(210 days)
No
The summary describes standard neurophysiological monitoring techniques and software for surgical guidance, with no mention of AI or ML.
No
Explanation: This device is for intraoperative neuromonitoring to provide information to the surgeon and does not directly treat a disease or condition.
Yes
The device monitors electromyography (EMG), motor evoked potential (MEP), and somatosensory evoked potential (SSEP) responses, and integrates functionalities like XLIF (Detection) to locate and evaluate spinal nerves, and Screw Test to provide proximity information during surgery. These functions are explicitly stated as providing information to help assess a patient's neurophysiologic status and aid in nerve avoidance or evaluation, which are diagnostic in nature within an intraoperative setting.
No
The device description explicitly states that the NG-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. This indicates the device includes significant hardware components beyond just software.
Based on the provided text, the Next Generation NVM5® System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This testing is performed outside of the body.
- NG-NVM5 System Function: The NG-NVM5 System operates intraoperatively (during surgery) and directly interacts with the patient's nervous system through electrical stimulation and monitoring of physiological responses (EMG, MEP, SSEP). It does not analyze specimens taken from the body.
- Intended Use: The intended use clearly states it's for "intraoperative neurophysiologic monitoring" and provides information "directly to the surgeon" to assess the patient's neurophysiologic status in real-time during the procedure.
Therefore, the NG-NVM5 System falls under the category of a medical device used for physiological monitoring and surgical guidance, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Next Generation NVM5® System is a medical device that is intraoperative neurophysiologic monitoring during spinal surgery, neck dissections, thoracic surger and lower extremities. 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 (EMC), transcranial or lumbar motor evoked potential (MEP) or somatosensory evoked potential (SSEP) responses of nerves. The System also integrates BendiniTM 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 evaltiate 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 alive 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.
· MEP - Transcranial or lumbar (i.e., conus in region ofLI-L2) stimulation techniques for motor evoked potentials are used to assess for acute dysfunction in axonal conduction of the corticospinal tract and peripheral nerves. The ME? 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 Access - The remote monitoring and local wireless control provides real-time capabilities to the NG-NVM5 System for additional physicians.
· 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.
The Next Generation NVM5® System is a medical device that is intended for intraoperative neurophysiologic monitoring during spinal surgery, neck dissections, thoracic surgeries, and upper and lower extremities. 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 or lumbar motor evoked potential (MEP) 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.
- MEP - Transcranial or lumbar (i.e., conus in region of L1-L2) stimulation techniques for motor evoked potentials are used to assess for acute dysfunction in axonal conduction of the corticospinal tract and peripheral nerves. The MEP 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 Access - The remote monitoring and local wireless control provides real-time capabilities to the NG-NVM5 System for additional physicians.
- 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.
Product codes (comma separated list FDA assigned to the subject device)
PDQ, ETN, GWF, HAW, IKN, OLO
Device Description
The NG-NVM5 System is a medical device that is intended for intraoperative neurophysiologic monitoring during spinal surgery, neck dissections, thoracic surgeries, and upper and lower extremities. The device provides information directly to the surgeon, to help assess a patient’s neurophysiologic status. NG-NVM5 provides this information by electrically stimulating nerves via electrodes located on surgical accessories and monitoring electromyography (EMG), motor evoked potential (MEP) or somatosensory evoked potential (SSEP) responses of nerves. Moreover. a Twitch Test 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.
The System also integrates Bendini® software used to locate spinal implant instrumentation for the placement of spinal rods as well as providing guidance to support the delivery of pedicle screws during EMG monitoring. Lastly, the system offers real-time control capabilities (local wireless control) to the NG-NVM5 System by additional monitoring physicians, in addition to remote monitoring capabilities.
In summary, the NG-NVM5 System includes the following five (5) software functionalities / modalities:
-
- Electromyography (EMG)
- Motor Evoked Potential (MEP) 2.
-
- Somatosensory Evoked Potential (SSEP)
-
- Remote Access
-
- Bendini
The NG-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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
spinal, neck, thoracic, upper and lower extremities, conus in region of L1-L2
Indicated Patient Age Range
Not Found
Intended User / Care Setting
surgeon, additional physicians
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Nonclinical testing was performed to demonstrate that the subject NG-NVM5 System is substantially equivalent to other predicate devices and to verify that the NG-NVM5 System meets design specifications and performance characteristics, based upon the intended use. The NG-NVM5 System was subjected to Verification and Validation Testing according to the Software Requirements Specifications defined for the system, to include the modifications made as part of the subject device. Laboratory bench top testing was performed to verify accuracy of angle and offset measurement and validate that the graphical user interface (GUI) and system components function as intended. Additionally, the current and power densities were calculated to support substantial equivalence of cutaneous electrodes.
The results of these studies showed that the subject NG-NVM5® System meets the same acceptance criteria as the performance of the predicate device, and the device was therefore found to be substantially equivalent.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 16, 2017
NuVasive Incorporated Mary Adams Regulatory Affairs Consultant 7475 Lusk Blvd. San Diego, California 92121
Re: K162313
Trade/Device Name: NuVasive Next Generation 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: February 15, 2017 Received: February 16, 2017
Dear Ms. Adams:
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, 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 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education 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. 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 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 Industry and Consumer Education 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,
Michael J. Hoffmann -S
Carlos L. Peña, PhD, MS for Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K162313
Device Name
NuVasive® Next Generation NVM5 System
Indications for Use (Describe)
The Next Generation NVM5® System is a medical device that is intraoperative neurophysiologic monitoring during spinal surgery, neck dissections, thoracic surger and lower extremities. 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 (EMC), transcranial or lumbar motor evoked potential (MEP) or somatosensory evoked potential (SSEP) responses of nerves. The System also integrates BendiniTM 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 evaltiate 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 alive 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.
· MEP - Transcranial or lumbar (i.e., conus in region ofLI-L2) stimulation techniques for motor evoked potentials are used to assess for acute dysfunction in axonal conduction of the corticospinal tract and peripheral nerves. The ME? 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 Access - The remote monitoring and local wireless control provides real-time capabilities to the NG-NVM5 System for additional physicians.
· 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.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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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:
A. Submitted by:
Mary Adams Regulatory Affairs Consultant NuVasive, Incorporated 7475 Lusk Blvd. San Diego, California 92121 Telephone: (909) 991-5235 Date Prepared: March 13, 2017
B. Device Name
| Trade or Proprietary Name: | NuVasive® Next Generation 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: | PDQ, ETN, GWF, HAW, IKN, OLO |
C. Predicate Devices
The subject NuVasive Next Generation (NG) NVM5 System is substantially equivalent to the following predicate devices:
NuVasive NVM5 System K152942 (Primary Predicate) Medtronic NIM 3.0 Nerve Integrity Monitor K083124 (Additional Predicate) NuVasive NVM5 System K132694 (Reference Predicate for current density of the cutaneous electrodes)
D. Device Description
The NG-NVM5 System is a medical device that is intended for intraoperative neurophysiologic monitoring during spinal surgery, neck dissections, thoracic surgeries, and upper and lower extremities. The device provides information directly to the surgeon, to help assess a patient's neurophysiologic status. NG-NVM5 provides this information by electrically stimulating nerves via electrodes located on surgical accessories and monitoring electromyography (EMG), motor evoked potential (MEP) or somatosensory evoked potential (SSEP) responses of nerves. Moreover. a Twitch Test 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.
The System also integrates Bendini® software used to locate spinal implant instrumentation for the placement of spinal rods as well as providing guidance to support the delivery of pedicle
4
Image /page/4/Picture/0 description: The image contains the logo for Nuvasive. The logo consists of a purple and gray abstract leaf-like shape on the left, followed by the word "NUVASIVE" in gray. Below the word "NUVASIVE" is the phrase "Speed of Innovation" in a smaller font size and a gradient of gray to purple.
screws during EMG monitoring. Lastly, the system offers real-time control capabilities (local wireless control) to the NG-NVM5 System by additional monitoring physicians, in addition to remote monitoring capabilities.
In summary, the NG-NVM5 System includes the following five (5) software functionalities / modalities:
-
- Electromyography (EMG)
- Motor Evoked Potential (MEP) 2.
-
- Somatosensory Evoked Potential (SSEP)
-
- Remote Access
-
- Bendini
The NG-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 Next Generation NVM5® System is a medical device that is intended for intraoperative neurophysiologic monitoring during spinal surgery, neck dissections, thoracic surgeries, and upper and lower extremities. 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 or lumbar motor evoked potential (MEP) 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.
- MEP - Transcranial or lumbar (i.e., conus in region of L1-L2) stimulation techniques for motor evoked potentials are used to assess for acute dysfunction in axonal conduction of the corticospinal tract and peripheral nerves. The MEP 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/5/Picture/0 description: The image shows the logo for Nuvasive. The logo consists of a purple and gray leaf-like shape on the left, followed by the word "NUVASIVE" in gray. Below the word "NUVASIVE" is the phrase "Speed of Innovation" in a smaller font size.
- Remote Access - The remote monitoring and local wireless control provides real-time capabilities to the NG-NVM5 System for additional physicians.
- 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 NG-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 device 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 additional angular and offset spinal parameter assessment.
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| Table 1 – Comparison of Technical Characteristics | |||
|---|---|---|---|
| Specification/ | |||
| Property | Predicate Device | ||
| Medtronic NIM 3.0 Nerve | |||
| Monitoring System (K083124) | Predicate Device | ||
| NuVasive NVM5 System (K152942 and K132694) | Subject Device | ||
| NuVasive NG-NVM5 System | |||
| Intended Use / | |||
| Indications for | |||
| Use | Intended Use: The NIM 3.0 is intended for | ||
| locating and identifying cranial and | |||
| peripheral motor and mixed motor-sensory | |||
| nerves during surgery, including spinal cord | |||
| and spinal cord nerve roots. The APS | |||
| electrode is an accessory intended for | |||
| providing automatic periodic stimulation to | |||
| nerves when used with the Medtronic Nerve | |||
| Monitoring Systems. |
Indications for NIM 3.0 EMG Monitoring
Procedures include:
Intracranial, Extracranial, Intratemporal,
Extratemporal, Neck Dissections, Thoracic
Surgeries, and Upper and Lower
Extremities
Indications for Spinal procedures which
may use NIM 3.0 EMG monitoring include:
Degenerative Treatments, Pedicle Screw
Procedures, Fusion Cages, Rhizotomy,
Orthopedic Surgery, Open and
Percutaneous Lumbar and Cervical Surgical
Procedures, and Thoracic Surgical
Procedures. | 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 or lumbar motor evoked
potential (MEP), 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.
• MEP - Transcranial or lumbar (i.e., conus in region of L1-L2) stimulation
techniques for motor evoked potentials are used to assess for acute
dysfunction in axonal conduction of the corticospinal tract and peripheral
nerves. The MEP 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 (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. | The Next Generation NVM5® System is a medical device that is
intended for intraoperative neurophysiologic monitoring during spinal
surgery, neck dissections, thoracic surgeries, and upper and lower
extremities. The device provides information directly to the surgeon,
to help assess a patient's neurophysiologic status. NG-NVM5 provides
this information by electrically stimulating nerves via electrodes
located on surgical accessories and monitoring electromyography
(EMG), transcranial or lumbar motor evoked potential (MEP) 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.
• MEP - Transcranial or lumbar (i.e., conus in region of L1-L2)
stimulation techniques for motor evoked potentials are used to
assess for acute dysfunction in axonal conduction of the
corticospinal tract and peripheral nerves. The MEP 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 Access - The remote monitoring and local wireless control
provides real-time capabilities to the NG-NVM5 System for
additional physicians.
• 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. |
| Specification/
Property | Predicate Device
Medtronic NIM 3.0 Nerve
Monitoring System (K083124) | Predicate Device
NuVasive NVM5 System (K152942 and K132694) | Subject Device
NuVasive NG-NVM5 System |
| Software
Modalities /
Functionalities | • Stimulating EMG (manual
and APS)
• Free run EMG | • XLIF Detection
• Basic & Dynamic Screw Test
• Free Run EMG
• Twitch Test (Train of Four)
• MEP
• SSEP
• Remote Reader
• Guidance
• Bendini
o NuvaMap O.R.
• NuvaLine spinal parameter assessment tools (optional) | • XLIF (Detection)
• Basic & Dynamic Screw Test
• Free Run EMG
• Twitch Test
• MEP
• SSEP
• Remote Access (Remote Monitoring and Local
Wireless Control)
• Bendini
o NuvaMap O.R. |
| Algorithms | • APS | • XLIF Detection
• Basic & Dynamic Screw Test
• Free Run EMG
• Twitch Test (Train of Four)
• MEP
• SSEP
• Guidance
• Bendini - Rod bending and spinal parameter assessment | • XLIF Detection
• Basic & Dynamic Screw Test
• Free Run EMG
• Twitch Test (Train of Four)
• MEP
• SSEP
• Remote Access
• Bendini – Rod bending and spinal parameter
assessment |
| Total Available
Channels | Up to 8 | 32 | 32 |
| Headbox/
Patient Module | Unknown | Yes | Yes |
| IEC 60601-1
Compliant | Yes | Yes | Yes |
| Full Scale View
Range | $\pm$ 2.5 μV to $\pm$ 50 mV | $\pm$ 0.5μV to $\pm$ 8mV | $\pm$ 0.5μV to $\pm$ 5mV |
| Frequency
Response | 15 Hz to 1.85 kHz | 3 Hz to 4.8 kHz | 3 Hz to 1.5 kHz |
| User Interface | Medtronic supplied computer with
keyboard and mouse | NuVasive-supplied computer with
optional touch screen and/or keyboard/mouse
Mobile device (for NuvaLine only) | NuVasive-supplied computer
with separate touch screen and/or keyboard/mouse
Mobile device |
| Remote Access | No | Yes | Yes |
| Train of Four
Testing | N/A | Yes | Yes |
| | | | |
| Specification/
Property | Predicate Device
Medtronic NIM 3.0 Nerve
Monitoring System (K083124) | Predicate Device
NuVasive NVM5 System (K152942 and K132694) | Subject Device
NuVasive NG-NVM5 System |
| Needle
Electrodes | Various | Various | Various |
| Surface
Electrodes | Various | Various | Various, including new cutaneous electrodes for lumbar
MEP |
| Electrode
Leads | Various | Various | Various |
| Stimulating
Probes | Various | Various | Various |
| Recording
Channels | EMG | EMG, MEP, and SSEP | EMG, MEP, and SSEP |
| EMG | | | |
| EMG
Modalities | • Free Run EMG | • XLIF (Detection)
• Basic & Dynamic Screw Test
• Free Run EMG
• Twitch Test | • XLIF (Detection)
• Basic & Dynamic Screw Test
• Free Run EMG
• Twitch Test |
| XLIF (Detection) | | | |
| Types of
Modes | Triggered Stimulation | Automatic Stimulation | Automatic Stimulation |
| Threshold
Values for
Color Alerts | No | Yes | Yes (Identical to predicate) |
| Audio feedback | No | Yes | Yes |
| Basic & Dynamic Screw Test | | | |
| Types of
Modes | N/A | Automatic Stimulation | Automatic Stimulation |
| Threshold
Values for
Color Alerts | N/A | Yes | Yes (Identical to predicate) |
| Audio feedback | N/A | Yes | Yes |
| Free Run EMG | | | |
| Types of
Modes | Manual Stimulation | Manual Stimulation | Manual Stimulation |
| Threshold
Values for
Color Alert | Yes | Yes | Yes (Identical to K152942) |
| Audio feedback | Yes | Yes | Yes |
| | Predicate Device | Predicate Device | Subject Device |
| Specification/
Property | Medtronic NIM 3.0 Nerve
Monitoring System (K083124) | NuVasive NVM5 System (K152942 and K132694) | NuVasive NG-NVM5 System |
| | | Twitch Test | |
| Types of
Modes | N/A | Manual and Automatic Stimulation | Manual and Automatic Stimulation |
| Threshold
Values for
Color Alerts | N/A | Yes | Yes |
| Audio feedback | N/A | Yes | Yes |
| | | MEP | |
| Types of
Modes | N/A | Manual and Automatic Stimulation | Manual and Automatic Stimulation |
| Threshold
Values for
Color Alerts | N/A | Yes | Yes (Identical to predicate) |
| Audio feedback | N/A | Yes | Yes |
| | | SSEP | |
| Types of
Modes | N/A | Manual Stimulation | Manual Stimulation |
| Threshold
Values for
Color Alerts | N/A | Yes | Yes (Identical to predicate) |
| Audio feedback | N/A | Yes | Yes |
| | | Remote Access | |
| Screen-sharing
accessibility | Remote Monitoring | Remote Monitoring | Remote Monitoring and Local Wireless Control |
| Guidance | | | |
| Clinical Use | N/A | Requires input derived from CT, MRI, or radiographic images Intended to assist the surgeon in cannulating the pedicle based on user predefined trajectory Integrated with EMG stimulation | Not applicable |
| Performance
Requirements | N/A | Angular tolerance of ±2° Confirmation of alignment to pre-planned trajectory Seamlessly integrated with an insulated Jamshidi Needle | Not applicable |
| IEC 60601
Compliant | N/A | YES | YES |
| User Interface | N/A | Touch screen, graphical user interface and audio | Not applicable |
| | | | |
| Specification/
Property | Predicate Device | Predicate Device | Subject Device |
| | Medtronic NIM 3.0 Nerve
Monitoring System (K083124) | NuVasive NVM5 System (K152942 and K132694) | NuVasive NG-NVM5 System |
| Bendini | | | |
| Components | N/A | Optical (IR) tracking technology system, IR tracking
instruments, computer. | Optical (IR) tracking technology system, IR tracking
instruments, computer. |
| User Interface | N/A | Touch screen, graphical user interface and audio. | Touch screen, graphical user interface and audio. |
| IEC 60601
Compliant | N/A | YES | YES |
| Instrumentation | N/A | • IR Digitizer (with integrated passive spheres)
• Rod Bender
• Optional Mobile application | • IR Digitizer (with integrated passive spheres)
• Rod Bender
• Optional Mobile application |
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Image /page/7/Picture/0 description: The image shows the Nuvasive logo. The logo consists of a purple and gray abstract shape on the left, followed by the word "NUVASIVE" in gray. Below the word "NUVASIVE" is the phrase "Speed of Innovation" in purple.
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Image /page/8/Picture/0 description: The image shows the logo for Nuvasive. The logo consists of a purple and gray abstract shape on the left, followed by the word "NUVASIVE" in gray. Below the word "NUVASIVE" is the phrase "Speed of Innovation" in a smaller font and purple color.
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Image /page/9/Picture/0 description: The image shows the logo for Nuvasive. The logo consists of a purple and gray abstract shape on the left, followed by the word "NUVASIVE" in gray. Below the word "NUVASIVE" is the phrase "Speed of Innovation" in a smaller font and purple color.
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Image /page/10/Picture/0 description: The image shows the logo for Nuvasive. The logo consists of a purple and gray abstract shape on the left, followed by the word "NUVASIVE" in gray, and the words "Speed of Innovation" in purple below the company name. The logo is simple and modern.
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G. Performance Data
Nonclinical testing was performed to demonstrate that the subject NG-NVM5 System is substantially equivalent to other predicate devices and to verify that the NG-NVM5 System meets design specifications and performance characteristics, based upon the intended use. The NG-NVM5 System was subjected to Verification and Validation Testing according to the Software Requirements Specifications defined for the system, to include the modifications made as part of the subject device. Laboratory bench top testing was performed to verify accuracy of angle and offset measurement and validate that the graphical user interface (GUI) and system components function as intended. Additionally, the current and power densities were calculated to support substantial equivalence of cutaneous electrodes.
The results of these studies showed that the subject NG-NVM5® System meets the same acceptance criteria as 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 NG-NVM5 System has been shown to be substantially equivalent to legally marketed predicate devices.