Neuralytix iD3 System (NTX-9001)

The Neuralytix iD3 System is a multichannel surgical device that locates, maps, and assesses motor nerves during surgery using mechanomyography (MMG) signals and electrical stimulation. It helps surgeons identify nerve activity and track changes in nerve conduction and transmission ability throughout a surgical procedure, with applications in spinal surgery, nerve decompressions, and treatment of nerve compression conditions.

The subject device features a maximum 8-channel control unit with a 7.0-inch display, weighs 0.72 kg, delivers constant-current stimulation (0–20 mA standard mode, 0.3–4 mA hi-res mode) via monophasic rectangular pulses at 100 µs width, uses accelerometer-based MMG sensors in 2-inch round form, and employs 316L stainless steel with Parylene C coating. Compared to the predicate (Sentio MMG Gen 2), the subject device has fewer channels (8 vs. 10), smaller display (7.0 vs. 9.8 inches), lower weight (0.72 vs. 2.0 kg), and slightly higher maximum voltage (160V vs. 115V).

ISO 11137-1, ISO 11137-2, ISO 11137-32 (sterilization); ISO 11607-1, ISO 11607-2 (package integrity); ASTM F88/F88M-21, ASTM F2096-19 (seal and leak testing); ASTM F1980-21 (accelerated aging); ASTM D4332, ASTM D4169 (transport stability); IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-2-40 (electrical safety and EMC); ISO 10993 series (biocompatibility); PSTC 101 Type F (adhesion testing).

The device is substantially equivalent because it performs the identical function as the predicate—locating and assessing motor nerves via MMG detection and electrical stimulation—with comparable technological characteristics and superior or equivalent performance. All key design attributes (stimulation type, waveform, pulse width, sensor technology, connector types, materials) are substantially equivalent or improved. Biocompatibility testing, comparative MMG-detection performance (>99% agreement), and all environmental, electrical safety, and sterilization tests confirm the device meets the same acceptance criteria and consensus standards as the predicate, with no new safety or effectiveness questions raised.