SonoTAP and SonoTAP II

The SonoTAP and SonoTAP II are single-use anesthesia conduction needles designed for ultrasound-guided regional anesthesia and analgesia. They feature ultrasound-enhancing CornerStone reflectors and are supplied sterile, with a standard time of use under 60 minutes and maximum intended use of 24 hours.

Both devices use stainless steel 1.4301 needles with silicone coating and copolyester or ABS hubs. SonoTAP offers 18G-24G diameters with LUER connectors and glued needle-to-hub bonding; SonoTAP II offers 21G-24G with NRFit or LUER connectors and direct molding. Both are sterilized by ethylene oxide at Sterigenics and/or HA2 to achieve SAL 10⁻⁶, with optional medical paper packaging in addition to Tyvek/foil.

ISO 7864 (sterile hypodermic needles), ISO 9626 (stainless steel needle tubing), ISO 80369-6 (neuraxial connectors), ISO 80369-7 (hypodermic connectors), ISO 80369-20 (common test methods), and ISO 10993 series (biocompatibility). Sterilization validation per ISO 11135.

The predicate (K113207 SonoTAP) and subject devices share identical intended use, materials, needle geometry, and ultrasound enhancement method. The main changes—addition of a second sterilization facility and optional medical paper packaging—do not affect device performance or safety. Both sterilization providers validated to the same SAL 10⁻⁶ per ISO 11135, and packaging materials passed exhaustive shelf-life testing maintaining sterility over 60 months. Hub-to-needle bonding strength testing confirms performance equivalence regardless of manufacturing method (glued vs. molded) or hub material (Tritan vs. ABS).