(601 days)
Not Found
No
The summary does not mention AI, ML, or any related concepts like image processing, training sets, or performance metrics typically associated with AI/ML devices. The description focuses on the hardware components and intended uses of a radiofrequency system.
Yes
The device is described as providing "non-invasive treatment of periorbital wrinkles and rhytids" and "non-invasive treatment of facial wrinkles and rhytids", which are therapeutic applications.
No
The intended use describes treatment procedures (electrocoagulation, hemostasis, wrinkle treatment), not diagnosis.
No
The device description clearly lists multiple hardware components including a system unit, handpiece, treatment tip, accessories, cables, tubing, and an optional footswitch. This indicates it is a hardware-based medical device with potential software control, not a software-only device.
Based on the provided information, the Thermage ThermaCool System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended uses listed are for dermatologic and general surgical procedures involving electrocoagulation and hemostasis, and non-invasive treatment of wrinkles and rhytids on the face and periorbital area. These are all procedures performed on the patient's body, not on samples taken from the patient.
- Device Description: The components described are a system, handpiece, treatment tips, and accessories used directly on the skin. There is no mention of reagents, analyzers, or anything used to test biological samples.
- Lack of IVD Indicators: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), diagnosing diseases, or providing information about a patient's health status based on laboratory tests.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. The Thermage ThermaCool System's function is to apply energy to the skin for therapeutic purposes.
N/A
Intended Use / Indications for Use
The Thermage ThermaCool System is indicated for use in:
- Dermatologic and general surgical procedures for electro coagulation and hemostasis,
- Non-invasive treatment of periorbital wrinkles and rhytids including the upper and lower eyelids
- Non-invasive treatment of facial wrinkles and rhytids
Product codes
GEI
Device Description
The Thermage ThermaCool System consists of the following components:
- ThermaCool System .
- Handpiece Assembly (consisting of Handpiece and Treatment Tip) ●
- Accessories: Coolant Canister, Coupling Fluid, Return Pad and Skin ● Marking Paper
- Accessory cables and tubing
- Optional footswitch component ●
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
periorbital (including upper and lower eyelids), facial
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)
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
Ko 52996 14.0 510(k) Safety Summary
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) | |
| Contact Person: | Pamela M. Buckman, RN, MS |
| Vice President of Regulatory/Clinical Affairs |
B. Predicate Devices
:
The predicate devices for the ThermaCool System for Eyelid Indication that is the subject of this 510(k) are:
| Predicate | Premarket Notification |
|---|---|
| ThermaCool System | K043042, et al. |
| Lumenis Family of UltraPulse | |
| SurgiTouch CO, Surgical Lasers | K030147 |
1
5 2936
C. Device Description
The Thermage ThermaCool System consists of the following components:
- ThermaCool System .
- Handpiece Assembly (consisting of Handpiece and Treatment Tip) ●
- Accessories: Coolant Canister, Coupling Fluid, Return Pad and Skin ● Marking Paper
- Accessory cables and tubing
- Optional footswitch component ●
D. Indication for Use
The Thermage ThermaCool System for the new indication is: Non-invasive treatment of periorbital wrinkles and rhytids including the upper and lower eyelids.
E. Technical characteristics
The technological characteristics of the Thermage ThermaCool System for Eyelid Indications are identical to the cleared system. The required eyeshield is a commercially available device and is not the subject of this 510(k).
F. Summary
By virtue of design, principle of operation, materials and intended use, the Thermage ThermaCool System for Eyelid Indication is substantially equivalent to referenced devices currently cleared for marketing in the United States.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle or other bird-like figure.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Thermage, Inc. % Ms. Pamela M. Buckman, MSN VP, Clinical/Regulatory 25881 Industrial Boulevard Hayward, California 94545-2991
[JUN 1 2 2007
Re: K052936
Trade/Device Name: Thermage ThermaCool System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: March 13, 2007 Received: March 14, 2007
Dear Ms. Buckman:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2 - Ms. Pamela M. Buckman, MSN
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours
foe
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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2.0 Indications for Use Statement
510(k) NUMBER (IF KNOWN): Not Known
DEVICE NAME: Thermage ThermaCool System INDICATIONS FOR USE:
The Thermage ThermaCool System is indicated for use in:
- Dermatologic and general surgical procedures for electro coagulation and . hemostasis,
- Non-invasive treatment of periorbital wrinkles and rhytids including the upper and ■ lower eyelids
- Non-invasive treatment of facial wrinkles and rhytids
(Division Sign-Off) Division of General, Restorativ and Neurological Devices
510(k) Number K052936
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(Per 21 CFR 801.109)
Concurrence of CDRH, Office of Device Evaluation (ODE)