(100 days)
The MYOtherm XP cardioplegia delivery system 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 system with Trillium biosurface 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 Trillium biosurface and Uncoated MYOtherm XP cardioplegia delivery system are comprised of polycarbonate housing and come pre-connected to tubing and connector components comprised of polycarbonate, polyvinyl chloride and plastisol materials which are provided in Y-type, straight, reducer and tubing configurations. Both the MYOtherm XP cardioplegia delivery system with Trillium biosurface and Uncoated MYOtherm XP cardioplegia delivery system are available with or without an additional optional bridge, a pre-connected 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 Trillium biosurface and associated tubing and connector components are coated with a heparin-based non-leaching thromboresistant surface.
This document describes a 510(k) premarket notification for the "MYOtherm XP Cardioplegia Delivery System with Trillium Biosurface and Uncoated MYOtherm XP Cardioplegia Delivery System." The submission seeks to allow the use of disinfectants (specifically hydrogen peroxide) in the device's water path and updates the indications for use statement.
Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Water path must withstand 45 PSI pressure for 6 hours without leaking | Pass |
| Water path burst testing should be comparable to that of the control devices | Pass |
| Water path break force shall be comparable to that of the control device | Pass |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
The document does not explicitly state the sample sizes used for each test. It also does not provide information on the data provenance such as country of origin or whether the studies were retrospective or prospective. The studies appear to be bench testing performed in a laboratory setting.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
This information is not applicable. The device validation tests (Pressure Integrity, Burst, Port Break) are objective engineering tests that do not require expert interpretation or establishment of ground truth in the same way as, for example, a diagnostic imaging study.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not applicable for these types of engineering performance tests. The results are objective measurements (e.g., pass/fail for pressure integrity, comparison to control for burst and break force) rather than subjective assessments requiring adjudication.
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:
A multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for medical devices involving human interpretation of data, typically AI-powered diagnostic tools. The MYOtherm XP Cardioplegia Delivery System is a Class II medical device for cardiopulmonary bypass procedures, and its safety and effectiveness are evaluated through engineering performance testing, not human reader studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
A standalone performance evaluation was done in the sense that the device's physical performance characteristics (pressure integrity, burst strength, port break force) were tested directly without human intervention or interpretation as part of the test (beyond setting up and operating the testing equipment). There is no "algorithm" in the context of AI being tested here.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for these tests are the objective engineering measurements related to material strength and integrity. For Pressure Integrity, the ground truth is whether the device withstands 45 PSI for 6 hours without leaking. For Burst and Port Break, the ground truth is the comparative performance against control devices, indicating that the device performs equivalently or acceptably.
8. The sample size for the training set:
This information is not applicable. The device is not an AI/ML algorithm that requires a training set. The tests performed are engineering validation tests for a physical device.
9. How the ground truth for the training set was established:
This information is not applicable as there is no training set for this device.
§ 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).