The DT Controlled Phototherapy Equipment devices are indicated for use to treat diagnosed skin disorders such as, but not limited to, psoriasis, vitiligo, and atopic dermatitis (eczema) under the direction of a physician. The population may range from pediatric to geriatric.

Device Description

The DT Controller is a modernization of the DermaPal Controller (510(k) K073587). Like its predicate, the DT Controller is designed to turn a phototherapy device on and off based on time. It is designed to be installed in a wider family of devices. It uses the same 4 button UI with a larger backlit screen for better readability and is based on a more commercially available PIC16 processor. A modification to the way a prescription is entered was done to harmonize the process across different devices.

AI/ML Overview

This is a 510(k) premarket notification for a phototherapy device, not an AI/ML device, therefore, many of the typical acceptance criteria and study attributes for AI/ML performance evaluation are not applicable. The device is a "DT Controlled Phototherapy Equipment" which is a modernization of a previous controller for phototherapy devices. The change is primarily to the controller unit's hardware and software (UI, processor, prescription entry method).

Here's an analysis based on the provided document:

1. A table of acceptance criteria and the reported device performance

The document does not specify quantitative acceptance criteria in the typical sense of AI/ML performance metrics (e.g., sensitivity, specificity, accuracy). Instead, the acceptance is based on the device performing as expected for a phototherapy controller and maintaining substantial equivalence to its predicates.

Acceptance Criteria (Implied)	Reported Device Performance (Summary)
Functional equivalence to predicate device (Dermapal Controller - K073587).	"Functional testing in the form of Black Box testing was completed on the DT controller and the functions appear to be working per the specifications."
Electrical safety and EMC compliance.	Conformance to IEC 60601-1 (electrical safety) and IEC 60601-1-2 (EMC) standards. (Indicated by device testing, though specific results are not detailed in the summary).
Software validation.	Software validation activities were performed. (Details not in summary, but indicated as required for this type of device).
Usability of User Interface (UI).	"uses the same 4 button UI with a larger backlit screen for better readability" and "A modification to the way a prescription is entered was done to harmonize the process across different devices." (Implied improvement and functional review).
Radiation output equivalence (as a component of the overall phototherapy system).	"The ultraviolet lamps and cabinet construction used in the production of the predicate device and the DT controlled phototherapy equipment are the same." (Ensures the core therapeutic elements remain consistent).

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

Not applicable for this type of device. The "test set" here refers to the functional testing of the controller, not a data set of patient cases or images. The testing would involve a rigorous set of test cases designed to exercise all functionalities of the controller. The document indicates "Functional testing in the form of Black Box testing."

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

Not applicable for this type of device. "Ground truth" for this device relates to whether the controller correctly performs its functions (e.g., sets time, turns on/off, displays correctly). This is typically verified by engineers and quality assurance personnel against design specifications, not clinical experts establishing medical ground truth.

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

Not applicable for this type of device. Functional verification and validation do not typically involve adjudication methods like those used for clinical image interpretation. Performance is assessed against predefined specifications.

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 controller and does not involve AI or human "readers" interpreting medical data.

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

Not applicable. This is not an AI algorithm. Its performance is evaluated as a standalone electronic device controller.

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

The "ground truth" for this device's performance is its conformance to engineering specifications and regulatory standards (e.g., electrical safety, EMC, software validation). Functional tests ensure the device operates as designed and intended.

8. The sample size for the training set

Not applicable. This is not an AI/ML device and does not have a "training set" in the context of machine learning.

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

Not applicable.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue box, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

December 13, 2023

Daavlin Distributing Co. Michele Thiel Regulatory Manager 205 West Bement Street Bryan, Ohio 43506

Re: K233811

Trade/Device Name: DT Controlled Phototherapy Equipment Regulation Number: 21 CFR 878.4630 Regulation Name: Ultraviolet Lamp For Dermatologic Disorders Regulatory Class: Class II Product Code: FTC Dated: November 29, 2023 Received: November 29, 2023

Dear Michele 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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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approvals in the device master record (21 CFR 820.181).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and

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 adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Jianting Wang Digitally Digitally signed by Jianting Date: 2023.12.13 16:38:26 -2 -05'00'

For Tanisha Hithe Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

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Indications for Use

510(k) Number (if known) K233811

Device Name DT Controlled Phototherapy Equipment

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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Special 510k Summary

510(K) Summary:
Date of Summary:	November 28, 2023
510(k) Submitter:	Daavlin Distributing Company
Contact Person:	Michele Thiel
	Regulatory Manager
	Daavlin Distributing Company
	205 West Bement StreetP.O. Box 626Bryan, Ohio 43506Phone: (419) 636-6304 Ext. 207Fax: (419) 636-1739Email: mthiel@daavlin.com
	Trade Name:	DT Controlled Phototherapy Equipment
Common Name:	Phototherapy Equipment
510(k) Number:	K233811
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 Devices:	Dermapal, 1 Series Phototherapy Equipment
510(k) Number:	K073587, K220840
Company:	Daavlin Distributing Company
Device Description:	The DT Controller is a modernization of the DermaPal Controller (510(k)K073587). Like its predicate, the DT Controller is designed to turn aphototherapy device on and off based on time. It is designed to be installed in awider family of devices. It uses the same 4 button UI with a larger backlit screenfor better readability and is based on a more commercially available PIC16processor. A modification to the way a prescription is entered was done toharmonize the process across different devices.
	Indications for Use:	The DT Controlled Phototherapy Equipment are medical ultraviolet devices,which are intended for use, by or under the direction of a physician, fortherapeutic treatment for individuals who require ultraviolet radiation fordiagnosed skin disorders.
		Intended Use:	The DT Controlled Phototherapy Equipment are indicated for use to treatdiagnosed skin disorders such as, but not limited to, psoriasis, vitiligo, andatopic dermatitis (eczema) under the direction of a physician. The population
			Predicate Comparison:
			Functional testing in the form of Black Box testing was completed on the DTcontroller and the functions appear to be working per the specifications.

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	Subject Device	Predicate Device	Predicate Device
Features	DT Controlled	Dermapal	1 Series Controlled
	Phototherapy Equipment		Phototherapy Equipment
510(k) Number	This Submission	K073587	K220840
Picture	Image: DT Controlled Phototherapy Equipment	Image: Dermapal	Image: 1 Series Controlled Phototherapy Equipment
Indications forUse	The DT ControlledPhototherapy Equipmentare indicated for use totreat diagnosed skindisorders such as but notlimited to, psoriasis,vitiligo, and atopicdermatitis (eczema) underthe direction of aphysician. The populationmay range from pediatricto geriatric.	Intended for use, by orunder the direction of aphysician, for thetreatment of localizedcases of psoriasis andvitiligo.	The 1 Series PhototherapyDevices are indicated foruse to treat diagnosed skindisorders such as but notlimited to, psoriasis,vitiligo, and atopicdermatitis (eczema) underthe direction of aphysician. The populationmay range from pediatricto geriatric.
Prescriptive	Yes	Yes	Yes
PatientPopulation	Pediatric to Geriatric	Dermatology Patients	Pediatric to Geriatric

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	Subject Device	Predicate Device	Predicate Device
Features	DT ControlledPhototherapy Equipment	Dermapal	1 Series ControlledPhototherapy Equipment
510(k) Number	This Submission	K073587	K220840
Patient Contact	The DT ControlledPhototherapy Equipmentdevice is designed have theareas of skin to be exposedto controlled lampradiation by placing thearea on the Acrylic, orfrom a distance ofapproximately 9 inches(22.86 cm) away.	N/A	The 1 Series device isdesigned have the areas ofskin to be exposed tocontrolled lamp radiationby placing the area on theAcrylic, or from a distanceof approximately 9 inches(22.86 cm) away.
Anatomical Sites	Topical skin treatment	Topical local skintreatment	Topical skin treatment
ApplicationEnvironment	Hospital, Clinic, MedicalCenter, Private MedicalPractice, or otherenvironment under thedirection of a physician.	N/A	Hospital, Clinic, MedicalCenter, Private MedicalPractice, or otherenvironment under thedirection of a physician.
Materials	Face of the controller is aplastic overlay. Thecontroller is a PC Boardpopulated with theprocessors, power supply,display and other standardelectronic parts.	Assembled componentshoused in plastic case	Assembled componentshoused in plastic framewith reflective internalsurfaces and fluorescentlamps
ManufacturingMethods	Identical	N/A	Identical

PerformanceStandards:	The DT controlled phototherapy equipment performance data is the same as or verysimilar to that of the claimed predicate devices. The ultraviolet lamps and cabinetconstruction used in the production of the predicate device and the DT controlledphototherapy equipment are the same. The only difference between the predicatedevices and the DT devices is the substitution of the DT controller for actual entry oftreatment. The rest of the devices (materials, construction, treatment modality, patientsafety, etc.) remains exactly the same.
Conclusion:	On the basis of the information provided in this Summary, the Daavlin DistributingCompany believes the DT controlled phototherapy equipment is substantiallyequivalent to the legally commercialized predicate devices.

PerformanceStandards:

The DT controlled phototherapy equipment performance data is the same as or verysimilar to that of the claimed predicate devices. The ultraviolet lamps and cabinetconstruction used in the production of the predicate device and the DT controlledphototherapy equipment are the same. The only difference between the predicatedevices and the DT devices is the substitution of the DT controller for actual entry oftreatment. The rest of the devices (materials, construction, treatment modality, patientsafety, etc.) remains exactly the same.

Conclusion:

On the basis of the information provided in this Summary, the Daavlin DistributingCompany believes the DT controlled phototherapy equipment is substantiallyequivalent to the legally commercialized predicate devices.

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.