JetCan® Pro Safety Huber Needle

The JetCan® Pro Safety Huber Needle is a non-coring needle used to access surgically implanted vascular access ports for delivery of intravenous fluids, blood sampling, and power injection of contrast media up to 325 psi for up to 24 hours. It incorporates a passive safety mechanism that activates upon needle withdrawal to prevent accidental needle sticks and minimize exposure to hazardous fluids.

The device is identical to the predicate in design, materials (stainless steel needle, polycarbonate housing, polyurethane tubing, copolyester luers), gauge sizes (19, 20, 22G), and lengths (0.5–1.5 inches). The primary difference is the subject device supports higher power injection pressure (325 psi versus 300 psi predicate) and incorporates a different passive safety mechanism activation method, both of which were validated through design verification testing.

Testing conforms to ISO 8536-4, ISO 6009, ISO 9626, ISO 10555-1, ISO 7864, ISO 80369-7, ISO 80369-20, ISO 10993-1, ISO 23908, ISO 10993-7, ISO 11135, ANSI/AAMI IEC 62366-1, and ISO 11607, covering infusion sets, needle requirements, intravascular catheters, connectors, biocompatibility, sharps protection, sterilization, and usability engineering.

Both devices share identical intended use (accessing implanted ports for fluid delivery and blood sampling), same patient population, identical design architecture and components, and comparable safety mechanisms (both passive, both activated on withdrawal). The differences—higher power injection rating and modified safety mechanism design—do not raise new safety questions because the hazards are identical and the higher pressure capability was demonstrated through design verification testing. The safety mechanism modification is not novel and was validated through simulated use testing, supporting equivalence in safety and effectiveness.