(92 days)
The membrane oxygenator QUADROX-i Adult is intended for use in extracorporeal circulation during cardiopulmonary bypass in cardiac surgery. The blood flow rate is defined from 0.5 – 7 I/min. Within the specified flow rate range, the device oxygenates the blood, eliminates carbon dioxide from the blood and requlates blood temperature. The QUADROX-i Adult (HMO 71000) version with integrated arterial filter also filters out air bubbles and particles larger than 40 µm. The device's utilization period is limited to six hours. Responsibility for deciding whether to use an oxygenator rests solely with the attending physician.
The membrane oxygenator QUADROX-i Small Adult is intended for use in extracorporeal circulation during cardiopulmonary bypass in cardiac surgery. The blood flow rate is defined from 0.5 – 5 I/min. Within the specified flow rate range, the device oxygenates the blood, eliminates carbon dioxide from the blood and regulates blood temperature. The QUADROX-i Small Adult (HMO 51000) version with integrated arterial filter also filters out air bubbles and particles larger than 40 µm. The device's utilization period is limited to six hours. Responsibility for deciding whether to use an oxygenator rests solely with the attending physician.
The membrane oxygenator QUADROX-iD Adult is intended for use in extracorporeal circulation during cardiopulmonary bypass in cardiac surgery. The blood flow rate is defined from 0.5 - 7 I/min. Within the specified flow rate range, the device oxygenates the blood, eliminates carbon dioxide from the blood and regulates the blood temperature. The device's utilization period is limited to six hours. Responsibility for deciding whether to use an oxygenator rests solely with the attending physician.
The QUADROX-i Small Adult / Adult and QUADROX-iD Adult oxygenators are blood-gas exchangers with integrated heat exchanger and optionally integrated arterial blood filter (only available for QUADROX-I Small Adult / Adult). They are used in cardiac surgery, in combination with a heart-lung machine, to oxygenate blood, remove carbon dioxide and adjust blood temperature. The integrated arterial filter is intended to filter out air bubbles and particles larger than 40µm. It is used for removing gaseous embolisms and aggregates from blood components from the arterial blood during extracorporeal circulation. It is a screen filter with pre-post-de-airing mechanic.
The provided text is a 510(k) summary for medical devices, specifically cardiopulmonary bypass oxygenators. This type of document focuses on demonstrating substantial equivalence to a predicate device rather than detailing extensive clinical studies or acceptance criteria for independent device performance. Therefore, many of the requested details about acceptance criteria, study methodologies, and ground truth establishment are not present in this submission.
Here's a breakdown of the available information:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table of acceptance criteria in the sense of predefined thresholds for performance metrics. Instead, it describes "performance testing" that demonstrated the modified devices perform "within its specifications and within the acceptable limits of the applied performance standards." The specific performance characteristics tested are listed.
| Performance Characteristic | Reported Device Performance |
|---|---|
| Stability | Assumed to meet specifications and acceptable limits of applied performance standards. |
| Stability axial | Assumed to meet specifications and acceptable limits of applied performance standards. |
| Crash test | Assumed to meet specifications and acceptable limits of applied performance standards. |
| Blood Cell Damage | Assumed to meet specifications and acceptable limits of applied performance standards. |
| Blood side integrity | Assumed to meet specifications and acceptable limits of applied performance standards. |
| Heat exchanger side integrity | Assumed to meet specifications and acceptable limits of applied performance standards. |
| Sterile packaging integrity | Assumed to meet specifications and acceptable limits of applied performance standards. |
2. Sample sized 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 sizes used for the "performance testing." It also does not explicitly state the data provenance (country of origin or retrospective/prospective nature). The submitter, MAQUET Cardiopulmonary AG, is based in Germany, and the contact person is in the USA, so the testing could have occurred in either or both regions.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This is not applicable to the type of testing described. The "ground truth" for mechanical and biological performance of an oxygenator is typically established through standardized laboratory tests and engineering benchmarks, not expert consensus on medical images or clinical outcomes.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable. Adjudication methods like those described are typically used in clinical studies involving human interpretation or subjective assessments, which are not detailed here.
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 is not applicable. The device is an oxygenator, not an AI-powered diagnostic tool. No MRMC study involving human readers or AI assistance was conducted or mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is a physical medical device (oxygenator), not a software algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the non-clinical tests listed would be established by the physical and chemical properties measured during laboratory testing against defined standards. For example, "Blood Cell Damage" would likely be measured by hemolysis rates, "Stability" by structural integrity under stress, and "Integrity" by leak tests, all compared to pre-defined specifications derived from engineering standards and regulatory requirements.
8. The sample size for the training set
This is not applicable. The document describes a physical medical device and its non-clinical performance testing, not a machine learning model that requires a training set.
9. How the ground truth for the training set was established
This is not applicable for the reasons stated above.
§ 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.”