PIVO™ Pro Needle-free Blood Collection Device

The PIVO™ Pro Needle-free Blood Collection Device is a sterile, single-use device that attaches to a peripheral IV catheter to collect venous blood specimens into vacuum tubes, blood culture bottles, or syringes. It is designed for adult and pediatric patients, including those with difficult intravenous access and small, fragile, or non-palpable veins.

The subject device is technologically identical to the predicate device in all material respects: same materials (polycarbonate housing, polyimide inner flow tube, Vestamid proximal tubing, nylon components), same design features (clip-to-connect attachment, female Luer connector, cap and clamp blood control), same compatible IV sizes (20GA, 22GA, 24GA), and same sterilization method (gamma radiation).

ISO 10993-1 biocompatibility assessment was conducted to evaluate material safety for externally communicating devices in contact with circulating blood for limited duration (<24 hours). No other specific consensus standards (ISO, IEC, ASTM) are cited in this summary.

Substantial equivalence is supported because the subject device has identical technological characteristics, materials, and design to the predicate K230865, with only two modifications: the addition of blood culture collection (which is an extension of the existing general blood collection indication that does not raise new safety or effectiveness questions) and extension of shelf life to 3 years. Performance testing demonstrates the device meets all predetermined design requirements, and clinical studies are not required because the predicate pathway and identical design support SE.