ARTHROCARE DENTAL ELECTROSURGERY SYSTEM

K962445 · Arthrocare Corp. · EKZ · Jul 30, 1996 · Dental

Device Facts

• Record ID: K962445
• Device Name: ARTHROCARE DENTAL ELECTROSURGERY SYSTEM
• Applicant: Arthrocare Corp.
• Product Code: EKZ · Dental
• Decision Date: Jul 30, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4920
• Device Class: Class 2
• Attributes: Therapeutic

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.

Device Story

System comprises electrosurgical generator (Controller), probe cable, and sterile single-use dental probe (0.5-2.5 mm diameter, straight or angled, multi-electrode or loop tip). Bipolar design with integral return electrode on probe shaft eliminates need for patient return pad. Energy delivery localized to tissue at probe tip; no deep tissue penetration. Used by dentists/periodontists in clinical settings for soft tissue excision and bleeding control. Controller is high-frequency electronic instrument; no software involved. Probe cable reusable via ethylene oxide or steam autoclave.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Bipolar electrosurgical unit. Components: Controller (high-frequency generator), probe cable, and sterile single-use probes. Probes feature multi-electrode or loop configurations. Sterilization: Probes (sterile, single-use); Cable (ethylene oxide or steam autoclave). No software.

Indications for Use

Indicated for dental and periodontal surgical procedures requiring soft tissue removal and hemostasis in the oral cavity.

Regulatory Classification

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.

Predicate Devices

• ArthroCare Arthroscopic Electrosurgery System (K943450)
• ArthroCare Bipolar Loop Electrosurgery System (K955531)
• ArthroCare Urologic Multi-electrode Electrosurgery System (K961069)
• Parkell 500SE Sensimatic Electrosurge (K952039)

Submission Summary (Full Text)

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K962445
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
Classification name: Dental Electrosurgical Unit and Accessories (21 CFR 872.4920)

## B. Predicate devices

| Device | Premarket Notification |
| --- | --- |
| ArthroCare Arthroscopic Electrosurgery System | K943450 |
| ArthroCare Bipolar Loop Electrosurgery System | K955531 |
| ArthroCare Urologic Multi-electrode Electrosurgery 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.

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{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.