(94 days)
The Xomed SHARPSITE Ac rigid rod lens endoscopes are intended for use in surgical imaging in otolaryngology and Head and Neck procedures, including rhinology, and endoscopic plastic and reconstructive surgery.
The SHARPSITE Ac endoscopes are a series of small diameter, rigid rod lens endoscopes; available in diameters of 2.7mm, 4.0mm and 5.0mm with tip angles o 0, 30 and 70 degrees. The length of the scopes range from 175mm to 188 mm. Each scope is fitted with a removable light port adapter for use with light cables from different manufacturers.
The provided text is a 510(k) Summary for a medical device (SHARPSITE Ac endoscopes) seeking market clearance. It details the device's description, intended use, and claims of substantial equivalence to existing devices. However, it does not contain information about acceptance criteria, a study proving the device meets those criteria, or any of the detailed study parameters requested in the prompt.
The 510(k) process for a Class II device like this primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring extensive clinical trials with pre-defined acceptance criteria for performance, especially for devices where performance is well-understood and similar to existing technologies.
Therefore, I cannot fulfill the request with the provided input. The document explicitly states: "Substantial equivalency is based on the fact that the SHARPSITE Ac endoscopes are equivalent to current Xomed endoscopes in their intended use and materials. They are likewise equivalent in design, intended use and performance claims to sinuscopes currently marketed by Smith & Nephew (S&N) ENT." This indicates that a direct comparative study with acceptance criteria for device performance, as implied by the prompt, was not conducted or reported in this summary.
I would need a different type of document, such as a clinical study report or a different section of a regulatory submission (e.g., a performance testing summary), to provide the requested information.
§ 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.