(15 days)
The TheraLight UV120-2 UVA / UVB Phototherapy System is indicated for use in PUVA photochemistry and UVB phototherapy for the treatment of psoriasis, vitiligo, atopic dermatitis (eczema), and seborrheic dermatitis.
The TheraLight UV120-2 UVA / UVB Phototherapy System is a microprocessorcontrolled, high-intensity ultraviolet light source. The desired dose of UVA or UVB light is selected using controls on the System front panel. The System provides "targeted" phototherapy, whereby the specified dose of UVA or UVB light is delivered via a flexible Lightguide and Handpiece. The System delivers a homogenous UV light dose to a localized ¼'' square patch of skin without exposure to neighboring, healthy tissues.
Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the TheraLight UV120-2 UVA/UVB Phototherapy System:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| UVA Spectral Output: 330-380nm | TheraLight System emits UVA within spectral band of 330-380nm |
| UVB Spectral Output: 290-330nm | TheraLight System emits UVB within spectral band of 290-330nm |
| Safety and Effectiveness (implied): | "similar to spectra emitted by predicate devices" (for UVB) |
2. Sample Size Used for the Test Set and Data Provenance
The provided 510(k) summary does not mention a test set sample size in the traditional sense of a clinical or performance study with patient data. The "Performance Data" section focuses on instrumental verification of spectral output.
- Test Set Sample Size: Not applicable/Not specified in the provided document for clinical performance. The "test" here refers to device characterization.
- Data Provenance: The document does not provide details on the origin of data for spectral output measurements (e.g., country of origin, retrospective/prospective). It simply states that "Performance data were submitted."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable or not provided. Since the device performance data described is related to spectral output measurements, there isn't a need for expert-established ground truth in the context of clinical outcomes or diagnostic accuracy. The ground truth for spectral output would be established by calibrated measurement instruments.
4. Adjudication Method for the Test Set
This information is not applicable or not provided. As explained above, the "test set" in this context refers to instrumental measurements, not a set of clinical cases requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Improvement with vs. without AI Assistance
- No, an MRMC comparative effectiveness study was not done.
- Effect Size: Not applicable. The device is a phototherapy system, not an AI-assisted diagnostic or interpretative tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Yes, in a way, a standalone performance was done for the device itself. The performance data section describes the inherent spectral output of the device (UVA and UVB bands) without human intervention in its operation or interpretation for this specific performance metric.
- However, this is not in the context of an "algorithm only" performance as would be relevant for an AI device. It's a statement of the physical characteristics of the light emitted by the device.
7. The Type of Ground Truth Used
The ground truth used for the "Performance Data" is instrumental measurement of spectral output. This involves comparing the device's emitted wavelengths against a defined range (e.g., 330-380nm for UVA, 290-330nm for UVB). This is based on established physics and measurement standards, not expert consensus, pathology, or outcomes data.
8. The Sample Size for the Training Set
This information is not applicable or not provided. The device is a physical light therapy system, not a machine learning or AI algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable or not provided as there is no training set for a phototherapy device of this nature.
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K022165 1/2
(JUL 1 8 2002
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 92008-6616 |
| Telephone: | (760) 930-8000 |
| Contact: | Raymond A. Hartman |
| Date Prepared: | June 26, 2002 |
| Device Trade Name: | UV120-2 UVA / UVB Phototherapy System |
| Device Common Name: | Targeted UVA / UVB Phototherapy System |
| Device Classification Name: | Ultraviolet lamp for dermatologic / skindisorders (ref. 21 CFR 878.4630) |
| Predicate Devices: | Lumenis, Ltd.BClear UVB Phototherapy SystemK020591 |
| National Biological CorporationHOUVA II UVA Phototherapy SystemK885025 | |
| National Biological CorporationHOUVA II UVB Phototherapy System |
Device Description:
The TheraLight UV120-2 UVA / UVB Phototherapy System is a microprocessorcontrolled, high-intensity ultraviolet light source. The desired dose of UVA or UVB light is selected using controls on the System front panel. The System provides "targeted" phototherapy, whereby the specified dose of UVA or UVB light is delivered via a flexible Lightguide and Handpiece. The System delivers a homogenous UV light dose to a localized ¼'' square patch of skin without exposure to neighboring, healthy tissues.
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022165 2/2
Intended Use:
The TheraLight UV120-2 UVA / UVB Phototherapy System is intended for use in PUVA photochemistry and UVB phototherapy for the treatment of psoriasis, vitilizo, atopic dermatitis (eczema), and seborrheic dermatitis.
Substantial Equivalence:
The TheraLight UV120-2 UVA / UVB Phototherapy System emits UVA within a spectral band of 330-380nm, which is the same as that for the predicate HOUVA II UVA device (K885025). The TheraLight System and each of the cited predicate devices emit UVB within a spectral band of 290-330nm, which has been shown to be safe and effective in the treatment of the indicated skin diseases.
The major difference between the TheraLight device and the cited predicate devices is that the TheraLight device will emit either UVA or UVB. The user selects which spectra will be emitted using a switch on the device front panel. However, TheraLight believes that this difference is an added convenience, and does not raise new questions of safety or effectiveness.
Performance Data:
With regard to UVA light emissions, the TheraLight System is the first device to emit light via a small (3/4" square) Handpiece aperture. The predicate device was designed to provide whole body (or limb) exposure. The TheraLight, Inc. design allows for the treatment of lesional skin without exposure to healthy, neighboring tissues.
Performance data were submitted as part of the 510(k) to confirm that the spectral output from the TheraLight System is between 330-380nm for UVA, and between 290-330nm for UVB, which is similar to spectra emitted by predicate devices.
With regard to UVB light emission, the performance specifications for the TheraLight UV120-2 UVA / UVB Phototherapy System are the same as, or very similar to, those claimed by predicate devices.
Conclusion:
On the basis of the information provided in this Summary, TheraLight, Inc. believes the UV120-2 UVA / UVB Phototherapy System is substantially equivalent to legally commercialized predicate devices.
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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 is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract design featuring three horizontal lines above a stylized human figure.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1 8 2002
TheraLight, Inc. c/o Mrs. Elizabeth Drew Medical Device Services Underwriters Laboratories, Inc. 1655 Scott Boulevard Santa Clara, CA 95050-4169
Re: K022165
Trade/Device Name: TheraLight UV120-2 UVA/UVB Phototherapy System Regulation Number: 878.4630 Regulation Name: Ultraviolet lamp for dermatological disorders Regulatory Class: II Product Code: FTC Dated: June 17, 2002 Received: July 3, 2002
Dear Mrs. Drew:
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 – Mrs. Elizabeth Drew
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,
Stypk Rurdio
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
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Page ___ of __
510(k) Number (if known): K022165
Device Name: . TheraLight UV120-2 UVA/UVB Phototherapy System
Indications for Use:
The TheraLight UV120-2 UVA / UVB Phototherapy System is indicated for use in PUVA photochemistry and UVB phototherapy for the treatment of psoriasis, vitiligo, atopic dermatitis (eczema), and seborrheic dermatitis.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Htd Rluds
(Division/Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K022165
(Optional Format 3-10-98
§ 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.