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510(k) Data Aggregation

    K Number
    K170489
    Device Name
    Skylit Phototherapy System
    Manufacturer
    Skylit Medical
    Date Cleared
    2017-05-23

    (95 days)

    Product Code
    FTC
    Regulation Number
    878.4630
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K073587,K072035
    Why did this record match?
    Applicant Name (Manufacturer) :

    Skylit Medical

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Clarify Medical Phototherapy System is an Ultraviolet Light Emitting Medical Device. It is intended for use in localized phototheraputic treatment of dermatologic conditions such as psoriasis, vitiligo, atopic dermatitis (eczema), seborrheic dermatitis and lenkoderma on all skintypes (I-VI).

    Device Description

    The Clarify Phototherapy System is a handheld medical device that produces UVB light for the purpose of phototherapy. It was developed and will be marketed by Skylit Medical, Inc. DBA Clarify Medical, Inc. and is referred to herein as "Clarify Medical" or "Clarify". The Clarify Medical Phototherapy System is an Ultraviolet Light Emitting Medical device. It is indicated for use in localized phototherapeutic treatment of dermatologic conditions such as psoriasis, vitiligo, atopic dermatitis (eczema), seborrheic dermatitis and leukoderma on all skin types (I-VI). The system consists of the following components and accessories:

    • Handheld UV light Emission device that delivers the UVB light
    • Mobile Software Application that runs on smartphone (Android and iOS) platforms. This Application is the primary user interface, and provides patient guidance when phototherapy is delivered and treatment reminders
    • Physician Portal Software is a cloud based software application that links the patient to the prescribing physician during home therapy.
    AI/ML Overview

    The provided text describes a 510(k) premarket notification for the "Skylit Phototherapy System" (later referred to as "Clarify Medical Phototherapy System"). This device is a handheld UV light treatment system for dermatologic conditions. The submission aims to demonstrate substantial equivalence to previously marketed devices.

    Based on the provided document, the device in question is a phototherapy system, not an AI/algorithm-based device. Therefore, the questions related to AI acceptance criteria, sample size for AI test sets, number of experts for ground truth, adjudication methods, MRMC studies, standalone algorithm performance, and training set information are not applicable to this medical device submission.

    The acceptance criteria provided focus on the electrical, optical, software, and biocompatibility safety and performance of the phototherapy device. The study proving these criteria are met consists of various performance tests and validations.

    Here's a breakdown of the applicable information:

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

    Element of ComparisonMethod for Safety AssessmentTest Result Meet Design Input Specifications and Demonstrate EquivalenceNotes
    UBV light Source, Max Power OutputPerformance Testing (optical emissions spectrum measured at the treatment surface, biologically weighted emissions curve computed using the International Commission on Illumination accepted erythema curve, optical power at treatment surface measured). Evaluated in accordance with IEC 60601-2-57.YesVerification testing demonstrated weighted peak of emissions within established therapeutic range (300-320nm) and optical power at treatment surface met specified requirements.
    Power SourceElectrical Safety Testing, Battery Performance Testing. Evaluated in accordance with IEC 60601-1 and IEC 60601-1-4.YesNot explicitly detailed in the provided text beyond "Yes."
    Prescription Stored on the deviceSystem Validation. Compliance with relevant FDA guidance documents for software (e.g., Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices) and IEC 62304.YesThis refers to prescriptions being stored on a cloud server for the subject device, a feature that distinguishes it from some predicate devices.
    Treatment RemindersSoftware Validation. Compliance with relevant FDA guidance documents for software (e.g., Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices) and IEC 62304.YesThis feature is built into the mobile software application.
    Auto Calculation of treatment adjustmentSystem Validation. Compliance with relevant FDA guidance documents for software (e.g., Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices) and IEC 62304.YesThis capability is built into the software in accordance with the prescribed protocol.
    Skin Contact MaterialsPerformance testing. Evaluated for biocompatibility in accordance with ISO 10993-1 (cytotoxicity, sensitization, irritation) as a "surface device" with limited contact duration (
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