(17 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 .
- 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 .
The provided text is a 510(k) Safety Summary for the Thermage ThermaCool System. It focuses on demonstrating substantial equivalence to a predicate device, particularly for the Skin Marking Paper accessory, and does not contain information about specific acceptance criteria, detailed study designs, or performance metrics in the way modern medical device submissions typically do for efficacy.
Therefore, I cannot provide the requested information in full detail. Here's a breakdown of what can and cannot be extracted from the provided text, based on the categories requested:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated in the document. The submission relies on "substantial equivalence" to the predicate device. This means the acceptance criterion is that the new device (Thermage ThermaCool Skin Marking Paper) is as safe and effective as the predicate device (Skin Marking Paper from K032088).
- Reported Device Performance: No specific performance metrics (e.g., sensitivity, specificity, accuracy, clinical outcomes) are reported for the Skin Marking Paper. The statement "The technological characteristics of the Thermage ThermaCool Skin Marking Paper are substantially equivalent to those of the predicate device" is the primary "performance" statement, referring to its design, principle of operation, materials, and intended use.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- This information is not provided. The submission focuses on the substantial equivalence of the Skin Marking Paper as an accessory, not a detailed clinical study with a test set of data.
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)
- Not applicable/not provided. No test set requiring expert ground truth establishment is mentioned for the Thermage ThermaCool Skin Marking Paper.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/not provided.
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 predates widespread AI in medical devices, and the submission is for an electrosurgical unit accessory (skin marking paper), not an AI diagnostic tool. No MRMC study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. The device is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable/not provided for the Skin Marking Paper. The "ground truth" for this 510(k) submission is the regulatory clearance and performance of the predicate device to which it is compared for substantial equivalence.
8. The sample size for the training set
- Not applicable. There is no mention of a "training set" as this is not an AI/machine learning device submission.
9. How the ground truth for the training set was established
- Not applicable.
Summary based on the provided text:
The provided document is a 510(k) premarket notification for the Thermage ThermaCool System, specifically highlighting the Skin Marking Paper accessory. The study proving the device meets acceptance criteria is essentially a substantial equivalence comparison to a legally marketed predicate device (Skin Marking Paper, K032088).
Here's what we can infer:
| Information Category | Details from Text |
|---|---|
| Acceptance Criteria | Implicit: Substantial equivalence to the predicate device (Skin Marking Paper, K032088) in terms of safety and effectiveness, based on design, principle of operation, materials, and intended use. No specific quantitative performance metrics are listed as acceptance criteria. |
| Reported Device Performance | "The technological characteristics of the Thermage ThermaCool Skin Marking Paper are substantially equivalent to those of the predicate device." This is the core performance statement, implying that its function and safety are comparable to the previously cleared device. No quantitative performance data, clinical efficacy/safety rates, or specific measurements are provided in this summary. |
| Sample Size (Test Set) & Data Provenance | Not specified, as this is a substantial equivalence claim for an accessory, not a detailed clinical trial. |
| Number & Qualifications of Experts for Ground Truth | Not applicable. |
| Adjudication Method for Test Set | Not applicable. |
| MRMC Comparative Effectiveness Study | No. |
| Standalone Performance Study (Algorithm Only) | No. |
| Type of Ground Truth Used | The "ground truth" implicitly references the regulatory clearance and established safety/effectiveness profile of the predicate device. |
| Sample Size (Training Set) | Not applicable. |
| How Ground Truth for Training Set was Established | Not applicable. |
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510(k) Safety Summary 14.0
OCT 2 0 2005
Name of Device A.
| 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 |
Predicate Devices B.
The predicate device for the ThermaCool Skin Marking Paper that is the subject of this 510(k) is:
| Accessorv | Predicate | Premarket Notification |
|---|---|---|
| Skin Marking Paper ThermaCool Skin Marking PaperAcres and of a free shoulded in of Chind Chief Child Child Child Child Child Child Child Children Mill 141 Me 11807 Million Comments | K032088, Cleared 8/01/03 |
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 .
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D. Indicated Use
The Thermage ThermaCool System is 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 facial wrinkles and rhytids.
Technical characteristics E.
The technological characteristics of the Thermage ThermaCool Skin Marking Paper are substantially equivalent to those of the predicate device.
F. Summary
By virtue of design, principle of operation, materials and intended use, the Thermage ThermaCool Skin Marking Paper is substantially equivalent to devices currently cleared for marketing in the United States.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo consists of a stylized eagle with three lines forming its body and head. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" is arranged in a circle around the eagle.
OCT 2 0 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Pamela M. Buckman, RN, MS Vice President of Regulatory/Clinical Affairs Thermage, Inc. 25881 Industrial Boulevard Hayward, California 94545-2991
Re: K052778
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: September 30, 2005 Received: October 3, 2005
Dear Ms. Buckman:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your betermined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for abounded in 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). and cooming the efect 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 adultcration.
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 mary of 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 HDA has made a determination that your device complics 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- Pamela M. Buckman, RN, MS
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter with anow you to begin maining of substantial equivalence of your device to a legally prematication: The PDF intentigation 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 IT you desire specific at no 10-10-1 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 other general international and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html
Sincerely yours.
Barbara Buchner
for
Mark N. Melkerson Acting Director Division of General. Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Not Known K052778 510(k) NUMBER (IF KNOWN):
Thermage ThermaCool™ System DEVICE NAME:
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 .
- Non-invasive treatment of facial wrinkles and rhytids .
| Prescription Use | X | OR | Over-The-Counter-Use |
|---|---|---|---|
| ------------------ | ---------- | ---- | ---------------------- |
(Per 21 CFR 801.109)
Concurrence of CDRH, Office of Device Evaluation (ODE)
[Signature]
(Division Sign-Off)
Division of General, Restorative, and Neurological Devices
Thermage ThermaCool Skin Marking Paper 510(k)
| 510(k) Number | K052778 |
|---|---|
| --------------- | --------- |
3
§ 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.