(91 days)
The CardioQ-EDM+ cardiac function and fluid status monitoring system is designed to provide clinicians with real-time information about a patient's left ventricular blood flow and key hemodynamic parameters. The CardioQ-EDM+ 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+, is a medical instrument designed to monitor cardiac function and fluid status, providing clinicians with real-time information about a patient's left ventricular blood flow and key hemodynamic parameters in anesthetized, sedated or conscious patients in the operating room, intensive care unit, emergency room or ward. In addition, the CardioQ-EDM+ includes a function to calculate arterial blood pressure based parameters from an output slaved from a vital signs monitor. The CardioQ-EDM+ combines Doppler measurement of blood flow with Pulse Pressure Waveform Analysis (PPWA). In "Flow Monitoring Mode" the system employs esophageal Doppler monitoring (EDM) techniques 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. Real-time information about cardiac function, in particular left ventricular flow, is displayed continuously. For the CardioQ-EDM+, the newly added "Pressure Monitoring Mode" the system slaves the arterial blood pressure signal supplied by the hospital patient monitoring system to provide systolic and diastolic pressures and derived parameters. The CardioQ-EDM+ uses these classical blood pressure measurements to calculate Stroke Volume (SV), Cardiac Output (CO), Stroke Volume Variation (SVV). Pulse Pressure Variation (PPV) and a small number of derived parameters. The pressure derived stroke volume is calibrated from the CardioQ-EDM+'s Doppler ultrasound measurement of stroke volume ensuring consistency and allowing frequent recalibration.
Here's a breakdown of the acceptance criteria and study information for the Deltex Medical CardioQ-EDM+ device, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided 510(k) summary does not contain a specific table detailing acceptance criteria for the CardioQ-EDM+ device's performance in terms of accuracy, precision, sensitivity, or specificity. Instead, the submission focuses on demonstrating substantial equivalence to a predicate device (CardioQ-EDM) by highlighting that the new device is a modification incorporating additional functionalities for blood pressure-based parameter calculation.
The performance comparison is implicitly made through the "Comparison technological features" table, which shows that the CardioQ-EDM+ offers the same ranges for directly measured Doppler parameters as the predicate device. The new "Pressure Monitoring Mode" adds new calculated parameters with specified ranges, but these are not compared against a defined acceptance criterion from a performance study within this document.
Implicit Performance Claim (based on substantial equivalence):
The CardioQ-EDM+ is designed to provide real-time information about a patient's left ventricular blood flow and key hemodynamic parameters, similar to the predicate device. The new pressure-based calculations are presented as additions to the existing capabilities, relying on the established performance of the Doppler measurement and the slaved arterial blood pressure signal.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size:
- Clinical Testing: The document explicitly states: "No clinical testing was conducted in support of this 510(k)." Therefore, there is no clinical test set sample size.
- Bench Testing: The document mentions "Comparative bench testing," but does not provide details on the number of samples, cases, or specific data points used in this testing.
- Data Provenance: Not applicable for clinical data. For bench testing, the provenance is internal to Deltex Medical, as it was "Comparative bench testing... using a CardioQ-EDM Cardiac Output and Fluid Status Monitoring System (K111542)."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Since "No clinical testing was conducted in support of this 510(k)," there was no ground truth established by experts for a clinical test set.
4. Adjudication Method for the Test Set
Not applicable, as no clinical test set was used to establish performance against a ground truth.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Was it done? No. The document explicitly states: "No clinical testing was conducted in support of this 510(k)."
- Effect size of human readers improvement: Not applicable, as no such study was performed.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
While the device operates as a standalone monitoring system, the term "standalone study" typically refers to an evaluation of an AI algorithm's performance independent of human input or review. As this device is a medical instrument (hardware and integrated software) designed to measure physiological parameters rather than an AI-driven diagnostic or interpretative tool, this concept doesn't directly apply in the same way it would for, for instance, an AI-powered image analysis product.
The device's performance is demonstrated through its ability to measure and calculate parameters, and the validation of these calculations would be part of the bench testing. The 510(k) focuses on the "substantial equivalence" of the device, particularly the new features, to the predicate. The "Bench Testing" section confirms that the new device's performance is substantially equivalent to the predicate, implying that the algorithm's calculations were validated against expected outputs or the predicate's known outputs, but specific details of this validation are not provided.
7. Type of Ground Truth Used
- Clinical: Not applicable, as no clinical testing was performed.
- Bench Testing: The implicit ground truth for the bench testing would have been reference measurements or known values used to compare the CardioQ-EDM+ against the predicate CardioQ-EDM. The document states: "Comparative bench testing... supports the conclusion that the two systems have substantially equivalent performance." This implies that the CardioQ-EDM+'s outputs for new and existing parameters were compared against established and accepted values (e.g., from the predicate device or simulated physiological signals) during bench testing.
8. Sample Size for the Training Set
This device does not appear to use machine learning or AI in a way that requires a "training set" in the conventional sense (e.g., for image recognition or predictive modeling from a large dataset). Its algorithms are based on established physiological principles and signal processing for Doppler measurements and arterial pressure analysis. Therefore, there's no reported training set sample size.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no apparent training set for machine learning. The algorithms are likely deterministic and based on validated mathematical models and physiological relationships.
§ 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).