(74 days)
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No
The summary describes a hand-held phototherapy device (UV lamp) and makes no mention of AI, ML, image processing, or any data-driven algorithms.
Yes
The device is described as being "intended for the treatment of psoriasis, vitiligo, and atopic dermatitis (eczema)," indicating its therapeutic purpose.
No
Explanation: The device is described as a "phototherapy device" intended for "treatment of psoriasis, vitiligo, and atopic dermatitis (eczema)". It is a "medical ultraviolet lamp" used for therapeutic purposes, not for diagnosing conditions.
No
The device is described as a "hand-held phototherapy device" and a "medical ultraviolet lamp," indicating it is a physical hardware device that emits UV light for treatment. It does not mention being software only.
Based on the provided information, the DermaPal device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the DermaPal is a "medical ultraviolet lamp, which is intended for the treatment of psoriasis, vitiligo, and atopic dermatitis (eczema)." This describes a therapeutic device that applies energy to the body for treatment.
- Device Description: The description reinforces this by calling it a "hand-held phototherapy device, which is a medical ultraviolet lamp."
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) taken from the human body to provide information about a physiological state, health, or disease. The DermaPal does not perform any such analysis of specimens. It directly treats the skin.
Therefore, the DermaPal falls under the category of a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The DermaPal, hand-held phototherapy device, is a medical ultraviolet lamp, which is intended for the treatment of psoriasis, vitiligo, and atopic dermatitis (eczema). The DermaPal, hand-held phototherapy device, is intended for use on all skin types (I - V).
Product codes
FTC
Device Description
The DermaPal, hand-held phototherapy device, is a medical ultraviolet lamp, which is intended for the treatment of psoriasis, vitiligo, and atopic dermatitis (eczema).
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus, a symbol often associated with healthcare. The symbol consists of three curved lines that converge to form a wing-like shape.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 0 2002
Daavlin Distributing Company Chad Reynolds Regulatory Affairs Coordinator P. O. Box 626 205 West Bement Street Bryan, Ohio 43506
Re: K022104
Trade/Device Name: DermaPal Regulation Number: 878.4630 Regulation Name: Ultraviolet lamp for dermatologic/skin disorders Regulatory Class: Class II Product Code: FTC Dated: June 27, 2002 Received: June 28, 2002
Dear Mr. Reynolds:
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 mav 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 setforth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the clectronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.
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Page 2 – Mr. Chad Reynolds:
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" (21 CFR 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.
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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Indication For Use
510(k) Number: K022104
Device Name: DermaPal
Indications for Use:
The DermaPal, hand-held phototherapy device, is a medical ultraviolet lamp, which is intended for the treatment of psoriasis, vitiligo, and atopic dermatitis (eczema). The DermaPal, hand-held phototherapy device, is intended for use on all skin types (I - V).
(Please do not write below this line - Continue on another page if needed) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
OR (per 21 CFR 801.109)
Over-the-Counter Use _________________________________________________________________________________________________________________________________________________________
Stylo Purdo
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number_________________________________________________________________________________________________________________________________________________________________