(106 days)
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 including upper and lower eyelids. 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 Multiplex Assembly is a 4-electode design incorporating four 3.00-cm electrode footprints with required spacing. The tip is fabricated from the same materials as the previous tips, with the addition of a ceramic coolant spreader. Tip fabrication will be performed in the same manner and the treatment procedure will be similar to previous methods. The Handpiece, Coupling Fluid, Return Pad and Skin Marking Paper have been modified to accommodate the larger tip dimensions.
The provided text does not contain detailed information about specific acceptance criteria and a study proving a device meets these criteria in the context of typical medical device performance evaluation (e.g., sensitivity, specificity, accuracy). Instead, it's a 510(k) summary for a ThermaCool NXT Multiplex Assembly, an electrosurgical unit and accessories.
The document primarily focuses on establishing substantial equivalence to predicate devices rather than presenting a performance study with specific acceptance criteria as you've requested. Substantial equivalence is determined by comparing the new device's technological characteristics and intended use to those of legally marketed predicate devices.
Therefore, many of the specific details you asked for (e.g., sample size, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth establishment) are not present in the provided text.
However, I can extract the relevant information regarding the equivalence claim:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied by 510(k) submission) | Reported Device Performance |
|---|---|
| Technological Characteristics: Substantially equivalent to predicate devices. | "The technological characteristics of the Multiplex Assembly, components and accessories are substantially equivalent to those of the standard NXT Assembly, components and accessories." |
| Intended Use: Similar to predicate devices. | Indicated for 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 appearance of cellulite, temporary improvement in local circulation, relief of minor muscle aches and pains, relief of muscle spasms. (These indications are consistent with the predicate's general use as an electrosurgical unit). |
| Design, Principle of Operation, Materials: Similar to predicate device. | "By virtue of design, principle of operation, materials and intended use, the Multiplex Assembly 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
- Not Applicable. The document does not describe a performance study with a test set. The evaluation is based on a comparison of design, materials, and intended use to predicate devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. No ground truth establishment is described for a performance study.
4. Adjudication method for the test set
- Not Applicable. No performance study or test set described.
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
- No. This is not an AI-assisted device, and no MRMC study is described. The device is an electrosurgical unit.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is not an algorithm-based device.
7. The type of ground truth used
- Not Applicable. No ground truth is described for a performance study. The "ground truth" for a 510(k) substantial equivalence submission is essentially the legally marketed predicate devices and their established safety and effectiveness.
8. The sample size for the training set
- Not Applicable. No training set is mentioned as this device is not based on machine learning or AI.
9. How the ground truth for the training set was established
- Not Applicable. No training set is mentioned.
Summary of the Study (or Basis for Clearance):
The "study" or basis for clearance here is a 510(k) Premarket Notification which asserts substantial equivalence of the ThermaCool NXT Multiplex Assembly to legally marketed predicate devices (K033942, K032088, K031046, K043402, K051710, K052778).
The crucial elements for this type of submission are:
- Device Description: The Multiplex Assembly is a 4-electrode design with a ceramic coolant spreader. The handpiece, coupling fluid, return pad, and skin marking paper were modified to accommodate larger tip dimensions.
- Intended Use: The indications for use match those of the predicate devices: dermatologic and general surgical procedures for electrocoagulation and hemostasis, non-invasive treatment of wrinkles and rhytids (including periorbital), temporary improvement in the appearance of cellulite, temporary improvement in local circulation, and relief of minor muscle aches/pains and muscle spasms.
- Technological Characteristics: The manufacturer claims the technological characteristics are "substantially equivalent." This means there were no new questions of safety or effectiveness raised by the device's design, materials, or principle of operation compared to the predicates.
Essentially, the device was cleared because it was deemed to be equally safe and effective as existing, legally marketed devices. There was no need for a new clinical performance study with specific metrics like sensitivity or specificity because the design changes were considered minor enough not to alter fundamental safety or efficacy.
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14.0 510(k) Safety Summary
Name of Device A.
| Trade Name: | ThermaCool NXT Multiplex Assembly |
|---|---|
| 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 Device B.
| Predicate Devices | Premarket Notification Number |
|---|---|
| Components and accessoriescompatible with the ThermaCoolSystem (Model NXT) | K033942 |
| K032088 | |
| K031046 | |
| K043402 | |
| K051710 | |
| K052778 |
C. Device Description
The Multiplex Assembly is a 4-electode design incorporating four 3.00-cm electrode footprints with required spacing. The tip is fabricated from the same materials as the previous tips, with the addition of a ceramic coolant spreader. Tip fabrication will be performed in the same manner and the treatment procedure will be similar to previous methods. The Handpiece, Coupling Fluid, Return Pad and Skin Marking Paper have been modified to accommodate the larger tip dimensions.
D. Indicated Use
The Thermage ThermaCool NXT Multiplex Assembly, including accessories and all components, is indicated for use in dermatologic and general surgical procedures for electrocoagulation and hernostasis, non-invasive treatment of periorbital wrinkles and rhytids including upper and lower evelids, non invasive treatment of wrinkles and rhytids, temporary improvement in the appearance of cellulite, temporary improvement in local circulation, i.e., blood circulation, relief of minor muscle aches and pains, relief of muscle spasms.
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0728419
E. Technical characteristics
The technological characteristics of the Multiplex Assembly, components and accessories are substantially equivalent to those of the standard NXT Assembly, components and accessories.
F. Summary
By virtue of design, principle of operation, materials and intended use, the Multiplex Assembly is substantially equivalent to 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 and Human Services. The logo consists of a stylized eagle with three stripes forming its body and wing. The eagle is enclosed in a circle of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The logo is black and white.
Public Health Service
JAN 1 8 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Thermage, Inc % Ms. Pamela M. Buckman, RN MS Vice President of Regulatory Clinical Affairs 25881 Industrial Boulevard Hayward, California 94545
Re: K072849
Trade/Device Name: Thermage ThermaCool System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories. Regulatory Class: Class II Product Code: GEI Dated: January 14 2008 Received: January 15, 2008
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, RN, MS
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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,
Mark N Millerson
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
Ko72849 510(k) NUMBER (IF KNOWN):
DEVICE NAME:
Thermage ThermaCool System
INDICATIONS FOR 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 including upper and lower eyelids
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)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use X (Per 21 CFR 801.109)
OR Over-The-Counter-Use
Laubara Buem
Division of General, Restorative, and Neurological Devices
Page 5 of 174
510(k) Number K072841
§ 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.