(227 days)
The Gish Reliance™ Oxygenator is indicated for use in procedures requiring the extracorporeal oxygenation of, and carbon dioxide removal from, human blood. It is designed to operate at blood flow rates of one half (0.5) to eight (8.0) liters per minute for periods of up to six (6.0) hours.
The Gish Reliance TM Oxygenator is designed to control blood gases in the extracorporeal circuit during cardiopulmonary bypass surgery. The Gish Reliance ™ Oxygenator is a sterile, non-pyrogenic, single use, disposable extracorporeal device. It is intended for the supply of oxygen to, and the removal of carbon dioxide from, the blood of humans. An integral heat exchanger is included which is intended to control the temperature of the blood. The Gish Reliance The Oxygenator has one (1) blood inlet located at the bottom of the assembly, an integral heat exchanger intended to control the temperature of blood, a bundle of microporous hollow fibers for the exchange of gases, two (2) blood outlet ports, one (1) gas inlet port, one (1) gas outlet port and three (3) gas vents to prevent over pressurization. The design of the oxygenator allows for a bottom-up flow of blood through the heat exchanger and around and between the hollow fibers of the gas exchange bundle. The bottom-up flow aids in priming and air removal from the unit. Once the blood reaches the top of the unit, it flows into a manifold which directs the blood downward and out the main blood outlet. The other blood outlet port is located at the top of the unit and may be used for air removal or recirculation. Gas enters the oxygenator through a gas inlet located at the top of the unit and then flows downward (countercurrent to the blood flow) through the inside of the hollow fibers. Gas exchange occurs with the blood through diffusion across the hollow fiber membrane. Gas leaves the oxygenator through gas outlets or vents. One (1) gas outlet port is provided to scavenge gas leaving the oxygenator. The integral heat exchanger controls the temperature of blood. Blood flows on the outside of the heat exchanger while heated or cooled water flows on the inside. Heat is transferred between the blood and water by the stainless steel bellows.
The provided text describes a medical device, the Gish Reliance™ Oxygenator, and its comparison to predicate devices for 510(k) clearance. However, it does not contain information regarding
acceptance criteria for a study proving device performance, sample sizes for test or training sets, data provenance, expert involvement for ground truth, adjudication methods, MRMC studies, or standalone algorithm performance.
Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance or details about the study, as this information is not present in the provided text. The document focuses on establishing substantial equivalence based on intended use, technological characteristics, biocompatibility, and in-vitro bench testing, rather than reporting on a study designed to meet specific performance acceptance criteria for a new AI/software device.
§ 870.4350 Cardiopulmonary bypass oxygenator.
(a)
Identification. A cardiopulmonary bypass oxygenator is a device used to exchange gases between blood and a gaseous environment to satisfy the gas exchange needs of a patient during open-heart surgery.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance for Cardiopulmonary Bypass Oxygenators 510(k) Submissions.”