Predicate Devices

Reference Devices

K/DEN number and list them here in a comma separated list exactly as they appear in the text:

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes standard neurophysiological monitoring techniques (EMG, MEP, SSEP) and a guidance system that appears to rely on established imaging and measurement principles, not AI/ML. There is no mention of AI, ML, or related terms in the text.

Therapeutic

No.
The device is intended for intraoperative neurophysiologic monitoring and guidance, providing information to the surgeon to assess neurophysiologic status and aid in surgical procedures, rather than directly treating a disease or condition.

Diagnostic

Yes

Explanation: The device is intended for "intraoperative neurophysiologic monitoring during spinal surgery" and "provides information directly to the surgeon, to help assess a patient's neurophysiologic status" by monitoring "EMG, transcranial motor evoked potential (TceMEP) or somatosensory evoked potential (SSEP) responses of nerves," all of which are diagnostic functions.

SaMD (Software as a Medical Device)

No

The device description explicitly states that 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. This indicates the presence of physical hardware components beyond just software.

IVD (In Vitro Diagnostic)

Based on the provided text, the 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.
NVM5 System Function: The NVM5 System is used for intraoperative neurophysiologic monitoring during spinal surgery. It works by electrically stimulating nerves within the patient's body and monitoring the resulting responses (EMG, TcMEP, SSEP). It also assists with surgical guidance and rod bending.
No Specimen Testing: The description of the NVM5 System's intended use and device description clearly indicates that it does not involve the testing of specimens taken from the body.

Therefore, the NVM5 System falls under the category of a medical device used for monitoring and guidance during surgery, not an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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.
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.

Product codes

PDQ, ETN, GWF, HAW, IKN, OLO

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.
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.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Radiographic imaging (CT, MRI, X-ray, fluoroscopic imagery are referenced as comparable imaging modalities for the predicate device functions)

Anatomical Site

Spinal, lumbar, and sacral spine (L1-S1)

Indicated Patient Age Range

Adult patients

Intended User / Care Setting

Surgeon, secondary physician (for remote monitoring) / Intraoperative, operating room

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 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 screw 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 three-dimensional 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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K112718, K122742, K050438, K012448

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 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.

Summary

0

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.

1

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:

1. Electromyography (EMG)
Transcranial Motor Evoked Potential (TceMEP), or simply MEP 2.
Somatosensory Evoked Potential (SSEP) 3.
1. Guidance
1. 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.

2

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. .

3

NUVASIVE:

123307/S01 – NuVasive® NYM5® System
March 15, 2013 March 15, 2013

| Specification/
Property | Subject Device | Predicate Device | Substantially
Equivalent? |
|------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use /
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. NVMS 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. | 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. NVMS 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. | YES.
The differences in the
Indications do not result
in a new intended use and
do not alter the intended
therapeutic effect or
impact safety/
effectiveness as the
Bendini indications are
identical to those cleared
in K122742; and
Guidance indications
were only expanded to
include the S1 level of
the spine. |
| | • XLIF (Detection) - The XLIF (Detection) function allows the surgeon to locate and
evaluate spinal nerves, and is used as a nerve avoidance tool. | 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. | 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. | 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. | 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. | 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 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. | 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. | 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. | The Guidance function is intended as an aid for use in either open or
percutaneous pedicle cannulation procedures in the lumbar spine 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. | | |

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K 123307/S01 -- NuVasive® NVM5® System
March 15, 2013

March 15, 2013

| Specification/
Property | Subject Device
NuVasive NVM5 System | Predicate Device
NuVasive NVM5 System (K112718) | March 15, 2013
Substantially
Equivalent? | |
|--------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------|
| Software
Functionalities/
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 function
was cleared in
510(k) K122742,
and verification
testing demonstrated
use with the NVM5
System. | |
| Algorithms | Identical algorithms as predicate, with additional algorithms for SSEP
Auto and Bendini functions | XLIF Detection Basic & Dynamic Screw Test Free Run EMG Twitch Test (Train of Four) TceMEP SSEP Guidance | Yes.
Bendini algorithm is
substantially
equivalent to
predicate 510(k)
K122742. | |
| Total Available
Channels | 32 | 32 | Yes | |
| Headbox/
Patient Module
IEC 60601-1
Compliant | Yes | Yes | Yes | |
| Full Scale View
Range | $\pm 0.5\mu V$ to $\pm 8mV$ | $\pm 0.5\mu V$ to $\pm 8mV$ | Yes | |
| Frequency
Response | 3 Hz to 4.8 kHz | 3 Hz to 4.8 kHz | Yes | |
| User Interface | NuVasive-supplied computer with
optional touch screen and/or keyboard/mouse | Control Unit: Touch screen and [optional] keyboard/mouse | Yes | |
| Remote
Monitoring | Yes | Yes | Yes | |
| Train of Four
Testing | Yes | Yes | Yes | |
| Needle
Electrodes | Various (Identical to predicate) | Various | Yes | |
| Surface
Electrodes | Various (Identical to predicate) | Various | Yes | |
| Electrode Leads | Various (Identical to predicate) | Various | Yes | |
| Specification/
Property | Subject Device
NuVasive NVM5 System | Predicate Device
NuVasive NVM5 System (K112718) | Substantially
Equivalent? | |
| Stimulating
Probes | Various (Identical to predicate) | Various | Yes | |
| Recording
Channels | 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 Modes
Threshold Values
for Color Alerts
Audio feedback | Automatic Stimulation
Yes (Identical to predicate)
Yes | Automatic Stimulation | Yes | |
| Types of Modes
Threshold Values
for Color Alerts
Audio feedback | Automatic Stimulation
Yes (Identical to predicate)
Yes | Basic & Dynamic Screw Test | Yes | |
| Types of Modes
Threshold Values
for Color Alert
Audio feedback | Manual Stimulation
Yes (Identical to predicate)
Yes | Free Run EMG | Yes | |
| Types of Modes
Threshold Values
for Color Alerts
Audio feedback | Manual and Automatic Stimulation
Yes (Identical to predicate)
Yes | Twitch Test (Train of Four) | Yes | |
| Types of Modes
Threshold Values
for Color Alerts
Audio feedback | Manual and Automatic Stimulation
Yes (Identical to predicate)
Yes | TceMEP | Yes | |
| Types of Modes
Threshold Values
for Color Alerts
Audio feedback | Manual and Automatic Stimulation
Yes (Identical to predicate)
Yes | Manual and Automatic Stimulation | Yes | |
| Specification/
Property | Subject Device
NuVasive NVM5 System | Predicate Device
NuVasive NVM5 System (K112718) | | Substantially
Equivalent? |
| Types of Modes | | | Manual Stimulation | |
| Threshold Values
for Color Alerts | Manual Stimulation | No | | Yes |
| Audio feedback | Yes | No | | Waveform output is
the same regardless
of background color.
Yes.
Waveform output is
the same regardless
of audio feedback. |
| Number of
Recording
Channels | | | 10 | Yes |
| Response
Threshold | | | 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 Muting
During Artifact | | | Yes | Yes |
| Stimulation
Waveform | | | Rectangular, Monophasic Pulse | Yes |
| Constant
Current/Voltage | | | Yes | Yes |
| Theoretical Max
Voltage | | | 300 V | Yes |
| Max Current | | | 0.09 A | Yes |
| Max Pulse Width | | | 0.0002 sec | Yes |
| Max Number of
Pulses per second | | | 5 | Yes |
| Min Probe Surface
Area | | | 0.169 cm² | Yes |

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5

NUVASIVE

K123307/S01 – NuVusive® NVM5® System
Multine MuVusive® NVM50013

27 of 441

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6

28 of 441

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123307/501 -- NuVasive® NVMS® System
March 15, 2013 March 15, 2013

| Specification/
Property | Subject Device
NuVasive NVM5 System.
Guidance. | Predicate Devices
Medtronic StealthStation®
(K050438) | BrainLAB VectorVision® Trauma
(K012448) | Substantially
Equivalent |
|----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------|
| Indications
for Use | The Guidance function is
intended as an aid for use in either
open or percutaneous pedicle
cannulation procedures in the
lumbar and sacral spine (LI-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. | The StealthStation® System is
intended as an aid for precisely
locating anatomical structures in
either open or percutaneous
procedures. The StealthStation
System is indicated for any
medical condition in which the use
of stereotactic surgery may be
appropriate, and where reference to
a rigid anatomical structure, such
as the skull, a long bone, or
vertebra, can be identified relative
to a CT or MR based model,
fluoroscopy images, or digitized
landmarks of the anatomy.
( Note: For the purposes of this
predicate comparison the full
indications have been limited. ) | BrainLAB VectorVision® Trauma is
intended to be a pre- and intraoperative
image guided localization system to
enable minimally invasive surgery. It
links a freehand probe, tracked by a
passive marker sensor system to virtual
computer image space on a patient's
pre- or intraoperative image data being
processed by a Vector Vision
workstation. The system is indicated
for any medical condition in which the
use of stereotactic surgery may be
appropriate and where a reference to a
rigid anatomical structure, such as the
skull, a bone structure like tubular
bones, pelvic, calcaneus and talus, or
vertebra, can be identified relative to a
CT, fluoroscopic, X-ray, or MR based
model of the anatomy.
Example procedures include but are not
limited to:
Spinal procedures and spinal implant
procedures such as pedicle screw
placement....( Note: For the purposes of
this predicate comparison the full indications
have been limited. ) | Yes - the Guidance
function has limited
indications compared
to the predicate. |
| Clinical Use | 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 | 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 | Requires input derived from CT,
MRI, or radiographic images Intended to assist the surgeon in
cannulating the pedicle based on
user predefined trajectory | Yes |
| | NuVasive NVM5 System
Guidance (K112718) | | | |
| | The Guidance function is
intended as an aid for use in
either open or percutaneous
pedicle cannulation procedures
in the lumbar spine 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. | | | |
| | 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 | | | |

Page 8 of 12

8

K123307/S01 – NuVasive® NVM5® System
March 15, 2013

| "Spead of Innovation

1
CALLARIA | Photos The Comments of Consistentify of the Street Comments of the States
A PERSONAL PROPERTY PROPERTY PROPERTY PROPERTY PROPERTY PROPERTY PROPERTY PROPERTY PROPERTY PROPERTY PROPERTY PROPERTY PRODUCTION PRODUCTION CONTRACTION CONTRACTION CONTRACTI |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | |

| Specification/
Property | Subject Device
NuVasive NVM5 System
Guidance | NuVasive NVM5 System.
Guidance (K112718)" | Predicate Devices
Medtronic StealthStation®
(K050438) | BrainLAB Vector Vision® Trauma
(K012448) | Substantially
Equivalent |
|-----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Scientific
Principles | References angular sensing
technology coupled with
associated tracking
instruments Utilizes a C-Arm Reticle
with radio dense markers Uses accelerometers to
sense angular
measurements based on
gravity by collecting 2
degrees of freedom (DOF)
(rx, ry) data Displays instrument
orientation only (rotational
information in the x and y
planes only) with respect to
gravity | References angular
sensing technology
coupled with associated
tracking instruments Utilizes a C-Arm Reticle
with radio dense markers Uses accelerometers to
sense angular
measurements based on
gravity by collecting 2
degrees of freedom (DOF)
(rx, ry) data Displays instrument
orientation only
(rotational information in
the x and y planes only)
with respect to gravity | References angular and
position sensing technology
coupled with associated
tracking instruments Utilizes a C-Arm Reticle
with radio dense markers Uses infrared technology to
capture positional and
rotational information via 6
DOF (x, y, z; rx, ry, rz) data Displays the location and
orientation (positional and
rotational information in the
x, y, and z planes) of
instruments in real time
merged with pre-operatively
obtained images of patient
anatomy | References angular and position
sensing technology coupled with
associated tracking instruments Utilizes a C-Arm Reticle with
radio dense markers Uses infrared technology to
capture positional and rotational
information via 6 DOF (x, y, z,
rx, ry, rz) data Displays the location and
orientation (positional and
rotational information in the x, y,
and z planes) of instruments in
real time merged with pre-
operatively obtained images of
patient anatomy | Yes |
| Performance
Requirements | Angular tolerance of ±2° Confirmation of alignment
to pre-planned trajectory Seamlessly integrated with
an insulated Jamshidi
Needle | | | | Yes - The reduced degree
of data collected by
Guidance is still deemed
substantially equivalent
since it is used in
conjunction with
fluoroscopic imaging, not
indicated for use by the
predicate StealthStation.
The amount of data
collected by Guidance is
sufficient to provide angular
outputs to compare against
the angular inputs identified
by the user as the planned
trajectory, considering that
intraoperative radiographic
imaging is used to confirm
the starting point and correct
trajectory of the cannulation
needle. |
| Conformance
to 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 to
pre-planned trajectory Others unknown IEC 60601-1, IEC 60601-1-2 | Yes |
| Specification/
Property | Subject Device
NuVasive NVM5 System
Guidance | Predicate Devices
NuVasive NVM5 System
Guidance (K112718): | Predicate Devices
Medtronic StealthStation®
(K050438) | Predicate Devices
BrainLAB VectorVision® -Trauma
(K012448) | Substantially
Equivalent |
| System
Materials/
Biosafety | Tracking instruments
composed of known and
accepted (biocompatible)
materials. | Tracking instruments
composed of known and
accepted (biocompatible)
materials. | Tracking instruments composed
of known and accepted
(biocompatible) materials. | Tracking instruments composed of
known and accepted
(biocompatible) materials. | Yes |
| System
Sterilization | As selected for individual
accessories, and validated to
assure an SAL of 10-6. | As selected for individual
accessories, and validated to
assure an SAL of 10-6. | As selected for individual
accessories, and validated to
assure an SAL of 10-6. | As selected for individual
accessories, and validated to assure
an SAL of 10-6. | Yes |

Page 9 of 12

30 of 441

,

9

123307/S01 -- NuVasive® NVM5® System
March 15, 2013

NUVASIVE:

Page 10 of 12

10

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 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. [Bendini function only shown below:]	The NuVasive Bendini Spinal Rod Bending System 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.
Indications for
Use	• 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.		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 interface
and audio.	User Interface: Touch screen, graphical user interface
and 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.

12

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

13

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

14

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.

15

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

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