InstaFAN

The InstaFAN is an endoscopic ultrasound-guided fine needle aspiration/biopsy device that collects multiple samples from submucosal and extramural lesions in the gastrointestinal tract. It features a single handle with two moving parts and five peripheralized needles that can be deployed individually or simultaneously through the accessory channel of a curvilinear echo-endoscope.

The InstaFAN uses the same fundamental technology as the predicate Acquire Endoscopic Ultrasound Fine Needle Biopsy device. It has a central 22-gauge needle and five peripheral 25-gauge needles with a single handle design containing two moving parts controlling needle deployment and positioning.

Not stated in this summary.

The InstaFAN does not introduce new intended uses and does not raise different questions of safety and effectiveness compared to the predicate. Performance testing verified the device specifications and demonstrated substantial equivalence through needle property testing (tensile strength, elasticity, bend strength) and overall device performance metrics. Non-clinical testing showed the device performs as intended and animal studies confirmed safety and performance criteria equivalent to the predicate.