(102 days)
The Fusion™ System and accessories blood pressure measurement system is intended to be used on patients with wrist circumference of 11 cm - 22 cm by trained medical personnel to continually monitor systolic, diastolic and mean blood pressure and pulse rate.
The Fusion System module option of Nellcor OxiMAX Option (K012891), is indicated for the continuous non-invasive monitoring of a patient's functional oxygen saturation of arterial hemoglobin (SpO2) by trained medical personnel.
The Fusion System module option of Kendall Genius Thermometer (K920713) is indicated for the measuring of a patient's body temperature.
This device is prescription use only.
The Fusion™ System is a non-invasive blood pressure monitor that uses a pressure sensor placed directly on top of the radial artery. This sensor is noninvasive and eliminates the need for an occlusive inflatable cuff. This device is intended to be used on patients by trained medical personnel to continually monitor systolic, diastolic and mean blood pressure, and pulse rate.
The Fusion™ System uses a patented "sweep technique" which applies a varying force on the radial artery. The counterpressure in the artery produces a signal which is digitized and used to calculate blood pressure parameters.
The sensor measures the pulse at the point of maximum energy transfer; the wave shapes are analyzed by Medwave's proprietary algorithms. Parameters are extracted from the waveforms and a set of coefficients are applied to them yielding systolic, mean, and diastolic pressures approximately every 15 heart beats. These algorithms have been tested and validated in clinical studies by synchronized comparisons to arterial line pressure waveforms.
Patient pressures can be monitored visually by viewing the screen and audibly entering limits into the Fusion™ System alarm menu. Patient measurements above or below the limits will be automatically brought to the attention of the caregiver through these visual and audible alarms. A Start/Stop key provides the operator with an option to cancel operation at anytime.
The Fusion™ System can be ordered with additional module options:
- · Tyco Healthcare Nellcor OxiMax Pulse Oximetry System (K012891) provides monitoring of a patient's functional oxygen saturation of arterial hemoglobin.
- · Kendall Genius Thermometer (K920713) provides patient's body temperature readings.
- · Seiko Thermal Printer SII providing hardcopy of readings selected to print.
The Medwave, Inc. Fusion™ System is a non-invasive blood pressure monitor. Here's an analysis of its acceptance criteria and the supporting study:
1. Acceptance Criteria and Reported Device Performance
The device's performance claims are based on meeting industry standards for non-invasive blood pressure monitors.
| Acceptance Criteria (ANSI/AAMI SP10-2002) | Reported Device Performance (Fusion™ System) |
|---|---|
| Mean Difference | ± 5 mmHg or less (for systolic, diastolic, and mean blood pressure) |
| Standard Deviation | 8 mmHg or less (for systolic, diastolic, and mean blood pressure) |
| Pulse Measurement Range | 40 - 200 bpm |
| Pulse Measurement Accuracy | ± 5 bpm or 10% of the measured pulse frequency |
| Blood Pressure Measurement Range | 40 - 240 mmHg (systolic and diastolic) |
| Operating Temperature Conditions | 10°C (50°F) - 40°C (104°F) |
| Operating Humidity Conditions | 15 - 90 percent (noncondensing) |
| Operating Range in Altitude Conditions | -170 to 1700 meters (-500 to 5000 feet), referenced to sea level |
| Life test | minimum of 10,000 full scale cycles |
| Electrical Safety | Meets IEC60601 and IEC601 standards |
| Electromagnetic Compatibility | Meets IEC60601 standards |
| Biocompatibility | Meets Center For Devices And Radiological Health Noninvasive Blood Pressure Monitor Guidance Document |
| Device Labeling | Meets ANSI/AAMI SP10-2002, IEC60601, and Center For Devices And Radiological Health Noninvasive Blood Pressure Monitor Guidance Document |
| Outer Container Labeling | Meets ANSI/AAMI SP10-2002, IEC60601, and Center For Devices And Radiological Health Noninvasive Blood Pressure Monitor Guidance Document |
| Information Manual | Meets ANSI/AAMI SP10-2002, IEC60601, and Center For Devices And Radiological Health Noninvasive Blood Pressure Monitor Guidance Document |
| Component Labeling | Meets ANSI/AAMI SP10-2002, IEC60601, and Center For Devices And Radiological Health Noninvasive Blood Pressure Monitor Guidance Document |
| Power System Labeling | Meets ANSI/AAMI SP10-2002 and Center For Devices And Radiological Health Noninvasive Blood Pressure Monitor Guidance Document |
| Storage Conditions | -20°C (-40°F) - 50°C (122°F) |
| Pressure Indicator Accuracy | Meets ANSI/AAMI SP10-2002 |
| Overall System Efficacy | Meets ANSI/AAMI SP10-2002 |
| Software Testing | Meets Medwave 795-0000 guidelines |
| Intraarterial Method as Reference Standard | Used as the reference standard |
2. Sample Size and Data Provenance
The document indicates that clinical data supporting the performance claims is "on file at Medwave, Inc." However, it does not specify the sample size used for the test set or the country of origin. It also doesn't explicitly state whether the data was retrospective or prospective.
3. Number of Experts and Qualifications
The document does not provide information on the number of experts used to establish ground truth or their qualifications.
4. Adjudication Method
The document does not specify an adjudication method for the test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
An MRMC study was not conducted as this is a medical device for automated measurements, not an AI diagnostic imaging system that would typically involve human readers. The device is intended to provide automated measurements.
6. Standalone Performance Study
Yes, a standalone study was performed. The device's algorithms were "tested and validated in clinical studies by synchronized comparisons to arterial line pressure waveforms." This indicates that the algorithm's performance was evaluated independently against a gold standard.
7. Type of Ground Truth Used
The ground truth used for validating the blood pressure measurements was the intra-arterial line pressure waveforms. This is considered a highly accurate and invasive "gold standard" for blood pressure measurement.
8. Sample Size for the Training Set
The document does not specify the sample size used for the training set of the proprietary algorithms.
9. How Ground Truth for the Training Set Was Established
The document states that "Parameters are extracted from the waveforms and a set of coefficients is applied to them, yielding systolic, mean and diastolic pressures. The algorithms have been tested against intra arterial line pressure waveforms and proven to meet industry standards..." This implies that the ground truth for training (or at least for validation) was established using intra-arterial line pressure waveforms.
§ 870.1130 Noninvasive blood pressure measurement system.
(a)
Identification. A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.(b)
Classification. Class II (performance standards).