(91 days)
The intended purpose of the MAQUET Blood Monitoring Unit BMU 40 is to monitor blood parameters during cardiopulmonary bypass (CPB) or similar procedures with extracorporeal circulation, which require continuous monitoring of the arterial and/or venous blood parameters: partial pressure of oxygen (pO2), temperature (Ta and Tv), oxygen saturation (SO2), hemoglobin (Hb) and hematocrit (Hct). Oxygen consumption (VO2) can also be calculated. Blood flow (QBlood) can be entered manually or values can be received from a connected heart-lung machine.
The duration of application of the disposable products (arterial BMU Sensor and venous BMU Cell) is limited to six hours.
The BMU 40 is designed for continuous operation.
The Blood Monitoring Unit BMU 40 monitors blood parameters during cardiopulmonary bypass or similar procedures with extracorporeal circulation, which require continuous monitoring of the arterial and/or venous blood parameters
The Blood Monitoring Unit BMU 40 is blood monitoring system consisting of the following componens:
- the control unit (monitor, called BMU 40) which comprises a display i showing the actual measured sensor values and time course.
- Sterile single use connectors (BMU Sensor/ BMU Cell) to be clamped י on the probes, one in the venous line and one in the arterial line. The connectors are available in different sizes. BMU Sensor is connected to arterial probe and BMU Cell is connected to venous probe.
The provided text describes a medical device, the MAQUET Blood Monitoring Unit BMU 40, and its 510(k) submission for substantial equivalence. However, it does not contain the specific details about acceptance criteria, a study that proves the device meets those criteria, or the methodology of such a study in the format requested.
The document states that the performance characteristics of the BMU 40 were exhaustively tested and compared with the predicate device (CDI 500) and that the device performs as intended according to its performance specifications. It also lists areas that were tested such as "Performance", "Electrical and mechanical safety", "Software Validation", "Biocompatibility", "Sterility", and "Integrity".
Therefore, I cannot provide the requested table or detailed information about the study because the source document does not contain this level of detail.
The information provided only confirms that:
- The device is intended to monitor blood parameters during cardiopulmonary bypass.
- It was compared to predicate devices (CDI Blood Parameter Monitoring System 500 and M3 Monitor) for substantial equivalence in intended use, design, and performance.
- Testing was performed to demonstrate safety and effectiveness.
To answer your request, specific performance specifications and the results of those tests would be required, which are not present in the provided text.
§ 870.4330 Cardiopulmonary bypass on-line blood gas monitor.
(a)
Identification. A cardiopulmonary bypass on-line blood gas monitor is a device used in conjunction with a blood gas sensor to measure the level of gases in the blood.(b)
Classification. Class II (performance standards).