(30 days)
Cardioplegia Delivery Sets are intended for use as adapters for connecting cardioplegia administration tubing to cardioplegia delivery catheters.
Extracorporeal circuit components with a Duraflo coating are intended for use in cardiopulmonary surgery when a heparin coated blood path is desired.
Edwards Lifesciences cardioplegia delivery sets are comprised of various configurations of clear manifold connections in either straight, Y-shaped, or 4-way connections which are joined by appropriate lengths of clear, flexible tubing. Depending upon configuration, the cardioplegia delivery set may contain a vent port adapter with female luer lock, a tapered tubing adapter, tubing clamps, and/ or male and/ or female luer lock connectors.
The exterior and/ or inner-luminal cannula surfaces of product codes containing a "D" or "DII" are coated with Duraflo TM (heparin) coating.
When used on devices for cardiopulmonary surgery, the Duraflo coating improves the blood compatibility of non-biological surfaces in the extracorporeal circuit.
Each Edwards Lifesciences device is packaged sterile and non-pyrogenic in a sealed, peel-type pouch.
This document describes the acceptance criteria and the study that proves the device meets the acceptance criteria for the Edwards Lifesciences™ Cardioplegia Delivery Sets.
1. Table of Acceptance Criteria and Reported Device Performance:
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Pressure vs. flow | Not explicitly detailed, but implied to demonstrate comparable performance to the predicate device. | Met acceptance criteria. |
| Clamp closure | Not explicitly detailed, but implied to demonstrate comparable performance to the predicate device. | Met acceptance criteria. |
| Kink | Not explicitly detailed, but implied to demonstrate comparable performance to the predicate device. | Met acceptance criteria. |
| Assembly tensile | Not explicitly detailed, but implied to demonstrate mechanical integrity comparable to the predicate device. | Met acceptance criteria. |
| Overall Functional/Safety Performance | Device performs in a substantially equivalent manner compared to the predicate device. | All data met acceptance criteria. |
2. Sample Size and Data Provenance:
The document does not explicitly state the sample sizes used for each functional test. The study appears to be a retrospective comparison based on the statement "The functional data indicate that the Cardioplegia Delivery sets perform in a substantially equivalent manner when compared to the predicate device" and the comparative analysis section. There is no information regarding the country of origin of the data.
3. Number of Experts and Qualifications:
Not applicable. This device is a medical accessory, and its performance evaluation relies on engineering and functional testing rather than clinical interpretation by experts for ground truth establishment.
4. Adjudication Method:
Not applicable. As noted above, the evaluation is based on engineering and functional testing, not expert adjudication of clinical findings.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
Not applicable. This type of study is typically used for diagnostic devices that assist human readers in interpreting medical images or data. The Edwards Lifesciences™ Cardioplegia Delivery Sets are an accessory used in cardiopulmonary bypass, and their effectiveness is evaluated through functional performance, not reader accuracy.
6. Standalone (Algorithm Only) Performance:
Not applicable. The device is a physical medical accessory, not an algorithm or AI system.
7. Type of Ground Truth Used:
The ground truth for the device's functional performance是在engineering standards and established performance characteristics of the predicate device. The goal was to prove substantial equivalence to a legally marketed predicate device, meaning the new device performs within expected parameters for its intended use.
8. Sample Size for the Training Set:
Not applicable. The device is not an AI/ML model, so there is no "training set."
9. How the Ground Truth for the Training Set was Established:
Not applicable. As there is no training set, this question is not relevant.
§ 870.4290 Cardiopulmonary bypass adaptor, stopcock, manifold, or fitting.
(a)
Identification. A cardiopulmonary bypass adaptor, stopcock, manifold, or fitting is a device used in cardiovascular diagnostic, surgical, and therapeutic applications to interconnect tubing, catheters, or other devices.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.