(130 days)
The MYOtherm XP with Cortiva bioactive surface is a device intended for the mixing, warming/cooling and delivery of oxygenated blood/cardioplegia solution in a predetermined ratio during routine cardiopulmonary bypass (CPB) procedures up to 6 hours in duration. Blood/cardioplegia solution is delivered to the patient through the cardioplegia delivery system and appropriate cannula by the operation of a single occlusive roller pump.
The MYOtherm XP cardioplegia delivery system with Cortiva bioactive surface is comprised of polycarbonate housing and comes preconnected to tubing and connector components comprised of polycarbonate, polyvinyl chloride and plastisol materials and provided in Y-type, straight, reducer and tubing configurations. The MYOtherm XP cardioplegia delivery system with Cortiva bioactive surface is available with or without an additional optional bridge, which is a preconnected independent tubing line for the delivery of additional arterial blood without the mixing with cardioplegia solution. The blood contacting surfaces of the MYOtherm XP cardioplegia delivery system with Cortiva bioactive surface and associated tubing and connector components are coated with a heparin-based non-leaching thromboresistant surface.
Please find the information regarding the acceptance criteria and the study that proves the device meets the acceptance criteria, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Testing | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Pressure Integrity | Water path must withstand 45 PSI pressure for 6 hours without leaking | Pass |
| Burst | Water path burst testing should be comparable to that of the control devices | Pass |
| Port Break | Water path break force shall be comparable to that of the control device | Pass |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes used for the pressure integrity, burst, and port break tests. It also does not specify the provenance of the data (e.g., country of origin, retrospective or prospective).
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not applicable. The study described involves engineering performance testing of a medical device (MYOtherm XP™ Cardioplegia Delivery System with Cortiva™ BioActive Surface) for physical characteristics like pressure integrity, burst strength, and port break force, not a clinical study requiring expert ground truth for interpretation of medical data.
4. Adjudication Method for the Test Set
This information is not applicable for the type of engineering performance testing described. Adjudication methods are typically used in clinical studies or studies involving human assessment.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was done. The document states, "Clinical testing was not required to establish substantial equivalence." This indicates that the evaluation focused on physical and performance characteristics of the device, not its comparative effectiveness in a clinical setting involving human readers.
6. Standalone (Algorithm Only) Performance Study
This information is not applicable. The device is a physical medical device (cardioplegia delivery system) and does not involve an algorithm or AI component for standalone performance evaluation.
7. Type of Ground Truth Used
The "ground truth" for the engineering performance tests (pressure integrity, burst, port break) was based on established engineering specifications and physical measurements. For example, for pressure integrity, the ground truth is the device withstanding a specific pressure (45 PSI) for a specific duration (6 hours) without leaking.
8. Sample Size for the Training Set
This information is not applicable. The document describes a traditional engineering performance study for a physical medical device, not a machine learning model that would require a training set.
9. How the Ground Truth for the Training Set was Established
This information is not applicable, as there was no training set for a machine learning model. The ground truth for the device's physical performance was established by engineering specifications and objective measurements.
§ 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).