(149 days)
The MPS450 Multiparameter Simulator is an electronic signal source for determining that patient monitors are performing within their operating specifications. The MPS450 provides the following function categories: ECG Functions Arrhythmia Functions ECG-Performance Testing Respiration Blood Pressure Temperature Cardiac Output (Optional) Fetal/Maternal ECG & IUP (Optional)
Fluke Biomedical's MPS450 Multiparameter Simulator (hereafter referred to as the MPS450) provides a basis to train, evaluate, and perform preventive maintenance for virtually all patient monitors found in the healthcare industry. This is accomplished with multiple physiological simulations for ECG, blood pressure, respiration, temperature, artifact, and arrhythmia conditions. The MPS450 is a lightweight, battery powered unit that is portable enough to test a patient monitor anywhere the monitor is being used.
The provided document describes the Fluke Biomedical MPS450 Multiparameter Simulator, a device intended to test the operation of patient monitors by simulating various physiological parameters. The submission focuses on demonstrating substantial equivalence to a predicate device, the MedSim300B.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Acceptance Criteria and Reported Device Performance
The acceptance criteria for the MPS450 are implicitly defined by comparing its performance specifications to those of the predicate device, the MedSim300B. The differences highlight where the MPS450 either meets or exceeds the predicate's capabilities or where features were deemed "not needed by customers."
| Feature/Parameter | Acceptance Criteria (Predicate - MedSim300B) | Reported Device Performance (MPS450) | Notes |
|---|---|---|---|
| Physical Characteristics | |||
| Construction | Aluminum case | Plastic case | MPS450 is Lighter. |
| Size | 10 L x 7 W x 3 H inches | 7.5 L x 6 W x 2 H inches | MPS450 is Smaller. |
| Weight | 3.55 lbs | 1 lbs 8 oz | MPS450 is Lighter. |
| Display | 2 by 24 character LCD | 4 by 20 character LCD | MPS450 has More lines on display. |
| High level ECG connection | ¼" standard phone jack w/ lead II waveform at .2V/mV of ECG lead II signal | 0.2 V/mV +/- 5% of the ECG amplitude setting available on the BP3 connector | Different type of connector – same functionality. |
| Battery test | Yes, 8.4V or 9V, low battery signal if |
§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).
(a)
Identification. A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.(b)
Classification. Class II (performance standards).