VereSee Optical Veres Needle and Endoscopic Camera

The VereSee Optical Veres Needle and Endoscopic Camera is a minimally invasive surgical device consisting of three concentric stainless steel cannulas with an integrated CMOS camera and light fibers. It is used for percutaneous insertion into the peritoneal cavity to insufflate carbon dioxide and establish pneumoperitoneum prior to laparoscopic surgery, and also serves as an endoscopic video camera for visualization during diagnostic and surgical procedures.

The device consists of a sterile handpiece with distal LED illumination and a CMOS camera chip, plus a camera control unit that connects via umbilical cable and converts signals to HDMI-compatible display format. Both the subject device and its predicate (Arthrex NanoScope System) use rigid endoscopes with CMOS cameras, monitors for image display, and similar field of view and direction of view, though the predicate offers wider view capability and image storage features not present in the subject device.

Optical performance testing per ISO 8600-3 through ISO 8600-5; physical characteristics testing (weight, maximum handle temperature); mechanical testing including flow and leakage evaluation, destructive bond strength testing, and spring obturator and needle penetration tip force testing.

The device shares the same intended use, indications for use, and technological characteristics as the predicate VereSee Optical Veres Needle System (K232464). The same design with no design changes, combined with successful completion of the same performance testing and verification activities, demonstrates that any minor differences between the subject device and predicates are not material and do not raise new safety or effectiveness questions.