Tangent Single-Use Digital System: Tangent Single-Use Digital Catheter and Tangent Digital Controller

The Tangent Single-Use Digital System is a choledochoscope consisting of a single-use digital catheter and a digital controller used for diagnostic and therapeutic endoscopic procedures in the pancreaticobiliary system including hepatic ducts. The catheter provides direct visualization and guides optical and accessory devices, while the controller provides illumination, receives video signals, processes images, and outputs them to a display.

The subject device has a 650 mm working length, 950 mm total length, 9.9 Fr shaft OD, 4.8 Fr working channel ID, and uses digital video technology with LEDs at the catheter tip. Key differences from the predicate (SpyGlass Discover K200483) include a smaller shaft OD (9.9 Fr vs 10.8 Fr), smaller working channel (4.8 Fr vs 3.6 Fr), and HD medical grade monitors instead of Sony LMD monitors.

Not stated in this summary.

The Tangent Single-Use Digital System is substantially equivalent to the SpyGlass Discover Digital System because both devices serve identical intended uses in pancreaticobiliary endoscopy, employ the same digital imaging technology and basic design architecture, and differ only in minor technological parameters (shaft diameter, working channel size, monitor specification) that have been demonstrated through bench testing not to raise new safety or effectiveness concerns. The device characteristics and performance specifications support functional equivalence to the predicate despite these dimensional and component differences.