EzVu Visual Vasopressor injector (EV-19)

The EzVu Visual Vasopressor Injector (EV-19) is a laparoscopic injection device designed to deliver vasopressor solution into the uterine muscle during laparoscopic surgery. It features a 330 mm long, 5 mm diameter hollow shaft with a stainless steel needle, a transparent window for visualization, and a stopcock with luer connection for syringe attachment.

The device differs from the predicate in working length (330 mm vs. 600–2500 mm), outer diameter (5 mm vs. 1.8–2.4 mm), needle gauge (19G only vs. 19G, 22G, 23G, 25G), and intended application (laparoscopic vs. endoscopic). Both are single-use injection needles with similar fundamental tube-and-needle configuration for delivering liquid agents into tissue.

ISO 10993-1:2020 and related biocompatibility standards (ISO 10993-5, 10993-10, 10993-11); ISO 11135:2014 for ethylene oxide sterilization; ISO 11607-1:2019 for packaging; ASTM F1929-23, F88-23, F1980-21 for seal and packaging testing; ISO 7864:2016 and ISO 9626:2016 for needle performance and stainless steel tubing.

Both devices share the same product code (FBK), regulation (21 CFR 876.1500), and class (II), and both perform injection of solutions into tissue. Although the subject device is designed for laparoscopic use versus the predicate's endoscopic use, the fundamental intended function—delivery of liquid agents into tissue—is identical. The dimensional differences (length, diameter, gauge) reflect anatomical context rather than new safety or effectiveness concerns, and non-clinical testing (biocompatibility, sterility, bench performance) and clinical data (24 injections with no adverse events, favorable usability scores) demonstrate equivalent safety and performance.