(55 days)
The Stöckert Air Purge Control (APC) System detects air in the venous line and removes air from the venous bubble trap of the Synergy™/ECC.O™ System tubing circuit. The Synergy™/ECC.O™ shall only be used in conjunction with the Stöckert S5 (or any compatible system using the S5 firmware versions of 3.0 or greater) and the SCP Plus System.
The Stöckert S5 System is indicated for speed controlled pumping of blood through the cardiopulmonary bypass circuit for durations of six hours or less, left ventricular venting, cardiotomy suction and administration of cardioplegia solution.
The Stöckert APC System consists of the APC sensor module (Catalog Number: 23-45-22), 3-joint mast holder with fast clamp connectors for two bubble sensors, 420mm (Catalog Number: 23-26-96), bubble sensor for 3/8 inch tubing (Catalog Number: 23-07-50), and ultrasonic gel, bottle, 250 mL (Catalog Number: 96-06-10). All of these components are identical to those used with the Stöckert S5 System (K091008).
The Stöckert APC can be operated automatically and manually using the APC displet of the heart lung machine.
The Stöckert APC bubble trap is placed just before the venous bubble trap of the Synergy™/ECC.OTM. When bubble activity is sensed, the assigned roller pump on the heart lung machine console begins operation to remove a set tubing volume (as determined by tubing size and pump speed (RPM)) or to run for a set time (in seconds) at a perfusionist-selected flow rate. This fluid is pumped into an appropriate blood collection reservoir. The technology of the Stöckert APC is based on the technology of the Stöckert Air Purge Control System (K041558).
The Stöckert APC is used for detecting air in the venous line and removing air from the venous bubble trap of the Synergy™/ECC.O™ System tubing circuit.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Stöckert Air Purge Control (APC) System:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria or a detailed "reported device performance" against specific metrics. Instead, it makes a general statement about the device fulfilling "prospectively defined functional acceptance test" criteria.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Safety (electrical and mechanical) | Fulfills IEC60601-1 (with National Deviations) |
| Electromagnetic Compatibility (EMC) | Fulfills IEC60601-1-2 |
| Functional Performance (air detection and removal) | Fulfills prospectively defined functional acceptance test and simulated use/in-use validation testing. The System performs in an identical manner as the System integrated with the Sorin C5 System. Meets user needs. |
| Substantial Equivalence with predicate device (K091007) | Identical hardware, firmware, electronics, and components. Performs the same function (detecting and removing air). Performance is unchanged when integrated with the heart lung machine. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a distinct "test set" in the sense of a dataset for evaluating an algorithm. The testing described is hardware and system validation.
- Sample Size for Test Set: Not applicable as it's not a data-driven algorithmic evaluation. The testing involved the Stöckert APC System itself, integrated with a heart-lung machine.
- Data Provenance: Not applicable. The testing was described as "non-clinical performance testing" and "simulated use/in-use validation testing" of the physical system, likely conducted internally by the manufacturer (Sorin Group Deutschland GmbH).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Not applicable. The ground truth for electrical safety, EMC, and functional performance would be established by engineering standards and internal testing protocols, not by expert consensus on a dataset.
4. Adjudication Method for the Test Set
Not applicable. This is not a study involving human reader interpretation or diagnostic output that requires adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
No. This device is a hardware system for detecting and removing air during cardiopulmonary bypass, not an AI or diagnostic imaging device that would involve human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, in a way. The "functional acceptance test and simulated use/in-use validation testing" evaluated the Stöckert APC System's performance in detecting air and initiating removal autonomously (which could be considered its "standalone" performance), even though it operates within the larger Stöckert S5 heart-lung machine system. The device's function is automated.
7. The Type of Ground Truth Used
The ground truth used for this type of device would be:
- Engineering Standards: For electrical safety (IEC60601-1) and electromagnetic compatibility (IEC60601-1-2).
- Physical Principles and Design Specifications: For the air detection and removal capabilities. The "prospectively defined functional acceptance test" would have protocols and metrics based on the expected physical behavior of the system (e.g., ability to reliably detect a certain volume of air, ability to remove air within a specified time).
8. The Sample Size for the Training Set
Not applicable. This is not a machine learning or AI device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable.
§ 870.4205 Cardiopulmonary bypass bubble detector.
(a)
Identification. A cardiopulmonary bypass bubble detector is a device used to detect bubbles in the arterial return line of the cardiopulmonary bypass circuit.(b)
Classification. Class II (performance standards).