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The SleepImage System is Software as a Medical Device (SaMD) that establishes sleep quality. The SleepImage System analyzes, displays and summarizes Electrocardiogram (ECG) or Plethysmogram (PLETH) data, typically collected during sleep, that is intended for use by or on the order of a Healthcare Professional to aid in the evaluation of sleep disorders, where it may inform or drive clinical management for children, adolescents and adults. The SleepImage Apnea Hypopnea Index (sAHI), presented when oximeter data is available, is intended to aid healthcare professionals in diagnosis and management of sleep disordered breathing. The SleepImage System output is not interpreted or clinical action taken without consultation of a qualified healthcare professional.

The SleepImage System is a Class II Software as a Medical Device (SaMD), intended to aid in the evaluation of sleep disorders, where it may inform or drive clinical management. The Sleeplmage System automatically analyzes and displays Electrocardiogram (ECG) and Plethysmogram (PLETH) data. When provided in addition to the ECG or PLETH data, the SleepImage System can optionally analyze and display accelerometer and oximeter data. The results of the processed data are graphical and numerical presentations and reports of sleep latency, sleep duration, sleep quality and sleep pathology for the use by or on the order of physicians, trained technicians, or other healthcare professionals to evaluate sleep disorders where it may inform or drive clinical management taking into consideration other factors that normally are considered for clinical management of sleep disorders for children, adolescents and adults. When oximeter data is available, the Sleeplmage System will generate the Sleeplmage Apnea Hypopnea Index (sAHI) to aid healthcare professionals in diagnosis and management of sleep disordered breathing. The SleepImage System reports results of the automated data analysis, including expected values for sleep quality, sleep duration and sleep pathology based on published peer-reviewed publications, and guidelines for sleep duration (National Sleep Foundation) and sleep apnea (American Academy of Sleep Medicine). The clinician can view raw data for interpretation, adjust study duration, write clinical notes in the report and make recommendations to patients for further testing, recommend a referral to another clinician and/or recommendations for therapy. The SleepImage System output is not intended to be interpreted or clinical action taken without consultation of a qualified healthcare professional. Due to the intra-night variability of sleep, it is recommended that patients track their sleep over time. The SleepImage System is a sleep health evaluation application that is indicated for use on a general-purpose computing platform. Like the predicate device, it processes data typically recorded during sleep, using a cloud-based web application.

The SleepImage System is medical software that establishes sleep quality. The SleepImage system analyzes, displays and summarizes ECG data, typically collected during sleep that is intended for use by or on the order of a Health Care Professional to aid in the evaluation of sleep disorders, where it may inform or drive clinical management.

The SleepImage System consists of an operator-independent process that automatically analyzes Electrocardiography data using a general purpose computing platform. When provided in addition to the ECG data, the SleepImage System can optionally display accelerometer and oximeter data. The results of the processed data are graphical and numerical presentations and reports of sleep latency, sleep duration, sleep quality and sleep pathology for the use by or on the order of physicians, trained technicians, or other healthcare professionals. The data output establishes sleep quality and allows the healthcare professional to evaluate sleep disorders, where it may inform or drive clinical management taking into consideration other factors that normally are considered for clinical management of sleep disorders. The clinician can create unique patient reports for the patient being evaluated, and configure parameters in the software. The SleepImage System is a standalone, sleep health evaluation application that provides automated analysis of cardiovascular and respiratory waveforms. Like the predicate device, it processes information recorded during sleep. The SleepImage System is considered to be medical software. The SleepImage System is being updated from the predicate device, the M1 Sleep Data Recorder and CPC Application Software to operate independent of the dedicated M1 Sleep Data Recorder cleared under K092003.

Sleep Data Recorder: The M1 sleep data recording device is intended for use by a physician or a trained technician for the collection of physiological (Actigraphy) and Electrocardiogram (ECG) recordings during sleep that will be used for screening different sleep associated disorders. CPC WEB Application Software: The CPC application software (and associated modules) is intended for use by a physician or a trained technician for the analysis, manipulation and final presentation of physiological (Actigraphy) and Electrocardiogram (ECG) recordings during sleep.

Cardiopulmonary coupling (CPC) is currently a functional module included as one of many features in Embla's polysomnographic (PSG) presentation software of the predicate device. This can be invoked by the user to provide a CPC analysis from the EKG signals provided by the current multi-channel recorders in Embla's hardware product line. It has been decided to duplicate this presentation software module into its own product line with a separate web based application using a dedicated recorder. Therefore. MyCardio and Embla have developed a single channel (EKG) hardware recording device (M1 Sleep Data Recorder) and associated WEB site (CPC Web Application Software) to present the data and provide graphs and reports for manual diagnosis. The model M1 Sleep Data Recorder is intended to be used as a sleep quality screening device. The M1 is a small palm size data recorder used with two commercially available EKG patient electrodes. One electrode snaps directly onto the recorder body. while the second electrode snaps onto a short cable in turn connected to a connector on the M1. The M1 is to be attached to the patient at home by the two electrodes and used to record multiple individual sleep periods. Following the home study, the M1 is returned to the clinic and the data is uploaded by the clinician to the CPC Web Application Software. The CPC Application Software consists of three separate software programs working as a system. (1) CPC Console software - this software is similar to the predicate device presentation software CPC module and receives the data uploaded from the M1 recorder and performs the actual data graphing and reporting. (2) CPC Client software - this software manages the interaction between the user and the M1 device and uploads the analyzed M1 data from the CPC Console to the CPC Web software. (3) CPC Web software - this software creates the user interface screens, manages the data inputted by the user, keeps track of the studies and patient demographics, and provides charts, graphs and reports for manual evaluation of sleep quality screening. A trained physician would typically review and analyze the charts, graphs and reports created and presented by the CPC Web Application Software. After this screening evaluation, the patient may require further testing and examination for possible treatment. The battery operated M1 device will be capable of 72 hours (representing approximately 10 overnight studies) of recording to an internal memory. The general intended environment is the patient home but the device is capable of functioning in any environment where patients can sleep reasonably comfortably. The users are the general public, trained physicians, trained sleep technicians (RPGST) or people working under the supervision of one of these professionals. The user may or may not possess knowledge of the physiological signals or test criteria. The M1 Sleep Data Recorder and CPC Web Application Software do not provide any alarms and are not intended as a monitor.