(308 days)
The Somnus Model 30xx Disposable Tri-Needle Coagulating Electrode is indicated for use in the coagulation of tissue. This device is intended for use by qualified medical personnel trained in the use of Somnus Tissue Coagulating Electrodes.
The Somnus™ Model 30xx Disposable Tri-Needle Coagulating Electrode is a modification of the Model 3000 Disposable Tri-Needle Coagulating Electrode cleared under 510(k) #K963884. Both devices provide a reliable method of performing coagulation on target areas of tissue using a handle grip for ease of placement. The configuration of the handle grip of the Model 30xx is identical to the Model 3000 handle grip.
This 510(k) summary does not contain information on acceptance criteria or a study proving the device meets acceptance criteria. It primarily focuses on demonstrating substantial equivalence to a predicate device. The document states:
"The Somnus has been carefully compared to legally marketed devices with respect to intended use and technological characteristics. In addition, performance validation testing has been done to validate the performance of the device. The comparison and validation results presented in this 510(k) notification to the FDA show that the device is substantially equivalent to predicate devices and is safe and effective in its intended use."
However, it does not provide details about the specific 'performance validation testing,' including the acceptance criteria, study design, sample sizes, or ground truth establishment.
Therefore, I cannot populate the requested table or answer the specific questions about the study design, sample size, expert qualifications, or comparative effectiveness. The information is not present in the provided 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.