ACE Cannula

The ACE Cannula is a single-use, sterile hypodermic needle device consisting of a needle, hub, and protective cap in various gauges and lengths. It is intended to inject fluids intradermally and comes in two types: an AN type with a sharpened tip for site preparation and a B type with a closed blunt tip and lateral opening for fluid administration.

The device is available in 13 models with needle gauges from 21G to 30G and lengths from 13 mm to 70 mm. The needle is stainless steel 304, the hub is polypropylene, and connections use Luer Taper design. The predicate device lacks the 13 mm needle length configuration but is otherwise identical in gauge range, materials, tip configurations, and hub structure.

ISO 7864 (sterile hypodermic needles), ISO 9626 (stainless steel needle tubing), ISO 10993 series (biocompatibility including cytotoxicity, hemolysis, skin sensitization, pyrogen testing), ISO 80369-7 and ISO 80369-20 (connector performance), ISO 11135 (ethylene oxide sterilization), ISO 11737-2 (sterility testing), USP 39 (bacterial endotoxins), and ASTM D4169-22 (shipping validation).

The ACE Cannula performs identically to the predicate Eclipse DermaFlex Cannula in principle of operation, materials, structure, biocompatibility profile, and sterilization methods. The sole difference is the addition of a 13 mm needle length option; however, performance testing confirms this configuration meets all relevant ISO standards (ISO 7864, ISO 9626) and does not raise new safety or effectiveness questions. All other specifications, needle gauges, tip configurations, and functional requirements are substantially identical to the predicate.