(284 days)
The Somté System is a multi-functional ambulatory recording device intended to be used to collect and store signals related to sleep disorders, including respiratory signals, ECG signals and limb movement signals, to aid in the diagnosis of respiratory and/or cardiac related sleep disorders.
The Somté System is not intended for use as life support equipment such as vital signs monitoring in intensive care units.
The Somté System is only to be used under the direction and supervision of a physician, technologist or clinician. It will not prevent or restore the interruption or loss of any physiological system.
The Compumedics Somté Patient Recording System is a multi-functional, ambulatory recording device. The Somté is used to collect and store a patient's ECG and respiratory signals, which are then used as an aid in the diagnosis of cardiac and/or respiratory related sleep disorders by qualified physicians.
The system is comprised of hardware and software, which provides up to 13 separate parameters for recording, review and analysis.
The data are acquired from a combination of electrodes, sensors and transducers. Signal types can include electrocardiogram (ECG), pressure, airflow, snore, respiratory effort, body position, limb movement, oxygen saturation, pulse rate and pulse waveform.
The electrodes and sensors used to acquire patient data are connected between the patient and the Somté System Recorder. Patient Studies are recorded using the Compumedics Somté Software which allows the user to view, print, summarise, analyse and create Patient Study reports.
The Somté Patient Recording Unit has a built in Compact Flash Disk interface for storage and convenient transfer to review workstations. There is no proprietary hardware required to transfer the study data.
This 510(k) summary for the Compumedics Somté Patient Recording Unit does not include acceptance criteria or detailed results from a study proving the device meets acceptance criteria.
The document primarily focuses on establishing substantial equivalence to previously cleared devices. It describes the device, its intended use, and lists predicate devices (Compumedics Limited E-Series System (K000068) and Oxford Instruments Medilog® Excel 3 Holter Management System (K002544)).
Therefore, I cannot provide the requested table or information about specific studies, sample sizes, ground truth establishment, or expert involvement based on the provided text.
What is present is a general description of the device's function: "The Somté is used to collect and store a patient's ECG and respiratory signals, which are then used as an aid in the diagnosis of cardiac and/or respiratory related sleep disorders by qualified physicians." This implies that the device is intended to accurately record these physiological signals, but specific performance metrics are not given.
§ 868.2375 Breathing frequency monitor.
(a)
Identification. A breathing (ventilatory) frequency monitor is a device intended to measure or monitor a patient's respiratory rate. The device may provide an audible or visible alarm when the respiratory rate, averaged over time, is outside operator settable alarm limits. This device does not include the apnea monitor classified in § 868.2377.(b)
Classification. Class II (performance standards).