(65 days)
The CardioQ cardiac output and fluid status monitoring system is designed to provide clinicians with real-time information about left-ventricular blood flow. The CardioQ is designed to operate in a clinical setting in which the patients are under general anesthesia or are sedated in the intensive care unit. The CardioQ offers the anesthetist and intensive care physician with beat-to-beat data on cardiovascular status and circulating blood volume, providing immediate feedback on the effect of any therapeutic intervention.
The CardioQ cardiac output and fluid status monitoring system is designed to provide clinicians with real-time information about left-ventricular blood flow. The CardioQ is designed to operate in a clinical setting in which the patients are under general anesthesia or are sedated in the intensive care unit. The CardioQ offers the anesthetist and intensive care physician with beat-to-beat data on cardiovascular status and circulating blood volume, providing immediate feedback on the effect of any therapeutic intervention.
The CardioQ system employs esophageal Doppler using 4 MHz continuous wave ultrasound to monitor and quantify the blood flow in the descending thoracic aorta, displaying this data as a maximum velocity curve, a velocity spectrum and derived measurements. Thus, real-time information about cardiac function and haemodynamic status, in particular flow, is displayed continuously.
The CardioQ system transmits the 4 MHz ultrasonic 'carrier' signal from the probe tip at a fixed angle to the descending aorta, by excitation of a piezo-electric transducer. The ultrasound is reflected by the red blood cells and is received by a separate transducer in the probe tip. Blood flow away from the probe results in frequencies less than 4 MHz being present in the received signal. Conversely, any reverse flow will produce frequencies higher than the carrier.
The received signal is first demodulated, such that those frequencies corresponding to the blood flow are extracted and displayed as a real-time velocity spectrum. The spectrum displays the distribution of red blood cell velocities at a given point in time, i.e. a histogram of velocities over time. Thus, the brightness at any point in the spectrum is directly proportional to the number of red blood cells traveling at a given velocity at a given time in the cardiac cycle.
The CardioQ automatically traces the maximum velocity of the spectrum at each time point. By calculating the area under this maximum-velocity curve during systole, a beat-to-beat value for Stroke Distance (SD) is given, being the distance a column of blood moves in the aorta during systole. Using a proprietary algorithm called the nomogram, the CardioQ estimates Stroke Volume (SV) using the measured SD and the size and age of the patient. The Stroke Volume is the volume of blood output by the heart during systole. Since the machine automatically calculates the patient's heart rate (HR) from the spectrum, it can also provide a beat-to-beat measurement of Cardiac Output (SV*HR). Other parameters calculated include:
- . Peak Velocity (PV) - highest blood velocity recorded during systole
- Mean Acceleration (MA) acceleration of the blood at the beginning of systole ●
- Corrected Flow Time (FTc) systolic flow time (normalized to 60 bpm) .
- Cardiac Index (CI) cardiac output normalized to body surface area o
- Minute Distance (MD) a linear surrogate for cardiac output, being the distance a . column of blood moves in the aorta in one minute
The CardioQ Cardiac Output and Fluid Status Monitoring System is comprised of the following components:
CardioQ monitor
Esophageal Doppler monitor (including power cord) which generates and processes the transmitted and received ultrasound signals, displays the resulting velocity spectrum and calculates the associated cardiac parameters. It is connected to the probe via the patient interface cable. The monitor displays the waveform and numerical data on a 10.4" color TFT LCD screen, which also provides the user interface and 'help' text. The monitor is operated by a large rotary 'encoder' knob and six 'soft' buttons whose function depends on the current screen mode. The monitor operates from a 100 – 240V A.C. supply.
Patient Interface Cable
6' 3" long interconnect cable between the CardioQ monitor and probe, providing signal amplification and electrical isolation.
CardioQ probe
Esophageal Doppler monitor probe is placed orally and inserted to a depth of 35 – 40 cm. (approx. 14" - 16") for insonation of the descending thoracic aorta at the 60 thoracic vertebra (approximately). The CardioQ probe is the only component in contact with the patient and is manufactured with an outer insulating cover of medical grade silicone rubber. The probe is flexible and has a shaft diameter of 17 French (~5.5 mm, approx. 0.22"). The probe is supplied sterile and is for single-use only.
The provided text describes the CardioQ Cardiac Output and Fluid Status Monitoring System, but does not contain information about acceptance criteria or a specific study proving the device meets acceptance criteria. The document is a 510(k) summary for a premarket notification, indicating substantial equivalence to previously cleared devices. It mainly focuses on device description, intended use, and the FDA's clearance letter.
Therefore, I cannot provide the requested information from the given text.
The information sought, such as acceptance criteria, reported device performance, sample sizes, data provenance, expert qualifications, ground truth establishment, adjudication methods, and details of MRMC or standalone studies, are typically found in detailed validation studies or clinical trial reports, which are not present in this 510(k) summary.
§ 870.2100 Cardiovascular blood flowmeter.
(a)
Identification. A cardiovascular blood flowmeter is a device that is connected to a flow transducer that energizes the transducer and processes and displays the blood flow signal.(b)
Classification. Class II (performance standards).