BioFlo Hybrid PICC with ENDEXO Technology and PASV Valve Technology; BioFlo PICC with ENDEXO Technology and PASV Valve Technology; BioFlo PICC with ENDEXO Technology; BioFlo Midline Catheter; Xcela Power Injectable PICC; Xcela PICC with PASV Valve Technology; Xcela Hybrid PICC with PASV Valve Technology

This 510(k) submission covers seven PICC (Peripherally Inserted Central Catheter) and midline catheter devices from Spectrum Vascular. These catheters are polyurethane devices with Luer lock hubs used for short or long-term peripheral venous access to deliver fluids, medications, nutrients, contrast media, and for blood sampling. Some models include ENDEXO technology and/or PASV (Passive) valve technology, and some are hybrid configurations with both valved and non-valved lumens for power injection and pressure monitoring.

The subject devices are identical in design, material, geometry, outer diameter, lumen configurations, and lumen sizes to the predicate devices (K163452). All use polyurethane construction with colored Luer lock hubs, polyurethane extension tubes, and suture wings. Sizes range from 3F to 6F in single, dual, and triple lumen configurations with effective lengths of 20 cm (midline) or 55 cm (PICC). The only change is to sterilization cycle parameters; the devices themselves remain unchanged from the predicate.

Not stated in this summary. The document mentions biocompatibility testing was not conducted because the devices are identical to the predicate in formulation and composition. Performance testing focused on ethylene oxide sterilization qualification and evaluation of EO and ECH residuals, but no specific consensus standards (ISO, IEC, ASTM) are cited.

Substantial equivalence is based on technological and design identity to the predicate device K163452. The subject devices have identical materials, geometry, specifications, and indications for use to the predicate. No changes were made to the catheter designs themselves—only sterilization cycle parameters were modified. Performance testing confirmed sterilization efficacy and residual levels remain acceptable. Because the final finished devices are identical to the predicate and all changes have been validated through the Quality System, the devices pose no new safety or efficacy concerns.