The ML24000 UVA-1 Phototherapy Unit is a medical ultraviolet light source, which is intended for use by or under the direction of a licensed physician for the treatment of atopic dermatitis (eczema) on all skin types (I - VI).

The ML24000 UVA-1 Phototherapy Unit is a full body medical ultraviolet device, which is intended for the treatment of atopic dermatitis (eczema) on all skin types (I - VI).

Device Description

The ML24000 UVA-1 Phototherapy Unit is a microprocessor controlled full body ultraviolet light source, with spectral output at peak wavelengths of 370-390 nm. It is intended for use by or under the direction of a physician, for the treatment of atopic dermatitis (eczema). The desired dose is selected using the operator interface located on the front panel of the device. The ML24000 UVA-1 Phototherapy Unit delivers full body phototherapy, whereby Philips CLEO HPA 1018 Medium Pressure Lamps, which surround the patient, deliver the specified dose of UVA-1.

AI/ML Overview

The provided document is a 510(k) summary for the ML24000 UVA-1 Phototherapy Unit. It states that the device is substantially equivalent to a legally commercialized predicate device. This type of submission relies on demonstrating similarity to an already approved device rather than conducting new clinical studies with detailed acceptance criteria and performance statistics as would be found in a PMA (Pre-Market Approval) application.

Therefore, many of the specific details requested regarding acceptance criteria, study design, sample sizes, ground truth establishment, expert qualifications, and MRMC studies are not present in this document because they are not typically required for a 510(k) submission that demonstrates substantial equivalence to a predicate device for this type of medical device.

Here's a breakdown based on the information available:

1. Table of Acceptance Criteria and Reported Device Performance:

There is no explicit table of acceptance criteria or reported device performance metrics in the provided 510(k) summary. The submission focuses on demonstrating "substantial equivalence" to a predicate device, meaning its performance is considered comparable enough that specific new performance metrics are not required.

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

No specific test set or clinical study data is provided to determine sample size or data provenance. The substantial equivalence argument relies on the design, materials, and intended use being similar to the predicate device.

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

Not applicable. No new clinical study data with ground truth established by experts is mentioned or required for this type of 510(k) submission.

4. Adjudication Method for the Test Set:

Not applicable. No new clinical study or test set requiring adjudication 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 device is a phototherapy unit, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study related to human reader performance with or without AI assistance is not relevant.

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

Not applicable. This is a medical device for treatment, not an algorithm.

7. The type of ground truth used:

Not applicable. The basis for approval is substantial equivalence to a predicate device, not a new clinical study generating ground truth data.

8. The Sample Size for the Training Set:

Not applicable. This document refers to a phototherapy unit, not an AI/ML algorithm that would require a training set.

9. How the ground truth for the training set was established:

Not applicable, as there is no training set for an AI/ML algorithm.

Summary of the Device's Justification for Marketing based on Substantial Equivalence:

The ML24000 UVA-1 Phototherapy Unit is considered substantially equivalent to its predicate devices (Daavlin Distributing Company 3 Series PC & SP Phototherapy Cabinet Ultraviolet Phototherapy Cabinet K063621 and Flex Controlled Phototherapy Equipment 3 Series X Ultraviolet Phototherapy Cabinet K0050695) based on the following:

Design Configuration: Constructed in the same design configuration.
Energy Sources: Utilizes similar energy sources (UV lamps).
Materials: Uses materials of similar and/or identical composition.
Intended Use: The intended use, general and specific indications for use (treatment of atopic dermatitis (eczema) on all skin types I-VI), mode of operation, labeling, treatment area, and general operating principles are the same or similar.
Performance Data: The performance data is stated to be "the same as or very similar to that of the claimed predicate devices." The UV lamps and cabinet construction are also noted as similar.

The primary difference noted is the peak wavelength of the UV lamps: the ML24000 has a peak wavelength of 365nm (output spectrum 340nm to 400nm), while the predicate devices had a peak wavelength of 350nm (output spectrum 320nm to 400nm). This change was deemed not to impact the substantial equivalence for its intended use.

Summary

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K082731

DEC 1 7 2008

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:

Address:

419.636.6304

David W. Swanson

September 11, 2008

ML24000 UVA-1 Phototherapy Unit

1526255

205 West Bement Street Bryan, Ohio 43506

Telephone:

Contact:

Date Prepared:

Device Trade Name:

Device Common Name:

Device Classification:

Product Code:

Regulation Number:

Regulation Name:

Predicate Device:

CFR 878.4630

Class II

FTC

Ultraviolet lamp for dermatologic/skin disorders

UVA-1 Ultraviolet Full Body Phototherapy Unit

Daavlin Distributing Company 3 Series PC & SP Phototherapy Cabinet Ultraviolet Phototherapy Cabinet

K063621

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Device Description:

Predicate Device Comparison:

The ML24000 UVA-1 Phototherapy Unit is constructed in the same design configuration as the predicate devices, utilizing similar energy sources (UV lamps) and materials of similar and/or identical composition. The ML24000 UVA-1 Phototherapy Unit varies from the predicate device, in that the UV lamps used in the ML24000 device have a peak wavelength of 365nm, instead of a peak wavelength of 350nm. Specifically, on the Predicate Device, the output spectrum is 320-400nm with a peak at 350nm, and the ML24000 has an output spectrum of 340nm to 400nm with a peak at 365nm. The intended use, general and specific indications for use, mode of operation, labeling, treatment area, and general operating principals of the ML24000 UVA-1 Phototherapy Unit are the same or similar to those of the predicate device.

Intended Use:

Performance Data:

The ML24000 UVA-1 Phototherapy Unit performance data is the same as or very similar to that of the claimed predicate devices. The UV lamps and cabinet construction used in the production of the predicate device and the ML24000 UVA-1 Phototherapy Unit are similar.

Conclusion:

On the basis of the information provided in this Summary, the Daavlin Distributing Company believes the ML24000 UVA-1 Phototherapy Unit is substantially equivalent to the legally commercialized predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circle around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Daavlin Distributing Company % Ms. Tara Mansur Regulatory Affairs Coordinator 205 West Bement Street P.O. Box 626 Bryan, Ohio 43506

DEC 1 7 2008

Re: K082731

Trade/Device Name: ML24000 UVA-1 Phototherapy Unit Regulation Number: 21 CFR 878.4630 Regulation Name: Ultraviolet lamp for dermatologic disorders Regulatory Class: II Product Code: FTC Dated: September 12, 2008 Received: September 18, 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

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Page 2 – Ms. Tara Mansur

forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 yours,

Mark N. Millman

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 K 082731

ML24000 UVA-1 Phototherapy Unit Device Name

Indications for Use

The ML24000 UVA-1 Phototherapy Unit is a full body medical ultraviolet device, which is intended for the treatment of atopic dermatitis (eczema) on all skin types (I - VI).

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 A. Mulkerson

(Division Shou-Ca) (Division of General, Restorative, Divisiou of Secological Devices 08 27 3

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.