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).

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.

AI/ML Overview

The provided 510(k) summary for the DermaPal® device (K073587) indicates that the device's performance data is "the same as or very similar to that of the claimed predicate device" (DermaPal® K022104). The submission concludes that the new DermaPal® with Digital Timer is substantially equivalent to the predicate device due to identical energy sources, similar materials, and the same intended use, indications for use, spectral output, mode of operation, labeling, treatment area, and general operating principles.

This submission does NOT include a "study that proves the device meets the acceptance criteria" in the way one might expect for a digital health or AI/ML device. Instead, it relies on substantial equivalence to a predicate device. Therefore, many of the requested elements for a study (like sample size, ground truth, experts, etc.) are not applicable in this context.

Here's a breakdown based on the provided text, acknowledging the nature of the submission:

1. Table of Acceptance Criteria and Reported Device Performance:

Since this is a substantial equivalence claim based on an existing device, there are no explicit "acceptance criteria" presented as quantitative performance metrics for a new study. The acceptance criterion is essentially that the new device performs "the same as or very similar to" the predicate device.

Acceptance Criteria (Implied for Substantial Equivalence)	Reported Device Performance (as stated in 510(k) Summary)
Utilization of identical energy sources (UV lamps)	Yes, "utilizing identical energy sources (UV lamps)"
Materials of identical composition	Yes, "materials of identical composition"
Same intended use	Yes, "The intended use... are the same or similar"
Same general and specific indications for use	Yes, "The... indications for use... are the same or similar"
Same spectral output	Yes, "The... spectral output... are the same or similar"
Same mode of operation	Yes, "The... mode of operation... are the same or similar"
Same labeling	Yes, "The... labeling... are the same or similar"
Same treatment area	Yes, "The... treatment area... are the same or similar"
Same general operating principles	Yes, "The... general operating principals... are the same or similar"
Performance data same as or very similar to predicate	Yes, "The DermaPal's® with Digital Timer's performance data is the same as or very similar to that of the claimed predicate device."
Updated control system hardware and software (as a difference, not a criterion)	Yes, "the control system hardware and software has been updated to utilize current technology."

Regarding the specific questions about a study:

Given this is a 510(k) for a physical medical device (an ultraviolet phototherapy unit) and not a digital health or AI/ML device, the concept of a "test set," "ground truth," "experts for ground truth," "adjudication method," "MRMC comparative effectiveness study," or "standalone performance" for an algorithm is not applicable to this submission.

The "study" cited is the comparison to the predicate device. The performance data is stated to be "the same as or very similar" because the core components (UV lamps and construction) are identical to the predicate device.

Let's address the questions with this context in mind:

2. Sample Size Used for the Test Set and the Data Provenance:

Not Applicable. There is no explicit "test set" in terms of patient data or new device performance data generated for this substantial equivalence claim. The claim is based on the known performance and design of the predicate device.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:

Not Applicable. No ground truth establishment by experts is mentioned, as there isn't a new clinical or diagnostic performance study for this device.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set:

Not Applicable. No adjudication method is mentioned.

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 is a physical phototherapy device, not an AI-assisted diagnostic or interpretation tool. MRMC studies are irrelevant here.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Not Applicable. This device does not involve an "algorithm only" component in the sense of AI/ML. Its core function is emitting UV light.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Not Applicable. No ground truth of this nature is established or used for the purpose of this 510(k) where "performance data" refers to the physical characteristics and output of the device compared to its predecessor.

8. The Sample Size for the Training Set:

Not Applicable. This is not an AI/ML device that requires a training set.

9. How the Ground Truth for the Training Set Was Established:

Not Applicable. No training set is involved.

Summary

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K073587

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 StreetBryan, 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 CompanyDermaPal®K022104

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Device Description:

The DermaPal® a hand held ultraviolet light-emitting medical device.

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.

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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

Prescription Use X

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_

Regulation Number and Section

§ 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.