Thermage CPT System and Accessories
Device Facts
| Record ID | K173759 |
|---|---|
| Device Name | Thermage CPT System and Accessories |
| Applicant | Solta Medical |
| Product Code | GEI · General, Plastic Surgery |
| Decision Date | Jan 8, 2018 |
| Decision | SESE |
| Submission Type | Special |
| Regulation | 21 CFR 878.4400 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
The radiofrequency energy delivery components of the Thermage CPT System and Accessories 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 CPT System and Accessories are 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).
Device Story
Thermage CPT System delivers radiofrequency (RF) energy to tissue via disposable tips while conductively cooling epidermis; system monitors skin contact and impedance during treatment. Device operates via manual or footswitch control; provides RF energy through single or multiple pass stamping motions. Used in clinical settings by healthcare professionals. Output consists of controlled RF energy and mechanical skin vibration. Benefits include non-invasive wrinkle reduction, cellulite appearance improvement, and relief of muscle-related discomfort. System includes LCD/touchscreen interface for clinician control.
Clinical Evidence
Bench testing only. Verification and validation testing confirmed device performance against requirements: treatment tip reliability, latching mechanism, fluid barrier integrity, absence of sharp features, dielectric strength, and burst pressure (minimum 12 psi).
Technological Characteristics
Electrosurgical unit; 6.78 MHz RF energy; 400W max power. Features disposable treatment tips with conductive cooling and vibration. Interface: LCD/touchscreen. Operation: Manual or footswitch. Connectivity: Not specified. Sterilization: Not specified.
Indications for Use
Indicated for dermatologic/general surgical electrocoagulation and hemostasis, non-invasive treatment of periorbital and general wrinkles/rhytids, temporary improvement of cellulite appearance, relief of minor muscle aches/pains and spasms, and temporary improvement of local blood circulation.
Regulatory Classification
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.
Predicate Devices
Submission Summary (Full Text)
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January 8, 2018
Solta Medical Inc. Mr. Ken Nehmer, BSEET Director, Regulatory Affairs 351 Buena Vista Avenue E Unit 501E San Francisco, California 94117
Re: K173759
Trade/Device Name: Thermage CPT System and Accessories Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI Additional product Code: ISA Dated: December 7, 2017 Received: December 11, 2017
Dear Mr. Nehmer:
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. 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
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801); medical device reporting of medical device-related adverse events) (21 CFR 803); 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.
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.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
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
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# Indications for Use
510(k) Number (if known) K173759
#### Device Name
Thermage CPT System and Accessories
### Indications for Use (Describe)
The radiofrequency energy delivery components of the Thermage CPT System and Accessories 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 CPT System and Accessories are 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) | <table><tr><td>☑ Registration Use (Part 21 CFR 601 Subpart D)</td><td>☐ Over-The-Counter Use (21 CFR 601 Subpart C)</td></tr></table> | ☑ Registration Use (Part 21 CFR 601 Subpart D) | ☐ Over-The-Counter Use (21 CFR 601 Subpart C) |
|-------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------|-----------------------------------------------|
| ☑ Registration Use (Part 21 CFR 601 Subpart D) | ☐ Over-The-Counter Use (21 CFR 601 Subpart C) | | |
> Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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# 510(k) SUMMARY
# 1. General Information Submitter:
Contact Person:
| Solta Medical Inc.<br>11720 North Creek Pkwy N., Suite 100<br>Bothell, WA 98011<br>Tel: 510-259-5299 | Mr. Ken Nehmer, BSEET<br>Director, Regulatory Affairs<br>351 Buena Vista Avenue E, Unit 501E<br>San Francisco, CA 94117<br>Tel: 415-297-0408<br>ken.nehmer@bausch.com |
|------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
Revised: December 26, 2017
# 2. Names
| Device Name | Thermage CPT System and Accessories |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------|
| Classification Name | Electrosurgical Cutting and Coagulation Device and<br>Accessories |
| Common Name: | Electrosurgical Unit and Accessories |
| CFR References: | 21 CFR 878.4400 |
| Product Codes: | GEI/ISA |
| Performance Standards: | No performance standards for this device have been<br>promulgated under Section 514, Federal Food, Drug and<br>Cosmetics Act. |
# 3. Predicate Device
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 Special 510(k) submission is for the Thermage CPT System and Accessories which is substantially equivalent to the predicate Thermage CPT System and Accessories.
The Thermage CPT System delivers radio frequency energy for selective coagulation of tissue while conductively cooling the epidermis. The Thermage CPT System delivers energy from the disposable tip to the patient. The System and its Handpiece monitor skin contact
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during treatment. The System employs radio frequency tuning to provide radio frequency energy across a range of impedances for delivery to the patient through single and multiple pass stamping motions of the tip.
- 5. Indications for Use
The radiofrequency energy delivery components of the Thermage CPT System and Accessories 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 CPT System and Accessories are 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).
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- 6. Summary of Intended Use and Technological Characteristics
The technological characteristics of the Thermage CPT System are substantially equivalent to those of the predicate device.
| Characteristic | Subject Device<br>Thermage CPT System and Accessories | K090580 and<br>K132431 |
|--------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------|
| Intended Use | Dermatologic and general surgical procedures for<br>electrocoagulation and hemostasis, non-invasive<br>treatment of periorbital wrinkles and rhytids. | Identical to<br>subject<br>device |
| Indications for<br>Use | The radiofrequency energy only delivery components of<br>the Thermage CPT System and Accessories are indicated<br>for use in:<br>Dermatologic and general surgical procedures for<br>electrocoagulation and hemostasis; Non-invasive treatment of periorbital wrinkles<br>and rhytids including upper and lower eyelids; Non-invasive treatment of wrinkles and rhytids. The simultaneous application of radio frequency energy<br>and skin vibration by the Thermage CPT System and<br>Accessories is indicated for use in: Dermatologic and general surgical procedures for<br>electrocoagulation and hemostasis; Non-invasive treatment of periorbital wrinkles and<br>rhytids; Non-invasive treatment of wrinkles and rhytids; Temporary improvement in the appearance of<br>cellulite; Relief of minor muscle aches and pains; Relief of muscle spasms; Temporary improvement of local circulation (i.e.,<br>blood circulation). | Identical to<br>subject<br>device |
| Maximum<br>Average Power | 400W | Identical to<br>subject<br>device |
| User interface | LCD / Touchscreen Technology for user interaction and<br>controls | Identical to<br>subject<br>device |
| Mode of<br>Operation | Manual or Footswitch | Identical to<br>subject<br>device |
| Frequency | 6.78 MHz | Identical to<br>subject<br>device |
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- 7. Safety and Effectiveness Information
The review of the intended use and technical characteristics provided demonstrates the Thermage CPT System and Accessories is substantially equivalent to the predicate device.
- 8. Summary of the design control activities (verification/validation testing) to support the proposed changes
Risk analysis was conducted to assess the impact of modification on device and the acceptance criteria of the testing.
| Summary of Testing | |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| Requirement | Results |
| The treatment tip design shall be capable of delivering up to the maximum REP<br>count, and shall be verified or validated to show with 90% confidence that the tips<br>will do so with a minimum of 90% reliability. | Pass |
| Latching of the Treatment Tip onto the handpiece shall be accomplished with a snap<br>fit or latching tab. | Pass |
| The treatment tip design shall include a barrier against any fluid from leaking inside<br>the tip and possibly causing an electrical short. | Pass |
| Treatment tips shall exhibit no external features that are sharp or that could puncture<br>or tear nitrile gloves. | Pass |
| Treatment Tip design must maintain sufficient dielectric strength and integrity over<br>the anticipated number of treatments at its highest treatment level setting in an actual<br>or simulated use environment and include, where appropriate, applicable accessories<br>such as Coupling Fluid, etc. | Pass |
| The treatment tip design shall include a tamper resistant feature that is identifiable. | Pass |
| Treatment tip assembly must withstand a minimum of 12 psi internal burst pressure. | Pass |
- 9. Conclusion
The Thermage CPT System shares the same indications for use, design features, and functional features, and thus is substantially equivalent to, the predicate device. Non-clinical test results demonstrate the Thermage CPT System is substantially equivalent to the predicate device and no new issues of safety or effectiveness have been raised.
