(88 days)
These cannulae are intended for the perfusion of the ascending aorta during short-term (6 hours or less) cardiopulmonary bypass.
The Medtronic DLP Arterial Cannulae with 3D Tip represent modified versions of existing Medtronic DLP Arterial Cannulae. The proposed change involves the incorporation of a baffled tip design into the 22 Fr. cannula. This baffled tip imparts a more diffuse pattern of blood flow exiting from the cannula tip than exists with the existing open tip cannula design.
The provided document is a 510(k) Summary for a medical device (Medtronic DLP Arterial Cannulae with 3D Tip - 22 Fr.) and describes non-clinical performance data rather than a study with acceptance criteria and device performance in the context of human data or AI algorithms. As such, many of the requested categories are not applicable.
Here's an analysis based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Biocompatibility: In accordance with ISO 10993-1 for externally communicating devices in contact with circulating blood for |
§ 870.4210 Cardiopulmonary bypass vascular catheter, cannula, or tubing.
(a)
Identification. A cardiopulmonary bypass vascular catheter, cannula, or tubing is a device used in cardiopulmonary surgery to cannulate the vessels, perfuse the coronary arteries, and to interconnect the catheters and cannulas with an oxygenator. The device includes accessory bypass equipment.(b)
Classification. Class II (performance standards).