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510(k) Data Aggregation

    K Number
    K971533
    Device Name
    VIBRA-SURGE SYSTEM MODEL VS2120
    Manufacturer
    SONICS & MATERIALS, INC.
    Date Cleared
    1997-07-25

    (88 days)

    Product Code
    LFL
    Regulation Number
    N/A
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K961919,K023608,K933221
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Aids in the fragmentation, emulsification and removal of soft tissue in General and Plastic & Reconstructive Surgery

    Device Description

    The VIBRA-SURGE ™ System VS2120 is comprised of a generator, operating at one of several possible standard line voltages, contained in a console which feeds a 20-22 kHz electrical signal to a surgical handpiece containing piezoceramic crystals. These crystals convert the electrical energy into mechanical motion. This mechanical motion has the same frequency of 20-22 kHz. Fragmentation of unwanted tissues occurs at the end of the tip which is hollow allowing the use of a vacuum source to remove these fragments.

    AI/ML Overview

    The provided document is a 510(k) summary for the VIBRA-SURGE™ System VS2120 Ultrasonic Surgical Instrument. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, the document does not contain information regarding detailed acceptance criteria, specific device performance data from studies, sample sizes, data provenance, expert qualifications, ground truth establishment, or multi-reader multi-case studies.

    Therefore, I cannot provide the requested information from the given text. The document primarily focuses on establishing substantial equivalence to previously marketed devices as part of the 510(k) premarket notification process.

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