Ampa One System (AMPA-001)

The Ampa One System is a computerized, non-invasive transcranial magnetic stimulation (TMS) device that delivers magnetic pulses to treat Major Depressive Disorder in adult patients who have failed prior antidepressant medications. It uses two coils (L and M) to target the dorsolateral prefrontal cortex of the brain and includes a pulse generator, control interface, positioning arm, and neuronavigation cap.

The subject device replaces a bridging connector and external MagVenture MagPro R30 pulse generator with an integrated Ampa Pulse Generator designed to closely match the MagVenture R30's electrical topology. All coils, treatment protocol parameters, and other system components (cap, arm, software interface) remain identical to the predicate device.

IEC 60601-1 and IEC 60601-1-2 (electrical safety standards). Testing also followed the FDA Special Controls Guidance on Transcranial Magnetic Stimulator devices and employed voluntary consensus standards methods.

The Ampa Pulse Generator was intentionally designed with nearly identical electrical topology to the MagVenture R30 to achieve functionally equivalent output. Nonclinical testing demonstrated that magnetic field strength and spatial characteristics are substantially equivalent to the predicate. Since the coils, treatment parameters, indications for use, and all other system components are identical, and the pulse generator produces equivalent magnetic output, the devices pose equivalent safety and effectiveness risks for the same intended use.