(175 days)
No
The document describes image enhancement and tracking based on traditional algorithms, not AI/ML. There is no mention of AI, ML, or related terms like deep learning or neural networks.
No.
The primary purpose of this device is neurophysiologic monitoring and surgical navigation/guidance, which are diagnostic and procedural aids, not direct therapeutic interventions.
Yes
The device, specifically "Pulse NVM5," is explicitly stated to be "intended for intraoperative neurophysiologic monitoring during spinal surgery... The device provides information directly to the surgeon, to help assess a patient's neurophysiologic status." This assessment of a patient's status constitutes a diagnostic function. Furthermore, "The Pulse LessRay is intended for use in any application where a fluoroscope is incorporated to aid in diagnosis and treatment of disease."
No
The device description explicitly states that the Pulse System hardware includes a Patient Module (PM) and computer, as well as accompanying accessory components. This indicates the device is not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Device Function: The Pulse System's intended use and device description clearly indicate that it is used for:
- Intraoperative neurophysiologic monitoring: Monitoring nerve responses during surgery.
- Image-guided navigation: Using imaging data to guide surgical instruments during procedures.
- Image enhancement: Improving the quality of fluoroscopic images during procedures.
- Spinal rod bending assistance: Providing information to help bend spinal rods during surgery.
None of these functions involve the examination of specimens taken from the human body in vitro (outside the body). The device interacts directly with the patient or uses imaging data acquired from the patient in vivo (within the body) or from previously acquired images.
N/A
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 intended for intraoperative neurophysiologic monitoring during spinal surgery, neck dissections, thoracic surgeries, and upper and lower extremities. The device provides information directly to the surgeon, to help assess a patient's neurophysiologic status. The Pulse this information by electrically stimulating nerves via electrodes located on surgical accessories and monitoring electromyography (EMG), motor evoked potential (MEP) or somatosensory evoked potential (SSEP) responses of nerves. The System also integrates Bendini® software used to locate spinal implant instrumentation for the placement of spinal rods.
· XLIF (Detection) – The XLIF (Detection) function allows the surgeon to locate and evaluate spinal nerves, and is used as a nerve avoidance tool.
· Basic & Dynamic Screw Test - The Screw Test functions allow the surgeon to locate and evaluate spinal nerves by providing proximity information before, during or after bone preparation and placement of bone screws.
· Free Run EMG – The Free Run EMG function identifies spontaneous EMG activity of spinal nerves by continually displaying a live stream waveform of any mechanically induced myotome contractions.
· Twitch Test (Train of Four) – The Twitch allows the surgeon to assess moderate degrees of neuromuscular block in effect by evaluating muscle contraction following a train of four stimulation pulses.
· MEP - Transcranial or lumbar (i.e., conus in region of L1-L2) stimulation techniques for motor evoked potentials are used to assess for acute dysfunction in axonal conduction of the corticospinal tract and peripheral nerves. The MEP function provides an adjunctive method to allow the surgeon to monitor spinal cord and motor pathway integrity during procedures with a risk of surgically induced motor injury.
· SSEP = The SSEP function allows the surgeon to assess sensory spinal cord function in surgical procedures during which the spinal cord is at risk.
· Remote Access - The remote monitoring and local wireless control provides real-time capabilities to the Pulse System.
· Bendini - The Bendini Spinal Rod Bending function is used to locate spinal implant system instrumentation (screws, hooks) to determine their relative location to one another to generate bend instructions to shape a spinal rod. A surgeon is able to use those instructions and bend a rod using the Bendini Bender, a mechanical rod bender.
The Pulse LessRay is intended for use in any application where a fluoroscope is incorporated to aid in diagnosis and treatment of disease.
Pulse Navigation is intended as an intraoperative image-guided localization system in either open or minimally-invasive spinal surgical procedures. Instruments and implants tracked by a passive marker sensor system are virtually displayed on a patient's 2D or 3D radiographic image data. The system enables computer-assisted navigation for spinal surgical procedures in which the use of stereotactic surgery may be appropriate and where a reference to a rigid anatomical structure can be identified relative to the acquired image of the anatomy.
This may include the following spinal implant procedures:
o Pedicle Screw Placement (2D Navigation in Sacral and Lumbar Spine and 3D Navigation in Sacral and Thoracolumbar Spine)
o Interbody Device Placement (2D and 3D Navigation in Lumbar Spine via Lateral Approach)
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 Patient Module (PM) and computer, as well as accompanying accessory components.
The Pulse NVM5 is a medical device that is intended for intraoperative neurological monitoring and status assessment during spinal surgery. The device provides information directly to the surgeon, to help assess a patient's neurological status. The Pulse NVM5 provides this information by electrically stimulating nerves via electrodes located on surgical accessories and monitoring electromyography (EMG), motor evoked potential (MEP) or somatosensory evoked potential (SSEP) responses of the muscle groups innervated by the nerves. Moreover, a Twitch Test ("Train of Four") function is utilized to test the ability of the nerve to respond, or contract, following four stimulation pulses to determine the presence of neuromuscular block.
Additionally, the Pulse NVM5 System includes a software function that measures spinal parameters and acquires the location of spinal implants (screws, hooks) to assist the surgeon in bending spinal rods (Bendini). Lastly, the Pulse NVM5 provides Remote Access in two pathways, Local Wireless Control and Remote Monitoring.
LessRay is a software application which can be interfaced to a fluoroscope with a video cable. The images produced by the fluoroscope are transmitted to a frame grabber in the computer running LessRay where the images are enhanced and then displayed. When used in connection with the low dose and/or pulse setting on the fluoroscope, the user can improve the quality (clarity, contrast, noise level, and usability') of a noisy (low-quality) image. Using this system, much of the graininess of low radiation dose images can be eliminated. This allows for greater utility of low dose imaging." LessRay provides the additional feature of being able to interface LessRay with a tracking system in order to aid the C-arm technician in positioning the fluoroscope between the various views of the patient necessary for the intervention. LessRay with Tracking ensures that the fluoroscope is centered over the correct anatomy prior to taking any additional x-ray images.
LessRay System has additional capability of instrument tracking to aid the user in positioning an instrument using prior baseline x-rays. A tracker is attached to the instrument and as the instrument moves, the tracking system connected to LessRay tracks the location of the instrument. LessRay System uses this information to aid the user in positioning the instrument.
Pulse Navigation is a stereotactic surgical application intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. It is intended for intraoperative image-guided localization which allows for surgical instruments to be tracked in three dimensional space. The device provides real-time information directly to the surgeon, enabling the surgeon to evaluate the instrument depth and trajectory for computer-assisted navigation during spine surgery. Instruments are tracked in three dimensional space with an Infrared (IR) Camera, being virtually displayed and superimposed on registered radiographic images. Radiographic images can be either 2D fluoroscopic images (C-arm) or 3D intraoperative scan (CT or Cone Beam CT).
Mentions image processing
Yes, "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."
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
2D fluoroscopic images (C-arm) or 3D intraoperative scan (CT or Cone Beam CT).
Anatomical Site
Spine (spinal, sacral, lumbar, thoracolumbar), neck, thoracic, upper and lower extremities.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Surgeon, C-arm technician, physicians/surgeons, intraoperative, surgical procedures.
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 software requirements specifications defined for the system.
- Tracking accuracy verification per ASTM F2554-10
- Accessories attachment verification
- 2D navigation distortion and calibration verification
- 3D navigation segmentation and tracking error verification
- Navigation software validation
- Cadaver validation for 2D and 3D navigation for pedicle screw and interbody device placement
- System integration testing
The results of these studies showed that the subject Pulse System meets software requirements defined for the system and satisfies same acceptance criteria as the performance of the predicate device. Therefore, subject Pulse System was found to be substantially equivalent.
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.
NuVasive Next Generation NVM5 System (K162313), LessRay System (K173314), StealthStation S8 Spine Software V1.0.0 (K170011)
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.
NuVasive Navigation Instruments (K172623)
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
§ 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).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION".
June 29, 2018
NuVasive, Incorporated Olga Lewis Regulatory Affairs Senior Manager 7475 Lusk Blvd. San Diego, California 92121
Re: K180038
Trade/Device Name: NuVasive® Pulse™ System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO, PDQ, ETN, GWF, HAW, IKN, OWB, LLZ, JAA Dated: May 31, 2018 Received: June 1, 2018
Dear Olga Lewis:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known) K180038
Device Name NuVasive® Pulse™ System
Indications for Use (Describe)
The Pulse System is a medical device comprised of Pulse NVM5, Pulse LessRay, and Pulse Navigation. The Pulse NVM5 is intended for intraoperative neurophysiologic monitoring during spinal surgery, neck dissections, thoracic surgeries, and upper and lower extremities. The device provides information directly to the surgeon, to help assess a patient's neurophysiologic status. The Pulse this information by electrically stimulating nerves via electrodes located on surgical accessories and monitoring electromyography (EMG), motor evoked potential (MEP) or somatosensory evoked potential (SSEP) responses of nerves. The System also integrates Bendini® software used to locate spinal implant instrumentation for the placement of spinal rods.
· XLIF (Detection) – The XLIF (Detection) function allows the surgeon to locate and evaluate spinal nerves, and is used as a nerve avoidance tool.
· Basic & Dynamic Screw Test - The Screw Test functions allow the surgeon to locate and evaluate spinal nerves by providing proximity information before, during or after bone preparation and placement of bone screws.
· Free Run EMG – The Free Run EMG function identifies spontaneous EMG activity of spinal nerves by continually displaying a live stream waveform of any mechanically induced myotome contractions.
· Twitch Test (Train of Four) – The Twitch allows the surgeon to assess moderate degrees of neuromuscular block in effect by evaluating muscle contraction following a train of four stimulation pulses.
· MEP - Transcranial or lumbar (i.e., conus in region of L1-L2) stimulation techniques for motor evoked potentials are used to assess for acute dysfunction in axonal conduction of the corticospinal tract and peripheral nerves. The MEP function provides an adjunctive method to allow the surgeon to monitor spinal cord and motor pathway integrity during procedures with a risk of surgically induced motor injury.
· SSEP = The SSEP function allows the surgeon to assess sensory spinal cord function in surgical procedures during which the spinal cord is at risk.
· Remote Access - The remote monitoring and local wireless control provides real-time capabilities to the Pulse System.
· Bendini - The Bendini Spinal Rod Bending function is used to locate spinal implant system instrumentation (screws, hooks) to determine their relative location to one another to generate bend instructions to shape a spinal rod. A surgeon is able to use those instructions and bend a rod using the Bendini Bender, a mechanical rod bender.
The Pulse LessRay is intended for use in any application where a fluoroscope is incorporated to aid in diagnosis and treatment of disease.
Pulse Navigation is intended as an intraoperative image-guided localization system in either open or minimally-invasive spinal surgical procedures. Instruments and implants tracked by a passive marker sensor system are virtually displayed on a patient's 2D or 3D radiographic image data. The system enables computer-assisted navigation for spinal surgical procedures in which the use of stereotactic surgery may be appropriate and where a reference to a rigid anatomical structure can be identified relative to the acquired image of the anatomy.
This may include the following spinal implant procedures:
o Pedicle Screw Placement (2D Navigation in Sacral and Lumbar Spine and 3D Navigation in Sacral and Thoracolumbar Spine)
o Interbody Device Placement (2D and 3D Navigation in Lumbar Spine via Lateral Approach)
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
3
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Image /page/4/Picture/0 description: The image shows the logo for Nuvasive. The logo consists of a stylized leaf shape on the left, with the word "NUVASIVE" in gray letters to the right of the leaf. The leaf is split into two colors, purple and gray.
510(k) Summary
K180038
In accordance with Title 21 of the Code of Federal Regulations, Part 807, and in particular 21 CFR §807.92, the following summary of information is provided:
A. Submitted by:
Olga Lewis Senior Manager, Regulatory Affairs NuVasive, Incorporated 7475 Lusk Blvd. San Diego, California 92121 Telephone: (858) 909-1800
Date Prepared: June 29, 2018
B. Device Name
| Proprietary Name: | NuVasive® Pulse™ System |
|---|---|
| Common or Usual Name: | Neurological Surgical Monitor; |
| Image-intensified fluoroscopic x-ray system | |
| Stereotaxic instrument | |
| Classification Name: | Stereotaxic Instrument |
| Device Class: | Class II |
| Classification: | 21 CFR §882.4560 |
| Product Code: | OLO, PDQ, ETN, GWF, HAW, IKN, OWB, LLZ, JAA |
Predicate Devices C.
The subject NuVasive Pulse System is substantially equivalent to the primary predicate NuVasive Next Generation NVM5 System (K162313). It is also substantially equivalent to the additional predicate devices LessRay System (K173314), StealthStation S8 Spine Software V1.0.0 (K170011), and NuVasive Navigation Instruments (K172623).
D. Device Description
The Pulse System is a medical device consisting of Pulse NVM5, Pulse LessRay, and Pulse Navigation. The Pulse System hardware includes a Patient Module (PM) and computer, as well as accompanying accessory components.
The Pulse NVM5 is a medical device that is intended for intraoperative neurological monitoring and status assessment during spinal surgery. The device provides information directly to the surgeon, to help assess a patient's neurological status. The Pulse NVM5 provides this information by electrically stimulating nerves via electrodes located on surgical accessories and monitoring electromyography (EMG), motor evoked potential (MEP) or somatosensory evoked potential (SSEP) responses of the muscle groups innervated by the nerves. Moreover, a Twitch Test ("Train of Four") function is utilized to test the ability of the nerve to respond, or contract, following four stimulation pulses to determine the presence of neuromuscular block.
Additionally, the Pulse NVM5 System includes a software function that measures spinal parameters and acquires the location of spinal implants (screws, hooks) to assist the surgeon in
5
bending spinal rods (Bendini). Lastly, the Pulse NVM5 provides Remote Access in two pathways, Local Wireless Control and Remote Monitoring.
LessRay is a software application which can be interfaced to a fluoroscope with a video cable. The images produced by the fluoroscope are transmitted to a frame grabber in the computer running LessRay where the images are enhanced and then displayed. When used in connection with the low dose and/or pulse setting on the fluoroscope, the user can improve the quality (clarity, contrast, noise level, and usability') of a noisy (low-quality) image. Using this system, much of the graininess of low radiation dose images can be eliminated. This allows for greater utility of low dose imaging." LessRay provides the additional feature of being able to interface LessRay with a tracking system in order to aid the C-arm technician in positioning the fluoroscope between the various views of the patient necessary for the intervention. LessRay with Tracking ensures that the fluoroscope is centered over the correct anatomy prior to taking any additional x-ray images.
LessRay System has additional capability of instrument tracking to aid the user in positioning an instrument using prior baseline x-rays. A tracker is attached to the instrument and as the instrument moves, the tracking system connected to LessRay tracks the location of the instrument. LessRay System uses this information to aid the user in positioning the instrument.
Pulse Navigation is a stereotactic surgical application intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. It is intended for intraoperative image-guided localization which allows for surgical instruments to be tracked in three dimensional space. The device provides real-time information directly to the surgeon, enabling the surgeon to evaluate the instrument depth and trajectory for computer-assisted navigation during spine surgery. Instruments are tracked in three dimensional space with an Infrared (IR) Camera, being virtually displayed and superimposed on registered radiographic images. Radiographic images can be either 2D fluoroscopic images (C-arm) or 3D intraoperative scan (CT or Cone Beam CT).
E. Indications for Use
The Pulse System is a medical device comprised of Pulse NVM5, Pulse LessRay, and Pulse Navigation.
The Pulse NVM5 is intended for intraoperative neurophysiologic monitoring spinal surgery, neck dissections, thoracic surgeries, and upper and lower extremities. The device provides information directly to the surgeon, to help assess a patient's neurophysiologic status. The Pulse NVM5 provides this information by electrically stimulating nerves via electrodes located on surgical accessories and monitoring electromyography (EMG), motor evoked potential (MEP) or somatosensory evoked potential (SSEP) responses of nerves. The System also integrates Bendini® software used to locate spinal implant instrumentation for the placement of spinal rods.
- XLIF (Detection) The XLIF (Detection) function allows the surgeon to locate and ● evaluate spinal nerves, and is used as a nerve avoidance tool.
- Basic & Dynamic Screw Test - The Screw Test functions allow the surgeon to locate and evaluate spinal nerves by providing proximity information before, during or after bone preparation and placement of bone screws.
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Image /page/6/Picture/1 description: The image shows the logo for Nuvasive. The logo consists of a stylized leaf shape on the left, with the word "NUVASIVE" in gray letters to the right of the leaf. The leaf shape is divided into two parts, with the top part being a darker purple color and the bottom part being a lighter gray color. The logo is simple and modern, and the colors are muted and professional.
- . Free Run EMG - The Free Run EMG function identifies spontaneous EMG activity of spinal nerves by continually displaying a live stream waveform of any mechanically induced myotome contractions.
- . Twitch Test (Train of Four) - The Twitch Test Function allows the surgeon to assess moderate degrees of neuromuscular block in effect by evaluating muscle contraction following a train of four stimulation pulses.
- MEP Transcranial or lumbar (i.e., conus in region of L1-L2) stimulation techniques for . motor evoked potentials are used to assess for acute dysfunction in axonal conduction of the corticospinal tract and peripheral nerves. The MEP function provides an adjunctive method to allow the surgeon to monitor spinal cord and motor pathway integrity during procedures with a risk of surgically induced motor injury.
- . SSEP - The SSEP function allows the surgeon to assess sensory spinal cord function in surgical procedures during which the spinal cord is at risk.
- . Remote Access - The remote monitoring and local wireless control provides real-time capabilities to the Pulse System.
- Bendini The Bendini Spinal Rod Bending function is used to locate spinal implant . system instrumentation (screws, hooks) to determine their relative location to one another to generate bend instructions to shape a spinal rod. A surgeon is able to use those instructions and bend a rod using the Bendini Bender, a mechanical rod bender.
The Pulse LessRay is intended for use in any application where a fluoroscope is incorporated to aid in diagnosis and treatment of disease.
Pulse Navigation is intended as an intraoperative image-guided localization system in either open or minimally-invasive spinal surgical procedures. Instruments and implants tracked by a passive marker sensor system are virtually displayed on a patient's 2D or 3D radiographic image data. The system enables computer-assisted navigation for spinal surgical procedures in which the use of stereotactic surgery may be appropriate and where a reference to a rigid anatomical structure can be identified relative to the acquired image of the anatomy.
This may include the following spinal implant procedures:
- O Pedicle Screw Placement (2D Navigation in Sacral and Lumbar Spine and 3D Navigation in Sacral and Thoracolumbar Spine)
- Interbody Device Placement (2D and 3D Navigation in Lumbar Spine via Lateral O Approach)
F. Technological Characteristics
As was established in this submission, the subject Pulse System is substantially equivalent to other predicate devices cleared by the FDA for commercial distribution in the United States. The subject device was shown to be substantially equivalent and have equivalent technological characteristics to its predicate device through comparison in areas including design, intended use, material composition, and functions.
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Image /page/7/Picture/0 description: The image shows the logo for Nuvasive. The logo consists of a stylized leaf shape in purple and gray, followed by the word "NUVASIVE" in gray sans-serif font. The logo is simple and modern, with a focus on the company name.
Table 1 – Comparison of Technical Characteristics
| Specification/
Property | Predicate Device
NuVasive Next Generation NVM5 System
(K162313) | Predicate Device
LessRay System (K173314) | Predicate Device
StealthStation S8 Spine Software v1.0.0
(Medtronic- K170011) | Subject Device
Pulse System |
|---------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use /
Indications for Use | The Next Generation NVM5® System 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. 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. | LessRay System is intended for use in any application
where a fluoroscope is incorporated to aid in diagnosis
and treatment of disease. | 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.
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. |
| Specification/
Property | Predicate Device
NuVasive Next Generation NVM5 System
(K162313) | Predicate Device
LessRay System (K173314) | Predicate Device
StealthStation S8 Spine Software v1.0.0
(Medtronic- K170011) | Subject Device
Pulse System |
| Intended Use /
Indications for Use
(Continued) | • 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
NG NVM5 System for additional physicians.
• Bendini - The Bendini Spinal Rod Bending function
is used to 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. | | | • Remote Access - The remote monitoring and local wireless
control provides real-time capabilities to the Pulse System
• Bendini - The Bendini Spinal Rod Bending function is used to
locate spinal implant system instrumentation (screws, hooks) to
determine their relative location to one another to generate
bend instructions to shape a spinal rod. A surgeon is able to use
those instructions and bend a rod using the Bendini Bender, a
mechanical rod bender
The Pulse LessRay is intended for use in any application where a
fluoroscope is incorporated to aid in diagnosis and treatment of
disease.
Pulse Navigation is intended as an intraoperative image-guided
localization system in either open or minimally-invasive spinal
surgical procedures. Instruments and implants tracked by a passive
marker sensor system are virtually displayed on a patient's 2D or
3D radiographic image data. The system enables computer-assisted
navigation for spinal surgical procedures in which the use of
stereotactic surgery may be appropriate and where a reference to a
rigid anatomical structure can be identified relative to the acquired
image of the anatomy. This may include the following spinal
implant procedures:
o Pedicle Screw Placement (2D Navigation in Sacral and
Lumbar Spine and 3D Navigation in Sacral and
Thoracolumbar Spine)
o Interbody Device Placement (2D and 3D Navigation in
Lumbar Spine via Lateral Approach) |
| Device Class | II | II | II | II |
| Product Code | PDQ, ETN, GWF, HAW, IKN, OLO, | OWB, LLZ, JAA | OLO | OLO, PDQ, ETN, GWF, HAW, IKN, OWB, LLZ,
JAA |
| Regulation Number
(21CFR) | §874.1820, §882.1870, §882.4560,
§890.1375 | §892.1650 | §882.4560 | §882.4560, §874.1820, §882.1870, §890.1375,
§892.1650, |
| Device
Classification
Name | Surgical nerve stimulator/locator; Evoked
response electrical stimulator;
Neurological stereotaxic instrument;
Electromyography (EMG) monitor/stimulator | Image-intensified fluoroscopic x-ray system | Stereotaxic Instrument | Surgical nerve stimulator/locator; Evoked response
electrical stimulator;
Neurological stereotaxic instrument;
Electromyography (EMG) monitor/stimulator
Image-intensified fluoroscopic x-ray system;
Stereotaxic Instrument |
| Specification/
Property | Predicate Device
NuVasive Next Generation NVM5 System
(K162313) | Predicate Device
LessRay System (K173314) | Predicate Device
StealthStation S8 Spine Software v1.0.0
(Medtronic- K170011) | Subject Device
Pulse System |
| Functionalities | • XLIF Detection
• Basic & Dynamic Screw Test
• Free Run EMG
• Twitch Test (Train of Four)
• MEP
• SSEP
• Remote Access
• Bendini
• NuvaMap O.R.
• NuvaLine spinal parameter assessment
tools - Optional | • Software based device used to provide
computer display systems interfaced to
fluoroscope through a video cable. The
images produced by the fluoroscope are
transmitted through a cable to a frame
capture board in the computer where the
images are enhanced and then displayed
on the monitor.
• Enhanced images are displayed on a
computer monitor at the same time that
the corresponding original image is
displayed on the fluoroscope monitor(s).
• Uses software to control the frame
capture, intermediate image
manipulation, and subsequent image
display.
• The delay between frame acquisition
and frame display is less than the time
between frames, i.e. 33 msec.
• Serves only as an image display which
is in addition to the fluoroscope's
standard image display device. Device
is passive, in that the operation depends
only on the video output of the
fluoroscope, and it does not transmit any
signals or images to the fluoroscope. | StealthStation Spine Software functionality is
described in terms of its feature sets which are
categorized as imaging modalities, registration,
planning, interfaces with medical devices, and
views. Feature sets include functionality that
contributes to clinical decision making and are
necessary to achieve system performance. | • XLIF Detection
• Basic & Dynamic Screw Test
• Free Run EMG
• Twitch Test (Train of Four)
• MEP
• SSEP
• Remote Access
• Bendini
• NuvaMap O.R.
• NuvaLine spinal parameter assessment tools -
Optional
• LessRay Image Enhancement
• LessRay C-arm tracking
• LessRay Instrument Tracking
• Navigation: imaging modalities, registration,
interfaces with medical devices, and views. |
| Specification/
Property | Predicate Device
NuVasive Next Generation NVM5 System
(K162313) | Predicate Device
LessRay System (K173314) | Predicate Device
StealthStation S8 Spine Software v1.0.0
(Medtronic- K170011) | Subject Device
Pulse System |
| Algorithms | • XLIF Detection
• Basic & Dynamic Screw Test
• Free Run EMG
• Twitch Test (Train of Four)
• MEP
• SSEP
• Bendini - Rod bending and spinal
parameter assessment | • Image quality improvement using
averaging algorithm
• Contrast and brightness enhancement
with simultaneous reduction of random
noise | Unknown | • XLIF Detection
• Basic & Dynamic Screw Test
• Free Run EMG
• Twitch Test (Train of Four)
• MEP
• SSEP
• Bendini - Rod bending and spinal parameter
assessment
• Image quality improvement using averaging
algorithm
• Contrast and brightness enhancement with
simultaneous reduction of random noise |
| Total Available
Channels | 32 | | | 32 |
| Headbox/ Patient
Module | Digital Preamplifier with A/D Converter | | Unknown | Digital Preamplifier with A/D Converter |
| IEC 60601-1
Compliant | Yes | Yes | Yes | Yes |
| User Interface | NuVasive supplied computer with separate
touch screen and/or keyboard/mouse Mobile
device | | | NuVasive supplied computer with separate touch
screen and/or keyboard/mouse Mobile device |
| User Comments | Free form text entry saved with time marks | | | Free form text entry saved with time marks |
| Video Inputs | Yes | | | Yes |
| Network
Compatible | Yes | | | Yes |
| Embedded Help | Yes | | | Yes |
| Artifact Rejection | User Defined and automatic | | | User Defined and automatic |
| Remote Access | Remote Access includes Remote Reader
Monitoring Client and Local Wireless
Control | | | Remote Access includes Remote Reader Monitoring
Client and Local Wireless Control |
| Needle Electrodes | Various | | | Various |
| Surface Electrodes | Dual Surface Ag-AgCl Film and Hydrogel | | | Dual Surface Ag-AgCl Film and Hydrogel |
| EMG Endotracheal
tube | Yes with integrated electrodes for
intraoperative monitoring | | | Yes with integrated electrodes for intraoperative
monitoring |
| Electrode Leads | Various | | | Various |
| Specification/
Property | Predicate Device
NuVasive Next Generation NVM5 System
(K162313) | Predicate Device
LessRay System (K173314) | Predicate Device
StealthStation S8 Spine Software v1.0.0
(Medtronic- K170011) | Subject Device
Pulse System |
| Stimulating Probes | Various | | | Various |
| EMG Modalities | • XLIF (Detection)
• Basic & Dynamic Screw Test
• Free Run EMG
• Twitch Test (Train of Four) | | | • XLIF (Detection)
• Basic & Dynamic Screw Test
• Free Run EMG
• Twitch Test (Train of Four) |
| Types of Modes | Automatic Stimulation (red/yellow/green) | | | Automatic Stimulation (red/yellow/green) |
| Threshold Values
for
Red/Yellow/Green | Yes | | | Yes |
| Audio feedback | Yes | | | Yes |
| Interpretation for
alerts | Green = Nerve in close proximity
Yellow = Nerve in closer proximity
Red = Nerve in very close proximity | | | Green = Nerve in close proximity
Yellow = Nerve in closer proximity
Red = Nerve in very close proximity |
| EMG Monitoring | Continuous free running and stimulated
(triggered) | | | Continuous free running and stimulated (triggered) |
| Recording
Channels | 10 | | | 10 |
| Audible EMG | Yes | | | Yes |
| Automatic Muting
During Artifact | Yes | | | Yes |
| Train of Four
Testing | Yes | | | Yes |
| MEP Types of
Modes | • Alert (red/green) - transcranial MEP
only
• Threshold (red/yellow/green)
Stimulation - transcranial and lumbar
MEP | | | • Alert (red/green) - transcranial MEP only
• Threshold (red/yellow/green) Stimulation -
transcranial and lumbar MEP |
| Recording
Channels | 10 | | | 10 |
| Specification/
Property | Predicate Device
NuVasive Next Generation NVM5 System
(K162313) | Predicate Device
LessRay System (K173314) | Predicate Device
StealthStation S8 Spine Software v1.0.0
(Medtronic- K170011) | Subject Device
Pulse System |
| Audible
MEP/EMG | Yes | | | Yes |
| Automatic Muting
During Artifact | Yes | | | Yes |
| SSEP Types of
Modes | Manual Stimulation (SSEP Standard and
"SSEP Alert" with automatic color
background alerts and anatomical
representation) | | | Manual Stimulation (SSEP Standard and "SSEP
Alert" with automatic color background alerts and
anatomical representation) |
| Threshold Values
for
Red/Yellow/Green | Yes
(Green/Yellow only for simplified SSEP
Harness and Red/Yellow/Green for Standard
SSEP Harness) | | | Yes
(Green/Yellow only for simplified SSEP Harness and
Red/Yellow/Green for Standard SSEP Harness) |
| Audio feedback | Yes | | | Yes |
| Recording
Channels | 8 | | | 8 |
| | Predicate Device | Predicate Device | Predicate Device | Subject Device |
| Specification/
Property | NuVasive Next Generation NVM5 System
(K162313) | LessRay System (K173314) | StealthStation S8 Spine Software v1.0.0
(Medtronic- K170011) | Pulse System |
| C-arm Tracking | | • When tracking is enabled, will
automatically choose the Baseline when the
fluoroscope is near the location and
orientation that the Baseline was initially
taken. | | • When tracking is enabled, will automatically choose
the Baseline when the fluoroscope is near the
location and orientation that the Baseline was
initially taken.
• When tracking is enabled, requires hardware |
| | | • When tracking is enabled, requires
hardware components in order to mount the
off-the-shelf tracking hardware to the C-
arm and to the operating table.
• When tracking is enabled, requires the use
of an off-the-shelf tracking system in order
to track the 6 DOF location of the C-arm
relative to the operating table. When
tracking is enabled, visual cues are
provided which help guide the user in
positioning the C-arm back to where a prior
Baseline was taken. | | components in order to mount the off-the-shelf
tracking hardware to the C-arm and to the operating
table.
• When tracking is enabled, requires the use of an off-
the-shelf tracking system in order to track the 6 DOF
location of the C-arm relative to the operating table.
When tracking is enabled, visual cues are provided
which help guide the user in positioning the C-arm
back to where a prior Baseline was taken. |
| Tracking Options | | Optical | | Optical |
| Instrument
Tracking | | NuVasive LessRay System has additional
capability of instrument tracking to aid the
user in positioning an instrument using prior
baseline x-rays. | | Pulse LessRay has additional capability of instrument
tracking to aid the user in positioning an instrument
using prior baseline x-rays. |
| Imaging Modalities | | | X-Ray Based Imaging | X-Ray Based Imaging |
| Registration
Features | | | PointMerge Registration
SurfaceMerge Registration
FluoroMerge Registration
Automatic 2D Image Registration
Automatic 3D Image Registration | Automatic 2D Image Registration
Automatic 3D Image Registration |
| Planning Features | | | Plan Entry and Target Selection
3D Model Building
Deformity Planning | n/a |
| Specification/
Property | Predicate Device | Predicate Device | Predicate Device | Subject Device |
| NuVasive Next Generation NVM5 System
(K162313) | LessRay System (K173314) | StealthStation S8 Spine Software v1.0.0
(Medtronic- K170011) | Pulse System | |
| Medical Device
Interfaces | | | O-arm Imaging System
Ziehm Vision FD Vario 3D C-Arm
ISO-C 3D C-Arm
Orbic 3D C-Arm | O-arm Imaging System
Ziehm Vision FD Vario 3D C-Arm
Mobius Airo |
| View (Display
Features) | | | Look Sideways
3D
Anatomic Orthogonal
Trajectory 1 and 2
Trajectory Guidance
Look Ahead
Probe's Eye
AP and Lateral
Synthetic AP and Lateral
Maximum Intensity Projection
Video Input | 3D
Anatomic Orthogonal
Trajectory 1 and 2
Probe's Eye
AP and Lateral
Synthetic AP and Lateral |
| Software Interface
(GUI) | | | Basic gray and black style with 4 main tasks and
tab interface to access tools. Controls on the right. | Basic gray and black style with tab interface to access
tools and controls. |
| Scanner Interface
Technology (to
imaging devices) | | | Network Connectivity
CD, DVD, USB
DICOM Import
DICOM Export | Network Connectivity
CD, DVD, USB
DICOM Import |
| Localization
Technology | | | Optical | Optical |
8
Image /page/8/Picture/0 description: The image shows the logo for Nuvasive. The logo consists of a stylized leaf-like shape on the left, with the word "NUVASIVE" in gray letters to the right of the shape. The leaf-like shape is split into two colors, with the left side being a dark purple and the right side being gray.
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Image /page/9/Picture/0 description: The image shows the logo for Nuvasive. The logo consists of a stylized purple and gray leaf-like shape on the left, followed by the word "NUVASIVE" in a gray, sans-serif font. The logo is simple and modern, with a focus on the company name.
10
Image /page/10/Picture/0 description: The image shows the logo for Nuvasive. The logo consists of a stylized leaf shape in purple and gray, followed by the company name "NUVASIVE" in gray sans-serif font. The leaf shape is on the left side of the logo, and the company name is on the right.
11
Image /page/11/Picture/0 description: The image features the Nuvasive logo. The logo consists of a stylized leaf-like shape on the left, with the word "NUVASIVE" in gray, sans-serif font to the right of the shape. The leaf-like shape is divided into two sections, with the top section in purple and the bottom section in gray.
12
Image /page/12/Picture/0 description: The image shows the Nuvasive logo. The logo consists of a stylized leaf shape in purple and gray, followed by the word "NUVASIVE" in gray sans-serif font. The leaf shape is on the left side of the logo, and the word "NUVASIVE" is on the right side.
13
Image /page/13/Picture/0 description: The image shows the logo for Nuvasive. The logo consists of a stylized leaf shape in purple and gray, followed by the word "NUVASIVE" in gray sans-serif font. The leaf shape is split into two parts, with the top part in purple and the bottom part in gray.
14
Image /page/14/Picture/0 description: The image shows the logo for Nuvasive. The logo consists of a stylized leaf shape in purple and gray, followed by the word "NUVASIVE" in gray sans-serif font. The logo is simple and modern, and the colors are muted and professional.
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Image /page/15/Picture/1 description: The image shows the Nuvasive logo. The logo consists of a stylized leaf shape on the left, with the top half of the leaf in purple and the bottom half in gray. To the right of the leaf is the word "NUVASIVE" in gray, with a trademark symbol after the word. The logo is simple and modern, with a clean font and a limited color palette.
G. Performance Data
Nonclinical testing was performed to demonstrate that the subject Pulse System is substantially equivalent to other predicate devices and to verify that the Pulse System meets design specifications and performance characteristics, based upon the intended use. The Pulse System was subjected to the following verification and validation testing according to the software requirements specifications defined for the system.
- Tracking accuracy verification per ASTM F2554-10 ●
- Accessories attachment verification
- 2D navigation distortion and calibration verification ●
- 3D navigation segmentation and tracking error verification
- Navigation software validation ●
- Cadaver validation for 2D and 3D navigation for pedicle screw and interbody ● device placement
- System integration testing ●
The results of these studies showed that the subject Pulse System meets software requirements defined for the system and satisfies same acceptance criteria as the performance of the predicate device. Therefore, subject Pulse System was found to be substantially equivalent.
Conclusions H.
Based on the indications for use, technological characteristics, performance testing, and comparison to predicate devices, the subject Pulse System has been shown to be substantially equivalent to legally marketed predicate devices.
1 As evaluated by a human observer in a side by side visual comparison of 30 image pairs with and without LessRay processing.
ii In clinical practice, the amount of image quality improvement achieved when a Pulsed and/or Low Dose image is processed with LessRay is dependent on the clinical task, patient size, anatomical location, and clinical practice. The dose should be set at a level to which the physician is able to achieve the adequate image quality needed for the particular clinical task. A consultation with a radiologist and a physicist may aid in determining the appropriate dose settings.