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Masimo W1™ and the integrated Masimo W1 Module are intended to record, store and transfer single-channel electrocardiogram (ECG) rhythms. The Masimo W1 also displays ECG rhythms, and the Masimo W1 Module detects the presence of atrial fibrillation. The Masimo W1 and the integrated Masimo W1 Module are intended for use by healthcare professionals, patients with known or suspected heart conditions, and health-conscious individuals. Masimo W1 Module ECG software is an over-the-counter (OTC) software that operates on the Masimo W1 Module that can be used with compatible watches (e.g., Masimo W1). The software is intended to create, record, store, transfer, and display a single channel electrocardiogram (ECG) for informational use only in adults 22 years and older. It supports the classification of either atrial fibrillation (AFib) or sinus rhythm with the intention of aiding heart rhythm identification; it is not intended to replace traditional methods of diagnosis or treatment. The software is not intended for users with other known arrhythmias and users should not interpret or take clinical action based on the device output without consultation of a qualified healthcare professional. The Masimo W1™ and the integrated Masimo W1 Module are also intended for the spot-checking of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR). The Masimo W1 and the integrated Masimo W1 Module are indicated for adults in hospitals, clinics, long-term care facilities, and homes.

The Masimo W1 is a watch that incorporates the Masimo W1 Module, which is the device that is responsible for the physiological signal detection and algorithm used to support the different parameters. The Masimo W1 Module incorporates spot check ECG functionality and Masimo SET Pulse Oximetry technology so that it can provide both ECG and Masimo SET pulse oximetry parameters. As part of this submission, Masimo is requesting clearance for an automated atrial fibrillation "AFib" Classification Feature that is used to analyze the single channel ECG waveform. The parameter outputs from the Masimo W1 Module are communicated and displayed on the watch screen so that the data can be viewed and recorded. Masimo W1 also supports wireless communication of monitored data to a compatible smart device application. The sharing of the parameter data to the applications allows the users to see and track their data using their smart phones. Smart phone applications can also help to share information to caregivers and healthcare professionals.

The Inmedix® CloudHRV™ System is intended to acquire, display, and record electrocardiographic (ECG) information to measure heart rate variability (HRV) in adult patients (age 22 or above) with normal sinus rhythm and resting heart rate within 40 - 110 bpm. These measurements are not intended for any specific clinical diagnosis. The clinical significance of HRV must be determined by the physician. Assessment is indicated for patients in a healthcare facility including a physician office or a hospital outpatient clinic where the patient is able to remain supine and still. The CloudHRV™ System is not indicated for use in a surgical suite or during transport. Normal sinus rhythm is determined by the physician. The ECG is not intended to be used to diagnose or monitor cardiovascular conditions. The device does not provide assessments of cardiovascular abnormalities/arrhythmias.

The Inmedix® CloudHRV™ System acquires approximately 5 minutes of 3-lead electrocardioaraphic (ECG) data from a patient lying supine and at rest to measure heart rate variability (HRV). The raw cardiac electrical signals are detected using four standard ECG electrodes applied to the wrists and ankles of the patient and a custom 4-lead wire (one reference) ECG cable assembly. The ECG data collected from the patient are transmitted to a cloud-based service hosted by Inmedix. where proprietary mathematical algorithms calculate HRV. The CloudHRV™ System outputs are used as an aid by clinicians who are accustomed to evaluating HRV as a part of their overall medical assessment.

The Cardiac Workstation is intended to acquire multi-channel ECG signals from adult and pediatric patients from body surface ECG electrodes, and to record, display, analyze and store these ECG signals for review by the user. They are to be used in healthcare facilities by trained healthcare professionals. Analysis of the ECG signals is accomplished with algorithms that provide measurements, data presentations, graphical presentations and interpretations for review by the user. The interpreted ECG with measurements and interpretive statements is offered to the clinician on an advisory basis only. It is to be used in conjunction with the clinician's knowledge of the patient, the results of the physical examination, the ECG tracings, and other clinical findings. A qualified physician is asked to over-read and validate (or change) the computer-generated ECG interpretation.

The Cardiac Workstation 5000 (aka: CW 5000) and Cardiac Workstation 7000 (aka: CW 7000) are intended to acquire multi-channel ECG signals from adult and pediatric patients from body surface ECG electrodes, and to record, display, analyze and store these ECG signals for review by the user. They are to be used in healthcare facilities by trained healthcare professionals. Analysis of the ECG signals is accomplished with algorithms that provide measurements, data presentations, graphical presentations for review by the user. The interpreted ECG with measurements and interpretive statements are offered to the clinician on an advisory basis only. They are to be used in conjunction with the clinician's knowledge of the results of the physical examination, the ECG tracings, and other clinical findings. A qualified physician is asked to over-read and validate (or change) the computer-generated ECG interpretation. The CW 5000 and CW 7000 are mid- and high-range interpretive cardiographs, differing primarily in display size, the number of standard options. Both devices offer a full array of features built on the Linux operating system, with touch screen operation, a configurable feature set, and interpretation from the clinically proven Philips DXL ECG Algorithm (K132068). They provide a cardiograph solution for hospitals and cardiology clinics in processing large volumes of ECGs. The DXL ECG algorithm in the software analyzes up-to 18 leads of simultaneously acquired ECG waveform to interpret rhythm and morphology for a variety of patient populations. The measurements are then analyzed by the DXL ECG Algorithm. The resulting ECG reports may include ECG measurements, reasons, or analysis statements. The algorithm covers both adult and pediatric populations. The CW 5000 and CW 7000 consist of the following: - An electrocardiograph device with integrated display and printer. CW 5000 provides 12.1'' display panel. CW 7000 provides 15.6″ and 18.5″ options for the display panel. - Optional Trolley (ordered via a separate part number) The subject devices are further structured with options relating to software. Ul language, keyboard locale, and a wide range of other configuration choices to optimize the user's experience with the devices.

Masimo W1 and the integrated Masimo W1 module are intended for the spot-check determination of Heart Rate using a single-channel electrocardiogram (ECG). The Masimo W1 and the integrated Masimo W1 module records, stores, transfers, and displays the single-channel ECG for the manual interpretation of heart rate. It is worn on the wrist and also provides the spot-checking of other continuous parameters (e.g., pulse oximetry). The Masimo W1 and the integrated Masimo W1 module are also intended for the spot-checking of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR). The Masimo W1 and the integrated Masimo W1 Module are indicated for adults in hospitals, clinics, long-term care facilities, and homes.

The Masimo W1 is a watch that incorporates the W1 Module, which is the device that is responsible for the physiological signal detection and algorithm in providing the supported parameters. The W1 Module incorporates ECG functionality and Masimo SET Pulse Oximetry technology so that it can provide both ECG parameters and Masimo SET pulse oximetry parameters. As part of this submission, Bluetooth connectivity has been added to the Masimo W1 to support the wireless communication of monitored data to a compatible smart device application, such as the Masimo SafetyNet. The sharing of the parameter data to applications like the Masimo SafetyNet allows for users to see and track their data using their smart phone applications can also help to share information to caregivers and healthcare professionals.

The DeepRhythm Platform is intended for use by qualified healthcare professionals for the assessment of arthythmias using ECG data in adult patients. The product supports downloading and analyzing data recorded in compatible formats from 1-channel and 2-channel ambulatory ECG recording devices used for the arthythmia diagnostics such as Holter, event recorder or other similar devices when retrospective assessment of the rhythm is necessary. The DeepRhythm Platform is intended for the storage, analysis, visualization, review and reporting of arthythmias. The DeepRhythm Platform utilizes DeepRhythmAl (FDA-cleared device) for QRS and arrhythmia detection on the received signal. The DeepRhythm Platform provides further ECG signal annotations processing on a beat-by-beat basis, heart rate measurement and rhythm analysis, for both symptomatic and asymptomatic events. The DeepRhythm Platform is not for use in life supporting or sustaining systems or ECG monitor and Alarm devices. The product can be integrated with computerized ECG monitoring devices compatible with DeepRhythmAI. The DeepRhythm Platform interpretation results are not intended to be the sole means of diagnosis. It is offered to physicians and clinicians on an advisory basis only in conjunction with the physician's knowledge of ECG patterns, patient background, clinical history, symptoms, and other diagnostic information.

The DeepRhythm Platform system is a cloud-based software with microservice architecture and browser-based user interface. It provides arrhythmia diagnosis process and monitoring session management capabilities. The DeepRhythm Platform's functionality consists of: - enrolling a patient for an ECG monitoring session in a medical facility (performed . by Healthcare Professionals users), - receiving the signal from a compatible monitoring device worn by the patient, . - using an external AI service for signal analysis and classification (not a part of the . subject device), - processing signal and annotations received from the external Al service, including . statistics computation, - · reviewing the signal and annotations by an ECG Technician user, - generating and publishing a report for a single ECG episode (Urgent report) and . for the entire monitoring session (End of Study report), performed by an ECG Technician user, - reviewing a published report back at the medical facility that ordered the monitoring . session in the first place (performed by a Physician user).

The Digital Electrocardiograph ME3 is intended to acquire ECG signals from adult and pediatric patients through body surface ECG electrodes. The electrocardiograph is only intended to be used in hospitals or healthcare facilities by doctors and trained healthcare professionals. The carded by the electrocardiograph can help users to analyze and diagnose heart disease. The proposed device has analysis feature, however the ECG with measurements and interpretive statements is offered to clinician on an advisory basis only. The ME6 is intended to acquire ECG signals from adult and pediatric patients through body surface ECG electrodes. The obtained ECG records can help users to analyze and disease. Digital Electrocardiographs shall be used in healthcare facilities by doctors and/or trained healthcare professionals. Digital Electrocardiographs ME12P is intended to acquire ECG signals from adult and pediatric patients through body surface ECG electrodes. The obtained ECG records can help users to analyze and diagnose heart disease. Digital Electrocardiographs shall be used in healthcare facilities by doctors and/or trained healthcare professionals. Digital Electrocardiograph ME15P is intended to acquire ECG signals from adult and pediatric patients through body surface ECG electrodes. The obtained ECG records can help users to analyze and diagnose heart disease. Digital Electrocardiographs shall he used in healtheare facilities by doctors and/or trained healthcare professionals.

The Mediblu ME3 Digital Electrocardiograph is intended to acquire, display and record ECG signals from adult and pediatric patients through body surface ECG electrodes. ECG data result and patient information could be stored in the memory of the device. The obtained ECG records can help users to analyze and diagnose heart disease. The Mediblu ME6P Digital Electrocardiograph is intended to acquire, display and record ECG signals from adult and pediatric patients through body surface ECG electrodes. ECG data result and patient information could be stored in the memory of the device. The obtained ECG records can help users to analyze and diagnose heart disease. The Mediblu ME12P Digital Electrocardiograph is designed to acquire ECG signals from adult and pediatric patients through body surface ECG electrodes. After been amplified and filtered, the ECG signal waveforms are displayed in the LCD and recorded in the paper through thermal printer. ECG data result and patient information could be stored in the memory of the device. The Mediblu ME15P Digital Electrocardiograph is designed to acquire, display and record ECG signals from adult and pediatric patients through body surface ECG electrodes. After been amplified and filtered, the ECG signal waveforms are displayed in the LCD and recorded in the paper through thermal printer. ECG data result and patient information could be stored in the memory of the device.

Impala is intended to record, store, and transfer a 12-lead resting electrocardiogram (ECG). Impala acquires four standard diagnostic-bandwidth leads (Leads I, II, V2, V4, or Leads I, II, V1, V4). The device derives four standard diagnosticbandwidth, Lead-III and unipolar limb leads aVR, aVF and aVL. The device also synthesizes Leads V1 or V2, V3, V5, V6, which are similar to but not identical to the same leads of a standard diagnostic 12-lead. The 4 synthesized chest leads are not intended for diagnostic use and may fail to show important findings limited to those leads. This device is not a substitute for a diagnostic 12-lead ECG and is contraindicated for use in ruling out any condition (including but not limited to certain ischemia/infarcts, Brugada syndrome) for which the diagnosis may be solely dependent on the synthesized leads. The device also provides ECG measurements and ECG analysis (rhythm and morphological interpretation) using the acquired leads. The automated ECG analysis results are provisional and should not be used for clinical action if it has not been reviewed by a qualified physician capable of interpreting the ECG signal in the context of the patient's condition. The automated analysis may then be confirmed, edited, or qualified physician. ECG analysis should be used only as an adjunct to clinical history, symptoms, and the results of other non-invasive tests. Impala is intended for use with patients aged 18 years and older. Impala is intended for use by healthcare professionals, or trained personnel in healthcare facilities (e.g. the doctor's office or hospital) and in acute settings.

Impala is a portable 12-Lead resting electrocardiograph (ECG) device that acquires 4 standard diagnostic-bandwidth ECG leads from a patient (I, II, V1 or V2, V4), derives 4 standard diagnostic-bandwidth leads (aVL, aVR, aVF, III), and using software generates the remaining leads (V2 or V1, V3, V5, V6) to create a 12-Lead ECG recording. The device can be used by healthcare professionals (HCPs) to record a reduced lead, diagnostic-bandwidth, resting ECG, where traditional 10 electrode, 12 lead ECG recorders are not practical to administer due to size, time, or need for specialized clinicians to administer. Examples may include physician offices, and remote and field locations. The Impala hardware consists of the Impala ECG Module that connects to the Patient Lead Wire. The Patient Lead Wire is a single cable that includes five snap-on electrodes. Impala also consists of a mobile software application, the Impala App that executes on a mobile computing platform (MCP), such as an Apple iPhone smartphone. To record an ECG, the user positions standard off-the-shelf (OTS) ECG gel electrodes on the patient and snaps on the connectors in the Patient Lead Wire on to the electrodes. Impala allows for two options for which set of leads are acquired: 1. Lead Set 1: Leads {I, II, V2, and V4}, with electrodes on RA, LA, LL, V2, V4; and 2. Lead Set 2: Leads {I, II, V1, and V4} with electrodes on RA, LA, LL, V1, and V4. Impala incorporates AliveCor's Corvair (K231010), a software as a medical device, to provide rhythm analysis, morphological analysis, and ECG measurements. Corvair has two modes of operation, Symptomatic Mode, which is used when the pre-test probability for a specific rhythm is high, and Asymptomatic Mode, which optimizes the PPV, by optimizing the specificity, to detect the various rhythms and morphologies. The user can choose which Impala Lead Set and which Corvair mode of determinations to utilize based on the target clinical application.

The intended use of ECG301 is to acquire ECG signals from adult and pediatric patients(above 3 years old) through body surface ECG electrodes. The electrocardiograph is intended to be used only in hospitals or healthcare facilities by doctors and trained healthcare professionals. The cardiogram recorded by ECG301 can help users to diagnose heart disease. ECG301 does not include any automated measurement or analysis of the ECG signal, and does not produce interpretative statements. The ECG recorded is not intended to be used for measurement or analysis of the ECG signal, or for the automated generation of interpretative statements.

Electrocardiograph, models: ECG301, is to acquire multi-channel ECG signals from adult and pediatric patients(above 3 years old) through body surface ECG electrodes. The device can gather and record ECG signals of 12 leads simultaneously. The cardiogram recorded by ECG301 can help users to diagnose heart disease. ECG301 does not include any automated measurement or analysis of the ECG signal, and does not produce interpretative statements. The ECG recorded is not intended to be used for measurement or analysis of the ECG signal, or for the automated generation of interpretative statements. Electrocardiograph, models: ECG301, has LCD display with touchscreen and functional buttons. The device can be powered from AC power or through an embedded re-chargeable battery. The device contains built-in thermal dot-matrix recorder for ECG report printing. The Electrocardiograph includes main unit and an AC power cord.

The CSF-4 is intended to record, store, transfer, and display single-channel electrocardiogram (ECG) rhythms. The ECG signal is for quality checks of the data and for manual interpretation of heart rate. The CSF-4 also measures, records and displays pulse rate. The CSF-4 is also indicated for use in measuring and displaying functional oxygen saturation of arterial hemoglobin (SpO2). The CSF-4 is for adult patients and health-conscious individuals in hospitals, clinics, long-term care facilities, and homes. The CSF-4 is a prescription device and should be used under the care of a physician. CSF-4 does not provide any alarms. It is not intended for pediatric use or use in critical care settings. The device is not intended to provide outputs during periods of motion.

The CSF-4 is a non-invasive system comprised of software, hardware and mechanical components that enables the user to measure electrocardiography (ECG) and oxygen saturation of arterial hemoglobin (SpO2), as well as measuring pulse rate using photoplethysmography (PPG). CSF-4 is a single-patient use, wearable monitoring device that collects intermittent data of physiological parameters, when little to no motion is detected. The CSF-4 is comprised of 3 main components; - 1) CS Watch 3 with CSF-4 Watch firmware ("Watch"): The CS Watch 3 is a wrist worn device embedded with non-invasive sensors. The watch includes firmware that activates the sensors, synchronizes the data sampled by the sensors, processes the data, stores the processed data in nonvolatile memory, and provides the data to the user. The processed data is transferred to the Mobile App via a secured BLE communication channel. In addition, the watch sends real-time raw data signals to the Mobile App. - 2) CSF-4 Mobile Application ("Mobile App"): The Mobile App works on both Android OS and iOS. The mobile app communicates with the watch via BLE and to the Cloud App via HTTPS, thus acting as the watch gateway to the cloud application. The Mobile App caches the processed data from the watch and transfers it to the cloud application. It allows the user to conveniently view the measurement results and real time raw data. The Mobile App provides the user with the capability of creating an on-demand report and sharing it using 3rd party sharing applications. - 3) CSF-4 Cloud Application ("Cloud App"): The Cloud App securely stores the user and processed data over designated databases. It provides the mechanism of creating and sending periodical reports which are sent to the user's email both automatically and on-demand.