THERMAGE CPT SYSTEM

K132431 · Solta Medical, Inc. · GEI · Sep 6, 2013 · General, Plastic Surgery

Device Facts

• Record ID: K132431
• Device Name: THERMAGE CPT SYSTEM
• Applicant: Solta Medical, Inc.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Sep 6, 2013
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The radiofrequency-energy only 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 in 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 monopolar radiofrequency (RF) energy to tissue for selective coagulation while conductively cooling epidermis. System comprises console with RF generator, handpiece, disposable treatment tips, footswitch, and accessories (return pad, coupling fluid, cryogen). Handpiece provides RF energy and optional vertical vibration to manipulate tissue during treatment. Used in clinical settings by healthcare providers. RF energy heats tissue; cooling protects surface. Vibration provides mechanical stimulation. Output allows coagulation, wrinkle reduction, cellulite improvement, and muscle pain relief. Modification involves transitioning treatment tips from sterile to non-sterile, single-patient-use status.

Clinical Evidence

Bench testing only. Assessment included risk document review (FMEA/Hazard Analysis), complaint incidence review, and manufacturing environment/process evaluation including bioburden monitoring trends. No new clinical data required for this modification.

Technological Characteristics

Monopolar RF electrosurgical unit. Energy: 6.78 MHz, 500W max. Components: Console, handpiece, disposable tips (0.25cm² to 16.0cm²), return pad, cryogen cooling. Connectivity: Standalone. Software: Embedded control of power delivery and vibration. Sterilization: Tips are non-sterile, single-patient-use.

Indications for Use

Indicated for dermatologic/general surgical electrocoagulation and hemostasis, non-invasive treatment of wrinkles/rhytids (including periorbital/eyelids), temporary cellulite improvement, relief of minor muscle aches/pains/spasms, and temporary improvement of local blood circulation in adult patients.

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

• Thermage ThermaCool NXT/CPT System and Accessories (K090580)
• Pelleve GlideSafe™ Treatment System (K102698)
• Accent and Accent Family Alma Lasers (K070004, K072699, K101147)

Submission Summary (Full Text)

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SEP 0 6 2013

#### 510(k) SUMMARY

Thermage CPT® System (TG-2B)

- Manufacturer: Solta Medical, Inc. 25881 Industrial Blvd Hayward, CA 94545
Contact:

August 2, 2013 Date:

Thermage CPT® System Trade Name:

Common Name: Electrosurgical Unit and Accessories

Raymond Lee

Ph: 510-259-7159 FAX: [phone]

Classification Name: Coagulation and Device, Electrosurgical Cutting and Accessories (21 CFR 878.4400)

Senior Director, requlatory Affairs

Product code: GEI, ISA

Device Classification: Class II

Predicate Devices: Thermage ThermaCool NXT/CPT System and Accessories K090580

> Pelleve GlideSafe™ Treatment System K102698

> Accent and Accent Family Alma Lasers K070004. K072699. K101147

#### Description:

The Thermage CPT System delivers monopolar radiofrequency energy for selective coagulation of tissue while conductively cooling the epidermis. Cleared for commercial distribution under K090580, the Thermage CPT System delivers a maximum power of 500W of energy from the disposable tip to the patient.

The Handpiece delivers output energy and cooling while also offering user-selectable vibration in the vertical dimension for mechanical manipulation of tissue. Vibration is active only during each treatment cycle while the 3cm² treatment tip is in contact with the Vibration is not active when either the activation switch is released, when the skin. treatment tip is not in contact with the skin, or when the 0.25cm2 eye tip is used.

Single-use, disposable Treatment Tips are attached to the Handpiece that comes in contact with the patient during the treatment procedure. The Treatment Tip is classified as a direct skin contact device of limited duration (<24 hours). Tips are interchangeable

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to allow for treatment of a broad range of depths and surface areas. The Thermage CPT System includes the major components listed below:

| Component | Description |
|------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| TG-2B Console | The Thermage CPT System contains a radio frequency (RF) generator whose hardware and software control power to deliver a maximum power of 500W of energy from the disposable tip to the patient. |
| TH-3 Hand Piece<br>TH-4 Hand Piece | The Handpiece and RF cable conducts the RF signal to the Thermage tip. The Handpiece also provides vibration. |
| Thermage Treatment Tips<br>(sizes range from 0.25cm² to 16.0cm²) | The Thermage Treatment Tips are single use, disposable tips which contact the surface of the patient's skin and delivery the RF energy through the skin. |
| Footswitch | Pressing the Footswitch changes the System mode from READY to ACTIVE in preparation for RF delivery. |
| <b>Accessories</b> | |
| Return Pad | The return pad completes the RF return path to the console |
| Return Pad Cable | The return pad cable connects the Return Pad to the Console |
| Skin Marking Grid Paper | The skin paper provides pre-defined and precise treatment zones on the applied skin area. |
| Coupling Fluid | The coupling fluid contributes to consistent electrical contact between the skin and the Thermage Tip and reduces friction |
| Cryogen | The cryogen supplies cooling effects to the skin during treatment (Cryogen is non-contact) |

#### Device Modification:

Currently, all treatment tips (0.25cm², 3cm² and 16cm²) are provided to the user as sterile. The change involves supplying all treatment tips to the user as "clean" and nonsterile for single patient use only.

#### Indications for Use:

The radiofrequency-energy only 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 evelids:
- Non-invasive treatment of wrinkles and rhytids. i

The simultaneous application of radiofrequency energy and skin vibration by the Thermage CPT System and Accessories in indicated for use in:

- Dermatologic and General Surgical procedures for electrocoagulation and ﯿﮯ hemostasis:
- Non-invasive treatment of periorbital wrinkles and rhytids; -

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- 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).

## Substantial Equivalence Comparison:

Based on the design, component materials, function and intended use the Thermage CPT System remains substantially equivalent to devices currently marketed under the Federal Food, Drug and Cosmetic Act except for one characteristic: the condition of use of the Treatment Tips. This difference is rendered inconsequential by the "single patient use" and disposable nature of the Thermage CPT Treatment Tips that eliminates the risk of cross contamination between patients. Summarized in the tables below are the key technological characteristics and indications for use of the Thermage CPT System compared to the predicate devices listed in this Special 510(k): ·

| Feature | Modified<br>Thermage<br>CPT™ System | Thermage<br>CPT™ System | Pelleve GlideSafe™<br>Treatment System | Accent and Accent<br>Family Alma Lasers | SE? |
|-------------------------------------------|--------------------------------------------------|--------------------------------------------------|--------------------------------------------------|--------------------------------------------------|-----|
| 510(k) | -- | K090580 | K102698 | K070004, K072699,<br>K101147 | -- |
| Classification | Class II | Class II | Class II | Class II | Yes |
| Energy | Radio Frequency | Radio Frequency | Radio Frequency | Radio Frequency | Yes |
| Frequency | 6.78 MHz | 6.78 MHz | 4.0 MHz | 40, 680 MHz | Yes |
| Maximum RF<br>Power | 500 Watts | 500 Watts | 120 Watts | 300 Watts | Yes |
| Treatment<br>Type | Non-Ablative | Non-Ablative | Non-Ablative | Noninvasive | Yes |
| Treatment<br>Levels | Multiple Treatment<br>Levels | Multiple Treatment<br>Levels | Multiple Treatment<br>Levels | Discrete Treatment<br>Levels | Yes |
| <br>HAND PIECE AND TREATMENT TIP FEATURES | | | | | |
| Characteristics | Hand-held<br>handpeice | Hand-held<br>handpeice | Hand-held handpeice | Hand-held handpeice | Yes |
| Electrode | Removable,<br>exchangeable to<br>different sizes | Removable,<br>exchangeable to<br>different sizes | Removable,<br>exchangeable to<br>different sizes | Removable,<br>exchangeable to<br>different sizes | Yes |
| Treatment Tip<br>Condition | Non-sterile | Sterile | Non-sterile | Non-sterile | Yes |
| Condition of<br>Use | Disposable<br>Single Patient Use<br>Only | Disposable<br>Single Patient Use<br>Only | Reusable<br>Multiple Patient Use* | Reusable<br>Multiple Patient Use* | No |
| Style | Monopolar/Bipolar | Monopolar/Bipolar | Monopolar/Bipolar | Unipolar/Bipolar | Yes |
| Treatment Tip<br>Size | 0.25 cm2 to 16cm2<br>surface area | 0.25 cm2 to 16cm2<br>surface area | 7.5 mm to 20 mm<br>diameter | 153.3 mm to 185 | Yes |

* Requires cleaning between patient uses.

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| | INDICATIONS FOR USE | SE? |
|-----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----|
| Modified Thermage<br>CPTTM System | - Dermatologic and General Surgical procedures for electrocoagulation and hemostasis;<br>- Non-invasive treatment of periorbital wrinkles and rhytids including upper and lower<br>eyelids;<br>- Non-invasive treatment of wrinkles and rhytids.<br>- Temporary improvement in the appearance of cellulite;<br>- Relief of minor muscle aches and pains;<br>- Relief of muscle spasms;<br>- Temporary improvement of local circulation (i.e., blood circulation). | Yes |
| Thermage CPTTM<br>System | - Dermatologic and General Surgical procedures for electrocoagulation and hemostasis;<br>- Non-invasive treatment of periorbital wrinkles and rhytids including upper and lower<br>eyelids;<br>- Non-invasive treatment of wrinkles and rhytids.<br>- Temporary improvement in the appearance of cellulite;<br>- Relief of minor muscle aches and pains;<br>- Relief of muscle spasms;<br>- Temporary improvement of local circulation (i.e., blood circulation). | Yes |
| Pelleve GlideSafeTM<br>Treatment System | Non-ablative treatment of mild to moderate facial wrinkles and rhytides for skin<br>phototypes I-IV | Yes |
| Accent and Accent<br>Family Alma Lasers | The Accent device is intended for use in dermatologic and general surgical procedures.<br>The Accent device is indicated for use in dermatologic and general surgical procedures<br>for the non-invasive treatment of wrinkles and rhytids using combined treatment with<br>UniPolar and BiPolar. | Yes |

HP = Hand Piece

## Summary of Verification & Validation Activities:

The Special 510(k) for this device modification to the cleared Thermage CPT System (K090580) utilized the design control requirement of the Quality System Regulation (21 CFR 820). Solta Medical declares conformance to design controls in making this change and utilized the following assessments:

- 1. Risk documents review: FMEA's and Hazard Analysis
- 2. Complaints incidence and review
- 3. Manufacturing environment and process evaluation including bioburden monitoring trends.

Risk control measures were focused on manufacturing environment and process evaluation and providing the user with cleaning directions. No new risks remain as a result of this change.

## Conclusion:

The Thermage CPT System and Accessories is substantially equivalent to devices currently marketed under the Federal Food, Drug and Cosmetic Act. The safety and effectiveness of the device modification are reasonably assured with no remaining risks justifying 510(k) clearance.

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Image /page/4/Picture/0 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the seal is a stylized symbol that resembles a caduceus, a traditional symbol of medicine.

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring MD 20993-0002

September 6, 2013

Solta Medical Incorporated Mr. Raymond Lec Senior Director, Regulatory Affairs 25881 Industrial Boulevard Hayward. California 94545

Re: K132431

Trade/Device Name: Thermage CPT* System (TG-2B) 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 2, 2013 Received: August 14. 2013

Dear Mr. Raymond Lee:

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 (IPMA). 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 mislcading.

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 l'ederal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (2 l CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Mr. Raymond Lee

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 Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] 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" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.goy/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# Mark N. Melkerson -S

Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# STATEMENT OF INDICATIONS FOR USE

K132431 510(k) NUMBER (IF KNOWN):

Thermage CPT® System (TG-2B) DEVICE NAME:

INDICATIONS FOR USE:

The radiofrequency-energy only 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. ー

The simultaneous application of radiofrequency energy and skin vibration by the Thermage CPT® System and Accessories in 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). ﮯ

Prescription Use X (Per 21 CFR 801.109) OR

Over-The-Counter Use_

Concurrence of CDRH, Office of Device Evaluations (ODE)

Joshua C. Nipper -S