BrainsWay Deep TMS System

The BrainsWay Deep TMS System is a non-invasive transcranial magnetic stimulation device that delivers brief magnetic pulses to the brain via an electromagnetic coil placed on the scalp. It is indicated for treating depressive episodes and reducing anxiety symptoms in adults with Major Depressive Disorder (MDD) who have failed prior antidepressant medication. The device consists of a mobile cart with a TMS neurostimulator, cooling system, positioning device, and a helmet containing the electromagnetic coil and aiming apparatus.

The subject device has identical hardware components (mobile cart, coil/helmet unit, positioning arm, cooling system, TMS stimulator) to the previously cleared predicate BrainsWay Deep TMS Systems (K222196). The key modifications are updated stimulator software and the addition of an accelerated iTBS (intermittent theta burst stimulation) treatment protocol alongside the existing standard-of-care high-frequency protocol. The head cap materials were changed to new biocompatible materials, and software validation and biocompatibility testing were provided to support these changes.

The device complies with IEC 60601-1 (electrical equipment general safety), IEC 60601-1-2 (electromagnetic disturbances), IEC 62304 (medical device software lifecycle), ISO 14971 (risk management), ISO 10993-5/10993-23/10993-10 (biocompatibility testing for cytotoxicity, irritation, and skin sensitization). Non-clinical testing included Output Waveform, Electrical Field Spatial Distribution, and Magnetic Field Strength Gradient Testing per FDA Class II Special Controls guidance for rTMS systems.

The device is substantially equivalent because it uses identical hardware architecture and the same mechanism of action as the predicate K222196, with only software updates and the addition of a new treatment protocol. Clinical data from a multicenter, randomized, controlled study demonstrated that the accelerated iTBS protocol achieved non-inferior outcomes to standard-of-care high-frequency stimulation (adjusted mean HDRS-21 reduction of -19.02 vs. -19.79 points, p=0.7783), with response rates of 87.8% vs. 87.5% and remission rates of 78.0% vs. 87.5%. Adverse events were consistent with known TMS risks, and the secondary predicate Magnus MNS (K220177) shows similar clinical outcomes with an accelerated iTBS approach, further supporting equivalence of the new protocol.