(117 days)
To gently dissect planes of soft tissue using controlled bursts of CO2 gas. The device may be used in both open and endoscopic procedures in which gentle, blunt dissection of soft tissue planes is desired.
The Carbodissecting Endoscope consists of two components: The Spatula is a surgical tool used in combination with CO2 and saline, and is designed to be used with the supplied Scope to provide accurate visual feedback during a carbodissection procedure. The tip allows the surgeon to slide between the tissue planes. The front of the tip is slightly curved and has multiple CO2 outlets. The multiple CO2 outlets are used to fan the gas out along the entire front of the tip to help peel apart the two layers, to aid in the separation of the tissue The Scope is a flexible fiberscope intended for use with the Spatula.
The provided text does not contain information about acceptance criteria or a study proving that a device meets such criteria. The document is an FDA 510(k) premarket notification summary for a "Carbodissecting Endoscope," indicating it has been deemed substantially equivalent to a predicate device.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria based on the provided text. The requested information regarding sample size, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, type of ground truth, and training set details are not present.
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.