(225 days)
ThermaClear is indicated for the treatment of individual acne pimples in persons with mild to moderate inflammatory acne.
ThermaClear™ is a portable hand-held device that uses a short thermal pulse to treat mild to moderate inflammatory acne. The treatment tip is comprised of biocompatible material and delivers a short duration thermal pulse that heats the area being treated. The device is powered by two AA alkaline batteries.
Acceptance Criteria and Device Performance for ThermaClear™
Based on the provided 510(k) summary, the ThermaClear™ device underwent clinical testing to confirm its safety and effectiveness. However, specific quantifiable acceptance criteria and detailed reported device performance metrics (e.g., percentage reduction in acne lesions) are not explicitly stated in the provided document. The submission focuses on demonstrating substantial equivalence to predicate devices, which primarily involves showing that the new device is as safe and effective without raising new issues.
The core acceptance criterion, though not quantitatively defined, is implicitly that the device is "as safe and effective as the predicate device" for the treatment of individual acne pimples in persons with mild to moderate inflammatory acne.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implicit) | Reported Device Performance and Study Findings |
|---|---|
| Device is safe and effective for its indicated use (treatment of individual acne pimples in persons with mild to moderate inflammatory acne). | "Clinical testing was conducted in both a controlled practitioner office environment and a consumer home-use environment and submitted as part of the 510(k) application to confirm that ThermaClear™ is as safe and effective as the predicate device.""Based on the indications for use, technological characteristics, performance testing and comparison to predicate devices, the proposed device has been shown to be safe and effective for its intended use." |
| No new issues of safety or efficacy are raised compared to predicate devices. | "The minor differences in the technological characteristics of ThermaClear™ and its predicate devices do not raise any new issues of safety or efficacy." |
| Operates within EMI emission, susceptibility, and static discharge levels (preclinical). | "ThermaClear™ operates within the EMI emission, susceptibility and static discharge levels specified in the IEC 60601-1 standard." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for the clinical test set. It mentions "clinical testing was conducted."
Regarding data provenance:
- Country of Origin: Not specified.
- Retrospective or Prospective: The "controlled clinical study design was a randomized, blinded study," which indicates a prospective study design.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not specify the number of experts, their qualifications, or how ground truth was established for the clinical testing.
4. Adjudication Method for the Test Set
The document does not describe any adjudication method for the test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study or any effect sizes related to human readers improving with or without AI assistance. The device in question is a physical medical device, not an AI diagnostic tool, so an MRMC study in the typical sense would not be applicable.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
The device is a hand-held thermal treatment device, not an algorithm or AI system. Therefore, a standalone (algorithm only) performance study is not applicable and was not conducted. Its function is to be used by a human.
7. Type of Ground Truth Used
The type of ground truth used is not explicitly defined. Given the nature of acne treatment, it would likely involve clinical assessment of acne pimples by a healthcare professional (in the office environment) or self-assessment (in the home-use environment). The "randomized, blinded study" design implies some form of objective assessment was intended.
8. Sample Size for the Training Set
The document does not mention or imply the existence of a "training set" in the context of an AI or algorithm. The device is a physical treatment device, not an AI model.
9. How the Ground Truth for the Training Set Was Established
As there is no "training set" for an AI or algorithm mentioned, this question is not applicable.
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ThermaClear™ Traditional 510K Document
0C1 2 4 2006
5. 510(k) Summary DermaCare, Incorporated - ThermaClear™ Device
This 510(k) Summary is submitted in accordance with 21 CFR Part 807, Section 807.92(c).
| Owner's Name and Address: | DermaCare, Inc.6248 Preston AvenueLivermore, CA 94551(925) 371-3900 – Telephone(925) 371-3903 – Fax |
|---|---|
| Contact Information: | Heidi StarkDermaCare, Inc.6248 Preston AvenueLivermore, CA 94551(925) 371-3900 - Telephone(925) 371-3903 - Fax |
| Date Prepared: | March 2, 2006 |
| Device Trade Name: | ThermaClear™ |
| Common Name: | Acne Treatment Device |
| Classification Name: | Class II - Laser instrument, surgical,powered (21 CFR 878.4810, Product CodeGEX) |
| Predicate Devices: | Tyrell, Inc.ZenoK043377Radiancy (Israel) Ltd.Radiancy Acne System With ClearTouch™K032205 |
Description of the Device:
ThermaClear™ is a portable hand-held device that uses a short thermal pulse to treat mild to moderate inflammatory acne. The treatment tip is comprised of biocompatible
Page 8 Proprietary and Confidential
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KO60653 ThermaClear™ Traditional 510K Document
material and delivers a short duration thermal pulse that heats the area being treated. The device is powered by two AA alkaline batteries.
Indications for Use:
ThermaClear™ is indicated for the treatment of individual acne pimples in persons with mild to moderate inflammatory acne.
Performance Data:
Non-clinical and clinical performance testing was conducted with the ThermaClear™ device.
Preclinical Testing
ThermaClear™ was tested for EMI in accordance with the IEC 60601-1 standard. ThermaClear™ operates within the EMI emission, susceptibility and static discharge levels specified in the IEC 60601-1 standard.
Clinical Testing
Clinical testing was conducted in both a controlled practitioner office environment and a consumer home-use environment and submitted as part of the 510(k) application to confirm that ThermaClear™ is as safe and effective as the predicate device. The controlled clinical study design was a randomized, blinded study.
Substantial Equivalence:
ThermaClear™ and its predicate devices are all devices that use either heat or light to treat the dermatological condition of mild to moderate acne by exposing the surface of the skin to a precise energy fluence. The delivered energy heats the skin to accelerate resolution of the acne lesion with no risk of burns. The minor differences in the technological characteristics of ThermaClear™ and its predicate devices do not raise any new issues of safety or efficacy. Thus, ThermaClear™ is substantially equivalent to the predicate device for treatment of mild to moderate acne.
Conclusion:
Based on the indications for use, technological characteristics, performance testing and comparison to predicate devices, the proposed device has been shown to be safe and effective for its intended use.
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo consists of two main elements: a circular text element and a symbol. The text element reads "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" arranged in a circular fashion. The symbol is a stylized representation of a human figure with three flowing lines above it, possibly representing care or support.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 4 2006
DermaCare, Inc. % Mr. Peter Scocimara CEO/President 6248 Preston Avenue Livermore, California 94551
Re: K060653
Trade/Device Name: ThermaClear Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: GEX Dated: July 24, 2006
Received: July 26, 2006
Dear Mr. Scocimara:
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 - Mr. Peter Scocimara
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,
ﺍﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘ
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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4. Indications for Use Statement
510(k) Number (if known): )</ O 6 6 ( 3
Device Name: ThermaClear
Indications for Use: ThermaClear is indicated for the treatment of individual acne pimples in persons with mild to moderate inflammatory acne.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use X (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) |
|---|
| -------------------------------------------------------- |
signature
(Division Division of General, Restorative, and Neurological De
12 Page 7 510(k) Number. Proprietary and Confidential Page 1 of 1
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.