Lyka® PORT Needle Free Access Device (4170Y)

The Lyka® PORT Needle Free Access Device is a needle-free accessory for vascular access devices (catheters) used in hemodialysis or IV administration. It allows administration or withdrawal of fluids through a cannula or needle placed in the vein or artery without using needles, and is approved for use in patient populations including very low birth-weight infants through adults for up to 7 days.

Both the Lyka® PORT and predicate device are needle-free, swabable, and luer-activated with minimized dead space. Key differences exist in flow rate (Lyka® PORT: ≤600 mL/min vs. predicate: >600 mL/min), priming volume (Lyka® PORT: ~0.1 mL vs. predicate: 0.06 mL), maximum pressure (Lyka® PORT: 1550 mmHg vs. predicate: >15 psi), shelf life (3 years vs. 5 years), and valve mechanism (silicone vs. automatic positive displacement). Both use biocompatible materials and ethylene oxide sterilization.

ISO 10993-1 (biocompatibility), ISO 10993-7:2008 (ethylene oxide residuals), ASTM F756 (hemolysis testing), and FDA consensus standard AMD1:2019 for needle-free vascular access devices.

The Lyka® PORT demonstrates substantial equivalence through identical intended use (needle-free vascular access for fluid administration/withdrawal), comparable design (needle-free, swabable, luer-activated), and equivalent performance against critical specifications. While differences exist in flow rate, priming volume, pressure tolerance, and valve mechanism, performance testing validates these differences do not compromise safety or effectiveness for the intended clinical application, and biocompatibility and residual sterilant testing confirm material equivalence.