(106 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on hardware components and treatment procedures without mentioning any AI/ML functionalities.
Yes
The device is indicated for non-invasive treatment of wrinkles and rhytids, temporary improvement in the appearance of cellulite, and relief of minor muscle aches and pains, which are all therapeutic claims.
No
The device is indicated for electrocoagulation, hemostasis, treatment of wrinkles, cellulite, muscle aches, and circulation improvement, none of which are diagnostic functions.
No
The device description explicitly details hardware components like electrodes, a tip fabricated from specific materials, a ceramic coolant spreader, a handpiece, coupling fluid, a return pad, and skin marking paper. This indicates it is a hardware-based medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device being used for dermatologic and general surgical procedures, including electrocoagulation, hemostasis, treatment of wrinkles and cellulite, and relief of muscle aches and spasms. These are all procedures performed on the patient's body.
- Device Description: The device description details a system with electrodes, a handpiece, coupling fluid, and a return pad. This is consistent with a device that interacts directly with the patient's tissue.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information about a physiological state, health, or disease.
IVD devices are specifically designed to perform tests on samples taken from the body. This device is designed to apply energy to the body for therapeutic and surgical purposes.
N/A
Intended Use / Indications for Use
The Thermage ThermaCool NXT Multiplex Assembly, including accessories and all components, is indicated for use in dermatologic and general surgical procedures for electrocoagulation and hernostasis, non-invasive treatment of periorbital wrinkles and rhytids including upper and lower evelids, non invasive treatment of wrinkles and rhytids, temporary improvement in the appearance of cellulite, temporary improvement in local circulation, i.e., blood circulation, relief of minor muscle aches and pains, relief of muscle spasms.
The Thermage ThermaCool System is indicated for use in Dermatologic and General Surgical procedures for electrocoagulation and hemostasis.
Non-invasive treatment of periorbital wrinkles and rhytids including upper and lower eyelids
Non-invasive treatment of wrinkles and rhytids
Temporary improvement in the appearance of cellulite
Relief of minor muscle aches and pains
Relief of muscle spasms
Temporary improvement of local circulation (i.e., blood circulation)
Product codes (comma separated list FDA assigned to the subject device)
GEI
Device Description
The Multiplex Assembly is a 4-electode design incorporating four 3.00-cm electrode footprints with required spacing. The tip is fabricated from the same materials as the previous tips, with the addition of a ceramic coolant spreader. Tip fabrication will be performed in the same manner and the treatment procedure will be similar to previous methods. The Handpiece, Coupling Fluid, Return Pad and Skin Marking Paper have been modified to accommodate the larger tip dimensions.
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.
K033942, K032088, K031046, K043402, K051710, K052778
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
14.0 510(k) Safety Summary
Name of Device A.
| Trade Name: | ThermaCool NXT Multiplex Assembly |
|---|---|
| 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 |
Predicate Device B.
| Predicate Devices | Premarket Notification Number |
|---|---|
| Components and accessories | |
| compatible with the ThermaCool | |
| System (Model NXT) | K033942 |
| K032088 | |
| K031046 | |
| K043402 | |
| K051710 | |
| K052778 |
C. Device Description
The Multiplex Assembly is a 4-electode design incorporating four 3.00-cm electrode footprints with required spacing. The tip is fabricated from the same materials as the previous tips, with the addition of a ceramic coolant spreader. Tip fabrication will be performed in the same manner and the treatment procedure will be similar to previous methods. The Handpiece, Coupling Fluid, Return Pad and Skin Marking Paper have been modified to accommodate the larger tip dimensions.
D. Indicated Use
The Thermage ThermaCool NXT Multiplex Assembly, including accessories and all components, is indicated for use in dermatologic and general surgical procedures for electrocoagulation and hernostasis, non-invasive treatment of periorbital wrinkles and rhytids including upper and lower evelids, non invasive treatment of wrinkles and rhytids, temporary improvement in the appearance of cellulite, temporary improvement in local circulation, i.e., blood circulation, relief of minor muscle aches and pains, relief of muscle spasms.
1
0728419
E. Technical characteristics
The technological characteristics of the Multiplex Assembly, components and accessories are substantially equivalent to those of the standard NXT Assembly, components and accessories.
F. Summary
By virtue of design, principle of operation, materials and intended use, the Multiplex Assembly is substantially equivalent to 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 and Human Services. The logo consists of a stylized eagle with three stripes forming its body and wing. The eagle is enclosed in a circle of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The logo is black and white.
Public Health Service
JAN 1 8 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Thermage, Inc % Ms. Pamela M. Buckman, RN MS Vice President of Regulatory Clinical Affairs 25881 Industrial Boulevard Hayward, California 94545
Re: K072849
Trade/Device Name: Thermage ThermaCool System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories. Regulatory Class: Class II Product Code: GEI Dated: January 14 2008 Received: January 15, 2008
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, RN, MS
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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,
Mark N Millerson
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
2.0 Indications for Use Statement
Ko72849 510(k) NUMBER (IF KNOWN):
DEVICE NAME:
Thermage ThermaCool System
INDICATIONS FOR USE:
The Thermage ThermaCool System is indicated for use in Dermatologic and General Surgical procedures for electrocoagulation and hemostasis.
Non-invasive treatment of periorbital wrinkles and rhytids including upper and lower eyelids
Non-invasive treatment of wrinkles and rhytids
Temporary improvement in the appearance of cellulite
Relief of minor muscle aches and pains
Relief of muscle spasms
Temporary improvement of local circulation (i.e., blood circulation)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use X (Per 21 CFR 801.109)
OR Over-The-Counter-Use
Laubara Buem
Division of General, Restorative, and Neurological Devices
Page 5 of 174
510(k) Number K072841