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510(k) Data Aggregation

    K Number
    K213519
    Device Name
    Rune Labs Tremor Transducer System
    Manufacturer
    Rune Labs, Inc.
    Date Cleared
    2022-06-10

    (219 days)

    Product Code
    GYD, ISD, NXQ
    Regulation Number
    882.1950
    Why did this record match?
    Applicant Name (Manufacturer) :

    Rune Labs, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Rune Labs Kinematic System is intended to quantify kinematics of movement disorder symptoms including tremor and dyskinesia, in adults (45 years of age or older) with mild to moderate Parkinson's disease.
    Device Description
    The Rune Labs Kinematic System collects derived tremor and dyskinesia probability scores using processes running on the Apple Watch, and then processes and uploads this data to Rune's cloud platform where it is available for display for clinicians. The Rune Labs Kinematic System uses software that runs on the Apple Watch to measure patient wrist movements. These movements are used to determine how likely dyskinesias or tremors are to have occurred. The times with symptoms are then sent to the Rune Labs Cloud Platform using the Apple Watch's internet connection, which is then displayed for clinician use. The Apple Watch contains accelerometers and gyroscopes which provide measurements of wrist movement. The Motor Fluctuations Monitor for Parkinson's Disease (MM4PD) is a toolkit developed by Apple for the Apple Watch that assesses the likely presence of tremor and dyskinesia as a function of time. Specifically, every minute, the Apple Watch calculates what percentage of the time that tremor and dyskinesia were likely to occur. The movement disorder data that is output from the Apple's MM4PD toolkit have been validated in a clinical study (Powers et al., 20211). The Rune Labs Kinematic System is software that receives, stores, and transfers the Apple Watch MM4PD classification data to the Rune Labs Cloud Platform where it is available for visualization by clinicians. The device consists of custom software that runs on the users' smart watch and web browsers.
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