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The MC3 26 Fr. QuickFlow™ Dual Lumen Catheter is a single use dual lumen catheter, which provides both venous drainage and reinfusion of blood via the femoral vein, that is indicated for use for up to 72 hours in patients with acute respiratory failure requiring partial Veno-Venous Extracorporeal Membrane Oxygenation (full hemodynamic support is not required and predicted flows needed to maintain adequate oxygenation do not exceed 31/min) where other available treatment options have failed and continued clinical deterioration is expected or the risk of death is imminent.

The MC3 28 Fr. QuickFlow™ Dual Lumen Catheter is a single use dual lumen catheter, which provides both venous drainage and reinfusion of blood via the femoral vein, that is indicated for use for up to 72 hours in patients with acute respiratory failure requiring partial Veno-Venous Extracorporeal Membrane Oxygenation (full hemodynamic support is not required and predicted flows needed to maintain adequate oxygenation do not exceed 3.5l/min) where other available treatment options have failed and continued clinical deterioration is expected or the risk of death is imminent.

The MC3 QuickFlow Dual Lumen Catheters are dual lumen catheters supplied with an introducer to facilitate wire guided placement into the vasculature by normal access techniques. The introducer is designed to follow a pre-positioned standard 0.038" (0.97 mm) or 0.035" (0.89 mm) guide wire (not included). The catheter is wire-reinforced for flexibility and kink-resistance and includes depth marks. Both the introducer and catheter are made of radiopaque materials and the catheter has radiopaque markers at the tip and most proximal set of drainage holes.

The devices are comprised of two separate thin-walled catheters made of silicone and polyurethane polymer and reinforced with a spring wire. The dual lumen design involves two catheters of different diameters joined together in a co-axial configuration. An arrangement of side holes in the outer (drainage) catheter allows for egress of blood. An open tip on the inner (return) catheter allow s for blood ingress. Unreinforced tube extensions with barbed connectors, allowing clamping and connection to the extracorporeal circuit, are joined to the wye junction. A tapered tip introducer is included to facilitate placement of the catheter into the blood vessel over a standard guide wire (not included). Securement of the device may be accomplished via a groove designed in the Y-connector to accept a suture and a suture around a 3/8" barb connector.

The provided text describes the MC3 QuickFlow Dual Lumen Catheter and its equivalency to a predicate device, focusing on its physical characteristics, intended use, and performance evaluations. However, it does not contain information related to an AI/ML device, nor does it present acceptance criteria or a study proving an AI/ML device meets such criteria.

The document is a 510(k) premarket notification for a medical device (a catheter), and the performance evaluations listed are typical for such hardware devices (durability, pressure/flow, kink resistance, etc.). There is no mention of "AI", "algorithm", "human readers", "MRMC", "ground truth" in the context of an AI-driven study, or any other terms that would suggest an AI/ML component.

Therefore, I cannot fulfill your request for information regarding acceptance criteria and a study proving an AI/ML device meets those criteria based on the provided text, as the text pertains to a non-AI medical device.

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