(135 days)
When used in conjunction with the CardioQ cardiac output and fluid status monitoring system, the DP240 is designed to provide clinicians with real-time information about left-ventricular blood flow. The DP240 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 DP240 can be placed into the esophagus via oral or nasal insertion in adults.
When used in conjunction with the Cardiac output and fluid status monitoring system (K031706), the DP240 is designed to provide clinicians with real-time information about leftventricular function by measuring blood flow in the descending thoracic aorta. The probe is designed to operate in a clinical setting in which patients are under general anesthesia or sedated in the intensive care unit.
The DP240 transmits a 4 MHz continuous wave 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.
The DP240 is placed orally or nasally and inserted into the esophagus to a depth of 35 – 45 cm, (approx. 14" - 18") for insonation of the descending thoracic aorta at the 6" thoracic vertebra (approximately). The shaft and tip of the DP240 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 14 French (~4.8 mm, approx. 0.18"). The probe is supplied sterile and is for single-use only in adults.
This 510(k) submission for the DP240 240 Hour Doppler Probe is a premarket notification aiming to demonstrate substantial equivalence to previously cleared devices. It does not contain information about acceptance criteria or a study proving the device meets those criteria. The provided text is a standard 510(k) summary and FDA clearance letter, which focuses on device description, intended use, and comparison to predicate devices, rather than detailed performance studies and acceptance criteria typically found in clinical trial reports or engineering validation documents.
Therefore, I cannot fulfill the request to describe the acceptance criteria and a study proving the device meets those criteria based solely on the provided text. The requested information regarding sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, standalone performance, and training set details are not present in this document.
§ 870.2120 Extravascular blood flow probe.
(a)
Identification. An extravascular blood flow probe is an extravascular ultrasonic or electromagnetic probe used in conjunction with a blood flowmeter to measure blood flow in a chamber or vessel.(b)
Classification. Class II (performance standards).