Promisemed Safety Huber Needles

The Promisemed Safety Huber Needles is a non-coring intravascular infusion set with a right-angle Huber needle and manually activated safety mechanism designed to access surgically implanted vascular ports. The device includes tubing, Y-injection site, clamp, and Luer lock adapter; the pressure-resistant model supports power injection up to 330 psi for CT contrast media administration in adults.

The subject device is identical to the predicate in common name, classification, product code, general description, materials, and safety mechanism. The modifications are limited to addition of new needle lengths for Type D and Type E (adding 16mm, 17mm, 20mm options) and a new specification allowing needles with or without lubrication on the tip; needle sizes (19G, 20G, 22G), bevel design, and performance remain unchanged.

ISO 7864:2016 (appearance, cleanliness, needle point, puncture force); ISO 9626:2016 (needle tube dimensions); ASTM F3212-16 (fragment testing); internal testing of needle sheath and cap.

The manufacturer argues substantial equivalence because the fundamental technology, operation, and design principle are identical to the predicate device. The addition of new needle lengths and a lubrication option expand product options without altering the basic mechanism or performance. All verification and validation tests passed without deviations, confirming design specifications are met. The modifications do not introduce new risks to safety or effectiveness because the core non-coring Huber needle design and safety sheathing mechanism remain unchanged.