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510(k) Data Aggregation

    K Number
    K131820
    Device Name
    AVAMAX VERTEBRAL BALLOON SYSTEM, 8G, AVAMAX VERTEBRAL BALLOON SYSTEM, 10G, AVAMAX VERTEBRAL BALLOON SYSTEM, 11G
    Manufacturer
    CAREFUSION
    Date Cleared
    2013-10-04

    (106 days)

    Product Code
    HRX,NDN
    Regulation Number
    888.1100
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K103064,K093463,K090211,K043518
    Predicate For
    K141419,K150523,K151704
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Intended for the reduction and fixation of fractures and/or creation of a void in cancellous bone in the spine for kyphoplasty (for use with CareFusion Radiopaque Bone Cement).

    Device Description

    The Inflatable Bone Tamp (IBT) was designed for use in balloon kyphoplasty. The balloon serves to create a cavity in the vertebral body, thereby reducing the fracture and preventing cement leakage, while still allowing for cement interdigitation. The balloon catheter is the functional part of the device that creates a cavity and reduces the fracture. The balloon catheter provides a conduit through which the physician can inflate the balloon at the distal end of the catheter.

    AI/ML Overview

    The provided document describes the acceptance criteria and study for the CareFusion AVAmax Vertebral Balloon.

    Acceptance Criteria and Reported Device Performance

    CharacteristicAcceptance Criteria (Standard/Test/FDA Guidance)Reported Device Performance (Results Summary)
    Inflation pressureConstrained burst testThe balloon catheters exceeded the requirements for the minimum burst pressure in a constrained environment.
    Inflation volumeUnconstrained burst testThe balloon catheters exceeded the requirements for the minimum burst volume in an unconstrained environment.
    Balloon double wall thicknessCalibrated measurementThe double wall thickness of the balloons was substantially equivalent to that of the predicate devices.

    Study Details

    1. Sample size used for the test set and the data provenance: Not applicable. This submission relies on non-clinical performance testing of the device itself, rather than clinical data from a "test set" of patients.

    2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The ground truth for the performance tests was based on engineering measurements and established test standards, not expert consensus.

    3. Adjudication method for the test set: Not applicable.

    4. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: No MRMC study was conducted. This device is a medical instrument, not an AI or imaging diagnostic tool.

    5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a physical medical instrument.

    6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The ground truth for the non-clinical performance tests was based on quantitative measurements against predefined engineering standards and requirements.

    7. The sample size for the training set: Not applicable. No training set was used as this involved non-clinical performance testing of a physical device.

    8. How the ground truth for the training set was established: Not applicable.

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