NuVasive Pulse System

K180038 · Nu Vasive, Incorporated · OLO · Jun 29, 2018 · Neurology

Device Facts

• Record ID: K180038
• Device Name: NuVasive Pulse System
• Applicant: Nu Vasive, Incorporated
• Product Code: OLO · Neurology
• Decision Date: Jun 29, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4560
• Device Class: Class 2

Intended Use

The Pulse System is a medical device comprised of Pulse NVM5, Pulse LessRay, and Pulse Navigation. The Pulse NVM5 is intended for intraoperative neurophysiologic monitoring during spinal surgery, neck dissections, thoracic surgeries, and upper and lower extremities. The device provides information directly to the surgeon, to help assess a patient's neurophysiologic status. The Pulse this information by electrically stimulating nerves via electrodes located on surgical accessories and monitoring electromyography (EMG), motor evoked potential (MEP) or somatosensory evoked potential (SSEP) responses of nerves. 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 allows the surgeon to assess moderate degrees of neuromuscular block in effect by evaluating muscle contraction following a train of four stimulation pulses. · MEP - Transcranial or lumbar (i.e., conus in region of L1-L2) stimulation techniques for motor evoked potentials are used to assess for acute dysfunction in axonal conduction of the corticospinal tract and peripheral nerves. The MEP function provides an adjunctive method to allow the surgeon to monitor spinal cord and motor pathway integrity during procedures with a risk of surgically induced motor injury. · SSEP = The SSEP function allows the surgeon to assess sensory spinal cord function in surgical procedures during which the spinal cord is at risk. · Remote Access - The remote monitoring and local wireless control provides real-time capabilities to the Pulse System. · Bendini - The Bendini Spinal Rod Bending function is used to locate spinal implant system instrumentation (screws, hooks) to determine their relative location to one another to generate bend instructions to shape a spinal rod. A surgeon is able to use those instructions and bend a rod using the Bendini Bender, a mechanical rod bender. The Pulse LessRay is intended for use in any application where a fluoroscope is incorporated to aid in diagnosis and treatment of disease. Pulse Navigation is intended as an intraoperative image-guided localization system in either open or minimally-invasive spinal surgical procedures. Instruments and implants tracked by a passive marker sensor system are virtually displayed on a patient's 2D or 3D radiographic image data. The system enables computer-assisted navigation for spinal surgical procedures in which the use of stereotactic surgery may be appropriate and where a reference to a rigid anatomical structure can be identified relative to the acquired image of the anatomy. This may include the following spinal implant procedures: o Pedicle Screw Placement (2D Navigation in Sacral and Lumbar Spine and 3D Navigation in Sacral and Thoracolumbar Spine) o Interbody Device Placement (2D and 3D Navigation in Lumbar Spine via Lateral Approach)

Device Story

Pulse System integrates three modules: NVM5 (neuro-monitoring), LessRay (fluoroscopic image enhancement), and Navigation (image-guided localization). NVM5 uses electrical stimulation via electrodes and EMG/MEP/SSEP monitoring to assess nerve status and neuromuscular block; provides real-time feedback to surgeons. LessRay interfaces with fluoroscopes to enhance low-dose images (noise reduction, contrast/brightness) and tracks C-arm/instruments to guide positioning. Navigation uses an infrared camera to track instruments/implants, superimposing them on 2D/3D radiographic images for trajectory guidance. Used in OR by surgeons; provides real-time intraoperative data to assist in nerve avoidance, implant placement, and rod bending (Bendini). Benefits include reduced radiation exposure via LessRay, improved surgical accuracy via navigation, and real-time monitoring of spinal cord/nerve integrity to prevent injury.

Clinical Evidence

Bench testing only. Includes tracking accuracy verification (ASTM F2554-10), 2D/3D navigation distortion/calibration/segmentation verification, software validation, and cadaver validation for pedicle screw and interbody device placement. No clinical trial data presented.

Technological Characteristics

System includes Patient Module (PM) with digital preamplifier/ADC, computer, and accessory electrodes (Ag-AgCl/hydrogel). Uses optical tracking for navigation. Connectivity via network, CD, DVD, USB. Software performs image processing (averaging, enhancement) and navigation. Compliant with IEC 60601-1.

Indications for Use

Indicated for intraoperative neurophysiologic monitoring during spinal surgery, neck dissections, thoracic surgeries, and upper/lower extremity procedures; intraoperative image-guided localization for open or minimally-invasive spinal surgery (e.g., pedicle screw/interbody device placement); and fluoroscopic image enhancement for diagnostic/treatment applications.

Regulatory Classification

Identification

A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.

Predicate Devices

• NuVasive Next Generation NVM5 System (K162313)
• LessRay System (K173314)
• StealthStation S8 Spine Software V1.0.0 (K170011)
• NuVasive Navigation Instruments (K172623)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION".

June 29, 2018

NuVasive, Incorporated Olga Lewis Regulatory Affairs Senior Manager 7475 Lusk Blvd. San Diego, California 92121

Re: K180038

Trade/Device Name: NuVasive® Pulse™ System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO, PDQ, ETN, GWF, HAW, IKN, OWB, LLZ, JAA Dated: May 31, 2018 Received: June 1, 2018

Dear Olga Lewis:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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.

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Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# Mark N. Melkerson -S

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

510(k) Number (if known) K180038

Device Name NuVasive® Pulse™ System

### Indications for Use (Describe)

The Pulse System is a medical device comprised of Pulse NVM5, Pulse LessRay, and Pulse Navigation. The Pulse NVM5 is intended for intraoperative neurophysiologic monitoring during spinal surgery, neck dissections, thoracic surgeries, and upper and lower extremities. The device provides information directly to the surgeon, to help assess a patient's neurophysiologic status. The Pulse this information by electrically stimulating nerves via electrodes located on surgical accessories and monitoring electromyography (EMG), motor evoked potential (MEP) or somatosensory evoked potential (SSEP) responses of nerves. 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 allows the surgeon to assess moderate degrees of neuromuscular block in effect by evaluating muscle contraction following a train of four stimulation pulses.

· MEP - Transcranial or lumbar (i.e., conus in region of L1-L2) stimulation techniques for motor evoked potentials are used to assess for acute dysfunction in axonal conduction of the corticospinal tract and peripheral nerves. The MEP function provides an adjunctive method to allow the surgeon to monitor spinal cord and motor pathway integrity during procedures with a risk of surgically induced motor injury.

· SSEP = The SSEP function allows the surgeon to assess sensory spinal cord function in surgical procedures during which the spinal cord is at risk.

· Remote Access - The remote monitoring and local wireless control provides real-time capabilities to the Pulse System.

· Bendini - The Bendini Spinal Rod Bending function is used to locate spinal implant system instrumentation (screws, hooks) to determine their relative location to one another to generate bend instructions to shape a spinal rod. A surgeon is able to use those instructions and bend a rod using the Bendini Bender, a mechanical rod bender.

The Pulse LessRay is intended for use in any application where a fluoroscope is incorporated to aid in diagnosis and treatment of disease.

Pulse Navigation is intended as an intraoperative image-guided localization system in either open or minimally-invasive spinal surgical procedures. Instruments and implants tracked by a passive marker sensor system are virtually displayed on a patient's 2D or 3D radiographic image data. The system enables computer-assisted navigation for spinal surgical procedures in which the use of stereotactic surgery may be appropriate and where a reference to a rigid anatomical structure can be identified relative to the acquired image of the anatomy.

This may include the following spinal implant procedures:

o Pedicle Screw Placement (2D Navigation in Sacral and Lumbar Spine and 3D Navigation in Sacral and Thoracolumbar Spine)

o Interbody Device Placement (2D and 3D Navigation in Lumbar Spine via Lateral Approach)

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/4/Picture/0 description: The image shows the logo for Nuvasive. The logo consists of a stylized leaf shape on the left, with the word "NUVASIVE" in gray letters to the right of the leaf. The leaf is split into two colors, purple and gray.

## 510(k) Summary

## K180038

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

#### A. Submitted by:

Olga Lewis Senior Manager, Regulatory Affairs NuVasive, Incorporated 7475 Lusk Blvd. San Diego, California 92121 Telephone: [phone]

Date Prepared: June 29, 2018

#### B. Device Name

| Proprietary Name: | NuVasive® Pulse™ System |
|-----------------------|---------------------------------------------------------------------------------------------------------|
| Common or Usual Name: | Neurological Surgical Monitor;<br>Image-intensified fluoroscopic x-ray system<br>Stereotaxic instrument |
| Classification Name: | Stereotaxic Instrument |
| Device Class: | Class II |
| Classification: | 21 CFR §882.4560 |
| Product Code: | OLO, PDQ, ETN, GWF, HAW, IKN, OWB, LLZ, JAA |

#### Predicate Devices C.

The subject NuVasive Pulse System is substantially equivalent to the primary predicate NuVasive Next Generation NVM5 System (K162313). It is also substantially equivalent to the additional predicate devices LessRay System (K173314), StealthStation S8 Spine Software V1.0.0 (K170011), and NuVasive Navigation Instruments (K172623).

#### D. Device Description

The Pulse System is a medical device consisting of Pulse NVM5, Pulse LessRay, and Pulse Navigation. The Pulse System hardware includes a Patient Module (PM) and computer, as well as accompanying accessory components.

The Pulse NVM5 is a medical device that is intended for intraoperative neurological monitoring and status assessment during spinal surgery. The device provides information directly to the surgeon, to help assess a patient's neurological status. The Pulse NVM5 provides this information by electrically stimulating nerves via electrodes located on surgical accessories and monitoring electromyography (EMG), motor evoked potential (MEP) or somatosensory evoked potential (SSEP) responses of the muscle groups innervated by the 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 Pulse NVM5 System includes a software function that measures spinal parameters and acquires the location of spinal implants (screws, hooks) to assist the surgeon in

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bending spinal rods (Bendini). Lastly, the Pulse NVM5 provides Remote Access in two pathways, Local Wireless Control and Remote Monitoring.

LessRay is a software application which can be interfaced to a fluoroscope with a video cable. The images produced by the fluoroscope are transmitted to a frame grabber in the computer running LessRay where the images are enhanced and then displayed. When used in connection with the low dose and/or pulse setting on the fluoroscope, the user can improve the quality (clarity, contrast, noise level, and usability') of a noisy (low-quality) image. Using this system, much of the graininess of low radiation dose images can be eliminated. This allows for greater utility of low dose imaging." LessRay provides the additional feature of being able to interface LessRay with a tracking system in order to aid the C-arm technician in positioning the fluoroscope between the various views of the patient necessary for the intervention. LessRay with Tracking ensures that the fluoroscope is centered over the correct anatomy prior to taking any additional x-ray images.

LessRay System has additional capability of instrument tracking to aid the user in positioning an instrument using prior baseline x-rays. A tracker is attached to the instrument and as the instrument moves, the tracking system connected to LessRay tracks the location of the instrument. LessRay System uses this information to aid the user in positioning the instrument.

Pulse Navigation is a stereotactic surgical application intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. It is intended for intraoperative image-guided localization which allows for surgical instruments to be tracked in three dimensional space. The device provides real-time information directly to the surgeon, enabling the surgeon to evaluate the instrument depth and trajectory for computer-assisted navigation during spine surgery. Instruments are tracked in three dimensional space with an Infrared (IR) Camera, being virtually displayed and superimposed on registered radiographic images. Radiographic images can be either 2D fluoroscopic images (C-arm) or 3D intraoperative scan (CT or Cone Beam CT).

#### E. Indications for Use

The Pulse System is a medical device comprised of Pulse NVM5, Pulse LessRay, and Pulse Navigation.

The Pulse NVM5 is intended for intraoperative neurophysiologic monitoring spinal surgery, neck dissections, thoracic surgeries, and upper and lower extremities. The device provides information directly to the surgeon, to help assess a patient's neurophysiologic status. The Pulse NVM5 provides this information by electrically stimulating nerves via electrodes located on surgical accessories and monitoring electromyography (EMG), motor evoked potential (MEP) or somatosensory evoked potential (SSEP) responses of nerves. 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.

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Image /page/6/Picture/1 description: The image shows the logo for Nuvasive. The logo consists of a stylized leaf shape on the left, with the word "NUVASIVE" in gray letters to the right of the leaf. The leaf shape is divided into two parts, with the top part being a darker purple color and the bottom part being a lighter gray color. The logo is simple and modern, and the colors are muted and professional.

- . Free Run EMG - The Free Run EMG function identifies spontaneous EMG activity of spinal nerves by continually displaying a live stream waveform of any mechanically induced myotome contractions.
- . Twitch Test (Train of Four) - The Twitch Test Function allows the surgeon to assess moderate degrees of neuromuscular block in effect by evaluating muscle contraction following a train of four stimulation pulses.
- MEP Transcranial or lumbar (i.e., conus in region of L1-L2) stimulation techniques for . motor evoked potentials are used to assess for acute dysfunction in axonal conduction of the corticospinal tract and peripheral nerves. The MEP function provides an adjunctive method to allow the surgeon to monitor spinal cord and motor pathway integrity during procedures with a risk of surgically induced motor injury.
- . SSEP - The SSEP function allows the surgeon to assess sensory spinal cord function in surgical procedures during which the spinal cord is at risk.
- . Remote Access - The remote monitoring and local wireless control provides real-time capabilities to the Pulse System.
- Bendini The Bendini Spinal Rod Bending function is used to locate spinal implant . system instrumentation (screws, hooks) to determine their relative location to one another to generate bend instructions to shape a spinal rod. A surgeon is able to use those instructions and bend a rod using the Bendini Bender, a mechanical rod bender.

The Pulse LessRay is intended for use in any application where a fluoroscope is incorporated to aid in diagnosis and treatment of disease.

Pulse Navigation is intended as an intraoperative image-guided localization system in either open or minimally-invasive spinal surgical procedures. Instruments and implants tracked by a passive marker sensor system are virtually displayed on a patient's 2D or 3D radiographic image data. The system enables computer-assisted navigation for spinal surgical procedures in which the use of stereotactic surgery may be appropriate and where a reference to a rigid anatomical structure can be identified relative to the acquired image of the anatomy.

This may include the following spinal implant procedures:

- O Pedicle Screw Placement (2D Navigation in Sacral and Lumbar Spine and 3D Navigation in Sacral and Thoracolumbar Spine)
- Interbody Device Placement (2D and 3D Navigation in Lumbar Spine via Lateral O Approach)

#### F. Technological Characteristics

As was established in this submission, the subject Pulse System is substantially equivalent to other predicate devices cleared by the FDA for commercial distribution in the United States. The subject device was shown to be substantially equivalent and have equivalent technological characteristics to its predicate device through comparison in areas including design, intended use, material composition, and functions.

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Image /page/7/Picture/0 description: The image shows the logo for Nuvasive. The logo consists of a stylized leaf shape in purple and gray, followed by the word "NUVASIVE" in gray sans-serif font. The logo is simple and modern, with a focus on the company name.

# Table 1 – Comparison of Technical Characteristics

| Specification/<br>Property | Predicate Device<br>NuVasive Next Generation NVM5 System<br>(K162313) | Predicate Device<br>LessRay System (K173314) | Predicate Device<br>StealthStation S8 Spine Software v1.0.0<br>(Medtronic- K170011) | Subject Device<br>Pulse System |
|---------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use /<br>Indications for Use | The Next Generation NVM5® System is a medical device<br>that is intended for intraoperative neurophysiologic<br>monitoring during spinal surgery, neck dissections,<br>thoracic surgeries, and upper and lower extremities. The<br>device provides information directly to the surgeon, to<br>help assess a patient's neurophysiologic status. NVM5<br>provides this information by electrically stimulating<br>nerves via electrodes located on surgical accessories and<br>monitoring electromyography (EMG), transcranial or<br>lumbar motor evoked potential (MEP) or somatosensory<br>evoked potential (SSEP) responses of nerves. The<br>System also integrates Bendini™ software used to locate<br>spinal implant instrumentation for the placement of<br>spinal rods.<br>XLIF (Detection) – The XLIF (Detection) function<br>allows the surgeon to locate and evaluate spinal<br>nerves, and is used as a nerve avoidance tool. Basic & Dynamic Screw Test – The Screw Test<br>functions allow the surgeon to locate and evaluate<br>spinal nerves by providing proximity information<br>before, during or after bone preparation and<br>placement of bone screws. Free Run EMG – The Free Run EMG function<br>identifies spontaneous EMG activity of spinal nerves<br>by continually displaying a live stream waveform of<br>any mechanically induced myotome contractions. Twitch Test (Train of Four) - The Twitch Test<br>Function allows the surgeon to assess moderate<br>degrees of neuromuscular block in effect by<br>evaluating muscle contraction following a train of<br>four stimulation pulses. MEP – Transcranial or lumbar (i.e., conus in region<br>of L1-L2) stimulation techniques for motor evoked<br>potentials are used to assess for acute dysfunction in<br>axonal conduction of the corticospinal tract and<br>peripheral nerves. The MEP function provides an<br>adjunctive method to allow the surgeon to monitor<br>spinal cord and motor pathway integrity during<br>procedures with a risk of surgically induced motor<br>injury. | LessRay System is intended for use in any application<br>where a fluoroscope is incorporated to aid in diagnosis<br>and treatment of disease. | The StealthStation System is intended as an aid for precisely<br>locating anatomical structures in either open or percutaneous<br>procedures.<br>The StealthStation® System, with StealthStation Spine<br>Software, is intended as an aid for precisely locating<br>anatomical structures in either open or percutaneous<br>neurosurgical and orthopedic procedures. Their use is<br>indicated for any medical condition in which the use of<br>stereotactic surgery may be appropriate, and where reference<br>to a rigid anatomical structure, such as the spine or pelvis, can<br>be identified relative to images of the anatomy.<br>This can include the following spinal implant procedures,<br>such as: Pedicle Screw Placement Iliosacral Screw Placement Interbody Device Placement | The Pulse System is a medical device comprised of Pulse NVM5,<br>Pulse LessRay, and Pulse Navigation.<br>The Pulse NVM5 is a medical device that is intended for<br>intraoperative neurophysiologic monitoring during spinal surgery,<br>neck dissections, thoracic surgeries, and upper and lower<br>extremities. The device provides information directly to the<br>surgeon, to help assess a patient's neurophysiologic status. Pulse<br>NVM5 provides this information by electrically stimulating nerves<br>via electrodes located on surgical accessories and monitoring<br>electromyography (EMG), transcranial or lumbar motor evoked<br>potential (MEP) or somatosensory evoked potential (SSEP)<br>responses of nerves. The System also integrates Bendini™ software<br>used to locate spinal implant instrumentation for the placement of<br>spinal rods. XLIF (Detection) – The XLIF (Detection) function allows the<br>surgeon to locate and evaluate spinal nerves, and is used as a<br>nerve avoidance tool. Basic & Dynamic Screw Test - The Screw Test functions allow<br>the surgeon to locate and evaluate spinal nerves by providing<br>proximity information before, during or after bone preparation<br>and placement of bone screws. Free Run EMG - The Free Run EMG function identifies<br>spontaneous EMG activity of spinal nerves by continually<br>displaying a live stream waveform of any mechanically induced<br>myotome contractions. Twitch Test (Train of Four) – The Twitch Test Function allows<br>the surgeon to assess moderate degrees of neuromuscular block<br>in effect by evaluating muscle contraction following a train of<br>four stimulation pulses. MEP - Transcranial or lumbar (i.e., conus in region of L1-L2)<br>stimulation techniques for motor evoked potentials are used to<br>assess for acute dysfunction in axonal conduction of the<br>corticospinal tract and peripheral nerves. The MEP function<br>provides an adjunctive method to allow the surgeon to monitor<br>spinal cord and motor pathway integrity during procedures with<br>a risk of surgically induced motor injury. SSEP – The SSEP function allows the surgeon to assess sensory<br>spinal cord function in surgical procedures during which the<br>spinal cord is at risk. |
| Specification/<br>Property | Predicate Device<br>NuVasive Next Generation NVM5 System<br>(K162313) | Predicate Device<br>LessRay System (K173314) | Predicate Device<br>StealthStation S8 Spine Software v1.0.0<br>(Medtronic- K170011) | Subject Device<br>Pulse System |
| Intended Use /<br>Indications for Use<br>(Continued) | • SSEP - The SSEP function allows the surgeon to<br>assess sensory spinal cord function in surgical<br>procedures during which the spinal cord is at risk.<br>• Remote Access - The remote monitoring and local<br>wireless control provides real-time capabilities to the<br>NG NVM5 System for additional physicians.<br>• Bendini - The Bendini Spinal Rod Bending function<br>is used to to locate spinal implant system<br>instrumentation (screws, hooks) to determine their<br>relative location to one another to generate bend<br>instructions to shape a spinal rod. A surgeon is able<br>to use those instructions and bend a rod using the<br>Bendini Bender, a mechanical rod bender. | | | • Remote Access - The remote monitoring and local wireless<br>control provides real-time capabilities to the Pulse System<br>• Bendini - The Bendini Spinal Rod Bending function is used to<br>locate spinal implant system instrumentation (screws, hooks) to<br>determine their relative location to one another to generate<br>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<br>mechanical rod bender<br>The Pulse LessRay is intended for use in any application where a<br>fluoroscope is incorporated to aid in diagnosis and treatment of<br>disease.<br>Pulse Navigation is intended as an intraoperative image-guided<br>localization system in either open or minimally-invasive spinal<br>surgical procedures. Instruments and implants tracked by a passive<br>marker sensor system are virtually displayed on a patient's 2D or<br>3D radiographic image data. The system enables computer-assisted<br>navigation for spinal surgical procedures in which the use of<br>stereotactic surgery may be appropriate and where a reference to a<br>rigid anatomical structure can be identified relative to the acquired<br>image of the anatomy. This may include the following spinal<br>implant procedures:<br>o Pedicle Screw Placement (2D Navigation in Sacral and<br>Lumbar Spine and 3D Navigation in Sacral and<br>Thoracolumbar Spine)<br>o Interbody Device Placement (2D and 3D Navigation in<br>Lumbar Spine via Lateral Approach) |
| Device Class | II | II | II | II |
| Product Code | PDQ, ETN, GWF, HAW, IKN, OLO, | OWB, LLZ, JAA | OLO | OLO, PDQ, ETN, GWF, HAW, IKN, OWB, LLZ,<br>JAA |
| Regulation Number<br>(21CFR) | §874.1820, §882.1870, §882.4560,<br>§890.1375 | §892.1650 | §882.4560 | §882.4560, §874.1820, §882.1870, §890.1375,<br>§892.1650, |
| Device<br>Classification<br>Name | Surgical nerve stimulator/locator; Evoked<br>response electrical stimulator;<br>Neurological stereotaxic instrument;<br>Electromyography (EMG) monitor/stimulator | Image-intensified fluoroscopic x-ray system | Stereotaxic Instrument | Surgical nerve stimulator/locator; Evoked response<br>electrical stimulator;<br>Neurological stereotaxic instrument;<br>Electromyography (EMG) monitor/stimulator<br>Image-intensified fluoroscopic x-ray system;<br>Stereotaxic Instrument |
| Specification/<br>Property | Predicate Device<br>NuVasive Next Generation NVM5 System<br>(K162313) | Predicate Device<br>LessRay System (K173314) | Predicate Device<br>StealthStation S8 Spine Software v1.0.0<br>(Medtronic- K170011) | Subject Device<br>Pulse System |
| Functionalities | • XLIF Detection<br>• Basic & Dynamic Screw Test<br>• Free Run EMG<br>• Twitch Test (Train of Four)<br>• MEP<br>• SSEP<br>• Remote Access<br>• Bendini<br>• NuvaMap O.R.<br>• NuvaLine spinal parameter assessment<br>tools - Opti…