(54 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.
The 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 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 within the field of view from the body cavity.
The Endoscopic Image Processor is used for endoscopic diagnosis and therapies. It connects to the electronic endoscopes, displaying the images on the monitor detected within the field of view from the body cavity.
The subject device, Broncho Videoscope System, is consisting of a Single-use Broncho Videoscope and a Full HD Visualization Endoscopic Image Processor or 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 Single-use Broncho Videoscope is a single use in conjunction with Full HD Visualization 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 Single-use Broncho Videoscope has six models, which are available in three kinds of outer diameter of insertion section (02.8mm and 05.6mm), one working length (600mm), two different material of the insertion (Nylon and PEEK) and two plug types (Square type and round type). The six models with round type have been cleared in K210739.
The Full HD Visualization Endoscopic Image Processor is used for endoscopic diagnosis and therapies. It connects to the Single-use Broncho Videoscope, displaying the images on its LCD display and/or within the field of view from the body cavity. The Full HD Visualization Endoscopic Image Processor has four models, they have and the difference is only on the image adjustment functions.
The Endoscopic Image Processor is a reusable device. The Endoscopic Image Processor has two models. The only difference between the two models is that the HDVS-S100A has Enhance function and the HDVS-S100D does not have the Enhance function.
I am sorry, but the provided text does not contain the acceptance criteria or a study proving the device meets those criteria. The document is an FDA 510(k) clearance letter for a Broncho Videoscope System, indicating that the device has been found substantially equivalent to a legally marketed predicate device.
The document primarily focuses on regulatory aspects such as:
- Device Name and Classification: Broncho Videoscope System, classified as Class II, product code EOO.
- Intended Use/Indications for Use: For endoscopic diagnosis and therapies within the respiratory system (trachea, bronchi, lungs).
- Regulatory Compliance: Mentions various FDA regulations like annual registration, device listing, good manufacturing practice, labeling, and prohibitions against misbranding.
- Comparison to Predicate Device: States that the subject device has the same indications for use and technological characteristics as the predicate device.
- Biocompatibility Testing: Notes that biocompatibility tests (cytotoxicity, sensitization, irritation) were re-conducted on representative models per ISO 1099-1, and the results comply with the requirements. This is presented as non-clinical testing supporting substantial equivalence.
While biocompatibility testing is mentioned, it is part of the non-clinical tests that support substantial equivalence to a predicate device, rather than a detailed study proving the device meets specific (quantitative) performance acceptance criteria as would be typical for an AI/ML medical device.
Therefore, I cannot provide the information requested in your prompt regarding acceptance criteria, device performance, sample sizes, ground truth establishment, or any MRMC study details, as these are not present in the provided text.
§ 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.