(58 days)
Electrosurgical Pads are Neutral Electrode which is also known as plate, plate electrode, passive, return, or dispersive electrode. They are indicated for use to adhere to the patient over the entire pad surface to complete an electrical circuit during electrosurgery between the electrosurgical generator, the active electrode and the patient.
Solid Electrosurgical Pads are for use with generators that do not have a Contact Quality Monitoring System (CQMS). Split Electrosurgical Pads are for use with generators that have a CQMS (i.e. REM, ARM, NESSY, etc.).
Electrosurgical Pads are single-use, non-sterile dispersive electrode with or without a pre-attached cord. This devices are used in monopolar surgery to complete the electrical circuit with the generator. Providing a low-impedance path back to the generator through the return electrode helps to prevent unintended RF burns. The Electrosurgical Pads are designed to be compatible with the return electrode monitoring function of compatible OBS generators.
This document is an FDA 510(k) Clearance Letter for "Electrosurgical Pads." It demonstrates no AI/ML algorithm in its description, and therefore, the requested information regarding acceptance criteria, study design, expert involvement, and ground truth for an AI-powered device is not applicable.
The document primarily focuses on demonstrating substantial equivalence of the Electrosurgical Pads to a predicate device and reference devices through:
- Indications for Use comparison: Showing the subject device has the same intended use as the predicate and highly similar indications for use as reference devices.
- Technological Characteristics comparison: Detailing material composition, size, corded/non-corded options, patient weight applicability, and safety/performance standards met.
- Non-clinical performance testing: Listing compliance with relevant IEC and ISO standards for electrical safety, EMC, performance, and biocompatibility.
Therefore, I cannot provide the requested information for an AI/ML device from this document.
§ 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.