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This instrument has been designed to be used with an Olympus video system center, light source, documentation equipment, display monitor, endo-therapy accessories, and other ancillary equipment for endoscopic diagnosis and treatment within the bladder and urethra.

The subject device is used for endoscopic diagnosis and treatment within the bladder and urethra. The optical system is modified from the image guide to CCD and the resolution is improved.

The provided document is a 510(k) premarket notification letter from the FDA to Olympus America, Inc. regarding a medical device, the Olympus VISCERA Cystovideoscope Type CYF V/VA.

Crucially, the document does NOT contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, or other details typically found in a clinical study report.

This type of FDA letter confirms that the device is "substantially equivalent" to previously marketed devices (predicates) and can be legally marketed. It does not elaborate on the specific performance benchmarks or validation studies conducted by the manufacturer for this substantial equivalence determination.

Therefore, I cannot provide the requested information based on the text provided.

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