Evala Nerve Stimulator (EPNR002)

The Evala Nerve Stimulator is a small handheld, sterile, single-use surgical device that delivers electrical stimulation to exposed motor nerves or muscle tissue during surgery to locate nerves, identify them, and test nerve and muscle function. It is battery-powered, operated with one hand, and provides feedback to the surgeon via visual indicators and vibration.

Both devices are hand-held, sterile, single-use, disposable, battery-powered surgical nerve stimulators with LED visual indicators and biphasic rectangular waveforms. Key differences: Evala uses a bipolar probe (versus monopolar) for more localized stimulation, offers additional output current levels, operates at 4 Hz higher frequency, and includes a haptic motor for vibration feedback.

IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10 (electrical/safety); ISO 10993-1, 10993-5, 10993-7, 10993-11, 10993-12, 10993-23 (biocompatibility); IEC 62366-1 (usability); ISO 15223-1, IEC 60601-1 (labeling); ISO 11607-1, ASTM D4332-22, ASTM D4169-23 (packaging); ASTM F2096, ASTM F88 (sterile barrier); ISO 14937, ISO 11737 (sterility); ASTM F1980-21 (shelf life); IEC 62304 (software validation).

The Evala Nerve Stimulator and predicate device (Checkpoint Head & Neck) are substantially equivalent because they share identical intended use, principles of operation, fundamental technology, and general operation. The differences in probe configuration (bipolar vs. monopolar), output current levels, frequency, and haptic motor do not raise new safety or effectiveness questions, as the underlying mechanism remains the same.