Search Results

The flexible fiberscopes are used to examine body cavities and hollow organs via natural accesses or surgically created accesses.

For examination, diagnosis, and / or therapy in connection with endoscopic accessories and auxiliary instruments, in particular, for intracorporal flexible lithotripsy probes, e.g., via the working channel of the instrument.

The instruments are used in the medical disciplines of urology, surgery, gynecology, and ENT by adequately trained medical personnel. Applications to the heart, the heart, the circulatory systems are excluded.

Important! Product dimensions must correspond to the anatomic requirements, i.e., use the flexible fiberscope appropriate to the medical discipline.

The flexible fiberscopes consist of a flexible insertion part, a control part, a bent eyepiece for direct view or connection of a video camera and straight working channel, especially for the use with lithotripsy probes.

The tip of the sheath has an active 130° / 160° up/down. The image is transmitted via objective, fiber bendle and eyepiece for direct view or connection of a video camera. The straight working channel is used for procedures such as lithotripsy and biopsy removal while simultaneously providing irrigation. The bent eyepiece funnel can be moved to the right or left. Auxiliary instruments, such as gaping forceps, sone extractors, or HF button electrodes are inserted by a proximal mounted insertion cock with supply and discharge. A leakage test unit or a gas sterilization valve can be connected to an attachment of the fiberscope.

I am sorry, but based on the provided text, I cannot provide the requested information about acceptance criteria, device performance, or study details.

The document is a 510(k) premarket notification from the FDA regarding a "Flexible Fiberscope" by Richard Wolf Medical Instruments Corporation. This type of document primarily establishes substantial equivalence of a new device to a predicate device already on the market. It describes the device's intended use, technological characteristics, and claims of substantial equivalence, but it does not contain:

• A table of acceptance criteria and reported device performance.
• Information about sample sizes for test sets, data provenance, or the number/qualifications of experts.
• Details on adjudication methods, MRMC studies, or standalone algorithm performance.
• The type and method of establishing ground truth for either test or training sets.

The document explicitly states:

• "No known FDA performance standard exists." (Section 5.0 Performance Data)
• "No clinical tests performed." (Section 6.0 Clinical Tests)

Therefore, the requested information is not present within the provided text.

Ask a specific question about this device