Primum Hydrophilic Guiding Catheter

The Primum Hydrophilic Guiding Catheter is a flexible plastic tube with a reinforced body, hub, strain relief, and preformed distal tip shapes. It provides a pathway for introducing therapeutic and diagnostic devices into the coronary or peripheral vascular system during percutaneous procedures. The device features a hydrophilic coating on part of its body and is available with or without small side holes for vessel perfusion.

The Primum Guiding Catheter incorporates the same materials, design, construction (hub, strain relief, braided stainless steel reinforcement, intermediate and soft tips), packaging, and sterilization process as the predicate Convey Guiding Catheter. Both devices are available in 5F, 6F, 7F, and 8F sizes with identical dimensional specifications, shelf life of 3 years, and single-use disposal design. The only difference between the devices is the trade name.

ISO 10993-1 (biocompatibility material characterization), ISO 10993-4 (haemocompatibility including hemolysis and coagulation assays), ISO 10993-5 (cytotoxicity), ISO 10993-7 (ethylene oxide sterilization residuals), ISO 10993-10 (sensitization and irritation), ISO 10993-11 (acute systemic toxicity and pyrogenicity), USP <661> (plastic leachables), and USP <85> (endotoxin pyrogenicity). Performance testing included shape retention, diameter measurements, bending and kink resistance, coating integrity, radiopacity, and particulate testing.

The manufacturer (PendraCare) produces both the new Primum and predicate Convey devices, which are identical in design, materials, and technical specifications with only a trade name difference. All non-clinical bench testing, design validation, and clinical post-market surveillance data from the predicate Convey devices (K120585 and K132197) are directly applicable to the Primum because the devices are the same generation developed by the same manufacturer. No new safety or performance issues were identified during testing, supporting substantial equivalence in intended use, fundamental technology, and mechanism of action.