(238 days)
The Stöckert Centrifugal Pump (SCP) is a cardiopulmonary bypass speed control device (21 CFR 870.4380) indicated for use exclusively with the COBE Revolution Pump Head, for speed-controlled pumping through the cardiopulmonary bypass circuit for typical durations of six hours or less.
The SCP 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 Stöckert Centrifugal Pump, developed to address the needs of the health care marketplace, consists of the following components:
- SCP Control Panel .
- SCP Drive Unit .
- Flow Probe .
- Emergency Drive Unit .
The SCP is designed to be used exclusively with the COBE® Revolution Disposable Pump Head and in connection with Stöckert S3 and SC Systems. The power supply voltage (24 V DC) as well as the CAN Bus connection is provided through a connection cable. The SCP utilizes the battery backup power from the S3/SC System Uninterruptible Power Supply in case of mains power failure.
1. Acceptance Criteria and Reported Device Performance
| Characteristic | Acceptance Criteria (from predicate devices) | Reported Stöckert Centrifugal Pump Performance |
|---|---|---|
| RPM Range | 0-4500 RPM (Medtronic) / 0-5000 RPM (Jostra) | 0-3500 RPM |
| RPM Accuracy | Not specified (Medtronic) / ±20 RPM (Jostra) | ±10% |
| RPM Display Resolution | Not specified (Medtronic) / 10 RPM (Jostra) | 1 RPM |
| LPM Range | -2 to 9.99 LPM (Medtronic) / 0 to 9.9 LPM (Jostra) | -10 LPM to +10.0 LPM |
| LPM Accuracy | Not specified (Medtronic) / 0.1 LPM (Jostra) | ±10% or 0.1 LPM, whichever is greater |
| LPM Resolution | Not specified (Medtronic) / 0.01 LPM (Jostra) | 0.01 LPM (Flow > 0) / 0.1 LPM (Flow |
§ 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).