Zeta Cranial Navigation System (ZNS131-US)
Zeta Surgical Inc.The Zeta Cranial Navigation System is a stereotaxic image guidance system designed to help neurosurgeons spatially position and orient surgical instruments during cranial surgery. It uses 3D preoperative CT or MRI scans to assist in real-time navigation without requiring rigid fixation of the patient. This system enhances the precision of neurosurgical procedures by providing visual guidance based on medical imaging data.
Intended Use
The Zeta Cranial Navigation System is a stereotaxic image guidance system intended for the spatial positioning and orientation of neurosurgical instruments used by surgeons in cranial surgery where reference to a rigid anatomical structure can be identified, without rigid fixation of the patient or instrument guide; intended for operating and interventional procedure rooms.
Technology
The system is a stereotaxic image-guided planning and intraoperative guidance system that assists neurosurgeons by displaying the position of tracked surgical instruments relative to 3D preoperative CT and MRI scans. It uses structured light and machine vision for optical tracking of unpowered wireless instruments, with image-based real-time display. The system includes components such as a cart, sensor head, positioning arms, touchscreen monitor, tracked instruments, and specialized software.
Performance
Performance testing included bench testing for accuracy under various conditions (simulated clinical procedures, illumination levels, patient motion, physical/environmental variations), design validation, and human factors/usability testing. Electrical safety, electromagnetic compatibility, software verification and validation, and cybersecurity documentation were also completed. No clinical testing was required.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
8/8/2024
1 month - 2
FDA Approval
10/4/2024
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