(15 days)
The Quart Arterial Filter with Safeline Coating is designed for use in an extracorporeal circulation system during surgical procedures involving a cardiopulmonary bypass. Within the cited flowrates, 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 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 Safeline 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 Jostra Quart Arterial Filter with Safeline Coating is identical to the Jostra Quart Arterial Filter uncoated with the only exception that the Quart Arterial Filter with Safeline Coating has been coated with Safeline. The Safeline Coating is the same as with the Jostra RotaFlow Centrifugal Pump with Safeline Coating. Besides this difference the both Quart Arterial Filters are the same in design, intended use, method of operation, components, packaging, and fundamental scientific technology.
The provided text does not contain information about acceptance criteria, device performance, sample sizes, expert qualifications, or study
methodologies in the context of a typical AI/ML device submission. Instead, these documents are part of a 510(k) submission for a
medical device called "Quart Arterial Filter with Safeline Coating," which underwent a review for substantial equivalence to existing
predicate devices.
The document focuses on the mechanical and biocompatibility aspects of the device and its coating, not on an algorithm's
performance against a ground truth dataset. Therefore, I cannot extract the information requested for AI/ML device studies.
The provided text only gives information of two predicate devices, an arterial filter and a centrifugal pump with the same safeline coating.
The new device (Quart Arterial Filter with Safeline Coating) is "substantially equivalent" to these two predicate devices.
The following areas have been tested and / or evaluated: Integrity, Performance, Biocompatibility, Sterility.
No information is provided about:
- Sample size used for the test set and data provenance
- Number of experts and their qualifications
- Adjudication method
- Multi-Reader Multi-Case (MRMC) comparative effectiveness study
- Standalone performance
- Type of ground truth used
- Sample size for the training set
- How ground truth for the training set was established
§ 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.”