(118 days)
Not Found
No
The summary describes a radiofrequency (RF) system for electrocoagulation and hemostasis, listing standard components like an RF generator, handpiece, and cooling module. There is no mention of AI, ML, image processing, or any data-driven algorithms typically associated with AI/ML in medical devices.
Yes
The device is indicated for "electrocoagulation and hemostasis," which are therapeutic procedures.
No
The device's intended use is for "electrocoagulation and hemostasis" in "Dermatologic and General Surgical procedures," which are therapeutic/surgical functions, not diagnostic ones.
No
The device description explicitly lists multiple hardware components including an RF Generator, Handpiece Connection Module, Cooling Module, Handpiece Assembly, and accessory cables and tubing.
Based on the provided information, the Thermage ThermaCool System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for "Dermatologic and General Surgical procedures for electrocoagulation and hemostasis." This describes a therapeutic or surgical intervention performed on the patient's body, not a test performed on a sample taken from the body.
- Device Description: The components described (RF Generator, Handpiece, Electrodes, Cooling Module) are typical of devices used for applying energy to tissue for surgical or therapeutic purposes. There is no mention of components for analyzing biological samples.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information about a patient's health status
- Using reagents or assays
Therefore, the Thermage ThermaCool System is a therapeutic/surgical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Thermage ThermaCool System is indicated for use in Dermatologic and General Surgical procedures for electrocoagulation and hemostasis.
Product codes (comma separated list FDA assigned to the subject device)
GEI
Device Description
The Thermage ThermaCool System consists of the following components.
- RF Generator .
Handpiece Connection Module . - Cooling Module .
- Handpiece Assembly (consisting of Handpiece and RF Electrode Insert), and .
Accessory cables and tubing. .
The Handpiece Assembly connects to the distal end of the Handpiece Connection Module and to the distal end of the Cooling Module. The proximal end of the Handpiece Connection Module and the proximal end of the Cooling Module connect to the RF Generator.
The Thermage ThermaCool System is monopolar. Commercially available dispersive electrodes (return pads) are required for operation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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): 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.
Radionics Cool-Tip RF System K984552, ArthroCare Visage Cosmetic Surgery System K981870, Candela Dynamic Cooling Device K981033
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.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
JUL 1 9 2000
Koo94
510(k) Safety Summary 16.
A. Name of Device
| Trade Name: | Thermage ThermaCool System |
|---|---|
| Common Name: | Electrosurgical Unit and Accessories |
| Classification Name: | Device, Electrosurgical Cutting and Coagulation and Accessories |
| (21 CFR 878.4400) |
B. Predicate Devices
| Device | Premarket Notification |
|---|---|
| Radionics Cool-Tip RF System | K984552, 03/05/99 |
| ArthroCare Visage Cosmetic Surgery System | K981870, 08/20/98 |
| Candela Dynamic Cooling Device | K981033, 08/15/96 |
C. Device Description:
The Thermage ThermaCool System consists of the following components.
-
RF Generator .
Handpiece Connection Module . -
Cooling Module .
-
Handpiece Assembly (consisting of Handpiece and RF Electrode Insert), and .
Accessory cables and tubing. .
The Handpiece Assembly connects to the distal end of the Handpiece Connection Module and to the distal end of the Cooling Module. The proximal end of the Handpiece Connection Module and the proximal end of the Cooling Module connect to the RF Generator.
The Thermage ThermaCool System is monopolar. Commercially available dispersive electrodes (return pads) are required for operation.
Indicated Use D.
The Thermage ThermaCool System is indicated for use in Dermatologic and General Surgical procedures for electrocoagulation and hemostasis.
1
Technical characteristics E.
The technological characteristics of the Thermage ThermaCool System are substantially equivalent to those of the Radionics Cool-Tip RF System, as well as the ArthroCare Visage Cosmetic Surgery System, and the Candela Dynamic Cooling Device.
F. Summary
By virtue of design, principle of operation, materials and intended use, the Thermage ThermaCool System is substantially equivalent to devices currently marketed in the United States.
Thermage ThermaCool System 510(k)
Page 23 of 173
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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the department's name around the perimeter. In the center of the seal is an emblem featuring a stylized caduceus, a symbol often associated with medicine and healthcare. The caduceus is depicted with a staff and two snakes intertwined around it.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1 9 2000
Mr. Keith Mullowney President Thermage, Inc. 4058 Point Eden Way Hayward, California 94545
K000944 Re: Trade Name: ThermaCool System Regulatory Class: II Product Code: GEI Dated: May 30, 2000 Received: June 1, 2000
Dear Mr. Mullowney:
We have reviewed your Section 510(k) notification of intent to market the devide referenced we nave leviewed your becally be o(is) is substantially equivalent (for the indications for above and we have dosure) to devices marketed in interstate commerce prior to use stated in the enerosure) to device Amendments, or to device Amendments, or to devices that May 20, 1770, the chance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls Costicult Act (186). Fouring) in controls provisions of the Act include requirements for provisions of the Fiel. "Ins & 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 (1 cenailed Approval), it in a read of found in the Code of Federal Regulations, Title 21, regulations arrounity your doily equivalent determination assumes compliance with the Furrent Good Manufacturing Practice requirement, as set forth in the Quality System Current Good Manafactaring Persices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify through perroans. Failure to comply with the GMP regulation may result in regulatory such assumptions: "Further announcements concerning your device in the action: In addition, PDF may premarket notification submission submission does I cucual Register. Trease noter in teave under sections 531 through 542 of the Act for not arrect any obtigation you might and and and provisions, or other Federal laws or regulations.
3
Page 2 - Mr. Keith Mullowney
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,
ina R. lochner
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) NUMBER (IF KNOWN):
1000944
DEVICE NAME:
Thermage ThermaCool System
INDICATIONS FOR USE:
INDICATIONS FOR OSE.
The Thermage ThermaCool System is indicated for use in Dermatologic and General The Thermage ThermaSoor Dycludion and hemostasis.
Concurrence of CDRH, Office of Device Evaluation (ODE)
OR
Dune R. Vochner
(Division Sign-Off)
Division of General Restorative Devices
K000944 510(k) Number
Prescription Use (Per 21 CFR 801.109) Over-The-Counter-Use
Thermage ThermaCool System 510(k)
Page 11 of 173