(89 days)
The Novasys "Ariel" RF Electrosurgical Control Module and Accessories, in combination with various Novasys electrodes, is indicated for the coagulation of tissue. This device is intended for use by qualified medical personnel trained in the use of electrosurgery.
Novasys "Ariel" RF Electrosurgical Control Module and Accessories
This 510(k) premarket notification for the Novasys "Ariel" RF Electrosurgical Control Module and Accessories does not contain the requested information regarding acceptance criteria, device performance studies, or ground truth establishment.
The provided document is a summary of safety and effectiveness, a 510(k) clearance letter from the FDA, and an Indications for Use statement. These documents primarily confirm the device's classification, intended use, and substantial equivalence to legally marketed predicate devices, allowing it to proceed to market. They do not detail the specific performance studies, acceptance criteria, or experimental methodologies that would be found in a more comprehensive technical report or clinical study summary.
Therefore, I cannot provide the requested information.
§ 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.