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 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.

· 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.

Pulse LessRay is intended for use in any application where a fluoroscope is incorporated to aid 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 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:

Pedicle Screw Placement (cervical, thoracic, lumbar)
Iliosacral screw placement

Device Description

The Pulse System is a medical device consisting of Pulse NVM5, Pulse LessRay, and Pulse Navigation. The Pulse System hardware includes a control unit, 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.

Pulse 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.

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 are in the form of 3D intraoperative scan (CT or Cone Beam CT).

The reason for this submission is to update indications for the Pulse Navigation application and to introduce design modifications to hardware and software components of the Navigation application.

AI/ML Overview

The information provided describes a 510(k) premarket notification for the NuVasive Pulse System. The document focuses on demonstrating substantial equivalence to predicate devices rather than a direct study proving the device meets specific acceptance criteria in the way a clinical trial might. However, it does mention nonclinical testing and comparison points that serve as "acceptance criteria" for demonstrating substantial equivalence.

Here's an attempt to extract and structure the requested information based on the provided text, while noting the limitations of a 510(k) summary regarding detailed study designs:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't provide a formal table of quantitative acceptance criteria with corresponding performance metrics in a pass/fail format for clinical outcomes. Instead, it states that the device was found "substantially equivalent" based on various nonclinical tests meeting product and software requirements specifications and showing equivalence to predicate devices. The closest to a performance metric is for LessRay's image quality improvement.

Acceptance Criteria (Implied)	Reported Device Performance
General
Meets product and software requirements specifications	The subject Pulse System meets product and software requirements defined for the system.
Satisfies same acceptance criteria as predicate device performance	The subject Pulse System satisfies the same acceptance criteria as the performance of the predicate device.
Navigation Functionality
Tracking accuracy verification per ASTM F2554-10	Testing demonstrated compliance with ASTM F2554-10.
3D navigation registration and tracking error verification	Testing successfully verified 3D navigation registration and tracking error.
Navigation software validation	Navigation software validation was successfully completed.
Cadaver validation for 3D navigation for pedicle screw placement	Cadaver validation for 3D navigation for pedicle screw placement was successfully completed.
Navigation system accuracy performance	The system's accuracy performance was demonstrated.
Electrical Safety and EMC
Electrical safety and EMC testing per IEC 60601	Testing demonstrated compliance with IEC 60601.
LessRay Image Enhancement
Image quality improvement (clarity, contrast, noise, usability)	Improves the quality of noisy (low-quality) images, eliminating much of the graininess of low radiation dose images. (As evaluated by a human observer in a side-by-side visual comparison of 30 image pairs).

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

LessRay Image Enhancement: A "side by side visual comparison of 30 image pairs with and without LessRay processing" was performed.
Other tests (Tracking accuracy, 3D navigation registration, cadaver validation): The document does not specify the sample sizes for these test sets.
Data Provenance: Not explicitly stated, but given the context of FDA submission, these would typically be internal company data from non-clinical lab settings, potentially using phantoms or cadavers. There is no mention of country of origin for the data or whether it was retrospective or prospective in detail, beyond being pre-market nonclinical testing.

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

LessRay Image Enhancement: Evaluated by "a human observer." No specific number or qualifications of experts (e.g., radiologist with 10 years of experience) are provided beyond "human observer."
Other tests: Not specified.

4. Adjudication Method for the Test Set

Not specified for any of the tests.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study is not explicitly mentioned or detailed in this 510(k) summary. The evaluation for LessRay was a "side by side visual comparison of 30 image pairs" by "a human observer," which does not constitute a full MRMC study for comparative effectiveness with human readers with and without AI assistance. The focus is on demonstrating substantial equivalence rather than comparative effectiveness.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

The document describes the "Pulse System" as a medical device for intraoperative monitoring and navigation, implying human-in-the-loop operation.
For LessRay, the "image quality improvement" assessment itself appears to be a standalone evaluation of the algorithm's output (processed image vs. unprocessed image) that is then visually evaluated by a human. However, this is not a diagnostic performance study of the algorithm providing a final interpretation without human intervention.
The "Tracking accuracy verification" and "3D navigation registration and tracking error verification" would primarily assess the standalone technical performance of the algorithms.

7. The Type of Ground Truth Used

LessRay Image Enhancement: The ground truth for "image quality improvement" appears to be subjective visual assessment by a human observer.
Navigation / Tracking Accuracy: For "Tracking accuracy verification per ASTM F2554-10" and "3D navigation registration and tracking error verification," the ground truth would likely be established by precise measurements from a known reference standard (e.g., precise phantom coordinates, highly accurate measurement systems).
Cadaver validation for 3D navigation for pedicle screw placement: The ground truth would involve confirmatory imaging (e.g., post-placement CT scans) and potentially dissection to verify pedicle screw placement relative to anatomical structures.
Electrical safety and EMC: Ground truth would be adherence to established industry standards like IEC 60601.

8. The Sample Size for the Training Set

The document is a 510(k) summary focused on substantial equivalence and nonclinical performance testing. It does not provide information on the training set size for any AI/algorithm components within the system (e.g., LessRay's enhancement algorithm or navigation algorithms).

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

Since information on the training set itself is not provided, the method for establishing its ground truth is also not detailed.

Summary

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NuVasive, Incorporated Emily Chung Regulatory Affairs 7475 Lusk Boulevard San Diego, California 92121

Re: K210574

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: June 28, 2021 Received: June 29, 2021

Dear Emily Chung:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Shumaya Ali, M.P.H. Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K210574

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.

· 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

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

This may include the following spinal implant procedures:

Pedicle Screw Placement (cervical, thoracic, lumbar)
Iliosacral screw placement

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

Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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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 in purple and gray, followed by the word "NUVASIVE" in a light gray sans-serif font. The leaf shape is split into two parts, with the top part in purple and the bottom part in gray.

510(k) Summary

K210574

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:

Manthan J. Damani Manager, Regulatory Affairs NuVasive, Incorporated 7475 Lusk Blvd. San Diego, California 92121 Telephone: (858) 909-1800

Date Prepared: July 28, 2021

B. Device Name

Proprietary Name:	NuVasive® Pulse™ System
Common or Usual Name:	Stereotaxic Instrument;Neurological Surgical Monitor;Image-intensified fluoroscopic x-ray system.
Classification Name:	Stereotaxic Instrument
Device Class:	Class II
Regulation Number:	21 CFR §882.4560
Classification Product Code:	OLO
Subsequent Product Codes:	PDO, ETN, GWF, HAW, IKN, OWB, LLZ, JAA

C. Predicate Devices

The subject NuVasive Pulse System is substantially equivalent to the primary predicate NuVasive Pulse System (K180038). It is also substantially equivalent to the additional predicate devices StealthStation S8 Spine Software V1.0.0 (K170011), and NuVasive Navigation.S Instruments (K200719).

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 control unit, as well as accompanying accessory components.

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Image /page/5/Picture/1 description: The image shows the logo for Nuvasive. The logo consists of a stylized leaf shape in purple and gray on the left, followed by the word "NUVASIVE" in gray. The leaf shape is partially shaded to give it a three-dimensional appearance.

("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.

The reason for this submission is to update indications for the Pulse Navigation application and to introduce design modifications to hardware and software components of the Navigation application.

E. Indications for Use

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

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.

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Image /page/6/Picture/1 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 gray, sans-serif font. The leaf shape is partially purple and partially gray, with the purple portion appearing to be on top of the gray portion.

. 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.
. 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.

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:

Pedicle Screw Placement (cervical, thoracic, lumbar) l
트 Iliosacral screw placement

Technological Characteristics F.

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 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 contains the logo for Nuvasive. The logo consists of a purple and gray abstract shape resembling a stylized leaf or curved shape on the left. To the right of the shape, the word "NUVASIVE" is written in gray, sans-serif font.

Table 1 – Comparison of Technical Characteristics

Specification/Property	Predicate DeviceNuVasive Pulse System(K180038)	Predicate DeviceStealthStation S8 Spine Software v1.0.0(K170011)	Subject DevicePulse System
Intended Use /Indications for Use	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 spinalsurgery, neck dissections, thoracic surgeries, and upper andlower extremities. The device provides information directly tothe surgeon, to help assess a patient's neurophysiologicstatus. Pulse NVM5 provides this information by electricallystimulating nerves via electrodes located on surgical accessoriesand monitoring electromyography (EMG), transcranial orlumbar motor evoked potential (MEP) or somatosensoryevoked potential (SSEP) responses of nerves. The System alsointegrates Bendini™ software used to locate spinal implantinstrumentation for the placement of spinal rods.• XLIF (Detection) – The XLIF (Detection) function allowsthe surgeon to locate and evaluate spinal nerves, and is usedas a nerve avoidance tool.• Basic & Dynamic Screw Test - The Screw Test functionsallow the surgeon to locate and evaluate spinal nerves byproviding proximity information before, during or after bonepreparation and 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 mechanicallyinduced myotome contractions.• Twitch Test (Train of Four) – The Twitch Test Functionallows the surgeon to assess moderate degrees ofneuromuscular block in effect by evaluating musclecontraction 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 usedto assess for acute dysfunction in axonal conduction of thecorticospinal tract and peripheral nerves. The MEP functionprovides an adjunctive method to allow the surgeon tomonitor spinal cord and motor pathway integrity duringprocedures with a risk of surgically induced motor injury.• SSEP - The SSEP function allows the surgeon to assesssensory spinal cord function in surgical procedures duringwhich the spinal cord is at risk.	The StealthStation System is intended as anaid for precisely locating anatomicalstructures in either open or percutaneousprocedures.The StealthStation® System, withStealthStation Spine Software, is intended asan aid for precisely locating anatomicalstructures in either open or percutaneousneurosurgical and orthopedic procedures.Their use is indicated for any medicalcondition in which the use of stereotacticsurgery may be appropriate, and wherereference to a rigid anatomical structure, suchas the spine or pelvis, can be identifiedrelative to images of the anatomy.This can include the following spinal implantprocedures, 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.Pulse NVM5 is a medical device that is intended forintraoperative neurophysiologic monitoring during spinalsurgery, neck dissections, thoracic surgeries, and upper andlower extremities. The device provides information directly tothe surgeon, to help assess a patient's neurophysiologicstatus. Pulse NVM5 provides this information by electricallystimulating nerves via electrodes located on surgical accessoriesand monitoring electromyography (EMG), transcranial orlumbar motor evoked potential (MEP) or somatosensoryevoked potential (SSEP) responses of nerves. The System alsointegrates Bendini™ software used to locate spinal implantinstrumentation for the placement of spinal rods.• XLIF (Detection) – The XLIF (Detection) function allowsthe surgeon to locate and evaluate spinal nerves, and is usedas a nerve avoidance tool.• Basic & Dynamic Screw Test - The Screw Test functionsallow the surgeon to locate and evaluate spinal nerves byproviding proximity information before, during or after bonepreparation and 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 mechanicallyinduced myotome contractions.• Twitch Test (Train of Four) – The Twitch Test Functionallows the surgeon to assess moderate degrees ofneuromuscular block in effect by evaluating musclecontraction 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 usedto assess for acute dysfunction in axonal conduction of thecorticospinal tract and peripheral nerves. The MEP functionprovides an adjunctive method to allow the surgeon tomonitor spinal cord and motor pathway integrity duringprocedures with a risk of surgically induced motor injury.• SSEP – The SSEP function allows the surgeon to assesssensory spinal cord function in surgical procedures duringwhich the spinal cord is at risk.
Specification/Property	Predicate DeviceNuVasive Pulse System(K180038)	Predicate DeviceStealthStation S8 Spine Software v1.0.0(K170011)	Subject DevicePulse System
	• Remote Access - The remote monitoring and local wirelesscontrol provides real-time capabilities to the Pulse System		• Remote Access - The remote monitoring and local wirelesscontrol provides real-time capabilities to the Pulse System
	• Bendini – The Bendini Spinal Rod Bending function is usedto locate spinal implant system instrumentation (screws,hooks) to determine their relative location to one another togenerate bend instructions to shape a spinal rod. A surgeonis able to use those instructions and bend a rod using theBendini Bender, a mechanical rod bender		• Bendini – The Bendini Spinal Rod Bending function is usedto locate spinal implant system instrumentation (screws,hooks) to determine their relative location to one another togenerate bend instructions to shape a spinal rod. A surgeonis able to use those instructions and bend a rod using theBendini Bender, a mechanical rod bender
Intended Use /Indications for Use(Continued)	The Pulse LessRay is intended for use in any application wherea fluoroscope is incorporated to aid in diagnosis and treatmentof disease.		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 apassive marker sensor system are virtually displayed on apatient's 2D or 3D radiographic image data. The systemenables computer-assisted navigation for spinal surgicalprocedures in which the use of stereotactic surgery may beappropriate and where a reference to a rigid anatomicalstructure can be identified relative to the acquired image of theanatomy.This may include the following spinal implant procedures: oPedicle Screw Placement (2D Navigation in Sacral and LumbarSpine and 3D Navigation in Sacral and Thoracolumbar Spine)o Interbody Device Placement (2D and 3D Navigation inLumbar Spine via Lateral Approach)		Pulse Navigation is intended as an intraoperative image-guidedlocalization system in either open or minimally-invasive spinalsurgical procedures. Instruments and implants tracked by apassive marker sensor system are virtually displayed on apatient's 3D radiographic image data. The system enablescomputer-assisted navigation for spinal surgical procedures inwhich the use of stereotactic surgery may be appropriate andwhere a reference to a rigid anatomical structure can beidentified relative to the acquired image of the anatomy.This may include the following spinal implant procedures:o Pedicle Screw Placement (cervical, thoracic, lumbar)o Iliosacral screw placement
Device Class	II	II	II
Product Code	OLO, PDQ, ETN, GWF, HAW, IKN, OWB, LLZ, JAA	OLO	OLO, PDQ, ETN, GWF, HAW, IKN, OWB, LLZ, JAA
RegulationNumber (21CFR)	§882.4560, §874.1820, §882.1870, §890.1375, §892.1650	§882.4560	§882.4560, §874.1820, §882.1870, §890.1375, §892.1650
DeviceClassificationName	Stereotaxic Instrument;Surgical nerve stimulator/locator; Evoked response electricalstimulator;Neurological stereotaxic instrument; Electromyography (EMG)monitor/stimulator;Image-intensified fluoroscopic x-ray system.	Stereotaxic Instrument	Stereotaxic Instrument;Surgical nerve stimulator/locator; Evoked response electricalstimulator;Neurological stereotaxic instrument; Electromyography (EMG)monitor/stimulator;Image-intensified fluoroscopic x-ray system.
	Predicate Device	Predicate Device	Subject Device	Comments/
Specification/Property	NuVasive Pulse System(K180038)	StealthStation S8 Spine Software v1.0.0(K170011)	Pulse System	If not identical, SE rationale
Functionalities	1. XLIF Detection2. Basic & Dynamic Screw Test3. Free Run EMG4. Twitch Test (Train of Four)5. MEP6. SSEP7. Remote Access8. Bendini9. NuvaMap O.R.10. NuvaLine spinal parameter assessment tools - Optional11. LessRay Image Enhancement12. LessRay C-arm tracking13. LessRay Instrument Tracking14. Navigation: imaging modalities, registration, interfaceswith medical devices, and views.	15. StealthStation Spine Softwarefunctionality is described in terms of itsfeature sets which are categorized as imagingmodalities, registration, planning, interfaceswith medical devices, and views. Feature setsinclude functionality that contributes toclinical decision making (which includestrajectory projections and save virtual screwpositions) and are necessary to achievesystem performance.	1. XLIF Detection2. Basic & Dynamic Screw Test3. Free Run EMG4. Twitch Test (Train of Four)5. MEP6. SSEP7. Remote Access8. Bendini9. NuvaMap O.R.10. NuvaLine spinal parameter assessment tools - Optional11. LessRay Image Enhancement12. LessRay C-arm tracking13. Navigation: imaging modalities, registration, interfaceswith medical devices, and views; screw planning (screwplacement and trajectory saving).	Substantially Equivalent.The addition of screw planning is the only difference in the subjectPulse System and the predicate Pulse System. The StealthStationS8 predicate allows the user to use trajectory projections and savevirtual screw positions. In the Subject Device these features arereferred to as trajectory saving and screw placement, respectively.Testing has been completed and successfully demonstrated thatthese differences in functionality have no impact on deviceperformance when compared to the predicate device and do notintroduce any new risks or impact any existing risks. Therefore,these differences do not impact safety or effectiveness of thesubject device when compared to the predicate devices.
Algorithms	1. XLIF Detection2. Basic & Dynamic Screw Test3. Free Run EMG4. Twitch Test (Train of Four)5. MEP6. SSEP7. Bendini - Rod bending and spinal parameter assessment8. Image quality improvement using averaging algorithm9. Contrast and brightness enhancement with simultaneousreduction of random noise10. Registration11. Instrument Confirmation	1. Trajectory projections and save virtualscrew positions2. Other algorithm features	1. XLIF Detection2. Basic & Dynamic Screw Test3. Free Run EMG4. Twitch Test (Train of Four)5. MEP6. SSEP7. Bendini - Rod bending and spinal parameter assessment8. Image quality improvement using averaging algorithm9. Contrast and brightness enhancement with simultaneousreduction of random noise10. Registration11. Instrument Confirmation12. Screw planning (screw placement and trajectory saving)	Substantially Equivalent.The addition of screw planning is the only difference in the subjectPulse System and the predicate Pulse System. The StealthStationS8 predicate allows the user to use trajectory projections and savevirtual screw positions. In the Subject Device these features arereferred to as trajectory saving and screw placement, respectively.Testing has been completed and successfully demonstrated thatthese differences in the algorithms have no impact on deviceperformance when compared to the predicate device and do notintroduce any new risks or impact any existing risks. Therefore,these differences do not impact safety or effectiveness of thesubject device when compared to the predicate devices.
Headbox/ PatientModule	Digital Preamplifier with A/D Converter	Unknown	Digital Preamplifier with A/D Converter	Identical
IEC 60601-1Compliant	Yes	Yes	Yes	Identical
Impedance Test	Automatic	Yes	Automatic	Identical
User Interface	NuVasive supplied computer with separate touch screen and/orkeyboard/mouse Mobile device		NuVasive supplied computer with separate touch screen and/orkeyboard/mouse Mobile device	Identical
User Comments	Free form text entry saved with time marks		Free form text entry saved with time marks	Identical
Video Inputs	Yes		Yes	Identical
NetworkCompatible	Yes		Yes	Identical
Embedded Help	Yes		Yes	Identical
Artifact Rejection	User Defined and Automatic		User Defined and Automatic	Identical
Remote Access	Remote Access includes Remote Reader Monitoring Client andLocal Wireless Control		Remote Access includes Remote Reader Monitoring Client andLocal Wireless Control	Identical
Needle Electrodes	Various		Various	Identical
Surface Electrodes	Dual Surface Ag-AgCl Film and Hydrogel		Dual Surface Ag-AgCl Film and Hydrogel	Identical
Specification/Property	Predicate DeviceNuVasive Pulse System(K180038)	Predicate DeviceStealthStation S8 Spine Software v1.0.0(K170011)	Subject DevicePulse System	Comments/If not identical, SE rationale
EMG Endotrachealtube	Yes with integrated electrodes for intraoperative monitoring		Yes with integrated electrodes for intraoperative monitoring	Identical
Electrode Leads	Various		Various	Identical
Stimulating Probes	Various		Various	Identical
EMG
EMG Modalities	3.0XLIF (Detection)4.0Basic & Dynamic Screw Test5.0Free Run EMG6.0Twitch Test (Train of Four)		a) XLIF (Detection)b) Basic & Dynamic Screw Testc) Free Run EMGd) Twitch Test (Train of Four)	Identical
Types of Modes	Automatic Stimulation (red/yellow/green)		Automatic Stimulation (red/yellow/green)	Identical
Threshold ValuesforRed/Yellow/Green	Yes		Yes	Identical
Audio feedback	Yes		Yes	Identical
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	Identical
Types of Modes	Manual Stimulation		Manual Stimulation	Identical
EMG Monitoring	Continuous free running and stimulated (triggered)		Continuous free running and stimulated (triggered)	Identical
Audible EMG	Yes		Yes	Identical
Automatic MutingDuring Artifact	Yes		Yes	Identical
Train of FourTesting	Yes		Yes	Identical
MEP
MEP Types ofModes	1. Alert (red/green) - transcranial MEP only2. Threshold (red/yellow/green) Stimulation – transcranialand lumbar MEP		1. Alert (red/green) - transcranial MEP only2. Threshold (red/yellow/green) Stimulation -3. transcranial and lumbar MEP	Identical
Threshold ValuesforRed/Yellow/Green	Yes		Yes	Identical
Audio feedback	Yes		Yes	Identical
AudibleMEP/EMG	Yes		Yes	Identical
Automatic MutingDuring Artifact	Yes		Yes	Identical
SSEP
SSEP Types ofModes	Manual Stimulation (SSEP Standard and "SSEP Alert" withautomatic color background alerts and anatomicalrepresentation)		Manual Stimulation (SSEP Standard and "SSEP Alert" withautomatic color background alerts and anatomicalrepresentation)	Identical
Threshold ValuesforRed/Yellow/Green	Yes(Green/Yellow only for simplified SSEP Harness andRed/Yellow/Green for Standard SSEP Harness)		Yes(Green/Yellow only for simplified SSEP Harness andRed/Yellow/Green for Standard SSEP Harness)	Identical
	Predicate Device	Predicate Device	Subject Device
Specification/Property	NuVasive Pulse System(K180038)	StealthStation S8 Spine Software v1.0.0(K170011)	Pulse System
Audio feedback	Yes		Yes
		LessRay
	• When tracking is enabled, LessRay will automatically choosethe Baseline when the fluoroscope is near the location andorientation that the Baseline was initially taken.• When tracking is enabled, LessRay requires hardware		•When tracking is enabled, Pulse LessRay will automaticallychoose the Baseline when the fluoroscope is near the locationand orientation that the Baseline was initially taken.•When tracking is enabled, Pulse LessRay requires hardware
C-arm Tracking	components in order to mount the tracking hardware to the C-arm and to the operating table.		components in order to mount the tracking hardware to the C-arm and to the operating table.
	• When tracking is enabled, LessRay requires the use of an off-the-shelf tracking system in order to track the 6 DOF locationof the C-arm relative to the operating table. When tracking isenabled, visual cues are provided which help guide the user inpositioning the C-arm back to where a prior Baseline wastaken.		•When tracking is enabled, Pulse LessRay requires the use ofan off-the-shelf tracking system in order to track the 6 DOFlocation of the C-arm relative to the operating table. Whentracking is enabled, visual cues are provided which help guidethe user in positioning the C-arm back to where a priorBaseline was taken.
Tracking Options	Optical		Optical
InstrumentTracking	Pulse LessRay has additional capability of instrument trackingto aid the user in positioning an instrument using prior baselinex-rays.		Pulse LessRay has additional capability of instrument trackingto aid the user in positioning an instrument using prior baselinex-rays.
		Navigation
Imaging Modalities	X-Ray Based Imaging	X-Ray Based Imaging	X-Ray Based Imaging
RegistrationFeatures	Automatic 2D Image RegistrationAutomatic 3D Image Registration	PointMerge RegistrationSurfaceMerge RegistrationFluoroMerge RegistrationAutomatic 2D Image RegistrationAutomatic 3D Image Registration	Automatic 3D Image Registration
Planning Features	n/a	Plan Entry and Target Selection3D Model BuildingDeformity Planning	Screw planning (screw placement and trajectory saving)	The SprojectiontheseTestingthese devicesperformanceintroducingthesestudies
Specification/Property	Predicate DeviceNuVasive Pulse System(K180038)	Predicate DeviceStealthStation S8 Spine Software v1.0.0(K170011)	Subject DevicePulse System
Medical DeviceInterfaces	O-arm Imaging SystemZiehm Vision FD Vario 3D C-ArmMobius Airo	O-arm Imaging SystemZiehm Vision FD Vario 3D C-ArmISO-C 3D C-ArmSiemens Orbic 3D C-Arm	O-arm Imaging SystemZiehm Vision RFD 3D C-ArmSiemens Cios Spin
View (DisplayFeatures)	3DAnatomic OrthogonalTrajectory 1 and 2Probe's EyeAP and LateralSynthetic AP and Lateral	Look Sideways3DAnatomic OrthogonalTrajectory 1 and 2Trajectory GuidanceLook AheadProbe's EyeAP and LateralSynthetic AP and LateralMaximum Intensity ProjectionVideo Input	3DAxial CT (Trajectory 1)Sagittal CT (Trajectory 2)Probe's EyeAxial DRRSagittal DRR (Synthetic Lateral)Coronal DRR (Synthetic AP)
Software Interface(GUI)	Basic grey and black style with tab interface to access tools andcontrols.	Basic gray and black style with 4 main tasksand tab interface to access tools. Controls onthe right.	Basic grey and black style with tab interface to access tools andcontrols.
Scanner InterfaceTechnology (toimaging devices)	Network ConnectivityCD, DVD, USBDICOM Import	Network ConnectivityCD, DVD, USBDICOM ImportDICOM Export	Network ConnectivityUSBDICOM Import
Specification/Property	Predicate DeviceNuVasive Pulse System(K180038)	Predicate DeviceStealthStation S8 Spine Software v1.0.0(K170011)	Subject DevicePulse System
LocalizationTechnology	Optical	Optical	Optical

If not identical, SE rationale

Substantially Equivalent.

ng has been completed and successfully demonstrated that lifferences in indications for use have no impact on device rmance when compared to the predicate device and do not luce any new risks or impact any existing risks. Therefore, e differences do not impact safety or effectiveness of the ubject device when compared to the predicate devices.

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Image /page/8/Picture/0 description: The image features the logo of Nuvasive, a medical device company. The logo consists of a stylized leaf-like shape in purple and gray, positioned to the left of the company name, "NUVASIVE," which is written in gray, sans-serif font. The overall design is clean and modern, reflecting the company's focus on innovation in the medical field.

If not identical, SE rationale Identical tical (Incorporates all product codes) ( tical (Incorporates all regulation numbers)

tical (Incorporates all Device Classification Names)

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Image /page/9/Picture/0 description: The image contains the logo for Nuvasive. The logo consists of a stylized leaf-like shape in purple and gray, followed by the word "NUVASIVE" in gray. The leaf shape is abstract and modern, and the text is in a simple, sans-serif font.

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Image /page/10/Picture/0 description: The image shows the logo for Nuvasive. The logo consists of a stylized purple and gray graphic on the left, followed by the word "NUVASIVE" in gray, sans-serif font. The graphic appears to be an abstract representation of a leaf or a curved shape, with the purple portion on top and the gray portion on the bottom.

Traditional 510(k) Premarket Notification

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Image /page/11/Picture/0 description: The image contains the logo for "NUVASIVE". The logo consists of a stylized purple and gray graphic on the left, followed by the word "NUVASIVE" in gray, sans-serif font. The graphic appears to be an abstract shape, possibly representing a leaf or a stylized letter. The overall design is clean and modern.

Comments/If not identical, SE rationale
Identical
Identical
Identical
Identical
Identical
Identical
Substantially Equivalent.
The StealthStation S8 predicate allows the user to use trajectory sections and save virtual screw positions. In the Subject Device these features are referred to as trajectory saving and screw placement, respectively.
Testing has been completed and successfully demonstrated that differences in the planning features have no impact on device performance when compared to the predicate device and do not introduce any new risks or impact any existing risks. Therefore, these differences do not impact safety or effectiveness of the subject device when compared to the predicate devices.

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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 partially purple and partially gray, with the purple portion appearing to be on top of the gray portion.

Comments/ If not identical, SE rationale

Substantially Equivalent.

e Siemens Cios Spin and Ziehm RFD 3D are 2D and 3D scopic imaging devices. They are similar in technology and on to the Siemens Orbic 3D C-arm, which is a predecessor to he Siemens Cios Spin. Both devices are indicated for operative imaging for spine surgery and cleared by FDA.

has been completed and successfully demonstrated that ifferences in the medical device interfaces have no impact ce performance when compared to the predicate device and introduce any new risks or impact any existing risks. ore, these differences do not impact safety or effectiveness ubject device when compared to the predicate devices.

Substantially Equivalent.

xial CT and Sagittal CT views are different names for the ctory 1 and 2 views - they are equivalent in function. The al DRR and Coronal DRR views are different names for the etic Lateral and Synthetic AP views, respectively - they are equivalent in function.

ial DRR image is created the same way as the Sagittal DRR Coronal DRR views, but from the third plane of the CT 3D ume. The function is equivalent to the Sagittal DRR and ronal DRR view, but from a different visual perspective.

ng has been completed and successfully demonstrated that differences in the view/display features have no impact on performance when compared to the predicate device and do st introduce any new risks or impact any existing risks. fore, these differences do not impact safety or effectiveness e subject device when compared to the predicate devices.

Identical

Substantially Equivalent.

oredicates allow Network Connectivity, USB, and DICOM ort interface technology, which is identical to the subject CD and DVD interface was removed from scope of subject device as this technology is no longer required.

ng has been completed and successfully demonstrated that e differences in the scanner interface technology have no ct on device performance when compared to the predicate and do not introduce any new risks or impact any existing ks. Therefore, these differences do not impact safety or veness of the subject device when compared to the predicate devices.

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Image /page/13/Picture/0 description: The image contains the logo for Nuvasive. The logo consists of a stylized purple and gray graphic on the left, followed by the word "NUVASIVE" in gray, sans-serif font. The graphic appears to be an abstract representation of a leaf or a curved shape, with the purple portion at the top and the gray portion at the bottom.

If not identical, SE rationale

Identical

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Image /page/14/Picture/1 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.

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 product and software requirements specifications defined for the system.

Tracking accuracy verification per ASTM F2554-10
3D navigation registration and tracking error verification
Navigation software validation ●
Cadaver validation for 3D navigation for pedicle screw placement
Electrical safety and EMC testing per IEC 60601 ●
Navigation system accuracy performance

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

H. Conclusions

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).