(318 days)
The CardioQ-EDM series fluid management and cardiac output monitoring systems are designed to provide clinicians with real-time information about patients left ventricular blood flow and key hemodynamic parameters. The CardioQ-EDM series beat to beat data on cardiovascular status can be used by the managing clinician to evaluate and optimize hemodynamic performance in anesthetized, sedated or conscious patients in the operating room, intensive care unit, emergency room or ward.
The CardioQ-EDM series monitors when used in Flow Monitoring Mode (esophageal Doppler) or Pressure Monitoring Mode (EDM+ only) are intended for use with adult and pediatric patients. When the CardioQ-EDM series monitors are used for High-Definition Impedance CardioGraphy with a PhysioFlow Q-Link module the intended use is for adult patients only.
The CardioQ-EDM series are medical instruments designed to monitor cardiac function and fluid status. The CardioQ-EDM & EDM+ achieve this by combining Doppler measurements of the blood flow (4MHz continuous wave ultrasound) to monitor and quantify the blood flow in the descending thoracic aorta. In addition to this the CardioQ-EDM+ previously introduced as an upgrade to the EDM under (K132139) allows additional Pulse Pressure Waveform Analysis (PPWA) through arterial blood pressure based parameters slaved from a high-end monitor.
The CardioQ-EDM (K111542) & Cardio EDM+ (K132139) have now been introduced with the addition of a USB Hub accessory and software modifications that allow the CardioQ-EDM series monitors to display hemodynamic parameters from the coupled together hemodynamic impedance cardiography device.
The addition of USB Hub accessory and software modifications allow the CardioQ-EDM series monitors to become a non-invasive cardiac output measurement system which displays hemodynamic parameters, allowing analysis of a trans-thoracic impedance cardiography signal & cardiac output monitoring. The only addition to the CardioQ-EDM & CardioQ-EDM+ is the enabling of HD-ICG functionality through the USB Hub accessory introduction and software modifications to display the hemodynamic parameters from the coupled hemodynamic impedance cardiography device.
The provided document is a 510(k) summary for the Deltex Medical CardioQ-EDM and Deltex Medical CardioQ-EDM+ device. It outlines the regulatory submission, device description, intended use, technological features, and a summary of completed testing.
However, the document does not contain any information about acceptance criteria or a study that specifically proves the device meets acceptance criteria related to its performance in terms of accuracy or efficacy, particularly concerning AI or algorithms. The submission focuses on substantial equivalence to predicate devices, primarily due to software modifications and the addition of a USB hub accessory to enable the display of hemodynamic parameters from a coupled impedance cardiography device.
Therefore, I cannot extract the detailed information requested in the prompt. The document explicitly states:
- "No Acoustic Output Testing has been conducted, because the CardioQ-EDM series monitors are only displaying data rather than performing any primary calculations are conducted by the hemodynamic impedance cardiography device coupled to the CardioQ-EDM series monitors."
- "No animal testing was conducted in support of this 510(k)."
- "No clinical testing was conducted in support of this 510(k)."
The "Bench Testing" mentioned is comparative and aims to show that "the software modifications and introduced USB Hub accessory have enabled additional HD-ICG functionality to be introduced to the existing CardioQ-EDM series monitors" and that "the software correctly displays the information received from the coupled hemodynamic impedance cardiography device without any manipulation of the coupled device." This is a functional verification, not a performance study against specific acceptance criteria for a new clinical claim or algorithm.
The document discusses "Letter-to-File Changes" for "Addition of Cardiac Power (CPO) and Cardiac Power Index (CPI)" and "Addition of Elastance (Ea) and Dynamic Arterial Elastance (Eadyn)," citing published papers to validate the use of these formulae. This indicates that the device displays these calculated parameters, but the 510(k) submission itself does not contain a study proving the device's performance in calculating or displaying these against acceptance criteria from a statistical clinical trial.
In summary, based on the provided text, the document does not contain the information required to answer your specific questions regarding acceptance criteria and performance studies for an AI/algorithm-driven device. The device described here is a display unit for parameters calculated by another coupled device and its assessment is for substantial equivalence relating to software and hardware changes enabling this display functionality.
§ 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).