LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K974719
    Device Name
    PHACOPAK
    Manufacturer
    PARADIGM MEDICAL INDUSTRIES, INC.
    Date Cleared
    1998-01-20

    (33 days)

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

    PHACOPAK

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

    The Paradigm Phaco Tip is intended to be used in conjunction with an ultrasonic handpiece for ophthalmic surgery to remove cataract tissue.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a device called "Phacopak" (also referred to as "Phaco Tip"). It explicitly states that the device is substantially equivalent to legally marketed predicate devices.

    However, this document DOES NOT contain any information regarding acceptance criteria, device performance, sample sizes for testing, ground truth establishment, expert qualifications, adjudication methods, or results from any studies (standalone or MRMC comparative effectiveness).

    The letter is a regulatory approval document and focuses on the administrative aspects of substantial equivalence, not the detailed technical data that would be found in a study report.

    Therefore, I cannot fulfill your request for the acceptance criteria and study details based on the provided text. The requested information is simply not present in these documents.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1