Hemodialysis Catheter

The Hemodialysis Catheter is a dual-lumen vascular access device made of radiopaque polyurethane with a dual D cross-sectional design. It is indicated for short-term or long-term hemodialysis and apheresis therapy, typically inserted percutaneously into the internal jugular vein, with alternative sites including the subclavian and femoral veins. The device ranges from 13–55 cm in length, offers straight or curved configurations, and is provided sterile and single-use with accessories for catheter placement.

The subject device features a polyurethane catheter tubing with silicone extension legs and dual lumens with red (arterial) and blue (venous) clamps; it covers a broader outer diameter range (8F–15.5F) than the primary predicate (12.5Fr) and includes pediatric sizes (8–10Fr). The luer connectors conform to ISO 80369-7:2021, and the device is offered in three configurations: straight tubing with straight extension legs, straight tubing with curved extension legs, and curved tubing with straight extension legs. Material composition differs from the predicate (polyurethane + silicone versus silicone alone) and includes indications for both short- and long-term use, whereas the predicate addresses only long-term use.

ISO 10555-1:2013 (hemodialysis catheter standards), ISO 10993-1 (biocompatibility evaluation), ISO 80369-7:2021 (luer connectors), ISO 11607-1:2019 (packaging for sterilized devices), and ISO 11135:2014 (ethylene oxide sterilization). Testing also referenced FDA guidance on Implanted Blood Access Devices for Hemodialysis (January 21, 2016).

The subject device is substantially equivalent because it performs the same intended function as the predicate devices (vascular access for hemodialysis/apheresis) using similar technological principles and materials. Although the subject device offers a broader size range (8F–15.5F versus 12.5Fr) and includes pediatric indications, these differences do not raise new safety or effectiveness concerns: the size range remains within existing market offerings (e.g., GlidePath 7.5F and Pristine 15.5F), and performance testing per ISO 10555-1 and FDA guidance confirms the pediatric catheter meets safety standards. Similarly, the use of polyurethane in addition to silicone does not affect safety or effectiveness, as biocompatibility evaluation per ISO 10993-1 confirmed material compatibility. The device undergoes identical sterilization (EO), has the same shelf life (3 years), dual lumens, and insertion sites as predicate devices.