Promisemed Safety Huber Needles

The Promisemed Safety Huber Needles is a non-coring intravascular infusion set designed to access surgically implanted vascular ports. It features a manually activated needle-stick prevention safety mechanism that sheathes the needle after use to reduce accidental needlestick injuries. The device is for adult use only and includes an integrated extension set with tubing, Y-injection site, clamp, and Luer lock adapter. High-pressure resistant models can be used for power injection of contrast media up to 330 psi for CT imaging.

The subject device maintains the same fundamental design as the predicate: non-coring Huber type right-angle needle with manual safety activation mechanism. Changes include renaming Type C to Type D, adding Type E (identical to Type D but without wings), and expanding needle length options for Types D and E from three to six sizes (13mm, 15mm, 19mm, 25mm, 32mm, 38mm). Needle gauges (19G, 20G, 22G), material composition, color coding, performance specifications, and safety mechanism operation remain unchanged.

ISO 7864, ISO 9626, ASTM F3212-16, and ISO 23908. Testing included visual inspections for labeling compliance, dimensional verification of needle specifications, and full performance testing of appearance, dimensions, and safety mechanism function.

The device is substantially equivalent because it shares the identical intended use, design principle, and safety mechanism as the predicate device (K230715). The modifications—nomenclature changes and additional needle length options—do not alter the fundamental technology or operation. Verification and validation testing confirmed all design specifications and regulatory requirements were met, and the product modifications introduced no new safety or effectiveness risks compared to the predicate.