Vaccess™ CT Low-Profile Power-Injectable Implantable Port; Vaccess™ CT Power-Injectable Implantable Port; PowerPort™ duo M.R.I. ™ Implantable Port

The Bard Power-Injectable Implantable Port is a totally implantable vascular access device consisting of an injection port with a self-sealing silicone septum and a radiopaque catheter. It is indicated for repeated vascular access to deliver medications (including chemotherapy), IV fluids, parenteral nutrition, blood products, and to withdraw blood samples. When used with the PowerLoc™ Safety Infusion Set, it supports power injection of contrast media at up to 5 ml/s.

The subject devices share the same materials, principle of operation, insertion site, catheter tip location, sterilization method (ethylene oxide), and shelf life as predicate devices. Key differences are minor dimensional variations in port body height and width (e.g., Vaccess™ CT Low-Profile: 9.8 mm height, 21.29 × 24.64 mm width versus PowerPort™ Slim: 9.8 mm, 21.2 × 25.5 mm). The Vaccess™ CT devices lack raised palpation bumps on the septum, and locking solution options have been expanded to include sterile normal saline or other approved solutions per institutional protocol, not just heparinized saline.

Port Subassembly Air Burst (FDA Port Guidance) and Port Subassembly Tensile Strength (BAS Internal). Historical testing used chemical simulants of FDA-approved oncology drugs, total parenteral nutrition (TPN), and vesicants, with chemical conditioning to simulate worst-case solutions.

The subject devices are substantially equivalent because they use identical materials, maintain the same intended use and indications for use, and employ the same principle of operation and sterilization method as predicate devices. Minor dimensional changes were qualified and fulfilled performance criteria without introducing new hazards. The removal of palpation bumps does not create new risks since multiple identification methods exist. Expanded locking solution options align with current Infusion Therapy Standards of Practice (9th Edition, 2024) and were previously cleared for the reference device, demonstrating safety and effectiveness without changing device function or safety profile.