(24 days)
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 Vmin. Within the specified flow rate range, the device oxygenates the blood, eliminates carbon dioxide and requiates 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. The oxygenator is suitable for delivery of the volatile anesthetics isoflurane and sevoflurane. The anesthetic gas is administered through the oxygenator's gas inlet by means of a suitable anesthetic gas vaporizer. Responsibility for deciding whether to use an oxygenator rests solely with the attending physician.
The QUADROX-i Small Adult Microporous Membrane Oxygenator with and without Integrated Arterial Filter with BIOLINE Coating is a blood-gas exchanger with integrated heat exchanger and optional integrated arterial blood filter.
The provided document is a 510(k) summary for a medical device called the "QUADROX-i Small Adult Microporous Membrane Oxygenator with and without Integrated Arterial Filter with BIOLINE Coating." It describes the device, its intended use, and its substantial equivalence to previously marketed devices. However, it does not contain specific acceptance criteria or details of a study that directly proves the device meets such criteria in terms of performance metrics like accuracy, sensitivity, or specificity.
Instead, the document details a substantial equivalence determination study, which is a regulatory pathway for medical devices in the US. This type of study demonstrates that a new device is as safe and effective as a legally marketed predicate device.
Here's an analysis of the provided text in relation to your request, highlighting what is present and what is absent:
1. Table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated as numerical performance targets (e.g., "sensitivity must be >X%"). The acceptance criteria are implicitly that the device performs equivalently to the predicate devices across certain aspects.
- Reported Device Performance: No specific numerical performance results (e.g., actual oxygenation rates, CO2 elimination rates, or filtering efficiencies) are reported in a granular manner. The study concludes that the device is "substantially equivalent" in key areas described below.
2. Sample size used for the test set and the data provenance
- The document does not specify sample sizes for test sets in terms of individual patients, images, or data points.
- It refers to "evaluation and testing" but does not detail the methodology or scale of this testing.
- Data Provenance: Not mentioned (e.g., country of origin, retrospective or prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable to this type of regulatory submission. The "ground truth" here is not an expert-derived clinical diagnosis or measurement, but rather a comparison against established performance benchmarks of predicate devices.
4. Adjudication method for the test set
- Not applicable. There is no expert adjudication mentioned for performance comparison.
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. This is not an AI-enabled device, nor is it a diagnostic device where human reader performance would be a primary metric. Therefore, an MRMC study is not relevant here. The device is a physical medical device (oxygenator) used during surgery.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This is not a software algorithm or an AI device. The "performance" relates to the physical and biological function of the oxygenator itself.
7. The type of ground truth used
- The "ground truth" in this context is the established safety and effectiveness profile of the legally marketed predicate devices. The new device aims to demonstrate it is "substantially equivalent" to these known and accepted devices. The evaluation included:
- Integrity
- Performance (general, not specific metrics detailed)
- Biocompatibility
- Sterility
8. The sample size for the training set
- Not applicable. This is not a machine learning or AI device that requires a training set.
9. How the ground truth for the training set was established
- Not applicable.
Study Description (What was done, based on the document):
The study was a substantial equivalence determination study. The objective was to demonstrate that the new device, the "QUADROX-i Small Adult Microporous Membrane Oxygenator with and without Integrated Arterial Filter with BIOLINE Coating," is as safe and effective as its predicate devices.
Predicate Devices:
- QUADROX-i Small Adult Microporous Membrane Oxygenator with and without Integrated Arterial Filter with Softline Coating (K090689)
- QUADROX-i Adult Microporous Membrane Oxygenator with and without Integrated Arterial Filter with BIOLINE Coating (K000511)
Methodology (as inferred from the summary):
The sponsor conducted "evaluation and testing" in the following categories:
- Integrity: Likely assessed the structural soundness and leak protection of the device.
- Performance: This would involve testing the device's ability to oxygenate blood, eliminate carbon dioxide, regulate blood temperature, and for the filtered version, filter out air bubbles and particles >40 µm. No specific metrics or results are provided, but the conclusion states it's substantially equivalent.
- Biocompatibility: Likely involved tests to ensure the materials used in the device, particularly the BIOLINE coating, are compatible with blood and human tissue and do not cause adverse reactions. (This is the key difference from the primary predicate, which uses Softline coating).
- Sterility: Tests to ensure the device is sterile when provided for use.
Conclusion of the Study:
The data demonstrated that the new device is substantially equivalent to the named predicate devices. The primary change was the coating (BIOLINE vs. Softline), and the new device was shown to be equivalent to an existing device that also uses the BIOLINE coating (K000511), as well as being equivalent in its oxygenator function to a similar small adult device (K090689) with the Softline coating.
§ 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.”