· 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 Description

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 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.

AI/ML Overview

The provided text describes a Special 510(k) submission for the Thermage CPT System and Accessories, demonstrating its substantial equivalence to a predicate device. This submission focuses on modifications to an existing device rather than a new AI/ML device, so it doesn't contain all the information requested about AI model performance.

Here's what can be extracted and inferred from the document regarding acceptance criteria and testing:

1. A table of acceptance criteria and the reported device performance

The document lists "Summary of Testing" with "Requirement" as the acceptance criteria and "Results" as the reported performance.

Acceptance Criteria (Requirement)	Reported Device Performance (Results)
The treatment tip design shall be capable of delivering up to the maximum REP count, and shall be verified or validated to show with 90% confidence that the tips will do so with a minimum of 90% reliability.	Pass
Latching of the Treatment Tip onto the handpiece shall be accomplished with a snap fit or latching tab.	Pass
The treatment tip design shall include a barrier against any fluid from leaking inside the tip and possibly causing an electrical short.	Pass
Treatment tips shall exhibit no external features that are sharp or that could puncture or tear nitrile gloves.	Pass
Treatment Tip design must maintain sufficient dielectric strength and integrity over the anticipated number of treatments at its highest treatment level setting in an actual or simulated use environment and include, where appropriate, applicable accessories 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

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document states, "The treatment tip design shall be capable of delivering up to the maximum REP count, and shall be verified or validated to show with 90% confidence that the tips will do so with a minimum of 90% reliability." This implies that a sample of treatment tips was tested to determine their reliability in delivering REP counts. However, the exact sample size or the provenance of the data (e.g., how many tips were tested, if they were from a specific country, or if the testing was prospective) is not explicitly stated in this document. The testing appears to be centered on the physical and functional aspects of the device and its accessories, not clinical data from patients.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided. The testing described appears to be engineering verification/validation, not human expert evaluation of clinical data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable, as the testing described is not clinical adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is not an AI/ML device and no MRMC study is mentioned.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an AI/ML device. The testing described is for the device's physical and functional integrity.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for the tests described is based on engineering specifications and performance requirements (e.g., maximum REP count delivery, snap fit, fluid barrier, dielectric strength, burst pressure). It's essentially "meets design specifications."

8. The sample size for the training set

Not applicable. This is not an AI/ML device, so there is no training set in the context of machine learning.

9. How the ground truth for the training set was established

Not applicable. This is not an AI/ML device.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

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)	☑ 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)
☑ 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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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510(k) SUMMARY

1. General Information Submitter:

Contact Person:

Solta Medical Inc.11720 North Creek Pkwy N., Suite 100Bothell, WA 98011Tel: 510-259-5299	Mr. Ken Nehmer, BSEETDirector, Regulatory Affairs351 Buena Vista Avenue E, Unit 501ESan Francisco, CA 94117Tel: 415-297-0408ken.nehmer@bausch.com
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Revised: December 26, 2017

2. Names

Device Name	Thermage CPT System and Accessories
Classification Name	Electrosurgical Cutting and Coagulation Device andAccessories
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 beenpromulgated under Section 514, Federal Food, Drug andCosmetics 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.

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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.

1. 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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1. 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 DeviceThermage CPT System and Accessories	K090580 andK132431
Intended Use	Dermatologic and general surgical procedures forelectrocoagulation and hemostasis, non-invasivetreatment of periorbital wrinkles and rhytids.	Identical tosubjectdevice
Indications forUse	The radiofrequency energy only delivery components ofthe Thermage CPT System and Accessories are indicatedfor use in:Dermatologic and general surgical procedures forelectrocoagulation and hemostasis; Non-invasive treatment of periorbital wrinklesand rhytids including upper and lower eyelids; Non-invasive treatment of wrinkles and rhytids. The simultaneous application of radio frequency energyand skin vibration by the Thermage CPT System andAccessories is indicated for use in: Dermatologic and general surgical procedures forelectrocoagulation and hemostasis; Non-invasive treatment of periorbital wrinkles andrhytids; Non-invasive treatment of wrinkles and rhytids; Temporary improvement in the appearance ofcellulite; Relief of minor muscle aches and pains; Relief of muscle spasms; Temporary improvement of local circulation (i.e.,blood circulation).	Identical tosubjectdevice
MaximumAverage Power	400W	Identical tosubjectdevice
User interface	LCD / Touchscreen Technology for user interaction andcontrols	Identical tosubjectdevice
Mode ofOperation	Manual or Footswitch	Identical tosubjectdevice
Frequency	6.78 MHz	Identical tosubjectdevice

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1. 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.
1. 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 REPcount, and shall be verified or validated to show with 90% confidence that the tipswill do so with a minimum of 90% reliability.	Pass
Latching of the Treatment Tip onto the handpiece shall be accomplished with a snapfit or latching tab.	Pass
The treatment tip design shall include a barrier against any fluid from leaking insidethe tip and possibly causing an electrical short.	Pass
Treatment tips shall exhibit no external features that are sharp or that could punctureor tear nitrile gloves.	Pass
Treatment Tip design must maintain sufficient dielectric strength and integrity overthe anticipated number of treatments at its highest treatment level setting in an actualor simulated use environment and include, where appropriate, applicable accessoriessuch 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

1. 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.

Regulation Number and Section

§ 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.