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510(k) Data Aggregation
(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 <20 EU/device (ANSI/AAMI ST72:2011). | Endotoxin recoveries all below <20 EU/device. |
| Shelf Life | Non-comparative | Shelf life substantiated after simulated distribution and aging. | Shelf life substantiated. |
Since this is a submission for a physical medical device (Cardiopulmonary Bypass Oxygenator) and not an AI/ML-driven diagnostic or assistive technology, the following requested details are not applicable to the provided document:
- Sample size used for the test set and the data provenance: Not applicable. The "test set" here refers to physical testing of the device, not a data set for an AI model.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI model is established by experts, but for a physical device, performance is measured against engineering and biological standards.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. This refers to expert review for AI ground truth.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is for AI-assisted human reading studies.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable as this is not an AI/ML device. The "ground truth" for this device's performance is based on established engineering and biological standards (e.g., ISO standards, FDA guidance).
- The sample size for the training set: Not applicable. This is only relevant for AI/ML models.
- How the ground truth for the training set was established: Not applicable.
In summary, the provided document details the testing and performance evaluation of a traditional medical device against established industry standards and a predicate device, rather than the performance of an AI/ML algorithm.
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