(214 days)
The Stöckert Centrifugal Pump Console (SCPC System) is a software-controlled cardiopulmonary bypass device containing an uninterruptable power supply (UPS) and S3 Sensor Modules that is designed for operation of the Stöckert Centrifugal Pump (SCP) and monitoring the cardiopulmonary bypass circuit. The SCPC System, in combination with the SCP and the COBE Revolution Pump Head, is indicated for speed-controlled pumping through the cardiopulmonary bypass circuit for typical durations of six hours or less.
The SCPC System has been qualified only for durations appropriate to cardiopulmonary bypass procedures and has not been qualified through in vivo, or clinical studies, for long term use as a bridge to transplant, pending recovery of the natural heart, or extracorporeal membrane oxygenation (ECMO) procedures.
The SCPC System provides electrical power and sets specific operational parameters for the Stöckert Centrifugal Pump Control Panel and Drive Unit described in K011838. The SCPC System also monitors the following parameters of the cardiopulmonary bypass circuit:
- . Pressure
- Temperature .
- Level monitoring/bubble detection .
- Elapsed time .
The SCPC System provides procedural flexibility for use of the Stöckert Centrifugal Pump, allowing the pump to be used as a component of other legally marketed heartlung machine consoles.
The provided document, K020571 for the Stöckert Centrifugal Pump Console, describes performance testing but does not explicitly detail acceptance criteria in a quantitative table or the specific results against such criteria for the device itself. Instead, it broadly states that testing was performed to confirm that the proposed SCPC System performed as designed and met user requirements.
The document outlines the types of testing performed rather than specific performance metrics against pre-defined acceptance thresholds.
Re-interpreting for Acceptance Criteria and Study Information:
Given the nature of the device (a cardiopulmonary bypass system console) and the information provided, the "acceptance criteria" can be inferred to be compliance with relevant standards and successful functionality as per design specifications and user requirements. The "study" refers to the performance testing conducted.
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria Category (Inferred) | Reported Device Performance (From Section 7: "PERFORMANCE TESTING") |
|---|---|
| Electrical Safety | Conformance with appropriate standards. |
| Electromagnetic Compatibility (EMC) | Conformance with appropriate standards. |
| Functional Performance | Performed as designed and met user requirements. |
| Hardware Testing | Performed as designed and met user requirements. |
| Software Testing | Performed as designed and met user requirements. |
| Validation Testing | Confirmed the system performed as designed and met user requirements. |
| Compatibility with Stöckert CAPS (K863541) | Demonstrated compatibility. |
| Compatibility with Stöckert S3 | Demonstrated compatibility. |
| Compatibility with COBE® Century™ (K960974) HLM consoles | Demonstrated compatibility. |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated. The document refers to "testing" performed, which generally implies a test set of devices or scenarios, but no specific numbers are given for units tested or duration of tests beyond the "typical durations of six hours or less" for use.
- Data Provenance: Not explicitly stated, but based on the manufacturer's location (Munich, Germany) and the regulatory submission to the FDA (USA), the testing was likely conducted in a controlled environment, potentially in Germany, for submission to US regulatory bodies. The nature of the device suggests in-vitro testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not applicable and hence not provided in the document. This device is a medical instrument console, not an AI/diagnostic software. "Ground truth" in the context of expert consensus or pathology is typically relevant for diagnostic devices or AI algorithms. The "ground truth" for this device would be its adherence to engineering specifications and regulatory standards, evaluated by engineers and regulatory compliance experts.
4. Adjudication method for the test set:
- Not applicable as this is not a diagnostic device involving human interpretation requiring adjudication. Performance was assessed against engineering and regulatory standards.
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:
- Not applicable. This device is a physical medical instrument (a pump console), not an AI-assisted diagnostic or interpretive system. Therefore, MRMC studies are not relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a hardware console with integrated software, not a standalone algorithm. Its performance is assessed as an integrated system.
7. The type of ground truth used:
- The "ground truth" for this device is its adherence to:
- Engineering specifications and design requirements: The device was tested to confirm it "performed as designed."
- User requirements: Confirmed it "met user requirements."
- Regulatory standards: Demonstrated "conformance with the appropriate standards" for electrical safety and EMC.
- Compatibility: Demonstrated successful interaction with other specified heart-lung machine consoles.
8. The sample size for the training set:
- Not applicable. This is not an AI/machine learning device that requires a training set in the conventional sense. The "training" for such devices involves design, prototyping, and testing phases to ensure functionality, not data-driven model training.
9. How the ground truth for the training set was established:
- Not applicable for the same reasons as point 8.
§ 870.4220 Cardiopulmonary bypass heart-lung machine console.
(a)
Identification. A cardiopulmonary bypass heart-lung machine console is a device that consists of a control panel and the electrical power and control circuitry for a heart-lung machine. The console is designed to interface with the basic units used in a gas exchange system, including the pumps, oxygenator, and heat exchanger.(b)
Classification. Class II (performance standards).