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510(k) Data Aggregation

    K Number
    K240934

    Validate with FDA (Live)

    Device Name
    Quantum Perfusion Blood Oxygenator ECC VT160-E3 (VT160-E3); Quantum Perfusion Blood Oxygenator ECC VT200-E3 (VT200-E3); Quantum Perfusion Blood Oxygenator VT75- E3 (VT75- E3);
    Manufacturer
    Spectrum Medical S.R.L.
    Date Cleared
    2026-03-12

    (706 days)

    Product Code
    DTZ
    Regulation Number
    870.4350
    Type
    Traditional
    Panel
    Cardiovascular
    Age Range
    All
    Reference & Predicate Devices
    K231982,K203424
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Quantum Perfusion Blood Oxygenator VT75-E3 is a diffusion membrane oxygenator, designed to oxygenate and remove carbon dioxide from venous blood during cardiac surgery requiring cardiopulmonary bypass and to measure blood pressure and temperature during the procedure. The device is limited to 6 hours of use.

    Devices are intended for Paediatric patients with a Body Surface Area (BSA) ranging from 0.6 m² to 1 m².

    Quantum Perfusion Blood Oxygenator VT160- E3 and VT200-E3 are a diffusion membrane oxygenator, designed to oxygenate and remove carbon dioxide from venous blood during cardiac surgery requiring cardiopulmonary bypass and to measure blood pressure and temperature during the procedure. The devices are limited to 6 hours of use.

    Devices are intended for adult patients.

    Device Description

    Quantum Perfusion Blood Oxygenator (acronym VT-E) diffusion membrane devices are designed to oxygenate blood and remove carbon dioxide from venous blood during cardiac surgical procedures requiring cardiopulmonary bypass for a maximum duration of 6 hours.

    Blood enters the oxygenator through the blood inlet connector, flows through a blood chamber, touching the outer surface of hollow fibers membrane; while the sweep gas flows into the hollow fiber membrane. The hollow fibers are made of Polymethylpentene (PMP). In this chamber, carbon dioxide moves from the blood to the gas compartment, while oxygen enters into the red blood cells. Then, blood exits the oxygenator with the desired level of oxygen content and saturation, and carbon dioxide content. Sweep gas composition and flowrate are used to control saturation, and oxygen and carbon dioxide content of blood at the outlet of the oxygenator.

    A sensor component is embedded in the Blood OUT connector of the oxygenator, to measure blood pressure and temperature during the procedure.

    The device is non-toxic, non-pyrogenic, sterilized by ethylene oxide and packaged in a single box.

    All the device surfaces in contact with blood are treated with a phosphorylcholine-based biocompatible coating.

    AI/ML Overview

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