Nexstim Navigated Brain Stimulation (NBS) 6 System (NBS6)

The Nexstim Navigated Brain Stimulation (NBS) 6 System is a non-invasive repetitive transcranial magnetic stimulation (rTMS) device that delivers magnetic pulses to treat Major Depressive Disorder in adults who have failed antidepressant medication, and as an adjunct for Obsessive Compulsive Disorder. It uses MRI-based 3D localization and EMG measurement to target the prefrontal cortex and is operated by trained medical professionals in clinical settings.

The NBS 6 System employs the same technological characteristics as the predicate Horizon 3.0 device, including identical treatment protocols (10 Hz frequency, 120% motor threshold for MDD; 20 Hz, 100% motor threshold for OCD), figure-8 coil design, biphasic sinusoidal waveform, and similar magnetic field outputs. The primary difference is a new workflow-oriented graphical user interface designed for improved ease of use, with no substantive changes to core stimulation parameters or safety features.

IEC 60601-1, ANSI/AAMI ES 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 62304, IEC 62366, ISO 10993-1, FDA guidance on rTMS systems, software validation, cybersecurity, EMC, and usability engineering. Electrical safety, electromagnetic compatibility, software functionality, and usability were validated against these standards.

The NBS 6 System is substantially equivalent because it shares identical indications for use, treatment protocols, coil specifications, magnetic field parameters, and regulatory classifications with the Horizon 3.0 predicate. Bench testing of the coil and magnetic/electrical field characteristics demonstrates equivalence; the new GUI does not affect safety or efficacy, and no clinical testing was necessary given the technological parity with the predicate device.