The 1 Series Unit is a therapeutic product designed for individuals who require ultraviolet radiation for diagnosed skin disorders. The 1-Series, equipped with PL-L36W /03 blue lamps, is indicated for the treatment of mild to moderate acne vulgaris

Device Description

The 1 Series Unit is a partial-body phototherapy panel ultraviolet light source controlled by an integrated digital timer or a microprocessor controller. The operator interface consists of two main components: a LCD, and a Membrane with 4 buttons. When the operator sets the treatment time or the desired dose using the operator interface located on the control panel, the treatment begins by illuminating the lamps which emit ultraviolet light or blue light. The spectral output peaks at wavelengths of 305nm,311nm,350nm,365nm, or 420nm depending on lamp. The 1 Series Unit is a therapeutic product designed for individuals who require ultraviolet radiation for diagnosed skin disorders or blue light radiation for acne vulgaris.

AI/ML Overview

This 510(k) summary for the Daavlin 1 Series Phototherapy Unit is a substantial equivalence submission, not a study demonstrating the device meets performance criteria in the way a clinical trial would for an AI algorithm. Instead, it argues that the new device is safe and effective because it is essentially the same as already legally marketed devices.

Therefore, many of your requested items (e.g., sample sizes, ground truth establishment, expert qualifications, MRMC studies) are not applicable (N/A) to this type of regulatory submission and device.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied)	Reported Device Performance
Safety and Effectiveness	Substantially Equivalent to Predicate Devices
- Intended Use	Same or similar
- Design Configuration	Same
- Energy Sources	Identical (UV or blue light lamps)
- Materials	Identical composition
- General/Specific Indications for Use	Same or similar
- Spectral Output	Same or similar
- Mode of Operation	Same or similar
- Labeling	Same or similar
- Treatment Area	Same or similar
- General Operating Principles	Same or similar
Performance Data	UV or blue light lamps and cabinet construction are similar to predicate devices.

2. Sample size used for the test set and the data provenance

N/A. This device approval is based on substantial equivalence to existing devices, not a test set and performance metrics derived from data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

N/A. Ground truth establishment for a test set is not relevant for this type of device submission.

4. Adjudication method for the test set

N/A. Not applicable.

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

N/A. This is a phototherapy unit, not an AI-powered diagnostic or assistive tool.

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

N/A. This is not an algorithm; it's a physical medical device.

7. The type of ground truth used

N/A. Not applicable. The "ground truth" for this submission is that the predicate devices are already legally marketed and presumed safe and effective.

8. The sample size for the training set

N/A. This is not an AI/ML device that requires a training set.

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

N/A. Not applicable.

Summary

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510(k) Summary

The 510(k) Summary is submitted in accordance with 21 CFR Part 807, Section 807.92

APR 2 8 2010

The Daavlin Distributing Company Submitter's Name:

Registration Number: 1526255

Address:

POSSESS

205 West Bement Street Bryan, Ohio 43506

419.636.6304

Michele Thiel

Telephone:

late

Contact:

Date Prepared: February 3, 2010

Device Trade Name: 1 Series Phototherapy Unit

1 Series Partial- Body Phototherapy Unit Device Common Name:

Device Classification: Class II

ം Product Code: FTC

Regulation Number: CFR 878.4630

Regulation Name: Ultraviolet lamp for dermatologic/skin disorders

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60037y

Predicate Device: Daavlin Distributing Company Digital DermaPal® K073587

Daavlin Distributing Company Flex Controlled Phototherapy Equipment K050695

National Biological Corporation Panosol Tru-Blu Phototherapy System · K070934

DUSA Pharmaceuticals, Inc. BLU-U, MODEL 4170 K031805

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100378

Device Description:

Predicate Device Comparison:

The 1 Series Unit is constructed in the same design configuration as the predicate device, utilizing identical energy sources (UV or blue light lamps ) and materials of identical composition. The intended use, general and specific indications for use, spectral output, mode of operation, labeling, treatment area, and general operating principals of the 1 Series light emitting medical device are the same or similar to those of the predicate devices.

Intended Use:

The 1 Series Unit is a therapeutic product designed for individuals who require ultraviolet or blue light radiation for diagnosed skin disorders.

Performance Data:

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

Conclusion:

On the basis of the information provided in this Summary, the Daavlin Distributing Company believes the 1 Series 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 features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The caduceus is a common symbol associated with medicine and healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

The Daavlin Distributing Company % Ms. Michele Thiel 205 West Bement Street Bryan, Ohio 43506

APR 2 8 2010

Re: K100378

Trade/Device Name: 1 Series Phototherapy Unit Regulation Number: 21 CFR 878.4630 Regulation Name: Ultraviolet lamp for dermatologic disorders Regulatory Class: Class II Product Code: FTC Dated: April 22, 2010 Received: April 22, 2010

Dear Ms. Thiel:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical

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Page 2 - Ms. Michele Thiel

device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

signature

Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indication for Us

Ki00378 510(k) Number

1 Series Phototherapy Unit Device Name

Indications for Use

Prescription Use X

Over-the-Counter Use

(Please do not write below this line – Continue on another page if needed)

(per 21 CFR 801.109)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Neil R.P. Ogden for him
Division Sign Off

(Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K100378

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.