Bio-Medicus Life Support Catheter and Introducer

The Bio-Medicus Life Support Catheter and Introducer is a single-lumen catheter system used to drain or reinfuse blood during extracorporeal support procedures including cardiopulmonary bypass (CPB), extracorporeal membrane oxygenation (ECMO), and extracorporeal life support (ECLS). The introducer facilitates proper insertion and placement of the catheter within blood vessels. It is intended for use in adult and pediatric patients, with CPB applications limited to 6 hours and ECMO/ECLS for acute respiratory or cardiopulmonary failure when other treatments have failed.

The device maintains the same intended use, operating principle, design, material types, packaging, sterilization methods, and shelf life as the predicate. Design modifications include catheter body material formulation change, hemostasis cap material change, removal of encapsulated urethane layer, modification of catheter body reinforcements from radial slots to holes, introducer taper angle adjustment to 6 degrees (mini catheters only), and barbed connector variants utilizing reference device components.

ISO 18193:2021 (Cardiovascular Implants and Artificial Organs — Cannulae for Extracorporeal Circulation), ISO 10993-1:2018 (Biological evaluation of medical devices), and FDA guidance on Use of International Standard ISO 10993-1 dated September 8, 2023.

The modified device is substantially equivalent because it shares identical intended use, operating principle, device design, material types, packaging, sterilization, and shelf life with the predicate device (K201057, K201100). All component modifications underwent risk-based testing including functional and biocompatibility assessments, demonstrating that changes do not affect the fundamental safety and effectiveness profile. Performance testing confirms compliance with ISO 18193:2021 and equivalent technological characteristics, biocompatibility, sterility, and in vivo performance over 7 days of use.