(149 days)
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.
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 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.
The Neurosign® V4 is an integrated system consisting of a combination of hardware, software, and accessories.
The Neurosian® V4 is comprised of following four components:
- Neurosign® V4 Intraoperative Nerve Monitor
- Neurosign® V4 Pre-Amplifier Pod 4 Channel
- Neurosign® V4 Stimulator Pod
- 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. 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 for the mapping and locating of nerves within tissue, and to test the nerve activity at various stages during surgery.
The provided text describes the regulatory clearance of the Neurosign® V4 Intraoperative Nerve Monitor, primarily through demonstrating substantial equivalence to predicate devices, rather than an AI-driven device requiring extensive ground truth establishment and MRMC studies.
Therefore, many of the requested elements for an AI/ML-driven device evaluation, such as sample sizes for training/test sets, expert qualifications for ground truth, adjudication methods, and MRMC study details, are not applicable or detailed in this document. The document focuses on demonstrating that the new device performs similarly and is as safe and effective as existing legally marketed predicate devices through non-clinical testing and comparisons of technological characteristics.
However, I can extract the relevant information regarding acceptance criteria and the study that proves the device meets those criteria based on the provided text, primarily under the "Non-Clinical Testing" section.
Acceptance Criteria and Device Performance Study for Neurosign® V4 Intraoperative Nerve Monitor
This submission focuses on demonstrating substantial equivalence to predicate devices rather than meeting specific performance metrics for an AI/ML algorithm. The "acceptance criteria" are implied by compliance with recognized standards and performance parity with predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Test Method Summary | Reported Device Performance |
|---|---|---|
| Electrical Safety & Mechanical Safety | IEC 60601-1:2005 + CORR. 1:2006 + CORR. 2:2007 + A1:2012 (Medical electrical equipment - Part 1: General requirements for basic safety and essential performance) | A sample Neurosign® V4 tested and found compliant by independent test laboratory Element Materials Technology. |
| Electromagnetic Compatibility (EMC) | EN 60601-1-2: 2007 (Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests) | A sample Neurosign® V4 tested and found compliant by independent test laboratory Kiwa Blackwood Compliance Laboratories. (Note: EN 60601-1-2 (2007) is equivalent to FDA recognized standard IEC 60601-1-2). |
| Alarm Systems | IEC 60601-1-8 (Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems) | A sample Neurosign® V4 tested and found compliant by independent test laboratory Element Materials Technology. |
| Biocompatibility (for patient-contacting components) | ISO 10993-1:2009 (Biological Evaluation of Medical Devices - Part 1: Evaluation and testing within a risk management process)ISO 10993-5:2009 (Tests for in vitro cytotoxicity)ISO 10993-10:2010 (Tests for irritation and skin sensitization) | Samples of materials for Stimulator Pod, Pre-Amplifier Pod, and connecting leads (which may contact patient) tested and found compliant by independent test laboratories Harlan Laboratories Ltd and Envigo Research Ltd. (Note: The main device is not intended for patient contact). |
| Amplifier - EMG Acquisition & EMG Display Equivalence | Using a function generator, a range of input voltages at a set frequency were applied to both Neurosign® V4 and predicate device (NIM-Response 3.0) to replicate an EMG signal. | Measured EMG responses on both devices are within 5% of the target input and ±1% of each other, demonstrating equivalence and performance as well as or better than the predicate. |
| Stimulator Equivalence (Output Current) | 1kΩ Resistor connected across stimulator output terminals; oscilloscope used to measure potential difference across resistor. A range of input currents used to compare output waveforms and relative amplitude of Neurosign® V4 vs. NIM-Response 3.0. | Testing demonstrated almost identical stimulator performance between Neurosign® V4 and NIM-Response 3.0, demonstrating equivalence and performance as well as or better than the predicate. |
| Stimulator Equivalence (Pulse Width) | 1kΩ Resistor connected across stimulator output terminals; oscilloscope used to measure stimulator pulse width. A range of pulse width settings chosen as representative of typical use for Neurosign® V4 vs. NIM-Response 3.0. | Testing demonstrated almost identical stimulator pulse width performance between Neurosign® V4 and NIM-Response 3.0, demonstrating equivalence and performance as well as or better than the predicate. |
| Software Verification & Validation | Software documentation provided for a "major" level of concern. Standards and testing not explicitly detailed in this summary. | Software performs as intended and in accordance with specifications. Risks identified, assessed, and mitigated to an acceptable level as per ISO14971. |
| Overall Substantial Equivalence to Predicate Devices | Comparison of intended use, indications for use, technological characteristics, and principles of operation to predicate devices (NIM 3.0 and Neurosign® 400). | Intended use and indications for use of Neurosign® V4 are a subset of the primary predicate device. Technological characteristics and principles of operation are equivalent. Non-clinical test data demonstrates safety and effectiveness comparable to predicate devices. Concluded to be substantially equivalent. |
2. Sample Size Used for the Test Set and the Data Provenance
- Sample Size for Testing: The document refers to "A sample Neurosign® V4" being tested for electrical safety, EMC, and alarm systems. For biocompatibility, "Samples of these materials" were tested. For amplifier and stimulator equivalence, the testing was done by comparing the Neurosign® V4 directly against the predicate device (NIM-Response 3.0) using function generators and oscilloscopes, not patient data. Therefore, the "sample size" is effectively one device model, and samples of materials/components, tested under controlled laboratory conditions against various standard requirements.
- Data Provenance: This is a non-clinical, laboratory-based study. The data is generated from controlled tests of the device's hardware and software components against international standards and in direct comparison with a predicate device. There is no mention of human (patient) data or geographical origin of such data. This is retrospective in the sense that it evaluates the manufactured device against pre-defined performance and safety standards.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- N/A. This submission does not involve clinical data or deep learning models requiring "ground truth" established by human experts in the typical sense of AI/ML device evaluations. The ground truth for the non-clinical tests is based on the specifications of the standards (e.g., IEC 60601-1) and the measured performance of the predicate device. The testing was performed by "independent test laboratories" (e.g., Element Materials Technology, Kiwa Blackwood Compliance Laboratories, Harlan Laboratories Ltd, Envigo Research Ltd), implying their expertise in medical device testing and regulatory compliance.
4. Adjudication Method for the Test Set
- N/A. Since there's no qualitative assessment of clinical data by multiple readers, an adjudication method is not applicable. The tests are quantitative measurements against predefined specifications.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No. An MRMC study was not conducted as this device is not an AI/ML diagnostic aid intended to improve human reader performance on medical images. It is an intraoperative nerve monitor, and its safety and effectiveness were demonstrated through engineering (non-clinical) tests and substantial equivalence.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Yes, in spirit. The performance evaluation for the amplifier and stimulator equivalence was a "standalone" evaluation of the device's electrical characteristics. The software verification and validation are also a standalone assessment of the device's algorithmic performance. However, this is not an "algorithm only" study in the context of an AI/ML diagnostic device, but rather the performance of an integrated hardware and software system.
7. The Type of Ground Truth Used
- Engineering Specifications and Predicate Device Performance: The "ground truth" used for testing was primarily:
- Compliance with specific international standards (e.g., IEC 60601-1, EN 60601-1-2, IEC 60601-1-8, ISO 10993 series).
- The measured electrical output and signal processing characteristics of the legally marketed predicate device (NIM-Response 3.0). The acceptance criteria for the Neurosign® V4's performance were defined as being "within 5% of the target input and ±1% of each other" when compared to the predicate for EMG acquisition, and "almost identical" for stimulator performance.
8. The Sample Size for the Training Set
- N/A. This device does not employ a machine learning model that requires a training set in the typical sense. Its functionality is based on established electrophysiology principles and pre-programmed algorithms, not data-driven learning.
9. How the Ground Truth for the Training Set was Established
- N/A. As no training set was used, this question is not applicable.
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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). 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 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
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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.htm); 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,
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
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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)
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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
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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:
-
- Neurosign® V4 Intraoperative Nerve Monitor
-
- Neurosign® V4 Pre-Amplifier Pod 4 Channel
-
- Neurosign® V4 Stimulator Pod
-
- 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
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Non-Clinical Testing
| Test | Test Method Summary | Results |
|---|---|---|
| Electrical SafetyMechanical Safety | IEC 60601-1:2005 + CORR. 1:2006 +CORR. 2:2007 + A1:2012 -Medical electrical equipment - Part 1:General requirements forbasic safety and essential performance | A sample Neurosign® V4 has beentested and found to be compliant to therequirements of IEC 60601-1 byindependent test laboratory ElementMaterials Technology, , thusdemonstrating the Neurosign® V4 issubstantially equivalent to the legallymarketed predicate device. |
| ElectromagneticCompatibility | EN 60601-1-2: 2007 -Medical electrical equipment - Part 1-2:General requirements for basic safety andessential performance -Collateral standard: Electromagneticcompatibility -Requirements and tests | A sample Neurosign® V4 has beentested and found to be compliant to therequirements of EN 60601-1-2 byindependent test laboratory KiwaBlackwood Compliance Laboratories,thus demonstrating the Neurosign® V4is substantially equivalent to the legallymarketed predicate device.EN 60601-1-2 (2007) is equivalent to the FDArecognized standard IEC 60601-1-2. Ajustification of this assertion is provided inAppendix 06. |
| Alarm Systems | IEC 60601-1-8 -Medical electrical equipment - Part 1-8:General requirements for basic safety andessential performance - CollateralStandard: General requirements, tests andguidance for alarm systems in medicalelectrical equipment and medical electricalsystems | A sample Neurosign® V4 has beentested and found to be compliant to therequirements of IEC 60601-1-8 byindependent test laboratory ElementMaterials Technology, thusdemonstrating the Neurosign® V4 issubstantially equivalent to the legallymarketed predicate device. |
| Biocompatibility | ISO 10993-1:2009 - Biological Evaluationof Medical Devices - Part 1: Evaluation andtesting within a risk management process | The Neurosign® V4 Nerve Monitor is notintended to come into contact with thepatient, as patient contact is achievedvia use of single use electrodes andprobes. |
| ISO 10993-5:2009 - Biological evaluationof medical devices -- Part 5: Tests for invitro cytotoxicity | However, the Stimulator Pod, Pre-Amplifier Pod and connecting leads maycome into contact with the patient. | |
| ISO 10993-10:2010 - Biological evaluationof medical devices - Part 10: Tests forirritation and skin sensitization | Samples of these materials have beentested and found to be compliant to therequirements of ISO 10993-1, ISO10993-5 and ISO 10993-10 byindependent test laboratories HarlanLaboratories Ltd and Envigo ResearchLtd, thus demonstrating the Neurosign®V4 is substantially equivalent to thelegally marketed predicate device. | |
| Amplifier - EMG Acquisition& EMG DisplayEquivalence Testing | Using a function generator, a range ofinput voltages at a set frequency wereapplied to both the Neurosign® V4 andNIM-Response 3.0 to replicate an EMGsignal. | Testing demonstrated that themeasured EMG responses on theNeurosign® V4 and the NIM-Response3.0 are within 5% of the target input and±1% of each other, thus demonstratingthe Neurosign® V4 is substantiallyequivalent and performs as well as thanthe legally marketed predicate device. |
| A 1kΩ Resistor was connected across thestimulator output terminals and theoscilloscope was used to measure thepotential difference across the resistor. Arange of input currents were used tocompare the output waveforms and showthe relative amplitude. | Testing demonstrated that theNeurosign® V4 and the NIM-Response3.0 have almost identical stimulatorperformance, thus demonstrating theNeurosign® V4 is substantiallyequivalent and performs as well as thanthe legally marketed predicate device. | |
| Stimulator EquivalenceTesting | 1kΩ Resistor was connected across thestimulator output terminals and theoscilloscope was used to measure thestimulator pulse width. A range of pulsewidth settings were chosen as they arerepresentative of typical use. | Testing demonstrated that theNeurosign® V4 and the NIM-Response3.0 have almost identical stimulatorpulse width performance, thusdemonstrating the Neurosign® V4 issubstantially equivalent and performs aswell as than the legally marketedpredicate device. |
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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.
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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).
§ 874.1820 Surgical nerve stimulator/locator.
(a)
Identification. A surgical nerve stimulator/locator is a device that is intended to provide electrical stimulation to the body to locate and identify nerves and to test their excitability.(b)
Classification. Class II.