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510(k) Data Aggregation

    K Number
    K972063
    Device Name
    WHITTINGHAM ULTRACLEAN PHACO HANDPIECE
    Manufacturer
    WILLIAM F. WHITTINGHAM
    Date Cleared
    1997-11-25

    (175 days)

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

    WHITTINGHAM ULTRACLEAN PHACO HANDPIECE

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

    The Whittingham UltraClean Phaco Handpiece is indicated for surgical removal of cataract tissues or other unwanted eye tissue.

    Device Description

    The Whittingham UltraClean Phaco Handpiece is a phacoemulsification handpiece, for use with standard, disposable phaccemulsification needles, a 39 to 55 KHz Piezoelectric driver module, and the associated ophthalmic surgical system control units. A handpiece such as this is used in ophthalmic surgery to break up (emulsify) and remove unwanted or degenerative tissues, such as cataract tissue.

    AI/ML Overview

    The provided document is a 510(k) summary for the Whittingham UltraClean™ Phaco Handpiece. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with detailed acceptance criteria and results.

    Therefore, the document does not contain the requested information regarding acceptance criteria, a study proving device performance against those criteria, sample sizes, ground truth establishment, or expert involvement.

    The document primarily states:

    • Intended Use: The Whittingham UltraClean Phaco Handpiece is intended for use as a component of a phacoemulsification surgical system, in the surgical removal of unwanted or degenerative tissues, such as cataract tissue.
    • Comparison to Predicate Device: The device shares general technological characteristics with the predicate device (Allergan Model 5000 Ophthalmic Surgical System). Both are components of a surgical phacofragmentation system, are self-cooling, autoclavable, incorporate a piezoelectric motor, and accept a standard phaco needle.
    • Design Improvements: The new device includes changes that allow for easier cleaning, rotation of connectors, and improved irrigation fluid delivery to prevent cavitation bubbles. These changes are "expected to enhance the safety and effectiveness of the device."

    Without a dedicated performance study described in the document, it's impossible to populate the requested table and answer the specific questions about study methodology, sample sizes, and ground truth.

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