(143 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 Arterial 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 Arterial 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 Arterial Cannulae are intended to provide a means of perfusing blood into the body of a patient during cardiopulmonary bypass procedures.
Edwards Femoral Access Arterial Cannulae are also available with Duraflo® coating.
Here's a breakdown of the acceptance criteria and study information for the Edwards Lifesciences Femoral Access Arterial Cannulae, extracted from the provided 510(k) summary:
This submission is a clarification of the Indications for Use statement, and no physical changes were made to the device. The substantial equivalence is based on the device having the same technological characteristics as its predicate devices. Therefore, the "study" described is primarily bench and laboratory testing to confirm that the existing device continues to meet its specifications. It does not involve AI, human readers, or clinical trials in the way typically associated with AI-driven medical devices.
1. Table of Acceptance Criteria and Reported Device Performance
| Testing | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Sterility | Per ISO11135-1, Sterilization of health care products - Ethylene oxide - Part 1 | Performance met the acceptance criteria (assumed as per "The performance testing met the acceptance criteria.") |
| Ethylene oxide sterilization residuals | ISO 10993-7, Biological evaluation of medical devices - Part 7: | Performance met the acceptance criteria |
| Biocompatibility | Per ISO 10993-1 for External communicating device, direct circulating blood path, duration ≤ 24 hours. | Performance met the acceptance criteria |
| Conical Fittings | Fittings must be compatible with standard connections. | Performance met the acceptance criteria |
| Dimensional Inspection | Confirmation of critical dimensions such as ID, OD and length. | Performance met the acceptance criteria |
| Wire Encapsulation | Cannula body wire reinforcement shall be fully encapsulated. | Performance met the acceptance criteria |
| Cannula Leak | Pressure drop must meet minimum requirement. | Performance met the acceptance criteria |
| Kink | The cannulae shall not kink at a pre-determined diameter. | Performance met the acceptance criteria |
| Cannula Crush | The cannulae must not crush at a pre-determined compression. | Performance met the acceptance criteria |
| Cannula Collapse | The cannulae must not collapse at a pre-determined vacuum pressure. | Performance met the acceptance criteria |
| Tensile | Confirmation of the bond strength of the catheter assembly must meet pre determined loads. | Performance met the acceptance criteria |
| Cap removal force | Confirm cap removal force is within pre-determined limits. | Performance met the acceptance criteria |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated. The testing appears to be bench and laboratory-based, likely involving a representative number of cannulae for each test type, rather than human "test subjects" or diagnostic cases.
- Data Provenance: The data is from "Bench and laboratory testing." This indicates the testing was conducted in a controlled environment, likely by the manufacturer, rather than being derived from patient data (e.g., country of origin is not applicable in this context). The study is prospective in nature as new tests were performed on the device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This section is not applicable as the device is a physical medical device (cannula), not a diagnostic algorithm or image analysis system that requires expert interpretation for ground truth. The "ground truth" for this device's performance is established by objective engineering and safety standards (e.g., ISO standards, pre-determined physical limits).
4. Adjudication Method for the Test Set
This section is not applicable. Adjudication methods (like 2+1 or 3+1) are relevant for studies where subjective interpretation or discordance among experts needs to be resolved (e.g., in reading medical images). For physical device testing against objective criteria, there is no need for adjudication in this manner.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a MRMC comparative effectiveness study was not done. This type of study is typically performed for AI-driven diagnostic devices to assess how the AI affects human reader performance. As this submission is for a physical medical device and a clarification of its Indications for Use, such a study is not relevant or applicable.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Not applicable. The device is a physical medical instrument (cannula), not an algorithm. Therefore, "standalone algorithm performance" is not a concept that applies here.
7. The Type of Ground Truth Used
The "ground truth" for the device's performance is based on objective engineering specifications and recognized international standards (e.g., ISO11135-1 for sterility, ISO 10993-7 for residuals, ISO 10993-1 for biocompatibility). These standards and internal specifications define the acceptable limits and characteristics for each test item (e.g., "Cannula body wire reinforcement shall be fully encapsulated," "Pressure drop must meet minimum requirement").
8. The Sample Size for the Training Set
Not applicable. This device is a physical, non-AI medical device. The concept of a "training set" is relevant for machine learning algorithms, which are not involved in the design or evaluation of this cannula.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set for an algorithm, there is no ground truth established for a training set.
§ 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).