LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K071094
    Device Name
    MODIFICATION TO SOLAR GI
    Manufacturer
    MEDICAL MEASUREMENT SYSTEMS,B.V.
    Date Cleared
    2007-08-13

    (117 days)

    Product Code
    FFX
    Regulation Number
    876.1725
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    MODIFICATION TO SOLAR GI

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

    The Solar Perfusion Pump is an accessory device to be used with the MMS Solar GI system for intraluminal studies of the gastro-intestinal tract (Pharynx, esophagus, stomach, duodenum, Sphincter of Oddi, small bowel, colon, and anorectal area including rectum) to perfuse demineralized or distilled water through the lumen of a multi-lumen catheter to measure pressures. Designated catheters and accessories are required for measurement in each specific area.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a medical device called the "Solar Perfusion Pump." It does not contain information about acceptance criteria, study design, or device performance against specific metrics.

    Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment. This document only confirms that the device has received 510(k) clearance based on substantial equivalence to a predicate device.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1