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510(k) Data Aggregation

    K Number
    K231096
    Device Name
    Automatic Continuous Effusion Shunt (ACES) System ACES System
    Manufacturer
    Pleural Dynamics, Inc.
    Date Cleared
    2023-08-18

    (122 days)

    Product Code
    KPM
    Regulation Number
    876.5955
    Why did this record match?
    Applicant Name (Manufacturer) :

    Pleural Dynamics, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Automatic Continuous Effusion Shunt (ACES) System is indicated for use in adult (>21 years of age) patients with • chylothorax • intractable aseptic pleural effusion
    Device Description
    The ACES System is an implanted pleural-peritoneal shunt system intended to palliate symptoms of recurrent pleural effusion, an accumulation of fluid in the cavity around the lungs. The ACES System comprises a pump that is, generally, a resilient flexible bulb having an inlet and an outlet. The inlet is attached to a first fenestrated barium striped tube that extends from the inlet valve to the patient's pleural cavity. The outlet is connected to a second fenestrated barium striped tube that extends from the outlet valve to the patient's peritoneal cavity. Each one-way valve is connected to a single pump chamber with an internal automatic pump extension and external manual compression and an integrated implant securement flange for suture fixation in the muscular facia. Internal (intercostal) automatic (passive) pump extension is placed between adjacent ribs in the external (subdermal) manual compression (active) pump extension is positioned under the skin and external to the ribs. Using a patient's own respiration, the internal automatic pump extension operates by being successively compressed and decompressed between adjacent ribs, as the patient breathes, whereby pumping the fluid from the pleural cavity to the peritoneal cavity, where it is naturally reabsorbed by the external manual compression pump extension allows for intraprocedural priming of the pump chamber as well as manual compression by the patient, post procedurally, at will or as directed by their physician for movement of fluid from the pleural cavity to the peritoneal cavity.
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