Zeta Navigation System (ZNS131-US)

The Zeta TMS Navigation System is a stereotaxic image guidance system that helps clinicians accurately position transcranial magnetic stimulation (TMS) treatment coils to target specific brain locations using 3D patient imaging data (CT or MRI). It is intended for use with specific MagVenture TMS therapy systems and the Cool-B65 RO magnetic coil.

The subject device uses structured light-based infrared 3D camera registration (automatic, pinless, and markerless) compared to the predicate's manual point selection registration. It accepts both MRI and CT imaging (DICOM format) versus the predicate's MRI-only. It is compatible only with the Cool-B65 RO coil and uses an IZI Disposable Passive Blunt Probe instead of the predicate's multiple coil and pointer options. System accuracy is 0.45mm mean (standard case) versus the predicate's 3.47mm average.

IEC 60601-1:2005 Ed. 3 (general safety and essential performance), IEC 62304:2006+Amd 1:2015 (software life cycle), IEC 60601-1-2:2014+A1:2021 (electromagnetic compatibility), and IEC 60601-1-6 Ed. 3.2 2020-07 (usability).

Both devices are Class II stereotaxic instruments under 21 CFR 882.4560 used for TMS coil positioning with trained clinical professionals in medical offices. They share the same intended use, anatomical site (head), workflow components, and basic functionality despite differences in registration method, imaging modalities, and compatible accessories. Testing demonstrates the subject device is as safe and effective as the predicate device.