Who is the manufacturer of NUVASIVE NVM5 SYSTEM?

Nuvasive, Inc. filed the 510(k) submission for NUVASIVE NVM5 SYSTEM (K123307).

What is the FDA product code for NUVASIVE NVM5 SYSTEM?

PDQ. It is classified under 21 CFR 874.1820 as a Class 2 device in the Ear, Nose, Throat panel.

What is the regulatory pathway for NUVASIVE NVM5 SYSTEM?

510(k) clearance (submission type: Traditional).

What are the predicate devices for NUVASIVE NVM5 SYSTEM?

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

Who can help prepare an FDA 510(k) submission like NUVASIVE NVM5 SYSTEM?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

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
Attributes	Real-World Evidence

Real-World Evidence

Submission	Device	Sponsor	RWD Sources	RWE Use Summary	Key Tags
K123307 · Apr 23, 2013	NUVASIVE NVM5 SYSTEM	Nuvasive, Inc.	Published clinical literature (J Neurosurg Spine, 2009; J Neurosurg Spine, 2010)	Clinical literature reporting on large patient cohorts and percutaneous pedicle screw placement was used to demonstrate the substantial equivalence of the NVM5 Guidance function to predicate devices.	Clinical literature; Pedicle screw placement; Guidance function; Substantial equivalence

Clinical Evidence

Study Design	Population	Comparator	Key Endpoints
Placement of thoracolumbar pedicle screws using three-dimensional image guidance: experience in a large patient cohort (J Neurosurg Spine, 2009); Retrospective cohort study	Patients undergoing thoracolumbar pedicle screw placement; Sample Size: Large patient cohort	Not applicable for this study	Accuracy of pedicle screw placement
Accuracy of percutaneous lumbar pedicle screw placement using the oblique or 'owl's-eye' view and novel guidance technology (J Neurosurg Spine, 2010); Retrospective clinical study	Patients undergoing percutaneous lumbar pedicle screw placement	Not applicable for this study	Accuracy of percutaneous lumbar pedicle screw placement

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 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)

{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. - 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. {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. | | | Page 4 of 12 {4}------------------------------------------------ | c A-4-46-6-6-4 | |--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | | | 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 | 26 of 441 Page 5 of 12 {5}------------------------------------------------ NUVASIVE K123307/S01 – NuVusive® NVM5® System Multine MuVusive® NVM50013 27 of 441 Page 6 of 12 {6}------------------------------------------------ 28 of 441 {7}------------------------------------------------ 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 t…

NUVASIVE NVM5 SYSTEM

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