Intraosseous Infusion Needles

The Intraosseous Infusion Needles are sterile, disposable devices used primarily during pediatric emergencies as an alternative to unsuccessful intravenous access to allow infusion of resuscitative drugs or fluids. They consist of a needle (knob, stylet luer-lock, and beveled stylet) and a cannula (hub, base plate, and shaft) available in gauges 14, 16, and 18 with various length configurations.

The proposed device is identical in design to the predicate Cook Intraosseous Infusion Needle, with identical materials (polycarbonate hubs/base plates, stainless steel cannula shafts, nylon knobs, polypropylene stylet luer-locks). The key difference is a change to the sterilization process: the proposed device uses modified ethylene oxide (EO) sterilization parameters and location while maintaining the same SAL of 10⁻⁶, whereas the predicate used standard EO sterilization.

ANSI/AAMI/ISO 11135:2014 (Sterilization of health care products – Ethylene oxide – Requirements for development, validation, and routine control); ISO 10993-7:2008, Amendment 1:2019 (Biological evaluation of medical devices – Part 7: Ethylene oxide sterilization residuals).

The device design is completely identical to the predicate in formulation, geometry, materials, and performance; no new chemicals or processing steps were added. The only change is the sterilization cycle parameters and location, which were validated through performance qualification testing demonstrating equivalent sterility assurance levels (10⁻⁶) and acceptable residual ethylene oxide and ethylene chlorohydrin levels per applicable standards. Since the physical device and sterilization method (EO) remain the same and efficacy is unchanged, the modified sterilization cycle does not raise new or different safety and effectiveness questions.