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510(k) Data Aggregation

    K Number
    K973749
    Device Name
    FRAG COMMANDER
    Manufacturer
    SCIERAN TECHNOLOGIES, INC.
    Date Cleared
    1997-12-08

    (68 days)

    Product Code
    HQC
    Regulation Number
    886.4670
    Type
    Traditional
    Panel
    Ophthalmic (OP)
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    FRAG COMMANDER

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

    For use in fragmentation and aspiration of the human lens

    Device Description

    Frag Commander™ Phacofragmentation Device

    AI/ML Overview

    This document, a 510(k) clearance letter, does not contain any information about acceptance criteria or a study proving device performance.

    The letter from the FDA to Scieran Technologies for the "Frag Commander" device (K973749) indicates that the device has been found substantially equivalent to a legally marketed predicate device. This substantial equivalence determination means that the FDA believes the new device is as safe and effective as a device already on the market.

    However, the letter only certifies the regulatory clearance and does not provide details about:

    • Acceptance Criteria: What specific performance metrics were required for the device.
    • Study Data: Any clinical or non-clinical study results demonstrating the device meets performance thresholds.
    • Sample Sizes, Ground Truth, Expert Qualifications, Adjudication, MRMC studies, Standalone performance, or Training set details.

    These types of details would typically be found in the 510(k) submission itself, which is not provided in the input. The provided text is solely the FDA's decision letter.

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