Blood collection tube holders

Blood collection tube holders are single-use, sterile devices designed to be used with a vein puncture needle and vacuum blood collection tubes for multiple collections of venous blood in adult patients. The device consists of a puncture needle hub, puncture needle, rubber boot, and holder, packaged in a sealed sterility barrier with a validated 5-year shelf life.

Both the subject device and predicate (Luer Adapter with Holder, K230080) are disposable, sterile, single-use devices with the same intended use and operating principles. The subject device has a 20G needle with specific dimensions (OD 0.89-0.91mm, ID 0.66±0.02mm, effective length 14.5±1mm, holder length 53.3mm), while the predicate offers multiple gauges (21G-25G) and lengths. Both devices use EO sterilization, similar materials (ABS, polypropylene, stainless steel, polyisoprene rubber), and provide protection against accidental needlestick injury and blood splatter.

ISO 7864, ISO 9626, ISO 80369-7, ISO 10993 series (biocompatibility), ISO 11135 (EO sterilization), ISO 11607-1 and ISO 11607-2 (packaging for sterile devices), AAMI/ANSI/ISO 10993-7:2008(R)2012, and ASTM F1980-16 (shelf-life validation).

The subject device is substantially equivalent because it has identical intended use, identical operating principles, and comparable technological characteristics to the predicate. The subject device's dimensional differences fall within the predicate device's scope and comply with applicable ISO standards. Component descriptions differ only textually but are functionally similar. Performance testing (puncture force, stiffness, corrosion resistance, tensile strength, hemocompatibility) and biocompatibility assessment confirm safety and effectiveness equivalent to the predicate device.