(75 days)
The ClearLink Controlled Phototherapy Equipment are medical ultraviolet devices, which are intended for use, by or under the direction of a physician, for therapeutic treatment for individuals who require ultraviolet radiation for diagnosed skin disorders. When equipped with blue lamps the ClearLink Controlled Phototherapy Equipment is intended for use for the treatment of mild to moderate acne vulgaris.
The ClearLink Controlled Phototherapy Equipment are medical ultraviolet devices, which are 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 ClearLink Phototherapy Equipment delivers treatment, with Narrow Band UVB, Broad Band UVB and/or UVA ultraviolet light. Treatments are controlled through the ClearLink 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.
The provided document is a 510(k) premarket notification for the "ClearLink Controlled Phototherapy Equipment." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a device meets specific technical performance acceptance criteria through the kind of rigorous, independent study typically associated with AI/software as a medical device (SaMD).
Therefore, this document does not contain the information requested regarding acceptance criteria and a study proving a device meets them in the context of an AI/SaMD. This device is a phototherapy unit, and its substantial equivalence is based on its construction, intended use, energy sources, and control system updates, rather than diagnostic performance metrics.
Specifically, the document does not provide:
- A table of acceptance criteria and reported device performance (in the sense of AI performance metrics like sensitivity, specificity, AUC).
- Any details about a test set sample size, data provenance, or ground truth establishment by experts for diagnostic purposes.
- Information on Multi-Reader Multi-Case (MRMC) studies or standalone algorithm performance.
The "Performance Standards" section (page 6) explicitly states: "The ClearLink controlled phototherapy equipment performance data is the same as or very similar to that of the claimed predicate device. The ultraviolet light tubes and cabinet construction used in the production of the predicate device and the ClearLink controlled phototherapy equipment are the same. The only difference between the predicate flex devices and the link devices is the substitution of the link controller for the flex controller for actual entry of doses. The rest of the devices (materials, construction, treatment modality, patient safety, etc., remains exactly the same."
This statement highlights that the performance here refers to the physical and functional constancy with the predicate device, not the diagnostic accuracy or efficacy evaluation of an AI component.
In summary, none of the requested information regarding acceptance criteria, study design parameters (sample size, experts, ground truth, MRMC), or training set details for an AI/SaMD are present in this document because it is not an AI/SaMD submission.
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Daavlin Distributing Company Michele Thiel Management Representative 205 West Bement Street P.O. Box 626 Bryan, Ohio 43506
October 29, 2018
Re: K182215
Trade/Device Name: ClearLink Controlled Phototherapy Equipment Regulation Number: 21 CFR 878.4630 Regulation Name: Ultraviolet Lamp for Dermatologic Disorders Regulatory Class: Class II Product Code: FTC Dated: August 13, 2018 Received: August 15, 2018
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 (Act) that do not require approval of a premarket approval application (PMA). You mav, 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 avare that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located 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.
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
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requirements, including, but not limited to: registration and listing (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Neil R Ogden -S 2018.10.29 09:04:00 -04'00'
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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Indications for Use
510(k) Number (if known) K182215
Device Name
ClearLink Controlled Phototherapy Equipment
Indications for Use (Describe)
The ClearLink Controlled Phototherapy Equipment are medical ultraviolet devices, which are intended for use, by or under the direction of a physician, for therapeutic treatment for individuals who require ultraviolet radiation for diagnosed skin disorders. When equipped with blue lamps the ClearLink Controlled Phototherapy Equipment is intended for use for the treatment of mild to moderate acne vulgaris.
| 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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E. 510(K) Summary:
| Date of Summary: | October 26, 2018 |
|---|---|
| 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: | ClearLink Controlled Phototherapy Equipment |
| 510(K) Number: | K182215 |
| Common Name | Ultraviolet Phototherapy Equipment |
| 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: | Flex Controlled Phototherapy Equipment & 1 Series |
| 510(k) Numbers: | K050695 & K100378 |
| Product Code: | FTC |
| Company: | Daavlin Distributing Company |
| Device Description: | The ClearLink Controlled Phototherapy Equipment are medicalultraviolet devices, which are intended for use, by or under thedirection of a physician, for therapeutic treatment for individuals whorequire ultraviolet radiation for diagnosed skin disorders. The ClearLinkPhototherapy Equipment delivers treatment, with Narrow Band UVB,Broad Band UVB and/or UVA ultraviolet light.Treatments are controlled through the ClearLink Software interface.Access to this interface and stored information is restricted toindividuals who have been established by the physician as authorizedoperators. Authorized operators program treatments in joules based onestablished treatment protocols governed by the patient's skin type,condition, minimum erythemal dose (M.E.D.), and treatment frequency. |
| Indications for Use: | The ClearLink Controlled Phototherapy Equipment are medicalultraviolet devices, which are intended for use, by or under thedirection of a physician, for therapeutic treatment for individuals whorequire ultraviolet radiation for diagnosed skin disorders. Whenequipped with blue lamps the ClearLink Controlled PhototherapyEquipment is intended for use for the treatment of mild to moderateacne vulgaris. |
| Predicate Comparison: | The ClearLink controlled phototherapy equipment is constructed in thesame design configuration as the predicate device, utilizing identicalenergy sources (UV lamps) and materials of identical composition. TheClearLink controlled devices vary from the predicate device, in that thecontrol system hardware and software of the ClearLink control has beenupdated to utilize current technology. The intended use, general andspecific indications for use, spectral output, mode of operation,labeling, treatment area, and general operating principals of theClearLink controlled equipment are the same or similar to those of thepredicate device. The only difference between the predicate flexdevices and the link devices is the substitution of the link controller forthe flex controller for actual entry of doses. The rest of the devices(materials, construction, treatment modality, patient safety, etc.,remains exactly the same. |
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| Features | Subject Device | Predicate Device |
|---|---|---|
| ClearLink Phototherapy Equipment | Flex Controlled PhototherapyEquipment | |
| 510(k) Number | This Submission | K050695 & K100378 |
| Indications forUse | The ClearLink ControlledPhototherapy Equipment aremedical ultraviolet devices, whichare intended for use, by or underthe direction of a physician, fortherapeutic treatment forindividuals who require ultravioletradiation for diagnosed skindisorders.When equipped with blue lampsthe ClearLink ControlledPhototherapy Equipment isintended for use for thetreatment of mild to moderateacne vulgaris. | The Flex Controlled PhototherapyEquipment are ultraviolet emittingmedical light sources, which areintended for use by or under thedirection of a licensed physician for thetreatment of psoriasis, vitiligo, andatopic dermatitis (eczema) on all skintypes (I-VI).When equipped with blue lamps theSeries-1 Phototherapy Equipment isintended for use for the treatment ofmild to moderate acne vulgaris. |
| Prescriptive | Yes | Yes |
| PatientPopulation | Pediatric to Geriatric | Pediatric to Geriatric |
| Patient Contact | There is no direct patient contactwith the device during treatment– Areas of skin are exposed tocontrolled ultraviolet and bluelamp radiation from a distance ofapproximately 9 inches (22.86cm) away. | 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. |
| Anatomical Sites | Topical skin treatment | Topical skin treatment |
| ApplicationEnvironment | Hospital, Clinic, Medical Center,Private Medical Practice, or OtherProfessional MedicalEnvironments under direction ofphysician | Hospital, Clinic, Medical Center, PrivateMedical Practice, or Other ProfessionalMedical Environments under directionof physician |
| Materials | Assembled components housedin metal frame with reflectiveinternal surfaces and fluorescentlamps | Assembled components housed inmetal frame with reflective internalsurfaces and fluorescent lamps |
| ManufacturingMethods | Identical | Identical |
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| Performance Standards: | The ClearLink controlled phototherapy equipment performance data isthe same as or very similar to that of the claimed predicate device. Theultraviolet light tubes and cabinet construction used in the productionof the predicate device and the ClearLink controlled phototherapyequipment are the same. The only difference between the predicateflex devices and the link devices is the substitution of the link controllerfor the flex controller for actual entry of doses. The rest of the devices(materials, construction, treatment modality, patient safety, etc.,remains exactly the same. |
|---|---|
| ------------------------ | ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
On the basis of the information provided in this Summary, the Daavlin Conclusion: Distributing Company believes the ClearLink controlled phototherapy equipment is substantially equivalent to the legally commercialized predicate device.
§ 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.