(132 days)
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.
No.
The device is intended for surgical procedures to remove soft tissue and control bleeding, not for treating a disease or condition therapeutically.
No
The device is intended for "dermatologic surgical procedures to remove soft tissue and to control bleeding," which are therapeutic actions, not diagnostic ones.
No
The device description explicitly states that the system is comprised of hardware components (Handpiece, Tip, 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 Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Function: The ArthroCare Dermal Electrosurgery System and ConMed Hyfrecator are used directly on the patient's body during surgical procedures to remove tissue and control bleeding. They are not used to analyze specimens outside of the body.
- Intended Use: The stated intended use is for "dermatologic surgical procedures to remove soft tissue and to control bleeding," which is a therapeutic and surgical application, not an in vitro diagnostic one.
The device is an electrosurgical system used for surgical intervention, not for diagnostic testing of samples.
N/A
Intended Use / Indications for Use
The ArthroCare Dermal Electrosurgery System and ConMed Hyfrecator are intended for use in dermatologic surgical procedures to remove soft tissue and to control bleeding.
Product codes
Not Found
Device Description
The ArthroCare Dermal Electrosurgery System is comprised of three components: the Dermal Handpiece with Cable unit, the disposable Dermal Handpiece Tip, and an electrosurgical generator called the Controller. The Dermal Handpiece Tip attaches to the distal end of the Dermal Handpiece and Cable. The proximal end of the Dermal Handpiece and Cable unit connects to the Controller. The Dermal Handpiece Tip is provided in a variety of models, ranging in diameters from 0.5 mm to 2.5 mm with the distal tip of the dermal Handpiece as straight or bent at angles up to 90 degrees. The distal tip is configured with multi-electrodes. The Dermal Handpiece Tip is supplied sterile and intended for single patient use. The Dermal Handpiece and Cable unit are designed for repeat sterilization by either ethylene oxide gas or steam autoclaving methods. The Controller is a high frequency electronic instrument. There is no software utilized in the operation of the Controller.
The ArthroCare Dermal 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K943450, K962445, K955531, K961069, K800617
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
ArthroCare Corporation Sunnyvale, California Premarket Notification November 29, 1996
APR 1 4 1997
X. 510(k) Summary
964849
Name of Device A.
| Trade name: | ArthroCare Dermal Electrosurgery System |
|---|---|
| Common name: | Electrosurgical Unit and Accessories |
| Classification | |
| name: | Electrosurgical Cutting and Coagulation Device and |
| Accessories (21 CFR 878.4400) |
Predicate devices B.
| Device | Premarket
Notification |
|--------------------------------------------------------------|---------------------------|
| ArthroCare Arthroscopic Electrosurgery System | K943450 |
| ArthroCare Dental Electrosurgery System | K962445 |
| ArthroCare Bipolar Loop Electrosurgery System | K955531 |
| ArthroCare Urologic Multi-electrode Electrosurgery
System | K961069 |
| ConMed Hyfrecator Plus | K800617 |
C. Device description
The ArthroCare Dermal Electrosurgery System is comprised of three components: the Dermal Handpiece with Cable unit, the disposable Dermal Handpiece Tip, and an electrosurgical generator called the Controller. The Dermal Handpiece Tip attaches to the distal end of the Dermal Handpiece and Cable. The proximal end of the Dermal Handpiece and Cable unit connects to the Controller. The Dermal Handpiece Tip is provided in a variety of models, ranging in diameters from 0.5 mm to 2.5 mm with the distal tip of the dermal Handpiece as straight or bent at angles up to 90 degrees. The distal tip is configured with multi-electrodes. The Dermal Handpiece Tip is supplied sterile and intended for single patient use. The Dermal Handpiece and Cable unit are designed for repeat sterilization by either ethylene oxide gas or steam autoclaving methods. 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 November 29, 1996
The ArthroCare Dermal 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 Dermal Electrosurgery System and ConMed Hyfrecator are intended for use in dermatologic surgical procedures to remove soft tissue and to control bleeding.
Technological characteristics E.
The technological characteristics of the ArthroCare Dermal Electrosurgery System are the same as those of the ConMed Hyfrecator Plus as well as the ArthroCare Arthroscopic System, Bipolar Loop, Dental, and Urologic Multielectrode Systems. These devices are equivalent in terms of materials, principle of operation and sterilization.
F. Summary
By virtue of design, principle of operation, materials and intended use, we believe the ArthroCare Dermal Electrosurgery System is substantially equivalent to devices currently marketed in the United States. We believe that the ArthroCare Dermatologic Electrosurgery System, which is intended for removal of dermatologic lesions and hemostasis in dermatologic surgical procedures, does not raise any new issues of safety and/or effectiveness.
20