(182 days)
Sec. 878.4630, Ultraviolet lamp for dermatologic disorders - to provide ultraviolet (UVB) radiation of the body to photoactivate a drug in the treatment of dermatologic disorders.
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This document is a 510(k) clearance letter from the FDA for a medical device called UVBioTek 3200B / 4000B, an ultraviolet lamp for dermatologic disorders. This type of document does not contain information about acceptance criteria, study designs, or performance metrics in the way a clinical study report or a premarket approval (PMA) application would.
The purpose of a 510(k) is to demonstrate substantial equivalence to a legally marketed predicate device, not necessarily to prove efficacy or safety through new clinical studies. Therefore, the detailed information requested in your prompt (acceptance criteria, study design, sample sizes, expert qualifications, etc.) is not present in this document.
Here's why and what can be inferred:
- Acceptance Criteria and Reported Device Performance: Not applicable and not present. A 510(k) submission generally compares technical specifications and potentially safety data to a predicate, rather than setting and reporting against specific performance acceptance criteria from a new clinical study.
- Sample size for test set and data provenance: No new test set or clinical study data is reported here. The substantial equivalence is based on comparison to an existing predicate.
- Number of experts and qualifications, adjudication method: Not applicable as no new clinical study requiring expert review is described.
- MRMC comparative effectiveness study: Not mentioned and highly unlikely for a 510(k) for this type of device.
- Standalone performance: Not applicable in the context of this 510(k) summary.
- Type of ground truth used: Not applicable as there's no new data being generated through a study requiring ground truth establishment.
- Sample size for training set: Not applicable as this is not an AI/machine learning device requiring a training set in the conventional sense.
- How ground truth for training set was established: Not applicable for the same reason as above.
In summary, this document is a regulatory approval based on demonstrating substantial equivalence to a predicate device, not a report of a study proving a device meets specific performance criteria through new data.
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NOV 1 8 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Medtek Lighting Corp. c/o Robert T. Wagner, CEO American Export Group & International Services, Inc. 2840 Scherer Drive N. St. Petersburg, Florida 33716
Re: K051330
Trade/Device Name: UVBio Tek 3200B / 4000B Regulation Number: 21 CFR 878.4630 Regulation Name: Ultraviolet lamp for dermatologic disorders Regulatory Class: II Product Code: FTC Dated: October 7, 2005 Received: October 11, 2005
Dear Mr. Wagner:
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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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/industry/support/index.html.
Sincerely yours,
Sincerely yours,
Mark A. Mellema
Mark N. Melkerson Acting 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
KOXISSO
UVBioTek 3200B / 4000B, produced by MedTek Lighting Corp, Hudson Falls, NY
Indications for Use:
Sec. 878.4630, Ultraviolet lamp for dermatologic disorders - to provide ultraviolet (UVB) radiation of the body to photoactivate a drug in the treatment of dermatologic disorders.
Prescription Use X (21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark N. Mellkiser
051330
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number
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§ 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.