(60 days)
The EOS PMP hollow fiber oxygenator is intended for use in patients who undergo cardiopulmonary bypass surgery requiring extracorporeal circulation with a maximum blood flow rate of 5 LPM. 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 Hollow Fiber Oxygenator (hereinafter identified as EOS PMP) consist of an oxygenator with an integrated heat exchanger.
The EOS PMP consist of the following main components
- a heat exchanger consisting of a grooved and pleated stainless steel that is placed into a polycarbonate housing with integrated Hansen connectors and is sealed with resin potting at both ends. it controls blood temperature and allows the use of hypothermia or aids in the maintenance of normothermia during surqery.
- . an oxygenating module element made of a coiled bundle of polypropylene microporous hollow fibers rolled on the heat exchanger sub assembly. The hollow fiber membrane provides oxygenation and carbon dioxide removal from venous blood or suction blood..
The modified device is a modified version of the currently marketed EOS product.
Here's a breakdown of the acceptance criteria and study information for the EOS PMP device, based on the provided text:
Device: EOS PMP Hollow Fiber Oxygenator
1. Table of Acceptance Criteria and Reported Device Performance
The provided text describes performance testing related to the modification of the EOS PMP device (addition of an epoxy phenolic primer coating to the heat exchanger). The acceptance criteria are implicitly that the modified device performs comparably to the unmodified predicate device and meets established standards.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Biocompatibility: Meet requirements of ISO 10993-1 and FDA's 1995 Memorandum. | Not explicitly detailed, but implied as part of the overall testing in accordance with ISO 10993-1. The text states "Applicable tests were carried out in accordance with the requirements of ISO 10993-1...". |
| Functional Performance (General): Meet requirements of "Guidance for Cardiopulmonary Bypass Oxygenators 510(k) Submissions: Final Guidance for Industry and FDA Staff" (Nov 13, 2000) and ISO 7199. | Not explicitly detailed, but implied as part of the overall testing. The text states "Applicable tests were carried out in accordance with...relevant requirements of "Guidance for Cardiopulmonary Bypass Oxygenators...and ISO 7199". |
| Heat Exchanger Performance Factor Verification: Ensure heat exchanger function is maintained after coating. | The modified device "successfully met all acceptance criteria for the addition of the new material." The results of in vitro studies "demonstrate that the subject EOS PMP performs in a manner substantially equivalent to the Unmodified EOS PMP predicate device with respect to the relevant functional parameters." |
| Heat Exchanger Mechanical Integrity: Ensure the coating does not compromise the structural integrity. | The modified device "successfully met all acceptance criteria for the addition of the new material." The results of in vitro studies "demonstrate that the subject EOS PMP performs in a manner substantially equivalent to the Unmodified EOS PMP predicate device with respect to the relevant functional parameters." |
| Flaking/Leaching Test: Ensure no detrimental flaking or leaching of the new coating material. | The modified device "successfully met all acceptance criteria for the addition of the new material." The results of in vitro studies "demonstrate that the subject EOS PMP performs in a manner substantially equivalent to the Unmodified EOS PMP predicate device with respect to the relevant functional parameters." |
2. Sample Size Used for the Test Set and the Data Provenance
- Test Set Sample Size: Not explicitly stated. The text mentions "in vitro testing was performed" and "This performance testing was conducted on sterile aged devices." It does not provide a specific number of units tested.
- Data Provenance: The studies were retrospective in the sense that they evaluated a modified version of an existing device (EOS PMP) against its unmodified predicate. The testing itself (heat exchanger performance, mechanical integrity, flaking/leaching) appears to be laboratory-based and controlled, thus prospective in execution within that controlled environment. The country of origin of the data is not specified beyond "Sorin Group Italia S.R.L." which suggests it was likely performed in Italy or by a contracted lab.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
- This question is not applicable as the evaluation was based on non-clinical (in vitro) performance data against established standards and a predicate device, rather than on expert interpretation of patient data.
4. Adjudication Method for the Test Set
- This question is not applicable as the evaluation did not involve human interpretation or adjudication of results in the traditional sense; it was based on meeting pre-defined physical and chemical performance metrics.
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
- No, an MRMC comparative effectiveness study was not done. This device is a medical device (oxygenator), not an AI diagnostic tool. The document states: "No clinical testing was conducted in support of the EOS PMP, as the indications for use are equivalent to those of the predicate, which have been on the market for many years."
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
- No, a standalone (algorithm only) performance study was not done. This is a physical medical device, not an algorithm or AI system.
7. The Type of Ground Truth Used
- The ground truth used was based on established industry standards and regulatory guidance (ISO 10993-1, FDA Guidance for Cardiopulmonary Bypass Oxygenators, ISO 7199), and the performance of the legally marketed predicate device (Unmodified EOS PMP). The goal was to prove "substantial equivalence" of the modified device to the predicate for specific performance characteristics.
8. The Sample Size for the Training Set
- This question is not applicable as the device is a physical medical device, not a machine learning model, and therefore does not have a "training set" in the AI/ML context.
9. How the Ground Truth for the Training Set was Established
- This question is not applicable for the same reason as #8.
§ 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.”