The ML24000 PC UVA-1 Phototherapy Unit is a full body medical ultraviolet device, which is intended for use, by or under the direction of a physician, for therapeutic treatment for individuals who require ultraviolet or visible radiation for diagnosed skin disorders. The ML 24000 PC UVA-1 Phototherapy Unit delivers a 360 degree full body treatment, with spectral output at peak wavelengths of 370-390 nm, through an array of 24 metal halide lamps in conjunction with a filtering system that absorbs infrared output and eliminated emissions below 320 nm. The 24 metal halide lamps are arranged in a four column modular design containing six lamps in each column.

Treatments are controlled through the Soft Touch Software interface. Access to this interface and stored information is restricted to individuals who have been established by the physician as authorized operators. Authorized operators program treatments in joules based on established treatment protocols governed by the patient's skin type, condition, minimum erythemal dose (M.E.D.), and treatment frequency.

AI/ML Overview

I am unable to provide the detailed information requested regarding acceptance criteria and study data for the ML24000 PC UVA-1 Phototherapy Unit. My analysis of the provided text reveals that the document is a 510(k) premarket notification letter from the FDA to Daavlin Distributing Company, confirming the substantial equivalence of the ML24000 PC UVA-1 Phototherapy Unit to a legally marketed predicate device.

The document does not contain:

A table of specific acceptance criteria and reported device performance values. Instead, it states that "The ML24000 PC UVA-1 Phototherapy Unit performance data is the same as or very similar to that of the claimed predicate device." This is a general statement of equivalence, not a presentation of detailed performance metrics against defined acceptance criteria.
Details of a study proving the device meets acceptance criteria. The submission focuses on demonstrating substantial equivalence to a predicate device, largely based on similarities in design, materials, and intended use, rather than presenting a new clinical study with specific performance outcomes.
Information regarding sample size, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance studies, or ground truth details for either a test or training set. These are typically elements of a clinical performance study, which is not described in this 510(k) summary.

Key points from the document relevant to your request, but not directly answering it, are:

Predicate Device: ML24000 UVA-1 Phototherapy Unit (K103708)
Core Equivalence Argument: The new device is "identical in nearly every aspect" to the predicate, with the only difference being the incorporation of a "Smart Touch Control System." This control system has been safely used in another legally marketed phototherapy unit (K063621).
Performance Claim: The performance data for the subject device is "the same as or very similar" to the predicate, and "The ultraviolet lamps and cabinet construction used in the production of the predicate device and the ML24000 PC UVA-1 Phototherapy Unit are the same."

Therefore, based on the provided text, I cannot extract the specific acceptance criteria and study details you've requested. The document primarily serves to establish substantial equivalence based on a comparison to a predicate device, rather than presenting a self-contained performance study with defined acceptance criteria.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, overlapping each other to create a sense of depth and connection.

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

September 10, 2015

Daavlin Distributing Company Ms. Michele Thiel Management Representative 205 West Bement Street, P.O. Box 626 Bryan, Ohio 43506

Re: K151795

Trade/Device Name: ML24000 PC UVA-1 Phototherapy Unit Regulation Number: 21 CFR 878.4630 Regulation Name: Ultraviolet lamp for dermatologic disorders Regulatory Class: Class II Product Code: FTC Dated: July 16, 2015 Received: August 12, 2015

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 of medical device-related

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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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 Industry and Consumer Education 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,

David Krause -S

Binita S. Ashar, M.D., M.B.A., F.A.C.S. for Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure

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Indications for Use

510(k) Number (if known) K151795

Device Name ML24000 PC UVA-1 Phototherapy Unit

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)
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K. 510(k) Summary ·

Date of Summary:	June 26, 2015
510(k) Submitter:	Daavlin Distributing Company
Contact Person:	Michele ThielManagement RepresentativeDaavlin Distributing Company205 West Bement StreetP.O. Box 626Bryan, Ohio 43506Phone: (419) 636-6304 Ext. 207Fax: (419) 636-1739Email: mthiel@daavlin.com
Trade Name:	ML24000 PC UVA-1 Phototherapy Unit
Common Name	UVA-1 Ultraviolet Full Body Phototherapy Unit
Regulation Number:	21 CFR 878.4630
Classification Name:	Ultraviolet lamp for dermatologic disorders
Device Class:	Class II
Product Code:	FTC
Panel:	General and Plastic Surgery
Predicate Device:	ML24000 UVA-1 Phototherapy Unit
510(k) Number:	K103708
Product Code:	FTC
Company:	Daavlin Distributing Company
Device Description:	The ML24000 PC UVA-1 Phototherapy Unit is a full body medical ultraviolet device, which is intended for use, by or under the direction of a physician, for therapeutic treatment for individuals who require ultraviolet or visible radiation for diagnosed skin disorders. The ML 24000 PC UVA-1 Phototherapy Unit delivers a 360 degree full body treatment, with spectral output at peak wavelengths of 370-390 nm, through an array of 24 metal halide lamps in conjunction with a filtering system that absorbs infrared output and eliminated emissions below 320 nm. The 24 metal halide lamps are arranged in a four column modular design containing six lamps in each column.Treatments are controlled through the Soft Touch Software interface. Access to this interface and stored information is restricted to individuals who have been established by the physician as authorized operators. Authorized operators program treatments in joules based on established treatment protocols governed by the patient's skin type, condition, minimum erythemal dose (M.E.D.), and treatment frequency.
Indications for Use:	The ML24000 PC UVA-1 Phototherapy Unit is a full body medical ultraviolet device, which is intended for use, by or under the direction of a physician, for therapeutic treatment for individuals who require ultraviolet or visible radiation for diagnosed skin disorders.
Predicate Comparison:	The modified ML24000 PC UVA-1 Phototherapy Unit and the unmodified device are identical in nearly every aspect except for the incorporation of our Smart Touch Control System. Both the modified ML24000 PC UVA-1 Phototherapy Unit and the unmodified device are constructed using identical manufacturing methods, quality control operations, and are comprised of materials, components, and subassemblies which are identical or very similar in construction and composition. The modified ML24000 PC UVA-1 Phototherapy Unit and the unmodified device feature the same indications for use, patient population, application environment, lamp quantity, spectral output, labeling, treatment area, electrical requirements, ventilation requirements and device dimensions.As previously stated the only difference between the modified ML24000 PC UVA-1 Phototherapy Unit and the unmodified device is in regards to the incorporation of our Smart Touch Control System. Our Smart Touch control system has been safely used in a closely related, legally marketed full body phototherapy unit (3 Series PC & SP Phototherapy Cabinet, K063621, 01/17/2007) which shares an identical classification regulation (CFR 878.4630), Product Code (FTC), significantly similar indications for use, and has been in commercial distribution since 01/17/2007. Beyond this modification there has been no other changes between the ML24000 PC UVA-1 Phototherapy Unit and the unmodified device

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	Subject Device	Predicate Device
Features	ML24000 PC UVA-1 Phototherapy Unit	ML24000 UVA-1 Phototherapy Unit
510(k) Number	This Submission	K103708
Indications for Use	The ML24000 PC UVA-1 PhototherapyUnit is a full body medical ultravioletdevice, which is intended for use, by orunder the direction of a physician, fortherapeutic treatment for individualswho require ultraviolet or visibleradiation for diagnosed skin disorders.	The ML24000 UVA-1 Phototherapy Unit is afull body medical ultraviolet device, which isintended for use, by or under the direction of aphysician, for therapeutic treatment forindividuals who require ultraviolet or visibleradiation for diagnosed skin disorders.
Prescriptive	Yes	Yes
Patient Population	Pediatric to Geriatric	Pediatric to Geriatric
Patient Contact	There is no direct patient contact withthe device during treatment - Areas ofskin are exposed to controlledultraviolet radiation from a distance ofapproximately 9 inches (22.86 cm)away.	There is no direct patient contact with thedevice during treatment - Areas of skin areexposed to controlled ultraviolet radiationfrom a distance of approximately 9 inches(22.86 cm) away.
Anatomical Sites	Full Body	Full Body
ApplicationEnvironment	Hospital, Clinic, Medical Center, PrivateMedical Practice, or Other ProfessionalMedical Environments under directionof physician	Hospital, Clinic, Medical Center, PrivateMedical Practice, or Other ProfessionalMedical Environments under direction ofphysician
Dimensions	Height : 98" (249cm) Width : 49" (125cm) Depth : 62" (158 cm)	Height : 98" (249cm) Width : 49" (125 cm)Depth : 62" (158 cm)
Power	230V, 3~, 60Hz, 100A	230V, 3~, 60Hz, 100A
VentilationRequirements	Minimum: 500 cfmDesired: 2000 cfm	Minimum: 500 cfmDesired: 2000 cfm
Spectral Output	370-390 nm	370-390 nm
Materials	Interior: Assembles components,ballasts, electronics housed in a metalframe with reflective internal surfaces,fluorescent lamps, and protective acrylicand filter glass.	Interior: Assembles components, ballasts,electronics housed in a metal frame withreflective internal surfaces, fluorescent lamps,and protective acrylic and filter glass.
	Exterior: Powder Coated Metal Casing	Exterior: Powder Coated Metal Casing
Lamp Quantity	24	24
ManufacturingMethods	Identical	Identical

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Performance Standards: The ML24000 PC UVA-1 Phototherapy Unit performance data is the same as or very similar to that of the claimed predicate device. The ultraviolet lamps and cabinet construction used in the production of the predicate device and the ML24000 PC UVA-1 Phototherapy Unit are the same. Conclusion: In summary, the modified ML24000 PC UVA-1 Phototherapy Unit described in this submission is, in our opinion, substantially equivalent to the legally commercialized unmodified predicate device.

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.