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510(k) Data Aggregation

    K Number
    K024027
    Device Name
    LIGHTWAVE INFRARED LAMPS LW10D AND LW30D
    Manufacturer
    SKYTECH ENTERPRISES, INC.
    Date Cleared
    2003-12-03

    (362 days)

    Product Code
    ILY
    Regulation Number
    890.5500
    Type
    Traditional
    Panel
    Physical Medicine
    Reference & Predicate Devices
    K020851,K993684
    Predicate For
    K051046
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    To provide infrared light energy that penetrates the skin to promote increased blood flow and circulation, thereby, providing temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, and muscle spasm. The elevated tissue temperature also promotes relaxation of muscles and relief from pain resulting in improved range of motion

    Device Description

    The devices are a family (models) of infrared lamps having the same indication for use and equivalent technology. The units are electrical and mechanical designs for use and convenience of users to provide topical heating. Heat is generated by LEDs (light emitting diodes) at 940 nm wavelength.

    AI/ML Overview

    The provided 510(k) summary for the LightWave™ Infrared Photon Stimulator, Models LW10D and LW30D, does not contain information regarding traditional acceptance criteria or a study designed to prove device performance against such criteria in the context of diagnostic accuracy, which is typical for AI/ML devices.

    Instead, this submission focuses on establishing substantial equivalence to predicate devices for infrared lamps and demonstrating safety and performance in terms of heating capabilities to justify its intended use for temporary pain relief. Therefore, many of the requested categories related to AI/ML device studies (like sample sizes for test/training sets, ground truth establishment, expert adjudication, MRMC studies) are not applicable to this particular document.

    Here's an attempt to answer the questions based on the available information:

    1. Table of Acceptance Criteria and Reported Device Performance:

    Acceptance Criteria (Implied by Substantial Equivalence and Safety)Reported Device Performance
    Indications for Use: Promote increased blood flow and circulation, providing temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, and muscle spasm. Promote relaxation of muscles and relief from pain resulting in improved range of motion.Stated to have the "same indications for use as the predicate devices". "Design has been tested and verified to raise the skin temperature adequately to effect the indications for use."
    Technological Characteristics: Use light emitting diodes (LEDs) to convey heat energy to the skin, operating at 940nm wavelength."All are based on the mode of operation that light emitting diodes convey heat energy to the skin. The device LEDs all operate at 940nm." Specific wavelengths, number of LEDs, output power, and treatment areas are provided and compared to predicates.
    Safety: Device operates safely, potential hazards are mitigated. Electrical safety and skin temperature rise safely."A Risk Analysis was performed on all models using EN1441. Potential hazards are identified and have been mitigated by design and labeling." "The devices were tested for performance and found to raise skin temperature safely when used following the manufacturer's instructions." "Adapters to convert 110V power to 9V or 12V are UL listed to assure user safety."
    Performance: Raise skin temperature adequately to effect the indications for use."The design has been tested and verified to raise the skin temperature adequately to effect the indications for use."

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

    • Not applicable. This submission describes a physical device (infrared lamp) and its substantial equivalence to predicate devices, not an AI/ML diagnostic system. There is no "test set" in the context of AI/ML performance evaluation. The "testing" mentioned refers to non-clinical performance and safety testing of the physical hardware.

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

    • Not applicable. No ground truth for an AI/ML diagnostic test set was established.

    4. Adjudication method for the test set:

    • Not applicable.

    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 is not an AI-assisted diagnostic device.

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

    • Not applicable.

    7. The type of ground truth used:

    • Not applicable. The "ground truth" for this device relates to its ability to emit infrared light, safely raise skin temperature, and the known physiological effects of heat on pain and circulation. This is established through established scientific principles and non-clinical testing, not expert consensus on diagnostic images or pathology.

    8. The sample size for the training set:

    • Not applicable. There is no AI/ML model that would require a training set.

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

    • Not applicable.
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