NExT Station; NExT Station Advanced

The NExT Station and NExT Station Advanced are physiological signal amplifiers used during electromyography (EMG) and evoked potential (EP) exams to acquire bioelectric signals from the patient's nervous system and muscles. They include Galileo NT Line software to record and display acquired data, aiding diagnosis and monitoring of nervous system and muscle disorders. Optional electrical, auditory, and photic stimulators are included for evoked response analysis.

The subject devices bundle two previously cleared predicate devices (Nemus 2 hardware and Galileo NT software) into a single integrated system. Key enhancements include: 4 EMG channels (vs. 2 in predicate hardware), 8 EP channels, upgraded low-pass filters for noise reduction, three visual stimulators (vs. one), and higher maximum sampling frequencies (65536 Hz). Both versions feature 24-bit A/D conversion for EMG, >110 dB CMRR, and operate on 115V medical power supplies.

ANSI/AAMI ES60601-1 (electrical safety), IEC 60601-1-2 (electromagnetic compatibility), IEC 60601-2-40 (EMG/EP requirements), EN ISO 15004-2 (light hazard protection), EN 62471 (photobiological safety), IEC 62304 (medical device software), and ISO 14971 (risk management).

The subject devices are substantially equivalent because they are a bundled package of two previously 510(k)-cleared predicate devices with identical intended use and core technological characteristics. The predicate devices—Nemus 2 (hardware) and Galileo NT (software)—already demonstrated safety and effectiveness independently. Enhancements (additional channels, upgraded filters, extra visual stimulators) do not introduce new safety risks; they address market needs without altering the fundamental signal acquisition and analysis mechanism. All enhancements passed the same FDA-recognized standards as the predicates, and operational procedures remain identical.