Who is the manufacturer of NuVasive Pulse System?

Nu Vasive, Incorporated filed the 510(k) submission for NuVasive Pulse System (K210574).

What is the FDA product code for NuVasive Pulse System?

OLO. It is classified under 21 CFR 882.4560 as a Class 2 device in the Neurology panel.

What is the regulatory pathway for NuVasive Pulse System?

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

What are the predicate devices for NuVasive Pulse System?

NuVasive Pulse System (K180038); StealthStation S8 Spine Software V1.0.0 (K170011); NuVasive Navigation.S Instruments (K200719).

Who can help prepare an FDA 510(k) submission like NuVasive Pulse System?

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

NuVasive Pulse System

K210574 · Nu Vasive, Incorporated · OLO · Jul 29, 2021 · Neurology

Device Facts

Record ID	K210574
Device Name	NuVasive Pulse System
Applicant	Nu Vasive, Incorporated
Product Code	OLO · Neurology
Decision Date	Jul 29, 2021
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 882.4560
Device Class	Class 2

Intended Use

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

Pulse System integrates three modules: Pulse NVM5 (neuro-monitoring), Pulse LessRay (fluoroscopic image enhancement), and Pulse Navigation (image-guided surgery). NVM5 uses electrical stimulation via surgical electrodes to monitor EMG, MEP, and SSEP responses, providing real-time nerve proximity and neuromuscular block data to surgeons. Bendini software calculates spinal rod bending instructions based on implant locations. LessRay interfaces with fluoroscopes to enhance low-dose images via noise reduction and provides C-arm tracking. Pulse Navigation uses an infrared camera to track passive markers on instruments, superimposing them onto 3D radiographic images (CT/Cone Beam CT) for trajectory guidance during spinal procedures. Used in ORs by surgeons; provides visual/auditory feedback to assist in nerve avoidance, implant placement, and rod shaping. Benefits include reduced radiation exposure via LessRay, improved surgical accuracy through navigation, and real-time monitoring of neural integrity to prevent injury.

Clinical Evidence

Bench testing only. Verification and validation included tracking accuracy per ASTM F2554-10, 3D navigation registration/tracking error verification, navigation software validation, cadaver validation for pedicle screw placement, and electrical safety/EMC testing per IEC 60601. No clinical data presented.

Technological Characteristics

System includes control unit, digital preamplifier with A/D converter, infrared camera for optical tracking, and various surgical electrodes (Ag-AgCl film/hydrogel). Connectivity via network, USB, and DICOM. Software performs image registration, signal processing (averaging, noise reduction), and navigation. Compliant with IEC 60601-1.

Indications for Use

Indicated for patients undergoing spinal surgery, neck dissections, thoracic surgeries, and upper/lower extremity procedures requiring intraoperative neurophysiologic monitoring, nerve avoidance, or image-guided localization for spinal implants (pedicle/iliosacral screws).

Regulatory Classification

Identification

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

Predicate Devices

NuVasive Pulse System (K180038)
StealthStation S8 Spine Software V1.0.0 (K170011)
NuVasive Navigation.S Instruments (K200719)

Related Devices

K180038 — NuVasive Pulse System · Nu Vasive, Incorporated · Jun 29, 2018
K152942 — NuVasiveNVM5 System · Nu Vasive, Incorporated · Jan 13, 2016
K162313 — NuVasive Next Generation NVM5 System · Nu Vasive, Incorporated · Mar 16, 2017
K132694 — NUVASIVE NVM5 SYSTEM · Nu Vasive, Incorporated · May 16, 2014
K141968 — NUVASIVE NVM5 SYSTEM · Nuvasive, Inc. · Nov 14, 2014

Submission Summary (Full Text)

{0}------------------------------------------------ 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. Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: on the left, there is a seal with an abstract design, and on the right, there is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The text is arranged in three lines, with "FDA" being the largest and boldest, followed by "U.S. FOOD & DRUG" and then "ADMINISTRATION". 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 {1}------------------------------------------------ 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 {2}------------------------------------------------ ## 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. 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 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. {3}------------------------------------------------ This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {4}------------------------------------------------ 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. 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 {5}------------------------------------------------ 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. 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. #### 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. {6}------------------------------------------------ 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. 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) 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. {7}------------------------------------------------ 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 Device NuVasive Pulse System (K180038) | Predicate Device StealthStation S8 Spine Software v1.0.0 (K170011) | Subject Device Pulse 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 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. Pulse NVM5 provides this information by electrically stimulating nerves via electrodes located on surgical accessories and monitoring electromyography (EMG), transcranial or lumbar 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. | The StealthStation System is intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. The StealthStation® System, with StealthStation Spine Software, is intended as an aid for precisely locating anatomical structures in either open or percutaneous neurosurgical and orthopedic procedures. Their use is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the spine or pelvis, can be 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. Pulse NVM5 is a medical device that 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. Pulse NVM5 provides this information by electrically stimulating nerves via electrodes located on surgical accessories and monitoring electromyography (EMG), transcranial or lumbar 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. | | | Specification/ Property | Predicate Device NuVasive Pulse System (K180038) | Predicate Device StealthStation S8 Spine Software v1.0.0 (K170011) | Subject Device Pulse System | | | | • Remote Access - The remote monitoring and local wireless control provides real-time capabilities to the Pulse System | | • 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 | | • 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 | | | Intended Use / Indications for Use (Continued) | The Pulse LessRay is intended for use in any application where a fluoroscope is incorporated to aid in diagnosis and treatment of disease. | | 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) | | 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: 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…