(134 days)
Retrograde coronary sinus cardioplegia catheters with and without Duraflo coating are intended for delivery of blood or cardioplegia solution intraoperatively to avoid cardiac damage and aid in myocardial protection.
Retrograde coronary sinus cardioplegia catheters may be used in pediatric or adult populations based on the requirements of individual patient anatomy.
This device is for short-term use only (≤ 6 hours).
Extracorporeal circuit components with a Duraflo coating are intended for use in cardiopulmonary surgery when a heparin coated blood path is desired.
Edwards Retrograde Coronary Sinus Cardioplegia Catheters (or Retrograde Cardioplegia Cannulae) are sterile, non-pyrogenic, single-use catheters made of flexible and non-flexible polymeric materials. They are intended to provide retrograde cardioplegia to the coronary sinus during cardiopulmonary bypass procedures.
Retrograde Cardioplegia Catheters have two or three lumens. One lumen delivers cardioplegia. A second lumen monitors pressure within the coronary sinus. If a third lumen is present, it either facilitates a manually inflated balloon or a stiffening wire.
Catheters include manually inflating or self-inflating smooth or textured occlusion balloons. A curved semi-rigid or malleable insertion stylet is provided with each catheter.
Edwards Retrograde Cardioplegia Catheters are also available with Duraflo™ (heparin) coating.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Acceptance Criteria and Device Performance for Edwards Lifesciences® Retrograde Cardioplegia Catheters
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 | Met acceptance criteria |
| Ethylene oxide sterilization residuals | ISO 10993-7, Biological evaluation of medical devices - Part 7 | Met acceptance criteria |
| Biocompatibility | Per ISO 10993-1 for External communicating device, direct circulating blood path, duration ≤ 24 hours. | Met acceptance criteria |
| Conical Fittings | Fittings must be compatible with standard connections. | Met acceptance criteria |
| Wire Encapsulation | Cannula body wire reinforcement shall be fully encapsulated. | Met acceptance criteria |
| Assembly Leak | Pressure drop must meet minimum requirement. | Met acceptance criteria |
| Kink | The cannulae shall not kink at a pre-determined diameter. | Met acceptance criteria |
| Balloon Burst | Minimum pressures, diameter, and volume at burst must be maintained. | Met acceptance criteria |
| Balloon Leak | Balloon must not leak when inflated with pre-determined volumes. | Met acceptance criteria |
| Pressure Monitoring | Flow testing will confirm patency of the pressure monitoring lumen. | Met acceptance criteria |
| Corrosion | The metallic components shall show no signs of corrosion. | Met acceptance criteria |
| Tensile | Confirmation of the bond strength of the catheter assembly must meet pre-determined loads. | Met acceptance criteria |
General Study Information
The provided document describes a 510(k) submission (K123187) for Edwards Lifesciences® Retrograde Cardioplegia Catheters. The study conducted to demonstrate the device meets acceptance criteria is primarily Non-Clinical Testing (bench and laboratory testing).
Detailed Study Information:
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: The document does not specify the exact sample size for each non-clinical test. It generally states that "Bench and laboratory testing was performed."
- Data Provenance: The data is generated from non-clinical bench and laboratory testing. The document does not indicate a specific country of origin for this data, but it is presumably conducted by Edwards Lifesciences LLC or their contracted testing facilities. This is prospective testing, designed to evaluate the new device against established criteria.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
- Not Applicable. For non-clinical bench and laboratory testing of medical devices like catheters, the "ground truth" is established by adherence to recognized international standards (e.g., ISO standards) and pre-determined engineering specifications. These standards define the objective criteria for performance, and the tests are designed to measure against these objective criteria rather than relying on expert consensus for ground truth.
4. Adjudication Method for the Test Set:
- Not Applicable. As the ground truth is based on objective measurements against pre-defined standards and specifications, there is no need for an adjudication method typically used for subjective assessments (like image interpretation by multiple experts).
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
- No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic or interpretive devices where human readers are involved. This submission is for a physical medical device (catheter).
- Effect Size of Human Readers with AI vs. Without AI Assistance: Not applicable, as no AI component or human reader interaction with an AI system is mentioned.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
- Not Applicable. This device is a physical catheter, not an algorithm. Therefore, standalone algorithm performance is not relevant.
7. The Type of Ground Truth Used:
- The ground truth for the non-clinical testing is based on objective engineering specifications and recognized international standards. These standards (e.g., ISO 11135-1 for sterility, ISO 10993-7 for ETO residuals, ISO 10993-1 for biocompatibility) define the acceptable performance parameters. The "ground truth" is that the device must meet or exceed these physical and biological performance thresholds.
- For the pediatric indication, a "clinical assessment based on published studies" was used, which implies literature review/outcomes data from existing clinical evidence.
8. The Sample Size for the Training Set:
- Not Applicable. This submission describes a physical medical device, not a machine learning algorithm. Therefore, there is no "training set" in the context of AI.
9. How the Ground Truth for the Training Set Was Established:
- Not Applicable. As there is no training set, this question is not relevant.
§ 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).