(16 days)
The VersaClear™ Skin Therapy System UVA (350mm) Light Module is indicated for individuals who require specific ultraviolet radiation therapy for diagnosed skin disorders.
The VersaClear™ Skin Therapy System UVA (350mm) Light Module is a 120/240V 50/60 Hz AC illumination source that emits UVA radiation with a peak at 350mm ± S mm.
The provided document is a 510(k) summary for the TheraLight VersaClear™ Skin Therapy System UVA (350nm) Light Module. This type of regulatory submission focuses on demonstrating substantial equivalence to a predicate device, rather than providing extensive clinical study data with detailed acceptance criteria and performance metrics for a new device's efficacy or diagnostic accuracy.
Therefore, many of the requested details about acceptance criteria, study design for proving those criteria, sample sizes, expert involvement, and ground truth establishment are not typically found in a 510(k) summary for a device like this. This document primarily focuses on technical specifications and comparison to an existing device.
Here's an analysis based on the information available in the provided text:
1. Table of acceptance criteria and the reported device performance:
| Acceptance Criteria (Implicit from Predicate) | Reported Device Performance (VersaClear™ Skin Therapy System UVA (350nm) Light Module) |
|---|---|
| Emission of UVA radiation | Emits UVA radiation |
| Peak wavelength at 350nm ± 5mm | Peak at 350nm ± 5mm |
| Bandwidth (Full Width at Half Maximum) comparable to predicate | Bandwidth (Full Width at Half Maximum) of 40nm |
| Nominal skin irradiance comparable to predicate | Nominal skin irradiance of 10-35 mW/cm² |
| Intended for ultraviolet radiation therapy for diagnosed skin disorders | Indicated for individuals who require specific ultraviolet radiation therapy for diagnosed skin disorders |
Explanation: The document does not explicitly state "acceptance criteria" for a clinical study to prove the device's efficacy. Instead, the "Performance Data" section describes the technical specifications of the device. The implicit acceptance criteria are that these specifications should be substantially equivalent to the predicate device (Flex Controlled Phototherapy Equipment, K050695) for the purpose of treating dermatologic/skin disorders. The "Conclusion" explicitly states that the device "is substantially equivalent to legally commercialized UV phototherapy devices."
2. Sample size used for the test set and the data provenance:
- Sample Size: Not applicable. The document describes a technical characterization of the device's light output, not a clinical study involving human or even in vitro test subjects to evaluate performance against a "test set" in the context of diagnostic or treatment accuracy.
- Data Provenance: The data provided pertains to the physical characteristics of the device itself (light emission properties). It is not clinical data from patients or a specific country of origin.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not applicable. No clinical ground truth or expert consensus was required for the technical specifications of light output.
- Qualifications of Experts: Not applicable.
4. Adjudication method for the test set:
- Not applicable. There was no "test set" requiring adjudication in the context of clinical outcomes or expert review.
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 a light therapy system, not an AI-powered diagnostic or assistive tool. Therefore, no MRMC study or AI-related effectiveness assessment was performed or reported.
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. "Standalone performance" in this context refers to the device's ability to emit light with specified characteristics, which is described directly.
7. The type of ground truth used:
- In the context of the device's performance data (light emission): The "ground truth" is the physical measurement of the device's light output (e.g., peak wavelength, bandwidth, irradiance) using appropriate radiometric equipment.
8. The sample size for the training set:
- Not applicable. This device is not an AI/ML device that requires a "training set."
9. How the ground truth for the training set was established:
- Not applicable. (See #8)
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510(k) SUMMARY
The 510(k) Summary is submitted in accordance with 21 CFR Part 807, Section 807.92.
| Submitter's name: | TheraLight, Inc. |
|---|---|
| Submitter's Address: | 2794 Loker Avenue West, Suite 105Carlsbad, CA 92008 |
| Telephone: | (760) 930-8000 |
| Contact: | Kevin E. DalyChief Operating Officer |
| Date Prepared: | May 13, 2006 |
| Device Trade Name: | VersaClear™ Skin Therapy System UVA (350nm)Light Module |
| Device Common Name: | VersaClear™ Skin Therapy System UVA (350nm)Light Module |
| Device Classification Name: | Ultraviolet lamp for dermatologic / skin disorders(ref. 21 CFR 878.4630). |
| Predicate Devices: | Flex Controlled Phototherapy EquipmentDaavlin Distributing CompanyK050695 |
Device Description:
The VersaClear™ Skin Therapy System UVA (350mm) Light Module is a 120/240V 50/60 Hz AC illumination source that emits UVA radiation with a peak at 350mm ± S mm.
Intended Use and Indications for Use:
The VersaClear™ Skin Therapy System UVA (350mm) Light Module is indicated for individuals who require specific ultraviolet radiation therapy for diagnosed skin disorders.
Performance Data:
The VersaClear™ Skin Therapy System UVA (350nm) Light Module emits UVA radiation at a peak of 350mm +5mm and a bandwidth (Full Width at Half Maximum) of 40nm, and a nominal skin irradiance of from 10-35 mW/cm2.
Conclusion:
The VersaClear Skin Therapy System is substantially equivalent to legally commercialized UV phototherapy devices. Comments of
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" are arranged in a circular pattern around the caduceus.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 5 2006
TheraLight, Inc. % Mr. Kevin E. Daly Chief Operating Officer 2794 Loker Avenue West, Suite 105 Carlsbad, California 92010
Re: K061295
K001295
Trade/Device Name: VersaClear™ Skin Therapy UVA (350nm) Light Module Regulation Number: 21 CFR 878.4630 Regulation Name: Ultraviolet lamp for dermatologic disorders Regulatory Class: II Product Code: FTC Dated: May 8, 2006 Received: May 9, 2006
Dear Mr. Daly:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed 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 conninered pror to Thay 20, 1978, in accordance with the provisions of the Federal Food, Drug, de necs that have boon require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The I ou may, dicrororo, maniev of the Act include requirements for annual registration, listing of general controls proficturing 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 If your device is classified (600 a0070) als. Existing major regulations affecting your device can may be subject to back adden accept 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 that I Dr head statutes and regulations administered by other Federal agencies. You must or any I 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
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Page 2 - Mr. Kevin E. Daly
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. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
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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Indications For Use
510(k) Number (if known): K061295
Device Name: VersaClear™ Skin Therapy System UVA (350nm) Light Module
Indications for Use:
The VersaClear Skin Therapy System UVA (350mm) Light Module is indicated for individuals who require specific ultraviolet radiation therapy for diagnosed skin disorders.
Prescription Use X (Part 21 CFR 801 Subpart D) OR
ﻢ .
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
H, Office of Device Evaluation (ODE) Concurrence of
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(Division Sign-Off) Division of General, Restorative. and Neurological Devices
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KOGI 295 510(k) Numbe
§ 878.4630 Ultraviolet lamp for dermatologic disorders.
(a)
Identification. An ultraviolet lamp for dermatologic disorders is a device (including a fixture) intended to provide ultraviolet radiation of the body to photoactivate a drug in the treatment of a dermatologic disorder if the labeling of the drug intended for use with the device bears adequate directions for the device's use with that drug.(b)
Classification. Class II.