(16 days)
The Gyrus ACMI PlasmaKinetic SuperPulse System is intended for use for the ablation, removal, resection, and coagulation of soft tissue, and where associated hemostasis is required in open, endoscopic, and laparoscopic surgical procedures.
The currently marketed Gyrus ACMI PK SuperPulse System is a bipolar RF generator that accepts a variety of disposable hand pieces that utilize a PlasmaKinetic (PK) waveform. The generator face includes two sockets that allow a range of hand pieces to be utilized in a dry field environment, although only one socket may be active at any given time. The Gyrus ACMI PK SuperPulse System General Purpose Electrosurgical Generator employs a system of automatic instrument detection, through a capacitor located in the hand piece connector plug. This ensures that only the allowable range of waveform output and power level can only be applied to the instrument irrespective of the output socket. Accessories presently provided with the Gyrus ACMI PK SuperPulse System include a power cable and a foot switch. This Special 510(k) proposes the addition of a new optional accessory, the Dual Footswitch Connector Cable. The Dual Footswitch Connector Cable allows for easier use of the Gyrus ACMI PK SuperPulse System when multiple surgeons are present. This is achieved by allowing the connection and use of two footswitches on the same generator.
This document is a 510(k) summary for a medical device called the Gyrus ACMI PK SuperPulse System. It's a regulatory submission to the FDA, not a study report. Therefore, it does not contain the information requested about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or multi-reader multi-case studies.
The document proposes a "Special 510(k)" for the addition of a new accessory, a "Dual Footswitch Connector Cable," to an already cleared device. The core of this submission is to argue that this change does not significantly affect the safety or efficacy of the original device. No new performance studies or clinical trials are presented because the modification is deemed minor.
Therefore, I cannot provide the requested table or information because the provided text is a regulatory filing asserting equivalence, not a scientific study with performance metrics.
§ 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.