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The Happy Health Home Sleep Test is a Software as a Medical Device that uses data from wearable devices to record, analyze, display, export, and store biophysical parameters to aid in evaluating sleep‐related breathing disorders of adult patients suspected of sleep apnea. The device is intended for use on individuals who are 22 years of age or older in clinical and home settings under the direction of a trained healthcare provider.

The Happy Health Home Sleep Test is a Software as a Medical Device that uses data from wearable devices to record, analyze, display, export, and store biophysical parameters to aid in evaluating sleep-related breathing disorders of adult patients suspected of sleep apnea. The device is intended for use on individuals who are 22 years of age or older in clinical and home settings under the direction of a trained healthcare provider. The device is intended to process input data streams received from an external hardware device (i.e., a smart ring, K240236) and uses these signals to determine various sleep parameters that may be used and interpreted by a clinician in diagnosing sleep disorders such as sleep apnea. The input physiologic signals from the external device are: - Acceleration / Movement - Photoplethysmography (PPG) The external hardware device (K240236) includes a PPG sensor and accelerometer embedded within a housing to capture the above physiological signals. The K240236 device is worn on the finger and is indicated for continuous data collection of the above signals. Data from the external hardware device is transmitted over a secure API to the subject device for analysis. The device then uses a set of algorithms to compute the following outputs: - Happy Health Apnea Hypopnea Index (hAHI) - Total Sleep Time The outputs are available for a clinician to review as a report, accessible through a web-based viewer application.

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.

The TipTraQ is a wearable device intended for aiding in sleep apnea evaluation/diagnosis for adult patients suspected of sleep apnea in both home-based and clinical-use environments.

TipTraQ is a prescription-only medical device aiding in sleep apnea evaluation/diagnosis comprising a fingertip wearable device, a companion mobile app, a cloud-based AI analysis and an information display system. It collects essential physiological waveform information, including Photoplethysmogram (PPG) and accelerometer data. The TipTraQ Algorithm System determines Total Sleep Time (TST), Total REM Time (TREMT), Oxygen Desaturation Index (ODI), and Apnea-Hypopnea Index (AHI) from the recorded waveform signals. TipTraQ Sensor includes a PPG sensor, which uses light sources (green, red, and infrared) and two photodetectors to measure the blood volume changes in the microvascular bed of tissue. Additionally, the TipTraQ Sensor utilizes an Inertial Measurement Unit (IMU) with three-axis accelerometers (device-function) and three-axis gyroscopes (non-device function), monitoring movement and actigraphy to assess sleep stages. The TipTraQ Expert Panel can display recorded physiological waveforms, while the TipTraQ API System generates output for essential physiological parameters analyzed by the TipTraQ Algorithm System. The TipTraQ Sensor is rechargeable and designed to provide at least 12 hours of usage after fully charged. The TipTraQ Charging Case, which is also rechargeable, provides a battery capacity of eight full charges of the TipTraQ Sensor for user convenience. The TipTraQ Charging Case can be powered and charged using an external USB-C.

The Huxley Home Sleep Apnea Test (SANSA) is a wearable device intended for use in the recording, and storage of biophysical parameters to aid in the evaluation of sleep-related breathing disorders of adults suspected of sleep apnea. The device is intended for the clinical and home use setting under the direction of a Healthcare Professional (HCP).

The Huxley Home Sleep Apnea Test (SANSA™) is a wearable device intended for use in the recording, analysis, and storage of biophysical parameters to aid in the evaluation of sleep-related breathing disorders of adults suspected of sleep apnea. The device is intended for clinical and home use setting under the direction of a Healthcare Professional (HCP). The system is prescription use only. The SANSA HSAT collects multiple physiological signals using a single wearable patch worn on the chest. The SANSA device contains a reflective PPG sensor, a single-lead ECG sensor, and a 3-axis accelerometer. The signals from these sensors are passed into a cloud-based algorithm which utilizes a combination of signal processing and AI/ML components to compute time-series data for clinician review and summary metrics for report output. The device outputs the following time-series channels: Oximetry, Heart Rate, Chest Movement, Snoring, Body Position, Respiratory Effort, Actigraphy, Sleep staging (Sleep/Wake), and ECG (reference channel only). The following summary metrics are calculated: sansa-Apnea Hypopnea Index (sAHI) and Total Sleep Time (TST). Recorded data are uploaded to a software portal where physiological tracings are made available for review and event editing by a qualified healthcare professional. The device is intended to be worn for 10 hours per study. The ECG channel is used for diagnostic purposes and is not intended by any automated ECG analysis system or algorithm.

The DormoTech Nlab is a physiological data recorder intended to collect and record data from multiple physiological channels for use by clinical software used in polysomnography and sleep disorder studies. It is intended for use by or on the order of a physician. It is intended for use on patients greater than 6 years of age in a supervised (hospital) or unsupervised (home) environments.

The DormoTech Nlab is a physiological data recorder intended to collect and record data from multiple physiological channels for use by clinical software used in polysomnography and sleep disorder studies. It is intended for use by or on the order of a physician and is intended for use on patients greater than 6 years of age in a supervised (hospital) or unsupervised (home) environment. It consists of: The Head Unit The head unit acquires electric signals indicative of EEG and eye movement located in the upper part of the unit (on the patient's forehead). Plethysmograph for Heart rate and SpO2 measurements, and head relative position to body position are also measured using accelerometer sensors located in the upper part of the unit. The middle part of the unit is located below the mouth, it contains 2 nasal (one in each nostril) and 1 oral airflow sensors (thermistors), 1 EMG sensor, along with a snoring sensor. The Body Unit The body unit is made of 2 belts, the upper belt sits on the lower belt sits on the stomach of the patient. Both belts contain respiratory effort and accelerometer sensors, in addition, the upper belt contains an accelerometer to measure body position. The ExG Unit The ExG unit is put on using an adhesive sticker on the leg/arm/chest (either leg/arm is ok). It consists of 3 electrodes that acquire leg/arm/chest ExG signal. The Central Unit The head, chest and ExG units communicate with the central unit via Bluetooth, the wearable units send the measured data to the central unit receives the data, stores it within an internal flash drive and then transmits the data via Wi-Fi to online servers for further diagnosis. The central unit is located in the test room (up to 10 meters from the patient). The central unit has no contact with the patient. To ensure device reusability between sessions or patients, sections of the head unit have been designed to be detachable or with barriers between the sensor and patient's skin to stop direct contact. Specifically, the head unit incorporates (1) a detachable nasal and oral airflow section to allow for replacement of the section between each use of the device, (2) a removable barrier over the plethysmograph recorder to create a separation between the patient's skin and the recording device which is replaced between each use of the device and (3) a detachable textile on the inner side of the head unit (i.e., the side in direct contact with the patient's skin) to allow for replacement between each use of the device.

The Bluebird Single-Use Respiratory Effort Belt is intended to measure respiratory effort to assist in the diagnosis of sleep disorders or sleep related respiratory disorders. The respiratory effort belt signals are suitable for connection to sleep/polysomnography (PSG) systems. The intended environments are hospitals, institutions, sleep clinics, or other test environments, including the patient's home. The Bluebird Single-Use Respiratory Effort Belt is intended for diagnostic purposes only on patients greater than 2 years of age and is not intended to be used as an apnea monitor.

The Bluebird Single-Use Respiratory Effort Belt (Bluebird) is used to measure chest and abdomen expansion and contraction during respiration. The sensor consists of a sinusoidal wire coil attached along the length of an elastic belt. The inductance of the sensor changes as the belt is stretched. The Bluebird is suitable for connection to the inputs of physiological recording equipment. The Bluebird measures inductance and generates an output signal proportional to the amount of stretch. The elastic belt is held in place by a quick release buckle with a cinch function and the belt is adjusted to fit snugly but comfortably. Electrical connection to the two ends of the embedded coil is through a 1.5mm female touch proof connection jack on each side of belt buckle. The materials are elastics and plastics used in the clothing industry, and fine gauge copper wire for the embedded coil.

Withings Sleep Rx is indicated to record a patient's Withings index during sleep as an aid for diagnosis of obstructive sleep apnea (OSA). The Withings Sleep Rx is also indicated to record heart rate and movement in an automatic contactless manner. The device is designed for use in home-screening of adults with suspected possible sleep breathing disorders. Results are used to assist the healthcare professional in determining the need for further diagnosis and 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. The device is indicated for use in adults weighing ≤ 350 lbs in a home environment during sleep and resting conditions. This device is not indicated for active patient monitoring, as it does not provide alarms for timely response in life-threatening situations.

The Withings Sleep Rx is a device intended as an aid for diagnosis of obstructive sleep apnea (OSA). It is intended for home use. The device is placed under the mattress and is contactless with the user. It provides a Withings index based on breathing (sound, variations of pressure in the bladder) and heart rate measured in a contactless manner. The number of breathing events per hour is displayed to the user in the companion app. The results are used to assist the healthcare professional in determining the need for further diagnosis and evaluation. In addition, the device records heart rate and movement during sleep in an automatic contactless manner. The recordings are displayed in the companion app. Withings Sleep Rx is composed of the following components: (1) Mat (hardware); (2) Withings Sleep Rx embedded software included in the Mat and (3) Companion App included in a companion mobile application.

The Huxley Home Sleep Apnea Test (SANSA) is a wearable device intended for use in the recording, and storage of biophysical parameters to aid in the evaluation of sleep-related breathing disorders of adults suspected of sleep apnea. The device is intended for the clinical and home use setting under the direction of a Healthcare Professional (HCP).

The Huxley Home Sleep Apnea Test (SANSA™) is a wearable device intended for use in the recording, analysis, and storage of biophysical parameters to aid in the evaluation of sleep-related breathing disorders of adults suspected of sleep apnea. The device is intended for clinical and home use setting under the direction of a Healthcare Professional (HCP). The system is prescription use only. The SANSA HSAT collects multiple physiological signals using a single wearable patch worn on the chest. The SANSA device contains a reflective PPG sensor, a single-lead ECG sensor, and a 3-axis accelerometer. The signals from these sensors are passed into a cloud-based algorithm which utilizes a combination of signal processing and Al/ML components to compute time-series data for clinician review and summary metrics for report output. The device outputs the following time-series channels: Oximetry, Heart Rate, Chest Movement, Snoring, Body Position, Respiratory Effort, Actigraphy, Sleep staging (Sleep/Wake), and ECG (reference channel only). The following summary metrics are calculated: sansa-Apnea Hypopnea Index (sAHI) and Total Sleep Time (TST). Recorded data are uploaded to a software portal where physiological tracings are made available for review and event editing by a qualified healthcare professional. The device is intended to be worn for 10 hours per study. The ECG channel is intended to be used as a reference channel and is not intended to be used for diagnostic purposes and is not intended by any automated ECG analysis system or algorithm.