(29 days)
No
The device description and intended use focus solely on the physical operation of an ultraviolet light device with a timer, and there are no mentions of AI, ML, image processing, or data sets typically associated with AI/ML technologies.
Yes
The device is described as "intended for use, by or under the direction of a physician, for the treatment of psoriasis, vitiligo, and atopic dermatitis (eczema)". The term "treatment" clearly indicates a therapeutic purpose.
No
The device is described as being for "treatment of psoriasis, vitiligo, and atopic dermatitis (eczema)" and emits ultraviolet light for this purpose. There is no indication it collects or analyzes data for diagnostic purposes.
No
The device description explicitly states it is a "hand held ultraviolet light-emitting medical device" with physical components like a lamp wand, LCD, buttons, and a comb. This indicates it is a hardware device, not software-only.
Based on the provided information, the DermaPal® is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the DermaPal® is for the treatment of psoriasis, vitiligo, and atopic dermatitis using ultraviolet light. IVD devices are used for the diagnosis of diseases or conditions by examining samples taken from the human body (like blood, urine, tissue).
- Device Description: The description details a device that emits light and is applied to the body for therapeutic purposes. This is consistent with a therapeutic device, not a diagnostic one that analyzes samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any process related to in vitro testing.
Therefore, the DermaPal® is a therapeutic device, not an IVD.
N/A
Intended Use / Indications for Use
The DermaPal® with Digital Timer is a hand held ultraviolet light emitting fluorescent lamp. It is intended for use, by or under the direction of a physician, for the treatment of psoriasis, vitiligo, and atopic dermatitis (eczema) on all skin types (I - VI).
Product codes
FTC
Device Description
The DermaPal® a hand held ultraviolet light-emitting medical device.
The DermaPal® integrated operator interface consists of three main components: a LCD, a Membrane with 4 buttons, and a lamp wand. When the operator sets the treatment time and begins the treatment the famp illuminates, emitting ultraviolet light through the wand. The operator holds the wand over the effected area(s) of the body. When the time set on the DermaPal® timer has elapsed, the lamps turn off. The DermaPal® is also equipped with an integrated comb, which is removable. The comb allows for easier treatment of effected areas of skin covered by hair, such as the scalp.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
effected area(s) of the body, scalp
Indicated Patient Age Range
Not Found
Intended User / Care Setting
by or under the direction of a physician
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The DermaPal's® with Digital Timer's performance data is the same as or very similar to that of the claimed predicate device. The ultraviolet light tubes and construction used in the production of the predicate device and the DermaPal® with Digital Timer device are the same.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
510(k) Summary
The 510(k) Summary is submitted in accordance with 21 CFR Part 807, Section 807.92
| Submitter's Name: | The Daavlin Distributing Company |
|---|---|
| Registration Number: | 1526255 JAN 18 2008 |
| Address: | 205 West Bement Street |
| Bryan, Ohio 43506 | |
| Telephone: | 419.636.6304 |
| Contact: | David W. Swanson |
| Date Prepared: | September 21, 2007 |
| Device Trade Name: | DermaPal® |
| Device Common Name: | Hand Held Ultraviolet Phototherapy Unit |
| Device Classification: | Class II |
| Product Code: | FTC |
| Regulation Number: | CFR 878.4630 |
| Regulation Name: | Ultraviolet lamp for dermatologic/skin disorders |
| Predicate Device: | Daavlin Distributing Company |
| DermaPal® | |
| K022104 |
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Device Description:
The DermaPal® a hand held ultraviolet light-emitting medical device.
The DermaPal® integrated operator interface consists of three main components: a LCD, a Membrane with 4 buttons, and a lamp wand. When the operator sets the treatment time and begins the treatment the famp illuminates, emitting ultraviolet light through the wand. The operator holds the wand over the effected area(s) of the body. When the time set on the DermaPal® timer has elapsed, the lamps turn off. The DermaPal® is also equipped with an integrated comb, which is removable. The comb allows for easier treatment of effected areas of skin covered by hair, such as the scalp.
Predicate Device Comparison:
The DermaPal® with Digital Timer is constructed in the same design configuration as the predicate device, utilizing identical energy sources (UV lamps) and materials of identical composition. The DermaPal® with Digital Timer varies from the predicate device, in that the control system hardware and software has been updated to utilize current technology. The intended use, general and specific indications for use, spectral output, mode of operation, labeling, treatment area, and general operating principals of the DermaPal® hand held ultraviolet lightemitting medical device are the same or similar to those of the predicate device.
Intended Use:
The DermaPal® with Digital Timer is a hand held ultraviolet light emitting fluorescent lamp. It is intended for use, by or under the direction of a physician, for the treatment of psoriasis, vitiligo, and atopic dermatitis (eczema) on all skin types (I - VI).
Performance Data:
The DermaPal's® with Digital Timer's performance data is the same as or very similar to that of the claimed predicate device. The ultraviolet light tubes and construction used in the production of the predicate device and the DermaPal® with Digital Timer device are the same.
Conclusion:
On the basis of the information provided in this Summary, the Daavlin Distributing Company believes the DermaPal® with Digital Timer is substantially equivalent to the legally commercialized predicate device
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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 8 2008
Daavlin Distributing Company % Ms. Tara Mansur Management Representative 205 West Bement Street Bryan, Ohio 43506
Re: K073587
Trade/Device Name: DermaPal® Regulatory Number: 21 CFR 878.4630 Regulatory Name: Ultraviolet lamp for dermatologic disorders Regulatory Class: II Product Code: FTC Dated: December 10, 2007 Received: January 2, 2008
Dear Ms. Mansur:
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.
3
Page 2 -- Ms. Tara Mansur
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 vours.
Mark M. Milburn
- 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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Indication for Use
510(k) Number
DermaPal® Device Name
Indications for Use
The DermaPal® is a hand held ultraviolet light emitting fluorescent lamp. It is intended for use, by or under the direction of a physician, for the treatment of psoriasis, vitiligo, and atopic dermatitis (eczema) on all skin types (I - VI).
Prescription Use X
OR
Over-the-Counter Use
(per 21 CFR 801.109)
(Please do not write below this line - Continue on another page if needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark H. Millians
(Division Sign-Off) (Division of General, Restorative, Divisionomical Devices 073587
510(k) Number_