(30 days)
Not Found
No
The document describes image processing for enhancement and navigation based on tracking, but does not mention AI or ML.
No
The device, Pulse Navigation, is described as an image-guided localization system and a computer-assisted navigation system for spinal surgical procedures. While it aids surgeons during surgery, it does not directly deliver therapy or treat a disease. It primarily provides information and guidance for instrument placement.
No
The device is an intraoperative image-guided localization and navigation system for surgical procedures, not a diagnostic device. It helps the surgeon locate anatomical structures and track instruments during surgery, but does not diagnose medical conditions.
No
The device description explicitly states that the Pulse System hardware includes a control unit and accompanying accessory components, and the Pulse Navigation component utilizes an Infrared (IR) Camera for tracking. This indicates the presence of hardware beyond just software.
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 derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The Pulse Navigation system is an image-guided localization system used during surgical procedures. It uses radiographic images of the patient's anatomy and tracks surgical instruments in real-time to aid the surgeon.
- No Specimen Analysis: The device does not analyze any biological specimens from the patient. Its function is based on imaging and tracking within the surgical field.
The device is clearly described as a surgical navigation system, which falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
Pulse Navigation is intended as an intraoperative image-guided localization system in either open or minimally invasive spinal surgical procedures. Instruments and implants tracked by a passive marker sensor system are virtually displayed on a patient's 3D radiographic image data. The system enables computer-assisted navigation for spinal surgical procedures in which the use of stereotactic surgery may be appropriate and where a reference to a rigid anatomical structure can be identified relative to the acquired image of the anatomy.
This may include the following spinal implant procedures:
- Pedicle Screw Placement (cervical, thoracic, lumbar)
- Iliosacral screw placement
Product codes
OLO
Device Description
The subject device, Pulse ICT Adapter is introducing compatibility based on the design of existing fria patient reference hardware, the Spinous Process Clamp (Pulse System K210574) and Globus Medical 1CT Fixture (ExcelsiusGPS K171651 and K 191100). The subject device, Pulse ICT Adapter was designed to offer surgeons more flexibility during the registration process of Pulse Navigation by providing an additional patient reference hardware design option by attaching Globus Medical Intra-Op CT Fixture to the following: existing Articulating Arm and Bedrail Clamp. Despite the changes introduced to predicate Spinous Process Clamp (K210574), the subject device is substantially equivalent to the predicate as demonstration and validation testing performed using well established and previously cleared test methods.
The Pulse System is a medical device consisting of 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 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 NVMS 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 utility 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 bendini). Lastry, the Pulse NVMS 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 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 to evaluate the instrument depth and trajectory for computer-assisted navigation during spine surgery. Instruments are tracked in threedimensional 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 the submission is to introduce a new intra-operative CT (ICT) adapter for use with the ExcelsiusGPS ICT Registation Fixture for the Pulse Navigation application.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
3D radiographic image data, 3D intraoperative scan (CT or Cone Beam CT)
Anatomical Site
Spinal, Pedicle, Iliosacral
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Surgeon, intraoperative, computer-assisted navigation for spinal 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 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 testing acording to the product and software requirements specifications defined for the system.
- Non-clinical system, software, and instrument verification and validation demonstrated compliance with user needs and corresponding design inputs.
- Qualitative validation to confirm intended use .
- Testing was performed to ensure compliance with recognized standards mentioned below for tracking accuracy and usability.
- ASTM F2554-10: Standard Practice for Measurement of Positional Accuracy of Computer Assisted Surgical Systems
- IEC 62366:2020 Medical devices Part 1: Application of usability engineering to medical devices
- IEC 62304:2015 Medical device software - Software lifecycle processes
The results of testing demonstrated that the subject Pulse System meets product and software for the system and satisfies the same acceptance criteria as the predicate device. Therefore, the subject Pulse System was found to be substantially equivalent.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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 contains 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 features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG' and 'ADMINISTRATION' in blue text.
January 10, 2025
Globus Medical, Inc Jennifer Antonacci Group Manager, Regulatory Affairs Valley Forge Business Center 2560 General Armistead Ave Audubon, Pennsylvania 19403
Re: K243814
Trade/Device Name: Pulse ICT Adapter Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: December 11, 2024 Received: December 11, 2024
Dear Jennifer Antonacci:
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 (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 available 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.
1
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 medical devices and radiation-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-regulatory
2
assistance/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 -S
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
3
Indications for Use
510(k) Number (if known) K243814
Device Name NuVasive Pulse System
Indications for Use (Describe)
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) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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4
510(k) Summary
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:
Prem Pisupati Lead Regulatory Specialist, Regulatory Affairs NuVasive, Incorporated 7475 Lusk Blvd. San Diego, California 92121 Telephone: (858) 909-1800
Date Prepared: 08-Jan-2025
B. Device Name
| Trade or Proprietary Name: | NuVasive® Pulse™ System |
|---|---|
| Common or Usual Name: | Stereotaxic Instrument |
| Classification Name: | Stereotaxic Instrument |
| Device Class: | Class II |
| Regulation Number: | 21 CFR §882.4560 |
| Classification Product Code: | OLO |
| Subsequent Product Codes: | PDQ, ETN, GWF, HAW, IKN, OWB, LLZ, JAA |
C. Predicate Devices
Primary Predicate: NuVasive Pulse System (K210574) Other Predicates: ExcelsiusGPS (K171651 and K191100)
D. Device Description
The subject device, Pulse ICT Adapter is introducing compatibility based on the design of existing fria patient reference hardware, the Spinous Process Clamp (Pulse System K210574) and Globus Medical 1CT Fixture (ExcelsiusGPS K171651 and K 191100). The subject device, Pulse ICT Adapter was designed to offer surgeons more flexibility during the registration process of Pulse
5
K243814
Navigation by providing an additional patient reference hardware design option by attaching Globus Medical Intra-Op CT Fixture to the following: existing Articulating Arm and Bedrail Clamp. Despite the changes introduced to predicate Spinous Process Clamp (K210574), the subject device is substantially equivalent to the predicate as demonstration and validation testing performed using well established and previously cleared test methods.
The Pulse System is a medical device consisting of 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 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 NVMS 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 utility 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 bendini). Lastry, the Pulse NVMS 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 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 to evaluate
6
K243814
the instrument depth and trajectory for computer-assisted navigation during spine surgery. Instruments are tracked in threedimensional 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 the submission is to introduce a new intra-operative CT (ICT) adapter for use with the ExcelsiusGPS ICT Registation Fixture for the Pulse Navigation application.
E. Indications for Use
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 mare 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 to the acquired image of the anatomy.
This may include the following spinal implant procedures:
- Pedicle Screw Placement (cervical, thoracic, lumbar)
- Iliosacral screw placement
F. Technological Characteristics
The introduction of new hardware (the Pulse ) and a new registration algorithm in software allows an updated fiducial-based patient registration method, when used together with ExcelsiusGPS ICT fixture. The subject device is comparable to the predicates in terms of intended use, fundamental scientific technological characteristics and principles of operation.
| Characteristics | Subject Device:
NuVasive Pulse System Fiducial
based registration (ICT Fixture and
Pulse ICT adapter) | Predicate Device:
NuVasive Spinous Process Clamp
(K210574) | Predicate Device:
Globus Medical Intra-op CT
Registration Fixture (ICT Fixture)
ExcelsiusGPS (K171651 & K191100) |
|---------------------------|----------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------|
| Principle of
Operation | Fiducial registration hardware
provides a reference to a rigid
anatomical structure. | Patient reference hardware provides
a reference to a rigid anatomical
structure. | Patient reference hardware that
provides a reference to a rigid
anatomical structure. |
| System
Components | Pulse ICT Adapter and
ExcelsiusGPS ICT Fixture are | Clamps directly attached to
spinous process | ICT fixture attached to patient
reference hardware via pivoting arm |
7
| Registration
Compatibility | attached to surgical bed via
articulating arm and bedrail clamp | | |
|-------------------------------|--------------------------------------------------------------------|---------------------------------------|-----------------------|
| | Fiducial Registration | NaviLink and Fiducial
Registration | Fiducial Registration |
G. Performance Testing
Nonclinical testing was performed to demonstrate that the 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 testing acording to the product and software requirements specifications defined for the system.
- · Non-clinical system, software, and instrument verification and validation demonstrated compliance with user needs and corresponding design inputs.
- Qualitative validation to confirm intended use .
- · Testing was performed to ensure compliance with recognized standards mentioned below for tracking accuracy and usability.
- = ASTM F2554-10: Standard Practice for Measurement of Positional Accuracy of Computer Assisted Surgical Systems
- IEC 62366:2020 Medical devices Part 1: Application of usability engineering to medical devices
- . IEC 62304:2015 Medical device software - Software lifecycle processes
The results of testing demonstrated that the subject Pulse System meets product and software for the system and satisfies the same acceptance criteria as the predicate device. Therefore, the subject Pulse System was found to be substantially equivalent.
H. Conclusions
Based on the indications for use, technological characteristics, and comparison to predicate devices, the subject device has been shown to be substantially equivalent to legally marketed predicate devices.