Search Results

The IBC VRV is indicated for use as an intracardiac suction control valve for left ventricular venting during cardiopulmonary bypass surgery (up to six hours).

The IBC VRV Valve is a single use, disposable, vacuum and pressure relief, check valve that is intended for use during open-heart surgery for left ventricular venting. It is sometimes commonly referred to as a suction control valve for left ventricular venting. The device is designed for use in a suction line and must be used in accordance with the operating parameters of that blood recovery line. The fully assembled IBC VRV Valve is geometrically similar and clinically the same to the Omni Model RLV-2100"B" VRV valve, which is the predicate device for purposes of this 510(k) submission. The operating principles of the two devices are identical. The differences between the IBC VRV and the predicate device are found in the material selection and specific dimensions of the component parts neither of which effects safety or effectiveness of the product. The first of these differences is the choice of polymer for molding the plastic components. The main flow through body of the IBC VRV is made of polycarbonate and the Omni RLV-2100"B" is made of ABS. The polycarbonate is clear, has higher impact resistance, greater tensile and compression strength and superior chemical. Upon review of the predicate device, we found the inability to see the interior of the device made it difficult for the user to identify the vacuum relief point. The use of polycarbonate eliminated that problem. Secondly, the straight duck bill check valve in the predicate device represents a substantial resistance to flow which contributes significantly to hemolysis. The unique curved design of the duckbill check valve in the IBC VRV substantially reduces flow resistance and hemolysis.