Navi™ Needle-free Blood Collection Device (VNC20500FG, VNC22500FG, VNC24500FG)

The Navi™ Needle-free Blood Collection Device is a sterile, single-use device that attaches to an already-placed peripheral IV catheter to collect venous blood samples into vacuum tubes or syringes from adult and pediatric patients, including those with difficult IV access and small or fragile veins. It consists of an inner flow tube with an atraumatic tip, a plunger controlled by a slider, and a male cannula that connects to the IV catheter via push-connect clips.

The Navi device differs from its predicate (PIVO Pro) in several ways: it uses push-connect instead of clip-to-connect attachment; employs a user-activated discontinuous lumen blood control mechanism instead of a cap and clamp; has different inner flow tube lengths (147.07 mm for 20/22 GA vs. 155.28 mm in predicate) and smaller outer diameters; uses DEHP-free PVC proximal tubing instead of Vestamid; employs ethylene oxide sterilization instead of gamma; and has a 6-month shelf life versus 1 year. Packaging also differs (Tyvek pouch vs. Tyvek/PET or Nylon/Nylon).

Performance and design validation testing per ISO 10555-1 (intravascular catheters), ISO 80369 series (small-bore connectors), ISO 8536-14 (clamps and flow regulators), and IEC 62366-1 (usability engineering). Biocompatibility per ISO 10993-1, 10993-12, and 10993-18. Sterilization per ISO 11135 and TIR28 for ethylene oxide processes. Packaging per ISO 11607 and ASTM standards (F1980, F88, D4169, D4332). Specific tests included pressure/vacuum/pinch clamp leaks, kink resistance, tensile strength, flow rate, hemolysis, hemolysis, hemocompatibility, cytotoxicity, and human factors testing.

The device has identical indications for use, intended use (venous blood draw), patient interface (peripheral IV catheter), and classification (21 CFR 862.1675, Class II, product code JKA) as the predicate. Although technological differences exist in attachment mechanism, blood control, dimensions, materials, sterilization, and shelf life, the applicant conducted performance testing, simulated use testing, biocompatibility testing, and sterilization validation to demonstrate these differences do not raise new safety or effectiveness concerns. All performance testing met applicable standards, and the fundamental function—needle-free blood collection from an already-placed IV catheter—remains unchanged and substantially equivalent.