Zeta Navigation System

The Zeta Navigation System is a stereotaxic image-guided system that helps surgeons precisely position neurosurgical instruments during cranial procedures by displaying instrument location relative to 3D preoperative medical scans. It includes the Zeta Stylet (a single-use guiding stylet for catheters and shunts) and Zeta Bolt (a single-use instrument for brain biopsies), both designed for use only with the Zeta Navigation System.

The system uses optical tracking of wireless, unpowered instruments with automatic, pinless, markerless registration. Key additions over the predicate include a cloud pre-planning app and Zeta Cloud data input capability. The Zeta Stylet and Bolt are made of titanium (grade 23) and are single-use, whereas the main system is reusable. Both new instruments achieve navigational performance of mean error ≤2.00 mm and ≤2.00°.

IEC 60601-1:2005 (medical electrical equipment general requirements), IEC 62304:2006 (software life cycle), IEC 60601-1-2:2014 (electromagnetic compatibility), IEC 60601-1-6:2020 (usability), ISO 10993-1:2018 (biocompatibility), and FDA guidance on software verification, cybersecurity, and human factors engineering.

The Zeta Navigation System is substantially equivalent to its predicate (K242351) because it maintains identical indications for use, classification, product code, and core operational principles (preoperative imaging, surgical planning, patient registration, and instrument guidance). The Zeta Stylet and Bolt are substantially equivalent to their respective predicates (Medtronic Passive Planar Blunt Probe and Cranial Reducing Tubes) as single-use, optically-tracked instruments with the same navigational performance specifications and integration with stereotactic navigation systems.