(277 days)
The Heater-Cooler System 3T is used to circulate water through heat exchangers to warm or cool a patient during cardiopulmonary bypass procedures lasting 6 hours or less.
The 3T System is an independent (i.e., independent of the water supply) 3-circuit heating/cooling base unit that includes three water circuits (two circuits for the patient supplied by one tank (for the heating/cooling blanket, the oxygenator) and one interchangeable heating/cooling circuit for cardioplegia. If required, patient and cardioplegia circuits can be switched off separately, in order to increase the activated functional group's heating and/or cooling performance.
The following optional components and accessories are also available for the 3T System:
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- Heating-cooling blankets;
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- Water circuit tubing; and
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- Various cables.
The 3T System includes a disposable aerosol collection set that consists of a canister connected to the 3T System and the user facility's vacuum source that captures emissions that are drawn from the tank using negative pressure created by the user facility's vacuum.
- Various cables.
The Heater-Cooler System 3T is used to circulate water through heat exchangers to warm or cool a patient during cardiopulmonary bypass procedures lasting 6 hours or less.
Here's an analysis of the acceptance criteria and study information provided:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria / Performance Aspect | Reported Device Performance |
|---|---|
| Reduction in Emission (Aerosolized Mycobacteria) | - Microbiological and orthogonal assay testing during all phases of device operation to evaluate device emissions verified reduction. |
- Microbiological testing verified the hydrophobic filter of the disposable aerosol collection set's canister adequately prevents contamination of the user facility's vacuum source.
- Microbiological and orthogonal assay testing verified the seven-day use period of the disposable aerosol collection set. |
| Aerosol Collection Set Integrity and Efficacy | Testing verified the chemical resistance of materials, integrity, and efficacy of the disposable Aerosol Collection Set, as well as the integrity of its packaging design. |
| Heating and Cooling Functions | Testing verified the performance of the heating and cooling functions of the 3T System using a patient simulator circuit. |
| Corrosion and Erosion Resistance | Testing evaluated the chemical resistance of the metallic and plastic components and materials of the 3T System. |
| Cleaning, Disinfection, and Preservation of Water Circuit (Intermediate Level) | Validation testing demonstrated an intermediate level of disinfection. Long-term testing (58 weeks) verified that the instructions adequately prevent contamination of the device. |
| Cleaning and Disinfection of 3T System Surfaces | Validation testing of the 3T System surface cleaning instructions was performed. |
| Transportation and Storage Packaging | Testing of the transportation and shipping packaging of the 3T System was performed. |
| Production Disinfection and Drying Process Qualification | Process validation testing of the production disinfection and drying processes was conducted. |
| Human Factors | Human factors validation testing of the 3T System Operating Instructions was performed. |
| Substantial Equivalence to Predicate Device (Stöckert Heater-Cooler System 3T) | The Final Configuration 3T System has very similar indications for use, the same fundamental scientific technology, and similar technological characteristics. Performance and validation testing demonstrate that the modified 3T System is as safe and effective as the predicate device. |
2. Sample Size Used for the Test Set and Data Provenance
The provided text does not explicitly state the specific, quantitative sample sizes for each of the performance tests. It describes the types of testing performed (e.g., microbiological, orthogonal assay testing, long-term testing for 58 weeks).
The data provenance is not explicitly stated in terms of country of origin or whether it was retrospective/prospective. The testing appears to be laboratory-based performance testing conducted by the company.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The studies appear to be laboratory performance tests rather than clinical studies requiring expert ground truth for interpretation. For example, microbiological testing determines contamination levels, and heating/cooling tests measure temperature changes against predefined specifications.
4. Adjudication Method for the Test Set
This information is not applicable and thus not provided. Since the tests are described as performance and validation testing (e.g., measuring emissions, verifying filter efficacy, testing heating/cooling functions), there isn't a "ground truth" established by multiple experts that would require an adjudication method. The results are likely binary (pass/fail) or quantitative measurements compared against specifications.
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
An MRMC comparative effectiveness study was not conducted. This device is a medical apparatus (heater-cooler system) and not an AI-powered diagnostic or assistive technology that would involve human readers interpreting cases.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This concept is not applicable to the Heater-Cooler System 3T. It is a physical medical device, not an algorithm, so standalone algorithm performance is not relevant.
7. The Type of Ground Truth Used
The "ground truth" for the various performance tests appears to be based on:
- Established industry standards/specifications: For performance aspects like heating/cooling efficiency, corrosion resistance, transportation, and surface cleaning.
- Microbiological control principles: For assessing the reduction in emissions, filter efficacy, and prevention of contamination. This involves measuring microbial counts against acceptable limits.
- Chemical and material science principles: For testing chemical resistance and material integrity.
- FDA guidance: Specifically referenced for "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling" for cleaning, disinfection, and water preservation.
8. The Sample Size for the Training Set
This device does not involve a "training set" in the context of machine learning or AI. The performance testing focuses on the physical and functional aspects of the hardware and associated procedures.
9. How the Ground Truth for the Training Set was Established
As there is no training set for this device, this question is not applicable.
§ 870.4250 Cardiopulmonary bypass temperature controller.
(a)
Identification. A cardiopulmonary bypass temperature controller is a device used to control the temperature of the fluid entering and leaving a heat exchanger.(b)
Classification. Class II (performance standards).