(65 days)
The 5 Star Medical bronchoscope is intended for use in the direct visualization and diagnosis in the trachea and lungs.
A description of the Bronchoscope's components is as follows: Optical Catheters, Optical Handle, Fiber Optic Cables, Adapters and Light Sources.
This document, K960876, is a 510(k) summary for a Bronchoscope. It primarily focuses on demonstrating substantial equivalence to a predicate device (Microvasive Visicath) based on technological characteristics and intended use. It does not contain information about acceptance criteria or a study proving that the device meets specific performance criteria.
Therefore, I cannot populate the table or answer the questions related to acceptance criteria, device performance, sample sizes, ground truth, or study methodologies. The provided text is a regulatory submission for pre-market notification, not a clinical or performance evaluation report.
§ 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.