(181 days)
The NVM5® System is a medical device that is intended for intraoperative neurophysiologic monitoring during spinal surgery. The device provides information directly to the surgeon, to help assess a patient's neurophysiologic status. NVM5 provides this information by electrically stimulating nerves via electrodes located on surgical accessories and monitoring electromyography (EMG), transcranial motor evoked potential (TceMEP) or somatosensory evoked potential (SSEP) responses of nerves. The System also integrates Bendini™ software used to locate spinal implant instrumentation for the placement of spinal rods.
- XLIF® (Detection) -- The XLIF (Detection) function allows the surgeon to locate and evaluate spinal nerves, and is used as a nerve avoidance tool.
- Basic & Dynamic Screw Test The Screw Test functions allow the surgeon to locate and evaluate spinal nerves by providing proximity information before. during or after bone preparation and placement of bone screws.
- Free Run EMG -- The Free Run EMG function identifies spontaneous EMG activity of spinal nerves by continually displayinq a live stream waveform of any mechanically induced myotome contractions.
- Twitch Test (Train of Four) ~ The Twitch Test Function allows the surgeon to assess moderate degrees of neuromuscular block in effect by evaluating muscle contraction following a train of four stimulation pulses.
- TcMEP - Transcranial stimulation techniques for motor evoked potentials are used to assess for acute dysfunction in axonal conduction of the corticospinal tract. The TcMEP function provides an adjunctive method to allow the surgeon to monitor spinal cord and motor pathway integrity during procedures with a risk of surgically induced motor injury.
- SSEP - The SSEP function allows the surgeon to assess sensory spinal cord function in surgical procedures during which the spinal cord is at risk.
- Remote Reader The Remote Reader function provides real time remote access to the NVM5 System for a monitoring physician outside of the operating room.
- Guidance The Guidance function is intended as an aid for use in either open or percutaneous pedicle cannulation procedures in the lumbar and sacral spine (L 1-S1) of adult patients, and when used in conjunction with radiographic imaging and EMG, allows the surgeon to assess the anqulation of system accessories relative to patient spinal anatomy for the creation of a cannulation trajectory for bone screw placement.
- Bendini - The Bendini Spinal Rod Bending function is used to locate spinal implant system instrumentation (screws, hooks) to determine their relative location to one another to generate bend instructions to shape a spinal rod. A surgeon is able to use those instructions and bend a rod using the Bendini Bender, a mechanical rod bender.
NVM5 System is a medical device that is intended for intraoperative neurophysiologic monitoring during spinal surgery. The device provides information directly to the surgeon, to help assess a patient's neurophysiologic status. NVM5 provides this information by electrically stimulating nerves via electrodes located on surgical accessories and monitoring electromyography (EMG), transcranial motor evoked potential (TcMEP) or somatosensory evoked potential (SSEP) responses of nerves. Moreover, a Twitch Test ("Train of Four") function is utilized to test the ability of the nerve to respond, or contract, following four stimulation pulses to determine the presence of neuromuscular block. Additionally, the NVM5 System includes an integrated stereotactic guidance system (NVM5 Guidance) to support the delivery of pedicle screws during EMG monitoring. The System also integrates Bendini™ software used to locate spinal implant instrumentation for the placement of spinal rods. Lastly, the system also offers an optional screen sharing application (Remote Monitoring) to allow a secondary physician to remotely view the events represented on the NVM5 user interface. In summary, the NVM5 System includes the following six (6) software functionalities / modalities:
- Electromyography (EMG)
- Transcranial Motor Evoked Potential (TceMEP), or simply MEP
- Somatosensory Evoked Potential (SSEP)
- Guidance
- Bendini
- Remote Monitoring
The NVM5 System hardware consists of a Patient Module (PM) and computer, as well as accompanying accessory components which consist of an assortment of disposable conductive probes, electrodes, and electrode leads.
The NuVasive® NVM5® System is intended for intraoperative neurophysiologic monitoring during spinal surgery. The system provides information to the surgeon to assess a patient's neurophysiologic status by electrically stimulating nerves and monitoring electromyography (EMG), transcranial motor evoked potential (TceMEP), or somatosensory evoked potential (SSEP) responses. It also includes Bendini™ software for locating spinal implant instrumentation for rod placement.
The FDA 510(k) submission (K123307) dated March 15, 2013, concludes that the NuVasive® NVM5® System is substantially equivalent to legally marketed predicate devices based on indications for use, technological characteristics, and performance testing.
Here's the breakdown of the acceptance criteria and the study that demonstrates the device meets these criteria:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria provided in the document are primarily based on demonstrating substantial equivalence to predicate devices across various technical specifications and functionalities. The reported device performance is presented as a comparison between the subject NVM5 System and its predicate devices, where "YES" indicates substantial equivalence.
Note: The document does not provide specific quantitative acceptance criteria or numerical performance metrics for each function (e.g., a specific accuracy percentage for nerve detection as an absolute requirement set beforehand). Instead, it relies on demonstrating that the performance of the NVM5 System is comparable to or better than previously cleared predicate devices through verification and validation testing, and compliance with recognized standards.
| Specification/Property | Acceptance Criteria (Predicate Performance or Standard Compliance) | Reported Device Performance (Subject NVM5 System) | Meets Criteria? (Substantial Equivalence Claimed) |
|---|---|---|---|
| Intended Use / Indications | For intraoperative neurophysiologic monitoring during spinal surgery, providing information to assess neurophysiologic status by stimulating nerves and monitoring EMG, TceMEP, or SSEP responses. Predicate NVM5 also includes: XLIF (Detection), Basic & Dynamic Screw Test, Free Run EMG, Twitch Test (Train of Four), TcMEP, SSEP, Remote Reader, Guidance (lumbar spine). Predicate Bendini (K122742) for locating spinal implant instrumentation and generating rod bend instructions. | The NVM5 System's intended use matches the predicate NVM5. The Guidance indications were expanded to include the S1 level of the spine. The Bendini function is integrated, with indications identical to those cleared in predicate K122742. | YES |
| Software Functionalities | XLIF Detection, Basic & Dynamic Screw Test, Free Run EMG, Twitch Test (Train of Four), TceMEP, SSEP, Remote Monitoring, Guidance (from predicate K112718). Bendini function (from predicate K122742). | All predicate functionalities are present. Additionally, Bendini function is incorporated into the NVM5 System. | Yes |
| Algorithms | Identical algorithms to predicate (K112718) for XLIF Detection, Basic & Dynamic Screw Test, Free Run EMG, Twitch Test (Train of Four), TceMEP, SSEP, Guidance. Bendini algorithm (from predicate K122742). Other SSEP auto algorithms. | Identical algorithms as predicate, with additional algorithms for SSEP Auto and Bendini functions. Bendini algorithm is substantially equivalent to predicate 510(k) K122742. | Yes |
| Total Available Channels | 32 (from predicate K112718) | 32 | Yes |
| Headbox/Patient Module | IEC 60601-1 Compliant (from predicate K112718) | Yes (Compliant) | Yes |
| Full Scale View Range | ±0.5 μV to ±8mV (from predicate K112718) | ±0.5 μV to ±8mV | Yes |
| Frequency Response | 3 Hz to 4.8 kHz (from predicate K112718) | 3 Hz to 4.8 kHz | Yes |
| User Interface | Control Unit: Touch screen and [optional] keyboard/mouse (from predicate K112718) | NuVasive-supplied computer with optional touch screen and/or keyboard/mouse. | Yes |
| Remote Monitoring | Yes (from predicate K112718) | Yes | Yes |
| Train of Four Testing | Yes (from predicate K112718) | Yes | Yes |
| Guidance - Angular Tolerance | Predicate systems (Medtronic StealthStation, BrainLAB VectorVision Trauma) had 6 DOF (positional and rotational in x, y, z). The predicate NVM5 Guidance (K112718) only displayed instrument orientation (rotational in x, y planes) with respect to gravity. | Angular tolerance of ±2°. The subject device's Guidance is designed for 2 DOF (rx, ry) data. This is deemed substantially equivalent because it is used with fluoroscopic imaging and not indicated for use by the predicate StealthStation. The amount of data collected is sufficient to provide angular outputs for comparison with planned trajectory when radiographic imaging confirms starting point and trajectory. | Yes |
| Guidance - Clinical Use | Requires input from CT, MRI, or radiographic images. Assists surgeon in cannulating pedicle based on user predefined trajectory. Integrate with EMG stimulation. (Matched by predicate NVM5 Guidance K112718). | Matches predicate. | Yes |
| Bendini - System Design | Optical (IR) tracking technology system, IR tracking instruments, control unit, mobile stand. User interface: touch screen, GUI, audio. (from predicate K122742). | Optical (IR) tracking technology system, IR tracking instruments, computer. User Interface: Touch screen, graphical user interface and audio. Conformance with Recognized Standards: IEC 60601-1, IEC 60601-1-2. Power Supply - Line Input. | Yes |
| Bendini - Instrumentation | IR Stylus (with integrated passive spheres), Rod Bender (from predicate K122742). | IR Stylus (with integrated passive spheres), Rod Bender. | Yes |
| Safety and Standards | Compliance with IEC 60601-1, IEC 60601-1-2, IEC 60601-2-40. Tracking instruments composed of known and accepted (biocompatible) materials. Sterilization validated to assure SAL of 10-6. | The NVM5 System was subjected to verification and validation testing, as well as electrical safety/compatibility testing, including compliance with IEC 60601-1, IEC 60601-2-40, and IEC 60601-1-2. Tracking instruments used known, biocompatible materials. Sterilization for accessories as selected and validated to SAL of 10-6. | Yes (All listed standards met) |
| Guidance Performance | Clinical literature data from predicate devices (BrainLAB VectorVision Trauma and Medtronic StealthStation for lumbosacral levels) demonstrating accuracy for percutaneous lumbar pedicle screw placement and thoracolumbar pedicle screw placement using 3D image guidance. | Guidance performance data comparison from literature data from clinical literature demonstrates substantial equivalence. (References two specific studies: "Accuracy of percutaneous lumbar pedicle screw placement using the oblique or 'owl's-eye' view and novel guidance technology" (J Neurosurg Spine, 2010) and "Placement of thoracolumbar pedicle screws using three-dimensional image guidance: experience in a large patient cohort" (J Neurosurg Spine, 2009)). | Yes |
| Bendini Performance | Predetermined specifications outlined in the SRS for GUI functionality, error handling, system accuracy during data acquisition, verification of instrument performance in combination with the software, and verification of software algorithms. | Nonclinical testing included evaluation of software performance per predetermined specifications, GUI functionality, error handling, system accuracy during data acquisition, verification of instrument performance with software, and verification of software algorithms. | Yes |
2. Sample Size Used for the Test Set and Data Provenance
The document primarily refers to "nonclinical testing" and "verification and validation testing" for the NVM5 System. For the Guidance function, it explicitly mentions:
- Data Provenance: Clinical literature data. The references provided are from "J Neurosurg Spine, 2010" and "J Neurosurg Spine, 2009," suggesting the data would be retrospective and likely from various countries (though not specified, spine surgery research is often international).
- Sample Size: The document does not specify the sample size for the test set from these literature studies, nor does it provide a direct test set for the NVM5 System's Guidance functionality beyond comparing its performance to that presented in existing literature.
For the Bendini function, "nonclinical testing included evaluation of software performance per predetermined specifications outlined in the SRS." This indicates internal testing, but no sample size or data provenance (e.g., patient data) is provided.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
For the Guidance function, since the evaluation points to existing clinical literature, the "ground truth" would have presumably been established within those studies (e.g., confirmation of screw placement accuracy by post-operative imaging or surgical observation). The document does not specify the number or qualifications of experts involved in establishing this ground truth within the cited literature or for the NuVasive's internal comparison.
For other functions and general verification and validation, the document does not specify the number or qualifications of experts. Such testing typically involves engineers, quality assurance personnel, and potentially clinical consultants, but no details are provided here.
4. Adjudication Method for the Test Set
The document does not specify an adjudication method for any test set. Given the reliance on nonclinical testing and comparison to literature for the Guidance function, a formal adjudication process akin to those for AI clinical studies is not detailed.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The document does not indicate that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done. The assessment focuses on the device's technical specifications and substantial equivalence to predicates, not on improvements in human reader performance with or without AI assistance. The NVM5 System itself is a surgical monitoring and guidance device, not primarily an AI-driven diagnostic imaging interpretation tool that would typically undergo MRMC studies.
6. Standalone (Algorithm Only) Performance Study
The document refers to "nonclinical testing" and "verification and validation testing" which implies standalone testing of the algorithm (software) components. For example:
- "NVM5 System Verification and Validation Testing"
- "NVM5 System software Regression Testing"
- "Nonclinical testing performed for the Bendini function included evaluation of software performance per predetermined specifications outlined in the SRS. GUI functionality, error handling, system accuracy during data acquisition, verification of instrument performance in combination with the software, and verification of software algorithms."
These statements suggest that the algorithm's performance was tested independently of direct human-in-the-loop clinical use, but the nature and scope of these standalone tests are not detailed beyond meeting predetermined specifications.
7. Type of Ground Truth Used
- For the Guidance function, the "ground truth" implicitly relies on the confirmed accuracy of pedicle screw placement as reported in the referenced clinical literature. This would typically be based on post-operative imaging outcomes data (e.g., CT scans reviewing screw position).
- For other nonclinical and software verification tests (e.g., Bendini, General NVM5 functions), the ground truth would be based on predetermined specifications and expected system outputs. For example, an electrical stimulation test would have a known target response, or software algorithm verification would test against a predefined correct output for a given input.
8. Sample Size for the Training Set
The document does not specify any training set sample size. The NVM5 System is a medical device for intraoperative monitoring and surgical guidance. While it employs software and algorithms, the filing describes it in terms of "substantial equivalence" to existing technologies rather than as a machine learning/AI device requiring distinct training and test sets in the modern sense. The algorithms are likely rule-based or signal processing-based, rather than learned from large datasets.
9. How the Ground Truth for the Training Set Was Established
As no training set is described, there is no information on how ground truth was established for a training set. The nature of the device (monitoring and guidance, rather than pattern recognition from large image sets) suggests that the "ground truth" for its development would be based on established neurophysiological principles, biomechanical models, and engineering specifications, rather than labeled training data.
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Image /page/0/Picture/1 description: The image shows the logo for Nuvasive. The logo consists of a stylized leaf-like shape on the left, followed by the word "NUVASIVE" in bold, sans-serif font. Below the company name is the tagline "Speed of Innovation" in a smaller font size.
K 123307/S01 – NuVasive® NVM5® System March 15, 2013
510(k) Summary
In accordance with Title 21 of the Code of Federal Regulations, Part 807, and in particular 21 CFR §807.92, the following summary of information is provided:
Submitted by: A.
Sheila Bruschi Manager, Regulatory Affairs NuVasive, Incorporated 7475 Lusk Blvd. San Diego, California 92121 Telephone: (858) 909-1800
Date Prepared: March 13, 2013
Device Name B.
| Trade or Proprietary Name: | NuVasive® NVM5® System |
|---|---|
| Common or Usual Name: | Neurological surgical monitor;Stereotaxic Instrument |
| Classification Name: | Surgical Nerve Stimulator/Locator;Evoked response electrical stimulator;Neurological stereotaxic instrument;Electromyography (EMG) monitor/stimulator |
| Device Class: | Class II |
| Classification: | §874.1820, §882.1870, §882.4560, §890.1375 |
| Product Code: | PDO. ETN, GWF, HAW, IKN, OLO |
C. Predicate Devices
The subject NuVasive NVM5 System is substantially equivalent to one or more of the following predicate devices listed in Table 1 below.
| Table 1 – Predicate Devices | ||
|---|---|---|
| 510(k) | Trade or proprietary or model name | Manufacturer |
| K112718 | NVM5 System | NuVasive, Inc. |
| K122742 | BendiniTM Spinal Rod Bending System | NuVasive, Inc. |
| K050438 | StealthStation | Medtronic |
| K012448 | VectorVision Trauma | BrainLAB |
1 هاhام Tahle Predicate Devices
D. Device Description
NVM5 System is a medical device that is intended for intraoperative neurophysiologic monitoring during spinal surgery. The device provides information directly to the surgeon, to help assess a patient's neurophysiologic status. NVM5 provides this information by electrically stimulating nerves via electrodes located on surgical accessories and monitoring electromyography (EMG), transcranial motor evoked potential (TcMEP) or somatosensory evoked potential (SSEP) responses of nerves. Moreover, a Twitch Test ("Train of Four") function is utilized to test the ability of the nerve to respond, or contract, following four stimulation pulses to determine the presence of neuromuscular block.
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Image /page/1/Picture/0 description: The image shows the logo for Nuvasive. The logo consists of a stylized, abstract shape on the left, resembling a curved, incomplete circle. To the right of the shape is the word "NUVASIVE" in bold, sans-serif font. Below "NUVASIVE" is the tagline ":Speed of Innovation" in a smaller, italicized font.
Additionally, the NVM5 System includes an integrated stereotactic guidance system (NVM5 Guidance) to support the delivery of pedicle screws during EMG monitoring. The System also integrates Bendini™ software used to locate spinal implant instrumentation for the placement of spinal rods. Lastly, the system also offers an optional screen sharing application (Remote Monitoring) to allow a secondary physician to remotely view the events represented on the NVM5 user interface. In summary, the NVM5 System includes the following six (6) software functionalities / modalities:
-
- Electromyography (EMG)
- Transcranial Motor Evoked Potential (TceMEP), or simply MEP 2.
- Somatosensory Evoked Potential (SSEP) 3.
-
- Guidance
-
- Bendini
- Remote Monitoring 6.
The NVM5 System hardware consists of a Patient Module (PM) and computer, as well as accompanying accessory components which consist of an assortment of disposable conductive probes, electrodes, and electrode leads.
Intended Use E.
The NVM5 System is a medical device that is intended for intraoperative neurophysiologic monitoring during spinal surgery. The device provides information directly to the surgeon, to help assess a patient's neurophysiologic status. NVM5 provides this information by electrically stimulating nerves via electrodes located on surgical accessories and monitoring electromyography (EMG), transcranial motor evoked potential (TceMEP) or somatosensory evoked potential (SSEP) responses of nerves. The System also integrates Bendini" software used to locate spinal implant instrumentation for the placement of spinal rods.
- XLIF (Detection) The XLIF (Detection) function allows the surgeon to locate and . evaluate spinal nerves, and is used as a nerve avoidance tool.
- . Basic & Dynamic Screw Test - The Screw Test functions allow the surgeon to locate and evaluate spinal nerves by providing proximity information before, during or after bone preparation and placement of bone screws.
- Free Run EMG The Free Run EMG function identifies spontaneous EMG activity of . spinal nerves by continually displaying a live stream waveform of any mechanically induced myotome contractions.
- Twitch Test (Train of Four) The Twitch Test Function allows the surgeon to assess · � moderate degrees of neuromuscular block in effect by evaluating muscle contraction following a train of four stimulation pulses.
- TceMEP Transcranial stimulation techniques for motor evoked potentials are used to . assess for acute dysfunction in axonal conduction of the corticospinal tract. The TceMEP function provides an adjunctive method to allow the surgeon to monitor spinal cord and motor pathway integrity during procedures with a risk of surgically induced motor injury.
- SSEP -- The SSEP function allows the surgeon to assess sensory spinal cord function in . surgical procedures during which the spinal cord is at risk.
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Image /page/2/Picture/0 description: The image shows the logo for Nuvasive. The logo consists of a stylized leaf-like shape on the left, followed by the word "NUVASIVE" in a sans-serif font. Below the word "NUVASIVE" is the tagline ":Speed of Innovation" in a smaller font size.
- Remote Reader ~ The Remote Reader function provides real time remote access to the NVM5 System for a monitoring physician outside of the operating room.
- . Guidance - The Guidance function is intended as an aid for use in either open or percutaneous pedicle cannulation procedures in the lumbar and sacral spine (L1-S1) of adult patients, and when used in conjunction with radiographic imaging and EMG, allows the surgeon to assess the angulation of system accessories relative to patient spinal anatomy for the creation of a cannulation trajectory for bone screw placement.
- . Bendini - The Bendini Spinal Rod Bending function is used to locate spinal implant system instrumentation (screws, hooks) to determine their relative location to one another to generate bend instructions to shape a spinal rod. A surgeon is able to use those instructions and bend a rod using the Bendini Bender, a mechanical rod bender.
F. Technological Characteristics
As was established in this submission, the subject NVM5 System is substantially equivalent to other predicate devices cleared by the FDA for commercial distribution in the United States. The subject device was shown to be substantially equivalent and have equivalent technological characteristics to its predicate devices through comparison in areas including design, intended use, material composition, and functions. The technological differences within this 510(k) that were shown to be substantially equivalent to the predicates include:
- Addition of Red/Yellow/Green background alerts to the SSEP Function .
- Addition of the Bendini function (equivalent to predicate Bendini System K122742), ● and
- Use of the NVM5 System with NuVasive-supplied compatible computer. .
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NUVASIVE:
123307/S01 – NuVasive® NYM5® System
March 15, 2013 March 15, 2013
| Specification/Property | Subject Device | Predicate Device | SubstantiallyEquivalent? |
|---|---|---|---|
| Intended Use /Indications forUse | The NVM5 System is a medical device that is intended for intraoperativeneurophysiologic monitoring during spinal surgery. The device provides informationdirectly to the surgeon, to help assess a patient's neurophysiologic status. NVMS providesthis information by electrically stimulating nerves via electrodes located on surgicalaccessories and monitoring electromyography (EMG), transcranial motor evoked potential(TceMEP) or somatosensory evoked potential (SSEP) responses of nerves. The Systemalso integrates Bendini™ software used to locate spinal implant instrumentation for theplacement of spinal rods. | The NVM5 System is a medical device that is intended for intraoperativeneurophysiologic monitoring during spinal surgery. The device providesinformation directly to the surgeon, to help assess a patient's neurophysiologicstatus. NVMS provides this information by electrically stimulating nerves viaelectrodes located on surgical accessories and monitoring electromyography(EMG), transcranial motor evoked potential (TCMEP) or somatosensoryevoked potential (SSEP) responses of nerves. | YES.The differences in theIndications do not resultin a new intended use anddo not alter the intendedtherapeutic effect orimpact safety/effectiveness as theBendini indications areidentical to those clearedin K122742; andGuidance indicationswere only expanded toinclude the S1 level ofthe spine. |
| • XLIF (Detection) - The XLIF (Detection) function allows the surgeon to locate andevaluate spinal nerves, and is used as a nerve avoidance tool. | XLIF (Detection) - The XLIF (Detection) function allows the surgeon tolocate and evaluate spinal nerves, and is used as a nerve avoidance tool. | ||
| • Basic & Dynamic Screw Test - The Screw Test functions allow the surgeon to locateand evaluate spinal nerves by providing proximity information before, during or afterbone preparation and placement of bone screws. | Basic & Dynamic Screw Test - The Screw Test functions allow the surgeonto locate and evaluate spinal nerves by providing proximity informationbefore, during or after bone preparation and placement of bone screws. | ||
| • Free Run EMG - The Free Run EMG function identifies spontaneous EMG activity ofspinal nerves by continually displaying a live stream waveform of any mechanicallyinduced myotome contractions. | Free Run EMG - The Free Run EMG function identifies spontaneous EMGactivity of spinal nerves by continually displaying a live stream waveformof any mechanically induced myotome contractions. | ||
| • Twitch Test (Train of Four) - The Twitch Test Function allows the surgeon to assessmoderate degrees of neuromuscular block in effect by evaluating muscle contractionfollowing a train of four stimulation pulses. | Twitch Test (Train of Four) - The Twitch Test Function allows the surgeonto assess moderate degrees of neuromuscular block in effect by evaluatingmuscle contraction following a train of four stimulation pulses. | ||
| • TceMEP - Transcranial stimulation techniques for motor evoked potentials are used toassess for acute dysfunction in axonal conduction of the corticospinal tract. TheTceMEP function provides an adjunctive method to allow the surgeon to monitorspinal cord and motor pathway integrity during procedures with a risk of surgicallyinduced motor injury. | TCMEP - Transcranial stimulation techniques for motor evoked potentialsare used to assess for acute dysfunction in axonal conduction of thecorticospinal tract. The TcMEP function provides an adjunctive method toallow the surgeon to monitor spinal cord motor pathway integrity duringprocedures with a risk of surgically induced motor injury. | ||
| • SSEP - The SSEP function allows the surgeon to assess sensory spinal cord functionin surgical procedures during which the spinal cord is at risk. | SSEP- The SSEP function allows the surgeon to assess sensory spinal cordfunction in surgical procedures during which the spinal cord is at risk. | ||
| • Remote Reader - The Remote Reader function provides real time remote access to theNVM5 System for a monitoring physician outside of the operating room. | Remote Reader - The Remote Reader function provides real time remoteaccess to the NVM5 System for a monitoring physician outside of theoperating room. | ||
| • Guidance - The Guidance function is intended as an aid for use in either open orpercutaneous pedicle cannulation procedures in the lumbar and sacral spine (L1-S1) ofadult patients, and when used in conjunction with radiographic imaging and EMG,allows the surgeon to assess the angulation of system accessories relative to patientspinal anatomy for the creation of a cannulation trajectory for bone screw placement. | The Guidance function is intended as an aid for use in either open orpercutaneous pedicle cannulation procedures in the lumbar spine of adultpatients, and when used in conjunction with radiographic imaging andEMG, allows the surgeon to assess the angulation of system accessoriesrelative to patient spinal anatomy for the creation of a cannulation trajectoryfor bone screw placement. | ||
| • Bendini - The Bendini Spinal Rod Bending function is used to locate spinal implantsystem instrumentation (screws, hooks) to determine their relative location to oneanother to generate bend instructions to shape a spinal rod. A surgeon is able to usethose instructions and bend a rod using the Bendini Bender, a mechanical rod bender. |
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K 123307/S01 -- NuVasive® NVM5® System
March 15, 2013
March 15, 2013
| Specification/Property | Subject DeviceNuVasive NVM5 System | Predicate DeviceNuVasive NVM5 System (K112718) | March 15, 2013SubstantiallyEquivalent? | |
|---|---|---|---|---|
| SoftwareFunctionalities/Modalities | XLIF Detection Basic & Dynamic Screw Test Free Run EMG Twitch Test (Train of Four) TceMEP SSEP Remote Monitoring Guidance Bendini | XLIF Detection Basic & Dynamic Screw Test Free Run EMG Twitch Test (Train of Four) TceMEP SSEP Remote Monitoring Guidance | Yes.Bendini functionwas cleared in510(k) K122742,and verificationtesting demonstrateduse with the NVM5System. | |
| Algorithms | Identical algorithms as predicate, with additional algorithms for SSEPAuto and Bendini functions | XLIF Detection Basic & Dynamic Screw Test Free Run EMG Twitch Test (Train of Four) TceMEP SSEP Guidance | Yes.Bendini algorithm issubstantiallyequivalent topredicate 510(k)K122742. | |
| Total AvailableChannels | 32 | 32 | Yes | |
| Headbox/Patient ModuleIEC 60601-1Compliant | Yes | Yes | Yes | |
| Full Scale ViewRange | $\pm 0.5\mu V$ to $\pm 8mV$ | $\pm 0.5\mu V$ to $\pm 8mV$ | Yes | |
| FrequencyResponse | 3 Hz to 4.8 kHz | 3 Hz to 4.8 kHz | Yes | |
| User Interface | NuVasive-supplied computer withoptional touch screen and/or keyboard/mouse | Control Unit: Touch screen and [optional] keyboard/mouse | Yes | |
| RemoteMonitoring | Yes | Yes | Yes | |
| Train of FourTesting | Yes | Yes | Yes | |
| NeedleElectrodes | Various (Identical to predicate) | Various | Yes | |
| SurfaceElectrodes | Various (Identical to predicate) | Various | Yes | |
| Electrode Leads | Various (Identical to predicate) | Various | Yes | |
| Specification/Property | Subject DeviceNuVasive NVM5 System | Predicate DeviceNuVasive NVM5 System (K112718) | SubstantiallyEquivalent? | |
| StimulatingProbes | Various (Identical to predicate) | Various | Yes | |
| RecordingChannels | EMG, MEP, and SSEP | EMG, MEP, and SSEP | Yes | |
| EMG Modalities | XLIF (Detection) Basic & Dynamic Screw Test Free Run EMG Twitch Test (Train of Four) | XLIF (Detection) Basic & Dynamic Screw Test Free Run EMG Twitch Test (Train of Four) | Yes | |
| Types of ModesThreshold Valuesfor Color AlertsAudio feedback | Automatic StimulationYes (Identical to predicate)Yes | Automatic Stimulation | Yes | |
| Types of ModesThreshold Valuesfor Color AlertsAudio feedback | Automatic StimulationYes (Identical to predicate)Yes | Basic & Dynamic Screw Test | Yes | |
| Types of ModesThreshold Valuesfor Color AlertAudio feedback | Manual StimulationYes (Identical to predicate)Yes | Free Run EMG | Yes | |
| Types of ModesThreshold Valuesfor Color AlertsAudio feedback | Manual and Automatic StimulationYes (Identical to predicate)Yes | Twitch Test (Train of Four) | Yes | |
| Types of ModesThreshold Valuesfor Color AlertsAudio feedback | Manual and Automatic StimulationYes (Identical to predicate)Yes | TceMEP | Yes | |
| Types of ModesThreshold Valuesfor Color AlertsAudio feedback | Manual and Automatic StimulationYes (Identical to predicate)Yes | Manual and Automatic Stimulation | Yes | |
| Specification/Property | Subject DeviceNuVasive NVM5 System | Predicate DeviceNuVasive NVM5 System (K112718) | SubstantiallyEquivalent? | |
| Types of Modes | Manual Stimulation | |||
| Threshold Valuesfor Color Alerts | Manual Stimulation | No | Yes | |
| Audio feedback | Yes | No | Waveform output isthe same regardlessof background color.Yes.Waveform output isthe same regardlessof audio feedback. | |
| Number ofRecordingChannels | 10 | Yes | ||
| ResponseThreshold | 10-300 μV | Yes | ||
| High Filter | 1.5 kHz | Yes | ||
| Low Filter | 0.030 kHz | Yes | ||
| Notch Filter | None | Yes | ||
| Audible EMG | Yes | Yes | ||
| CMRR | > 100 dB @ 60 Hz | Yes | ||
| A/D Sampling Rate | 9.6 kHz | Yes | ||
| Automatic MutingDuring Artifact | Yes | Yes | ||
| StimulationWaveform | Rectangular, Monophasic Pulse | Yes | ||
| ConstantCurrent/Voltage | Yes | Yes | ||
| Theoretical MaxVoltage | 300 V | Yes | ||
| Max Current | 0.09 A | Yes | ||
| Max Pulse Width | 0.0002 sec | Yes | ||
| Max Number ofPulses per second | 5 | Yes | ||
| Min Probe SurfaceArea | 0.169 cm² | Yes |
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NUVASIVE
K123307/S01 – NuVusive® NVM5® System
Multine MuVusive® NVM50013
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123307/501 -- NuVasive® NVMS® System
March 15, 2013 March 15, 2013
| Specification/Property | Subject DeviceNuVasive NVM5 System.Guidance. | Predicate DevicesMedtronic StealthStation®(K050438) | BrainLAB VectorVision® Trauma(K012448) | SubstantiallyEquivalent |
|---|---|---|---|---|
| Indicationsfor Use | The Guidance function isintended as an aid for use in eitheropen or percutaneous pediclecannulation procedures in thelumbar and sacral spine (LI-S1)of adult patients, and when usedin conjunction with radiographicimaging and EMG, allows thesurgeon to assess the angulationof system accessories relative topatient spinal anatomy for thecreation of a cannulationtrajectory for bone screwplacement. | The StealthStation® System isintended as an aid for preciselylocating anatomical structures ineither open or percutaneousprocedures. The StealthStationSystem is indicated for anymedical condition in which the useof stereotactic surgery may beappropriate, and where reference toa rigid anatomical structure, suchas the skull, a long bone, orvertebra, can be identified relativeto a CT or MR based model,fluoroscopy images, or digitizedlandmarks of the anatomy.( Note: For the purposes of thispredicate comparison the fullindications have been limited. ) | BrainLAB VectorVision® Trauma isintended to be a pre- and intraoperativeimage guided localization system toenable minimally invasive surgery. Itlinks a freehand probe, tracked by apassive marker sensor system to virtualcomputer image space on a patient'spre- or intraoperative image data beingprocessed by a Vector Visionworkstation. The system is indicatedfor any medical condition in which theuse of stereotactic surgery may beappropriate and where a reference to arigid anatomical structure, such as theskull, a bone structure like tubularbones, pelvic, calcaneus and talus, orvertebra, can be identified relative to aCT, fluoroscopic, X-ray, or MR basedmodel of the anatomy.Example procedures include but are notlimited to:Spinal procedures and spinal implantprocedures such as pedicle screwplacement....( Note: For the purposes ofthis predicate comparison the full indicationshave been limited. ) | Yes - the Guidancefunction has limitedindications comparedto the predicate. |
| Clinical Use | Requires input derivedfrom CT, MRI, orradiographic images Intended to assist thesurgeon in cannulating thepedicle based on userpredefined trajectory Integrated with EMGstimulation | Requires input derived fromCT, MRI, or radiographicimages Intended to assist thesurgeon in cannulating thepedicle based on userpredefined trajectory Integrated with EMGstimulation | Requires input derived from CT,MRI, or radiographic images Intended to assist the surgeon incannulating the pedicle based onuser predefined trajectory | Yes |
| NuVasive NVM5 SystemGuidance (K112718) | ||||
| The Guidance function isintended as an aid for use ineither open or percutaneouspedicle cannulation proceduresin the lumbar spine of adultpatients, and when used inconjunction with radiographicimaging and EMG, allows thesurgeon to assess the angulationof system accessories relative topatient spinal anatomy for thecreation of a cannulationtrajectory for bone screwplacement. | ||||
| Requires input derivedfrom CT, MRI, orradiographic images Intended to assist thesurgeon in cannulating thepedicle based on userpredefined trajectory Integrated with EMGstimulation |
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K123307/S01 – NuVasive® NVM5® System
March 15, 2013
| "Spead of Innovation------------------------------------------------------------------------------------------------------------------------------------------------------------------------------1CALLARIA | Photos The Comments of Consistentify of the Street Comments of the StatesA PERSONAL PROPERTY PROPERTY PROPERTY PROPERTY PROPERTY PROPERTY PROPERTY PROPERTY PROPERTY PROPERTY PROPERTY PROPERTY PRODUCTION PRODUCTION CONTRACTION CONTRACTION CONTRACTI |
|---|---|
| Specification/Property | Subject DeviceNuVasive NVM5 SystemGuidance | NuVasive NVM5 System.Guidance (K112718)" | Predicate DevicesMedtronic StealthStation®(K050438) | BrainLAB Vector Vision® Trauma(K012448) | SubstantiallyEquivalent |
|---|---|---|---|---|---|
| ScientificPrinciples | References angular sensingtechnology coupled withassociated trackinginstruments Utilizes a C-Arm Reticlewith radio dense markers Uses accelerometers tosense angularmeasurements based ongravity by collecting 2degrees of freedom (DOF)(rx, ry) data Displays instrumentorientation only (rotationalinformation in the x and yplanes only) with respect togravity | References angularsensing technologycoupled with associatedtracking instruments Utilizes a C-Arm Reticlewith radio dense markers Uses accelerometers tosense angularmeasurements based ongravity by collecting 2degrees of freedom (DOF)(rx, ry) data Displays instrumentorientation only(rotational information inthe x and y planes only)with respect to gravity | References angular andposition sensing technologycoupled with associatedtracking instruments Utilizes a C-Arm Reticlewith radio dense markers Uses infrared technology tocapture positional androtational information via 6DOF (x, y, z; rx, ry, rz) data Displays the location andorientation (positional androtational information in thex, y, and z planes) ofinstruments in real timemerged with pre-operativelyobtained images of patientanatomy | References angular and positionsensing technology coupled withassociated tracking instruments Utilizes a C-Arm Reticle withradio dense markers Uses infrared technology tocapture positional and rotationalinformation via 6 DOF (x, y, z,rx, ry, rz) data Displays the location andorientation (positional androtational information in the x, y,and z planes) of instruments inreal time merged with pre-operatively obtained images ofpatient anatomy | Yes |
| PerformanceRequirements | Angular tolerance of ±2° Confirmation of alignmentto pre-planned trajectory Seamlessly integrated withan insulated JamshidiNeedle | Yes - The reduced degreeof data collected byGuidance is still deemedsubstantially equivalentsince it is used inconjunction withfluoroscopic imaging, notindicated for use by thepredicate StealthStation.The amount of datacollected by Guidance issufficient to provide angularoutputs to compare againstthe angular inputs identifiedby the user as the plannedtrajectory, considering thatintraoperative radiographicimaging is used to confirmthe starting point and correcttrajectory of the cannulationneedle. | |||
| Conformanceto Standards | IEC 60601-1, IEC 60601-1-2 | IEC 60601-1, IEC 60601-1-2 | IEC 60601-1, IEC 60601-1-2 | Confirmation of alignment topre-planned trajectory Others unknown IEC 60601-1, IEC 60601-1-2 | Yes |
| Specification/Property | Subject DeviceNuVasive NVM5 SystemGuidance | Predicate DevicesNuVasive NVM5 SystemGuidance (K112718): | Predicate DevicesMedtronic StealthStation®(K050438) | Predicate DevicesBrainLAB VectorVision® -Trauma(K012448) | SubstantiallyEquivalent |
| SystemMaterials/Biosafety | Tracking instrumentscomposed of known andaccepted (biocompatible)materials. | Tracking instrumentscomposed of known andaccepted (biocompatible)materials. | Tracking instruments composedof known and accepted(biocompatible) materials. | Tracking instruments composed ofknown and accepted(biocompatible) materials. | Yes |
| SystemSterilization | As selected for individualaccessories, and validated toassure an SAL of 10-6. | As selected for individualaccessories, and validated toassure an SAL of 10-6. | As selected for individualaccessories, and validated toassure an SAL of 10-6. | As selected for individualaccessories, and validated to assurean SAL of 10-6. | Yes |
Page 9 of 12
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,
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123307/S01 -- NuVasive® NVM5® System
March 15, 2013
NUVASIVE:
Page 10 of 12
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NUVASIVE:
K I 23307/S01 – NuVasive® NVMS® System
March 15, 2013
| March 15, 2013 | |||
|---|---|---|---|
| Table 4 - Comparison of Characteristics of the Subject NVM5 System Bendini Function vs. Predicate Device | |||
| Characteristics | Subject Device | Predicate Devices | Substantially Equivalent? |
| NVM5 System - Bendini Function | Bendini Spinal Rod Bending System (K122742) | ||
| The NVM5 System is a medical device that is intendedfor intraoperative neurophysiologic monitoring duringspinal surgery. The device provides information directlyto the surgeon, to help assess a patient'sneurophysiologic status. NVM5 provides thisinformation by electrically stimulating nerves viaelectrodes located on surgical accessories andmonitoring electromyography (EMG), transcranialmotor evoked potential (TceMEP) or somatosensoryevoked potential (SSEP) responses of nerves. TheSystem also integrates Bendini™ software used to locatespinal implant instrumentation for the placement ofspinal rods. [Bendini function only shown below:] | The NuVasive Bendini Spinal Rod Bending System isused to locate spinal implant system instrumentation(screws, hooks) to determine their relative location toone another to generate bend instructions to shape aspinal rod. A surgeon is able to use those instructionsand bend a rod using the Bendini Bender, a mechanicalrod bender. | ||
| Indications forUse | • Bendini - The Bendini Spinal Rod Bending functionis used to locate spinal implant systeminstrumentation (screws, hooks) to determine theirrelative location to one another to generate bendinstructions to shape a spinal rod. A surgeon is ableto use those instructions and bend a rod using theBendini Bender, a mechanical rod bender. | YES | |
| System Design | Components: Optical (IR) tracking technology system,IR tracking instruments, computer. | Components: Optical (IR) tracking technology system,IR tracking instruments, control unit, and mobile stand. | |
| User Interface: Touch screen, graphical user interfaceand audio. | User Interface: Touch screen, graphical user interfaceand audio. | YES | |
| Conformance with Recognized Standards:IEC 60601-1, IEC 60601-1-2 | Conformance with Recognized Standards:IEC 60601-1, IEC 60601-1-2 | ||
| Power Supply - Line Input | Power Supply - Line Input | ||
| Instrumentation | • IR Stylus (with integrated passive spheres)• Rod Bender | • IR Stylus (with integrated passive spheres)• Rod Bender | YES |
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Image /page/11/Picture/0 description: The image shows the logo for Nuvasive. The logo consists of a stylized, abstract shape on the left, followed by the word "NUVASIVE" in bold, sans-serif font. Below "NUVASIVE" is the tagline ":Speed of Innovation" in a smaller font size.
Performance Data G.
Nonclinical testing was performed to demonstrate that the subject NVM5 System is substantially equivalent to other predicate devices and to verify that the NVM5 System meets design specifications and performance characteristics, based upon the intended use. The NVM5 System was subjected to verification and validation testing, as well as electrical safety / compatibility testing, as follows:
- IEC 60601-1 (1988), A1 (1991), A2 (1995): Medical Electrical Equipment Part 1: . General Requirements for Safety
- IEC 60601-2-40 (1988): Medical Electrical Equipment Part 2-40:Particular . requirements for the safety of electromyographs and evoked response equipment
- . IEC 60601-1-2 (2001), A1 (2004): Medical Electrical Equipment Part 1-2: General Requirements for Safety Collateral Standard Electromagnetic Compatibility
- NVM5 System Verification and Validation Testing ●
- NVM5 System software Regression Testing .
- Guidance performance data comparison from literature data from clinical . literature demonstrated substantial equivalence of the subject device to the predicates BrainLAB VectorVision Trauma and Medtronic StealthStation for lumbosacral levels: (1) Accuracy of percutaneous lumbar pedicle šcrew placement using the oblique or "owl's-eye" view and novel guidance technology (J Neurosurg Spine, 2010) and (2) Placement of thoracolumbar pedicle screws using threedimensional image guidance: experience in a large patient cohort (J Neurosurg Spine, 2009)].
- Nonclinical testing performed for the Bendini function included evaluation of software performance per predetermined specifications outlined in the SRS. GUI functionality, error handling, system accuracy during data acquisition, verification of instrument performance in combination with the software, and verification of software algorithms.
The results of these studies showed that the subject NVM5 Svstem meets or exceeds the performance of the predicate device, and the device was therefore found to be substantially equivalent.
H. Conclusions
Based on the indications for use, technological characteristics, performance testing, and comparison to predicate devices, the subject NVM5 System has been shown to be substantially equivalent to legally marketed predicate devices, and safe and effective for its intended use.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/12/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or other bird-like figure. The symbol is composed of three curved lines that converge at the bottom.
April 23,2013
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Public Health Service
NuVasive, Inc. Sheila Bruschi Manager, Regulatory Affairs 7475 Lusk Blvd. San Diego, CA 92121
Re: K123307
Trade/Device Name: NuVasive NVM5 System Regulation Number: 21 CFR 874.1820 Regulation Name: Surgical nerve stimulator/locator Regulatory Class: Class II Product Code: PDQ, ETN, GWF, HAW, IKN, OLO Dated: March 15, 2013 Received: March 20, 2013
Dear Ms. Bruschi:
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. The general controls provisions of the Act include requirements for annual registration. Iisting 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 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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Page 2 - Ms. Sheila Bruschi
forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address:
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address:
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Joyce McWhang -S
for Victor Krauthamer, Ph.D. Acting 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): K123307
Device Name: NVM5 System
Indications For Use:
The NVM5® System is a medical device that is intended for intraoperative neurophysiologic monitoring during spinal surgery. The device provides information directly to the surgeon, to help assess a patient's neurophysiologic status. NVM5 provides this information by electrically stimulating nerves via electrodes located on surgical accessories and monitoring electromyography (EMG), transcranial motor evoked potential (TceMEP) or somatosensory evoked potential (SSEP) responses of nerves. The System also integrates Bendini™ software used to locate spinal implant instrumentation for the placement of spinal rods.
- XLIF® (Detection) -- The XLIF (Detection) function allows the surgeon to locate ● and evaluate spinal nerves, and is used as a nerve avoidance tool.
- Basic & Dynamic Screw Test The Screw Test functions allow the surgeon to . locate and evaluate spinal nerves by providing proximity information before. during or after bone preparation and placement of bone screws.
- Free Run EMG -- The Free Run EMG function identifies spontaneous EMG . activity of spinal nerves by continually displayinq a live stream waveform of any mechanically induced myotome contractions.
- Twitch Test (Train of Four) ~ The Twitch Test Function allows the surgeon to . assess moderate degrees of neuromuscular block in effect by evaluating muscle contraction following a train of four stimulation pulses.
- . TcMEP - Transcranial stimulation techniques for motor evoked potentials are used to assess for acute dysfunction in axonal conduction of the corticospinal tract. The TcMEP function provides an adjunctive method to allow the surgeon to monitor spinal cord and motor pathway integrity during procedures with a risk of surgically induced motor injury.
- . SSEP - The SSEP function allows the surgeon to assess sensory spinal cord function in surgical procedures during which the spinal cord is at risk.
- Remote Reader The Remote Reader function provides real time remote access ● to the NVM5 System for a monitoring physician outside of the operating room.
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- Guidance The Guidance function is intended as an aid for use in either open or . percutaneous pedicle cannulation procedures in the lumbar and sacral spine (L 1-S1) of adult patients, and when used in conjunction with radiographic imaging and EMG, allows the surgeon to assess the anqulation of system accessories relative to patient spinal anatomy for the creation of a cannulation trajectory for bone screw placement.
Bendini - The Bendini Spinal Rod Bending function is used to locate spinal . implant system instrumentation (screws, hooks) to determine their relative location to one another to generate bend instructions to shape a spinal rod. A surgeon is able to use those instructions and bend a rod using the Bendini Bender, a mechanical rod bender.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Joyce M. Whang -S | |
|---|---|
| (Division Sign Off) | |
| Division of Neurological and Physical Medicine | |
| Devices (DNPMD) |
510(k) Number K123307
Page 1 of 1
§ 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.