(246 days)
The Advanced Membrane Gas Exchange PMP STERILE (A.M.G. PMP STERILE) is intended for use in adult Surgical procedures requiring extracorporeal gas exchange support and blood temperature control for periods of up to 6 hours.
The Advanced Membrane Gas Exchange PMP STERILE (A.M.G. PMP STERILE) for extracorporeal circulation is a microporous hollow-fiber oxygenator with an integral heat exchanger used to perform cardiopulmonary bypass. It includes a detachable 4.5 liter blood reservoir.
The Advanced Membrane Gas Exchange and accessories PMP STERILE (A.M.G. PMP STERILE) is a microporous hollow-fiber oxygenator with an integral heat exchanger, used to perform cardiopulmonary bypass or surgical procedures requiring extracorporeal gas exchange support and blood temperature control for periods of up to 6 hours. It includes a detachable 4.5 liter blood reservoir.
The A.M.G. PMP STERILE is equipped with polymethyl pentene fibres, more hydrophobic than the polyethylene used for the predicate device and so considered a more reliable barrier between the blood pathway and gas pathway of the oxygenator.
The A.M.G. PMP STERILE is provided in different configurations:
- microporous hollow-fiber oxygenator with temperature probe and pre-connected venous cardiotomy reservoir (“A.M.G. PMP STERILE”),
- microporous hollow-fiber oxygenator with temperature probe and without pre-connected venous cardiotomy reservoir (“A.M.G. MODULE PMP STERILE”),
- microporous hollow-fiber oxygenator without temperature probe and without pre-connected venous cardiotomy reservoir (“A.M.G. MODULE PMP NO TP STERILE”),
- Venous Cardiotomy Reservoir 4500 PMP (“VCR 4500 PMP STERILE”).
The device is used to temporarily substitute the functions of the lung as it supplies oxygen and removes carbon dioxide from the blood. The device can be use with adult patients.
The provided text describes the 510(k) summary for the "Advanced Membrane Gas Exchange PMP STERILE (A.M.G. PMP STERILE)" device. This document is a regulatory submission to the FDA, demonstrating substantial equivalence to a predicate device, rather than a standalone study proving a device meets specific acceptance criteria in the context of an AI/ML algorithm.
Therefore, the requested information elements related to AI device performance are not applicable to this document. This document describes a medical device, specifically a cardiopulmonary bypass oxygenator, and its regulatory submission for market clearance. It does not involve an AI/ML algorithm or a study demonstrating the performance of such an algorithm.
However, I can extract the acceptance criteria and a summary of the performance testing for the manufacturing and functional aspects of the described medical device:
1. Table of acceptance criteria and reported device performance:
The document states that the new device, "Advanced Membrane Gas Exchange PMP STERILE (A.M.G. PMP STERILE)," met the acceptance criteria defined in the product specification and performed comparably to the predicate device. While specific quantitative acceptance criteria are not detailed in this summary, the areas tested and successfully met are listed.
| Acceptance Criteria Area / Parameter Tested | Reported Device Performance |
|---|---|
| Gas Transfer and Pressure Drop | Met acceptance criteria; performed comparably to predicate. |
| Fiber Hydrophilization | Met acceptance criteria; performed comparably to predicate. |
| Cracking test external body | Met acceptance criteria; performed comparably to predicate. |
| Coating Uniformity | Met acceptance criteria; performed comparably to predicate. |
| Plasma hemoglobin concentration | Met acceptance criteria; performed comparably to predicate. |
| Heat exchanger Efficiency and Filling Volume | Met acceptance criteria; performed comparably to predicate. |
| Seal Connection | Met acceptance criteria; performed comparably to predicate. |
| Structural and Mechanical Integrity | Met acceptance criteria; performed comparably to predicate. |
| Bioburden tests | Met acceptance criteria. |
| Sterility tests | Met acceptance criteria. |
| LAL-test | Met acceptance criteria. |
| Validation of the EtO Sterilization process | Met acceptance criteria. |
| EtO Residual (according to EN ISO 10993-7) | Met acceptance criteria. |
| Biocompatibility (according to ISO 10993 series requirements) | Met acceptance criteria. |
| Packaging evaluation | Met acceptance criteria. |
| Labelling evaluation | Met acceptance criteria. |
2. Sample size used for the test set and the data provenance:
This information is not provided in the document. The document refers to "in vitro bench tests" but does not specify the sample sizes (e.g., number of devices tested) or the provenance of any data used (as it's bench testing, not clinical data from patients or countries).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable as the document describes bench testing for a physical medical device, not an AI model or a dataset requiring expert ground truth labeling.
4. Adjudication method for the test set:
This information is not applicable as the document describes bench testing for a physical medical device, not an AI model or a dataset requiring expert adjudication.
5. 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:
This information is not applicable as the document describes a physical medical device (oxygenator) and not an AI/ML algorithm.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not applicable as the document describes a physical medical device (oxygenator) and not an AI/ML algorithm.
7. The type of ground truth used:
This information is not applicable as the document describes bench testing against predefined product specifications and regulatory standards for a physical medical device, not against "ground truth" in the context of AI model evaluation (e.g., pathology, expert consensus on images).
8. The sample size for the training set:
This information is not applicable as the document describes a physical medical device and its manufacturing/functional testing, not an AI/ML model that undergoes "training."
9. How the ground truth for the training set was established:
This information is not applicable as the document describes a physical medical device and its manufacturing/functional testing, not an AI/ML model.
§ 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.”