(90 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 (IONM) is a multi-channel nerve monitor designed for use in Ear, Nose and Throat (ENT) surgery and neurosurgery. The subject device differs from its primary predicate due to the introduction of improved Pre-amplifier and Stimulator pod cables, as well the addition of an 8-channel Pre-amplifier variant.
Using needle or surface electrodes connected to the Pre-amplifier, 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 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.
The provided document is a 510(k) Premarket Notification from the FDA for the Neurosign® V4 Intraoperative Nerve Monitor. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, not typically a study that establishes performance against discrete clinical acceptance criteria in the same way a PMA (Premarket Approval) submission would.
Therefore, the document does not contain a study with acceptance criteria and reported device performance in the typical sense of a clinical trial for a novel device. Instead, the "acceptance criteria" are compliance with various recognized standards and the "study" is non-clinical bench testing to demonstrate that modifications to an existing predicate device do not alter its safety or effectiveness.
Here's an analysis based on the information available:
1. Table of Acceptance Criteria and Reported Device Performance
| Criteria Category / Test | Acceptance Criteria (Method) | Reported Device Performance / Results |
|---|---|---|
| Electrical Safety / Mechanical Safety | ANSI/AAMI ES60601-1:2005/(R)2012 and A1:2012 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance | A sample Neurosign® V4 (4-Channel and 8-Channel Variants) was tested and found compliant with IEC 60601-1 by independent test laboratory Element Materials Technology. |
| Electromagnetic Compatibility (EMC) | IEC 60601-1-2: 2014 - 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 (4-Channel) was tested and found compliant with EN 60601-1-2 by independent test laboratory Eurofins Hursley. Non-clinical bench testing by Magstim confirmed no discernable difference in EMC performance of new cable design vs. old. |
| 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 was tested and found compliant with IEC 60601-1-8 by independent test laboratory Element Materials Technology. |
| Biocompatibility | 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 | The Neurosign®V4 Nerve Monitor itself does not contact the patient. The Stimulator Pod, Pre-amplifier, and connecting leads, which may contact the patient, had samples of their materials tested and found compliant with ISO 10993-1, ISO 10993-5, and ISO 10993-10 by an independent test laboratory. |
| Human Factors Testing / Usability Engineering | AAMI/ANSI HE75 - Human Factors Engineering - Design of Medical Devices; IEC 62366-1 - Medical Devices - Part 1: Application of Usability Engineering To Medical Devices | Usability testing was performed to analyze the user experience of the 8-Channel Neurosign® V4. The Human Factors Engineering report verifies the Neurosign V4, using the 8-channel pre-amplifier, to be safe and effective for the intended users, uses, and use environments. |
| Software Verification and Validation (V&V) | Software documentation for a "major" level of concern. Completion of software V&V testing according to specifications and risk mitigation in accordance with ISO14971. | Software verification and validation testing demonstrated that the software performs as intended and in accordance with specifications. Risks associated with the Neurosign® V4 were identified, assessed, and mitigated to an acceptable level per ISO14971. |
| Performance (Pre-amplifier & Stimulator Cables) | Demonstrated no discernable difference in isolation parameters and EMC performance compared to the old cable design. | Non-clinical bench testing performed by Magstim confirmed no discernable difference in the isolation parameters and EMC performance of the new cable design in comparison to the old. This testing specifically addressed the design changes to the Pre-amplifier and Stimulator Pod cables. |
| Performance (8-Channel Pre-amplifier vs. 4-Channel Predicate) | Substantial equivalence in function to the existing 4-channel pre-amplifier and secondary predicate device (Neurosign® 800) that already offers 8 channels. | The 8-channel Pre-amplifier is stated to be substantially equivalent, with the only difference being the addition of 4 extra electrode channels. Its functionality is supported by the existence of the secondary predicate (K053141) which also monitors up to eight separate neural pathways. |
2. Sample Sizes used for the Test Set and Data Provenance
This submission is based on non-clinical bench testing and does not involve human subjects as a "test set" in the sense of a clinical study.
- Electrical Safety, EMC, Alarm Systems, Biocompatibility: "A sample Neurosign® V4 (4-Channel and 8-Channel Variants)" or "A sample Neurosign® V4 (4-Channel)" or "Samples of these materials" were tested. The exact number of units/samples is not specified beyond "a sample" or "samples."
- Human Factors Testing: Not specified, but "Usability testing was performed to analyze the user experience of the 8-Channel Neurosign® V4." This typically involves a small group of representative users, but the size is not disclosed.
- Data Provenance: All testing appears to be retrospective relative to the design changes, commissioned by Magstim Company Ltd. and conducted by either Magstim or independent test laboratories (Element Materials Technology, Eurofins Hursley). The country of origin for the tests is not explicitly stated for all labs, but Magstim is a UK company.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of submission does not involve "ground truth" established by clinical experts in the context of diagnostic accuracy or treatment effectiveness. The "ground truth" here is compliance with recognized engineering and safety standards, as verified by independent test laboratories and Magstim's internal testing. The qualifications would be expertise in those specific standards and testing protocols, which are inherent to the testing bodies but not explicitly detailed for individual experts in this document.
4. Adjudication Method for the Test Set
Not applicable. This is not a clinical study requiring adjudication of clinical outcomes. The "adjudication" is essentially the determination of compliance with the specified standards by the testing bodies.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. This document does not describe a MRMC comparative effectiveness study. The device is an intraoperative nerve monitor, and the study focuses on its safety and performance based on engineering and safety standards, and its substantial equivalence to predicate devices, not on human reader performance with or without AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Yes, in a way. The testing described (electrical safety, EMC, alarm systems, biocompatibility, and software V&V) assesses the device's technical performance and safety characteristics in isolation, or as an integrated system, without necessarily involving a human-in-the-loop performance assessment of its diagnostic or treatment guidance capability in a clinical setting beyond usability testing for user experience. The "performance" mentioned for cables is also standalone bench testing.
7. Type of Ground Truth Used
The ground truth used in this context is:
- Compliance with recognized international and national standards (e.g., IEC 60601 series, ISO 10993 series for biocompatibility, AAMI/ANSI HE75, IEC 62366-1 for human factors).
- Performance specifications (e.g., isolation parameters, EMC performance, software functions) as tested against predefined engineering requirements.
- Usability metrics defined in the human factors engineering report.
8. Sample Size for the Training Set
Not applicable. This device is not an AI/ML algorithm that requires a "training set" in the computational sense. It is a hardware medical device with embedded software. The software underwent verification and validation, but this refers to traditional software testing, not AI model training.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no AI/ML training set in this context.
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April 1, 2021
Magstim Company Ltd. Tom Campbell Chief Quality & Regulatory Affairs Officer Spring Gardens Whitland, Carmarthenshire SA34 0HR United Kingdom
Re: K203684
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
Dear Tom Campbell:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated March 17, 2021. Specifically, FDA is updating this SE Letter due to typographical errors in the Indications for Use Statement as an administrative correction.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Jay Gupta, OHT5: Office of Neurological and Physical Medicine Devices, Jay Gupta, 301-796-2795, jay.gupta@fda.hhs.gov.
Sincerely,
Jay R. Gupta -S
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
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Image /page/1/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services USA logo, which features a stylized caduceus. To the right is the FDA U.S. Food & Drug Administration logo, with the FDA acronym in a blue square and the full name in blue text.
March 17, 2021
Magstim Company Ltd. Tom Campbell Chief Quality & Regulatory Affairs Officer Spring Gardens Whitland, Carmarthenshire SA34 0HR United Kingdom
Re: K203684
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: December 17, 2020 Received: December 17, 2020
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/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 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,
Jay R. Gupta -S
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
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Indications for Use
510(k) Number (if known) K203684
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.
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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K203684 Traditional 510(k) SUMMARY Magstim's Neurosign® V4 Intraoperative Nerve Monitor
Prepared according to the requirements outlined in 21 CFR 807.92
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, Chief Quality & Regulatory Affairs Officer requlatory@magstim.com
Date Prepared: March 17, 2021
Trade Name of Device
Neurosign® V4 Intraoperative Nerve Monitor
Common or Usual Name
Neurosurgical Nerve Locator
Classification
Neurosurgical Nerve Locator
21 CFR 874.1820, Class II, product code PDQ
Predicate Devices
K181559 Neurosign® V4 Intraoperative Nerve Monitor. The Magstim Company Limited (Primary Predicate Device), 21 CFR 874.1820, PDQ, ETN
K053141 Neurosign® Nerve Monitor, Model Neurosign® 400 and Neurosign® 800, The Magstim Company Limited (Secondary Predicate), 21 CFR 874.1820, ETN
Device Description
The Neurosign® V4 Intraoperative Nerve Monitor (IONM) is a multi-channel nerve monitor designed for use in Ear, Nose and Throat (ENT) surgery and neurosurgery. The subject device differs from its primary predicate due to the introduction of improved Pre-amplifier and Stimulator pod cables, as well the addition of an 8-channel Pre-amplifier variant.
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Using needle or surface electrodes 1 connected to the Pre-amplifier, 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 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.
Technological Characteristics
The Neurosign® V4 is comprised of following components:
-
- Neurosign® V4 Intraoperative Nerve Monitor
-
- Neurosign® V4 Pre-amplifier:
- a. Neurosign® V4 Pre-amplifier 4-Channel
- b. Neurosign® V4 Pre-amplifier 8-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] connected to the Neurosian® V4 Pre-amplifier. The pre-amplifier is available in a 4-channel or 8-channel variant, allowing the user to monitor up to eight separate neural pathways depending on the pre-amplifier used. The Neurosign® V4 Pre-amplifier 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.
Software documentation for a "major" level of concern has been provided.
1 Single use electrodes and probes not subject to this submission
2 Single use electrodes and probes not subject to this submission
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Non-Clinical Testing Table 1: Summary of Non-Clinical Testing
| Test | Method | Results/ Comment |
|---|---|---|
| Electrical SafetyMechanical Safety | ANSI/AAMI ES60601-1:2005/(R)2012 andA1:2012-Medical electrical equipment - Part 1:General requirements forbasic safety and essential performance;FDA Recognition Number: 19-4 | A sample Neurosign® V4 (4-Channeland 8-Channel Variants) has beentested and found to be compliant to therequirements of IEC 60601-1 byindependent test laboratory ElementMaterials Technology, to demonstratesafety and effectiveness of the systemfollowing incorporation of new/differentcharacteristics as compared to thepredicate device.Following the design changes to the Preamplifier and Stimulator Pod cables,non-clinical bench testing was performedby Magstim confirming that there is nodiscernable difference in the isolationparameters of the new cable design incomparison to the old. |
| ElectromagneticCompatibility | IEC 60601-1-2: 2014 -Medical electrical equipment - Part 1-2:General requirements for basic safety andessential performance -Collateral standard: Electromagneticcompatibility -Requirements and tests;FDA recognition number: 19-8 | A sample Neurosign® V4 (4-Channel)has been tested and found to becompliant to the requirements of EN60601-1-2 by independent testlaboratory Eurofins Hursley, todemonstrate safety and effectiveness othe system following incorporation ofnew/different characteristics ascompared to the predicate device.Following the design change to the Pre-amplifier and Stimulator Pod cables,non-clinical bench testing was performedby Magstim concluding there is nodiscernable difference in the EMCperformance of the new cable design incomparison to the old. |
| 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; FDA Recognition Number: 5-76 | 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 nointended to come into contact with thepatient, as patient contact is achieved |
| Human Factors Testing | ISO 10993-5:2009 - Biological evaluationof medical devices -- Part 5: Tests for invitro cytotoxicity; FDA RecognitionNumber: 2-245 | via use of single use electrodes andprobes.However, the Stimulator Pod, Pre-amplifier and connecting leads maycome into contact with the patient. |
| ISO 10993-10:2010 - Biological evaluationof medical devices - Part 10: Tests forirritation and skin sensitization; FDARecognition Number: 2-174 | Samples of these materials have beentested and found to be compliant to therequirements of ISO 10993-1, ISO10993-5 and ISO 10993-10 by anindependent test laboratory, thusdemonstrating the Neurosign® V4 issubstantially equivalent to the legallymarketed predicate device. | |
| AAMI/ANSI HE75 - Human FactorsEngineering - Design of Medical Devices;FDA Recognition Number: 5-57 | Usability testing was performed toanalyze the user experience of the 8-Channel Neurosign® V4.The Human Factors Engineering reportverifies the Neurosign V4, using the 8-channel pre-amplifier, to be safe andeffective for the intended users, uses,and use environments thusdemonstrating the Neurosign® V4 issubstantially equivalent to the legallymarketed predicate device. | |
| IEC 62366-1 - Medical Devices - Part 1:Application of Usability Engineering ToMedical Devices; FDA RecognitionNumber: 5-114 |
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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 Discussion
The Neurosign® V4 (subject of this submission) is substantially equivalent to the primary predicate device, the Neurosign® V4 Intraoperative Nerve Monitor (K181559) and the secondary predicate device, the Neurosign® Nerve Monitor Model Neurosign® 400 and Model Neurosign® 800® (K053141).
The intended use and indications for use are identical between the Neurosign® V4 (subject of this submission) and the primary predicate device, the Neurosign® V4 Intraoperative Nerve Monitor (K181559).
All devices have the same four principal components:
- (1) Intraoperative Nerve Monitor,
- (2) Pre-amplifier,
- (3) Stimulator and
- (4) Mute Sensor.
The notable difference between the subject device Neurosign® V4 and that which was cleared earlier in K181559 includes the redesign of the Pre-amplifier and Stimulator pod
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cables to improve reliability and malleability during use, as well the addition of an 8-channel Pre-amplifier variant, enabling the user to monitor up to eight separate neural pathways at risk during surgery. The Neurosign® V4 8-Channel Pre-amplifier is substantially equivalent to the Neurosign® V4 4-Channel Pre-amplifier previously cleared under K181559, with the addition of 4 additional electrode channels.
Furthermore, the addition of an 8-channel Pre-amplifier is supported by the clearance of the secondary predicate device (K053141), as the secondary predicate includes the option to monitor up to eight separate neural pathways at risk during surgery.
The Principles of Operation are identical to the primary predicate device, the Neurosign® V4 Intraoperative Nerve Monitor (K181559). Both the subject device and the predicate device systems are all systems that are intended for use in collecting, processing and representing EMG signals from nerves at of choice during surgery.
Both the subject and predicate devices use a stimulator for the mapping and locating of nerves within tissue and testing 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.
A summary of the similarities and minor differences between the Neurosign® V4, the previous Neurosign® V4 (primary predicate device) and the Neurosign® Nerve Monitor Model Neurosign® 400 and Model Neurosign® 800 (Secondary Predicate Device) are described in Table 2.
Conclusions
In summary, the subject and predicate devices are substantially equivalent based on their identical intended use and similar technological characteristics, which have been tested according to the applicable non-clinical performance testing.
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 Neurosign® V4 Intraoperative Nerve Monitor (K181559), and the secondary predicate device, the Neurosign® Nerve Monitor, Model Neurosign® 400.
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Table 2: Substantial Equivalence Summary
| Criteria ofComparison | K203684Neurosign® V4 IntraoperativeNerve Monitor(Subject of this submission) | K181559Neurosign® V4Intraoperative NerveMonitor(Primary Predicate Device) | K053141Neurosign® Nerve Monitor,Model Neurosign® 400 andModel Neurosign® 800®(Secondary PredicateDevice) |
|---|---|---|---|
| Manufacturer | Magstim Company Limited | Magstim Company Limited | Magstim Company Limited |
| Device Name | Neurosign® V4 IntraoperativeNerve Monitor | Neurosign® V4Intraoperative NerveMonitor | Neurosign® Nerve Monitor,Model Neurosign® 400 |
| Product code(s)& regulation | PDQ21 CFR 874.1820 | PDQ, ETN21 CFR 874.1820 | ETN21 CFR 874.1820 |
| Intended Use/Indications forUse | The Neurosign® V4Intraoperative Nerve Monitoris intended for locating andidentifying cranial andperipheral motor and mixedmotor-sensory nerves duringsurgery, including spinalnerve roots.Indications for Neurosign®V4 EMG MonitoringProcedures include:Intracranial, Extracranial,Intratemporal, Extratemporal,Neck Dissections, ThoracicSurgeries, and Upper andLower Extremities.Indications for spinalprocedures which may useNeurosign® V4 EMGmonitoring include:Degenerative Treatments,Pedicle Screw Procedures,Fusion Cages, Rhizotomy,Orthopedic Surgery andOpen and PercutaneousLumbar Procedures. | The Neurosign® V4Intraoperative NerveMonitor is intended forlocating and identifyingcranial and peripheral motorand mixed motor-sensorynerves during surgery,including spinal nerve roots.Indications for Neurosign®V4 EMG MonitoringProcedures include:Intracranial, Extracranial,Intratemporal,Extratemporal, NeckDissections, ThoracicSurgeries, and Upper andLower Extremities.Indications for spinalprocedures which may useNeurosign® V4 EMGmonitoring include:Degenerative TreatmentsPedicle Screw Procedures,Fusion Cages, Rhizotomy,Orthopedic Surgery andOpen and PercutaneousLumbar Procedures. | To locate and identifycranial motor nerves duringENT and intra-cranialprocedures. |
| Intraoperative Nerve Monitor | |||
| Type of monitor | EMG | EMG | EMG |
| Systemhardware | Digital | Digital | Digital |
| Display | 15" color touchscreen | 15" color touchscreen | 125mm x 95mmelectroluminescent display |
| Criteria ofComparison | K203684Neurosign® V4 IntraoperativeNerve Monitor(Subject of this submission) | K181559Neurosign® V4Intraoperative NerveMonitor(Primary Predicate Device) | K053141Neurosign® Nerve Monitor,Model Neurosign® 400 andModel Neurosign® 800®(Secondary PredicateDevice) |
| Stimulatoradjust | By control knob | By control knob | By control knob |
| Volume adjust | By control knob; individualchannels by touchscreen | By control knob; individualchannels by touchscreen | By control knob |
| Needleplacementimpedancechecking | Yes | Yes | No |
| Amplifier | |||
| Number ofchannels | 4 (4-Channel Pre-amplifier)8 (8-Channel Pre-amplifier) | 4 | 4 (Neurosign® 400)8 (Neurosign® 800) |
| Color codedelectrodesockets | Yes | Yes | Yes |
| Bandwidth | 10Hz - 1kHz | 10Hz - 1kHz | 10Hz - 5kHz |
| Common moderejection ratio | > 90dB @ 50/60Hz | > 90dB @ 50/60Hz | > 95dB @ 50/60Hz |
| Stimulator | |||
| Stimulatorchannels | Channel 1: 2 probes | Channel 1: 2 probes | Channel 1: 2 probes |
| Operationalmode | Constant Current orConstant Voltage | Constant Current orConstant Voltage | Constant Current orConstant Voltage |
| Current ranges | 10μΑ – 10mA | 10μA - 10mA | 50µA - 10mA |
| Voltage ranges | 10mV - 10V | 10mV - 10V | 50mV - 10V |
| Accuracy | Current Stimulating Mode± 10% (1mA – 10mA), into1kΩ load± 25% (10μA - 990 μA), into1kΩ loadVoltage Stimulating Mode± 10% (1V - 10V), into 1kΩload± 25% (10mV - 990 mV), into1kΩ load | Current Stimulating Mode± 10% (1mA – 10mA), into1kΩ load± 25% (10μA - 990 μA), into1kΩ loadVoltage Stimulating Mode± 10% (1V - 10V), into 1kΩload± 25% (10mV - 990 mV),into 1kΩ load | Current Stimulating Mode± 10% (50µA - 10mA), into1kΩ loadVoltage Stimulating Mode± 10% (50mV – 10V), into1kΩ load |
| Mute Sensor | |||
| Available | Yes | Yes | Yes |
| Operational Environment | |||
| Criteria ofComparison | K203684Neurosign® V4 IntraoperativeNerve Monitor(Subject of this submission) | K181559Neurosign® V4Intraoperative NerveMonitor(Primary Predicate Device) | K053141Neurosign® Nerve Monitor,Model Neurosign® 400 andModel Neurosign® 800®(Secondary PredicateDevice) |
| Operatingtemperature | 5°C to 40°C | 5°C to 40°C | 5°C to 30°C |
| Relativehumidity | 10% to 80% (non-condensing) | 10% to 80% (non-condensing) | 30% to 70% (non-condensing) |
| Atmosphericpressure | 70kPa to 106kPa | 70kPa to 106kPa | 50kPa to 106kPa |
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§ 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.