SonoPlex STIM; SonoPlex II

The SonoPlex STIM and SonoPlex II are single-use anesthesia conduction needles designed for peripheral nerve blocks under ultrasound guidance. The needles feature Cornerstone reflectors to enhance ultrasound visibility and can optionally be equipped with an electrical stimulation cable to assist physicians in pinpointing the injection site (dual guidance). They are intended to puncture tissue and deliver local anesthetics for regional anesthesia.

Both subject and predicate devices use stainless steel 1.4301 tubing with identical needle tip options (Tuohy, Quincke, Chiba, Facette). The key difference is that the subject device includes an optional electrical stimulation cable with PVC and brass/copper components, whereas the predicate lacks this feature. Both devices support Parylene coating, Cornerstone reflectors, Tampapur TPU graduation, and ISO 80369-6/7 connectors. The subject device offers optional medical paper packaging in addition to Tyvek, and optional sterilization at a second facility (HA2 Medizintechnik) in addition to Sterigenics.

ISO 9626 (stainless steel needle tubing), ISO 7864 (sterile hypodermic needles), ISO 80369-6 (neuraxial connectors), ISO 80369-7 (hypodermic/intravascular connectors), ISO 80369-20 (connector common test methods), ISO 11135-1 (sterilization validation), ISO 10993-series (biocompatibility), ISO 10993-7 (ethylene oxide residuals), ISO 13485 (quality management).

The subject and predicate devices perform identical core functions—ultrasound-guided nerve block needle placement—with the same materials, dimensions (20G–25G, 40–120 mm), tip geometries, and performance specifications. The optional electrical stimulation capability adds dual-guidance functionality but both ultrasound and ultrasound-plus-electrical-stimulus methods are established, safe, and state-of-the-art. The alternative packaging material (medical paper) and sterilization provider both underwent independent validation (ISO 11135 sterilization validation, packaging/shelf-life testing) confirming SAL 10⁻⁶ and 5-year sterility maintenance. Since the hub-to-needle bonding, injection tube materials, connectors, coatings, and biocompatibility are identical, and manufacturing changes (optional direct injection molding vs. gluing) have been separately validated without altering clinical performance or risk profile, the subject device is substantially equivalent.