(30 days)
The Quart Arterial Filter is designed for use in an extracorporeal circulation system during surgical procedures involving a cardiopulmonary bypass. Within the cited flowrates, the Quart Arterial Filter removes particulate and gaseous micro-embolisms from the extracorporeal circulation system. The eliminated gas can be removed via the purge line. The max. flow rate of the Quart Arterial Filter is 7 1/min.
The decision regarding the method in which the arterial filter is to be employed rests solely with the treating physician.
The unit may not be continuously employed for more than 6 hours. We do not recommend longer contact with the blood.
The Quart Arterial Filter with Bioline Coating is designed for use in an extracorporeal circulation system during surgical procedures involving a cardiopulmonary bypass. Within the cited flow rates, the arterial filter removes particulate and gaseous micro-embolisms from the extracorporeal circulation system. The eliminated gas can be removed via the purge line. The Bioline Coating improves the physical surface properties of products for the extracorporeal circulation system.
Acceptance Criteria and Device Performance for Quart Arterial Filter with Bioline Coating
The provided document describes a Special 510(k) submission for a modified device, the Quart Arterial Filter with Bioline Coating. This submission aims to demonstrate substantial equivalence to a predicate device, the Quart Arterial Filter (uncoated), by adding a Bioline coating. The Bioline coating itself is previously cleared for use with the Quadrox D Diffusion Membrane Oxygenator (K071774).
The acceptance criteria and device performance are not explicitly detailed with specific numerical targets in this summary, but the document states that "Evaluation and testing on safety and effectiveness was executed to demonstrate that the Quart Arterial Filter with Bioline Coating described in this submission is substantially equivalent to the Quart Arterial Filter as an arterial filter and to the Quadrox D Diffusion Membrane Oxygenator with Bioline Coating the Bioline coating."
The areas tested and/or evaluated are listed below, which serve as the broad acceptance criteria categories the device had to meet to demonstrate substantial equivalence.
1. Table of Acceptance Criteria (Categories) and Reported Device Performance
| Acceptance Criteria Category | Reported Device Performance (as stated in the document) |
|---|---|
| Integrity | Demonstrated through evaluation and testing. |
| Performance | Demonstrated through evaluation and testing. |
| Biocompatibility | Demonstrated through evaluation and testing. |
| Sterility | Demonstrated through evaluation and testing. |
Note: The document only mentions "demonstrated through evaluation and testing" for each category without providing specific metrics or results achieved. It implicitly means the device successfully met the established criteria within each category for demonstrating substantial equivalence.
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample sizes used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It generally refers to "evaluation and testing."
3. Number of Experts Used to Establish Ground Truth and Qualifications
The document does not provide any information regarding the number of experts used to establish ground truth or their qualifications. The evaluation appears to be based on laboratory testing and comparison to predicate devices, rather than expert-based ground truth for clinical outcomes or diagnostic accuracy.
4. Adjudication Method
The document does not mention any adjudication method. This type of device (an arterial filter) is not typically evaluated using adjudication methods relevant to diagnostic imaging or clinical decision-making.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A multi-reader multi-case (MRMC) comparative effectiveness study was not performed or mentioned. This type of study is typically relevant for diagnostic devices where human interpretation is involved. For an arterial filter, the focus is on physical and biological performance characteristics.
6. Standalone Performance
A standalone performance evaluation (algorithm only, without human-in-the-loop) was effectively done in the sense that the device's performance characteristics (integrity, performance, biocompatibility, sterility) were evaluated intrinsically. The device is a medical device, not an algorithm. The evaluation focused on the device itself meeting the criteria.
7. Type of Ground Truth Used
The ground truth used for this evaluation was primarily established through laboratory testing and established standards for medical devices, specifically related to:
- Integrity: Structural soundness, absence of leaks, etc.
- Performance: Efficiency of particle and gas removal as per expected function (within cited flow rates), pressure drop, etc. This would be based on validated test methods for arterial filters.
- Biocompatibility: In vitro and/or in vivo tests to confirm the material's compatibility with blood and tissues, as per ISO 10993 series.
- Sterility: Validation of the sterilization process to ensure the device is sterile when packaged.
The ultimate ground truth for this 510(k) submission is the demonstration of substantial equivalence to existing legally marketed predicate devices in terms of safety and effectiveness, based on these technical characteristics.
8. Sample Size for the Training Set
The concept of a "training set" is not applicable to this type of device modification submission. This is not an AI/ML powered device, so there is no algorithm that requires training data. The Bioline coating itself has a previous clearance (K071774), indicating its properties were validated as part of that submission.
9. How Ground Truth for the Training Set Was Established
As there is no training set for an AI/ML algorithm, this question is not applicable.
§ 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.”