Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes image enhancement and tracking systems, but there is no mention of AI or ML algorithms being used for analysis, interpretation, or decision-making. The image processing appears to be rule-based enhancement.

Therapeutic

No

Explanation: The device is primarily for monitoring, navigation, and imaging enhancement during surgery, providing information and guidance to the surgeon rather than directly treating a disease or condition. While some components involve electrical stimulation (Pulse NVM5), it is for diagnostic and monitoring purposes (e.g., assessing nerve response, locating nerves) to aid in surgical procedures, not for therapeutic intervention.

Diagnostic

Yes

The Pulse System, specifically the Pulse NVM5 component, is explicitly intended for "intraoperative neurophysiologic monitoring" and provides information to help "assess a patient's neurophysiologic status" by monitoring responses to electrical stimulation (EMG, MEP, SSEP). This involves evaluating the physiological state of nerves and muscles, which falls under the definition of a diagnostic device. While other components (LessRay, Navigation) focus on image guidance and enhancement, the NVM5 component performs direct physiological assessment.

SaMD (Software as a Medical Device)

No

The device description explicitly states that the Pulse System hardware includes a control unit and accompanying accessory components, in addition to the software.

IVD (In Vitro Diagnostic)

Based on the provided information, the Pulse System is not an In Vitro Diagnostic (IVD) device.

Here's why:

IVD Definition: In Vitro Diagnostic devices are used to examine specimens derived from the human body (like blood, urine, tissue) outside of the body to provide information for diagnosis, monitoring, or screening.
Pulse System Function: The Pulse System operates in vivo (within the living body) during surgical procedures. It uses electrical stimulation and monitors physiological responses (EMG, MEP, SSEP) directly from the patient's nerves and muscles. It also uses imaging modalities (fluoroscopy, CT/Cone Beam CT) and navigation technology to guide surgical instruments and assess anatomical structures.

The Pulse System is clearly a surgical guidance and monitoring system used during procedures, not a device that analyzes samples taken from the body.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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 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

Product codes (comma separated list FDA assigned to the subject device)

OLO, PDQ, ETN, GWF, HAW, IKN, OWB, LLZ, JAA

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.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

X-Ray Based Imaging (3D intraoperative scan (CT or Cone Beam CT))

Anatomical Site

Spine (cervical, thoracic, lumbar), neck, upper and lower extremities.

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Surgeon / Intraoperative

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K180038, K170011, K200719

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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).

Summary

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Image /page/0/Picture/0 description: The image shows the date July 29, 2021. The text is written in a clear, sans-serif font. The date is formatted with the month first, followed by the day and year. The text is black against a white background.

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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)