VECTR – Video Endoscopic Carpal Tunnel Release System

The VECTR is a single-use endoscopic surgical system for minimally invasive ligament and fascia release procedures, particularly carpal tunnel release in the wrist and cubital tunnel release in the elbow. It combines a surgical knife, camera, light, and cannula in one integrated handpiece that connects to a proprietary tablet for visualization and control during surgery.

The VECTR differs from its predicate (SMARTRELEASE) in two ways: (1) it is single-use with an integrated CMOS camera that is discarded after surgery, whereas the predicate uses a removable reusable endoscope, and (2) the housing is made of Makrolon M430-901510 instead of aluminum, stainless steel, and Radel polyphenylsulfone. Neither difference presents additional risks compared to the predicate.

ISO 10993 series (biocompatibility), ISO 11135 and 11137/11138 (sterilization and biological indicators), ASTM D5276/D642/D4728/D6344 (package stability), ASTM F1980/F2096/F88 (shelf life and seal strength), IEC 60601-1-2 (electromagnetic compatibility), ANSI/AAMI ES60601-1 (electrical/mechanical/thermal safety), and ISO 14971 (risk management).

Both devices perform identical indications for use (carpal tunnel and cubital tunnel release). The VECTR's single-use design with integrated camera does not introduce additional risks; it merely differs in reusability. Material substitution in the housing (Makrolon vs. aluminum/stainless steel/Radel) is a minor manufacturing change. Comprehensive nonclinical testing demonstrates the VECTR is sterile, stable, biocompatible, electromagnatically compatible, and functionally equivalent to the predicate. No clinical data were required because the intended use, basic function, and safety profile are substantially equivalent.