(28 days)
The CAPIOX® Arterial Filter with X-Coating is a pediatric filter that is intended to filtrate non-biologic particles and emboli, and to facilitate air bubble removal from the blood flowing through a cardiopulmonary bypass circuit for up to 6 hours. The polymethoxyethylacrylate coating (PMEA) is intended to reduce the adhesion of platelets to the blood-contacting surfaces of the device.
The device is a hardshell housing that contains a blood filter, and has both a blood inlet port and a blood outlet port. The blood inlet port is positioned along the side axis of the outer housing and provides the entry point for blood. The blood outlet port is positioned at the base of the device. The top surface of the device has a luered connection port (Air Vent Port) that will accommodate a stopcock assembly to facilitate the air removal process. The hardshell housing contains a pleated screen filter assembly in which blood passes through for filtration of particulate matter. After the blood has been filtered, it then exits the device via the blood outlet port.
The provided text describes the performance evaluation of the CAPIOX® CX*AF02X Arterial Filter with X-Coating. The study aims to demonstrate its substantial equivalence to the uncoated CAPIOX® Arterial Filter (K943917) and does not involve AI or human readers. Therefore, several sections of your request are not applicable.
Here's the information extracted from the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state acceptance criteria with numerical thresholds but rather describes performance comparisons to a predicate device. The underlying acceptance criterion for this 510(k) submission is "substantial equivalence" to the predicate device.
| Performance Characteristic | Reported Device Performance (CAPIOX® CX*AF02X with X-Coating) | Acceptance Criteria (Implicitly, Substantial Equivalence to Predicate) |
|---|---|---|
| Filtration Efficiency | Comparisons demonstrated no clinically significant performance differences between the two devices. | Performance is not clinically significantly different from the predicate uncoated CAPIOX® Arterial Filter. |
| Air Handling Capabilities | Comparisons demonstrated no clinically significant performance differences between the two devices. | Performance is not clinically significantly different from the predicate uncoated CAPIOX® Arterial Filter. |
| Device Effect Upon Cellular Blood Components (cellular destruction) | Comparisons demonstrated no clinically significant performance differences between the two devices. | Performance is not clinically significantly different from the predicate uncoated CAPIOX® Arterial Filter. |
| Pressure Drop (Short-term and 6-Hour) | Comparisons demonstrated no clinically significant performance differences between the two devices. | Performance is not clinically significantly different from the predicate uncoated CAPIOX® Arterial Filter. |
| Mechanical Integrity | Comparisons demonstrated no clinically significant performance differences between the two devices. | Performance is not clinically significantly different from the predicate uncoated CAPIOX® Arterial Filter. |
| Static Priming Volume | Comparisons demonstrated no clinically significant performance differences between the two devices. | Performance is not clinically significantly different from the predicate uncoated CAPIOX® Arterial Filter. |
| Evaluation of the Connection of PVC Tubing to Inlet and Outlet Ports | Comparisons demonstrated no clinically significant performance differences between the two devices. | Performance is not clinically significantly different from the predicate uncoated CAPIOX® Arterial Filter. |
| Intended Use | Pediatric filter for non-biologic particles, emboli, and air bubble removal in CPB for up to 6 hours. PMEA coating reduces platelet adhesion. | Identical to predicate device, with added benefit of X-Coating. |
| Principles of Operation and Technology | Same as predicate (spiral blood flow for air removal, polyester screen for filtration). | Identical to predicate device. |
| Design and Materials | Same identical design as predicate, screen mesh in hardshell housing, blood inlet/outlet, standard luer port. Materials are equivalent, with the addition of X-Coating. | Identical to predicate device in design. Materials are equivalent, with the X-Coating not raising new safety/effectiveness issues. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not provide details on the specific sample sizes used for each performance test (e.g., number of filters tested for filtration efficiency). It also does not specify the country of origin of the data or whether the studies were retrospective or prospective, though performance evaluations of medical devices for 510(k) submissions are typically prospective laboratory or bench tests.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This is a medical device performance study, not an AI or diagnostic study requiring expert ground truth for interpretation.
4. Adjudication Method for the Test Set
Not applicable. No expert adjudication method is described as this is not a study requiring human interpretation of results.
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 not an AI-assisted diagnostic study.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is not an algorithm-based device. The device's performance was evaluated as a standalone product against its predicate.
7. The Type of Ground Truth Used
The "ground truth" for this type of device performance study is established through controlled laboratory and bench testing, adhering to established test methods and standards relevant to arterial filters (e.g., measuring particulate capture, air removal rates, pressure drop, cellular damage). The comparison is against the documented performance of the predicate device.
8. The Sample Size for the Training Set
Not applicable. This is not a machine learning or AI-based device, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this device.
§ 870.4260 Cardiopulmonary bypass arterial line blood filter.
(a)
Identification. A cardiopulmonary bypass arterial line blood filter is a device used as part of a gas exchange (oxygenator) system to filter nonbiologic particles and emboli (blood clots or pieces of foreign material flowing in the bloodstream which will obstruct circulation by blocking a vessel) out of the blood. It is used in the arterial return line.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance for Cardiopulmonary Bypass Arterial Line Blood Filter 510(k) Submissions.”