LungFlow Basket Catheter

The LungFlow Basket Catheter is a sterile, single-use disposable device designed to endoscopically remove foreign bodies from the airway. It consists of a flexible stainless steel wire trunk with a multi-wire nitinol basket at the distal end that expands to 360 degrees to grip and retrieve inhaled objects, medical debris, mucus, or tissue during bronchoscope procedures.

The LungFlow differs from the predicate (Microvasive Zero Tip Airway Retrieval Basket) in several design features: it has no tip versus the predicate's zero tip design, uses a polyhedron basket style versus rectangular, expands to 10/16/30mm versus 12/16mm, has 32 or 64 wires versus 4 wires, and accommodates 2.0mm or 2.8mm working channels versus 2.0mm only. Despite these dimensional and design variations, both devices operate on the same mechanical foreign-body capture and retrieval principle.

ISO 10993-1, ISO 10993-5 (cytotoxicity), ISO 10993-10 (sensitization and intradermal reactivity), ISO 11137-1 and ISO 11137-2 (sterilization validation), ASTM F2063-18 (nitinol material), ASTM D4169, ASTM F1980, ASTM F1886, ASTM F2096, ASTM F88, and ISO 11607-1 (packaging and shelf-life).

The LungFlow Basket Catheter is substantially equivalent to the predicate because both devices share identical indications for use (endoscopic foreign body removal), materials (nitinol basket and stainless steel trunk), and fundamental operating principles. Design and dimensional differences do not alter intended use or scientific technology. Performance testing demonstrates equivalent results: both fit through ≥2.0mm bronchoscope channels, fully expand baskets, withstand 15 delivery/recapture cycles without damage, and meet biocompatibility standards.