SPRY TMS Therapy System (0550)

The SPRY TMS Therapy System is a non-invasive neuromodulation device that delivers repetitive transcranial magnetic stimulation (TMS) through a figure-of-eight transducer coil positioned on the scalp. It is indicated for treating Major Depressive Disorder in adult patients who have failed to achieve satisfactory improvement from prior antidepressant medication in the current episode.

Both the SPRY system and predicate device use biphasic figure-8 coils with identical core materials, cooling mechanisms, and treatment parameters (0.1-30 Hz frequency, 1.0 Tesla magnetic field, 0.3-1.9 SMT amplitude). Minor differences include device dimensions, pulse width (360 μs vs. 430 μs), coil conductor specifications, and magnetic field gradient rates (10 kT/s vs. 8.1 kT/s), which the submitter argues do not affect clinical performance.

Testing followed IEC 60601-1 and IEC 60601-1-2 (electrical safety and EMC), ISO 10993-1 (biocompatibility), IEC 62304 (software validation), ISO 14971 (risk analysis), and FDA's Class II Special Controls Guidance for rTMS Systems.

Both devices have identical intended use, target patient population, treatment procedure, brain location (DLPFC), and standard therapeutic protocol. Comparative testing demonstrated substantially equivalent output waveforms, magnetic field distribution, and performance. Design differences in dimensions, pulse width, and coil parameters represent variations only and do not raise new safety or effectiveness questions since stimulation is personalized to each patient's motor threshold.