(202 days)
The AMG Adult Hollow Fiber Oxygenator 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 AMG oxygenating device 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 device is used to temporarily substitute the functions of the lung as it supplies oxygen and removes carbon dioxide from the blood.
AMG is a single use device.
The AMG Adult Hollow Fiber Oxygenator 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 AMG oxygenating device 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 provided 510(k) summary for the Eurosets Advanced Membrane Gas Exchange (AMG) device details the device's substantial equivalence to predicate devices, but does not contain the specific acceptance criteria or a study proving the device meets those criteria in the way a typical AI/ML medical device submission would.
This document is a premarket notification for a traditional medical device (an oxygenator), which follows a different regulatory pathway and relies on different types of performance testing than an AI/ML device. Therefore, many of the requested categories for AI/ML device studies (like sample size for test/training sets, ground truth by experts, MRMC studies, standalone performance with metrics like AUC or sensitivity/specificity) are not applicable to this submission.
Instead, this submission focuses on demonstrating substantial equivalence through:
- Comparison to predicate devices: Highlighting similarities in design, intended use, method of operation, components, packaging, and fundamental scientific technology.
- In vitro performance testing: To show that the device meets established specifications, primarily related to its physical and functional properties, as guided by relevant ISO standards and FDA guidance for oxygenators.
Here's a breakdown of the available information based on your request, with explanations for why some categories are not present:
Acceptance Criteria and Device Performance (Not Applicable for AI/ML metrics)
The document states that "The results of these tests met established specifications," but the specific numerical acceptance criteria for each test are not explicitly detailed in this summary. Instead, the focus is on the device demonstrating equivalence to its predicates and meeting general safety and effectiveness requirements through standard in vitro tests for oxygenators.
Table of Acceptance Criteria and Reported Device Performance
| Performance Metric (Type of Test) | Acceptance Criteria (Not explicitly stated numerically in summary) | Reported Device Performance |
|---|---|---|
| Biocompatibility (ISO 10993-1:2003) | Met established specifications | Met established specifications |
| Sterility | Met established specifications | Met established specifications |
| Pyrogenicity | Met established specifications | Met established specifications |
| EO residuals | Met established specifications | Met established specifications |
| Package integrity | Met established specifications | Met established specifications |
| Gas transfer characteristics (ISO 7199) | Met established specifications | Met established specifications |
| Pressure drop (ISO 7199) | Met established specifications | Met established specifications |
| Plasma leakage (ISO 7199) | Met established specifications | Met established specifications |
| Heat exchanger performance (ISO 7199) | Met established specifications | Met established specifications |
| Hemolysis tests (blood damage) (ISO 7199) | Met established specifications | Met established specifications |
| Operating blood volume (ISO 7199) | Met established specifications | Met established specifications |
| Mechanical integrity (ISO 7199) | Met established specifications | Met established specifications |
Detailed Breakdown of Study Information (Acknowledging N/A for AI/ML Specifics):
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Sample size used for the test set and the data provenance:
- Sample Size (Test Set): Not specified in terms of "cases" or "patients" as this is an in-vitro performance study of a physical device, not an AI/ML diagnostic system. The "sample" would likely refer to the number of devices tested, but this detail is not provided.
- Data Provenance: Not applicable in the context of clinical data. The tests were "in vitro," meaning they were conducted in a controlled laboratory environment using test fluids/blood, not on human subjects. The testing was carried out by Eurosets srl (Italy).
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable: This type of "ground truth" (e.g., expert consensus on medical images) is not relevant for the performance testing of an oxygenator. The "ground truth" here is determined by physical and chemical measurements against engineering specifications and industry standards (ISO 7199).
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not Applicable: Adjudication is not part of this type of engineering and laboratory performance testing. Results are typically quantitative measurements compared to predefined thresholds.
-
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 a physical medical device, not an AI/ML algorithm that assists human readers. No MRMC study was conducted.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable: There is no AI/ML algorithm involved. The performance described is that of the physical device. The "standalone" performance is the intrinsic functional performance of the oxygenator itself in various in-vitro tests (e.g., gas transfer, pressure drop).
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Standard Specifications/Engineering Measurables: The "ground truth" for this device's performance is objective measurements (e.g., gas concentrations, flow rates, temperature, and material integrity) against established engineering specifications and international standards (ISO 7199) for cardiopulmonary bypass oxygenators.
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The sample size for the training set:
- Not Applicable: There is no AI/ML algorithm requiring a "training set."
-
How the ground truth for the training set was established:
- Not Applicable: There is no AI/ML algorithm requiring a "training set" or its associated ground truth.
Summary:
This 510(k) pertains to a traditional medical device (oxygenator) and demonstrates substantial equivalence through comparative analysis with predicate devices and in-vitro performance testing against established industry standards and specifications. It does not involve AI/ML technology, and therefore, many of the detailed questions related to AI/ML device study design (like ground truth establishment by experts, training/test set sizes for algorithms, or MRMC studies) are not pertinent to this submission. The device successfully met all "established specifications" for the performed biocompatibility and in-vitro functional tests.
§ 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.”