(36 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. Extracorporeal circuit components with a Duraflo coating are intended for use in cardiopulmonary surgery when a heparin coated blood path is desired.
The Edwards Femoral Access Venous and Arterial Cannulae with/out Duraflo® coating 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 1/4" or 3/8" tubing connection. The cannulae are available on 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 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 stripes for visualization. Edwards Femoral Access Cannulae are intended to provide a means of draining the blood flow (venous), or perfusing blood into the body (arterial) of a patient during cardiopulmonary bypass procedures. Each Edwards Lifesciences device is packaged sterile and non-pyrogenic in a sealed, peel-type pouch.
Here's an analysis of the provided text regarding the Edwards Lifesciences® Femoral Access Venous and Arterial Cannulae, focusing on acceptance criteria and study details.
Based solely on the provided 510(k) summary, the document does not contain the detailed study information typically associated with establishing device performance against specific acceptance criteria. The 510(k) summary explicitly states that the basis for the submission is the addition of contraindications to the Instructions for Use, and that no physical changes are being made to the devices. It claims substantial equivalence to previously cleared predicates without providing new performance data for this submission.
Therefore, many of the requested elements for describing the acceptance criteria and the study that proves the device meets them cannot be extracted from this document because such a study is not detailed here.
Here's a breakdown of what can be inferred or explicitly stated from the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in this 510(k) summary, as no new performance data is presented. | Not specified in this 510(k) summary. |
| Assumed to meet previously established safety and efficacy criteria for predicate devices. | The document states: "The Femoral Access Arterial and Venous Cannulae met all predetermined acceptance criteria to confirm safety and efficacy." However, the criteria themselves and the data supporting this are not provided in this summary. |
Explanation: The 510(k) summary, in this instance, is focused on a labeling change (adding contraindications) rather than demonstrating new performance. It relies on the prior clearance of its predicate devices to assert that the device "met all predetermined acceptance criteria." The specific criteria and the data proving performance against them are not included in this document.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified in this 510(k) summary.
- Data Provenance: Not specified in this 510(k) summary.
- Retrospective/Prospective: Not specified in this 510(k) summary.
Explanation: Since no new performance studies are detailed, this information is not available in the provided text.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable/Not specified in this 510(k) summary, as no new clinical or performance studies requiring expert ground truth establishment are detailed.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not specified in this 510(k) summary.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. This device is a physical medical device (cannulae), not an AI/software-based diagnostic tool that would typically involve human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable/Not specified in this 510(k) summary. For a physical device like a cannula, "ground truth" would typically relate to mechanical properties, biocompatibility, flow rates, and successful implantation/function in in vitro or in vivo studies, data which are not presented here.
8. The sample size for the training set
- Not applicable/Not specified in this 510(k) summary, as no AI model or complex algorithm requiring a training set is discussed.
9. How the ground truth for the training set was established
- Not applicable/Not specified in this 510(k) summary.
Summary of Findings from the Provided Text:
The provided 510(k) summary (K140208) is a submission primarily focused on labeling changes (adding contraindications) for existing, previously cleared devices. It explicitly states that "No physical changes are being made to these devices" and that the "design of the device remains unchanged." The basis for clearance is substantial equivalence to predicate devices (K123298 and K123303), which would have had their own studies (mechanical, biocompatibility, etc.) for initial clearance. This particular document does not present any new acceptance criteria or new data from studies to prove device performance. It simply asserts that the device "met all predetermined acceptance criteria" based on its equivalence and prior clearances.
§ 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).