(295 days)
The Paragon Adult Maxi PMP oxygenator is a hollow fiber membrane oxygenator intended for physiologic gas exchange in adults and small adults undergoing cardopulmonary bypass surgery. The integrated heat exchanger makes it possible to regulate the blood temperature. The Paragon Adult Maxi PMP Oxygenator is intended for up to 6 hours.
The Paragon Adult Maxi PMP oxygenator (Paragon Maxi) is a hollow fiber membrane oxygenator with an integrated heat exchanger. The Paragon Maxi facilitates the gas exchange into and out of the blood, and the regulation of blood temperature during cardiopulmonary bypass. The Paragon Maxi is supplied with a Rheopak surface coating that reduces platelet adhesion to coated surfaces. The gas exchanger part of the Paragon Maxi is formed of plasma tight hollow fiber membranes. The gas flow takes place through the inner lumen of the fibers. Blood is in contact with the outer side of the membranes, so that oxygen can diffuse into the venous blood, while carbon dioxide diffuses out of the blood. The heat exchanging part of the Paragon Maxi is made of non-porous hollow fiber membranes. Water flows through the inner lumen of the fibers, so that blood temperature flowing outside is regulated.
The provided text describes information for a K191246 submission regarding a Cardiopulmonary Bypass Oxygenator, not an AI/ML medical device. Therefore, it does not contain the specific details requested for an AI/ML device, such as acceptance criteria based on performance metrics (e.g., sensitivity, specificity), nor does it describe studies involving human readers, training/test sets, or ground truth established by experts.
The document focuses on the Paragon Adult Maxi PMP Oxygenator (Model: XCMOP405PMP), a physical medical device. The "acceptance criteria" and "study that proves the device meets acceptance criteria" are discussed in terms of the device's physical and functional performance, rather than AI model performance.
However, I can extract and present the physical device's performance evaluation in a table format as requested, interpreting "acceptance criteria" in the context of this traditional medical device.
1. Table of Acceptance Criteria and Reported Device Performance
| Test (Performance Characteristic Evaluated) | Method | Acceptance Criteria (Implied by Conclusion) | Reported Device Performance |
|---|---|---|---|
| Blood Pathway Integrity | Non-comparative | Device must meet integrity standards. | Acceptance criteria met by the devices. |
| Heat Exchanger Fluid Pathway Integrity | Non-comparative | Device must meet integrity standards. | Acceptance criteria met by the devices. |
| Gas Pathway Integrity | Non-comparative | Device must meet integrity standards. | Acceptance criteria met by the devices. |
| Connector Security | Non-comparative | Device must meet security standards. | Acceptance criteria met by the devices. |
| Coating Characterization | Non-comparative | Device must meet coating characterization standards (referring to Rheopak surface coating). | Acceptance criteria met by the devices. |
| Oxygen Transfer Rates | Comparative | No statistically significant difference compared to the predicate device. | No statistically significant difference in the O2 transfer rates of the Paragon Maxi oxygenator and the predicate. |
| Carbon Dioxide Transfer Rates | Comparative | No statistically significant difference compared to the predicate device. | No statistically significant difference in the CO2 transfer rates of the Paragon Maxi oxygenator and the predicate. |
| Blood Side Pressure Drop | Comparative | Acceptable blood side pressure drop, potentially lower than predicate due to design differences. | The Paragon Maxi has a lower blood side pressure drop than the predicate oxygenator as a consequence of slight differences in the oxygenator design. |
| Heat Exchanger Performance Factor | Comparative | No statistically significant difference compared to the predicate device. | No statistically significant difference in the heat exchanger performance of the Paragon Maxi oxygenator and the predicate. |
| Blood Cell Damage | Comparative | No statistically significant difference in markers like hemolysis, white blood cell count, platelet count compared to the predicate device. | No statistically significant difference in the blood cell damage test results (e.g. hemolysis, white blood cell count, platelet count) of the Paragon Maxi oxygenator and the predicate. |
| Biocompatibility | Non-comparative | Biocompatible and biologically safe according to ISO 10993-1:2009. | Biocompatibility and biological safety demonstrated. |
| Sterility (SAL) | Non-comparative | Sterility Assurance Level (SAL) of 10^-6. | Achieved a SAL of 10^-6 by ethylene oxide gas sterilization. |
| Pyrogen Levels | Non-comparative | Endotoxin levels below the 'Endotoxin Release Limit' of |
§ 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.”