(71 days)
The Cardeon® Ascending Balloon Cannula is intended to perfuse the aorta during open chest (sternotomy) procedures on cardiopulmonary bypass up to 6 hours. The occlusion balloon isolates the heart from the ascending aorta when inflated. The ABC also allows delivery of antegrade cardioplegia and venting of the aortic root.
The Ascending Balloon Cannula is substantially equivalent to currently marketed devices used to directly cannulate and perfuse from a general cardiac surgery patients undergoing coronary artery bypass grafting or valve replacement and/or repairs on CPB via sternotomy. Aortic occlusion is achieved by the fluid inflation of an integrated balloon thereby preventing the backflow of blood into the surgical field. Additional lumens allow delivery of antegrade cardioplegia or venting of the aortic root. The subject and predicate devices use standard attachments for connection(s) to cardiopulmonary bypass circuit.
The provided text describes the Cardeon® Ascending Balloon Cannula (ABCTM) and its regulatory clearance (K022042). However, it does not contain a detailed study report with specific acceptance criteria, reported device performance metrics, or data provenance as requested.
The submission is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than providing a comprehensive study with quantitative acceptance criteria and detailed performance data.
Here's an analysis based on the information available:
1. Table of Acceptance Criteria and Reported Device Performance:
- Acceptance Criteria: Not explicitly stated as quantitative metrics (e.g., specific force limits, flow rates, failure rates thresholds). The general "acceptance criteria" are implied to be that the device functions "as safely and effectively as predicate arterial return cannulae and aortic occlusive balloons."
- Reported Device Performance:
- "Results of product testing demonstrated that the Ascending Balloon Cannula functions as safely and effectively as predicate arterial return cannulae and aortic occlusive balloons."
- This is a qualitative statement of equivalence, not specific quantitative performance data against defined criteria (e.g., "burst pressure > X mmHg", "flow rate > Y L/min with
§ 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).