Evis Exera III Duodenovideoscope Olympus TJF-Q190V (TJF-Q190V)

The EVIS EXERA III DUODENOSCOPE OLYMPUS TJF-Q190V is a flexible endoscope designed for endoscopy and endoscopic surgery within the duodenum. It works with a video system center, light source, monitor, and endotherapy accessories (such as biopsy forceps) to visualize and treat conditions in the duodenum.

Compared to the predicate device (K202661), the only changes are design modifications to the adhesive used in the insertion section and distal end to improve material durability against reprocessing chemical stress. There are no changes to optical or electrical performance, compatible components, accessories, device specifications, indications for use contents, or conditions of use.

Not stated in this summary.

The device is substantially equivalent because the adhesive modifications are limited to material durability improvements that do not affect the device's intended use, optical/electrical performance, or safety profile. Verification/validation testing including bench performance, sterilization/shelf-life testing for residual toxicity of reprocessing chemicals, and biocompatibility evaluation all demonstrated that the changes do not adversely affect device performance, making it as safe and effective as the predicate.