CentroVena Central Venous Catheter (CVC) with the CentroVena One Insertion System

The CentroVena Central Venous Catheter (CVC) with the CentroVena One Insertion System is a power-injectable, short-term central venous access device made of medical-grade polyurethane. It is indicated for administering IV fluids, blood products, drugs, parenteral nutrition, blood withdrawal, central venous pressure monitoring, and power injection of contrast media for less than 30 days of use. The device comes in triple-lumen and dual-lumen configurations at various lengths with specified power injection flow rates and maximum pressure settings.

The subject device has a tapered catheter tip geometry (versus the predicate's blunt tip) achieved through reformulated polyurethane, which moved the skives distally on the catheter shaft. The polyurethane formulation was modified to achieve the tapered geometry. The CentroVena One Insertion System, not present in the predicate, integrates an introducer needle with passive needle safety, syringe, guidewire, and self-dilating catheter into a preassembled unit with an integrated drape clip. Packaging for the insertion system kits includes an additional sealed header bag. Contraindications in the predicate labeling were changed to precautions in the subject device.

ISO 10993-1:2018 (biocompatibility); ISO 10555-1:2013 and ISO 10555-3:2013 (intravascular catheters); ASTM F640-2020 (radiopacity); ASTM F756-17 (hemolysis); FDA 1995 guidance on short/long-term intravascular catheters; ISO 80369-1:2018 and ISO 80369-7:2021 (small-bore connectors); FDA 2023 MR safety guidance; USP <788>:2012 (particulate matter); FDA 2019 guidewire guidance; ISO 11070:2014 (introducers and guidewires); FDA 2005 sharps injury prevention; ISO 23908:2011 (sharps protection); ISO 7864:2016 (hypodermic needles); ISO 9626:2016 (needle tubing).

The tapered tip geometry and reformulated polyurethane were evaluated through functional performance testing, biocompatibility testing per ISO 10993-1, and mechanical testing per ISO 10555 standards; results showed no new safety or effectiveness concerns compared to the blunt-tip predicate. The dual-lumen configuration, though not in the predicate, was tested using the same methods as the triple-lumen and demonstrated equivalent function without raising new questions of safety. The CentroVena One Insertion System comprises components already used in predicate device traditional Seldinger kits and was evaluated using human factors and risk management approaches showing no additional or increased risks; the insertion system therefore does not raise new or different questions regarding safety or effectiveness. The changes to labeling and packaging do not affect the intended use or core safety profile.