(430 days)
The Minntech Corporation's EnGuard™ Cardioplegia Heat Exchanger is used to cool or warm cardioplegia solution prior to delivery to the patient through connected tubing sets which provide various ratios of cardioplegia solution to blood, depending upon the tubing set chosen.
The administration of cardioplegia solution is commonly used to provide myocardial protection or controlled arrest of the heart during coronary bypass procedures. As the oxygenated blood enters the EnGuard™ device through the inlet blood port, it passes through the fiber bundle lumens where the temperature of the blood is cooled or warmed as desired by passing water of the desired temperature into the heater/cooler section of the device, which surrounds the fiber bundle. The water enters and leaves through standard Hansen connector ports molded into the polycarbonate case. The EnGuard™ heat exchanger must be used with separately purchased, sterile tubing sets attached as explained in the labeling. These tubing sets will determine the ratio of crystalloid to blood. The Minntech device will produce cardioplegia solution at ratios of 1:1, 2:1, 4:1 and 8:1 depending upon the chosen tubing set.
Here's an analysis of the provided text regarding the EnGuard™ PHX Cardioplegia Heat Exchanger, focusing on acceptance criteria and study details:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria/Test | Reported Device Performance |
|---|---|---|
| Safety | Biocompatibility (according to EN10993) | All materials evaluated and found acceptable. |
| Performance/Effectiveness | Functional testing for equivalent performance to predicates | Performed functional testing; found equivalent performance. |
| Durability | Shelf life | Evaluated to be 4 years. |
2. Sample Size Used for the Test Set and Data Provenance
The provided text does not specify the sample size used for any test set or the data provenance (e.g., country of origin, retrospective/prospective). The document primarily focuses on regulatory approval based on functional testing and comparison to predicate devices, rather than detailed clinical study results.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
The text does not mention using experts to establish ground truth because the "study" described is functional testing comparing the device to predicates, not a diagnostic or AI-based system requiring expert interpretation of data.
4. Adjudication Method for the Test Set
The text does not mention an adjudication method, as it doesn't describe a process of expert review or consensus for establishing ground truth.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document describes functional testing and comparison against predicate devices for safety and equivalent performance, not a study involving human readers or AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The EnGuard™ PHX Cardioplegia Heat Exchanger is a physical medical device, not an algorithm or AI system. Therefore, the concept of "standalone (algorithm only)" performance and "human-in-the-loop" is not applicable to this device.
7. The Type of Ground Truth Used
For this physical device, the "ground truth" for the functional testing would primarily be established by:
- Engineering specifications and standards: The device's ability to cool/warm solution within set parameters, mix solutions at specified ratios, etc.
- Performance data from predicate devices: The "ground truth" for performance equivalence is the established and accepted performance of the legally marketed predicate devices.
8. The Sample Size for the Training Set
This refers to a physical device, not an AI/ML algorithm that requires a "training set." Therefore, the concept of a training set sample size is not applicable.
9. How the Ground Truth for the Training Set Was Established
As this is a physical device, the concept of a "training set" and establishing ground truth for it is not applicable. The device's design, manufacturing, and functional testing adhere to established engineering principles and regulatory standards.
§ 870.4240 Cardiopulmonary bypass heat exchanger.
(a)
Identification. A cardiopulmonary bypass heat exchanger is a device, consisting of a heat exchange system used in extracorporeal circulation to warm or cool the blood or perfusion fluid flowing through the device.(b)
Classification. Class II (performance standards).