(113 days)
The Medtronic centrifugal blood pumping system is intended to pump blood through the extracorporeal bypass circuit for extracorporeal support for periods appropriate to cardiopulmonary bypass procedures (up to 6 hours).
The Bio-Console® 560 is an extracorporeal blood pumping console consisting of a Base Unit with a display and a User Interface (touch screen) with integrated flow control knob. In order to perform its intended function, the Bio-Console® 560 is compatible with the Medtronic External Drive Motor, disposable Centrifugal Pump, Flow Transducer with disposable Insert, and emergency Handcrank.
The provided document (K070286) describes the 510(k) summary for the Medtronic Bio-Console® 560, specifically focusing on modifications made to version 1.5. This device is a cardiopulmonary bypass pump speed control system.
Based on the document, here's a summary of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The document states: "Functional, hardware and software testing was used to establish the performance characteristics for the modifications of this device compared to previously marketed devices." It does not provide a specific table of quantitative acceptance criteria or detailed reported performance figures for the new features (Bubble Detector, Level Sensors, AutoClamp options). Instead, it makes a general statement about testing being performed.
The "modifications for version 1.5 add optional Safety Systems: Bubble Detector, Level Sensors, and AutoClamp. User selectable options have also been added to control the speed of the centrifugal pump and/or activate the AutoClamp when air is detected or if there is low fluid in the reservoir." The performance is implied to be acceptable if it is "substantially equivalent" to the predicate devices.
Acceptance Criteria (Implied): The new features (Bubble Detector, Level Sensors, AutoClamp) and user-selectable options must perform their intended functions reliably and safely, demonstrating substantial equivalence to similar features in predicate devices.
Reported Device Performance: The document only states that "Functional, hardware and software testing was used to establish the performance characteristics." No specific metrics (e.g., sensitivity, specificity, accuracy, detection limits) are provided.
| Feature / Performance Metric | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Bubble Detection | Reliable detection of air in the circuit, comparable to predicate. | "Functional, hardware and software testing was used to establish the performance characteristics for the modifications... Air detection... are features that are already available on the Terumo System 1." (Implies satisfactory performance through testing and comparison to an established predicate device.) |
| Level Sensing | Reliable detection of low fluid levels, comparable to predicate. | "Functional, hardware and software testing was used to establish the performance characteristics for the modifications... level sensing are features that are already available on the Terumo System 1." (Implies satisfactory performance through testing and comparison to an established predicate device.) |
| AutoClamp Activation | Reliable activation for air detection/low fluid, comparable to predicate. | "Functional, hardware and software testing was used to establish the performance characteristics for the modifications... the automatic arterial clamp is already available as the Rocky Mountain Research, Inc. Automatic Tubing Clamp System." (Implies satisfactory performance through testing and comparison to an established predicate device.) |
| Pump Speed Control | Reliable control based on user-selected options for safety systems. | "Functional, hardware and software testing was used to establish the performance characteristics for the modifications... User selectable options have also been added to control the speed of the centrifugal pump and/or activate the AutoClamp when air is detected or if there is low fluid in the reservoir." (Implies satisfactory performance through testing.) |
2. Sample Size Used for the Test Set and Data Provenance
The document explicitly states: "Clinical testing was not required to establish substantial equivalence." This indicates that no human test set data was used. The testing described was "Functional, hardware and software testing." The provenance of this internal testing data (e.g., country of origin) is not provided, but it would typically be conducted internally by Medtronic. It is prospective testing of the device itself, not retrospective analysis of patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
Not applicable. Since no clinical testing or human test set was performed, no experts were used to establish ground truth in this context. The "ground truth" for functional, hardware, and software testing would be derived from engineering specifications and established test protocols, rather than expert judgment on clinical cases.
4. Adjudication Method for the Test Set
Not applicable. No human test set requiring adjudication was used.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. The document explicitly states: "Clinical testing was not required to establish substantial equivalence."
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
The device, the Bio-Console® 560, is a physical medical device with hardware and software, not a standalone algorithm in the typical sense of AI/machine learning. The "performance" assessment was of the integrated system's functions. Therefore, a standalone algorithm performance study, as understood in AI, was not conducted. The functional, hardware, and software testing would assess the device's ability to operate the pump, detect air/low levels, and activate the clamp independently of a human operator, but this isn't framed as an "algorithm only" study.
7. The Type of Ground Truth Used
For the "Functional, hardware and software testing," the ground truth would be based on:
- Engineering Specifications: The device's design requirements and intended operational parameters.
- Predicate Device Performance: The known and established performance characteristics of the legally marketed predicate devices (Medtronic Bio-Console® 560 (K051303), Terumo System 1 (K022947), Rocky Mountain Research, Inc. Automatic Tubing Clamp System (K961364)). The new features were compared to these established devices for substantial equivalence.
8. The Sample Size for the Training Set
The document does not mention any training set. This suggests that the device's logic for the new functions (Bubble Detector, Level Sensors, AutoClamp) was not based on machine learning or AI that would require a distinct training set. The functionality would have been developed using traditional engineering principles and programmed software.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as no training set (in the context of AI/machine learning) was mentioned or implied.
§ 870.4380 Cardiopulmonary bypass pump speed control.
(a)
Identification. A cardiopulmonary bypass pump speed control is a device used that incorporates an electrical system or a mechanical system, or both, and is used to control the speed of blood pumps used in cardiopulmonary bypass surgery.(b)
Classification. Class II (performance standards).