(58 days)
The AngioVac Cannula is indicated for use as a venous drainage cannula and for removal of fresh, soft thrombi or emboli during extracorporeal bypass for up to 6 hours.
The AngioVac device is a venovenous cannula with a balloon-actuated, expandable, funnel shaped distal tip that can be advanced through a 26 Fr sheath over a guidewire into the venous system percutaneously or via a surgical cut-down. During use, the cannula is connected to an extracorporeal circuit including an AngioVac Circuit, a commercially available centrifugal pump and bubble trap. A commercially available reinfusion cannula is placed for venous return (typically within internal jugular or one of the common femoral veins) and connected to the extracorporeal circuit. When the pump is started, suction is created, removing blood and debris from around the tip of the AngioVac Cannula, circulating the blood through the filter, returning the blood to the patient via the venous return cannula. A benefit of the AngioVac Cannula is that it allows for removal of thrombus/embolic material, while minimizing blood loss via recirculation of blood through a standard extracorporeal (venovenous) bypass circuit. Target vessels for thrombus/embolus extraction include, but are not limited to, the iliofemoral vein, Inferior Vena Cava (IVC), Superior Vena Cava (SVC) and Right Atrium (RA). The device is provided in a straight and an angled (20°) configuration.
I am sorry, but the provided text does not contain the requested information about acceptance criteria and a study proving a device meets those criteria. The document is an FDA 510(k) clearance letter and summary for the AngioVac Cannula, which focuses on demonstrating substantial equivalence to a predicate device, not on presenting acceptance criteria and a detailed study report.
Specifically:
- There is no table of acceptance criteria and reported device performance for the AngioVac Cannula in the provided text.
- The text describes bench testing, biocompatibility testing, and animal testing as performance data. However, it does not provide details like sample sizes for test sets, data provenance, ground truth establishment, or specific metrics typically associated with AI/software performance as requested in the bullet points.
- The document explicitly states "Clinical Testing - Not applicable" and does not mention any multi-reader multi-case (MRMC) comparative effectiveness studies or standalone algorithm performance.
- There is no information about the training set sample size or how its ground truth was established, as this device is a physical medical device, not an AI/software.
The provided document is primarily concerned with regulatory clearance based on substantial equivalence to a predicate device, outlining design modifications and general performance tests rather than a detailed study report with specific acceptance criteria and their fulfillment in the context of an AI/software device.
§ 870.4210 Cardiopulmonary bypass vascular catheter, cannula, or tubing.
(a)
Identification. A cardiopulmonary bypass vascular catheter, cannula, or tubing is a device used in cardiopulmonary surgery to cannulate the vessels, perfuse the coronary arteries, and to interconnect the catheters and cannulas with an oxygenator. The device includes accessory bypass equipment.(b)
Classification. Class II (performance standards).