(36 days)
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No
The device description explicitly states "There is no software utilized in the operation of the Controller." and there are no mentions of AI, ML, or related concepts in the provided text.
No.
The device is intended for surgical procedures, specifically for tissue removal and bleeding control, which are not considered therapeutic actions.
No
The device is described as an "Electrosurgery System" used for "surgical procedures to remove soft tissue and to control bleeding." It performs therapeutic actions, not diagnostic ones.
No
The device description explicitly states that the system is comprised of hardware components (Dental Probe, Probe Cable, and Controller) and that "There is no software utilized in the operation of the Controller."
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Function: The ArthroCare Dental Electrosurgery System is used directly on the patient's soft tissue in the oral cavity during surgical procedures. It removes tissue and controls bleeding. This is an in vivo (within the living body) procedure, not an in vitro test.
- Intended Use: The intended use clearly states "for use in dental and periodontal surgical procedures to remove soft tissue and to control bleeding in the oral cavity." This describes a surgical tool, not a diagnostic test.
The device description and intended use clearly indicate that this is a surgical device used for treatment, not a diagnostic device used for testing samples.
N/A
Intended Use / Indications for 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.
Product codes
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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. The ArthroCare Dental Electrosurgery System is bipolar, incorporating a return electrode on the shaft of the device.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
oral cavity
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K943450, K955531, K961069, K952039
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.
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 |
| 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.
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.