(50 days)
No
The summary does not mention AI, ML, or any related concepts like image processing or training/test sets for algorithms. The description focuses on a modified treatment tip.
Yes
The device is indicated for "non-invasive treatment of periorbital rhytids and wrinkles" and "dermatologic and general surgical procedures for electrocoagulation and hemostasis," which are therapeutic applications.
No
The intended use describes non-invasive treatment and electrocoagulation/hemostasis, which are therapeutic procedures, not diagnostic ones.
No
The device description explicitly states it includes a "modified Treatment Tip," which is a hardware component. The intended use also describes a system ("ThermaCool TC System") which implies hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
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, 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 Treatment Tip," which is consistent with a device used for direct application to tissue.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information based on laboratory tests
- Mentioning reagents, assays, or laboratory procedures
Therefore, the ThermaCool TC System, as described, is a therapeutic/surgical device, not an in vitro diagnostic device.
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
79GEI
Device Description
The device as described in the above referenced Premarket Notifications has been modified to include a modified Treatment Tip.
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
Not Found
Key Metrics
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
031046
510(k) Premarket Notification
Summary of Safety and Effectiveness Information
ThermaCool TC SYSTEM APRIL 1, 2003
ThermaCool TC System Device Name:
RF Unit, coagulator Common Name(s):
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 ThermaCool 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 Treatment Tip.
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 Havward, 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
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031046 4/2
Manufacturing Facility:
At the present time, this ThermaCool TC System component 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 Operating Procedures and QSR based vendor qualification procedures are in place and utilized in the production of the device.
2
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 eagle head in profile, with three curved lines representing the feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle.
MAY 22 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Pamela M. Buckman, R.N., M.S. Senior Director, Clinical/Regulatory Affairs Thermage 4058 Point Eden Way Hayward, California 94545
Re: K031046
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: April 1, 2003 Received: May 8, 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 (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, 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. 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" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained 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 vours.
Mark N Wilkerson
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: K © 3 1646
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.
Mark N. Wilkinson
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K031046
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