LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K970511
    Device Name
    DYONICS DISPOSABLE ENDOSCOPIC SURGERY BLADES
    Manufacturer
    SMITH & NEPHEW, INC.
    Date Cleared
    1997-08-12

    (182 days)

    Product Code
    HRX
    Regulation Number
    888.1100
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    DYONICS DISPOSABLE ENDOSCOPIC SURGERY BLADES

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

    Dyonics Disposable Endoscopic Surgery Blades are indicated for resection of soft and osseous tissues in large articular cavities, small articular cavities, and Functional Endoscopic Sinus Surgery (FESS). The FESS application is limited to those small blades which are appropriate for the procedure.

    Device Description

    Curved Small Joint Disposable Endoscopic Surgery Blades are utilized in conjunction with a control console, motor drive unit, footswitch and suction to resect soft and osseous tissues as per indications. The blades can be operated in forward, reverse and oscillate modes and at variable speeds controlled by the surgeon. The rotary action coupled with suction draws tissue into the window of the blade where rotation of the inner blade cleanly excises and evacuates the resected material. Irrigation aids in evacuation of resected materials through the blade.

    AI/ML Overview

    The provided text is a 510(k) summary for the Dyonics Curved Small Joint Disposable Endoscopic Surgery Blades. This type of submission is for demonstrating substantial equivalence to a predicate device, rather than proving safety and effectiveness through clinical trials with specific acceptance criteria and performance metrics.

    Therefore, the document does not contain the information requested regarding:

    • Acceptance criteria and reported device performance (beyond substantial equivalence to predicate devices).
    • Sample size for the test set or data provenance.
    • Number of experts and their qualifications for establishing ground truth.
    • Adjudication method for the test set.
    • MRMC comparative effectiveness study or effect size.
    • Standalone (algorithm only) performance.
    • Type of ground truth used.
    • Sample size for the training set.
    • How ground truth for the training set was established.

    Instead, the document focuses on comparing the new device to existing predicate devices (Stryker Endoscopy's Curved Small Joint/ENT Disposable Blades and Linvatec Merlin Disposable Arthroscopic Surgery Blade) in terms of intended use, materials, design, and function to demonstrate substantial equivalence. The FDA letter confirms this determination.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1