(32 days)
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).
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 skin. Vibration is not active when either the activation switch is released, when the 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 to allow for treatment of a broad range of depths and surface areas. The Thermage CPT System includes the major components listed below: TG-2B Console, TH-3 Hand Piece, TH-4 Hand Piece, Thermage Treatment Tips (sizes range from 0.25cm² to 16.0cm²), Footswitch, Return Pad, Return Pad Cable, Skin Marking Grid Paper, Coupling Fluid, Cryogen.
This 510(k) summary describes a modification to an existing device, the Thermage CPT System (TG-2B), specifically changing the treatment tips from sterile to "clean" and non-sterile for single patient use. It is not a study to prove acceptance criteria for a new device's performance, but rather a demonstration of substantial equivalence for a modified existing device.
Therefore, many of the requested categories for a new device's study and acceptance criteria (e.g., specific performance metrics, sample sizes for test and training sets, expert qualifications, MRMC studies, standalone performance) are not applicable in this context.
Here's an adaptation of your requested format based on the provided 510(k) summary:
Thermage CPT® System (TG-2B) Modification Acceptance Criteria and Justification of Equivalence
The document describes a modification to the Thermage CPT System (TG-2B), specifically changing the treatment tips from sterile to non-sterile ("clean") for single patient use. The acceptance criteria for this modification revolve around demonstrating that this change does not introduce new risks and that the modified device remains substantially equivalent to the cleared predicate device.
1. Table of Acceptance Criteria and the Reported Device Performance
| Acceptance Criteria | Reported Device Performance/Justification |
|---|---|
| Safety: No new risks introduced by the change to non-sterile, single-use tips. | Demonstrated by: 1. Risk documents review: FMEA's and Hazard Analysis conducted.2. Complaints incidence and review: No issues identified related to this change.3. Manufacturing environment and process evaluation, including bioburden monitoring trends: This evaluation confirmed the suitability of the "clean" non-sterile state for single-patient use.4. Design Control Conformance: Declared conformance to design controls (21 CFR 820).5. Elimination of Cross-Contamination Risk: The "single patient use" and disposable nature of the tips eliminates the risk of cross-contamination between patients, rendering the non-sterile condition inconsequential in this aspect. |
| Performance/Effectiveness: Maintain substantial equivalence in intended use and technological characteristics to the predicate device. | Demonstrated by: 1. Comparative Table Analysis: The provided tables show that all key technological characteristics (e.g., energy type, frequency, max RF power, treatment type, handpiece and electrode features, and indications for use) of the modified device are identical or substantially similar to the predicate Thermage CPT System and other predicate devices.2. Indications for Use: The indications for use for the modified device are identical to those of the predicate Thermage CPT System. The only difference in "Treatment Tip Condition" (non-sterile vs. sterile) and "Condition of Use" (Disposable Single Patient Use Only vs. Reusable Multiple Patient Use* for some predicates) is explicitly addressed by the single-use nature of the modified tips. |
2. Sample Size Used for the Test Set and the Data Provenance
This was not a clinical study with a "test set" as would be typically understood for evaluating device performance metrics. Rather, it was a regulatory submission demonstrating substantial equivalence for a manufacturing change.
- Sample Size: Not applicable in the context of a "test set" for performance evaluation. The "data" considered included risk assessments, manufacturing evaluations, and historical complaint data for the predicate device.
- Data Provenance: The data provenance is internal to Solta Medical, Inc., consisting of various internal analyses related to design control, manufacturing processes, and risk management. It is retrospective in the sense of reviewing existing safety and manufacturing data. Country of origin is the USA (manufacturer is Solta Medical, Inc., in Hayward, CA).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. This submission focused on regulatory compliance and risk management for a product modification, not on establishing a "ground truth" for a performance study dataset. The "experts" would be the internal regulatory, quality, and engineering teams at Solta Medical, Inc. responsible for design controls and risk assessments.
4. Adjudication Method for the Test Set
Not applicable. No "test set" or adjudication method was used for performance measurement. The evaluation was a regulatory assessment based on documented evidence.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No. An MRMC study is typically used for diagnostic or imaging devices to assess human reader performance with and without AI assistance. This device is an electrosurgical unit used for aesthetic and surgical procedures, and the submission concerns a change in tip sterility, making an MRMC study irrelevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
No. This device is a treatment system that requires human operation. It does not involve an "algorithm only" component in the sense of artificial intelligence. The submission focuses on the safety and equivalence of a physical component modification.
7. The Type of Ground Truth Used
The "ground truth" in this context is the established safety and effectiveness of the existing predicate Thermage CPT System (K090580) and the demonstration that the modification does not alter this "ground truth" or introduce new unacceptable risks. This is based on regulatory standards, risk management principles, and product performance history.
8. The Sample Size for the Training Set
Not applicable. There is no "training set" in the context of an AI/algorithm for this type of device modification submission.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as no training set was used.
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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: 510-780-4931
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 PieceTH-4 Hand Piece | The Handpiece and RF cable conducts the RF signal to the Thermage tip. The Handpiece also provides vibration. |
| Thermage Treatment Tips(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. |
| Accessories | |
| 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 | ModifiedThermageCPT™ System | ThermageCPT™ System | Pelleve GlideSafe™Treatment System | Accent and AccentFamily Alma Lasers | SE? |
|---|---|---|---|---|---|
| 510(k) | -- | K090580 | K102698 | K070004, K072699,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 RFPower | 500 Watts | 500 Watts | 120 Watts | 300 Watts | Yes |
| TreatmentType | Non-Ablative | Non-Ablative | Non-Ablative | Noninvasive | Yes |
| TreatmentLevels | Multiple TreatmentLevels | Multiple TreatmentLevels | Multiple TreatmentLevels | Discrete TreatmentLevels | Yes |
| HAND PIECE AND TREATMENT TIP FEATURES | |||||
| Characteristics | Hand-heldhandpeice | Hand-heldhandpeice | Hand-held handpeice | Hand-held handpeice | Yes |
| Electrode | Removable,exchangeable todifferent sizes | Removable,exchangeable todifferent sizes | Removable,exchangeable todifferent sizes | Removable,exchangeable todifferent sizes | Yes |
| Treatment TipCondition | Non-sterile | Sterile | Non-sterile | Non-sterile | Yes |
| Condition ofUse | DisposableSingle Patient UseOnly | DisposableSingle Patient UseOnly | ReusableMultiple Patient Use* | ReusableMultiple Patient Use* | No |
| Style | Monopolar/Bipolar | Monopolar/Bipolar | Monopolar/Bipolar | Unipolar/Bipolar | Yes |
| Treatment TipSize | 0.25 cm2 to 16cm2surface area | 0.25 cm2 to 16cm2surface area | 7.5 mm to 20 mmdiameter | 153.3 mm to 185 | Yes |
- Requires cleaning between patient uses.
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| INDICATIONS FOR USE | SE? | |
|---|---|---|
| Modified ThermageCPTTM System | - Dermatologic and General Surgical procedures for electrocoagulation and hemostasis;- Non-invasive treatment of periorbital wrinkles and rhytids including upper and lowereyelids;- 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). | Yes |
| Thermage CPTTMSystem | - Dermatologic and General Surgical procedures for electrocoagulation and hemostasis;- Non-invasive treatment of periorbital wrinkles and rhytids including upper and lowereyelids;- 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). | Yes |
| Pelleve GlideSafeTMTreatment System | Non-ablative treatment of mild to moderate facial wrinkles and rhytides for skinphototypes I-IV | Yes |
| Accent and AccentFamily Alma Lasers | The Accent device is intended for use in dermatologic and general surgical procedures.The Accent device is indicated for use in dermatologic and general surgical proceduresfor the non-invasive treatment of wrinkles and rhytids using combined treatment withUniPolar 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:
-
- Risk documents review: FMEA's and Hazard Analysis
-
- Complaints incidence and review
-
- 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 (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" (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 (800) 638-2041 or (301) 796-7100 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
§ 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.