(150 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 Cannula may be used in pediatic 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 Cannulae with or without Duraflo® coating are wire-reinforced thin-wall polymer 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 in various sizes and lengths. Edwards Femoral Access Venous Cannulae are available in a range of sizes with a variety of tip and hole configurations, including stainless steel and plastic tips. The cannulae tips are tapered for easy insertion.
Some cannulae feature incremental depth markings to aid in proper placement and positioning. As an additional aid to placement, the clear tip of some versions of the cannula contains two radiopaque barium stripes for visualization. Some product codes may also include a suture ring.
Edwards Femoral Access Venous Cannulae are intended to provide a means of draining the blood flow of a patient during cardiopulmonary bypass procedures.
Edwards Femoral Access Venous Cannulae are also available with Durafto® coating.
Here's the breakdown of the acceptance criteria and study information based on the provided text, focusing on the lack of AI-specific details as this product is a physical medical device.
1. Table of Acceptance Criteria and Reported Device Performance
| Testing | Criteria | Reported Device Performance |
|---|---|---|
| Sterility | Per ISO11135-1, Sterilization of health care products - Ethylene oxide - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices | Met the acceptance criteria. |
| Ethylene oxide sterilization residuals | ISO 10993-7, Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals | Met the acceptance criteria. |
| Biocompatibility | Per ISO 10993-1 for External communicating device, direct circulating blood path, duration ≤ 24 hours. | Met the acceptance criteria. |
| Dimensional Inspection | Confirmation of critical dimensions such as ID, OD and length. | Met the acceptance criteria. |
| Wire Encapsulation | Cannula body wire reinforcement shall be fully encapsulated. | Met the acceptance criteria. |
| Cannula Leak | Pressure drop must meet minimum requirement. | Met the acceptance criteria. |
| Kink | The cannulae shall not kink at a pre-determined diameter. | Met the acceptance criteria. |
| Cannula Crush | The cannulae must not crush at a pre-determined compression. | Met the acceptance criteria. |
| Cannula Collapse | The cannulae must not collapse at a pre-determined vacuum pressure. | Met the acceptance criteria. |
| Tensile | Confirmation of the bond strength of the catheter assembly must meet pre-determined loads. | Met the acceptance criteria. |
| Cap removal force | Confirm cap removal force is within pre-determined limits. | Met the acceptance criteria. |
| Corrosion | Metallic components shall show no signs of corrosion. | Met the acceptance criteria. |
2. Sample Size Used for the Test Set and Data Provenance
The provided document describes bench and laboratory testing of a physical medical device (Femoral Access Venous Cannulae). There is no mention of a "test set" in the context of patient data, images, or AI models. The testing described is for the physical and chemical properties of the device itself. Therefore, concepts like country of origin or retrospective/prospective data are not applicable here.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable as the document describes functional and safety testing of a physical medical device, not a study involving human experts establishing ground truth for diagnostic or AI-driven tasks. The ground truth for the functional/safety testing is based on established engineering and medical device standards (e.g., ISO standards, pre-determined physical limits).
4. Adjudication Method for the Test Set
This is not applicable for the same reasons as points 2 and 3. There is no "test set" in the context of needing expert adjudication.
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
A Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI or diagnostic imaging devices where human interpretation is involved. The submission describes a physical medical device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This is not applicable. The device is a physical medical cannula; there is no algorithm or AI component involved, hence no standalone algorithm performance study would be conducted.
7. The Type of Ground Truth Used
The "ground truth" for the functional and safety testing of the Femoral Access Venous Cannulae primarily relies on:
- Established Industry Standards: Such as ISO 11135-1 (sterilization), ISO 10993-7 (ethylene oxide residuals), ISO 10993-1 (biocompatibility), and ISO 14971 (risk management). These standards set the benchmarks and methodologies for testing.
- Pre-determined Specifications: The criteria for tests like dimensional inspection, wire encapsulation, cannula leak, kink, crush, collapse, tensile strength, and cap removal force are based on the device's design specifications and engineering requirements.
8. The Sample Size for the Training Set
This is not applicable. There is no AI model or "training set" described in the context of this medical device submission.
9. How the Ground Truth for the Training Set Was Established
This is not applicable as there is no training set for an AI model.
§ 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).