DT Controlled Phototherapy Equipment

{0}------------------------------------------------ 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). {1}------------------------------------------------ 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 {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K233811 Device Name DT Controlled Phototherapy Equipment ### Indications for Use (Describe) 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. Type of Use (Select one or both, as applicable) | <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) | |--------------------------------------------------------------------------------------| | <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. 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Below the word "Daavlin" is the phrase "Let's Be Clear" in a smaller, sans-serif font. # 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 Street<br>P.O. Box 626<br>Bryan, Ohio 43506<br>Phone: (419) 636-6304 Ext. 207<br>Fax: (419) 636-1739<br>Email: 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)<br>K073587). Like its predicate, the DT Controller is designed to turn a<br>phototherapy device on and off based on time. It is designed to be installed in a<br>wider family of devices. It uses the same 4 button UI with a larger backlit screen<br>for better readability and is based on a more commercially available PIC16<br>processor. A modification to the way a prescription is entered was done to<br>harmonize the process across different devices. | | | | | Indications for Use: | The DT Controlled Phototherapy Equipment are medical ultraviolet devices,<br>which are intended for use, by or under the direction of a physician, for<br>therapeutic treatment for individuals who require ultraviolet radiation for<br>diagnosed skin disorders. | | | | | Intended Use: | The DT Controlled Phototherapy Equipment are indicated for use to treat<br>diagnosed skin disorders such as, but not limited to, psoriasis, vitiligo, and<br>atopic 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 DT<br>controller and the functions appear to be working per the specifications. | {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logo for Daavlin. The word "Daavlin" is written in a stylized font, with the first half of the word in a light teal color and the second half in a light blue color. Below the word "Daavlin" is the phrase "Let's Be Clear" in a smaller, sans-serif font. | | 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 for<br>Use | The DT Controlled<br>Phototherapy Equipment<br>are indicated for use to<br>treat diagnosed skin<br>disorders such as but not<br>limited to, psoriasis,<br>vitiligo, and atopic<br>dermatitis (eczema) under<br>the direction of a<br>physician. The population<br>may range from pediatric<br>to geriatric. | Intended for use, by or<br>under the direction of a<br>physician, for the<br>treatment of localized<br>cases of psoriasis and<br>vitiligo. | The 1 Series Phototherapy<br>Devices are indicated for<br>use to treat diagnosed skin<br>disorders such as but not<br>limited to, psoriasis,<br>vitiligo, and atopic<br>dermatitis (eczema) under<br>the direction of a<br>physician. The population<br>may range from pediatric<br>to geriatric. | | Prescriptive | Yes | Yes | Yes | | Patient<br>Population | Pediatric to Geriatric | Dermatology Patients | Pediatric to Geriatric | {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the logo for Daavlin. The word "Daavlin" is written in a stylized font, with the first two letters in a light green color and the rest in a light blue color. Below the name is the phrase "Let's Be Clear" in a smaller, sans-serif font. | | Subject Device | Predicate Device | Predicate Device | |----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Features | DT Controlled<br>Phototherapy Equipment | Dermapal | 1 Series Controlled<br>Phototherapy Equipment | | 510(k) Number | This Submission | K073587 | K220840 | | Patient Contact | The DT Controlled<br>Phototherapy Equipment<br>device is designed have the<br>areas of skin to be exposed<br>to controlled lamp<br>radiation by placing the<br>area on the Acrylic, or<br>from a distance of<br>approximately 9 inches<br>(22.86 cm) away. | N/A | The 1 Series device is<br>designed have the areas of<br>skin to be exposed to<br>controlled lamp radiation<br>by placing the area on the<br>Acrylic, or from a distance<br>of approximately 9 inches<br>(22.86 cm) away. | | Anatomical Sites | Topical skin treatment | Topical local skin<br>treatment | Topical skin treatment | | Application<br>Environment | Hospital, Clinic, Medical<br>Center, Private Medical<br>Practice, or other<br>environment under the<br>direction of a physician. | N/A | Hospital, Clinic, Medical<br>Center, Private Medical<br>Practice, or other<br>environment under the<br>direction of a physician. | | Materials | Face of the controller is a<br>plastic overlay. The<br>controller is a PC Board<br>populated with the<br>processors, power supply,<br>display and other standard<br>electronic parts. | Assembled components<br>housed in plastic case | Assembled components<br>housed in plastic frame<br>with reflective internal<br>surfaces and fluorescent<br>lamps | | Manufacturing<br>Methods | Identical | N/A | Identical | | Performance<br>Standards: | The DT controlled phototherapy equipment performance data is the same as or very<br>similar to that of the claimed predicate devices. The ultraviolet lamps and cabinet<br>construction used in the production of the predicate device and the DT controlled<br>phototherapy equipment are the same. The only difference between the predicate<br>devices and the DT devices is the substitution of the DT controller for actual entry of<br>treatment. The rest of the devices (materials, construction, treatment modality, patient<br>safety, etc.) remains exactly the same. | |---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Conclusion: | On the basis of the information provided in this Summary, the Daavlin Distributing<br>Company believes the DT controlled phototherapy equipment is substantially<br>equivalent to the legally commercialized predicate devices. |