(177 days)
These cannulae are intended for collection of venous blood from the right side of the heart via the superior and inferior vena cava during cardiopulmonary bypass surgery.
The Medtronic DLP Malleable Single Stage Venous Cannulae represent modified versions of existing Medtronic Single Stage Venous Cannulae. The proposed change involves the incorporation of a malleable wire/tube assembly embedded within the wall of the cannula. This malleable wire/tube assembly allows the cannula body to be shaped into a surgeon preferred position.
The provided document, KO22272 for the Medtronic DLP Malleable Single Stage Venous Cannula, is a 510(k) summary for a medical device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than establishing completely new performance criteria. Therefore, the document does not contain detailed acceptance criteria in the form of specific performance metrics or a study that rigorously "proves" the device meets them in the same way a de novo or PMA submission might.
Instead, the acceptance criteria are implicitly met by demonstrating that the new device is as safe and effective as the predicate device, which is already on the market. The study described focuses on non-clinical tests to support this substantial equivalence.
Here's an analysis based on the provided text, addressing the requested points where information is available:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Material Biocompatibility (as per 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).