(132 days)
Aortic perfusion cannulae are Intended for perfusion of the aorta during short-term (≤ 6 hours) cardiopulmonary bypass procedures.
Aortic Perfusion Cannulae may be used in pediatric or adult populations based on the 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.
Edwards Aortic Perfusion Cannulae are sterile, non-pyrogenic, single-use cannulae made of flexible and non-flexible polymeric materials. They are intended for perfusion of the ascending aorta during cardiopulmonary bypass procedures.
Edwards' Aortic Perfusion Cannulae are available in a range of sizes with a variety of tip and hole configurations, including straight, angled, stainless steel, and plastic tips. They terminate in a connector or connector acceptance of 3/8" (9.5 mm) or 1/4" (6.3 mm), and are available in non-wire-reinforced and stainless steel wire-reinforced configurations to help prevent kinking and twisting of the cannulae. Edwards Aortic Perfusion Cannulae are also available with Duraflo™ coating.
Here's a breakdown of the acceptance criteria and the study information based on the provided text, formatted to address your questions:
1. Table of Acceptance Criteria and Reported Device Performance
| Testing | Criteria | Reported Device Performance(Met/Not Met/Not Mentioned) |
|---|---|---|
| Sterility | Per ISO 11135-1, Sterilization of health care products - Ethylene oxide - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices | Met |
| Ethylene oxide sterilization residuals | ISO 10993-7, Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals | Met |
| Biocompatibility | Per ISO 10993-1 for External communicating device, direct circulating blood path, duration ≤ 24 hours. | Met |
| Conical Fittings | Fittings must be compatible with standard connections. | Met |
| Assembly Leak | Pressure drop must meet minimum requirement. | Met |
| Kink | The cannulae shall not kink at a pre-determined diameter. | Met |
| Cannula Crush | Cannula shall not crush when a pre-determined compression is applied. | Met |
| Tip Crush | Distal tip of cannula shall withstand a minimum weight without cracking or breaking. | Met |
| Vent Plug Crush | Must withstand pre-determined compressive force without breaking or crumbling. | Met |
| Cap Removal Force | Removal force meets a pre-determined axial force. | Met |
| Corrosion | Metallic components shall show no signs of corrosion. | Met |
| Assembly Tensile | Confirmation of the bond strength of the catheter assembly must meet pre-determined loads. | Met |
| Hemolysis | Dynamic hemolysis testing must show that devices are non-hemolytic. | Met |
| Pressure Drop | Pressure drop testing to confirm flow rate values for product labeling. | Met |
Note: The document explicitly states, "The performance testing met the acceptance criteria," indicating that all listed criteria were satisfied.
2. Sample Size Used for the Test Set and the Data Provenance
The provided text describes bench and laboratory testing only. It does not mention a "test set" in the context of patient data or clinical trials. Therefore, information about sample size for a test set and data provenance (e.g., country of origin, retrospective/prospective) is not applicable to this submission. The tests were performed on the device itself.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not applicable. The ground truth for the "test set" (which consists of the device's physical and functional properties) was established through engineering specifications, industry standards (ISO), and direct measurement or observation during bench testing, not through expert human evaluation of clinical data.
4. Adjudication Method for the Test Set
This information is not applicable. Adjudication methods like 2+1 or 3+1 typically refer to the process of resolving discrepancies among multiple human reviewers during data labeling or clinical trial endpoint assessment. The testing described here is objective bench testing against pre-defined engineering criteria.
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
There was no MRMC comparative effectiveness study performed. This submission is for an Aortic Perfusion Cannula, which is a medical device (hardware), not an AI algorithm or a diagnostic tool utilizing human interpretation. Therefore, the concept of human readers improving with or without AI assistance is not applicable.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable. The device is an Aortic Perfusion Cannula, not an algorithm.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The ground truth for the device's performance was based on:
- Engineering specifications and standards: Pre-determined diameters for kinking, minimum weight for tip crush, pre-determined compressive force for vent plug crush, pre-determined axial force for cap removal, pre-determined tensile loads for assembly strength.
- International Standards (ISO): Specifically ISO 11135-1 (sterilization), ISO 10993-7 (EO residuals), and ISO 10993-1 (biocompatibility).
- Objective measurements and observations: Confirmation of compatibility with standard connections, meeting minimum pressure drop requirements, showing no signs of corrosion, and demonstrating non-hemolytic properties.
8. The Sample Size for the Training Set
This information is not applicable. There is no "training set" as this is a physical medical device, not a machine learning model.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reason as above; there is no training set. The "ground truth" for the device's design and manufacturing was established through established engineering practices, material science, and regulatory compliance requirements.
§ 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).