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    K Number
    K171939
    Device Name
    ALVUE Balloon Dilation System
    Manufacturer
    Globus Medical, Inc.
    Date Cleared
    2018-03-07

    (252 days)

    Product Code
    GCJ
    Regulation Number
    876.1500
    Type
    Traditional
    Panel
    General and Plastic Surgery (SU)
    Reference & Predicate Devices
    K110998,K110833,K132383,K143609,K090631,K973046
    Why did this record match?
    Reference Devices :

    K110998, K110833, K132383, K143609

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

    The ALVUE™ Balloon Dilation System is indicated for patients undergoing surgical procedures requiring tissue retraction including the following procedures: endoscopic; laparoscopic; general surgery; plastic and reconstructive surgery; spine surgery; orthopedic surgery; thoracoscopic surgery; and procedures in the extraperitoneal space. The system is intended to create an operative space by dissecting layers of connective tissue along natural tissue planes of separation of the extraperitoneal, subcutaneous extremity, or thoracic space.

    Device Description

    The ALVUE™ Balloon Dilation System is a surgical instrument that consists of an inflatable nylon balloon attached to the distal end of a dilator. ALVUE™ is used to dilate soft tissue to gain access to the surgical site and is available in a variety of sizes to accommodate the anatomical needs of the patient. The system includes accessories for inflation. ALVUE™ is a sterile single use device.

    AI/ML Overview

    This device is a physical medical device (ALVUE™ Balloon Dilation System) and not an AI/ML powered device, so acceptance criteria and studies are based on mechanical and biocompatibility testing rather than AI model performance metrics. Therefore, many of the requested fields are not applicable.

    Here's the relevant information from the provided document:

    1. Table of Acceptance Criteria and Reported Device Performance:

    Acceptance Criteria CategorySpecific Test/StandardReported Device Performance/Compliance
    Mechanical TestingInflation Volume and Pressure (in accordance with ISO 10555-1:2013 and ISO 10555-4:2013)Performance data demonstrates substantial equivalence to the predicate. (Quantitative values not provided in this summary.)
    Axial Tension (in accordance with ISO 10555-1:2013 and ISO 10555-4:2013)Performance data demonstrates substantial equivalence to the predicate. (Quantitative values not provided in this summary.)
    Fatigue (in accordance with ISO 10555-1:2013 and ISO 10555-4:2013)Performance data demonstrates substantial equivalence to the predicate. (Quantitative values not provided in this summary.)
    Biocompatibility TestingAccording to ISO 10993-1 on patient contacting materialsPerformed (Result is implied compliance for substantial equivalence, specific results not detailed in this summary.)
    Technological CharacteristicsDesign, intended use, material composition, and function compared to predicate devices.Similar technological characteristics to predicate devices. Consists of cylindrical balloons that dilate soft tissue. Uses fluid to inflate (predicates use fluid or gas).
    Intended UseFor patients undergoing surgical procedures requiring tissue retraction (endoscopic; laparoscopic; general surgery; plastic and reconstructive surgery; spine surgery; orthopedic surgery; thoracoscopic surgery; and procedures in the extraperitoneal space)The ALVUE™ Balloon Dilation System is indicated for these procedures. (Note: ALVUE™, unlike the predicates, is not indicated for vascular surgery nor laparoscopic surgery requiring a sealed port of access.)

    2. Sample Size Used for the Test Set and Data Provenance:

    • Sample Size for Test Set: Not specified in the provided summary.
    • Data Provenance: Not specified in the provided summary (as these are physical device tests, not clinical data from patients).

    3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

    • Not Applicable. This is not an AI/ML device relying on expert-established ground truth from clinical data. The "ground truth" for mechanical testing is compliance with established engineering standards (ISO 10555-1, ISO 10555-4) and biocompatibility standards (ISO 10993-1).

    4. Adjudication Method:

    • Not Applicable. This is not an AI/ML device.

    5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

    • No. This is not an AI/ML device.

    6. Standalone (Algorithm Only) Performance Study:

    • Not Applicable. This is a physical medical device, not an algorithm.

    7. Type of Ground Truth Used:

    • For mechanical testing: Engineering standards (ISO 10555-1:2013, ISO 10555-4:2013).
    • For biocompatibility: Biocompatibility standards (ISO 10993-1).

    8. Sample Size for the Training Set:

    • Not Applicable. This is a physical medical device, not an AI/ML model that requires a training set.

    9. How the Ground Truth for the Training Set Was Established:

    • Not Applicable. This is a physical medical device.
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