NUVASIVE NVM5 SYSTEM

K123307 · Nuvasive, Inc. · PDQ · Apr 23, 2013 · Ear, Nose, Throat

Device Facts

• Record ID: K123307
• Device Name: NUVASIVE NVM5 SYSTEM
• Applicant: Nuvasive, Inc.
• Product Code: PDQ · Ear, Nose, Throat
• Decision Date: Apr 23, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.1820
• Device Class: Class 2

Intended 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 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. 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 (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.

Device Story

NVM5 System is an intraoperative neurophysiologic monitoring device for spinal surgery. It uses disposable electrodes and probes to deliver electrical stimulation to nerves and record EMG, TcMEP, and SSEP responses. The system includes an integrated stereotactic guidance module (using accelerometers and C-arm reticle markers) to assist in pedicle screw placement and Bendini software to calculate spinal rod bending instructions based on implant locations. A Remote Reader application allows secondary physicians to view data outside the OR. The system processes signals to provide real-time waveforms, proximity alerts, and trajectory guidance to the surgeon. It is operated by surgeons and clinical staff to assess neurophysiologic status, avoid nerve injury, and guide instrumentation placement, potentially reducing surgical complications.

Clinical Evidence

Bench testing only. Verification and validation testing included electrical safety (IEC 60601-1, 60601-2-40, 60601-1-2), software regression, and performance verification of the Bendini function. Guidance accuracy was supported by clinical literature (J Neurosurg Spine 2009, 2010) comparing the technology to predicate systems for lumbosacral pedicle screw placement.

Technological Characteristics

Hardware includes Patient Module, computer, and disposable electrodes/probes. Sensing: EMG, TcMEP, SSEP, and angular sensing (accelerometers). Connectivity: Networked for remote monitoring. Software: Integrated modules for guidance, rod bending, and nerve monitoring. Sterilization: Validated to SAL 10^-6. Standards: IEC 60601-1, IEC 60601-1-2.

Indications for Use

Indicated for intraoperative neurophysiologic monitoring during spinal surgery in adult patients. Guidance function indicated for open or percutaneous pedicle cannulation (L1-S1).

Regulatory Classification

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.

Predicate Devices

• NVM5 System (K112718)
• Bendini Spinal Rod Bending System (K122742)
• StealthStation (K050438)
• VectorVision Trauma (K012448)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for Nuvasive. The logo consists of a stylized leaf-like shape on the left, followed by the word "NUVASIVE" in bold, sans-serif font. Below the company name is the tagline "Speed of Innovation" in a smaller font size.

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

### 510(k) Summary

In accordance with Title 21 of the Code of Federal Regulations, Part 807, and in particular 21 CFR §807.92, the following summary of information is provided:

#### Submitted by: A.

Sheila Bruschi Manager, Regulatory Affairs NuVasive, Incorporated 7475 Lusk Blvd. San Diego, California 92121 Telephone: [phone]

Date Prepared: March 13, 2013

#### Device Name B.

| Trade or Proprietary Name: | NuVasive® NVM5® System |
|----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common or Usual Name: | Neurological surgical monitor;<br>Stereotaxic Instrument |
| Classification Name: | Surgical Nerve Stimulator/Locator;<br>Evoked response electrical stimulator;<br>Neurological stereotaxic instrument;<br>Electromyography (EMG) monitor/stimulator |
| Device Class: | Class II |
| Classification: | §874.1820, §882.1870, §882.4560, §890.1375 |
| Product Code: | PDO. ETN, GWF, HAW, IKN, OLO |

#### C. Predicate Devices

The subject NuVasive NVM5 System is substantially equivalent to one or more of the following predicate devices listed in Table 1 below.

| Table 1 – Predicate Devices | | |
|-----------------------------|-------------------------------------|----------------|
| 510(k) | Trade or proprietary or model name | Manufacturer |
| K112718 | NVM5 System | NuVasive, Inc. |
| K122742 | BendiniTM Spinal Rod Bending System | NuVasive, Inc. |
| K050438 | StealthStation | Medtronic |
| K012448 | VectorVision Trauma | BrainLAB |

#### 1 هاhام Tahle Predicate Devices

#### D. Device Description

NVM5 System is a medical device that is intended for intraoperative neurophysiologic monitoring during spinal surgery. The device provides information directly to the surgeon, to help assess a patient's neurophysiologic status. NVM5 provides this information by electrically stimulating nerves via electrodes located on surgical accessories and monitoring electromyography (EMG), transcranial motor evoked potential (TcMEP) or somatosensory evoked potential (SSEP) responses of nerves. Moreover, a Twitch Test ("Train of Four") function is utilized to test the ability of the nerve to respond, or contract, following four stimulation pulses to determine the presence of neuromuscular block.

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Image /page/1/Picture/0 description: The image shows the logo for Nuvasive. The logo consists of a stylized, abstract shape on the left, resembling a curved, incomplete circle. To the right of the shape is the word "NUVASIVE" in bold, sans-serif font. Below "NUVASIVE" is the tagline ":Speed of Innovation" in a smaller, italicized font.

Additionally, the NVM5 System includes an integrated stereotactic guidance system (NVM5 Guidance) to support the delivery of pedicle screws during EMG monitoring. The System also integrates Bendini™ software used to locate spinal implant instrumentation for the placement of spinal rods. Lastly, the system also offers an optional screen sharing application (Remote Monitoring) to allow a secondary physician to remotely view the events represented on the NVM5 user interface. In summary, the NVM5 System includes the following six (6) software functionalities / modalities:

- 1. Electromyography (EMG)
- Transcranial Motor Evoked Potential (TceMEP), or simply MEP 2.
- Somatosensory Evoked Potential (SSEP) 3.
- 4. Guidance
- 5. Bendini
- Remote Monitoring 6.

The NVM5 System hardware consists of a Patient Module (PM) and computer, as well as accompanying accessory components which consist of an assortment of disposable conductive probes, electrodes, and electrode leads.

#### Intended Use E.

The NVM5 System is a medical device that is intended for intraoperative neurophysiologic monitoring during spinal surgery. The device provides information directly to the surgeon, to help assess a patient's neurophysiologic status. NVM5 provides this information by electrically stimulating nerves via electrodes located on surgical accessories and monitoring electromyography (EMG), transcranial motor evoked potential (TceMEP) or somatosensory evoked potential (SSEP) responses of nerves. The System also integrates Bendini" software used to locate spinal implant instrumentation for the placement of spinal rods.

- XLIF (Detection) The XLIF (Detection) function allows the surgeon to locate and . evaluate spinal nerves, and is used as a nerve avoidance tool.
- . Basic & Dynamic Screw Test - The Screw Test functions allow the surgeon to locate and evaluate spinal nerves by providing proximity information before, during or after bone preparation and placement of bone screws.
- Free Run EMG The Free Run EMG function identifies spontaneous EMG activity of . spinal nerves by continually displaying a live stream waveform of any mechanically induced myotome contractions.
- Twitch Test (Train of Four) The Twitch Test Function allows the surgeon to assess · � moderate degrees of neuromuscular block in effect by evaluating muscle contraction following a train of four stimulation pulses.
- TceMEP Transcranial stimulation techniques for motor evoked potentials are used to . assess for acute dysfunction in axonal conduction of the corticospinal tract. The TceMEP function provides an adjunctive method to allow the surgeon to monitor spinal cord and motor pathway integrity during procedures with a risk of surgically induced motor injury.
- SSEP -- The SSEP function allows the surgeon to assess sensory spinal cord function in . surgical procedures during which the spinal cord is at risk.

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Image /page/2/Picture/0 description: The image shows the logo for Nuvasive. The logo consists of a stylized leaf-like shape on the left, followed by the word "NUVASIVE" in a sans-serif font. Below the word "NUVASIVE" is the tagline ":Speed of Innovation" in a smaller font size.

- Remote Reader ~ The Remote Reader function provides real time remote access to the NVM5 System for a monitoring physician outside of the operating room.
- . Guidance - The Guidance function is intended as an aid for use in either open or percutaneous pedicle cannulation procedures in the lumbar and sacral spine (L1-S1) of adult patients, and when used in conjunction with radiographic imaging and EMG, allows the surgeon to assess the angulation of system accessories relative to patient spinal anatomy for the creation of a cannulation trajectory for bone screw placement.
- . Bendini - The Bendini Spinal Rod Bending function is used to locate spinal implant system instrumentation (screws, hooks) to determine their relative location to one another to generate bend instructions to shape a spinal rod. A surgeon is able to use those instructions and bend a rod using the Bendini Bender, a mechanical rod bender.

#### F. Technological Characteristics

As was established in this submission, the subject NVM5 System is substantially equivalent to other predicate devices cleared by the FDA for commercial distribution in the United States. The subject device was shown to be substantially equivalent and have equivalent technological characteristics to its predicate devices through comparison in areas including design, intended use, material composition, and functions. The technological differences within this 510(k) that were shown to be substantially equivalent to the predicates include:

- Addition of Red/Yellow/Green background alerts to the SSEP Function .
- Addition of the Bendini function (equivalent to predicate Bendini System K122742), ● and
- Use of the NVM5 System with NuVasive-supplied compatible computer. .

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NUVASIVE:

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

| Specification/<br>Property | Subject Device | Predicate Device | Substantially<br>Equivalent? |
|------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use /<br>Indications for<br>Use | The <i>NVM5</i> System is a medical device that is intended for intraoperative<br>neurophysiologic monitoring during spinal surgery. The device provides information<br>directly to the surgeon, to help assess a patient's neurophysiologic status. <i>NVMS</i> provides<br>this information by electrically stimulating nerves via electrodes located on surgical<br>accessories and monitoring electromyography (EMG), transcranial motor evoked potential<br>(TceMEP) or somatosensory evoked potential (SSEP) responses of nerves. The System<br>also integrates Bendini™ software used to locate spinal implant instrumentation for the<br>placement of spinal rods. | The <i>NVM5</i> System is a medical device that is intended for intraoperative<br>neurophysiologic monitoring during spinal surgery. The device provides<br>information directly to the surgeon, to help assess a patient's neurophysiologic<br>status. <i>NVMS</i> provides this information by electrically stimulating nerves via<br>electrodes located on surgical accessories and monitoring electromyography<br>(EMG), transcranial motor evoked potential (TCMEP) or somatosensory<br>evoked potential (SSEP) responses of nerves. | YES.<br>The differences in the<br>Indications do not result<br>in a new intended use and<br>do not alter the intended<br>therapeutic effect or<br>impact safety/<br>effectiveness as the<br>Bendini indications are<br>identical to those cleared<br>in K122742; and<br>Guidance indications<br>were only expanded to<br>include the S1 level of<br>the spine. |
| | • XLIF (Detection) - The XLIF (Detection) function allows the surgeon to locate and<br>evaluate spinal nerves, and is used as a nerve avoidance tool. | XLIF (Detection) - The XLIF (Detection) function allows the surgeon to<br>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<br>and evaluate spinal nerves by providing proximity information before, during or after<br>bone preparation and placement of bone screws. | Basic & Dynamic Screw Test - The Screw Test functions allow the surgeon<br>to locate and evaluate spinal nerves by providing proximity information<br>before, during or after bone preparation and placement of bone screws. | |
| | • Free Run EMG - The Free Run EMG function identifies spontaneous EMG activity of<br>spinal nerves by continually displaying a live stream waveform of any mechanically<br>induced myotome contractions. | Free Run EMG - The Free Run EMG function identifies spontaneous EMG<br>activity of spinal nerves by continually displaying a live stream waveform<br>of any mechanically induced myotome contractions. | |
| | • Twitch Test (Train of Four) - The Twitch Test Function allows the surgeon to assess<br>moderate degrees of neuromuscular block in effect by evaluating muscle contraction<br>following a train of four stimulation pulses. | Twitch Test (Train of Four) - The Twitch Test Function allows the surgeon<br>to assess moderate degrees of neuromuscular block in effect by evaluating<br>muscle contraction following a train of four stimulation pulses. | |
| | • TceMEP - Transcranial stimulation techniques for motor evoked potentials are used to<br>assess for acute dysfunction in axonal conduction of the corticospinal tract. The<br>TceMEP function provides an adjunctive method to allow the surgeon to monitor<br>spinal cord and motor pathway integrity during procedures with a risk of surgically<br>induced motor injury. | TCMEP - Transcranial stimulation techniques for motor evoked potentials<br>are used to assess for acute dysfunction in axonal conduction of the<br>corticospinal tract. The TcMEP function provides an adjunctive method to<br>allow the surgeon to monitor spinal cord motor pathway integrity during<br>procedures with a risk of surgically induced motor injury. | |
| | • SSEP - The SSEP function allows the surgeon to assess sensory spinal cord function<br>in surgical procedures during which the spinal cord is at risk. | SSEP- The SSEP function allows the surgeon to assess sensory spinal cord<br>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<br>NVM5 System for a monitoring physician outside of the operating room. | Remote Reader - The Remote Reader function provides real time remote<br>access to the NVM5 System for a monitoring physician outside of the<br>operating room. | |
| | • Guidance - The Guidance function is intended as an aid for use in either open or<br>percutaneous pedicle cannulation procedures in the lumbar and sacral spine (L1-S1) of<br>adult patients, and when used in conjunction with radiographic imaging and EMG,<br>allows the surgeon to assess the angulation of system accessories relative to patient<br>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<br>percutaneous pedicle cannulation procedures in the lumbar spine of adult<br>patients, and when used in conjunction with radiographic imaging and<br>EMG, allows the surgeon to assess the angulation of system accessories<br>relative to patient spinal anatomy for the creation of a cannulation trajectory<br>for bone screw placement. | |
| | • Bendini - The Bendini Spinal Rod Bending function is used to locate spinal implant<br>system instrumentation (screws, hooks) to determine their relative location to one<br>another to generate bend instructions to shape a spinal rod. A surgeon is able to use<br>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/<br>Property | Subject Device<br>NuVasive NVM5 System | Predicate Device<br>NuVasive NVM5 System (K112718) | March 15, 2013<br>Substantially<br>Equivalent? | |
|--------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------|
| Software<br>Functionalities/<br>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.<br>Bendini function<br>was cleared in<br>510(k) K122742,<br>and verification<br>testing demonstrated<br>use with the NVM5<br>System. | |
| Algorithms | Identical algorithms as predicate, with additional algorithms for SSEP<br>Auto and Bendini functions | XLIF Detection Basic & Dynamic Screw Test Free Run EMG Twitch Test (Train of Four) TceMEP SSEP Guidance | Yes.<br>Bendini algorithm is<br>substantially<br>equivalent to<br>predicate 510(k)<br>K122742. | |
| Total Available<br>Channels | 32 | 32 | Yes | |
| Headbox/<br>Patient Module<br>IEC 60601-1<br>Compliant | Yes | Yes | Yes | |
| Full Scale View<br>Range | $\pm 0.5\mu V$ to $\pm 8mV$ | $\pm 0.5\mu V$ to $\pm 8mV$ | Yes | |
| Frequency<br>Response | 3 Hz to 4.8 kHz | 3 Hz to 4.8 kHz | Yes | |
| User Interface | NuVasive-supplied computer with<br>optional touch screen and/or keyboard/mouse | Control Unit: Touch screen and [optional] keyboard/mouse | Yes | |
| Remote<br>Monitoring | Yes | Yes | Yes | |
| Train of Four<br>Testing | Yes | Yes | Yes | |
| Needle<br>Electrodes | Various (Identical to predicate) | Various | Yes | |
| Surface<br>Electrodes | Various (Identical to predicate) | Various | Yes | |
| Electrode Leads | Various (Identical to predicate) | Various | Yes | |
| Specification/<br>Property | Subject Device<br>NuVasive NVM5 System | Predicate Device<br>NuVasive NVM5 System (K112718) | Substantially<br>Equivalent? | |
| Stimulating<br>Probes | Various (Identical to predicate) | Various | Yes | |
| Recording<br>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<br>Threshold Values<br>for Color Alerts<br>Audio feedback | Automatic Stimulation<br>Yes (Identical to predicate)<br>Yes | Automatic Stimulation | Yes | |
| Types of Modes<br>Threshold Values<br>for Color Alerts<br>Audio feedback | Automatic Stimulation<br>Yes (Identical to predicate)<br>Yes | Basic & Dynamic Screw Test | Yes | |
| Types of Modes<br>Threshold Values<br>for Color Alert<br>Audio feedback | Manual Stimulation<br>Yes (Identical to predicate)<br>Yes | Free Run EMG | Yes | |
| Types of Modes<br>Threshold Values<br>for Color Alerts<br>Audio feedback | Manual and Automatic Stimulation<br>Yes (Identical to predicate)<br>Yes | Twitch Test (Train of Four) | Yes | |
| Types of Modes<br>Threshold Values<br>for Color Alerts<br>Audio feedback | Manual and Automatic Stimulation<br>Yes (Identical to predicate)<br>Yes | TceMEP | Yes | |
| Types of Modes<br>Threshold Values<br>for Color Alerts<br>Audio feedback | Manual and Automatic Stimulation<br>Yes (Identical to predicate)<br>Yes | Manual and Automatic Stimulation | Yes | |
| Specification/<br>Property | Subject Device<br>NuVasive NVM5 System | Predicate Device<br>NuVasive NVM5 System (K112718) | | Substantially<br>Equivalent? |
| Types of Modes | | | Manual Stimulation | |
| Threshold Values<br>for Color Alerts | Manual Stimulation | No | | Yes |
| Audio feedback | Yes | No | | Waveform output is<br>the same regardless<br>of background color.<br>Yes.<br>Waveform output is<br>the same regardless<br>of audio feedback. |
| Number of<br>Recording<br>Channels | | | 10 | Yes |
| Response<br>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<br>During Artifact | | | Yes | Yes |
| Stimulation<br>Waveform | | | Rectangular, Monophasic Pulse | Yes |
| Constant<br>Current/Voltage | | | Yes | Yes |
| Theoretical Max<br>Voltage | | | 300 V | Yes |
| Max Current | | | 0.09 A | Yes |
| Max Pulse Width | | | 0.0002 sec | Yes |
| Max Number of<br>Pulses per second | | | 5 | Yes |
| Min Probe Surface<br>Area | | | 0.169 cm² | Yes |

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NUVASIVE

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

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

| Specification/<br>Property | Subject Device<br>NuVasive NVM5 System.<br>Guidance. | Predicate Devices<br>Medtronic StealthStation®<br>(K050438) | BrainLAB VectorVision® Trauma<br>(K012448) | Substantially<br>Equivalent |
|----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------|
| Indications<br>for Use | The Guidance function is<br>intended as an aid for use in either<br>open or percutaneous pedicle<br>cannulation procedures in the<br>lumbar and sacral spine (LI-S1)<br>of adult patients, and when used<br>in conjunction with radiographic<br>imaging and EMG, allows the<br>surgeon to assess the angulation<br>of system accessories relative to<br>patient spinal anatomy for the<br>creation of a cannulation<br>trajectory for bone screw<br>placement. | The StealthStation® System is<br>intended as an aid for precisely<br>locating anatomical structures in<br>either open or percutaneous<br>procedures. The StealthStation<br>System is indicated for any<br>medical condition in which the use<br>of stereotactic surgery may be<br>appropriate, and where reference to<br>a rigid anatomical structure, such<br>as the skull, a long bone, or<br>vertebra, can be identified relative<br>to a CT or MR based model,<br>fluoroscopy images, or digitized<br>landmarks of the anatomy.<br>( <i>Note: For the purposes of this<br/>predicate comparison the full<br/>indications have been limited.</i> ) | BrainLAB VectorVision® Trauma is<br>intended to be a pre- and intraoperative<br>image guided localization system to<br>enable minimally invasive surgery. It<br>links a freehand probe, tracked by a<br>passive marker sensor system to virtual<br>computer image space on a patient's<br>pre- or intraoperative image data being<br>processed by a Vector Vision<br>workstation. The system is indicated<br>for any medical condition in which the<br>use of stereotactic surgery may be<br>appropriate and where a reference to a<br>rigid anatomical structure, such as the<br>skull, a bone structure like tubular<br>bones, pelvic, calcaneus and talus, or<br>vertebra, can be identified relative to a<br>CT, fluoroscopic, X-ray, or MR based<br>model of the anatomy.<br>Example procedures include but are not<br>limited to:<br>Spinal procedures and spinal implant<br>procedures such as pedicle screw<br>placement....( <i>Note: For the purposes of<br/>this predicate comparison the full indications<br/>have been limited.</i> ) | Yes - the Guidance<br>function has limited<br>indications compared<br>to the predicate. |
| Clinical Use | Requires input derived<br>from CT, MRI, or<br>radiographic images Intended to assist the<br>surgeon in cannulating the<br>pedicle based on user<br>predefined trajectory Integrated with EMG<br>stimulation | Requires input derived from<br>CT, MRI, or radiographic<br>images Intended to assist the<br>surgeon in cannulating the<br>pedicle based on user<br>predefined trajectory Integrated with EMG<br>stimulation | Requires input derived from CT,<br>MRI, or radiographic images Intended to assist the surgeon in<br>cannulating the pedicle based on<br>user predefined trajectory | Yes |
| | NuVasive NVM5 System<br>Guidance (K112718) | | | |
| | The Guidance function is<br>intended as an aid for use in<br>either open or percutaneous<br>pedicle cannulation procedures<br>in the lumbar spine of adult<br>patients, and when used in<br>conjunction with radiographic<br>imaging and EMG, allows the<br>surgeon to assess the angulation<br>of system accessories relative to<br>patient spinal anatomy for the<br>creation of a cannulation<br>trajectory for bone screw<br>placement. | | | |
| | Requires input derived<br>from CT, MRI, or<br>radiographic images Intended to assist the<br>surgeon in cannulating the<br>pedicle based on user<br>predefined trajectory Integrated with EMG<br>stimulation | | | |

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

| "Spead of Innovation<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>1<br>CALLARIA | Photos The Comments of Consistentify of the Street Comments of the States<br>A PERSONAL PROPERTY PROPERTY PROPERTY PROPERTY PROPERTY PROPERTY PROPERTY PROPERTY PROPERTY PROPERTY PROPERTY PROPERTY PRODUCTION PRODUCTION CONTRACTION CONTRACTION CONTRACTI |
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| Specification/<br>Property | Subject Device<br>NuVasive NVM5 System<br>Guidance | NuVasive NVM5 System.<br>Guidance (K112718)" | Predicate Devices<br>Medtronic StealthStation®<br>(K050438) | BrainLAB Vector Vision® Trauma<br>(K012448) | Substantially<br>Equivalent |
|-----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Scientific<br>Principles | References angular sensing<br>technology coupled with<br>associated tracking<br>instruments Utilizes a C-Arm Reticle<br>with radio dense markers Uses accelerometers to<br>sense angular<br>measurements based on<br>gravity by collecting 2<br>degrees of freedom (DOF)<br>(rx, ry) data Displays instrument<br>orientation only (rotational<br>information in the x and y<br>planes only) with respect to<br>gravity | References angular<br>sensing technology<br>coupled with associated<br>tracking instruments Utilizes a C-Arm Reticle<br>with radio dense markers Uses accelerometers to<br>sense angular<br>measurements based on<br>gravity by collecting 2<br>degrees of freedom (DOF)<br>(rx, ry) data Displays instrument<br>orientation only<br>(rotational information in<br>the x and y planes only)<br>with respect to gravity | References angular and<br>position sensing technology<br>coupled with associated<br>tracking instruments Utilizes a C-Arm Reticle<br>with radio dense markers Uses infrared technology to<br>capture positional and<br>rotational information via 6<br>DOF (x, y, z; rx, ry, rz) data Displays the location and<br>orientation (positional and<br>rotational information in the<br>x, y, and z planes) of<br>instruments in real time<br>merged with pre-operatively<br>obtained images of patient<br>anatomy | References angular and position<br>sensing technology coupled with<br>associated tracking instruments Utilizes a C-Arm Reticle with<br>radio dense markers Uses infrared t…