(86 days)
The Coronary Artery Perfusion Cannula with Self-Inflating Balloon is indicated for use in delivery of cardioplegia solution directly to the coronary arteries during cardiopulmonary bypass surgery.
The Coronary Artery Perfusion Cannula with Self-Inflating Balloon consists of a single lumen vinyl tube provided for with a vinyl female luer connector bonded proximally and a vinyl cuff bonded distally. The cuff is pre-molded to its inflated configuration and is purposely positioned directly over a hole generated in the extruded tubing for purposes of receiving the infused cardioplegia solution. The subject device is provided for in five sizes based upon the diameter of the cuff consisting of 4, 5, 6, 7 & 8 mm in diameter. Furthermore, the cannula is pre-shaped into two configurations both straight and right angle.
The provided document is a 510(k) summary for a medical device called the "Coronary Artery Perfusion Cannula with Self-Inflating Balloon." This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through extensive clinical trials with specific acceptance criteria and performance metrics.
Therefore, the document does not contain the information requested regarding acceptance criteria, device performance, study details (sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, standalone performance), or training set information.
Instead, the document focuses on:
- Claim of Substantial Equivalence: The key assertion is that the new device is substantially equivalent to a predicate device (California Medical Laboratories, Inc. Aortic Root Cannula) based on similar intended use and technologic characteristics (material, dimensional specifications, and performance characteristics).
- Intended Use: Both the new device and the predicate device are indicated for use in the delivery of cardioplegia solution during cardiopulmonary bypass surgery.
- Technological Characteristics: A general statement that the new device's characteristics are "substantially equivalent" to the predicate.
In summary, this 510(k) submission relies on a comparison to an existing device rather than presenting new performance data against pre-defined acceptance criteria from a study.
§ 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).