601-1 to ensure meet the electrical safety requirement. Therefore, we considered that this difference does not raise new questions of safety or effectiveness. #### Non-Clinical Testing 8. ## 8.1. Performance Testing-Bench Suzhou Haishen United Medical Device Associates Co., Ltd has performed the following non-clinical laboratory testing to determine substantial equivalence. | Test | Acceptable criteria | Result | |---------------------|------------------------------------------------------------------------------------------------------------------|--------| | Adhesive property | The electrode should be able to be firmly adhered. | Pass | | Electrode Impedance | Each path of the electrode should be able to conduct,<br>impedance: ≤100 Ω . | Pass | | Security | Normal state (μΑ):<br>AC: ≤0.01mA (10μA) and DC: ≤0.1mA(100μA)<br>Application part pressurized state (mA): ≤5mA | Pass | | Sterility testing | The products were sterile both before and after aged. | Pass | The essential performance and safety of Disposable Laryngeal Electrode was tested for performance in accordance with internal requirements. The adhesive property, electrode Impedance and security were evaluated for subject and predicate device to ensure that the subject device performed as intended and supported substantial equivalence to the predicate devices. ## 8.2. Biocompatibility testing The contact classification for the Disposable Laryngeal Electrode of the subject device is a surface contact device that directly contact with the mucosal membrane ( ≤ 24h). 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 management process", Guidance for Industry and Food and Drug Administration Staff. The results of biocompatibility {6}------------------------------------------------ testing included in the table below demonstrate that the device meets biological safety requirements per ISO 10993-1 for mucosal membrane contact device. | 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 | ## 8.3. 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 10th has been demonstrated. The device meets EO residuals per ISO 10993-7. A shelf-life of 3 years has been established based on accelerated aging testing. #### 8.4. Electrical safety testing Suzhou Haishen United Medical Device Associates Co., Ltd has performed the electrical safety testing according to IEC 60601-1 Medical Electrical Equipment Part 1: General requirements for basic safety and essential performance. Testing were performed and confirmed that the subject device is meet the requirement. #### 9. Conclusion The Disposable Laryngeal Electrode is substantially equivalent to the predicate device when evaluating intended use and technological characteristics. The subject device has the identical intended use as the predicate device and only has a minor technological difference that does not raise different questions of safety or effectiveness. The nonclinical performance data submitted in the 510(k) demonstrates the subject device is substantially equivalent to the predicate device.