(80 days)
The Karl Storz Video Bronchoscope System is intended for use by physicians for diagnostic and therapeutic procedures in nasal, sinus and nasopharyngeal endoscopy, bronchoscopy, tracheoscopy and esophagoscopy and laryngoscopy. The Karl Storz Video Bronchoscope is intended to provide visualization via a video monitor.
The Karl Storz Video Bronchoscope System includes a flexible endoscope, a CCU and a lightsource unit. The Bronchoscope is designed with distal CCD-chip technology which connects to the Karl Storz Camera Control Processor for treatment of ENT procedures.
The provided text does not contain information about acceptance criteria or a study proving the device meets them. The document is a 510(k) summary for a Bronchoscope system, focusing on its substantial equivalence to predicate devices rather than specific performance metrics or clinical study results.
Therefore, I cannot extract the requested information such as a table of acceptance criteria, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details. The document states that the "minor differences between the Karl Storz Video Bronchoscope System and the predicate devices raise no new issues of safety and effectiveness, as these differences have no effect on the performance, function or general intended use of these devices," implying that extensive performance testing may not have been deemed necessary beyond demonstrating equivalence.
§ 874.4680 Bronchoscope (flexible or rigid) and accessories.
(a)
Identification. A bronchoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the bronchoscope and is intended to examine or treat the larynx and tracheobronchial tree. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel or flexible plastic. This generic type of device includes the rigid ventilating bronchoscope, rigid nonventilating bronchoscope, nonrigid bronchoscope, laryngeal-bronchial telescope, flexible foreign body claw, bronchoscope tubing, flexible biopsy forceps, rigid biopsy curette, flexible biopsy brush, rigid biopsy forceps, flexible biopsy curette, and rigid bronchoscope aspirating tube, but excludes the fiberoptic light source and carrier.(b)
Classification. Class II.