Natus Ultrapro S100 (982A0594)

The Natus UltraPro S100 is a diagnostic electromyography system designed to acquire, display, analyze, store, and report electrophysiological information from the human nervous and muscular systems. It performs nerve conduction studies (NCS), electromyography (EMG), evoked potentials (EP), autonomic responses, and intra-operative monitoring including electroencephalography (EEG), and is intended for use by qualified healthcare providers in professional healthcare facilities.

The UltraPro S100 features 1 to 4 isolated channels with 24-bit analog-to-digital conversion at 192 kHz cumulative sampling rate, >120 dB common-mode rejection ratio, <0.4 µV RMS noise, and input impedance >1000 MΩ. It includes one constant-current electrical stimulator (100 mA maximum, 0.01–1 ms duration), auditory stimulators (0–139 dB pSPL, 125–8000 Hz), LED visual stimulators, and optical/transformer patient circuit isolation. The system runs Natus Elite software on Microsoft Windows via USB interface and supports all major EMG and EP application modules including SEP, AEP, VEP, P300, ERG, EOG, CNV, EEG, MEP, and autonomic testing.

Not stated in this summary.

The UltraPro S100 is substantially equivalent to the Synergy Focus (K130346) primary predicate because both devices have identical indications for use, identical product codes (GWF, IKN), identical design characteristics (computer-based with Windows interface, USB connection, optical/transformer isolation), and substantially identical acquisition specifications (1–4 channels, 24-bit conversion, 192 kHz sampling, >120 dB CMRR, <0.4 µV noise, >1000 MΩ impedance). The stimulator specifications, EMG application modules, and EP application modules are identical to the predicate. The few minor differences (e.g., integrated ultrasound display capability) represent enhancements that do not affect the fundamental intended use or safety profile.