(104 days)
The EV1000 Clinical Platform is indicated for use primarily for critical care patients in which the balance between cardiac function, fluid status and vascular resistance needs continuous or intermittent assessment. Analysis of the thermodilution curve in terms of mean transit time and the shape is used to determine intravascular and extravascular fluid volumes. When connected to an Edwards oximetry catheter, the monitor measures oximetry in adults and pediatrics. The EV1000 Clinical Platform may be used in all settings in which critical care is provided.
The EV1000 Clinical Platform consists of a Databox and Monitor components, which can be mounted to an IV pole. The EV1000 Clinical Platform measures patient physiologic parameters when it is used as a system with various Edwards components, including the Edwards pressure transducers, the FloTrac sensor, the components of the VolumeView System, oximetry catheters/sensors, and the corresponding accessories applied to the patient.
The EV1000 Databox receives incoming signals from the patient through the connections provided by the accessories applied to the patient. The algorithms embedded in the Databox process the signals and provide parameter calculations.
The EV1000 Monitor is connected to the Databox via an ethernet cable. The Monitor is a touchscreen, panel PC with a graphical user interface (GUI). The Monitor displays the measured and calculated parameter values from the Databox.
The EV1000 Clinical Platform, when used with the VolumeView System, measures and/or calculates hemodynamic parameters such as:
• Auto-calibrated continuous parameters: cardiac output, cardiac index, stroke volume, stroke volume index, systemic vascular resistance, systemic vascular resistance index, and stroke volume variation;
• Manual-calibrated continuous parameters: cardiac output, cardiac index, stroke volume, stroke volume index, systemic vascular resistance, systemic vascular resistance index, and stroke volume variation; and,
• Manual-calibrated intermittent parameters: cardiac output , cardiac index, extravascular lung water, extravascular lung water index, global ejection fraction, global end-diastolic volume, global end-diastolic volume index, intrathoracic blood volume, pulmonary vascular permeability index, stroke volume, stroke volume index, systemic vascular resistance, and systemic vascular resistance index.
When connected to a FloTrac sensor, the EV1000 Clinical Platform continuously measures/calculates arterial pressure cardiac output, cardiac index, stroke volume, stroke volume index, stroke volume variation, systemic vascular resistance, and systemic vascular resistance index.
When connected to Edwards oximetry sensors, the EV1000 Clinical Platform continuously measures/calculates oximetry parameters.
Acceptance Criteria and Study for EV1000 Clinical Platform
This document describes the acceptance criteria and the study performed to demonstrate that the EV1000 Clinical Platform meets these criteria, based on the provided 510(k) summary.
1. Table of Acceptance Criteria and Reported Device Performance
The provided document doesn't explicitly state quantitative acceptance criteria in a table format. Instead, it describes a comprehensive testing regimen designed to demonstrate the device's "safety and effectiveness and substantial equivalence to the cited predicate devices." The performance reported is that the EV1000 Clinical Platform has been shown to be safe and effective and substantially equivalent to the cited predicate devices for their intended use.
The comparative analysis and functional/safety testing sections indicate that the device met the performance and functionality of the predicate devices. Therefore, the implicit acceptance criteria are that the EV1000 Clinical Platform performs comparably to its predicate devices in terms of functionality and safety without introducing new questions of safety or effectiveness.
Implicit Acceptance Criteria and Reported Device Performance:
| Parameter/Characteristic | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Performance and Functionality | Equivalent to predicate devices (K100709, K082308, K072735) | Demonstrated through head-to-head bench and pre-clinical studies, and comparative analysis of archived and new clinical data. |
| Safety and Effectiveness | No new questions of safety or effectiveness compared to predicate devices | Demonstrated through functional/performance testing, software V&V, mechanical/electrical testing, bench/pre-clinical studies, simulated comparisons, and clinical study. |
| Intended Use | Suitable for use in OR and ICU environments for critical care patients requiring continuous/intermittent assessment | Demonstrated through testing and found substantially equivalent to predicate devices for their intended use. |
| Hemodynamic Parameter Measurement | Accurate measurement/calculation of listed parameters (CO, CI, SV, SVI, SVR, SVRI, SVV, EVLW, EVLWI, GEF, GEDV, GEDVI, ITBV, PVPI) | Device measures/calculates these parameters. Implicitly, these measurements are comparable to predicate devices. |
| Oximetry Parameter Measurement | Accurate measurement/calculation of oximetry parameters in adults and pediatrics | Device measures/calculates oximetry parameters. Implicitly, these measurements are comparable to predicate devices. |
2. Sample Sizes Used for the Test Set and Data Provenance
The document states:
- Archived clinical data: This implies retrospective data.
- Clinical data obtained during a multi-center clinical trial: This implies prospective data.
- The country of origin is not specified, but Edwards Lifesciences LLC is based in Irvine, CA.
However, specific sample sizes for the test sets used in the comparative analysis, bench studies, pre-clinical studies, or multi-center clinical trial are not provided in the summary.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided in the 510(k) summary. The document does not mention the use of experts to establish ground truth for the test set. Given the nature of the device (measuring physiological parameters), ground truth would typically be established by established medical measurement methods or reference devices, not expert consensus in the traditional sense of image interpretation.
4. Adjudication Method for the Test Set
The document does not specify any adjudication method. As mentioned above, for physiological parameter measurements, ground truth is usually established by comparison to reference methods rather than human adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
An MRMC study is relevant for devices involving human interpretation of clinical data (e.g., imaging devices). The EV1000 Clinical Platform measures and calculates physiological parameters directly. Therefore, a MRMC comparative effectiveness study was not conducted as it is not applicable to this type of device. The study involved comparing the device's measurements against predicate devices or established methods, not assessing human reader improvement with AI assistance.
6. Standalone (Algorithm Only) Performance
The device itself is an algorithm-driven platform for measuring and calculating physiological parameters. The entire study described, which includes head-to-head bench and pre-clinical studies, and comparative analysis of clinical data, is essentially a standalone performance assessment of the EV1000 Clinical Platform's algorithms and hardware in measuring these parameters. It doesn't involve a human-in-the-loop scenario where a human is assisting the algorithm's output for diagnosis or interpretation. The device provides information to human clinicians.
7. Type of Ground Truth Used
Based on the description of device functionality and the testing methods, the ground truth would likely be established through:
- Reference physiological measurements: Comparing the device's output to measurements obtained from established, validated methods or "gold standard" devices for hemodynamic and oximetry parameters.
- Pathology/Outcomes data: While not explicitly stated, clinical outcomes or direct physiological measurements taken during procedures would serve as the ultimate ground truth for validating the accuracy and clinical utility of the measured parameters.
- Predicate device comparison: The study explicitly mentions "head-to-head bench and pre-clinical studies, and comparative analysis of archived clinical data and clinical data obtained during a multi-center clinical trial of the EV1000 Clinical Platform" against predicate devices. This implies the predicate devices' performance serves as a form of "ground truth" or reference for evaluating substantial equivalence.
8. Sample Size for the Training Set
The document does not specify a sample size for any training set. The EV1000 Clinical Platform is a measurement device with embedded algorithms, not a machine learning "AI" device as typically understood that undergoes a distinct training phase on a large dataset. Its algorithms are likely based on established physiological models and signal processing, rather than being "trained" in the machine learning sense. The "comparative analysis" refers to testing the device's performance, not training it.
9. How the Ground Truth for the Training Set Was Established
As noted above, a distinct "training set" in the context of machine learning is not indicated for this device. Therefore, this information is not applicable and not provided in the summary. The algorithms' inherent accuracy would be based on underlying scientific principles and engineering design, with performance validated through the testing described.
§ 870.1435 Single-function, preprogrammed diagnostic computer.
(a)
Identification. A single-function, preprogrammed diagnostic computer is a hard-wired computer that calculates a specific physiological or blood-flow parameter based on information obtained from one or more electrodes, transducers, or measuring devices.(b)
Classification. Class II (performance standards).