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510(k) Data Aggregation

    K Number
    K960024
    Device Name
    STORZ D7120 PHACO HANDPIECE MAINTENANCE KIT & STORZ D7125 PHACO HANDPIECE NEEDLE WRENCH
    Manufacturer
    STORZ INSTRUMENT CO.
    Date Cleared
    1996-09-20

    (262 days)

    Product Code
    HQC
    Regulation Number
    886.4670
    Type
    Traditional
    Panel
    Ophthalmic
    Reference & Predicate Devices
    K854508,K921758,K950114,K894278,K921460,K946227,K935926,K952213
    Why did this record match?
    Device Name :

    STORZ D7120 PHACO HANDPIECE MAINTENANCE KIT & STORZ D7125 PHACO HANDPIECE NEEDLE WRENCH

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

    The Storz D7120 Phaco Handpiece Maintenance Kit and the Storz D7125 Needle Wrench are intended to be used as accessories to Storz DAISY® (K854508). Storz Protegé® (K921758 and K950114). and PREMIERE® (K894278, K921460, and K946227) Microsurgical Systems for use in performing phacoemulsification. The D7120 contains an assortment of tools useful in cleaning and maintaining the Phacoemulsification Hndpiece (K935926) and the D7125 is an individual tool used in the assembly and disassembly of the handpiece.

    Device Description

    The Storz D7120 Phaco Handpiece Maintenance Kit and the Storz D7125 Needle Wrench are intended to be used as accessories to Storz DAISY® (K854508). Storz Protegé® (K921758 and K950114). and PREMIERE® (K894278, K921460, and K946227) Microsurgical Systems for use in performing phacoemulsification. The D7120 contains an assortment of tools useful in cleaning and maintaining the Phacoemulsification Hndpiece (K935926) and the D7125 is an individual tool used in the assembly and disassembly of the handpiece.

    AI/ML Overview

    The provided text describes a 510(k) premarket notification for ophthalmic microsurgical system accessories (Storz D7120 Phaco Handpiece Maintenance Kit and Storz D7125 Needle Wrench). This is a submission for medical devices, but it does not contain information about acceptance criteria or a study proving device performance in the context of diagnostic accuracy, a common scenario for AI/ML devices.

    The document's purpose is to demonstrate substantial equivalence of these accessories to predicate devices, not to present performance data against specific acceptance criteria for diagnostic output. It's a comparison of features and intended use, not a performance study as typically understood for AI-enabled diagnostic tools.

    Therefore, I cannot provide the requested information from the provided text for the following reasons:

    • No Acceptance Criteria or Performance Metrics: The document does not define specific acceptance criteria (e.g., sensitivity, specificity, AUC, accuracy thresholds) that the device needs to meet. It focuses on comparing device characteristics.
    • No Performance Study: There is no mention of a study designed to evaluate the diagnostic or treatment performance of the device against a ground truth. The comparison chart focuses on "Intended Use," "Tools Recommended/Included," "Instrument Type," "Tools Provided Sterile?", and "Tools Commonly Available Or Available From Supplier?".
    • Device Type: The devices described are maintenance tools (handpiece maintenance kit, needle wrench), which are accessories for ophthalmic microsurgical systems. They are not AI/ML-enabled diagnostic tools that would typically undergo studies with performance metrics like those requested.

    In summary, the provided text is a 510(k) summary for accessories based on substantial equivalence, not a performance study for an AI/ML device that requires acceptance criteria and an evaluation of its diagnostic or predictive capabilities.

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