(186 days)
The ECOM Endotracheal Cardiac Output Monitor System is intended for the monitoring of cardiac output by impedance cardiography while providing airway management by oral intubation with an ECOM Endotracheal Tube. The ECOM System is indicated for use in patients who are expected to be intubated for 24 hours or less and in whom an arterial pressure line is used.
The ECOM System displays the R-Wave Detection and the Impedance Waveforms as well as the patient's Cardiac Output (CO), Stroke Volume (SV), Heart Rate (HR), Systolic and Diastolic Pressure.
The ECOM Endotracheal Cardiac Output Monitor System consists of a monitor, an endotracheal tube and various accessories. The system applies a high frequency, low amplitude electrical current to a series of electrodes applied to the endotracheal tube. The resulting signals, when used in conjunction with an arterial pressure signal, allow for the calculation and display of Cardiac Output (CO). Cardiac Input (CI). Stroke Volume (SV), Stroke Volume Variation (SVV), Heart Rate (HR), Systemic Vascular Resistance (SVR), Systemic Vascular Resistance Index (SVRI), and systolic, diastolic and mean blood pressures.
The provided text is a 510(k) summary for the ECOM™ Endotracheal Cardiac Output Monitoring System. It outlines the device's description, intended use, and claims substantial equivalence to a predicate device. However, it does not contain information about specific acceptance criteria or a detailed study proving the device meets those criteria, as typically found in clinical study reports.
The document primarily focuses on non-clinical performance testing and regulatory compliance for substantial equivalence. Therefore, many of the requested details cannot be extracted from the provided text.
Here is a summary of what can be extracted and an indication of what is not present:
Acceptance Criteria and Device Performance
The document does not explicitly state specific acceptance criteria in terms of numerical performance thresholds (e.g., accuracy, precision) for cardiac output measurements. Instead, it relies on demonstrating substantial equivalence to a predicate device. The "reported device performance" is described broadly in terms of functionality and safety.
| Criterion Type (Anticipated) | Acceptance Criteria (As per document) | Reported Device Performance (As per document) |
|---|---|---|
| Cardiac Output Accuracy | Not specified numerically | "substantially equivalent to the predicate" |
| Cardiac Output Precision | Not specified numerically | "substantially equivalent to the predicate" |
| Safety | Not specified numerically | "safe and effective for the intended use" |
| Functionality | Not specified numerically | "calculates and displays Cardiac Output (CO), Cardiac Input (CI), Stroke Volume (SV), Stroke Volume Variation (SVV), Heart Rate (HR), Systemic Vascular Resistance (SVR), Systemic Vascular Resistance Index (SVRI), and systolic, diastolic and mean blood pressures." |
| Electr. Safety/Comp. | Compliance with standards | "complies with the applicable sections of IEC 60601-1:1988/A1:1991/A2:1995, IEC 60601-1-1:2000, IEC 60601-1-2:2001/A1:2004 and IEC 60601-1-4:2000." |
| Biocompatibility | Compliance with standards | "patient contacting materials comply with the requirements of ISO 10993-1:2009." |
| Software Validation | Not specified numerically | Demonstrated by "Design verification testing, including software validation." |
Study Details (Based on the provided text)
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Sample size used for the test set and the data provenance:
- Not provided. The document mentions "Non-clinical bench testing" and "Design verification testing" but does not detail sample sizes for any specific test set, nor does it specify data provenance (country of origin, retrospective/prospective). This is a 510(k) summary, which often summarizes clinical evidence rather than providing raw study details.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not provided. The document does not describe any study that involved human experts establishing ground truth for performance evaluation of the device's measurements. The focus is on technical compliance and equivalence.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable/Not provided. Since no expert review or human-involved test set for clinical performance is detailed, no adjudication method is mentioned.
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If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No. The ECOM system is a monitoring device that provides physiological parameters (e.g., Cardiac Output). It does not appear to be an AI-driven image interpretation or diagnostic aid that would involve "human readers" or "AI assistance" in the typical sense of an MRMC study.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, indirectly. The "Non-clinical bench testing" and "Design verification testing," including software validation, would represent standalone performance assessments of the device's algorithms and hardware without a human "in the loop" of the measurement calculation. However, the specific results in terms of accuracy or precision are only generally stated as "substantially equivalent."
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not explicitly stated for clinical performance. For the non-clinical tests, the "ground truth" would be established by reference standards or validated testing equipment for electrical safety, biocompatibility, and functional performance. For cardiac output, if a clinical study were performed (which is not detailed here), the ground truth would typically be a gold standard cardiac output measurement technique (e.g., thermodilution, Fick principle, or another validated invasive method). The document only states "substantial equivalence" to a predicate, implying that the predicate's performance is the benchmark.
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The sample size for the training set:
- Not applicable/Not provided. The ECOM system is described as a monitoring device with specific algorithms for calculating physiological parameters. It is not presented as a machine learning or AI device that undergoes "training" in the conventional sense of deep learning models. Its algorithms are likely based on established physiological models and impedance cardiography principles.
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How the ground truth for the training set was established:
- Not applicable/Not provided. As above, the concept of a "training set" and its "ground truth" is not relevant to the type of device and testing described in this 510(k) summary.
In summary, the provided 510(k) summary focuses on demonstrating substantial equivalence through non-clinical testing and regulatory compliance, rather than detailing a specific clinical performance study with predefined acceptance criteria and robust statistical analysis often associated with direct performance claims for new technologies.
§ 870.2770 Impedance plethysmograph.
(a)
Identification. An impedance plethysmograph is a device used to estimate peripheral blood flow by measuring electrical impedance changes in a region of the body such as the arms and legs.(b)
Classification. Class II (special controls). The device, when it is a body composition analyzer which is not intended to diagnose or treat any medical condition, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.