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510(k) Data Aggregation

    K Number
    K050232
    Device Name
    RIGIFLEX SINGLE-USE ACHALASIA BALLOON DILATOR
    Manufacturer
    BOSTON SCIENTIFIC CORP.
    Date Cleared
    2005-03-11

    (38 days)

    Product Code
    PID
    Regulation Number
    876.5980
    Type
    Special
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    K781772
    Why did this record match?
    Device Name :

    RIGIFLEX SINGLE-USE ACHALASIA BALLOON DILATOR

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

    The Boston Scientific Corporation Rigiflex™ II Single-Use Achalasia Balloon Dilator is indicated for dilatation of the cardia in patients with achalasia.

    Device Description

    The Rigiflex™ II Single-Use Achalasia Balloon Dilator consists of a balloon, catheter shaft, distal tip and proximal end.

    AI/ML Overview

    I am sorry, but based on the text provided, I cannot answer your request. The document is a 510(k) premarket notification for a medical device (Rigiflex™ II Single-Use Achalasia Balloon Dilator) and confirms its substantial equivalence to a predicate device. However, it does not contain the specific acceptance criteria, details of a study proving device performance against those criteria, sample sizes, expert qualifications, adjudication methods, or other elements you've requested.

    The section "PERFORMANCE DATA" briefly mentions that "functional testing support a determination of substantial equivalence," but it does not elaborate on the data itself, the criteria it met, or the specifics of the study design. It also refers to a general FDA guidance document, not a report of specific study results for this device.

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