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510(k) Data Aggregation

    K Number
    K213163
    Device Name
    VersaWrap
    Manufacturer
    Alafair Biosciences Inc
    Date Cleared
    2021-10-29

    (31 days)

    Product Code
    FTM
    Regulation Number
    878.3300
    Type
    Special
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K203600
    Why did this record match?
    Reference Devices :

    K203600

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

    VersaWrap is indicated for the management and protection of tendon injuries in which there has been no substantial loss of tendon tissue. The device may also be used in the management and protection of surrounding tissues such as skeletal muscle and ligament.

    Device Description

    VersaWrap® is an absorbable implant (device), designed to serve as an interface between the target tissues and surrounding tissues to provide a non-constricting, protective encasement. VersaWrap consists of a clear Sheet and a wetting Solution. The clear Sheet is a thin membrane of crosslinked calcium alginate and glycosaminoglycan (GAG). VersaWrap Sheet is easy to handle, conformable, and is designed for placement under, around, or over injured tissues and/or surrounding tissues. VersaWrap Sheet is supplied sterile, non-pyrogenic, for single use, in double peel pouches. The VersaWrap Solution is applied to the Sheet rendering the Sheet a gelatinous, tissue adherent layer. The Solution, comprised of aqueous citrate, is provided sterile, non-pyrogenic, for single use, in a dropper, packaged in a double peel pouch.

    AI/ML Overview

    The provided text does not contain information about acceptance criteria or a study that proves a device meets such criteria. The document is an FDA 510(k) clearance letter for the VersaWrap device, which certifies its substantial equivalence to a predicate device.

    The document discusses the device description, indications for use, and confirms that non-clinical tests were performed. However, it does not detail specific acceptance criteria (e.g., performance metrics, thresholds) or the study design, sample sizes, ground truth establishment, or expert involvement that would typically be associated with proving these criteria were met for a new AI/medical device.

    Therefore, I cannot provide the requested information in the table format or answer the specific questions about sample sizes, ground truth, expert qualifications, or MRMC studies because this information is not present in the provided text.

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