(57 days)
The Stockert Centrifugal Pump System is a cardiopulmonary bypass speed control device (21CFR 870.4380) that is indicated for use with the Cobe Revolution® Pump Head/Dideco Synergy™/ECC.OTM for for speed controlled pumping through a cardiopulmonary bypass circuit for typical durations of six hours or less. The SCP Plus is intended for use as a component part of or optional accessory to the S3 and S5 System (or any compatible system using the SS firmware versions of 3.0. or greater) and the Stöckert Air Purge Control (APC) System.
The SCP Plus has been qualified only for typical durations of six hours or less, appropriate to cardiopulmonary bypass procedures and 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 Plus System is intended for use as a component part of or optional accessory to the S3 and S5 System (or any compatible system using the S5 firmware versions of 3.0. or greater) and with the Stöckert Air Purge (APC) System. The System consists of the drive unit, a mounting receptacle for the pump head, a retaining key, splash protection, and a 3-joint mast holder with fast clamp connector.
The Stöckert Centrifugal Pump (SCP) Plus System consists of hardware, firmware, and electronics that are used to drive the centrifugal pump for surgical procedures requiring cardiopulmonary bypass for typical durations of six (6) hours or less. The SCP drive unit uses magnetic coupling with the centrifugal pump.
This document describes the acceptance criteria and accompanying study for the Sorin Group Deutschland GmbH Stöckert Centrifugal Pump (SCP) Plus System.
No information regarding a multi-reader multi-case (MRMC) comparative effectiveness study, standalone algorithm performance, or training set details is available in the provided text, as this is a traditional 510(k) for a medical device (a pump), not an AI/ML-driven device.
1. Acceptance Criteria and Reported Device Performance
The SCP Plus System was evaluated against prospectively defined performance criteria. The document states that the device's performance characteristics remain unchanged from its predicate device (K091008). Therefore, the acceptance criteria are implicitly tied to maintaining the established performance and safety standards of the predicate device.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Safety | Tested in accordance with IEC60601-1 (with National Deviations), demonstrating safety. |
| Electromagnetic Compatibility (EMC) | Tested in accordance with IEC60601-1-2, demonstrating EMC compliance. |
| Performance | Fulfills prospectively defined functional acceptance tests and meets user needs. The system performs in an identical manner to the predicate device integrated with a different system (Sorin C5). |
| Intended Use Durations | Qualified for typical durations of six hours or less for cardiopulmonary bypass procedures. |
| Technological Characteristics | Identical in hardware, firmware, electronics, and components (drive unit, control panel, flow probe, emergency drive unit, flexible drive shaft, connection cables) to the predicate device (K091008). |
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not specify a "test set" in the context of diagnostic performance evaluation with a defined sample size for images or patient data. This is a submission for a physical medical device (a pump), not a diagnostic algorithm.
The testing conducted was primarily non-clinical performance testing (safety, EMC, functional acceptance tests) of the physical device and its components. The document does not describe any studies involving human subjects or data derived from patients.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This section is not applicable as the document does not describe a "test set" requiring ground truth established by experts (e.g., radiologists, pathologists). The evaluation focused on engineering and performance criteria for a physical pump.
4. Adjudication Method for the Test Set
This section is not applicable as there was no test set requiring expert adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The provided text describes a 510(k) submission for a physical medical device (a centrifugal pump), not an AI/ML-driven diagnostic or assistive tool. Therefore, there is no mention of human readers improving with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone performance study (in the context of an algorithm) was not done. The device is a physical pump designed to operate within a cardiopulmonary bypass circuit, and its performance is assessed through engineering and functional tests, not as an "algorithm only."
7. The Type of Ground Truth Used
For the non-clinical performance testing, the "ground truth" was established by:
- Compliance with international and national standards (IEC60601-1 for safety, IEC60601-1-2 for EMC).
- Adherence to formal prospectively defined functional acceptance test specifications.
- Meeting user needs and performance identical to the predicate device.
There was no "ground truth" derived from expert consensus, pathology, or outcomes data in the context of diagnostic accuracy, as this is not a diagnostic device.
8. The Sample Size for the Training Set
This section is not applicable. The SCP Plus System is a hardware device with firmware, not a machine learning model, so there is no concept of a "training set" for an algorithm.
9. How the Ground Truth for the Training Set Was Established
This section is not applicable for the same reasons as above.
§ 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).