(50 days)
The Olympus EVIS BF Type 200 Series video bronchoscopes have been designed for endoscopic diagnosis and treatment within the airways, including the tracheobronchial tree.
Olympus intends to offer three modified BF-200, and BF-1T200 models of video bronchoscopes to be used in conjunction with the EVIS 200 video system center. These video bronchoscopes are identical to the legally marketed video bronchoscopes, which were cleared for marketing through 510(k) # K931154, except for the insertion tube's outer coating material.
All characteristics such as design, construction, optical characteristics, mechanical specifications, electrical and thermal characteristics, intended use, method of use, and application sites remains unchanged.
The provided document pertains to a 510(k) summary for the Olympus EVIS 200 Video Endoscopy System, specifically referencing the Olympus EVIS BF 200 Series Video Bronchoscopes. This document is a pre-market notification to the FDA for a medical device that is substantially equivalent to a predicate device already on the market.
Crucially, the provided text describes a modification to an existing device (a change in the insertion tube's outer coating material) rather than a study demonstrating performance against acceptance criteria for a new device or an AI-powered diagnostic tool.
Therefore, none of the requested information regarding acceptance criteria, device performance studies, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, or training set details can be extracted from this document, as it is not relevant to this type of regulatory submission.
The document explicitly states: "All characteristics such as design, construction, optical characteristics, mechanical specifications, electrical and thermal characteristics, intended use, method of use, and application sites remains unchanged." This indicates that no new performance studies were required or conducted for this specific 510(k) submission, as the fundamental performance of the device is considered identical to its predicate.
In summary, the provided text does not contain the information required to answer the questions about acceptance criteria and study details because it describes a minor modification to an already cleared device, not a new performance study.
§ 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.