(27 days)
Intended use for the MediVision Sinoscope is to allow direct visualization through the sinoscope or the video monitor of the nasal cavity.
Not Found
I am sorry, but based on the provided text, there is no information about the acceptance criteria, device performance, or any study details for the MediVision Sinoscope.
The text is a 510(k) clearance letter from the FDA, which confirms that the device is substantially equivalent to a predicate device and can be marketed. It states the intended use of the device: "Intended use for the MediVision Sinoscope is to allow direct visualization through the sinoscope or the video monitor of the nasal cavity."
However, it does not include any performance data, study designs, sample sizes, expert qualifications, or ground truth information. Therefore, I cannot generate the requested table and study description.
§ 874.4760 Nasopharyngoscope (flexible or rigid) and accessories.
(a)
Identification. A nasopharyngoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the nasopharyngoscope and is intended to examine or treat the nasal cavity and nasal pharynx. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel and flexible plastic. This generic type of device includes the antroscope, nasopharyngolaryngoscope, nasosinuscope, nasoscope, postrhinoscope, rhinoscope, salpingoscope, flexible foreign body claw, flexible biopsy forceps, rigid biopsy curette, flexible biospy brush, rigid biopsy forceps and flexible biopsy curette, but excludes the fiberoptic light source and carrier.(b)
Classification. Class II.