(193 days)
Not Found
No
The summary describes a radiofrequency energy delivery system for dermatological procedures and does not mention any AI or ML components or functionalities.
Yes
The device is indicated for medical purposes such as electrocoagulation, hemostasis, relief of minor muscle aches and pains, relief of muscle spasms, and temporary improvement of local circulation, which are all therapeutic interventions.
No
The Intended Use/Indications for Use section describes the device for electrocoagulation, hemostasis, treatment of wrinkles and rhytids, improvement of cellulite, relief of minor muscle aches and pains, relief of muscle spasms, and temporary improvement of local circulation. These are all therapeutic applications, not diagnostic ones.
No
The device description explicitly details hardware components such as an RF Generator, Handpiece, Treatment Tip, Return Pad, and other accessories, indicating it is a hardware-based system that delivers energy.
Based on the provided information, the Thermage FLX System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Thermage FLX System's Intended Use: The Thermage FLX System's intended uses are focused on delivering radiofrequency energy and vibration directly to the patient's body for therapeutic and aesthetic purposes (electrocoagulation, hemostasis, wrinkle reduction, cellulite improvement, pain relief, circulation improvement). It does not involve the analysis of specimens taken from the body.
- Device Description: The device description details a system that applies energy externally to the patient, not a system for analyzing biological samples.
Therefore, the Thermage FLX System falls under the category of therapeutic or aesthetic medical devices, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
- The radiofrequency-energy only delivery components of the Thermage FLX System are 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.
The simultaneous application of radio frequency energy and skin vibration by the Thermage FLX System is indicated for use in:
- · Dermatologic and general surgical procedures for electrocoagulation and hemostasis;
- · Non-invasive treatment of periorbital wrinkles and rhytids:
- · 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
GEI, ISA
Device Description
The subject of this 510(k) submission is for the Thermage FLX System which is substantially equivalent to the predicate Thermage CPT. The Thermage FLX System is based on the technology and the performance of the existing Thermage CPT System and includes a similar RF (RF) Generator and Accessories.
The Thermage FLX System delivers RF energy for selective coagulation of tissue while conductively cooling the epidermis. The Thermage FLX System delivers energy from the disposable tip to the patient. The System and its Handpiece monitor skin contact during treatment. The System employs RF tuning to provide RF energy across a range of impedances for delivery to the patient through single and multiple pass stamping motions of the tip.
The Thermage FLX System is comprised of three sub-systems: (1) the Console, (2) Handpiece and (3) Treatment Tip. Accessories used during each individual treatment included the Return Pad, Skin Marking Grid Paper, Coupling Media, Cryogen and an optional Footswitch.
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
Prescription Use
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)
Safety tests of the Thermage FLX System have demonstrated its compliance with applicable requirements of the following electrical standards: IEC 60601-1:2005 + C1(2006) + C2(2007) + AM1(2012) or IEC 60601-1:2012-Ed. 3.1, IEC 60601-1-2 ed3.0 (2007)/AC: 2010, IEC 60601-1-6:2010+A1:2013, IEC 60601-2-2:2009+C1:2014, IEC 62366-1:2015. Functional, simulated use, environmental and transport testing were also performed on representative units. Software was verified and validated in accordance with the Solta Medical software quality procedures which comply with EN ISO 62304:2006/AC:2008. Electromagnetic Compatibility and Electrical Safety tests were conducted by a third party and the console was found to comply. Biocompatibility evaluation of patient contacting materials was conducted per FDA draft guidance document, "Use of International Standard ISO 10993-1, "Biological Evaluation of medical devices Part 1: Evaluation and Testing within a risk management process" dated June 16, 2016. The Thermage FLX System passed all applicable standards testing, demonstrating that functional requirements have been met and that the modified device is equivalent to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Thermage ThermaCool CPT cleared under K090580 on June 26, 2009, Thermage ThermaCool CPT cleared under K132431 on September 6, 2013
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
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - W 066-G609 Silver Spring, MD 20993-0002
September 22, 2017
Solta Medical. Inc. % Ms. Melissa Thomas Sr. Manager, Regulatory Affairs 1400 North Goodman Street Rochester, New York 14609
Re: K170758
Trade/Device Name: Thermage FLX System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI, ISA Dated: August 28, 2017 Received: August 30, 2017
Dear Ms. Thomas:
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. Ilsting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device
1
related adverse events) (21 CFR 803): 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Jennifer R. Stevenson -S3
For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K170758
Device Name Thermage FLX System
Indications for Use (Describe)
- The radiofrequency-energy only delivery components of the Thermage FLX System are 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.
The simultaneous application of radio frequency energy and skin vibration by the Thermage FLX System is indicated for use in:
- · Dermatologic and general surgical procedures for electrocoagulation and hemostasis;
- · Non-invasive treatment of periorbital wrinkles and rhytids:
- · 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).
| Type of Use (Select one or both, as applicable) | ||
|---|---|---|
| Prescription Use (Part 21 CFR 201 Subpart D) Over-The-Counter Use (21 CFR 201 Subpart C) | Prescription Use (Part 21 CFR 201 Subpart D) | Over-The-Counter Use (21 CFR 201 Subpart C) |
| Prescription Use (Part 21 CFR 201 Subpart D) | Over-The-Counter Use (21 CFR 201 Subpart C) |
Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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3
1 510(k) SUMMARY
1. General Information
| Submitter: | Contact Person: |
|---|---|
| Solta Medical Inc. | Melissa Thomas |
| 11720 North Creek Pkwy N., Suite 100 | 1400 North Goodman Street |
| Bothell, WA 98011 | Rochester, NY 14609 |
| USA | 585-338-6045 |
| General Telephone: 510-259-5299 | Melissa.Thomas@bausch.com |
Preparation Date:
February 23, 2017
-
- Names
Device Name Thermage FLX System Classification Name Electrosurgical Cutting and Coagulation Device and Accessories Electrosurgical Unit and Accessories Common Name: CFR References: 21 CFR 878.4400 Product Codes: GEX, ISA No performance standards for this device have been promulgated Performance Standards: under Section 514, Federal Food, Drug and Cosmetics Act.
- Names
3. Predicate Devices
Thermage ThermaCool CPT cleared under K090580 on June 26, 2009 Thermage ThermaCool CPT cleared under K132431 on September 6, 2013
4. Product Description
The subject of this 510(k) submission is for the Thermage FLX System which is substantially equivalent to the predicate Thermage CPT. The Thermage FLX System is based on the technology and the performance of the existing Thermage CPT System and includes a similar RF (RF) Generator and Accessories.
The Thermage FLX System delivers RF energy for selective coagulation of tissue while conductively cooling the epidermis. The Thermage FLX System delivers energy from the disposable tip to the patient. The System and its Handpiece monitor skin contact during treatment. The System employs RF tuning to provide RF energy across a range of impedances for delivery to the patient through single and multiple pass stamping motions of the tip.
4
The Thermage FLX System is comprised of three sub-systems: (1) the Console, (2) Handpiece and (3) Treatment Tip. Accessories used during each individual treatment included the Return Pad, Skin Marking Grid Paper, Coupling Media, Cryogen and an optional Footswitch.
5. Indications for Use
The radiofrequency (RF) energy delivery components of the Thermage FLX System are 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.
The simultaneous application of radiofrequency energy and skin vibration by the Thermage FLX System is indicated for use in:
- Dermatologic and general surgical procedures for electrocoagulation and hemostasis;
- Non-invasive treatment of periorbital wrinkles and rhytids;
- 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).
5
-
- Summary of Technological Characteristics
The technological characteristics of the Thermage FLX System are substantially equivalent to those of the predicate devices.
- Summary of Technological Characteristics
| Characteristic | Subject Device
Thermage FLX System | K090580 and
K132431 |
|--------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------|
| Intended Use | Dermatologic and general surgical procedures for
electrocoagulation and hemostasis, non-invasive treatment
of periorbital wrinkles and rhytids. | Identical as
subject device |
| Indications for
Use | The radiofrequency-energy only delivery components of the
Thermage FLX System are 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.The simultaneous application of radio frequency energy and
skin vibration by the Thermage FLX System is indicated for
use in:
Dermatologic and general surgical procedures for
electrocoagulation and hemostasis;Non-invasive treatment of periorbital wrinkles and
rhytids;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). | Identical as
subject device |
| Maximum
Average Power | 400W | Identical as
subject device |
| User interface | LCD / Touchscreen Technology for user interaction and
controls | LCD Screen |
| Mode of
Operation | Manual or Footswitch | Identical as
subject device |
| Frequency | 6.78 MHz | Identical as
subject device |
6
-
- Safety and Effectiveness Information
The review of the indications for use and technical characteristics provided demonstrates that the Thermage FLX System is substantially equivalent to the predicate devices.
- Safety and Effectiveness Information
8. Brief Summary of Nonclinical Tests and Results
Safety tests of the Thermage FLX System have demonstrated its compliance with applicable requirements of the following electrical standards:
| IEC 60601-1:2005 + C1(2006) +
C2(2007) + AM1(2012) or IEC
60601-1:2012-Ed. 3.1 | Medical electrical equipment - Part 1: General
requirements for basic safety and essential performance |
|--------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| IEC 60601-1-2 ed3.0 (2007)/AC:
2010 | Medical electrical equipment - Part 1-2: General
requirements for basic safety and essential performance
- Collateral standard: Electromagnetic compatibility -
Requirements and tests |
| IEC 60601-1-6:2010+A1:2013 | Medical electrical equipment. Part 1-6: General
requirements for basic safety and essential performance.
Collateral standard. Usability |
| IEC 60601-2-2:2009+C1:2014 | Medical electrical equipment - Part 2-2: Particular
requirements for the basic safety and essential
performance of high frequency surgical equipment and
high frequency surgical accessories |
| IEC 62366-1:2015 | Medical devices-Application of usability engineering
to medical devices |
Functional, simulated use, environmental and transport testing were also performed on representative units.
Software was verified and validated in accordance with the Solta Medical software quality procedures which comply with EN ISO 62304:2006/AC:2008 Medical device software --Software life cycle processes.
Electromagnetic Compatibility: The console was tested to by a third party and was found to comply.
Electrical Safety: The laser console was tested to by a third party and was found to comply.
Biocompatibility: The biocompatibility evaluation of patient contacting materials was conducted per FDA draft guidance document, "Use of International Standard ISO 10993-1,
7
"Biological Evaluation of medical devices Part 1: Evaluation and Testing within a risk management process" dated June 16, 2016.
The Thermage FLX System passed all of the above applicable standards testing. This testing demonstrates that the functional requirements have been met and that the modified device is equivalent to the predicate devices.
-
- Conclusion
The Thermage FLX System shares the same indications for use, design features, and functional features, and thus is substantially equivalent to, the predicate devices. Non-clinical test results demonstrate that the Thermage FLX System is substantially equivalent to the predicate devices and no new issues of safety or effectiveness have been raised.
- Conclusion