(106 days)
EOS PMP Integrated: Hollow Fiber Oxygenator with Integrated Hardshell Venous/Cardiotomy Reservoir
The device is intended for use in patients who undergo cardiopulmonary bypass surgery requiring extracorporeal circulation with a maximum blood flow rate of 5 liters /minute. It provides oxygenation and carbon dioxide removal from venous blood. The integrated heat exchanger provides blood temperature control and allows the use of hypothermia or aids in the maintenance of normothermia during surgery. The venous reservoir with cardiotomy filter is intended to collect blood aspirated from the operating field during surgical procedures and the blood from patient's veins (gravity or vacum assisted) during nomal operation to assure the proper oxygenation capability of the device. The device is intended to be used for 6 hours or less.
EOS PMP: Hollow Fiber Oxygenator
The device is intended for use in patients who undergo cardiopulmonary bypass surgery requiring extracorporeal circulation with a maximum blood flow rate of 5 liters /minute. It provides oxygenation and carbon dioxide removal from venous blood. The integrated heat exchanger provides blood temperature control and allows the use of hypothermia or aids in the maintenance of normothermia during surgery. The device is intended to be used for 6 hours or less.
The EOS PMP is a high efficiency hollow fiber diffusion membrane oxygenator with integrated heat exchanger.
The device provides oxygenation and carbon dioxide removal from patient's blood. The integrated heat exchanger controls blood temperature and allows the use of hypothermia, or aids in the maintenance of normothermia during surgery.
The device can be operated at flow rates up to 5 liters per minute (I/min).
The device can be connected with, but not limited to, the D905 EOS reservoir (K043323) that collects, defoams, and filters patient's blood.
The EOS PMP is a modified version of the currently marketed D905 EOS (K043323).
The provided text describes a 510(k) premarket notification for a medical device, the EOS PMP and EOS PMP Integrated, which are hollow fiber oxygenators. The document focuses on demonstrating substantial equivalence to a legally marketed predicate device (D905 EOS).
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based only on the provided text:
Summary of Device Performance and Acceptance Criteria:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Functional/Performance Tests: | EOS PMP successfully met all acceptance criteria for these tests. |
| 1. Blood trauma | Met acceptance criteria. |
| 2. Biological activity | Met acceptance criteria. |
| 3. Leaching of coating | Met acceptance criteria. |
| 4. Flaking of coating | Met acceptance criteria. |
| 5. Uniformity of coating | Met acceptance criteria. |
| 6. Blood volume capacity | Met acceptance criteria. |
| 7. Oxygenating performance/blood side pressure drops | Met acceptance criteria. |
| 8. Blood, water, gas pathway integrity | Met acceptance criteria. |
| 9. Plasma leakage | Met acceptance criteria. |
| Other Criteria: | |
| Sterile and non-pyrogenic | Effectiveness of production techniques demonstrated. |
| Substantial Equivalence to D905 EOS | Demonstrated for relevant functional parameters and device function. |
Study Details:
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Sample size used for the test set and the data provenance:
- The document states that "In vitro testing was conducted on the oxygenating module that is the only device element subject to modifications with respect to the unmodified device." However, it does not specify the sample size (e.g., number of devices tested) for these in vitro tests.
- Data provenance: The tests were "in vitro," meaning they were conducted in a controlled, non-living environment (e.g., laboratory setting), rather than with human or animal subjects. The document does not specify a country of origin for the data; the submitter is "Sorin Group Italia," suggesting the tests might have been performed in Italy or by a third-party laboratory.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided in the document. The tests are described as "in vitro" and against "relevant requirements of 'Guidance for Cardiopulmonary Bypass Oxygenators 510(k) Submissions; Final Guidance for Industry and FDA Staff, November 13, 2000'," suggesting objective, measurable criteria rather than expert interpretation of results.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This information is not provided as the testing involved in-vitro performance measurements against established guidances/standards, not expert adjudication of subjective findings.
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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:
- No MRMC comparative effectiveness study was done or mentioned. This device is a cardiopulmonary bypass oxygenator, not an AI-assisted diagnostic tool requiring human reader involvement.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This question is not applicable. The device is a physical medical device (an oxygenator), not an algorithm or software. The "standalone performance" was assessed through the in-vitro functional/performance tests.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth for the in-vitro performance tests was based on pre-defined acceptance criteria derived from "relevant requirements of 'Guidance for Cardiopulmonary Bypass Oxygenators 510(k) Submissions; Final Guidance for Industry and FDA Staff, November 13, 2000'" and ISO 10993-1 for biological evaluation. These guidances and standards establish objective measurable benchmarks for safe and effective performance of such devices.
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The sample size for the training set:
- This information is not applicable as this is not a machine learning/AI device that requires a training set. The "modified device" (EOS PMP) was compared to an "unmodified device" (D905 EOS) and evaluated against established performance criteria.
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How the ground truth for the training set was established:
- This information is not applicable as there is no training set for this type of 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.”