Apollo TMS Therapy System

The Apollo TMS Therapy System is a repetitive transcranial magnetic stimulation (rTMS) device that delivers rapidly pulsed magnetic fields to the brain to treat major depressive disorder (MDD). It is indicated for adult patients who failed prior antidepressant medication and as an adjunct treatment for adolescents aged 15-21 with MDD. The system consists of a user interface, main unit, stimulation coil, and coil positioning system that targets the left dorsolateral prefrontal cortex (DLPFC).

The Apollo system uses figure-of-eight biphasic coils (pCool and aCool variants) with passive or active cooling, generating an electric field of 130 V/m at 1.0 SMT. It supports standard treatment parameters (10 Hz, 120% MT, 3,000 pulses per session) and iTBS protocols (50 Hz, 80-120% MT, 600 pulses per session). The coil positioning system integrates landmark-aided placement or 10-20 EEG cap positioning with a coil positioning arm, and the stimulation software (Stimware) administers protocols based on individual motor thresholds. These characteristics are identical to previously cleared versions (K180313, K232639).

The device conforms to ISO 10993-1 (biocompatibility), IEC 60601-1 (general electrical safety), IEC 60601-1-2 (electromagnetic compatibility), IEC 60601-1-6 (usability), IEC 62304 (software lifecycle), ISO 14971 (risk management), ISO 15223 (symbols), and IEC 81001-5-1 (health IT security). Non-clinical testing addressed electrical safety, electromagnetic compatibility, and biocompatibility in compliance with FDA Class II Special Controls Guidance for rTMS systems.

The subject device is substantially equivalent because it is identical in hardware, software, and treatment protocols to the secondary predicate devices (K180313, K232639), which were previously cleared for adult MDD treatment. The only modification is expansion of the indications to include adolescent patients (15-21) as an adjunct to antidepressant therapy. This indication expansion is supported by a retrospective analysis and systematic literature review of the primary predicate (K231926, NeuroStar) demonstrating equivalent safety and efficacy in adolescents with no new hazards or risks. Since the device's technological characteristics, operational procedures, and performance standards are unchanged, and the clinical evidence supports safe and effective use in the new population, no different questions of safety or effectiveness are raised.