(151 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:
- RF Generator .
- Cooling Module ●
- Cryogen Canister .
- Handpiece Assembly (consisting of Handpiece and Treatment Tip) .
- Accessory cables and tubing .
- Optional footswitch component .
- Accessories: coupling fluid, return pad and skin marking paper .
The Handpiece Assembly and Cooling Module connect to the RF Generator.
This document is a 510(k) premarket notification for the Thermage ThermaCool System. It focuses on demonstrating substantial equivalence to a predicate device and safety aspects like sterilization and biocompatibility rather than demonstrating the performance of an AI/ML device against specific clinical acceptance criteria through a study.
Therefore, many of the requested sections about AI/ML device performance studies, such as sample sizes for test and training sets, ground truth establishment, MRMC studies, and stand-alone performance, are not applicable to the information provided.
However, I can extract information related to quality control and safety acceptance criteria.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance/Compliance |
|---|---|
| Sterility Assurance Level (SAL) | 10⁻⁶ SAL verified in accordance with EN 550, utilizing the half-cycle method of sterilization validation for the Thermage Treatment Tip. |
| Ethylene Oxide (EO) Residuals (Treatment Tip) | Acceptable EO residual levels in conformance with ISO 10993-7: Biological Evaluation of Medical Devices Part 7 Ethylene Oxide Sterilization Residuals. Allowable limits for "limited exposure" devices (up to 24 hours): 20 mg EO and 12 mg ECH (average daily dose). Verification of being below allowable limits confirmed as part of EO cycle and product aeration validation. Manufactured product routinely monitored (minimum quarterly). |
| Ethylene Oxide (EO) Residuals (Skin Marking Paper) | Acceptable EO residual levels in conformance with ISO 10993-7. Allowable limits for "limited exposure" devices (up to 24 hours): 20 mg EO and 12 mg ECH (average daily dose). Verification of being below allowable limits confirmed as part of EO cycle and product aeration validation. Manufactured product routinely monitored (minimum quarterly). |
| Sterilization Contract | Sterilization contract in compliance with 21 CFR 801.150 between Thermage and IBA Griffith. |
| Substantial Equivalence to Predicate Device | The technological characteristics and clinical use data of the ThermaCool System for the expanded indication are substantially equivalent to the previously cleared ThermaCool TC System (K021402). The device, by virtue of design, principle of operation, materials, and intended use, is substantially equivalent to devices currently cleared for marketing in the United States. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. The document describes compliance with sterilization and biocompatibility standards, and substantial equivalence, not a clinical efficacy or performance study with a test set of data in the context of AI/ML.
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. Ground truth for clinical performance for an AI/ML device is not mentioned as this is a 510(k) for an electrosurgical unit.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not a study requiring adjudication of a test set.
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 not an AI-assisted diagnostic or imaging device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is an electrosurgical unit, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the compliance aspects (sterilization, residuals), the "ground truth" is defined by adherence to established international standards (EN 550, ISO 10993-7) and regulatory requirements (21 CFR 801.150). For substantial equivalence, the "ground truth" is the established safety and effectiveness profile of the predicate device (ThermaCool TC, K021402).
8. The sample size for the training set
Not applicable. There is no mention of a training set as this is not an AI/ML device.
9. How the ground truth for the training set was established
Not applicable. There is no mention of a training set or its ground truth.
{0}------------------------------------------------
| JUN 2 1 2004 | K040135 1/3 |
|---|---|
| -------------- | ------------- |
13.0 510(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, Regulatory/Clinical Affairs |
B. Predicate Device
ThermaCool System
| 510 (k) Number | Name of Device | Decision Date |
|---|---|---|
| K021402 | ThermaCool TC | November 5, 2002 |
C. Device Description
The Thermage ThermaCool System consists of the following components:
- RF Generator .
- Cooling Module ●
- Cryogen Canister .
- Handpiece Assembly (consisting of Handpiece and Treatment Tip) .
- Accessory cables and tubing .
- Optional footswitch component .
- Accessories: coupling fluid, return pad and skin marking paper .
The Handpiece Assembly and Cooling Module connect to the RF Generator.
D. Indicated Use
The Thermage ThermaCool System is indicated for use in Dermatologic and General Surgical procedures for electro coagulation and hemostasis; noninvasive treatment of periorbital wrinkles and mytids and non-invasive treatment of facial wrinkles and rhytids.
{1}------------------------------------------------
040131 2/3
There is a sterilization contract in compliance with 21 CFR 801.150 between Thermage and IBA Griffith. This contract defines the responsibilities of both parties. Sterilization validation will be performed in accordance with EN 550, utilizing the half-cycle method of sterilization validation to verify a sterility assurance level of 10 .
EO Residuals
Acceptable EO residual levels will be in conformance with the requirements of consensus standard ISO 10993-7: Biological Evaluation of Medical Devices Part 7 Ethylene Oxide Sterilization Residuals. The Thermage Treatment Tip is a "limited exposure" device in accordance with ISO 10993-1:1992, subclause 5.2 (limited exposure; devices whose single or multiple use or contact is likely to be up to 24 hours). Allowable limits for limited exposure devices are: 20 mg EO and 12 mg ECH (average daily dose).
Verification that EO and ECH residuals are below allowable limits shall be confirmed as part of the EO cycle and product aeration validation. Manufactured product shall also be routinely monitored for EO and ECH residuals (minimum quarterly).
Skin Marking Paper
Sterilization
The Thermage Skin Marking Paper will be sterilized using 100% ethylene oxide at IBA Griffith in Salt Lake City, Utah. The address is 5725 West Harold Gatty Road, Salt Lake City, Utah 84116. The establishment registration number is 1721676.
There is a sterilization contract in compliance with 21 CFR 801.150 between Thermage and IBA Griffith. This contract defines the responsibilities of both parties. Sterilization validation will be performed in accordance with EN 550, utilizing the half-cycle method of sterilization validation to verify a sterility assurance level of 10 . O
EO Residuals
Acceptable EO residual levels will be in conformance with the requirements of consensus standard ISO 10993-7: Biological Evaluation of Medical Devices Part 7 Ethylene Oxide Sterilization Residuals. The Thermage Skin Marking Paper is a "limited exposure" device in accordance with ISO 10993-1:1992, subclause 5.2 (limited exposure: devices whose single or multiple use or contact is likely to be up to 24 hours). Allowable limits for limited exposure devices are: 20 mg EO and 12 mg ECH (average daily dose).
Verification that EO and ECH residuals are below allowable limits shall be confirmed as part of the EO cycle and product aeration validation. Manufactured product shall also be routinely monitored for EO and ECH residuals (minimum quarterly).
{2}------------------------------------------------
040135 3/3
Technical characteristics نا
The technological characteristics and clinical use data of the ThermaCool System for the expanded indication are substantially equivalent to the previously cleared ThermaCool TC System.
ப் Summary
By virtue of design, principle of operation, materials and intended use, the Thermage ThermaCool System is substantially equivalent to devices currently cleared for marketing in the United States.
{3}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/3/Picture/2 description: The image shows the seal of the Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
JUN 2 1 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Pamela M. Buckman, RN, MS Vice President, Regulatory/Clinical Affairs Thermage 4058 Point Eden Way Hayward, California 94545-3721
Re: K040135
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: April 30, 2004 Received: May 3, 2004
Dear Ms. Buckman:
We have reviewed your Section 510(k) premarket notification of intent to market the device we have reviewed your bector. 9 rQxy press.
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 for use stated in the encrosule) to regally manent date of the Medical Device Ameridae, or to commerce prior to May 20, 1776, the enational with the provisions of the Federal Food. Drug. devices that have been recalismed in assess approval of a premarket approval application (PMA). and Cosment Act (Act) market the device, subject to the general con.rols provisions of the Act. The You may, therefore, market the act include requirements for annual registration, listing of general controls provisions of the Fist labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), in If your device is classified (secure) nits existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulations iPA ma may be subject to such additional controller issues of the 21, Parts 800 to 898. In addition, FDA may be found in the Ood of Peachar Succerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that I Dri 3 issualites over device complies with other requirements of the Act that FDA has made a delemination administered by other Federal agencies. You must or any Federal statures and regulations daministered of registration and listing (21 letting (21 let comply with an the Act 3 requirements) 110, good manufacturing practice requirements as set CFK Part 807), labeling (21 CFR Part 820); and 1f applicable, the electronic forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.
{4}------------------------------------------------
Page 2 - Ms. Pamela M. Buckman, RN, MS
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to begin marketing of substantial equivalence of your device to a legally premarket notification. The PDA miding of substantal equice 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 if you desire specific advice for your do not on one and the regulation entitled, the regulation entitled, comaci the Office of Compunation at (301) of the Part 807.97). You may obtain "Misbranding by relerence to premantel notilities. In the Act from the Division of Small other general information on your responsions at its toll-free number (800) 638-2041 or
Manufacturers, International and Consumer Assistance at the consumer attrak Manufacturers, International and Consenter Passes http://www.fda.gov/cdrh/dsmamain.html
Sincerely yours,
Miriam C. Provost
fal Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{5}------------------------------------------------
(IF Not Known NUMBER 510(k) KNOWN):
Thermage ThermaCool System
INDICATIONS FOR USE:
DEVICE NAME:
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)
Miriam C. Provost
(Division Sign-Off)
Division of General, Restorative, and Neurological Devices
510(k) Number: K040135
Page 6 of 28
§ 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.