The 3 Series NeoLux, full body phototherapy device, is a medical ultraviolet cabinet, which is intended for the treatment of psoriasis, vitiligo, and atopic dermatitis (eczema) on all skin types (1 - VI).

Device Description

The 3 Series NeoLux 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 radiation for diagnosed skin disorders. The 3 Series NeoLux Phototherapy Unit delivers a 360 degree full body treatment, with spectral output at peak wavelengths of 311 nm (Narrow Band UVB) and/or 350 nm (UVA), through an array of 24-48 fluorescent lamps. 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

The provided document describes the Daavlin 3 Series NeoLux Phototherapy Unit, a medical device for dermatologic disorders. However, it is a 510(k) summary for substantial equivalence to a predicate device, not a study demonstrating the device meets specific acceptance criteria in terms of clinical performance or diagnostic accuracy. Instead, it focuses on demonstrating that the new device is as safe and effective as a previously cleared device. Therefore, a direct answer to the request to populate a table of acceptance criteria and reported device performance related to a diagnostic or clinical outcome study, and details about sample sizes, ground truth establishment, or multi-reader studies, cannot be fully provided from this document.

The document does however, provide information regarding performance standards and non-clinical testing for compliance with electrical and EMC standards.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

As this is a 510(k) for a phototherapy unit based on substantial equivalence, the "acceptance criteria" are primarily related to safety, electrical performance, and functional equivalence to the predicate device. It is not a diagnostic device with performance metrics like sensitivity, specificity, or AUC.

Criteria Type	Acceptance Criteria (Implied)	Reported Device Performance
Clinical Performance	Not applicable for this 510(k type.	Not applicable for this 510(k type.
Functional Equivalence	Identical indications for use, patient population, application environment, lamp types, spectral output, labeling, treatment area, electrical requirements, and ventilation requirements as predicate device.	The 3 Series NeoLux is stated to be "identical in nearly every aspect" to the predicate, with only exterior cosmetics and lamp covering changes.
Safety and EMC (Non-clinical)	Conformance to IEC 60601-1-2:2007 (EMC), IEC 60601-1:2012 (Safety), and IEC 60601-2-57:2011 (Safety-specific for phototherapy equipment).	Performance testing for conformance to these standards was conducted. (Implied successful conformance).

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

Not applicable. This document describes a medical device, not a diagnostic algorithm or AI system that uses medical image data for a test set. The substantial equivalence relies on design, function, and safety testing, not on a clinical test set of patient data with ground truth.

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

Not applicable. As stated above, there is no test set of patient data requiring expert ground truth in this submission.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable. No test set of patient data.

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 not an AI-assisted diagnostic device.

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

Not applicable. This is a phototherapy unit, not an algorithm.

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

Not applicable. No ground truth for clinical outcomes data is discussed in this 510(k) summary, as it is based on substantial equivalence to a predicate device for its intended use, rather than proving new clinical efficacy through trials. The "ground truth" for the device's performance is adherence to electrical and safety standards, and functional equivalence to the predicate.

8. The sample size for the training set

Not applicable. This is not an AI/ML-driven device that requires a training set.

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

Not applicable. No training set exists for this device.

Summary based on the provided document:

The Daavlin 3 Series NeoLux Phototherapy Unit is a medical ultraviolet device intended for the treatment of psoriasis, vitiligo, and atopic dermatitis. Its acceptance criteria for FDA clearance (via 510(k)) were primarily based on demonstrating substantial equivalence to a previously cleared predicate device (the 3 Series SP/PC Phototherapy Unit, K063621).

The study that proves the device meets the "acceptance criteria" (i.e., substantial equivalence) is the comparison of the new device's design, materials, manufacturing, indications for use, and performance characteristics (e.g., spectral output, electrical requirements) to that of the predicate device, along with non-clinical performance testing for adherence to recognized electrical and safety standards (IEC 60601-1-2:2007, IEC 60601-1:2012, and IEC 60601-2-57:2011). The document explicitly states that the new device is "identical in nearly every aspect" to the predicate, with the only differences being changes in exterior cosmetics and lamp covering. This implies that the performance in these non-clinical tests was successful and confirmed the device's safety and functional equivalence to the predicate.

Summary

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

June 30, 2016

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

Re: K153749

Trade/Device Name: 3 Series Phototherapy Unit Regulation Number: 21 CFR 878.4630 Regulation Name: Ultraviolet Lamp For Dermatologic Disorders Regulatory Class: Class II Product Code: FTC Dated: June 1, 2016 Received: June 1, 2016

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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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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/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 vours.

Jennifer R. Stevenson -A

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

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K153749

Device Name

3 Series NeoLux 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:	December 14, 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:	3 Series NeoLux Phototherapy Unit
Common Name	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:	3 Series SP/PC Phototherapy Unit
510(k) Number:	K063621
Product Code:	FTC
Company:	Daavlin Distributing Company

្រពួក ប

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The 3 Series NeoLux Phototherapy Unit is a full body medical ultraviolet device, which is Device Description: intended for use, by or under the direction of a physician, for therapeutic treatment for individuals who require ultraviolet radiation for diagnosed skin disorders. The 3 Series NeoLux Phototherapy Unit delivers a 360 degree full body treatment, with spectral output at peak wavelengths of 311 nm (Narrow Band UVB) and/or 350 nm (UVA), through an array of 24-48 fluorescent lamps.

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 3 Series NeoLux. full body phototherapy device, is a medical ultraviolet cabinet, which is intended for the treatment of psoriasis, vitiligo, and atopic dermatitis (eczema) on all skin types (I - VI).

Predicate Comparison: The 3 Series NeoLux Phototherapy Unit and the 3 Series SP/PC device are identical in nearly every aspect. Both the 3 Series NeoLux and the 3 Series SP/PC 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 3 Series NeoLux Phototherapy Unit and the 3 Series SP/PC device feature the same indications for use, patient population, application environment, lamp types, spectral output, labeling, treatment area, electrical requirements, and ventilation requirements. As previously stated the only difference between the 3 Series NeoLux Phototherapy Unit and the 3 Series SP/PC predicate device are changes in exterior cosmetics and lamp covering. Beyond this modification there has been no other changes between the 3 Series NeoLux Phototherapy Unit and the 3 Series SP/PC predicate device

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Features	Subject Device3 Series NeoLux Phototherapy Unit	Predicate Device3 Series SP/PC Phototherapy Unit
510(k) Number	This Submission	K063621
Indications for Use	The 3 Series NeoLux is a full bodyultraviolet emitting medical light source,which is intended for use by or under thedirection of a licensed physician for thetreatment of psoriasis, vitiligo, andatopic dermatitis (eczema) on all skintypes (I-VI).	The 3 Series PC & SP, full body phototherapydevice, is a medical ultraviolet cabinet, whichis itended for the treatment of psoriasis,vitiligo, and atopic dermatitis (eczema) on allskin types (I-VI)
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 : 83.6" (212.3cm) Width : 41.4"(104.4 cm) Depth : 39.3" (99.8 cm)	Height : 84" (213cm) Width : 42" (106 cm)Depth : 41" (104 cm)
Power	208-240V, 60Hz, 100A	208-240V, 60Hz, 100A
VentilationRequirements	Minimum: XXX cfmDesired: XXX cfm	Minimum: XXX cfmDesired: XXX cfm
Spectral Output	280-400 nm	280-400 nm
Materials	Interior: Assembles components,ballasts, electronics housed in a metalframe with reflective internal surfaces,fluorescent lamps, and protectiveacrylic.Exterior: Metal and Plastic Casing	Interior: Assembles components, ballasts,electronics housed in a metal frame withreflective internal surfaces, fluorescent lampsand protective metal grids.Exterior: Metal and Plastic Casing
Lamp Quantity	Up to 48F72 or F79UVB or UVA	Up to 48F72UVB or UVA
ManufacturingMethods	Identical	Identical

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Performance Standards:	The 3 Series NeoLux Phototherapy Unit performance data is the same as or verysimilar to that of the claimed predicate device. The ultraviolet lamps and cabinetconstruction used in the production of the predicate device and the 3 Series NeoLuxPhototherapy Unit are the same.
Non-clinical Testing:	Performance testing for conformance to IEC 60601-1-2:2007; IEC 60601-1:2012; IEC60601-2-57:2011 EMC and Safety.
Conclusion:	In summary, the 3 Series NeoLux Phototherapy Unit described in this submission is,in our opinion, substantially equivalent to the legally commercialized unmodifiedpredicate device.

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ે. જુવિલુલ ગુજરાત રાજ્યના

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.