(39 days)
The Stöckert Centrifugal Pump System with Tubing Clamp (SCP System TC) is a cardiopulmonary bypass speed control device that is indicated for speed-controlled pumping through the cardiopulmonary bypass circuit for typical durations of six hours or less. The SCP System TC has not been qualified through in vitro, 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 SCP System TC controls a Tubing Clamp that is positioned at the pump outlet to occlude the arterial line if the reservoir blood level, microbubble activity, or retrograde flow in the extracorporeal circuit reaches alarm levels during a cardiopulmonary bypass procedure.
The Stockert Centrifugal Pump System with Tubing Clamp (SCP System TC) is a modification of the Stöckert Centrifugal Pump (SCP). The proposed SCP System TC is identical in intended use and fundamental scientific technology to the parent SCP. The parent SCP is identical to the proposed SCP System TC with the exception of the addition of an Electrical Remote-Controlled Tubing Clamp (Tubing Clamp) that is positioned at the pump outlet to occlude the arterial line. The Tubing Clamp is designed to automatically close if the reservoir blood level, microbubble activity, flow rate, or retrograde flow in the extracorporeal circuit reaches alarm levels during a cardiopulmonary bypass procedure. The Tubing Clamp can also be manually opened and closed by the operator via membrane keys on the SCP Pump Control Panel.
The proposed Tubing Clamp is connected to the Stöckert Centrifugal Pump Console (SCPC System) or a Stöckert Compact (SC) or Stöckert S3 System (S3) heart-lung machine console via a CAN/24V connection cable. Mains power and emergency power is provided by the connected SCPC System or SC/S3 System. Both automatic and manual operation of the clamp is controlled via the SCP System microprocessor control system.
Given the provided text, here's a breakdown of the acceptance criteria and the study information for the Stöckert Centrifugal Pump System with Tubing Clamp:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Safety | Electrical Safety | Conforms to appropriate standards |
| Safety | Electromagnetic Compatibility | Conforms to appropriate standards |
| Functionality | Tubing Clamp performs as designed | Functional acceptance testing performed |
| Functionality | Meets user requirements | Validation testing performed |
| Software | Software testing | Performed |
| Hardware | Hardware testing | Performed |
Note: The document states that the addition of the Tubing Clamp represents a "minor design change that raises no new issues of safety or effectiveness." This implies the existing safety and effectiveness criteria for the predicate Stöckert Centrifugal Pump (K011838) were considered applicable and met. The "acceptance criteria" themselves are broadly defined by the performance tests conducted.
2. Sample Size Used for the Test Set and Data Provenance
The provided text does not specify a sample size for any clinical or in-vitro test set in the conventional sense (e.g., number of patients, number of test runs).
The study described is focused on the device's functional integrity rather than performance on a biological sample.
Data Provenance: Not applicable as the testing described is primarily engineering and functional validation.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
Not Applicable. The text describes engineering and functional testing ("Functional acceptance testing, hardware and software testing, and validation testing"). There is no mention of human experts establishing ground truth in the context of clinical or diagnostic performance for the described modifications.
4. Adjudication Method for the Test Set
Not Applicable. As the testing was primarily functional and engineering-based, there is no mention of an adjudication method typical for clinical or diagnostic studies requiring expert consensus.
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
No, an MRMC comparative effectiveness study was not done. The device in question is a medical pump system with an added tubing clamp, not an AI-assisted diagnostic or decision-support system. Therefore, AI is not involved, and human reader performance improvement is not relevant to this submission.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not Applicable. This device is a physical mechanical system, not an algorithm. Therefore, "standalone" performance in the context of an algorithm is not relevant. The functional tests described are essentially "standalone" in that they test the device's inherent operation.
7. The Type of Ground Truth Used
The "ground truth" for the performance testing described is the design specifications and user requirements for the Tubing Clamp and the system. The tests confirmed that the device performed as designed and met these predefined requirements.
8. The Sample Size for the Training Set
Not Applicable. This device is a mechanical system, not an AI/machine learning algorithm. Therefore, there is no "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set Was Established
Not Applicable. As there is no training set for a machine learning algorithm, there is no "ground truth for the training set" to be established.
§ 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).