BD Saf-T-Intima™ Subcutaneous Catheter System

The BD Saf-T-Intima™ Subcutaneous Catheter System is an over-the-needle catheter designed for short-term use to administer fluids and medications into a patient's subcutaneous tissue, or to administer fluids and sample blood from the peripheral venous system. The device includes a radiopaque polyurethane catheter, needle with wire stylet, wings for insertion, integrated extension tubing with single or dual ports, a clamp, PRN adapter, and passive needle safety protection.

The subject device is a single-lumen winged polyurethane IV or subcutaneous catheter with integrated extension set and either single port (straight with PRN adapter) or dual port (Y-connection with PRN adapter and vent plug). It offers catheter sizes of 22 GA and 24 GA with 0.75-inch length, compared to the predicate's 18-24 GA with 0.75-1.00 inch lengths. The wings and extension tubing use PVC with DOA (non-DEHP) plasticizer instead of DEHP, meeting the same physical property and performance criteria.

ISO 80369-7, ISO 10555-1, ISO 10555-7, ISO 23908, ISO 11607, ISO 10993-1, ISO 11135-1; plus internal studies on peak insertion force, catheter drag force, stylet/needle removal force, and decouple force (safety shield); usability testing per FDA's February 2016 human factors guidance.

The subject device is substantially equivalent to the predicate BD Saf-T-Intima™ Intravascular Catheter (K013800) because both use the same fundamental single-lumen winged polyurethane technology with integrated extension tubing and similar operational principles. Differences in indications (expanded to include subcutaneous access, narrowed intravenous use to fluids/blood only, excluding pressure monitoring) and reduced catheter size options do not raise new safety or effectiveness concerns and are supported by comprehensive performance testing demonstrating compliance with design requirements.