(72 days)
This grounding pad, also know as dispersive, neutral, or return electrode, is applied to the patient's skin during surgery to reliably conduct the required surgical R.F. current with minimal rise in skin temperature, thereby reducing the risk of electrosurgical effect or burns to the patient.
This device is used when electrosurgery generators and pencils with electodes are needed during a surgical procedure. The dispersive electrode is large in area, compared to the active electrode on pencil, thus promoting low current density so burns to the patient do not happen.
The electrosugical generator produces (radio frequency) R.F. current to high-density electrode known as the active electrode. The dispersive electrode reduces the current to low density and returns the current back to the generator. Again reducing the risk for burns to the skin of the patient.
The grounding pad is coupled to the patient usually by direct contact with the skin, and may be used with semi-liquid or conductive gel. This is usually done with the disposable grounding pad.
Not Found
This document is a 510(k) clearance letter from the FDA for a disposable electrosurgery grounding pad. It states that the device is substantially equivalent to legally marketed predicate devices.
However, the provided document does not contain any information about acceptance criteria, device performance tables, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details.
The document is purely a regulatory clearance and does not include the technical study details that would typically be found in a more comprehensive submission or performance report.
§ 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.