(85 days)
No
The device description and intended use focus on standard RF energy delivery for electrocoagulation and hemostasis. There is no mention of AI, ML, image processing, or data analysis that would suggest the use of such technologies.
Yes
The device is indicated for "electrocoagulation and hemostasis" in dermatologic and general surgical procedures, which are therapeutic interventions.
No
The device is indicated for electrocoagulation and hemostasis, which are treatment procedures, not diagnostic ones.
No
The device description explicitly lists multiple hardware components including an RF Generator, Coolant Control Center, Handpiece Assembly, cables, tubing, and an optional footswitch.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
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 directly on a patient, not a test performed on a sample taken from a patient to diagnose a condition.
- Device Description: The components listed (RF Generator, Handpiece, Coolant, etc.) are consistent with a device used for applying energy to tissue, not for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or diagnostic results.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device's function is clearly focused on surgical procedures.
N/A
Intended Use / Indications for Use
The Thermage ThermaCool TC 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 TC System consists of the following components:
- RF Generator .
- Coolant Control Center ●
- Coolant Canister .
- Handpiece Assembly (consisting of Handpiece and Treatment Tip) .
- Accessory cables and tubing ●
- Optional footswitch component .
- Accessories: coupling fluid, return pad and skin marking paper .
The Handpiece Assembly and Coolant Control Center connect to the RF Generator.
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.
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.
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
JAN 2 9 2002
510(k) Safety Summary 14.0
Name of Device A.
| Trade Name: | Thermage ThermaCool TC System (Model TC) | |
|---|---|---|
| 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 | |
| Sr. Director of Regulatory/Clinical Affairs |
Predicate Devices B.
ThermaCool TC System (including coolant canister and footswitch:
| Device | Premarket Notification |
|---|---|
| Thermage ThermaCool IIA System | K013034, Cleared 10/4/01 |
| Thermage ThermaCool II System | K003183, Cleared 12/8/00 |
| Thermage-ThermaCool System | K000944, Cleared 7/19/00 |
Other ThermaCool TC System Accessories (return pad, coupling fluid and skin marking paper):
| Accessory | Predicate | Premarket Notification |
|---|---|---|
| Return Pad | Nikomed Electrosurgical | |
| Grounding Pad | K000079, Cleared 2/4/00 | |
| Coupling Fluid | Cadwell Lectron II | K933804, Cleared 3/22/94 |
| Skin Marking | ||
| Paper | Skin Marker | Class I, Exempt (878.4660) |
Device Description C.
The Thermage ThermaCool TC System consists of the following components:
- RF Generator .
- Coolant Control Center ●
- Coolant Canister .
- Handpiece Assembly (consisting of Handpiece and Treatment Tip) .
- Accessory cables and tubing ●
- Optional footswitch component .
- Accessories: coupling fluid, return pad and skin marking paper .
The Handpiece Assembly and Coolant Control Center connect to the RF Generator.
1
Indicated Use D.
The Thermage ThermaCool TC System is indicated for use in Dermatologic and General Surgical procedures for electrocoagulation and hemostasis.
Technical characteristics E.
The technological characteristics of the Thermage ThermaCool TC System are substantially equivalent to those of the Thermage ThermaCool IIA System, ThermaCool II System, and ThermaCool System.
F. Summary
By virtue of design, principle of operation, materials and intended use, the Thermage ThermaCool TC System is substantially equivalent to devices currently cleared for marketing in the United States.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus. The logo is black and white.
JAN 2 9 2002
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Pamela M. Buckman, RN, MS Sr. Director of Regulatory/Clinical Affairs Thermage 4058 Point Eden Way Hayward, California 94545-3721
Re: K013639
Trade Name: Thermage Thermacool TC System Regulation Number: 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: November 2, 2002 Received: November 5, 2001
Dear Ms. Buckman:
We have reviewed your Section 510(k) premarket 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) 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 Buckman
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to begin maxeming your antial equivalence of your device to a legally premarket nothication: "The PDF micing of casification 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 II you desire specific au rio for you avitro diagnostic devices), please contact the Office of additionally 21 CT F Fatt 607.10 for questions on the promotion and advertising of Compliance at (301) 594 1057. Thenker Compliance at (301) 594-4639. Also, please note the your device, prodo combranding by reference to premarket notification™ (21CFR Part 807.97). It general information on your responsibilities under the Act may be obtained from the Other general information on your respectional and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
/ Mark n Millan
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) NUMBER (IF KNOWN):
Thermage ThermaCool TC System (Model TC)
INDICATIONS FOR USE:
DEVICE NAME:
The Thermage ThermaCool TC System (Model TC) is indicated for use in Dermatologic The Thermage Thematoon To 65 electrocoagulation and hemostasis.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter-Use
(Division Sign-Off)
Division of General, Restorative
and Neurological Devices
Thermage ThermaCool TC System 510(k)
510(k) Number. K013639
చి