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 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 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).

AI/ML Overview

The NuVasive Pulse System is comprised of Pulse NVM5, Pulse LessRay, and Pulse Navigation. The provided text details the indications for use and technological characteristics but lacks specific quantitative acceptance criteria or detailed study results for all components. However, it does mention nonclinical testing and a specific study related to the LessRay component.

Here's a breakdown of the requested information based on the provided text, focusing on the available details:

1. Table of Acceptance Criteria and Reported Device Performance

Component/Function	Acceptance Criteria	Reported Device Performance
LessRay (Image quality improvement)	Not explicitly stated as a quantitative metric in acceptance criteria, but implied to improve perceived image quality.	"As evaluated by a human observer in a side by side visual comparison of 30 image pairs with and without LessRay processing." The text states that LessRay allows for "greater utility of low dose imaging" by eliminating much of the graininess of low radiation dose images, implying improved image clarity, contrast, and noise level. The system "meets software requirements defined for the system and satisfies same acceptance criteria as the performance of the predicate device."
Pulse System (Overall)	Meets design specifications and performance characteristics, and satisfies acceptance criteria equivalent to predicate devices.	Nonclinical tests (tracking accuracy, accessories attachment, 2D/3D navigation distortion/calibration, navigation software validation, cadaver validation, system integration) were performed. Results showed that the Pulse System "meets software requirements defined for the system and satisfies same acceptance criteria as the performance of the predicate device."

2. Sample Size Used for the Test Set and Data Provenance

For the LessRay image quality evaluation:

Sample Size (Test Set): 30 image pairs.
Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).

For the overall Pulse System nonclinical testing:

Sample Size (Test Set): Not specified for each test.
Data Provenance: Not specified beyond being "nonclinical testing." Cadaver validation implies ex-vivo data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

For the LessRay image quality evaluation:

Number of Experts: Described as "a human observer." It's unclear if this was a single person or multiple individuals, and their qualifications are not provided (e.g., radiologist with X years of experience).

For other components of the Pulse System:

Number of Experts: Not specified.
Qualifications of Experts: Not specified.

4. Adjudication Method for the Test Set

For the LessRay image quality evaluation:

Adjudication Method: "Side by side visual comparison." No mention of formal adjudication like 2+1 or 3+1.

For other components of the Pulse System:

Adjudication Method: Not specified.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

MRMC Study: No explicit mention of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study to measure how much human readers improve with AI vs. without AI assistance. The LessRay evaluation mentions "a human observer" comparing image pairs, which suggests a single observer, not an MRMC study.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

The documentation mentions various software functionalities and algorithms (e.g., XLIF Detection, Basic & Dynamic Screw Test, LessRay's averaging algorithm, contrast/brightness enhancement). Nonclinical testing involved "software validation" and "tracking accuracy verification." This implies that standalone algorithm performance was assessed as part of the overall system validation, but specific results for the algorithm only (without human-in-the-loop) are not provided separately or in detail showing what performance was achieved for each algorithm.

7. The Type of Ground Truth Used

For LessRay's image quality, the ground truth was based on a "human observer's" subjective visual perception of improved clarity, contrast, and noise level in comparison to unprocessed images.
For the navigation components, "cadaver validation" was performed for 2D and 3D navigation for pedicle screw and interbody device placement, suggesting anatomical accuracy as a ground truth.
For other components (NVM5 functionalities, tracking accuracy), the ground truth would likely be established through engineering measurements against design specifications and physical tests.

8. The Sample Size for the Training Set

The document primarily describes validation and verification testing for regulatory submission (510(k)). It does not provide details on sample sizes for any training sets used for developing the algorithms within the Pulse System.

9. How the Ground Truth for the Training Set Was Established

Since details on training sets are not provided, the method for establishing ground truth for training data is also not available in this document.

Summary

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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)

· XLIF (Detection) – The XLIF (Detection) function allows the surgeon to locate and evaluate spinal nerves, and is used as a nerve avoidance tool.

· 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.

· 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.

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

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: (858) 909-1800

Date Prepared: June 29, 2018

B. Device Name

Proprietary Name:	NuVasive® Pulse™ System
Common or Usual Name:	Neurological Surgical Monitor;Image-intensified fluoroscopic x-ray systemStereotaxic 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

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.

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.

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/Property	Predicate DeviceNuVasive Next Generation NVM5 System(K162313)	Predicate DeviceLessRay System (K173314)	Predicate DeviceStealthStation S8 Spine Software v1.0.0(Medtronic- K170011)	Subject DevicePulse System
Intended Use /Indications for Use	The Next Generation NVM5® System is a medical devicethat is intended for intraoperative neurophysiologicmonitoring during spinal surgery, neck dissections,thoracic surgeries, and upper and lower extremities. Thedevice provides information directly to the surgeon, tohelp assess a patient's neurophysiologic status. NVM5provides this information by electrically stimulatingnerves via electrodes located on surgical accessories andmonitoring electromyography (EMG), transcranial orlumbar motor evoked potential (MEP) or somatosensoryevoked potential (SSEP) responses of nerves. TheSystem also integrates Bendini™ software used to locatespinal implant instrumentation for the placement ofspinal rods.XLIF (Detection) – The XLIF (Detection) functionallows the surgeon to locate and evaluate spinalnerves, and is used as a nerve avoidance tool. Basic & Dynamic Screw Test – The Screw Testfunctions allow the surgeon to locate and evaluatespinal nerves by providing proximity informationbefore, during or after bone preparation andplacement of bone screws. Free Run EMG – The Free Run EMG functionidentifies spontaneous EMG activity of spinal nervesby continually displaying a live stream waveform ofany mechanically induced myotome contractions. Twitch Test (Train of Four) - The Twitch TestFunction allows the surgeon to assess moderatedegrees of neuromuscular block in effect byevaluating muscle contraction following a train offour stimulation pulses. MEP – Transcranial or lumbar (i.e., conus in regionof L1-L2) stimulation techniques for motor evokedpotentials are used to assess for acute dysfunction inaxonal conduction of the corticospinal tract andperipheral nerves. The MEP function provides anadjunctive method to allow the surgeon to monitorspinal cord and motor pathway integrity duringprocedures with a risk of surgically induced motorinjury.	LessRay System is intended for use in any applicationwhere a fluoroscope is incorporated to aid in diagnosisand treatment of disease.	The StealthStation System is intended as an aid for preciselylocating anatomical structures in either open or percutaneousprocedures.The StealthStation® System, with StealthStation SpineSoftware, is intended as an aid for precisely locatinganatomical structures in either open or percutaneousneurosurgical and orthopedic procedures. Their use isindicated for any medical condition in which the use ofstereotactic surgery may be appropriate, and where referenceto a rigid anatomical structure, such as the spine or pelvis, canbe identified relative to images of the anatomy.This can include the following spinal implant procedures,such as: Pedicle Screw Placement Iliosacral Screw Placement Interbody Device Placement	The Pulse System is a medical device comprised of Pulse NVM5,Pulse LessRay, and Pulse Navigation.The Pulse NVM5 is a medical device that is intended forintraoperative neurophysiologic monitoring during spinal surgery,neck dissections, thoracic surgeries, and upper and lowerextremities. The device provides information directly to thesurgeon, to help assess a patient's neurophysiologic status. PulseNVM5 provides this information by electrically stimulating nervesvia electrodes located on surgical accessories and monitoringelectromyography (EMG), transcranial or lumbar motor evokedpotential (MEP) or somatosensory evoked potential (SSEP)responses of nerves. The System also integrates Bendini™ softwareused to locate spinal implant instrumentation for the placement ofspinal rods. XLIF (Detection) – The XLIF (Detection) function allows thesurgeon to locate and evaluate spinal nerves, and is used as anerve avoidance tool. Basic & Dynamic Screw Test - The Screw Test functions allowthe surgeon to locate and evaluate spinal nerves by providingproximity information before, during or after bone preparationand placement of bone screws. Free Run EMG - The Free Run EMG function identifiesspontaneous EMG activity of spinal nerves by continuallydisplaying a live stream waveform of any mechanically inducedmyotome contractions. Twitch Test (Train of Four) – The Twitch Test Function allowsthe surgeon to assess moderate degrees of neuromuscular blockin effect by evaluating muscle contraction following a train offour stimulation pulses. MEP - Transcranial or lumbar (i.e., conus in region of L1-L2)stimulation techniques for motor evoked potentials are used toassess for acute dysfunction in axonal conduction of thecorticospinal tract and peripheral nerves. The MEP functionprovides an adjunctive method to allow the surgeon to monitorspinal cord and motor pathway integrity during procedures witha risk of surgically induced motor injury. SSEP – The SSEP function allows the surgeon to assess sensoryspinal cord function in surgical procedures during which thespinal cord is at risk.
Specification/Property	Predicate DeviceNuVasive Next Generation NVM5 System(K162313)	Predicate DeviceLessRay System (K173314)	Predicate DeviceStealthStation S8 Spine Software v1.0.0(Medtronic- K170011)	Subject DevicePulse System
Intended Use /Indications for Use(Continued)	• SSEP - The SSEP function allows the surgeon toassess sensory spinal cord function in surgicalprocedures during which the spinal cord is at risk.• Remote Access - The remote monitoring and localwireless control provides real-time capabilities to theNG NVM5 System for additional physicians.• Bendini - The Bendini Spinal Rod Bending functionis used to to locate spinal implant systeminstrumentation (screws, hooks) to determine theirrelative location to one another to generate bendinstructions to shape a spinal rod. A surgeon is ableto use those instructions and bend a rod using theBendini Bender, a mechanical rod bender.			• Remote Access - The remote monitoring and local wirelesscontrol provides real-time capabilities to the Pulse System• Bendini - The Bendini Spinal Rod Bending function is used tolocate spinal implant system instrumentation (screws, hooks) todetermine their relative location to one another to generatebend instructions to shape a spinal rod. A surgeon is able to usethose instructions and bend a rod using the Bendini Bender, amechanical rod benderThe Pulse LessRay is intended for use in any application where afluoroscope is incorporated to aid in diagnosis and treatment ofdisease.Pulse Navigation is intended as an intraoperative image-guidedlocalization system in either open or minimally-invasive spinalsurgical procedures. Instruments and implants tracked by a passivemarker sensor system are virtually displayed on a patient's 2D or3D radiographic image data. The system enables computer-assistednavigation for spinal surgical procedures in which the use ofstereotactic surgery may be appropriate and where a reference to arigid anatomical structure can be identified relative to the acquiredimage of the anatomy. This may include the following spinalimplant procedures:o Pedicle Screw Placement (2D Navigation in Sacral andLumbar Spine and 3D Navigation in Sacral andThoracolumbar Spine)o Interbody Device Placement (2D and 3D Navigation inLumbar 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,JAA
Regulation Number(21CFR)	§874.1820, §882.1870, §882.4560,§890.1375	§892.1650	§882.4560	§882.4560, §874.1820, §882.1870, §890.1375,§892.1650,
DeviceClassificationName	Surgical nerve stimulator/locator; Evokedresponse electrical stimulator;Neurological stereotaxic instrument;Electromyography (EMG) monitor/stimulator	Image-intensified fluoroscopic x-ray system	Stereotaxic Instrument	Surgical nerve stimulator/locator; Evoked responseelectrical stimulator;Neurological stereotaxic instrument;Electromyography (EMG) monitor/stimulatorImage-intensified fluoroscopic x-ray system;Stereotaxic Instrument
Specification/Property	Predicate DeviceNuVasive Next Generation NVM5 System(K162313)	Predicate DeviceLessRay System (K173314)	Predicate DeviceStealthStation S8 Spine Software v1.0.0(Medtronic- K170011)	Subject DevicePulse System
Functionalities	• XLIF Detection• Basic & Dynamic Screw Test• Free Run EMG• Twitch Test (Train of Four)• MEP• SSEP• Remote Access• Bendini• NuvaMap O.R.• NuvaLine spinal parameter assessmenttools - Optional	• Software based device used to providecomputer display systems interfaced tofluoroscope through a video cable. Theimages produced by the fluoroscope aretransmitted through a cable to a framecapture board in the computer where theimages are enhanced and then displayedon the monitor.• Enhanced images are displayed on acomputer monitor at the same time thatthe corresponding original image isdisplayed on the fluoroscope monitor(s).• Uses software to control the framecapture, intermediate imagemanipulation, and subsequent imagedisplay.• The delay between frame acquisitionand frame display is less than the timebetween frames, i.e. 33 msec.• Serves only as an image display whichis in addition to the fluoroscope'sstandard image display device. Deviceis passive, in that the operation dependsonly on the video output of thefluoroscope, and it does not transmit anysignals or images to the fluoroscope.	StealthStation Spine Software functionality isdescribed in terms of its feature sets which arecategorized as imaging modalities, registration,planning, interfaces with medical devices, andviews. Feature sets include functionality thatcontributes to clinical decision making and arenecessary to achieve system performance.	• XLIF Detection• Basic & Dynamic Screw Test• Free Run EMG• Twitch Test (Train of Four)• MEP• SSEP• Remote Access• Bendini• NuvaMap O.R.• NuvaLine spinal parameter assessment tools -Optional• LessRay Image Enhancement• LessRay C-arm tracking• LessRay Instrument Tracking• Navigation: imaging modalities, registration,interfaces with medical devices, and views.
Specification/Property	Predicate DeviceNuVasive Next Generation NVM5 System(K162313)	Predicate DeviceLessRay System (K173314)	Predicate DeviceStealthStation S8 Spine Software v1.0.0(Medtronic- K170011)	Subject DevicePulse System
Algorithms	• XLIF Detection• Basic & Dynamic Screw Test• Free Run EMG• Twitch Test (Train of Four)• MEP• SSEP• Bendini - Rod bending and spinalparameter assessment	• Image quality improvement usingaveraging algorithm• Contrast and brightness enhancementwith simultaneous reduction of randomnoise	Unknown	• XLIF Detection• Basic & Dynamic Screw Test• Free Run EMG• Twitch Test (Train of Four)• MEP• SSEP• Bendini - Rod bending and spinal parameterassessment• Image quality improvement using averagingalgorithm• Contrast and brightness enhancement withsimultaneous reduction of random noise
Total AvailableChannels	32			32
Headbox/ PatientModule	Digital Preamplifier with A/D Converter		Unknown	Digital Preamplifier with A/D Converter
IEC 60601-1Compliant	Yes	Yes	Yes	Yes
User Interface	NuVasive supplied computer with separatetouch screen and/or keyboard/mouse Mobiledevice			NuVasive supplied computer with separate touchscreen and/or keyboard/mouse Mobile device
User Comments	Free form text entry saved with time marks			Free form text entry saved with time marks
Video Inputs	Yes			Yes
NetworkCompatible	Yes			Yes
Embedded Help	Yes			Yes
Artifact Rejection	User Defined and automatic			User Defined and automatic
Remote Access	Remote Access includes Remote ReaderMonitoring Client and Local WirelessControl			Remote Access includes Remote Reader MonitoringClient and Local Wireless Control
Needle Electrodes	Various			Various
Surface Electrodes	Dual Surface Ag-AgCl Film and Hydrogel			Dual Surface Ag-AgCl Film and Hydrogel
EMG Endotrachealtube	Yes with integrated electrodes forintraoperative monitoring			Yes with integrated electrodes for intraoperativemonitoring
Electrode Leads	Various			Various
Specification/Property	Predicate DeviceNuVasive Next Generation NVM5 System(K162313)	Predicate DeviceLessRay System (K173314)	Predicate DeviceStealthStation S8 Spine Software v1.0.0(Medtronic- K170011)	Subject DevicePulse System
Stimulating Probes	Various			Various
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)
Types of Modes	Automatic Stimulation (red/yellow/green)			Automatic Stimulation (red/yellow/green)
Threshold ValuesforRed/Yellow/Green	Yes			Yes
Audio feedback	Yes			Yes
Interpretation foralerts	Green = Nerve in close proximityYellow = Nerve in closer proximityRed = Nerve in very close proximity			Green = Nerve in close proximityYellow = Nerve in closer proximityRed = Nerve in very close proximity
EMG Monitoring	Continuous free running and stimulated(triggered)			Continuous free running and stimulated (triggered)
RecordingChannels	10			10
Audible EMG	Yes			Yes
Automatic MutingDuring Artifact	Yes			Yes
Train of FourTesting	Yes			Yes
MEP Types ofModes	• Alert (red/green) - transcranial MEPonly• Threshold (red/yellow/green)Stimulation - transcranial and lumbarMEP			• Alert (red/green) - transcranial MEP only• Threshold (red/yellow/green) Stimulation -transcranial and lumbar MEP
RecordingChannels	10			10
Specification/Property	Predicate DeviceNuVasive Next Generation NVM5 System(K162313)	Predicate DeviceLessRay System (K173314)	Predicate DeviceStealthStation S8 Spine Software v1.0.0(Medtronic- K170011)	Subject DevicePulse System
AudibleMEP/EMG	Yes			Yes
Automatic MutingDuring Artifact	Yes			Yes
SSEP Types ofModes	Manual Stimulation (SSEP Standard and"SSEP Alert" with automatic colorbackground alerts and anatomicalrepresentation)			Manual Stimulation (SSEP Standard and "SSEPAlert" with automatic color background alerts andanatomical representation)
Threshold ValuesforRed/Yellow/Green	Yes(Green/Yellow only for simplified SSEPHarness and Red/Yellow/Green for StandardSSEP Harness)			Yes(Green/Yellow only for simplified SSEP Harness andRed/Yellow/Green for Standard SSEP Harness)
Audio feedback	Yes			Yes
RecordingChannels	8			8
	Predicate Device	Predicate Device	Predicate Device	Subject Device
Specification/Property	NuVasive Next Generation NVM5 System(K162313)	LessRay System (K173314)	StealthStation S8 Spine Software v1.0.0(Medtronic- K170011)	Pulse System
C-arm Tracking		• When tracking is enabled, willautomatically choose the Baseline when thefluoroscope is near the location andorientation that the Baseline was initiallytaken.		• When tracking is enabled, will automatically choosethe Baseline when the fluoroscope is near thelocation and orientation that the Baseline wasinitially taken.• When tracking is enabled, requires hardware
		• When tracking is enabled, requireshardware components in order to mount theoff-the-shelf tracking hardware to the C-arm and to the operating table.• When tracking is enabled, requires the useof an off-the-shelf tracking system in orderto track the 6 DOF location of the C-armrelative to the operating table. Whentracking is enabled, visual cues areprovided which help guide the user inpositioning the C-arm back to where a priorBaseline was taken.		components in order to mount the off-the-shelftracking hardware to the C-arm and to the operatingtable.• When tracking is enabled, requires the use of an off-the-shelf tracking system in order to track the 6 DOFlocation of the C-arm relative to the operating table.When tracking is enabled, visual cues are providedwhich help guide the user in positioning the C-armback to where a prior Baseline was taken.
Tracking Options		Optical		Optical
InstrumentTracking		NuVasive LessRay System has additionalcapability of instrument tracking to aid theuser in positioning an instrument using priorbaseline x-rays.		Pulse LessRay has additional capability of instrumenttracking to aid the user in positioning an instrumentusing prior baseline x-rays.
Imaging Modalities			X-Ray Based Imaging	X-Ray Based Imaging
RegistrationFeatures			PointMerge RegistrationSurfaceMerge RegistrationFluoroMerge RegistrationAutomatic 2D Image RegistrationAutomatic 3D Image Registration	Automatic 2D Image RegistrationAutomatic 3D Image Registration
Planning Features			Plan Entry and Target Selection3D Model BuildingDeformity Planning	n/a
Specification/Property	Predicate Device	Predicate Device	Predicate Device	Subject Device
NuVasive Next Generation NVM5 System(K162313)	LessRay System (K173314)	StealthStation S8 Spine Software v1.0.0(Medtronic- K170011)	Pulse System
Medical DeviceInterfaces			O-arm Imaging SystemZiehm Vision FD Vario 3D C-ArmISO-C 3D C-ArmOrbic 3D C-Arm	O-arm Imaging SystemZiehm Vision FD Vario 3D C-ArmMobius Airo
View (DisplayFeatures)			Look Sideways3DAnatomic OrthogonalTrajectory 1 and 2Trajectory GuidanceLook AheadProbe's EyeAP and LateralSynthetic AP and LateralMaximum Intensity ProjectionVideo Input	3DAnatomic OrthogonalTrajectory 1 and 2Probe's EyeAP and LateralSynthetic AP and Lateral
Software Interface(GUI)			Basic gray and black style with 4 main tasks andtab interface to access tools. Controls on the right.	Basic gray and black style with tab interface to accesstools and controls.
Scanner InterfaceTechnology (toimaging devices)			Network ConnectivityCD, DVD, USBDICOM ImportDICOM Export	Network ConnectivityCD, DVD, USBDICOM Import
LocalizationTechnology			Optical	Optical

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Image /page/8/Picture/0 description: The image shows the logo for Nuvasive. The logo consists of a stylized leaf-like shape on the left, with the word "NUVASIVE" in gray letters to the right of the shape. The leaf-like shape is split into two colors, with the left side being a dark purple and the right side being gray.

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Image /page/9/Picture/0 description: The image shows the logo for Nuvasive. The logo consists of a stylized purple and gray leaf-like shape on the left, followed by the word "NUVASIVE" in a gray, sans-serif font. The logo is simple and modern, with a focus on the company name.

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Image /page/10/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 company name "NUVASIVE" in gray sans-serif font. The leaf shape is on the left side of the logo, and the company name is on the right.

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Image /page/11/Picture/0 description: The image features the Nuvasive logo. The logo consists of a stylized leaf-like shape on the left, with the word "NUVASIVE" in gray, sans-serif font to the right of the shape. The leaf-like shape is divided into two sections, with the top section in purple and the bottom section in gray.

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Image /page/12/Picture/0 description: The image shows the Nuvasive logo. The logo consists of a stylized leaf shape in purple and gray, followed by the word "NUVASIVE" in gray sans-serif font. The leaf shape is on the left side of the logo, and the word "NUVASIVE" is on the right side.

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Image /page/13/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 leaf shape is split into two parts, with the top part in purple and the bottom part in gray.

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Image /page/14/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, and the colors are muted and professional.

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Image /page/15/Picture/1 description: The image shows the Nuvasive logo. The logo consists of a stylized leaf shape on the left, with the top half of the leaf in purple and the bottom half in gray. To the right of the leaf is the word "NUVASIVE" in gray, with a trademark symbol after the word. The logo is simple and modern, with a clean font and a limited color palette.

G. Performance Data

Nonclinical testing was performed to demonstrate that the subject Pulse System is substantially equivalent to other predicate devices and to verify that the Pulse System meets design specifications and performance characteristics, based upon the intended use. The Pulse System was subjected to the following verification and validation testing according to the software requirements specifications defined for the system.

Tracking accuracy verification per ASTM F2554-10 ●
Accessories attachment verification
2D navigation distortion and calibration verification ●
3D navigation segmentation and tracking error verification
Navigation software validation ●
Cadaver validation for 2D and 3D navigation for pedicle screw and interbody ● device placement
System integration testing ●

The results of these studies showed that the subject Pulse System meets software requirements defined for the system and satisfies same acceptance criteria as the performance of the predicate device. Therefore, subject Pulse System was found to be substantially equivalent.

Conclusions H.

Based on the indications for use, technological characteristics, performance testing, and comparison to predicate devices, the subject Pulse System has been shown to be substantially equivalent to legally marketed predicate devices.

1 As evaluated by a human observer in a side by side visual comparison of 30 image pairs with and without LessRay processing.

ii In clinical practice, the amount of image quality improvement achieved when a Pulsed and/or Low Dose image is processed with LessRay is dependent on the clinical task, patient size, anatomical location, and clinical practice. The dose should be set at a level to which the physician is able to achieve the adequate image quality needed for the particular clinical task. A consultation with a radiologist and a physicist may aid in determining the appropriate dose settings.

Regulation Number and Section

§ 882.4560 Stereotaxic instrument.

(a)
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.(b)
Classification. Class II (performance standards).