(415 days)
Indications For Use: The Smoke Evacuation Attachment is intended to remove smoke and aerosols from the surgical site.
Not Found
The provided text is a 510(k) clearance letter from the FDA for a device called "Smoke Evacuation Attachment." This document is a regulatory approval, not a scientific study report. Therefore, it does not contain information about acceptance criteria, device performance metrics, study designs, sample sizes, expert qualifications, or ground truth establishment as typically found in clinical validation studies.
The letter explicitly states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the relevant indications for use and in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976..."
This means the device was approved based on its substantial equivalence to a predicate device, not on a new clinical study demonstrating specific performance metrics against pre-defined acceptance criteria. The FDA determined that the new device is as safe and effective as the predicate device.
Therefore, I cannot provide the requested information from the given text.
§ 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.