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The Karl Storz Video Gastroscope System is intended to be used by physician / endoscopist in the visual examination and treatment of the upper digestive tract including the esophagus, stomach, and duodenum. The Video Gastroscope System is intended to provide optical visualization via a video monitor and therapeutic access to the upper digestive tract.

The Karl Storz Video Gastroscope System is a flexible endoscope with a distal-CCD chip technology which connects to the Karl Storz Camera Control Processor (CCU) to provide clear images on the video monitor during the examination and treatment of the upper digestive tract. The flexible video gastroscope contains image module, air/water insufflation, jet nozzle, suction, and illumination light and biopsy channels. The Karl Storz Video Gastroscope is a Class II device under 21CFR876.1500, Endoscope and accessories.

This 510(k) summary does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria.

The provided document is a 510(k) summary for the Karl Storz Video Gastroscope System, which is a flexible endoscope used for visual examination and treatment of the upper digestive tract. The summary focuses on establishing substantial equivalence to predicate devices.

Here's why the requested information is absent:

• No specific performance study is detailed. The document asserts that "The Karl Storz Video Gastroscope System is substantially equivalent to predicate devices since the basic technology and design are similar. The intended usage is similar to predicate devices and raise no new issues of safety and effectiveness. The minor differences between the Karl Storz Video Gastroscope System and predicate devices have no effect on the performance, function or intended use of the devices." This indicates that the device's performance was not explicitly tested against novel acceptance criteria in a standalone study described here. Instead, it relies on the established safety and effectiveness of its predicate devices.
• No acceptance criteria are stated. Since no specific performance study is presented, there are no acceptance criteria for device performance to be found.
• No reported device performance metrics are provided.
• No information on sample sizes, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, or training set details is included. These are typically found in detailed study reports, which are not part of this 510(k) summary intended for establishing substantial equivalence.

In essence, the 510(k) process for this device, as described, did not require a new, extensive clinical or performance study with defined acceptance criteria because it demonstrated substantial equivalence to existing, legally marketed devices.

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