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VT75-E1
Quantum Perfusion Blood Oxygenator 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.
Device is intended for Paediatric patients with a Body Surface Area (BSA) ranging from 0.6 m² to 1 m².

VT75-E2
Quantum Perfusion Blood Oxygenator 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 during the procedure. The device is limited to 6 hours of use.
Device is intended for Paediatric patients with a Body Surface Area (BSA) ranging from 0.6 m² to 1 m².

The Quantum Perfusion Blood Oxygenator (acronym VT-E) diffusion membrane device is 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 flow rate are used to control saturation, and oxygen and carbon dioxide content of blood at the outlet of the oxygenator. 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.

The provided document, K231982, is a 510(k) Premarket Notification for a medical device (Quantum Perfusion Blood Oxygenator VT75-E1, Quantum Perfusion Blood Oxygenator VT75-E2). This document details the device's technical specifications, intended use, and comparison to predicate devices, along with performance data regarding non-clinical testing.

However, it does not describe acceptance criteria, nor a study that proves the device meets specific acceptance criteria in the context of an AI/ML medical device. The document explicitly states:

• "No clinical data have been included in the current Traditional 510(k) submission to support substantial equivalence to legally marketed predicate devices."
• "No animal studies have been performed except for mandatory biocompatibility tests according to International Standard ISO 10993-1:2018".

The performance data mentioned (Gas transfer performance, Temperature probe and Pressure sensor verification, Mechanical Blood Cell Damage, Device pressure Drop, Mechanical Integrity, Mechanical resistance of connectors, Coating coverage and durability, Air handling) are engineering and functional tests relevant to a blood oxygenator, not the kind of AI/ML performance metrics typically found in documents describing acceptance criteria for an AI-powered diagnostic or assistive device.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving the device meets them, as it pertains to an AI/ML device, because this document is for a non-AI/ML medical device and does not contain such information.

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