(172 days)
The Broncho videoscope system is designed to be used for endoscopic diagnosis and therapies within the respiratory system such as trachea, bronchi, and lungs. The Broncho videoscope System is for use in a hospital environment.
This Full HD Visualization Endoscopic Image Processor is used for endoscopic diagnosis and therapies. It connects to the electronic endoscopes, displaying the images on its LCD display and/or external monitor within the field of view from the body cavity.
This Single-use Broncho Videoscope is intended to use in conjunction with endoscopic image processor to provide images through the video monitor for observation, diagnosis, photography and treatment of the respiratory system such as trachea, bronchi, and lungs.
The subject device, Broncho Videoscope System is consisting of a Single-use Broncho Videoscope and a Full HD Visualization Endoscopic Image Processor. The subject device has been designed to be used for endoscopic diagnosis and therapies within the respiratory system such as trachea, bronchi, and lungs.
The provided text is a 510(k) Summary for a medical device called the "Broncho Videoscope System." It details the device's technical specifications and compares it to a predicate device to establish substantial equivalence. However, the document explicitly states that "No clinical study is included in this submission" (page 6, section 7).
This means there is no information available in this document regarding acceptance criteria, reported device performance against those criteria, or a study proving the device meets those criteria.
Therefore, I cannot provide the requested information based on the provided input.
However, I can extract information related to non-clinical testing and general device characteristics as described in the summary:
Section 1-7: No information available as no clinical study was conducted.
Section 8: Sample size for the training set - Not applicable, as no clinical study for AI model training is mentioned.
Section 9: How the ground truth for the training set was established - Not applicable, as no clinical study for AI model training is mentioned.
§ 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.