Electrosurgical Pads

Electrosurgical Pads are single-use, non-sterile dispersive electrodes (neutral/return electrodes) used in monopolar electrosurgery. They adhere to the patient's skin to complete the electrical circuit between the electrosurgical generator's active electrode and the patient, providing a low-impedance return path to prevent unintended RF burns. They come in corded and non-corded variants for use with generators with or without Contact Quality Monitoring Systems (CQMS).

The subject device uses conductive gel (sodium polyacrylate, glycerin, water, potassium chloride) with a pressure-sensitive adhesive border and includes a protective frame around the gel edge. It is offered in multiple sizes for three weight ranges (under 5 kg, 5–15 kg, over 15 kg) with corresponding conductive surface areas of 32.76, 75, and 141.3 cm². The predicate device has no frame and offers fifteen size variants. Both are single-use, non-sterile products with 3-year shelf life.

IEC 60601-2-2:2017 (high frequency surgical equipment performance), IEC 60601-1:2005+A1:2012+A2:2020 (general safety), IEC 60601-1-2:2014/AMD1:2020 (EMC), ISO 10993-1:2018 (biological evaluation framework), ISO 10993-5 (in vitro cytotoxicity), ISO 10993-10 (skin sensitization), and ISO 10993-23 (irritation).

The indications for use are identical to the predicate device—both are neutral electrodes for monopolar electrosurgery completing the circuit between generator, active electrode, and patient, with the same distinction between solid pads (non-CQMS generators) and split pads (CQMS generators). Technological characteristics are the same or highly similar (conductive gel formulation, single-use, non-sterile, 3-year shelf life). The addition of a frame and reduction to three weight-range sizes represent minor structural differences that do not raise safety or effectiveness concerns, as evidenced by non-clinical testing demonstrating compliance with all relevant electrical safety, EMC, and biocompatibility standards.