(601 days)
The Thermage ThermaCool System is indicated for use in:
- Dermatologic and general surgical procedures for electro coagulation and hemostasis,
- Non-invasive treatment of periorbital wrinkles and rhytids including the upper and lower eyelids
- Non-invasive treatment of facial wrinkles and rhytids
The Thermage ThermaCool System consists of the following components:
- ThermaCool System .
- Handpiece Assembly (consisting of Handpiece and Treatment Tip) ●
- Accessories: Coolant Canister, Coupling Fluid, Return Pad and Skin ● Marking Paper
- Accessory cables and tubing
- Optional footswitch component ●
This 510(k) premarket notification is for the Thermage ThermaCool System seeking an expanded indication for the non-invasive treatment of periorbital wrinkles and rhytids, including the upper and lower eyelids. The core information requested about acceptance criteria and a study to prove performance is not explicitly present in the provided text.
The document states that the "technological characteristics of the Thermage ThermaCool System for Eyelid Indications are identical to the cleared system" and that the device is "substantially equivalent to referenced devices currently cleared for marketing in the United States."
This implies that the previous clearance (K043042) for the Thermage ThermaCool System likely established the initial acceptance criteria and associated performance studies. For this 510(k), the focus is on demonstrating safety and effectiveness for a new indication (eyelid treatment) based on the existing, already-cleared technology. The document doesn't detail a new, standalone study for this specific expanded indication with explicit acceptance criteria provided.
Therefore, many of the requested data points (sample size of test set, ground truth experts, adjudication, MRMC, standalone study, training set details) are not directly addressed for this specific 510(k).
However, I can extract what is provided and explain the implications:
1. Table of Acceptance Criteria and Reported Device Performance:
No specific acceptance criteria or detailed performance data for the new eyelid indication are presented in this document. The submission relies on the substantial equivalence to previously cleared devices.
| Acceptance Criteria (Not Explicitly Stated for this 510(k)) | Reported Device Performance (Not Explicitly Stated for this 510(k)) |
|---|---|
| (Likely related to safety and effectiveness of the previously cleared device, extended to the new indication based on substantial equivalence.) | (Based on the assertion of substantial equivalence to previously cleared devices for wrinkle and rhytid treatment.) |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified in this document for the new indication.
- Data Provenance: Not specified in this document for the new indication. The submission relies on the existing clearance of the same device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not specified in this document for the new indication.
4. Adjudication method for the test set:
Not specified in this document for the new indication.
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 device is an electrosurgical unit, not an AI-powered diagnostic or assistive tool for human readers. No MRMC study is mentioned or relevant to this type of device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is an electrosurgical unit, not an algorithm.
7. The type of ground truth used:
Not specified for this 510(k). For a medical device like this, ground truth would typically be established through clinical outcomes, clinician assessments, or standardized photographic evaluations in a clinical trial setting. However, for a 510(k) seeking an expanded indication for an already cleared device, the ground truth for the original clearance would have been used.
8. The sample size for the training set:
Not applicable. This is not an AI/machine learning device.
9. How the ground truth for the training set was established:
Not applicable. This is not an AI/machine learning device.
Summary based on the provided text:
The Thermage ThermaCool System's 510(k) for the expanded eyelid indication does not contain a new, detailed study with explicit acceptance criteria and performance results in the provided text. Instead, it leverages the concept of substantial equivalence to existing, cleared devices (specifically, the previous clearance K043042 for the ThermaCool System itself for other wrinkle/rhytid indications).
The application asserts that the "technological characteristics... are identical to the cleared system" (for K043042). This means that the safety and effectiveness for this new indication are presumed to be similar to the already-cleared indications because the underlying technology is the same. The FDA's letter confirms that they have determined the device is substantially equivalent for the stated indications for use.
To fully understand the acceptance criteria and study proving performance, one would need to review the original 510(k) submission (K043042) for the Thermage ThermaCool System, which would have contained the detailed clinical data for its initial clearance for wrinkle and rhytid treatment. This current 510(k) is an extension of that initial clearance.
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Ko 52996 14.0 510(k) Safety Summary
A. Name of Device
| Trade Name: | Thermage ThermaCool™ System |
|---|---|
| Common Name: | Electrosurgical Unit and Accessories |
| Classification Name: | Device, Electrosurgical Cutting and Coagulation andAccessories (21 CFR 878.4400) |
| Contact Person: | Pamela M. Buckman, RN, MSVice President of Regulatory/Clinical Affairs |
B. Predicate Devices
:
The predicate devices for the ThermaCool System for Eyelid Indication that is the subject of this 510(k) are:
| Predicate | Premarket Notification |
|---|---|
| ThermaCool System | K043042, et al. |
| Lumenis Family of UltraPulseSurgiTouch CO, Surgical Lasers | K030147 |
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5 2936
C. Device Description
The Thermage ThermaCool System consists of the following components:
- ThermaCool System .
- Handpiece Assembly (consisting of Handpiece and Treatment Tip) ●
- Accessories: Coolant Canister, Coupling Fluid, Return Pad and Skin ● Marking Paper
- Accessory cables and tubing
- Optional footswitch component ●
D. Indication for Use
The Thermage ThermaCool System for the new indication is: Non-invasive treatment of periorbital wrinkles and rhytids including the upper and lower eyelids.
E. Technical characteristics
The technological characteristics of the Thermage ThermaCool System for Eyelid Indications are identical to the cleared system. The required eyeshield is a commercially available device and is not the subject of this 510(k).
F. Summary
By virtue of design, principle of operation, materials and intended use, the Thermage ThermaCool System for Eyelid Indication is substantially equivalent to referenced devices currently cleared for marketing in the United States.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle or other bird-like figure.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Thermage, Inc. % Ms. Pamela M. Buckman, MSN VP, Clinical/Regulatory 25881 Industrial Boulevard Hayward, California 94545-2991
[JUN 1 2 2007
Re: K052936
Trade/Device Name: Thermage ThermaCool System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: March 13, 2007 Received: March 14, 2007
Dear Ms. Buckman:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.
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Page 2 - Ms. Pamela M. Buckman, MSN
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours
foe
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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2.0 Indications for Use Statement
510(k) NUMBER (IF KNOWN): Not Known
DEVICE NAME: Thermage ThermaCool System INDICATIONS FOR USE:
The Thermage ThermaCool System is indicated for use in:
- Dermatologic and general surgical procedures for electro coagulation and . hemostasis,
- Non-invasive treatment of periorbital wrinkles and rhytids including the upper and ■ lower eyelids
- Non-invasive treatment of facial wrinkles and rhytids
(Division Sign-Off) Division of General, Restorativ and Neurological Devices
510(k) Number K052936
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(Per 21 CFR 801.109)
Concurrence of CDRH, Office of Device Evaluation (ODE)
§ 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.