(164 days)
The LiDCOunity Monitor is intended for use under the direct supervision of a licensed healthcare practitioner or by personnel trained in its proper use for:
- The measurement of blood pressure, cardiac output and associated hemodynamic parameters in adult patients.
- When connected to the BIS Module: monitoring the state of the brain by data acquisition of EEG signals and may be used as an aid in monitoring the effects of certain anesthetic agents. Use of BIS monitoring to help guide anesthetic administration may be associated with the reduction of the incidence of awareness with recall in adults during general anesthesia and sedation.
- When connected to the LiDCO CNAP Module it may be used for the continuous, non-invasive monitoring of arterial blood pressure in adults and pediatric (>4yrs) patients by medical professionals. The LiDCO CNAP Module is intended for use with the LiDCOunity Monitor
- The measurement of cardiac output via Lithium Indicator Dilution in adult patients (>40Kg/88lbs) with pre-inserted arterial and venous catheters, and for monitoring continuous blood pressure and cardiac output in patients with pre-existing peripheral arterial line access
- In addition to arterial blood pressure parameters and cardiac output, the LiDCOunity Monitor calculates a number of derived parameters: Body Surface Area, Pulse Pressure Variation, Stroke Volume Variation, Cardiac Index, Stroke Volume, Stroke Volume Index, Systemic Vascular Resistance, Systemic Vascular Resistance Index, Oxygen Delivery/Index
Not Found
The provided text is a 510(k) premarket notification approval letter for the "LiDCOunity Monitor." It details the device's intended uses and regulatory classification but does not contain information about acceptance criteria or a study proving the device meets these criteria in the context of an AI/ML medical device.
The document describes a traditional medical device (monitor for physiological parameters) and its substantial equivalence to previously marketed predicate devices. It focuses on regulatory approval based on the device's functional capabilities, not on performance metrics of an AI/ML algorithm against a ground truth.
Therefore, I cannot extract the requested information using the provided text. The questions assume the context of an AI/ML device study, which is not what this document describes.
§ 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).