Bridge Plus Occlusion Balloon (590-002)

The Bridge Plus Occlusion Balloon is a catheter designed for temporary vessel occlusion of the superior and inferior vena cava. It is used for perioperative occlusion and emergency control of hemorrhage during vascular procedures. The device consists of a compliant polyurethane balloon mounted on a 12Fr dual-lumen nylon shaft with an 80mm balloon length and inflation diameter of 20-29mm.

The Bridge Plus Occlusion Balloon is similar in design and performance to predicate devices but differs in materials of construction and balloon/catheter design. Like the predicates, it is deliverable to target vasculature and appropriately sized for vascular occlusion. The subject device includes vessel specificity for both SVC and IVC in its indication, whereas the predicates do not specify this dual-vessel use.

ISO 11135:2014 Amendment 1 was used for sterilization validation, including bioburden resistance studies and bioburden method validation. Biocompatibility testing followed standards covering cytotoxicity, sensitization, irritation, pyrogenicity, hemolysis, thromboplastin time, platelet/leukocyte counts, surface analysis, and complement activation.

The Bridge Plus Occlusion Balloon demonstrates substantial equivalence through design similarities and performance parity with both the QX Medical Occlusion Balloon Catheter and Bridge Occlusion Balloon Catheter predicates. Although materials and design details differ, comprehensive performance testing—including dimensional, deployment, inflation/deflation, vessel occlusion, fatigue, and biocompatibility assays—confirmed the device meets all specifications and performs comparably to predicates. No new preclinical or clinical data were required, as design similarities and test data adequately supported equivalence.