Angiography Injector

The Angiography Injector is a single-use, sterile syringe designed to aspirate and inject contrast media during interventional procedures. It can also be used to inject or withdraw fluids from the body. The device is available in volumes of 6 mL, 8 mL, 10 mL, and 12 mL and is sterilized using ethylene oxide.

The device consists of six components: piston, plunger cap, push-button, barrel, plunger, and rotating or fixed adapter. Materials include polycarbonate barrel, ABS plunger, polyisoprene rubber piston, HDPE plunger cap, ABS push-button, and polycarbonate with silicone rotating adapter. It complies with ISO 80369-7 for Luer connector and ISO 7886-1 for injector design standards, has a clear barrel, shelf life of 3 years, and sterility assurance level of 10⁻⁶.

ISO 7886-1 (injector performance and mechanical testing), ISO 80369-7 (Luer connector), ISO 10993-1 (biocompatibility evaluation), ISO 11135-1 (ethylene oxide sterilization validation), ISO 10993-7 (ethylene oxide residual limits), and ASTM 1980 (shelf life/aging conditions).

The proposed device has identical indications for use, mode of action (manual injection), design standards, sterilization method, sterilization assurance level, and shelf life as the Merit Coronary Control Syringe predicate (K163084). Although materials differ slightly (polyisoprene piston and HDPE cap versus silicone seal and O-ring), biocompatibility testing confirms safety. The volume range (6–12 mL) is slightly narrower than the predicate (6–20 mL), but performance testing demonstrates compliance with ISO 7886 standards. These differences do not raise new safety or effectiveness questions.