(57 days)
The ArthroCare Arthroscopic Electrosurgery System 980 is intended for use in arthroscopic surgical procedures of the knee, shoulder, ankle, elbow, hip and wrist for soft tissue resection and hemostasis.
The ArthroCare Arthroscopic Electrosurgery System 980 is comprised of three components: the Probe, the Probe Cable, and an electrosurgical generator called the Controller. The Probe Cable connects the Controller to the Probe. The Probe is provided in a variety of models, ranging in diameters from 1.5 mm to 4.5 mm with the distal tip of the probe as straight or bent at angles up to 90 degrees. The distal tip may be configured with multi-electrodes or loop electrodes. The Probe is supplied sterile and intended for single patient use. The Probe Cable is designed for repeat sterilization by either ethylene oxide gas or steam autoclaving methods, as selected by the user. The Controller is a high frequency electronic instrument. There is no software utilized in the operation of the Controller. The ArthroCare Arthroscopic Electrosurgery System 980 is bipolar, incorporating a return electrode on the shaft of the device. This means that a return pad is not required for operation. The return energy in a bipolar device with an integral return electrode does not penetrate the tissue as in a monopolar device. In a monopolar device, the energy passes through the patient's body to reach the return pad.
This document describes a premarket notification for the ArthroCare Arthroscopic Electrosurgery System 980. It does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement as requested.
Therefore, I cannot provide the requested information about acceptance criteria and the study proving the device meets them based on the provided text. The document focuses on establishing substantial equivalence to a predicate device, which is a regulatory pathway that often relies on demonstrating similar technological characteristics and intended use rather than presenting new performance study data against specific quantitative acceptance criteria.
§ 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.