(156 days)
The Bovie ICON GS system is an electrosurgical device that utilizes Helium gas for the coagulation of soft tissues during open soft tissue surgery.
The Bovie ICON GS (the Generator) operates by utilizing high frequency radiofrequency (RF) energy to create an ionized gas plasma channel which, when used in conjunction with the handpiece accessory, is used coagulate tissues. The plasma output is comparable between the generator and predicate device. The Generator has an RF mode of operation that can vary the output intensity, duty cycle and Helium gas flow to control the coagulation intensity. The generator is designed to comply with applicable Medical Electrical Equipment safety standards, including electromagnetic compatibility and other safety standards. The Generator uses technology substantially equivalent to the predicate devices. The generator incorporates an ergonomically designed user interface screen for the selection of device settings. Although different from the user interface of the predicate devices, the difference does not affect the safety and effectiveness and may provide improved visualization of the device settings. The Handpiece is a single use device designed to only be compatible with the ICON GS generator and cable. This handpiece contains a programmable memory device that requires a unique code for the generator to operate. The handpiece has a button for finger activation of the generator. Once activated, helium gas flows out the tip of the device and is excited by the high electric field resulting in a plasma flame.
The provided text does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the manner requested (i.e., a diagnostic study with performance metrics like sensitivity, specificity, or reader improvement). This device is an electrosurgical generator, which is not a diagnostic device typically evaluated with such metrics.
The document is a 510(k) summary for a medical device (Bovie ICON GS Generator and Handpiece), which focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through clinical studies in the context of diagnostic accuracy.
Therefore, I cannot provide the requested table and study details based on the input text. The information provided is primarily regulatory in nature, describing the device, its intended use, and its substantial equivalence to other legally marketed devices.
§ 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.