VANES Delivery System (VDS)

The VANES Delivery System is a catheter introducer consisting of an outer introducer catheter, two inner subselection catheters, and accessory tools. It is designed for single-use, short-term venous access (<24 hours) to introduce pacing or defibrillation leads, catheters, and guidewires into specific branches of the venous system. The outer and inner catheters feature hemostasis valves and side-ports for fluid infusion and contrast injection.

The VANES Delivery System is identical to the predicate Worley Advanced LVI Lateral Vein Introducer in materials, manufacturing processes, facility, packaging, sterilization, and technological characteristics. The only difference is working length: the subject device has a 30-cm outer guide catheter and dual 47-cm inner catheters, whereas the predicate has a 62-cm outer catheter and single 75-cm inner catheter. Both systems feature metal braid reinforcement and polymeric x-ray markers.

Not stated in this summary. The document lists specific bench tests performed (dimensional verification, torque performance, kink resistance, tensile force, leakage, corrosion resistance, particulate testing) but does not reference ISO, IEC, or ASTM standards.

The VANES Delivery System is substantially equivalent because it is identical to the legally marketed Worley Advanced LVI Lateral Vein Introducer in all materials, manufacturing processes, and technological characteristics except for catheter working lengths. Since indications for use are identical and nonclinical bench testing demonstrates equivalent performance, the device poses no greater safety or effectiveness concerns than the predicate.