Ampa One System (AMPA-001)

The Ampa One System is a computerized medical device that delivers non-invasive magnetic fields to induce electrical currents in specific brain regions for treating Major Depressive Disorder in adults who have failed prior antidepressant medication. It uses two coils (L and M) to target the left dorsolateral prefrontal cortex and bilateral prefrontal cortex, respectively, and operates with the MagVenture MagPro R30 pulse generator.

The Ampa One System has figure-of-eight air-core coils with nearly identical magnetic field characteristics to predicates (correlation coefficients 0.981–0.986). Key differences include: phase-change cooling with software cutoff instead of active cooling; preloaded tablet software for treatment control instead of capital equipment; and integrated camera with software for coil positioning instead of operator-marked caps or head straps.

ISO 14971 (risk management), IEC 60601-1 and IEC 60601-1-2 (electrical safety and EMC), IEC 62304 (software lifecycle), ISO 10993-1 (biocompatibility), ASTM D4169-22 and D4332-22 (shipping and packaging). Testing was performed per FDA Special Controls Guidance on Transcranial Magnetic Stimulator devices.

The Ampa One System produces virtually indistinguishable magnetic fields and induced electrical field distributions from the predicate devices (L coil vs. B70: 0.981 correlation; M coil vs. H7: 0.986 correlation), demonstrating equivalent effectiveness in achieving the same clinical mechanism. Safety testing confirmed proper function with the MagVenture R-30 generator with treatment parameters (magnetic field strength, repetition rates, pulse counts) that align with FDA seizure-safety limits established by prior clinical evidence. The minor ancillary differences in cooling, software interface, and positioning methodology do not introduce new safety or effectiveness questions because they serve the same underlying TMS therapy mechanism for MDD treatment.