SMART MEDICAL SYSTEMS LTD 31-010 NaviAid™ AB

Device Description (max 2000 characters):The NaviAid™ AB device is an accessory to an endoscope and is intended to ensure positioning of a standardendoscope in the small intestine. It enables the advancement of a standard endoscope into the small intestinewhile utilizing the existing endoscope optics and utilities.The NaviAid™ AB Device is comprised of a balloon catheter (‘AB Disposable’) which is inserted through theinstrument channel of the endoscope, similarly to other endoscopic accessories, and a supporting single balloonair supply and control unit – NaviAid™ SPARK (‘SPARK’) for providing controlled inflation and deflation of theballoon.The NaviAid™ AB Device is indicated for use in adults and adolescent population.