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510(k) Data Aggregation

    K Number
    K213712
    Device Name
    Pectus Support Bar System
    Manufacturer
    Biomet Microfixation
    Date Cleared
    2022-03-11

    (107 days)

    Product Code
    HRS
    Regulation Number
    888.3030
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K061384
    Why did this record match?
    Device Name :

    Pectus Support Bar System

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

    This device is intended for use in surgical procedures to repair Pectus Excavatum. It is intended to be used in pediatric (children and adolescents) populations.

    Device Description

    The Pectus Support Bar and stabilizers are surgical implants intended to aid treatment of Pectus Excavatum deformity. The Pectus Support Bar provides the surgeon with a means to reposition bony structures (sternum, breastbone) by applying internal force outwardly eliminating the funnel shape deformity. The device should be removed when remodeling is evident. These devices are offered as flat (unbent) bars requiring intraoperative shaping, or alternatively may be prebent to patient anatomy. These devices are intended to be used in professional healthcare facilities.

    The Pectus Support Bar are made of titanium alloy (ASTM F1472) or stainless steel (ASTM F138). The Pectus Stabilizers are made of stainless steel (ASTM F138) or titanium alloy (ASTM F136). The Pectus Support Bar system is provided non-sterilization by the end user.

    AI/ML Overview

    The provided text is a 510(k) summary for a medical device called the "Pectus Support Bar System." This document describes the device, its intended use, and how it demonstrates substantial equivalence to a predicate device. However, it does not include information about AI/ML device performance, acceptance criteria, or a study proving it meets those criteria, as it's a structural implant and not an AI/ML diagnostic or prognostic device.

    Therefore, I cannot fulfill the request to provide the acceptance criteria and study details as an AI/ML device. The document explicitly states:

    • "Clinical data was not required for the determination of substantial equivalence."
    • The performance testing described is focused on material properties, mechanical strength, MR compatibility, and biocompatibility, as relevant for an implantable device, not AI/ML performance.

    If you have a document describing an AI/ML-based medical device, I would be happy to analyze it for the requested information.

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