PowerPort™ isp Implantable Port; PowerPort™ Slim Implantable Port; PowerPort™ M.R.I. ™ Implantable Port; PowerPort™ M.R.I.™ isp Implantable Port

PowerPort™ Implantable Ports are subcutaneous, totally implantable vascular access devices designed to provide long-term, repeated access to the vascular system for infusion of medications (including chemotherapy), IV fluids, parenteral nutrition, blood products, and blood withdrawal. When used with the PowerLoc™ Safety Infusion Set, they support power injection of contrast media at up to 5 ml/s.

The subject devices maintain the same intended use, principle of operation, insertion site, catheter tip termination location, sterilization method (ethylene oxide), and materials as predicate devices. Key differences include: updated locking solution options (allowing sterile normal saline or other approved solutions per institutional protocol, not just heparin); dimensional changes (smaller port body for the Slim model, changes to the M.R.I.™ isp model); catheter material change from purple to white ChronoFlex polyurethane (colorant removal only); and extended shelf life from 1 year to 2 years.

NF S 94-370 (1999); ISO 10555-1 (1995); ISO 10555-3 (2002); ASTM D412; FDA Implanted Infusion Port Guidance; BAS Internal Test Methods for air leak, tensile strength, burst pressure, power injection, and flow rate testing.

The devices use identical materials and manufacturing processes as predicate devices, and all historical material evaluations apply directly. Although dimensional specifications changed, performance verification testing confirmed the new configurations met all performance criteria and controlled risks acceptably under aged and chemically conditioned scenarios. The colorant removal from the catheter is a historical material change with no effect on biocompatibility or sterilization. The expanded locking solution options align with current Infusion Therapy Standards of Practice, 9th Edition (2024), and this exact change was previously cleared for the reference device PowerPort™ ClearVUE™ (K242328). The extended shelf life was validated through design verification testing simulating worst-case oncology drugs, TPN, and vesicants, demonstrating continued safe function over 2 years with no impact to safety or effectiveness.