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510(k) Data Aggregation

    K Number
    K982748
    Device Name
    BI-POLAR CORD SET 1.88 TR, BI-POLAR CORD SET 1.83 TR, MODEL #'S SB223, SB 224
    Manufacturer
    NEW DEANTRONICS TAIWAN, LTD.
    Date Cleared
    1998-11-03

    (89 days)

    Product Code
    GEI
    Regulation Number
    878.4400
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    BI-POLAR CORD SET 1.88 TR, BI-POLAR CORD SET 1.83 TR, MODEL #'S SB223, SB 224

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

    Electrosurgical accessory. BiPolar Cord Set for use with foot switching electrosurgical accessories to conduct high-frequency electrical current intended to remove tissue and control bleeding.

    Device Description

    New Deantronics, Inc. Model SB 223 and SB 224 BiPolar Cord Sets.

    AI/ML Overview

    I am sorry, but based on the provided document, I cannot answer your request. The document is a 510(k) clearance letter from the FDA for a BiPolar Cord Set. It confirms that the device is substantially equivalent to a predicate device and can be marketed.

    However, the document does not contain any information regarding:

    • Acceptance criteria or reported device performance metrics.
    • Details of any specific studies (e.g., sample sizes, data provenance, ground truth establishment, expert qualifications, adjudication methods).
    • Information about multi-reader multi-case studies or standalone algorithm performance.
    • Details about training sets for any AI/ML models.

    The document is purely an administrative clearance and does not delve into the technical study details you are asking for.

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