(206 days)
Atrial Vent Catheters are intended for venting the left heart during short-term (≤6 hrs) cardiopulmonary bypass. Avoid direct ventriculotomy with entry into the left atrium across the mitral valve and into the left ventricle.
Left Ventricular Vent Catheters are intended for venting the left ventricle during short-term (≤6 hrs) cardiopulmonary bypass. Entrance is made into the left ventricle.
Extracorporeal circuit components with a Duraflo® coating are intended for use in cardiopulmonary surgery when a heparin coated blood path is desired.
Vent Catheters may be used in pediatric or adult populations based on individual patient anatomy.
Edwards Lifesciences atrial and left ventricular vent catheters consist of soft tubing with a radiused tip attached to a rigid clear plastic rear hub. Each catheter has a perforated venting segment and depth marker rings. Through the center of each catheter, extending slightly beyond the catheter tip and attached to the rear hub by a plastic locking device, is a removable rigid plastic stylet to facilitate insertion of the catheter. Silicone catheters have a closed tip and a malleable stainless steel stylet with a nonlocking hub. Models intended for right atrial insertion have additional side holes, Edwards Vent Catheters are also available with Duraflo® coating.
This document describes a 510(k) premarket notification for Edwards Lifesciences Vent Catheters. The submission is a "clarification of the Indications for Use statement" and explicitly states: "No physical changes are being made to these devices." and "No functional testing was performed in support of the change to the Indications for Use."
Therefore, the provided text does not contain information about acceptance criteria or a study proving the device meets those criteria, as no new studies were conducted for this submission. The device is deemed substantially equivalent based on existing technological characteristics and previous predicate device clearances.
Since no new studies were performed, the following information cannot be extracted from the provided text:
- A table of acceptance criteria and the reported device performance
- Sample size used for the test set and the data provenance
- Number of experts used to establish the ground truth for the test set and their qualifications
- Adjudication method for the test set
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done
- If a standalone performance study was done
- The type of ground truth used
- The sample size for the training set
- How the ground truth for the training set was established
§ 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).