(36 days)
The ArthroCare Dental Electrosurgery System is intended for use in dental and periodontal surgical procedures to remove soft tissue and to control bleeding in the oral cavity.
The ArthroCare Dental Electrosurgery System is comprised of three components: the Dental 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 0.5 mm to 2.5 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 as a loop electrode. 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 Dental Electrosurgery System 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.
I am sorry, but the provided text describes a medical device called the "ArthroCare Dental Electrosurgery System" and outlines its description, intended use, and technological characteristics, along with a statement of substantial equivalence to predicate devices.
However, the text does not contain any information regarding acceptance criteria, device performance metrics, clinical studies, sample sizes, ground truth establishment, expert qualifications, or adjudication methods. There is no data presented that would allow me to populate the requested table or answer the specific questions about a study proving the device meets acceptance criteria.
The submission is an FDA 510(k) summary from 1996, which typically focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed clinical study results with acceptance criteria.
{0}------------------------------------------------
JUL 30 1996
ArthroCare Corporation Sunnyvale, California Premarket Notification June 21, 1996
X. 510(k) Summary
A. Name of Device
| Trade name: | ArthroCare Dental Electrosurgery System |
|---|---|
| Common name: | Dental Electrosurgical Unit |
| Classificationname: | Dental Electrosurgical Unit and Accessories(21 CFR 872.4920) |
B. Predicate devices
| Device | PremarketNotification |
|---|---|
| ArthroCare Arthroscopic Electrosurgery System | K943450 |
| ArthroCare Bipolar Loop Electrosurgery System | K955531 |
| ArthroCare Urologic Multi-electrodeElectrosurgery System | K961069 |
| Parkell 500SE Sensimatic Electrosurge | K952039 |
C. Device description
The ArthroCare Dental Electrosurgery System is comprised of three components: the Dental 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 0.5 mm to 2.5 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 as a loop electrode. 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.
{1}------------------------------------------------
ArthroCare Corporation Sunnyvale, California Premarket Notification June 21, 1996
The ArthroCare Dental Electrosurgery System 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.
D. Intended use
The ArthroCare Dental Electrosurgery System is intended for use in dental and periodontal surgical procedures to remove soft tissue and to control bleeding in the oral cavity.
E. Technological characteristics
The technological characteristics of the ArthroCare Dental Electrosurgery System are the same as those of the ArthroCare Arthroscopic, Bipolar Loop and Urologic Multi-electrode Systems. These devices are equivalent in terms of design, materials, principle of operation, product specifications and sterilization.
F. Summary
By virtue of design, materials, function and intended use, the ArthroCare Dental Electrosurgery System is substantially equivalent to devices currently marketed in the United States.
§ 872.4920 Dental electrosurgical unit and accessories.
(a)
Identification. A dental electrosurgical unit and accessories is an AC-powered device consisting of a controlled power source and a set of cutting and coagulating electrodes. This device is intended to cut or remove soft tissue or to control bleeding during surgical procedures in the oral cavity. An electrical current passes through the tip of the electrode into the tissue and, depending upon the operating mode selected, cuts through soft tissue or coagulates the tissue.(b)
Classification. Class II.