Ultimate rTMS for OCD (M-series)

The Ultimate rTMS for OCD is a repetitive transcranial magnetic stimulation system that delivers non-invasive magnetic pulses to the dorsomedial prefrontal cortex to treat adult patients with Obsessive-Compulsive Disorder. It is intended for use as an adjunct therapy in clinical settings including hospitals, diagnostics centers, and research institutions.

The device uses a double-cone coil design with liquid cooling, similar to the predicate MagVenture TMS system. Both deliver identical treatment parameters: 100% motor threshold intensity, 20 Hz frequency, 2-second train duration, 20-second inter-train intervals, 50 trains per session, 2000 total pulses, and 18-minute session duration. The Ultimate rTMS coil (MY90A) has slightly different dimensions and turn configuration than the predicate coil (Cool D-B80), resulting in minor differences in pulse amplitude (1.240V vs 1.612V) and magnetic field strength, but generates equivalent therapeutic magnetic field distributions.

The device complies with IEC 60601-1 and IEC 60601-1-2 electrical safety standards, and the manufacturer complies with ISO 13485:2016 quality management and ISO 14971 risk management standards. Performance testing referenced FDA's Class II Special Controls Guidance for Repetitive Transcranial Magnetic Stimulation Systems.

The Ultimate rTMS and MagVenture predicate device share identical indications for use, target anatomy, and treatment protocol parameters. Although coil dimensions and electrical output parameters differ slightly due to different manufacturing designs, bench testing demonstrates the magnetic field characteristics are substantially equivalent across intensity settings. These minor differences are typical among different TMS manufacturers and are compensated by adjusting individual patient motor threshold determination, which normalizes stimulation intensity regardless of device. No new safety concerns are introduced, and the positioning methodology using cortical anatomy landmarks is equivalently reliable as the predicate.