NIM Vital, Nerve Integrity Monitor

{0}------------------------------------------------ October 28, 2020 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, with the letters "FDA" in a blue square. Next to that is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. Medtronic Xomed, Inc. Marek Pawlowski Senior Regulatory Affairs Specialist 6743 Southpoint Drive North Jacksonville, Florida 32216-0980 Re: K200759 Trade/Device Name: NIM Vital, Nerve Integrity Monitor Regulation Number: 21 CFR 882.1870 Regulation Name: Evoked Response Electrical Stimulator Regulatory Class: Class II Product Code: GWF. ETN Dated: September 25, 2020 Received: September 28, 2020 Dear Marek Pawlowski: 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 {1}------------------------------------------------ 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/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 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 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, for Jay Gupta Assistant Director DHT5A: Division of Neurosurgical, 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 {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K200769 Device Name NIM Vital™ Nerve Monitoring System ### Indications for Use (Describe) The NIM Vital™ System is intended for locating and monitoring, including stimulation, of cranial, spinal, peripheral motor and mixed motor-sensory nerves and registering EMG responses during surgery. The NIM Vital™ System may be used for EMG monitoring in surgical procedures including: Intracranial, Extracranial, Intratemporal and surgeries associated with the Neck, Spine, Thorax, and Upper and Lower Extremities. The NIM Vital™ is contraindicated for use with paralyzing anesthetic agents that will significantly reduce, if not completely eliminate, EMG responses to direct or passive nerve stimulation. | Type of Use ( <i>Select one or both, as applicable</i> ) | |----------------------------------------------------------| |----------------------------------------------------------| 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 K200759 | • 510(k) owner | Medtronic Xomed, Inc.<br>6743 Southpoint Drive North<br>Jacksonville, Florida 32216-0980 USA<br>Phone:904-296-9600<br>Fax: 904-296-2386 | |-----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | • Contact Information | Marek Pawlowski (Primary)<br>Senior Regulatory Affairs Specialist<br>Phone: 904-279-7587, Fax: 904-296-2386<br>marek.pawlowski@medtronic.com<br><br>Ed Chin (Alternate)<br>Regulatory Affairs Director<br>Phone: 904-279-7550, Fax: 904-296-2386<br>ed.chin@medtronic.com | This Traditional 510(k) submission notifies FDA of modifications to currently marketed product - NIMTM 3.0 Nerve Integrity Monitoring Console and Patient Interface to update mechanical, electrical and software platforms due to the progress of technology. | • Date Summary Prepared | October 28, 2020 | |-------------------------|-------------------| | • Proprietary Name; | NIM Vital™ System | - Device Name ● ● | Trade name: | NIM Vital™, Nerve Integrity Monitor | |-------------------------|-----------------------------------------------| | Common/Usual Name: | Nerve Stimulator | | Classification Name: | Evoked response electrical stimulator | | | (21 CFR 882.1870, Product Code GWF. Class II) | | | Surgical nerve stimulator/locator | | | (21 CFR 874.1820, Product Code ETN, Class II) | | Premarket Notification: | K200759 | | Predicate Device: | | | Trade Name: | NIM™ 3.0 Nerve Integrity Monitor | | Common/Usual Name: | Nerve Stimulator | | Classification Name: | Evoked response electrical stimulator | | | (21 CFR 882.1870, Product Code GWF. Class II) | | | Surgical nerve stimulator/locator | | | (21 CFR 874.1820, Product Code ETN, Class II) | | Premarket Notification: | K083124 | {4}------------------------------------------------ #### . Device Description The NIM Vital™ system is an electromyography (EMG) monitor for intraoperative use during surgeries in which a motor or motor-sensory nerve is at risk. The NIM Vital™ records EMG activity from the muscles innervated by the affected nerve. The system assists in early nerve identification by providing the surgeon with tools to help locate and identify the particular nerve at risk within the surgical field. The system monitors EMG activity from the muscles innervated by the nerve at risk, alerting the surgeon when a particular nerve has been activated. Nerve monitoring involves measuring and displaying amplitudes of EMG responses as well as the latency (delay) between the stimulus and the EMG response. The system also allows an option for Automatic Periodic Stimulation (APS), allowing for EMG monitoring, nerve activity trending and alerts. This information is used throughout the procedure to determine and/or change surgical strategy in order to promote the best outcome for the patient by preserving nerve function. In addition, intraoperative monitoring can help verify the integrity of the nerve throughout the procedure. NIM Vital™ system provides detailed intraoperative nerve condition information to inspire surgical strategy and help improve patient outcomes. Proprietary technology notifies user in real time of nerve condition - visually and audibly. NIM Nervassure™ continuous monitoring technology provides real-time feedback on nerve function so surgeons can adjust course, if necessary, during thyroid surgery and other procedures affecting head and neck nerves. NIM NerveTrend™ EMG reporting enables nerve condition tracking throughout a procedure, even when using intermittent nerve monitoring. During both continuous and intermittent trending, green, yellow and status bars provide visual information and their associated tones provide audible cues to users of current nerve function and EMG trends. NIM Vital™ nerve condition information can be captured in a single, meaningful snapshot. The following components of the NIM Vital™ Nerve Integrity Monitoring System including mechanical, electrical and software design are subject of this 510(k) submission: #### NIM Vital™ Console . NIM Vital™ Console controls the functions of the system: - Interacting with users via touch screen graphic user interface . - . Setting parameters for nerve stimulations - Executing stimulation procedures - . Processing and displaying EMG responses - . Notifying users about events by issuing audio signals - Interfacing with Patient Interface unit . - NIM Vital™ Patient Interface ● {5}------------------------------------------------ Under control of NIM Vital™ Console - Generating stimulation signals - Receiving and processing EMG responses ● - . Connecting with Console wirelessly or via cable #### NIM Vital™ Accessories: ● - · Cables allow connection between components of the system - · Cart provides housing for the component of the system and allows easy movement of the Console within the Operating Room - · Adaptors allow use of predicate NIM 3.0 System disposables with subject NIM Vital System The NIM Vital™ System uses sterile disposables that were developed and cleared for use with the predicate device NIM™ 3.0 and are not subject of this 510(k) submission: - . Disposables: - · Electrodes stimulation electrodes, return electrodes, Automatic Periodic Stimulation (APS) electrodes - · Incrementing Probes In addition, NIM Vital™ System is using a Mute Probe - a non-sterile component of NIM™ 3.0 System to detect activation of electrocautery devices during surgical procedures. #### Intended Use . The NIM Vital™ system is intended for locating and monitoring, including stimulation, of cranial, spinal, peripheral motor and mixed motor-sensory nerves and registering electromyography (EMG) responses during surgery. #### ● Indications for Use The NIM Vital™ System is intended for locating and monitoring, including stimulation, of cranial, spinal, peripheral motor and mixed motor-sensory nerves and registering EMG responses during surgery. The NIM Vital™ System may be used for EMG monitoring in surgical procedures including: Intracranial, Extracranial, Intratemporal, Extratemporal and surgeries associated with the Neck, Spine, Thorax, and Upper and Lower Extremities. The NIM Vital™ System is contraindicated for use with paralyzing anesthetic agents that will significantly reduce, if not completely eliminate, EMG responses to direct or passive nerve stimulation. #### . Comparison of Technological Characteristics with Predicate Device The differences between the subject device – NIM Vital System and the predicate device NIM 3.0 System are related to updating mechanical, electrical and software platforms due to the progress of technology. These differences do not change the intended use, indications for use nor functionality of this medical device. {6}------------------------------------------------ A summary of how the technological characteristics of the subject device NIM Vital compare to a legally marketed device NIM 3.0 is presented in Table 5.1. | Device Name | NIM Vital<br>(K200759) | NIM 3.0<br>(K083124) | |-------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Product Code | GWF, ETN | GWF, ETN | | Intended Use | The NIM VitalTM system is intended for<br>locating and monitoring, including<br>stimulation, of cranial, spinal, peripheral<br>motor and mixed motor-sensory nerves and<br>registering electromyography (EMG)<br>responses during surgery. | The NIM 3.0 is intended for locating<br>and identifying cranial and peripheral<br>motor and mixed motor-sensory<br>nerves during surgery, including<br>spinal cord and spinal nerve roots. The<br>APS electrode is an accessory<br>intended for providing automatic<br>periodic stimulation to nerves. | | Indications for Use | The NIM VitalTM System is intended for<br>locating and monitoring, including stimulation,<br>of cranial, spinal, peripheral motor and mixed<br>motor-sensory nerves and registering EMG<br>responses during surgery.<br>The NIM VitalTM System may be used for EMG<br>monitoring in support of surgical procedures<br>including:<br>Intracranial, Extracranial, Intratemporal,<br>Extratemporal and surgeries associated with the<br>Neck, Spine, Thorax, and Upper and Lower<br>Extremities.<br>The NIM VitalTM System is contraindicated for<br>use with paralyzing anesthetic agents that will<br>significantly reduce, if not completely eliminate,<br>EMG responses to direct or passive nerve<br>stimulation. | Indications for NIM EMG Monitoring<br>Procedures include: Intracranial,<br>Extracranial, Intratemporal,<br>Extratemporal, Neck Dissections,<br>Thoracic Surgeries, and Upper and<br>Lower Extremities.<br>Indications for Spinal Procedures<br>which may use NIM 3.0 EMG<br>monitoring include: Degenerative<br>Treatments, Pedicle Screw<br>Procedures, Fusion Cages, Rhizotomy,<br>Orthopedic Surgery, Open and<br>Percutaneous Lumbar and Cervical<br>Surgical Procedures, and Thoracic<br>Surgical Procedures. | | Complies with IEC 60601-<br>1 electrical safety<br>standards | Yes | Yes | | Console - Power supply | 100V-240V +/-10% 50/60 Hz +/-5%<br>Battery backup | 100V-240V +/-10% 50/60Hz +/-5%<br>No battery | | Patient Interface power<br>supply | DC power from Console during wired<br>connection, battery power in PI during<br>wireless connection | DC power from Console | | Multi-channel<br>intra operative<br>neurophysiological<br>monitor | Yes | Yes | | Patient Interface | Wired / Wireless | Wired | | Monitoring channels | 4 | 4, 8 | | EMG parameters display | Yes | Yes | | Monitoring through<br>bipolar cautery | Yes | Yes | | Device Name | NIM Vital<br>(K200759) | NIM 3.0<br>(K083124) | | Artifact detection software | Yes | Yes | | External screen data<br>display | Yes | Yes | | Speakers | Multiple audio speakers | Single audio speaker | | Continuous Intraoperative<br>Nerve Monitoring | Yes | Yes | | Event Threshold | Yes | Yes | | Touch screen control | Yes | Yes | | Surgeon / Procedure<br>Setting/ Customized<br>Quick Set-up | Yes | Yes | | Surgeon Incrementing<br>Probe control | Yes | Yes | | Monitoring Reports | Yes | Yes | | Synchronized Electro<br>Surgical Unit (ESU)<br>muting | Wired using Mute Detector/ Software<br>detection without using Mute Detector | Wired using Mute Detector | | Capable of connecting<br>various styles of patient<br>monitoring electrodes | Yes | Yes | | Capable of supplying<br>electrical stimulus for<br>evoked responses | Yes | Yes | | Max Stim 1 Current Max<br>Pulse Duration | 50mA<br>1000 µS | 30mA<br>250 µS | | Max Stim 2 Current Max<br>Pulse Duration | 3mA<br>1000 µS | 30mA<br>250 µS | | Absolute maximum<br>stimulation current<br>capability | 50mA | 30mA | | Maximum Current Density<br>with Standard Prass Probe<br>Contact Area = 0.204<br>(mm²) | 980 mA/cm² RMS | 36.8 mA/cm² RMS | | Actual current applied to<br>patient at maximum<br>stimulator setting | 50mA@1000Ohms 50mA@500Ohms<br>50mA@250Ohms 50mA@200Ohms | 30mA@1000Ohms 30mA@500Ohms<br>30mA@250Ohms 30mA@200Ohms | | Absolute maximum energy<br>/ pulse applied to patient at<br>maximum stimulator<br>setting | 2.5mJ@1000Ohms 1.25mJ@500Ohms<br>0.6mJ@250Ohms 0.5mJ@200Ohms | 0.23mJ@1000Ohms<br>0.13mJ@500Ohms<br>0.06mJ@250Ohms<br>0.05mJ@200Ohms | | Device Name | NIM Vital<br>(K200759) | NIM 3.0<br>(K083124) | | Lumbar, thoracic, and<br>cervical procedures | Yes | Yes | | Degenerative procedures | Yes | Yes | | Pedicle screw | Yes | Yes | | Neck Dissections | Yes | Yes | | Orthopedic Surgery | Yes | Yes | | Fusion Cages | Yes | Yes | | Rhizontomy | Yes | Yes | | Peripheral nerve<br>monitoring | (Yes) Upper and lower extremities) | (Yes) Upper and lower extremities) | | Accessories | | | | Subdermal electrode | Yes | Yes | | Sterile/Single Use | Yes | Yes | | Method of Sterilization | ETO | ETO | | Intended for nerve<br>stimulation | Yes | Yes | | Automatic Stimulation | Yes | Yes | | Intended for nerve<br>monitoring | Yes | Yes | | System with Custom Cart | Yes | Yes | | Use Limited to Medtronic<br>NIM Systems | Yes | Yes | # Table 5.1. Summary of Characteristics {7}------------------------------------------------ {8}------------------------------------------------ #### Performance Characteristics . Performance testing was performed due to the changes introduced to the device to verify that all characteristics of the predicate device are preserved in the subject device. All testing passed. # Electrical Safety Testing Electrical Safety compliance is demonstrated through testing in accordance with: | FDA<br>Recognition<br>Number | Standard<br>Developing<br>Organization | Recognition<br>List Number | Standard<br>Designation<br>Number and<br>Date | Title of Standard…