JMS CAVEO A.V. Fistula Needle Set

The JMS CAVEO A.V. Fistula Needle Set is a single-use needle set for temporary vascular access during hemodialysis. It includes an anti-needlestick safety feature (needle guard) and an integrated safety mechanism with a torsion spring and footplate that partially occludes the blood path and triggers the dialysis machine to alarm and shut off if the venous needle becomes completely dislodged from the patient's arm.

The CAVEO differs from the predicate (WingEater) primarily in its novel venous needle dislodgement (VND) detection mechanism: an internal torsion spring and footplate that generate increased venous line pressure upon complete needle dislodgement. It uses a pre-attached needle guard instead of a retractable wing-and-guard design. The CAVEO also offers additional cannula gauges (includes 18G), different tube lengths (270mm and 400mm vs. 135mm and 270mm), translucent wing colors, and updated connector standards (ISO 80369-7 vs. ISO 594-1/2).

ISO 10993 series (biocompatibility: cytotoxicity, sensitization, irritation, hemocompatibility, pyrogenicity, acute/subacute toxicity, genotoxicity); ISO 80369-7 (female Luer Lock connectors); ISO 594-1/2 (predicate Luer standards); ISO 594-2 (connector air-tightness). Performance testing included needle penetration resistance, retention strength, leak tests, connector separation tests, and VND-specific activation and needle pushback tests.

The device is substantially equivalent because it maintains the same intended use (temporary hemodialysis vascular access, single-use, needle safety protection) and basic technological characteristics (cannula gauge, length, Luer lock connector, ETO sterilization) as the predicate. Although the CAVEO introduces a novel VND detection mechanism and different anti-needlestick design, extensive bench testing (20 passed tests on the CAVEO), clinical trials on 15 subjects, biocompatibility testing, and human factors studies demonstrated that the novel components do not impede safe or efficacious hemodialysis delivery and perform equivalently to the predicate.