TSK SELECT™ Needle

The TSK SELECT™ Needle is a single-lumen hypodermic needle consisting of a sharpened stainless-steel tube joined to a polypropylene or polycarbonate female luer hub. It is intended for subcutaneous injection of pharmaceutical products or withdrawal of fluids and is provided sterile, single-use only, and sterilized by gamma irradiation.

The device offers needle gauges ranging from 25G to 34G and exposed lengths of 4mm to 25mm with regular bevel tips and low dead volume (≤0.0054 ml). It differs from the predicate in hub material (polycarbonate vs polypropylene), sterilization method (gamma irradiation vs ethylene oxide gas), and the absence of a safety feature, while maintaining the same stainless-steel needle composition and luer compatibility per ISO 80369-7.

ISO 7864 (sterile hypodermic needles), ISO 9626 (stainless steel needle tubing), ISO 80369-7 (small-bore connectors), USP <788> (particulate matter), ISO 11137-1 (radiation sterilization validation), ISO 10993 series (biocompatibility including cytotoxicity, sensitization, irritation, systemic toxicity, and pyrogenicity), and ISO 11607 (packaging for sterilized devices).

The subject device performs the same intended function as the predicate (subcutaneous injection and fluid withdrawal) with equivalent dead volume and luer compatibility. Although the subject device has material differences (hub composition) and a different sterilization method, comprehensive biocompatibility testing across multiple ISO 10993 categories and performance testing per recognized standards demonstrate these differences do not raise new safety or effectiveness questions. The device design has been adequately supported by verification and validation data showing it is as safe and effective as the predicate.