(229 days)
The QUADROX-iD Adult diffusion membrane oxygenator is intended for use in an extracorporeal circulation during cardiopulmonary bypass in cardiac surgery. Within the specified flow rate range, the device oxygenates the blood, removes carbon dioxide from the blood and regulates the blood temperature. The application duration is limited to 6 hours.
Responsibility for deciding whether to use an oxygenator rests solely with the attending physician.
The QUADROX-iD Adult diffusion membrane oxygenator with BIOLINE Coating and with SOFTLINE Coating is a blood-gas exchanger with integrated heat exchanger.
This document is a 510(k) summary for the MAQUET QUADROX-iD Adult diffusion membrane oxygenator. It outlines the device's technical comparison to predicate devices and the non-clinical testing performed to establish substantial equivalence.
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state acceptance criteria in a quantitative format with corresponding reported device performance values. Instead, it refers to compliance with established international standards for medical devices.
| Acceptance Criteria Category | Reported Device Performance (Compliance) |
|---|---|
| Integrity | Tested and / or evaluated |
| Performance | Tested and / or evaluated |
| Biocompatibility | Met the requirements of ISO 10993-1 |
| Sterility | Tested and / or evaluated |
| General Cardiovascular Implants and Artificial Organs Standards | Met the requirements of ISO 7199 (Blood-gas exchangers) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the sample size used for the test set or the data provenance (country of origin, retrospective/prospective). The testing appears to be non-clinical (laboratory/bench testing) as opposed to human subject trials.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is a non-clinical evaluation of a medical device (oxygenator) against performance standards, not an AI/diagnostic device requiring expert consensus for ground truth.
4. Adjudication method for the test set
Not applicable. This is a non-clinical evaluation of a medical device against performance standards.
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
Not applicable. This is a medical device (oxygenator) and not an AI or diagnostic imaging device involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a medical device (oxygenator), not an algorithm. The testing described is for the physical device's performance characteristics.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance is compliance with established international standards (ISO 10993-1 and ISO 7199) and the performance characteristics demonstrated during testing (e.g., oxygenation, CO2 removal, heat exchange). This is based on objective measurements against engineering and biological standards, not expert consensus or pathology in the diagnostic sense.
8. The sample size for the training set
Not applicable. This is a medical device, not a machine learning model. There is no concept of a "training set" in the context of this 510(k) submission.
9. How the ground truth for the training set was established
Not applicable. See point 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.”