Neuromuscular Transmission Monitor TOF3D (2510091)

The TOF3D is a neuromuscular transmission monitor used to objectively measure muscle contraction following electrical nerve stimulation during surgery or intensive care. It can also function as a peripheral nerve stimulator for subjective monitoring and is intended for use by anesthetists and nurses specializing in anesthesia care for patients aged 18 and older.

The subject device adds a mechanomyography (MMG) sensor option for direct force measurement, whereas the predicate uses acceleromyography (AMG) to calculate force. Both devices share identical maximum stimulation voltage (300 V), current range (0-60 mA), pulse width (monophasic 200-300 µs), stimulation patterns (TOF, PTC, TET, DBS, ST), accuracy (±5%), and contact characteristics (surface contact, intact skin, limited ≤24 hours).

IEC 60601-1 (electrical safety), IEC 60601-1-2 (electromagnetic compatibility), IEC 60601-2-10 (nerve/muscle stimulator safety), IEC 60601-1-6 and IEC 62366-1 (usability), and ISO 10993-1 (biocompatibility). All testing was performed by independent accredited laboratories.

The TOF3D with MMG sensor is substantially equivalent because it has identical intended use, user profile, and patient population as the predicate; employs substantially similar technological characteristics with only the measurement method differing (mechanomyography versus acceleromyography); and demonstrates equivalent safety and performance through comprehensive testing showing no new safety or effectiveness questions. The MMG sensor is reusable with identical biocompatibility and cleaning procedures as approved patient-contacting parts.