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AcuPebble Ox200 is a wearable device intended for use in the recording, analysis, displaying, exporting, and storage of biophysical parameters to aid in the evaluation of adult patients with, or with suspected, obstructive sleep apnea (OSA). The device is primarily intended for home setting use (although can also be used in healthcare settings) under the direction of a Healthcare Professional (HCP).

AcuPebble Ox200 is prescribed by a Health Care Professional for the patient to use in the home as a 'home sleep apnea test' (HSAT). AcuPebble Ox200 comprises: 1- A small microphones/accelerometer sensor, identical to the one in the previously cleared devices AcuPebble SA100 (K210480) and AcuPebble Ox100 (K222950) that is worn on the front of the neck around the suprasternal notch area (the "AcuPebble SA100 sensor"), and attaches with a single use biocompatible adhesive tape (same one as for "AcuPebble SA100" and "AcuPebble Ox100)); 2- Another PPG/accelerometer sensor ("AcuPebble_oximetry sensor") worn either on the finger or on the forehead; 2- A mobile device app (the "AcuPebble Ox200 app") that guides the patient through the steps of the test, collects the data from the sensors, and uploads them in the cloud ; 3- A cloud-based software that analyses the collected signals as in the previously cleared devices; 4- A web app user interface for healthcare professionals where they can set up a study and see the results, including different physiological channel traces and OSA diagnostic parameters, as in the previously cleared devices. The differences between AcuPebble Ox200 and the previously cleared device (K222950) are: - A new sensor for sensing the PPG signal and extraction of the SpO2 and pulse rate channel from. This new sensor can be placed either on the finger or the forehead. - The addition of new parameters extracted from the acoustic neck sensor including position, respiratory efforts and respiratory rate channels. The OSA diagnostic indexes are still extracted from the signals measured with the identical sensor as in the predicate (neck sensor only), and with the same algorithms, remain unchanged with respect to the predicate device (K222950) and hence have not been separately tested in this device.

AcuPebble Ox100 is a wearable device intended for use in the recording, analysis, displaying, exporting, and storage of biophysical parameters to aid in the evaluation of adult patients with, or with suspected, obstructive sleep apnea (OSA). The device is primarily intended for home settings use (although can also be used in healthcare settings) under the direction of a Healthcare Professional (HCP).

AcuPebble Ox100 is prescribed by a Health Care Professional for the patient to use in the home as a 'home sleep apnea test' (HSAT). AcuPebble Ox100 comprises: 1- A small physiological sensing device, identical to the previously cleared device AcuPebble SA100 (K210480) that is worn on the front of the neck around the suprasternal notch area (the "AcuPebble SA100 sensor"), and attaches with a single use biocompatible adhesive tape (same one as for "AcuPebble SA100" too); 2- Another physiological wireless sensing device ("AcuPebble finger oximetry sensor") worn on the finger; 3- A mobile device app (the "AcuPebble Ox100 app") that guides the patient through the steps of the test, collects the data from the sensor (continuously in the case of the "AcuPebble SA100 sensor", and at the end of the test in the case of the "AcuPebble finger oximetry sensor"), and uploads them in the cloud ; 4- A cloud-based software that analyses the signals from the "AcuPebble SA100 sensor" (already cleared as part of K210480); 5- A web app user interface for healthcare professionals where they can set up a study and see the results, including different physiological channel traces and OSA diagnostic parameters. Outputs of the device relevant to its intended use are further described in the comparison table below.

AcuPebble SA100 is indicated to sense, record, and interpret a patient's physiological signals (including respiratory pattern) during sleep for the purpose of prescreening patients for obstructive sleep apnea (OSA) syndrome. The designed for use in home-screening of adults with suspected possible sleep breathing disorders (although it can also be used in clinic). Results are used to assist the healthcare professional's in the patient's evaluation. The system is not intended as a substitute for full polysomnography when additional parameters such as sleep stages, limb movements, or EEG activity are required.

AcuPebble SA100 comprises a sensor that is worn on the front of the neck around the suprasternal notch area (the "AcuPebble SA100 sensor"), a mobile device app that guides the patient through the steps of the test, collects the data from the sensor, and uploads them in the "AcuPebble SA100 app"), and a cloud-based analysis software (the "AcuPebble SA100 algorithms". The "AcuPebble SA100 Sensor" consists of a small biocompatible enclosure with very low power sensors and electronics inside. It is attached to the front of the neck (somewhere between the Adam's apple and the suprasternal notch area) by single-use biocompatible adhesive tape. The sensor measures physiological body sounds. The data sensed is streamed via a Bluetooth link to the "AcuPebble SA100 app" on a smart device (mobile phone/tablet). The data can be uploaded into the cloud where it is analyzed, any time after the sleep study test is finished at the tap of a button in the app. AcuPebble SA100 signal processing algorithms produce a number of OSA diagnostic traces and parameters. These can be accessed by the Health Care Professional through a healthcare professional portal, which can be accessed from any computer or smart device with an Internet connection. AcuPebble SA100 is not intended to be used with patients with pacemakers or other implantable devices, or with patients with known or suspected arrhythmias. This device has not been validated in patients with congestive heart failure or patients with neuromuscular disorders. Patients with significant cardiopulmonary or neurological disorders need to be excluded from using the device.