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510(k) Data Aggregation

    K Number
    K181455
    Device Name
    ProSun sunlamp products, Luxura sunlamp products
    Manufacturer
    ProSun International LLC
    Date Cleared
    2018-09-10

    (98 days)

    Product Code
    LEJ
    Regulation Number
    878.4635
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K944015
    Why did this record match?
    Device Name :

    ProSun sunlamp products, Luxura sunlamp products

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

    Tanning Bed Systems are intended to provide tanning of the human skin.

    Device Description

    The primary technical components of sunlamp products are whole body tanning devices consisting of a mechanical frame with Ultraviolet (UV) lamps providing an artificial source of UV radiation. The UV light is intended for irradiation of the human body to induce skin tanning. The user of the proposed devices device either lies in the horizontal tanning bed or stands in the vertical tanning booth.

    Skin tanning varies with skin type and as the UV sources intensities with characteristic UV-A and UV-B proportions result in cosmetic tanning of the human skin.

    The UV-A proportion primarily generates a superficial tan, which appears rapidly and is intensive but fades more rapidly. The UV-B radiation is primarily responsible for more longterm tanning results.

    AI/ML Overview

    This document describes ProSun International LLC's submission for their sunlamp products, establishing substantial equivalence to previously marketed predicate devices. This is a 510(k) submission for tanning bed systems, which are classified as Class II medical devices. The document does not describe an AI/ML powered device, therefore the typical acceptance criteria and study data for AI/ML devices involving human readers, test sets, ground truth, and training sets are not applicable.

    Instead, the acceptance criteria for these devices revolve around compliance with established performance standards and safety regulations for sunlamp products.

    Here's a breakdown of the requested information, adapted to the context of this device:

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

    Acceptance Criteria (FDA Performance Standards & Guidance)Reported Device Performance (Summary of Performed Tests)
    Biocompatibility: In accordance with DIN EN ISO 10993Non-clinically tested in accordance with DIN EN ISO 10993.
    Electrical and Mechanical Safety: In accordance with IEC 60601-1 (IEC 60335-2-27 and UL 482)Non-clinically tested in accordance with IEC 60601-1 (IEC 60335-2-27 and UL 482).
    EMC (Electromagnetic Compatibility): In accordance with IEC 60601-1-2 (CISPR 14-1 and 14-2)Non-clinically tested in accordance with IEC 60601-1-2 (CISPR 14-1 and 14-2).
    Spectral Emissions: Measured in accordance with IEC 6033-2-27 and 21 CFR 1002, 1010-1050Spectral emissions of all sunlamp products were measured (test procedure in accordance with IEC 6033-2-27 and 21 CFR 1002, 1010-1050).
    Irradiance Ratio Limits: In accordance with 21 CFR 1040.2(c)(1)Irradiance ratio limits of all proposed sunlamp products are in accordance with 21 CFR 1040.2(c)(1).
    Software Verification & Validation: According to FDA's "Guidance for the Content of Premarket Submission for Software Contained in Medical Devices" (if applicable)Non-clinically tested for software verification & validation testing according to FDA's "Guidance for the Content of Premarket Submission for Software Contained in Medical Devices" (implying compliance, as the devices are presented as being substantially equivalent).
    Maximum Timer Intervals and Exposure Schedules: Determined according to FDA's "Policy on maximum timer interval and exposure schedule for sunlamp products."The maximum timer intervals and exposure schedules have been determined according to FDA's "Policy on maximum timer interval and exposure schedule for sunlamp products." (The table in section 1.5.6 on page 6 details the "Max Exposure Min." for each model, ranging from 9 to 20 minutes, which represents the device's adherence to these schedules).
    Performance Standards Testing: In accordance with 21 CFR 1040.20Performance Standards testing in accordance with 21 CFR 1040.20.

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

    This information is not applicable as this is not an AI/ML study involving a test set of data. The devices themselves are the "test set" and their performance is evaluated against regulatory standards. The testing described is primarily non-clinical, evaluating the physical device characteristics and compliance with electrical, mechanical, and radiation emission standards.

    3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

    This information is not applicable. The "ground truth" for sunlamp products relies on established engineering and medical device safety standards and regulations (e.g., IEC, UL, 21 CFR). Expert review would be conducted by regulatory bodies and internal engineering teams to ensure compliance, rather than clinical experts establishing a ground truth for a diagnostic AI.

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

    This information is not applicable. This is not a study requiring adjudication of interpretations from multiple readers.

    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

    This information is not applicable. This submission is for sunlamp products, not a device with AI assistance for human readers.

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

    This information is not applicable. These are physical sunlamp devices, not software algorithms.

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

    The "ground truth" in this context is the set of established safety and performance standards, regulations, and internationally recognized testing procedures for sunlamp products. This includes:

    • 21 CFR 878.4635 (Regulation for Ultraviolet Lamp for Tanning)
    • 21 CFR 1040.20 (Performance standards for sunlamp products)
    • 21 CFR 1002, 1010-1050 (Electronic product radiation control)
    • IEC 60601-1 (Medical electrical equipment - General requirements for basic safety and essential performance)
    • IEC 60335-2-27 (Household and similar electrical appliances - Safety - Part 2-27: Particular requirements for appliances for skin exposure to ultraviolet and infrared radiation)
    • UL 482 (Standard for Portable Sun/Health Lamps)
    • DIN EN ISO 10993 (Biological evaluation of medical devices)
    • CISPR 14-1 and 14-2 (Electromagnetic compatibility for household appliances, electric tools and similar apparatus)
    • FDA Guidance documents (e.g., "Guidance for the Content of Premarket Submission for Software Contained in Medical Devices" and "Policy on maximum timer interval and exposure schedule for sunlamp products")

    8. The sample size for the training set

    This information is not applicable. This is not an AI/ML device that requires a training set.

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

    This information is not applicable. There is no training set for this device.

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