(30 days)
The Levitronix CentriMag Primary and Back-Up Consoles are indicated for use with the Levitronix CentriMag Extracorporeal Blood Pumping System. The Levitronix CentriMag Extracorporeal Blood Pumping System is indicated to pump blood through the extracorporeal bypass circuit for extracorporeal circulatory support for periods appropriate to cardiopulmonary bypass (up to six hours). It is also indicated for use in extracorporeal circulatory support systems (for periods up to six hours) not requiring complete cardiopulmonary bypass (e.g. valvuloplasty, circulatory support during mitral valve reoperation, surgery of the vena cava or aorta, liver transplants etc).
The CentriMag Primary Console is a microprocessor-based device. The microprocessor generates the primary Motor control signal, monitors system sensors, generates front display outputs, and provides alarm functions. The microprocessor acquires the sensor data for use in generating operator displays and alarms. An alphanumeric screen is used to display monitored data, system options, and menus. Operator adjustable alarms and parameters are accessible via the system menus.
The CentriMag Back-Up Console is a microprocessor-based device. The microprocessor generates the primary Motor control signal, monitors system sensors, generates front display outputs, and provides alarm functions. The microprocessor acquires the sensor data for use in generating operator displays and alarms. An alphanumeric screen is used to display monitored data.
This document pertains to a 510(k) submission for the Levitronix CentriMag Primary Console and Back-Up Console. It specifically states that the submission is for a "labeling change" and that this change "did not require any performance characteristics testing."
Therefore, the document does not contain information about acceptance criteria or a study proving the device meets acceptance criteria as typically understood for new device submissions or modifications requiring performance validation.
Here's why the requested information cannot be extracted from this document:
- No Acceptance Criteria or Performance Data: The document explicitly states: "The proposed labeling change did not require any performance characteristics testing." This means no new tests were conducted to establish performance or acceptance criteria for this particular submission.
- Substantial Equivalence to Predicate Device: The entire premise of this 510(k) is based on demonstrating substantial equivalence to previously cleared predicate devices (K083340 and K090004). This implies that the performance characteristics (and thus, presumably, acceptance criteria met by those predicate devices) are considered already established.
- No Study Conducted: Since no performance testing was required or conducted for this submission, there is no study to describe in terms of sample size, data provenance, ground truth, expert involvement, or MRMC analysis.
In summary, the provided document does not contain the information requested because the 510(k) submission described is for a labeling change that did not necessitate new performance testing or the establishment of new acceptance criteria.
§ 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).