Rapid2 Magnetic Stimulators (Magstim Rapid2, Magstim Super Rapid2, Magstim Super Rapid2 Plus1)

The Rapid² Magnetic Stimulators (Magstim Rapid², Magstim Super Rapid², Magstim Super Rapid² Plus¹) are computerized electromagnetic devices that deliver brief, focused magnetic pulses to non-invasively stimulate peripheral nerves for relief of chronic intractable, post-traumatic, and post-surgical pain in patients 18 years or older. The system is intended for use in hospitals and pain management clinics.

The subject device operates at pulse frequencies of 0.1–50 Hz (Rapid²) or 0.1–100 Hz (Super Rapid² variants) with 0–100% amplitude control and a 2–800 second on-cycle duty period, similar to the predicate. Pulse width is biphasic (300–425 µs) compared to the predicate's 280–320 µs. Peak magnetic field is 1.0–1.5 T versus the predicate's 1.15–2.6 T, representing a smaller peak over a longer duration. The subject device includes temperature monitoring with automatic cutoff at 40°C and uses circular and butterfly coils with equivalent configurations to the predicate.

IEC 60601-1 (Ed. 3.2) for electrical, mechanical, and thermal safety; IEC 60601-1-2 (Ed. 4.1) for electromagnetic compatibility; IEC 60601-1-8 for alarm systems; IEC 62304 for software verification and validation; ISO 14971:2019 for risk management; ISO 10993 series (parts 1, 5, 10) for biocompatibility; ISO 13485 for quality management; AAMI TIR57 for security assessment; and guidance from the FDA's 2011 rTMS Special Controls document for coil characterization.

The subject device is substantially equivalent because it shares identical indications for use, anatomical sites, treatment time (13 minutes per session), and pulse amplitude (0–100%) with the predicate. Although peak magnetic field and pulse width ranges differ, the submission demonstrates through field mapping and energy calculations that the subject device's smaller peak magnetic field delivered over a longer pulse width produces equivalent energy deposition into tissue as the predicate's higher peak field over shorter pulse width. Critically, the recommended treatment protocol is fixed at 0.5 Hz with 400 pulses, cannot be modified by users, and is the same as the predicate's standard protocol. All coil configurations use the same copper-wound construction as the predicate, and biocompatibility and safety testing demonstrate no new or differing safety risks.