Safety Winged Blood Collection Sets

The Safety Winged Blood Collection Set is a single-use, sterile venipuncture needle with flexible tubing, optional luer adapter, and tube holder. It is designed for blood collection and short-term intravenous fluid infusion (up to 2 hours under direct clinical supervision), with an integrated safety mechanism that covers the needle immediately after venipuncture to prevent accidental needlestick injury.

The subject device adds a new model (RBC) with the same fundamental design, operation, and indication as the predicate SBC model. Changes include: needle gauges expanded from 21G/23G/25G to include 22G and 24G; safety protective mechanism material changed from ABS to polypropylene (PP) for RBC model; color coding added for new gauges per ISO 6009. All other components, tubing length, needle length (10cm, 19cm, 30cm), sterility assurance level (SAL 10⁻⁶), and 3-year shelf life remain unchanged.

ISO 6009:2016 (hypodermic needle color coding); ISO 8536-4:2019 (infusion sets); ISO 9626:2016 (stainless steel needle tubing); ISO 23908:2011 (sharps injury protection); ISO 10993-1 and ISO 10993-5:2009 (biocompatibility testing for material change).

The subject device is substantially equivalent because it uses identical fundamental technology, principles of operation, indications, and design as the predicate device K211293. The additions of needle gauges 22G and 24G do not alter safety or effectiveness, only expand clinical options. The change in safety mechanism material from ABS to PP (limited skin contact exposure) is supported by biocompatibility data from an already-cleared device (K230715) with equivalent or more stringent contact conditions, demonstrating no new safety concerns. All verification and validation testing passed without deviations.