(84 days)
Not Found
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 document.
Yes
The device is intended for use in general dermatologic surgery for soft tissue resection/removal and hemostasis/coagulation. These are medical procedures performed to treat or modify body function, which classifies it as a therapeutic device.
No
The device is described as a surgical tool for tissue resection, removal, hemostasis, and coagulation, not for diagnosing conditions.
No
The device description explicitly states that the system includes hardware components (Handpiece and Cable unit, Handpiece Tip, and Controller) and that "There is no software utilized in the operation of the Controller." This clearly indicates it is a hardware-based medical device, not software-only.
Based on the provided information, the Visage Cosmetic Surgery System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for "general dermatologic surgery for soft tissue resection/removal, and hemostasis/coagulation". This describes a surgical procedure performed directly on the patient's body, not a test performed on a sample taken from the body.
- Device Description: The device is a surgical system (handpiece, tip, controller) used for tissue ablation and coagulation. It interacts directly with the patient's tissue during surgery.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue samples, etc.) or providing diagnostic information based on such analysis. The device's function is therapeutic (tissue removal and hemostasis) rather than diagnostic.
IVD devices are designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. The Visage Cosmetic Surgery System does not fit this description.
N/A
Intended Use / Indications for Use
The Visage Cosmetic Surgery System is intended for use in general dermatologic surgery for soft tissue resection/removal, and hemostasis/coagulation in procedures using conductive solutions such as saline or Ringer's Lactate as an irrigant.
Product codes
GEI
Device Description
The Visage Cosmetic Surgery System is shown in Figure 1 (Figures Section), and includes three components. The components are the Handpiece and Cable unit, Handpiece Tip, and the Controller. The Handpiece Tip attaches to the distal end of the Handpiece and Cable unit. The proximal end of the Handpiece and Cable unit connects to the Controller.
The Handpiece Tip is provided in a variety of electrode configurations. The distal tip of the Handpiece is configured with single electrodes or in loop, sheet, or wire form. The Handpiece Tip is supplied sterile and intended for single patient use. The Handpiece and Cable unit are designed for repeat sterilization by steam autoclave. The Controller is a high frequency electronic instrument. There is no software utilized in the operation of the Controller.
The Visage Cosmetic Surgery System is designed for use in general dermatologic surgery for soft tissue resection/removal, and hemostasis/coagulation in procedures using conductive solutions such as saline or Ringer's Lactate as an irrigant. Tissue is removed by ablation and hemostasis is performed by coagulation of tissue.
The Visage Cosmetic Surgery 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
general dermatologic surgery
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)
K964849, K963123, K973478, 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
AUG 20 1998 K981870
ArthroCare Corporation Sunnyvale, California Premarket Notification May 26, 1998
X. 510(k) Summary
Name of Device A.
| Trade name: | Visage Cosmetic Surgery System |
|---|---|
| Common name: | Electrosurgical Unit and Accessories |
| Classification | |
| name: | Electrosurgical Cutting and Coagulation Device and |
| Accessories (21 CFR 878.4400) |
B. Predicate devices
| Device | Premarket Notification |
|---|---|
| ArthroCare Dermal Electrosurgery System | K964849, 04/14/97 |
| ArthroCare Arthroscopic Electrosurgery System | |
| (System 2000) | K963123, 10/08/96 |
| ArthroCare Sinus Electrosurgery System | |
| (System 2000) | K973478, 1/9/98 |
| ConMed Hyfrecator Plus | K800617, 05/02/80 |
C. Device description
The Visage Cosmetic Surgery System is shown in Figure 1 (Figures Section), and includes three components. The components are the Handpiece and Cable unit, Handpiece Tip, and the Controller. The Handpiece Tip attaches to the distal end of the Handpiece and Cable unit. The proximal end of the Handpiece and Cable unit connects to the Controller.
The Handpiece Tip is provided in a variety of electrode configurations. The distal tip of the Handpiece is configured with single electrodes or in loop, sheet, or wire form. The Handpiece Tip is supplied sterile and intended for single patient use. The Handpiece and Cable unit are designed for repeat sterilization by steam autoclave. The Controller is a high frequency electronic instrument. There is no software utilized in the operation of the Controller.
20
1
The Visage Cosmetic Surgery System is designed for use in general dermatologic surgery for soft tissue resection/removal, and hemostasis/coagulation in procedures using conductive solutions such as saline or Ringer's Lactate as an irrigant. Tissue is removed by ablation and hemostasis is performed by coagulation of tissue.
The Visage Cosmetic Surgery 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 Visage Cosmetic Surgery System is intended for use in general dermatologic surgery for soft tissue resection/removal, and hemostasis/coagulation in procedures using conductive solutions such as saline or Ringer's Lactate as an irrigant.
E. Technological characteristics
The technological characteristics of the Visage Cosmetic Surgery System are the same as those of the ArthroCare Dermal Electrosurgery System, as well as the ArthroCare Arthroscopic Systems and the ConMed Hyfrecator Plus. 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 Visage Cosmetic Surgery System is substantially equivalent to devices currently marketed in the United States. We believe that the Visage Cosmetic Surgery System, which is intended for use in general dermatologic surgery for soft tissue resection/removal, and hemostasis/coagulation does not raise any new issues of safety and/or effectiveness.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol of medicine, with three lines forming a bird-like shape. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 20 1998
Mr. Mark Smutka Director, Regulatory Affairs and Quality Assurance ArthroCare Corporation 595 North Pastoria Avenue Sunnyvale, California 94086
Re: K981870 Trade Name: Visage Cosmetic Surgery System Regulatory Class: II Product Code: GEI Dated: May 26, 1998 Received: May 28, 1998
Dear Mr. Smutka:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
3
Page 2 - Mark Smutka
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Stephen Rhodes
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
4
ArthroCare Corporation Sunnyvale, California Premarket Notification Additional Information May 26, 1998
Indications Statement
Visage Cosmetic Surgery System Device Name: 510(k) Number: K981870
Indications for use:
The Visage Cosmetic Surgery System is a bipolar high frequency electrosurgical device intended for general dermatologic surgery for soft tissue resection/removal, and hemostasis/coagulation in procedures using conductive solutions such as saline or Ringer's Lactate as an irrigant.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Stut Rhodes
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