SonoMSK

The SonoMSK is a single-use anesthesia conduction needle enhanced with ultrasound-visibility features (CornerStone reflectors) for transient delivery of anesthetics to provide regional anesthesia and analgesia. It is equipped with an injection tube and LUER connector, with a standard use time under 60 minutes and maximum intended use of 24 hours.

The SonoMSK features a stainless steel 1.4301 needle with beveled tip and relief grind, copolyester hub, silicone coating, Cornerstone ultrasound enhancement, TPU graduation marking, and glued needle-to-hub bonding using epoxy or UV adhesive. It differs from the predicate SonoTAP in offering gauge sizes 22G–27G (versus 18G–24G) and optional packaging with medical paper in addition to Tyvek, plus optional sterilization at a second facility (HA2 Medizintechnik).

ISO 9626 (stainless steel needle tubing), ISO 7864 (sterile hypodermic needles), ISO 80369-7 and 80369-20 (small-bore connectors), ISO 11135-1 (sterilization validation), ISO 10993-1 and 10993-7 (biocompatibility and residuals).

The SonoMSK is substantially equivalent because it maintains identical core design, materials, and manufacturing processes to the predicate SonoTAP while offering expanded gauge options and sterilization flexibility. Bench testing showed equivalent or reduced insertion forces; the modified tip geometry remains within standard clinical ranges and introduces no novel risks. Sterilization at the second facility (HA2) and alternative packaging (medical paper) were each validated independently to maintain SAL 10−6 and shelf life performance, demonstrating that these process variations do not compromise safety or effectiveness.