(49 days)
The Karl Storz intubation fiberscope is designed to provide visual access to the larynx and tracheobronchial tree during ENT endoscopic procedures.
The Karl Storz intubation fiberscope consists of a focusing ocular lens, a moveable eyepiece, a rigid curved stainless steel shaft that houses the fiber optic imaging and illumination system, a distal objective lens, a channel for insufflation of oxygen, a sliding cap to accommodate endotracheal catheters of various sizes and a connection for a fiber optic light cable.
I am sorry, but the provided text does not contain the information required to describe the acceptance criteria and the study that proves the device meets those criteria. The document is a 510(k) summary for a Karl Storz intubation fiberscope, focusing on its description, indication, and substantial equivalence to predicate devices. It does not include details about specific performance acceptance criteria, study methodologies, sample sizes, expert qualifications, or ground truth establishment relevant to AI/device performance evaluation.
§ 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.