Neurosign V4 Intraoperative Nerve Monitor

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG' and 'ADMINISTRATION' in blue text. November 9, 2018 Magstim Company Ltd. Tom Campbell Regulatory Affairs Manager Spring Gardens Whitland, SA34 0HR Gb Re: K181559 Trade/Device Name: Neurosign V4 Intraoperative Nerve Monitor Regulation Number: 21 CFR 874.1820 Regulation Name: Surgical Nerve Stimulator/Locator Regulatory Class: Class II Product Code: PDQ Dated: October 8, 2018 Received: October 10, 2018 Dear Tom Campbell: 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). 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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, # Jay R. Gupta -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) K181559 Device Name Neurosign® V4 Intraoperative Nerve Monitor Indications for Use (Describe) The Neurosign® V4 Intraoperative Nerve Monitor is intended for locating and identifying cranial and peripheral motor and mixed motor-sensory nerves during surgery, including spinal nerve roots. Indications for Neurosign® V4 EMG Monitoring Procedures include: Intracranial, Extracranial, Extratemporal, Neck Dissections, Thoracic Surgeries, and Upper and Lower Extremities. Indications for spinal procedures which may use Neurosign® V4 EMG monitoring include: Degenerative Treatments, Pedicle Screw Procedures, Fusion Cages, Rhizotomy, Orthopedic Surgery and Open and Percutaneous Lumbar Procedures. | Type of Use (Select one or both, as applicable) | |-------------------------------------------------| |-------------------------------------------------| 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}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the logo for Neurosign. The logo consists of a stylized, teal-colored symbol resembling a brain or a wave pattern on the left. To the right of the symbol is the word "NEUROSIGN" in a bold, teal font, with a registered trademark symbol to the upper right of the "N". ### 510(k) SUMMARY Magstim's Neurosign® V4 Intraoperative Nerve Monitor #### Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared Magstim Company Limited Spring Gardens, Whitland, Carmarthenshire SA34 OHR, United Kingdom Phone: +44 (0) 1994 240798 Facsimile: +44 (0) 1994 240061 Contact Person: Tom Campbell Date Prepared: October 5, 2018 #### Name of Device Neurosign® V4 Intraoperative Nerve Monitor #### Common or Usual Name/ Surgical Nerve Stimulator / Locator #### Classification Surgical Nerve Stimulator / Locator 21 C.F.R. § 874.1820, Class II, product code PDQ #### Predicate Devices NIM 3.0, MEDTRONIC XOMED, INC. (K083124) (Primary Predicate Device) Neurosign® Nerve Monitor, Model Neurosign® 400, The Magstim Company Limited (K053141) (Secondary Predicate Device) #### Device Description The Neurosign® V4 Intraoperative Nerve Monitor is a multi-channel nerve monitor designed for use in Ear, Nose and Throat (ENT) surgery and neurosurgery. Using needle or surface electrodes [1] connected to the Pre-Amplifier Pod, the nerve monitor detects electromyographic (EMG) signals within muscles caused by the contraction of the muscle due to mechanical manipulation or electrical stimulation of the nerve controlling it. The Neurosign® V4 then amplifies the EMG data into an audible signal and displays the data as a waveform on the active monitoring screen. ^[1] Single use electrodes and probes not subject to this submission {4}------------------------------------------------ The Neurosign® V4 Intraoperative Nerve Monitor is used for patient treatment by prescription only under the supervision of a licensed physician. The Neurosign® V4 is an integrated system consisting of a combination of hardware, software, and accessories. Its technological characteristics are described in further detail below. #### Intended Use The Neurosign® V4 Intraoperative Nerve Monitor is intended for locating and identifying cranial and peripheral motor and mixed motor-sensory nerves during surgery, including spinal nerve roots. #### Indications for Use Indications for Neurosign® V4 EMG Monitoring Procedures include: Intracranial, Intratemporal, Extratemporal , Neck Dissections , Thoracic Surgeries, and Upper and Lower Extremities. Indications for spinal procedures which may use Neurosign® V4 EMG monitoring include: Degenerative Treatments, Pedicle Screw Procedures, Fusion Cages, Rhizotomy, Orthopedic Surgery and Open and Percutaneous Lumbar Procedures. #### Technological Characteristics The Neurosian® V4 is comprised of following four components: - 1. Neurosign® V4 Intraoperative Nerve Monitor - 2. Neurosign® V4 Pre-Amplifier Pod 4 Channel - 3. Neurosign® V4 Stimulator Pod - 4. Neurosign® V4 Mute Sensor The Neurosign® V4 Intraoperative Nerve Monitor (IONM) includes a user interface comprised of an audio output, a color graphics display with a touch screen and dedicated rotary controls for frequently adjusted parameters. EMG signals are collected from the patient using needle and surface electrodes [1]. The Neurosign® V4 Pre-Amplifier Pod collects, processes and transmits the EMG signals to the IONM for display and for an audio output. The Neurosign® V4 Stimulator Pod allows the simultaneous connection of two stimulating probes 111 for the mapping and locating of nerves within tissue, and to test the nerve activity at various stages during surgery. Software documentation for a "major" level of concern has been provided. ^[1] Single use electrodes and probes not subject to this submission {5}------------------------------------------------ ## Non-Clinical Testing | Test | Test Method Summary | Results | |---------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Electrical Safety<br>Mechanical Safety | IEC 60601-1:2005 + CORR. 1:2006 +<br>CORR. 2:2007 + A1:2012 -<br>Medical electrical equipment - Part 1:<br>General requirements for<br>basic safety and essential performance | A sample Neurosign® V4 has been<br>tested and found to be compliant to the<br>requirements of IEC 60601-1 by<br>independent test laboratory Element<br>Materials Technology, , thus<br>demonstrating the Neurosign® V4 is<br>substantially equivalent to the legally<br>marketed predicate device. | | Electromagnetic<br>Compatibility | EN 60601-1-2: 2007 -<br>Medical electrical equipment - Part 1-2:<br>General requirements for basic safety and<br>essential performance -<br>Collateral standard: Electromagnetic<br>compatibility -Requirements and tests | A sample Neurosign® V4 has been<br>tested and found to be compliant to the<br>requirements of EN 60601-1-2 by<br>independent test laboratory Kiwa<br>Blackwood Compliance Laboratories,<br>thus demonstrating the Neurosign® V4<br>is substantially equivalent to the legally<br>marketed predicate device.<br>EN 60601-1-2 (2007) is equivalent to the FDA<br>recognized standard IEC 60601-1-2. A<br>justification of this assertion is provided in<br>Appendix 06. | | Alarm Systems | IEC 60601-1-8 -<br>Medical electrical equipment - Part 1-8:<br>General requirements for basic safety and<br>essential performance - Collateral<br>Standard: General requirements, tests and<br>guidance for alarm systems in medical<br>electrical equipment and medical electrical<br>systems | A sample Neurosign® V4 has been<br>tested and found to be compliant to the<br>requirements of IEC 60601-1-8 by<br>independent test laboratory Element<br>Materials Technology, thus<br>demonstrating the Neurosign® V4 is<br>substantially equivalent to the legally<br>marketed predicate device. | | Biocompatibility | ISO 10993-1:2009 - Biological Evaluation<br>of Medical Devices - Part 1: Evaluation and<br>testing within a risk management process | The Neurosign® V4 Nerve Monitor is not<br>intended to come into contact with the<br>patient, as patient contact is achieved<br>via use of single use electrodes and<br>probes. | | | ISO 10993-5:2009 - Biological evaluation<br>of medical devices -- Part 5: Tests for in<br>vitro cytotoxicity | However, the Stimulator Pod, Pre-<br>Amplifier Pod and connecting leads may<br>come into contact with the patient. | | | ISO 10993-10:2010 - Biological evaluation<br>of medical devices - Part 10: Tests for<br>irritation and skin sensitization | Samples of these materials have been<br>tested and found to be compliant to the<br>requirements of ISO 10993-1, ISO<br>10993-5 and ISO 10993-10 by<br>independent test laboratories Harlan<br>Laboratories Ltd and Envigo Research<br>Ltd, thus demonstrating the Neurosign®<br>V4 is substantially equivalent to the<br>legally marketed predicate device. | | Amplifier - EMG Acquisition<br>& EMG Display<br>Equivalence Testing | Using a function generator, a range of<br>input voltages at a set frequency were<br>applied to both the Neurosign® V4 and<br>NIM-Response 3.0 to replicate an EMG<br>signal. | Testing demonstrated that the<br>measured EMG responses on the<br>Neurosign® V4 and the NIM-Response<br>3.0 are within 5% of the target input and<br>±1% of each other, thus demonstrating<br>the Neurosign® V4 is substantially<br>equivalent and performs as well as than<br>the legally marketed predicate device. | | | A 1kΩ Resistor was connected across the<br>stimulator output terminals and the<br>oscilloscope was used to measure the<br>potential difference across the resistor. A<br>range of input currents were used to<br>compare the output waveforms and show<br>the relative amplitude. | Testing demonstrated that the<br>Neurosign® V4 and the NIM-Response<br>3.0 have almost identical stimulator<br>performance, thus demonstrating the<br>Neurosign® V4 is substantially<br>equivalent and performs as well as than<br>the legally marketed predicate device. | | Stimulator Equivalence<br>Testing | 1kΩ Resistor was connected across the<br>stimulator output terminals and the<br>oscilloscope was used to measure the<br>stimulator pulse width. A range of pulse<br>width settings were chosen as they are<br>representative of typical use. | Testing demonstrated that the<br>Neurosign® V4 and the NIM-Response<br>3.0 have almost identical stimulator<br>pulse width performance, thus<br>demonstrating the Neurosign® V4 is<br>substantially equivalent and performs as<br>well as than the legally marketed<br>predicate device. | {6}------------------------------------------------ The software verification and validation testing further demonstrated that the software performs as intended and in accordance with specifications. In accordance with ISO14971, risks associated with the Neurosign® V4 have been identified, assessed and, where necessary, mitigated with risk control measures to an acceptable level. #### Substantial Equivalence The Neurosign® V4 is substantially equivalent to the predicate device, the NIM 3.0 (K083124). The intended use and indications for use of the Neurosign® V4 is a subset of the primary predicate device, the NIM 3.0 (K083124). The difference includes the omission of 'Spinal Cord and reference to the 'APS Electrode' in the intended use and 'Cervical Surgical Procedures, and Thoracic Surgical Procedures' in the indications for use. A discussion on this omission is given in Section XIV. The technological characteristics are equivalent. All devices have the same four principle components: (1) Intraoperative Nerve Monitor. (2) Amplifier, (3) Stimulator and (4) Mute Sensor. The principals of operation of the Neurosign® V4 is equivalent to the primary predicate device, the NIM 3.0 (K083124) and the secondary predicate device Neurosign® Nerve Monitor, Model Neurosign® 400 (K053141) as all systems are based on collecting, processing and representing EMG signals from nerves at risk during surgery. All devices use a stimulator for the mapping and locating of nerves within tissue, and to test the nerve activity at various stages during surgery. All offer the option to use a mute sensor to silence the audio output during episodes of RF interference from electrocautery. {7}------------------------------------------------ The Neurosign V4® meets the same electrical and mechanical safety standards (IEC 60601-1) and the same EMC standards (EN 60601-1-2). The similarities and minor differences between the Neurosign® V4, the NIM 3.0 (primary predicate device) and the Neurosign® Nerve Monitor, Model Neurosign® 400 (Secondary Predicate Device) are described in Table 2. #### Conclusions In summary, the intended use and indications for use of the Neurosign® V4 is a subset of the primary predicate device, the NIM 3.0 (K083124). Furthermore, the Neurosign® V4 has equivalent technological characteristics and equivalent principles of operation compared to the predicate devices. Non-clinical test data demonstrates that the Neurosign® V4 is as safe and effective as the predicate devices. Thus, the Neurosign® V4 Intraoperative Nerve Monitor is substantially equivalent to the primary predicate device, the NIM 3.0 (K083124) and the secondary predicate device the Neurosign® Nerve Monitor, Model Neurosign® 400 (K053141).