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510(k) Data Aggregation

    K Number
    K071394
    Device Name
    MODIFICATION TO:SBI RINGFIX
    Manufacturer
    SMALL BONE INNOVATIONS INC.
    Date Cleared
    2007-06-29

    (39 days)

    Product Code
    KTT
    Regulation Number
    888.3030
    Type
    Special
    Panel
    Orthopedic
    Reference & Predicate Devices
    K890814
    Why did this record match?
    Device Name :

    MODIFICATION TO:SBI RINGFIX

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

    The RingFIXTM System is intended for:

    1. fracture fixation (open and closed)
    2. pseudarthrosis or nonunions of long bones
    3. limb lengthening by epiphyseal or metaphyseal distraction
    4. correction of bony or soft tissue deformities
    5. correction of segmental bony or soft tissue defects
    Device Description

    This Special 510(k) Submission is intended to add additional components to the RingFIX™ System

    AI/ML Overview

    The provided text is a 510(k) Summary and an FDA clearance letter for the SBi RingFIX™ System. It focuses on establishing substantial equivalence to a predicate device and adding new components to an existing system.

    Therefore, it does not contain the detailed information requested regarding acceptance criteria, specific device performance studies with sample sizes, expert involvement, ground truth establishment, or multi-reader multi-case studies typically associated with AI/software medical devices.

    Medical devices like the SBi RingFIX™ System (a bone fixation appliance) are typically evaluated through different types of studies, such as:

    • Mechanical Testing: To assess strength, fatigue, and other physical properties.
    • Biocompatibility Testing: To ensure the materials are safe for use in the body.
    • Sterilization Validation: To confirm the device can be effectively sterilized.
    • Pre-clinical (animal) studies: In some cases, to assess performance in a living system.
    • Clinical studies (human trials): For new or high-risk devices, to demonstrate safety and effectiveness in patients.

    The 510(k) Summary states: "The Design Control Activities Summary demonstrates that the modified device met all of the pre-determined acceptance criteria. The modified RingFIX™ System will achieve the same stability as afforded by the currently available RingFIX™ System." This indicates that performance data exists, but the specifics are not included in this summary document.

    Based on the provided text, I cannot complete the requested tables and sections as the information is not present. The document describes a "Special 510(k) Submission" intended to add additional components to an existing system, rather than a clinical trial for a novel device or an AI-powered one.

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