NuVasive Pulse System

The Pulse ICT Adapter is a fiducial-based registration hardware component that enables the NuVasive Pulse Navigation system to provide intraoperative image-guided localization during spinal surgery. It allows surgical instruments and implants to be tracked in 3D space and displayed on the patient's radiographic images to assist in procedures such as pedicle screw placement and iliosacral screw placement.

The subject device introduces a new hardware design (Pulse ICT Adapter) that attaches the Globus Medical Intra-Op CT Fixture to an articulating arm and bedrail clamp, providing fiducial-based registration. This differs from the predicate Spinous Process Clamp design but maintains the same principle of providing a reference to a rigid anatomical structure for patient registration, with a new corresponding registration algorithm in software.

ASTM F2554-10 (Standard Practice for Measurement of Positional Accuracy of Computer Assisted Surgical Systems); IEC 62366:2020 (Application of usability engineering to medical devices); IEC 62304:2015 (Medical device software — Software lifecycle processes).

Although the Pulse ICT Adapter introduces different hardware attachment geometry compared to the predicate Spinous Process Clamp, both devices operate on the identical principle of fiducial-based registration to provide a reference to rigid anatomical structures for patient registration. Verification and validation testing demonstrated the subject device meets the same product and software requirements and achieves equivalent performance acceptance criteria as the predicate, confirming substantial equivalence despite the design changes.