(25 days)
Not Found
No
The summary only describes a modification to a skin marking paper and does not mention any AI or ML components.
Yes
The device is used for non-invasive treatment of periorbital rhytids and wrinkles, and for electrocoagulation and hemostasis in dermatologic and general surgical procedures, which are therapeutic applications.
No
The "Intended Use / Indications for Use" section describes the device for "Non-invasive treatment of periorbital rhytids and wrinkles" and "Dermatologic and general surgical procedures for electrocoagulation and hemostasis," which are therapeutic and surgical functions, not diagnostic.
No
The device description explicitly mentions a "modified Skin Marking Paper," indicating a physical component and not a software-only device. The intended use also describes a "ThermaCool TC System," which is typically a hardware-based system for electrocoagulation and hemostasis.
Based on the provided information, the ThermaCool TC System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states "Non-invasive treatment of periorbital rhytids and wrinkles" and "Dermatologic and general surgical procedures for electrocoagulation and hemostasis." These are therapeutic and surgical procedures performed directly on the patient's body, not tests performed on samples taken from the body (which is the definition of an in vitro diagnostic).
- Device Description: The description mentions a "modified Skin Marking Paper," which is consistent with a device used for external application or treatment.
- Lack of IVD Indicators: There is no mention of analyzing biological samples, performing tests on specimens, or providing diagnostic information based on laboratory analysis.
Therefore, the ThermaCool TC System is a therapeutic/surgical device, not an IVD.
N/A
Intended Use / Indications for Use
The ThermaCool TC System is indicated for use in
- Non-invasive treatment of periorbital rhytids and wrinkles •
- · Dermatologic and general surgical procedures for electrocoagulation and hemostasis.
Product codes (comma separated list FDA assigned to the subject device)
79GEI, GEI
Device Description
The device as described in the above referenced Premarket Notifications has been modified to include a modified Skin Marking Paper.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
periorbital
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.
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
/2 AUG - 1 2003
510(k) Premarket Notification
Summary of Safety and Effectiveness Information
ThermaCool TC SYSTEM July 3, 2003
ThermaCool TC System Device Name:
Common Name(s): RF Unit, coagulator
Classification Name: Electrosurgical cutting and coagulation device and accessories
Establishment Name & Registration Number:
Thermage Name: Number: 2954746
Classification:
Title 21, Code of Federal Regulations,
$ 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.
ProCode: 79GEI
Equivalent Device(s):
The modified ThermaCool TC System claims substantial equivalence to the ThermacCool TC System K013639 and K021402.
Description of the Device:
The device as described in the above referenced Premarket Notifications has been modified to include a modified Skin Marking Paper.
Applicant / Sponsor Name / Address:
Thermage 4058 Point Eden Way Hayward, CA 94545-3721 510.782.2286 telephone 510.782.2287 fax
Contact Person:
Pamela M. Buckman, R.N., M.S. Thermage 4058 Point Eden Way Hayward, CA 94545-3721 510.782.2286 telephone 510.723.3348 fax
Submission Correspondent:
Pamela M. Buckman, R.N., M.S. Thermage 4058 Point Eden Way Hayward, CA 94545-3721 510.782.2286 telephone 510. 723.3348 fax
1
032088 1/2
Manufacturing Facility:
At the present time, this ThermaCool TC System accessory is manufactured by Thermage Inc. in accordance with defined Thermage specifications
Performance Standards:
There are no applicable FDA mandated performance standards for electrosurgical cutting and coagulation device and accessories. However, voluntary standards such as in-house Standard Operaing Procedures and QSR based vendor qualification procedures are in place and utilized in the production of the device.
2
Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services USA. The logo features a stylized abstract design resembling a bird or human figure with flowing lines. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the figure.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG - 1 2003
Ms. Pamela Buckman, R.N., M.S. Vice President Clinical/Regulatory Affairs Thermage 4058 Point Eden Way Hayward. California 94545-3721
Re: K032088
Trade/Device Name: ThermaCool TC System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: July 3, 2003 Received: July 15, 2003
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 (OS) 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, R.N., M.S.
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 (301) 594-4659. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours.
Muriam C. Provost
for 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
Page 1 of 1
510(k) NUMBER: Ko32088
DEVICE NAME: ThermaCool TC System
INDICATIONS FOR USE:
The ThermaCool TC System is indicated for use in
- Non-invasive treatment of periorbital rhytids and wrinkles ●
- · Dermatologic and general surgical procedures for electrocoagulation and hemostasis.
Muriam C. Provost
(Division Sign-Off) Division of General, Restorative and Neurological Devices
K032088 510(k) Number_
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use (Optional format 1-2-96)
ThermaCool510.doc
5