Disposable Subdermal Needle Electrode, Corkscrew

The Disposable Subdermal Needle Electrode, Corkscrew is a single-patient use electrode with a stainless steel needle formed in a corkscrew shape, connected to a lead wire with a DIN 42802 connector. It is intended for use by trained healthcare professionals to record biopotential signals (EEG, EMG, nerve potentials) and for stimulation/recording with electromyography and nerve potential equipment in hospital settings.

The device is nearly identical to the predicate (K130136) except for two internal modifications: the needle-to-lead wire connection changed from soldering to a brass crimp bushing glued to the hub, and the hub's internal shape was optimized to accommodate the new connection. All external dimensions, materials, electrical properties, and functional characteristics remain unchanged.

ASTM F1980-21 (accelerated aging), ASTM F1929-15 (pouch integrity), ISTA 3A (transit simulation), ISO 10993 series (biocompatibility), IEC 60601-1 Ed. 3.2 (electrical/mechanical/thermal safety), ISO 11135:2014 (sterilization validation), IEC 62366-1:2015 (usability), and ISO 20417 (labeling).

The crimped connection with glue replaces the solder joint as the needle-to-lead wire interface, and mechanical testing demonstrated the new connection meets or exceeds strength requirements (>25N tensile strength vs. >22N for predicate). Non-clinical testing including mechanical, electrical, biocompatibility, sterilization, and usability testing showed no new or different safety and effectiveness questions. Since device materials, dimensions, shape, intended use, and functional principles remain substantially equivalent, the modification does not alter the fundamental safety and effectiveness profile.