(29 days)
Edwards Lifesciences Femoral Access Cannulae are intended for use in situations which require rapid femoral venous and arterial access for short-term (≤ 6 hours) cardiopulmonary bypass. Vessel access (venous or arterial) is left to the discretion of the physician. Femoral access cannulae may be used in pediatric populations or adult populations based on flow rate requirements and individual patient anatomy. Please consult labeling to determine pressure drop related to flow rates.
The Edwards Femoral Access Venous and Arterial Cannulae are wire-reinforced thin-wall polyurethane or PVC cannulae. The wire reinforcement is intended to prevent kinking during use. The clear proximal section of the cannula is unreinforced for clamping and terminates in either a barbed connector for ¼" or 3/8" tubing connection. The cannulae are available in various sizes and lengths. Each cannula is furnished with one, or in some cases two, dilator(s). In the case of cannulae supplied with two dilators, one is solid and the other is hollow. The hollow dilator will pass over guidewires up to 0.038" (0.97 mm) in diameter. The guidewire, when used, facilitates percutaneous insertion, or insertion under direct visualization. The cannulae tips are tapered for easy insertion. Some cannulae feature incremental depth markings to aid in proper placement and positioning. Some versions have, as an additional aid to placement, the clear tip section of the cannula contain two radiopaque barium strips for visualization. Edwards Femoral Access Cannulae are intended to provide a means of draining the blood flow (venous), or cardiopulmonary bypass procedures. Each Edwards Lifesciences device is packaged sterile and non-pyrogenic in a sealed, peel-type pouch.
This document is an FDA 510(k) premarket notification for Edwards Lifesciences LLC's Fem-Flex II Femoral Arterial Cannula, Fem-Flex II Femoral Venous Cannula, Femoral Venous Cannula, and FemTrak Femoral Venous Cannula (K200358).
The key takeaway is that this submission is not for a new device requiring extensive performance studies to prove it meets acceptance criteria. Instead, it is a modification to the Instructions for Use (IFU) of an already legally marketed device (predicate device K140208). Therefore, the information typically found in a standard performance study proving acceptance criteria for a new device is not present in this document.
The document explicitly states:
- "No functional/safety testing was performed for the Femoral Access Venous and Arterial Cannulae. The only changes being made are modifications to the Instructions for Use."
- "The devices, with the proposed modification statements, have the identical design, materials, technology, and operating principles as the current legally marketed version of the devices, and as such no performance testing was conducted."
- "The current legally marketed version of the Femoral Access Venous and Arterial Cannulae complies will all applicable design practices and regulations and was most recently cleared by FDA via K140208 (SE March 5, 2014) for modifications of its packaging."
Therefore, I cannot provide a table of acceptance criteria and reported device performance or information about sample sizes, experts, adjudication methods, MRMC studies, standalone studies, or ground truth establishment relevant to this specific 510(k) submission because such studies were not conducted for this submission.
The acceptance criteria for market clearance in this case would have been satisfied by demonstrating substantial equivalence to the predicate device, primarily by showing that the modification to the IFU did not introduce new questions of safety or effectiveness, and that the device itself remains unchanged from its previously cleared version.
§ 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).