K-Pack Enhance Needle (KH-2713RBBTC and KH-2913RBBTC)

The K-Pack Enhance Needle is a sterile, single-use hypodermic needle intended to inject fluids into or withdraw fluids from parts of the body below the skin surface. It consists of a stainless steel cannula (0.33 mm or 0.40 mm diameter, 12 mm length) with a sharpened tip and 45° cut end, connected to a polycarbonate hub with a female luer connector for attachment to syringes.

The subject device differs from the predicate in three key areas: (1) hub material is polycarbonate instead of polypropylene; (2) adhesive is acrylic instead of epoxy; (3) the cannula features a 0.5 mm protrusion with a 45° back-end cut versus a straight back-end cut on the predicate. The subject device offers both 27G and 29G gauges compared to the predicate's 27G and 30G options.

ISO 7864:2016 (sterile hypodermic needles), ISO 9626:2016 (stainless steel needle tubing), ISO 80369-7:2021 (small bore connectors for hypodermic applications), ISO 6009:2016 (needle color coding), ISO 11607-1:2019 (packaging), ISO 11135:2014 (EO sterilization), ISO 10993-1:2018 (biocompatibility), USP <788> (particulate matter), USP <71> (sterility), and ASTM F1980 (accelerated aging).

The intended uses and indications are identical between subject and predicate. Material differences (polycarbonate hub, acrylic adhesive) do not raise safety concerns because adhesive contact is only indirect (with injected fluids), and biocompatibility testing confirms the new materials are suitable for the limited-exposure device category. Design differences—the 45° back-end cut and 0.5 mm protrusion—provide improved fluid passage without compromising safety; both devices meet the same consensus standards (ISO 7864, ISO 9626, ISO 80369-7). The 29G gauge variant is a minor variation analogous to the predicate's 30G option, presenting no new risks.