(203 days)
The Quest MPS consisting of a control unit, associated disposable cassette sets with a heat exchanger, additive cassettes, and extension sets used together are indicated for delivery of cardioplegic solutions to the heart during open heart surgery
The Quest MPS device consists of a microprocessor based system for monitoring and controlling the mixing, pumping, pressure, and the heating and cooling of cardioplegia solutions. Sterile disposables are part of the system as well as pumping cassettes, and a heat exchanger with an integral bubble trap. The MPS includes a primary pump where blood crystalloid solutions are mixed at defined ratios, and two secondary pumps for the addition of an arresting agent and other physician-defined additives. The device also contains a water circulation system for supplying warm or cold water to the heat exchanger to achieve user-defined cardioplegia temperatures.
The Quest Myocardial Protection System (MPS) is a device indicated for the delivery of cardioplegic solutions to the heart during open-heart surgery. It is a microprocessor-based system that monitors and controls the mixing, pumping, pressure, and heating/cooling of cardioplegia solutions. The safety and effectiveness of the device were established through a combination of substantial equivalence claims to predicate devices and extensive functional testing.
Here's a breakdown of the acceptance criteria and the supporting study details:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Leak Test Requirements | No leaks at 15 psi. |
| Pull Test Requirements | No leaks at 5 lbs for small bore and 10 psi for large bore tubing. |
| Luer Connections | Meets ANSI/HIMA MD70.1-1983 for Medical Materials Luer Taper Fittings. |
| Package Integrity | Tyvek/Polystyrene tray and Tyvek/Polymylar pouches passed burst test in accordance with ASTM F1140-88. |
| Shipping and Distribution Testing | Passed Distribution Simulation Test I/NSTA Project 1A. ASTM D-775-80 and D-999-75. |
| Accelerated Aging | One (1) year with no effects on performance characteristics. |
| Heat Exchanger Corrosion Test | Resists corrosion for periods of up to 72 hours. |
| Air In-line Detection | Detects 100μL size air bubbles in blood and saline. |
| Hemolytic Characteristics | MPS disposable and instrument lower than predicate devices. |
| Level Sensing and Autoventing | Meets performance specifications for venting and is equivalent to the predicate device for level sensing. |
| Pressure Control Delivery | Allows greater control of pressure than does the predicate device. |
| Pressure Alarm Verification | Operates within predicate device's alarm range of 0% to ± 10% of preset value. Allows ability to set lower pressure limits. |
| Pressure Sensor Accuracy | Equivalent to predicate device specification of ± 5 mmHg. |
| Pump Performance at Temperature Extremes | MPS has a mean accuracy of 95% of the flow rates (50, 150, 500 ml/minute) delivered at 36°C and 5°C. |
| Use with Crystalloid Filter | Pressure cuffs allow MPS to provide maximum settable flow rate with the use of a crystalloid filter. |
| Arrest Agent/Additive Concentration Delivery | Adjustable from 4-40 mEq/L and delivers within ± 10% of desired concentration. |
| Blood/Crystalloid Ratio Accuracy | Less than 3% of each component's required proportion. |
| Delivery Rate Accuracy | Meets AAMI recommended 5% accuracy specification for infusion pumps. |
| Pump Output Flow Profile | Depicts a more linear flow rate than the predicate device at 50, 300, 500 ml/minute. |
| Environmental Tests | Meets temperature, humidity specification requirements and UL External Surface Temperature Safety requirements. |
| Electrical Safety | Meets UL/CSA requirements for electrical safety. |
| Temperature Sensor Accuracy | Meets temperature sensor accuracy specifications of 5% of the reading. |
| Warm and Cold Temperature Control | Heats and cools cardioplegia solution within operating flow rate ranges. |
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not explicitly state a specific "test set" sample size in terms of patient data or clinical trials. The evaluation primarily relies on functional testing of device components and overall system performance. Therefore, the "sample size" for these tests would refer to the number of units or repetitions used for each specific test. This information is not detailed in the summary.
The data provenance is Quest Medical, Inc., indicating these are internal validation tests conducted by the manufacturer. The document does not specify country of origin for the data or whether it's retrospective or prospective, but given it's manufacturer validation for pre-market notification, it's typically prospective testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This type of information (number and qualifications of experts for ground truth) is not applicable to the functional testing described. Functional tests for medical devices typically rely on objective measurements and established engineering standards/specifications rather than expert consensus on a test set. For example, a leak test result is a direct measurement against a predefined threshold, not an expert's interpretation.
4. Adjudication Method
Not applicable. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies where expert consensus is needed to establish ground truth for diagnostic or prognostic observations. The tests described are engineering and performance validation tests with objective pass/fail criteria.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not mentioned or implied. This type of study is used to assess diagnostic accuracy or the impact of assistive technologies on human performance in interpreting medical images or data. The Quest MPS is a delivery system, and its evaluation focuses on its mechanical, fluidic, and control system performances, not interpretive tasks for human readers.
6. Standalone Performance Study
Yes, a form of standalone performance study was done. The functional testing described ("Functional Testing" section) evaluates the algorithm (microprocessor-based control system) and the hardware components of the device in isolation or as an integrated system, without human intervention in the core operational logic. For example, "Pump Performance at Temperature Extremes" or "Delivery Rate Accuracy" assesses the device's intrinsic capabilities. The "Human-in-the-loop" aspect for this device would be the clinician setting parameters and initiating operation, but the performance criteria are assessed for the device's autonomous function.
7. Type of Ground Truth Used
The ground truth used for these functional tests is based on:
- Engineering specifications and standards: e.g., "Meets ANSI/HIMA MD70.1-1983 for Medical Materials Luer Taper Fittings," "Meets AAMI recommended 5% accuracy specification for infusion pumps," "UL/CSA requirements for electrical safety."
- Objective physical measurements: e.g., "No leaks at 15 psi," "Detects 100μL size air bubbles," "Delivers within ± 10% of desired concentration."
- Comparison to predicate devices: e.g., "Equivalent to predicate device for level sensing," "Equivalent to predicate device specification of ± 5 mmHg."
8. Sample Size for the Training Set
The concept of a "training set" is not applicable here in the context of machine learning model training. The Quest MPS is a medical device with a microprocessor-based control system, but it's not described as an AI/ML-driven device that undergoes a training phase with a specific dataset. Its performance is validated against established engineering and safety standards, not learned from a "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" in the machine learning sense for this device. The development process would have involved design specifications, engineering principles, and iterative testing, but not a data-driven training phase to establish performance metrics like an AI algorithm.
§ 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).