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The RTM Vital Signs RTMsense is indicated for use by healthcare professionals in healthcare facilities, such as post-operative care and general wards, to monitor breathing in adult (at least 22 years old) patients. RTMsense is a non-invasive system that graphically displays respiratory function against time and reports respiratory rate. RTMsense measurements are used as an adjunct to other clinical information sources.

The RTMsense Respiratory Monitoring System is a single use wearable device consisting of a wearable trachea sound sensor (TSS) and software that continuously measures a patient's respiratory rate by analyzing the sounds of air flow within the proximal trachea during inhalation and exhalation. The acoustic signal is transmitted wirelessly to a Lenovo Tablet, and the respiratory measurement values are displayed on the tablet after analysis of the acoustic data by a proprietary software algorithm. The RTMsense software application has three parts: firmware on the TSS, a web-based application on the Lenovo tablet, and a cloud-based proprietary software algorithm. The TSS securely transmits acoustic data wirelessly to the local, Bluetooth low energy enabled Lenovo tablet. The tablet uses a web-based application to securely transmit the acoustic data to the cloud for analysis in RTM's proprietary cloud-based algorithm. The web application retrieves the processed data from the algorithm to display respiratory rate on the tablet. The device will be used by healthcare professionals in healthcare facilities such as post-operative care or general wards. The RTMsense respiratory measurements are used as an adjunct to other clinical information sources. The TSS is held in place by a flexible wearable carrier adhered to the patient's proximal trachea with commercially available medical grade adhesive. The TSS contains the audio sensor, onboard processing, wireless communications technology, and Lithium-ion coin cell rechargeable battery. A custom charger is provided to charge the battery.

The Lap.Ox™ Laparoscopic Tissue Oximeter is intended to estimate the percent oxygen saturation (StO2) in a volume of tissue, including bowel tissue, during laparoscopy. The Lap.Ox™ Laparoscopic Tissue Oximeter is indicated for use in monitoring patients during circulatory or perfusion assessment during laparoscopy. The Lap.Ox™ Laparoscopic Tissue Oximeter is intended to be used by physicians, surgeons, nurses, or other skilled users in a medical environment. The Lap.Ox™ Laparoscopic Tissue Oximeter should only be used on adult patients.

The proposed Lap.Ox™ Laparoscopic Tissue Oximeter ("Lap.Ox" or "Device") is a cordless, battery-powered device that estimates the percent oxygen saturation (StO2) in a volume of tissue, including bowel tissue. The device includes two components: - a Reusable Main Unit that shows a digital readout of percent oxygen saturation (StO2) when the system is in contact with tissue (also denoted as "main unit" or "durable"); and - a Disposable Kit that contains two AA batteries and a sterile single-use disposable consisting of sources, detectors, a laparoscopic tube, and a sheath that is placed around the Reusable Main Unit (denoted as "Disposable"). The Device uses spatially-resolved optical measurements at three wavelengths. The Device displays the StO2 estimate on the built-in screen. The Device is constructed from biocompatible materials that can tolerate bodily fluids. The basic principle of operation of the Lap.Ox Laparoscopic Tissue Oximeter is spectrophotometric oximetry which entails utilizing red and near-infrared light to measure the color of blood and determine an oxygen saturation value.

The Empatica Health Monitoring Platform is a wearable device and paired mobile and cloud-based software platform intended to be used by trained healthcare professionals or researchers for retrospective remote monitoring of physiologic parameters in ambulatory individuals 18 years of age and older in home-healthcare environments. As the platform does not provide real-time alerts related to variation of physiologic parameters, users should use professional judgment in assessing patient clinical stability and the appropriateness of using a monitoring platform designed for retrospective review. The device is intended for continuous data collection supporting intermittent retrospective review of the following physiological parameters: - Pulse Rate, - Blood Oxygen Saturation under no-motion conditions, - Respiratory Rate under no motion conditions, - Peripheral Skin Temperature, - Electrodermal Activity, - Activity associated with movement during sleep The Empatica Health Monitoring Platform can be used to analyze circadian rhythms and assess activity in any instance where quantifiable analysis of physical motion is desirable. The Empatica Health Monitoring Platform is not intended for SpO2 monitoring in conditions of motion or low perfusion. The Empatica Health Monitoring Platform is intended for peripheral skin temperature monitoring, where monitoring temperature at the wrist is clinically indicated. The Empatica Health Monitoring Platform is not intended for Respiratory Rate monitoring in motion conditions. This device does not detect apnea and should not be used for detecting or monitoring cessation of breathing. The Empatica Health Monitoring Platform is not intended for Pulse Rate monitoring in patients with chronic cardiac arrhythmias, including atrial fibrillation and atrial/ventricular bigeminy and trigeminy, and is not intended to diagnose or analyze cardiac arrhythmias. The Empatica Health Monitoring Platform is not a substitute for an ECG monitor, and should not be used as the sole basis for clinical decision-making.

The Empatica Health Monitoring Platform is a wearable device and software platform composed by: - A wearable medical device called EmbracePlus, - A mobile application running on smartphones called "Care App", - A cloud-based software platform named "Care Portal". The EmbracePlus is worn on the user's wrist and continuously collects raw data via specific sensors. These data are wirelessly transmitted via Bluetooth Low Energy to a paired mobile device where the Care App is up and running. The data received are analyzed by one of the Care App software modules, EmpaDSP, which computes the user physiological parameters. Based on the version of the Care App installed, the user can visualize a subset of these physiological parameters. The Care App is also responsible for transmitting, over cellular or WiFi connection sensors' raw data, device information, Care App-specific information, and computed physiological parameters to the Empatica Cloud. On the Empatica Cloud, these data are stored, further analyzed, and accessible by healthcare providers or researchers via a specific cloud-based software called Care Portal. The Empatica Health Monitoring Platform is intended for retrospective remote monitoring of physiological parameters in ambulatory adults in home-healthcare environments. It is designed to continuously collect data to support intermittent monitoring of the following physiological parameters and digital biomarkers by trained healthcare professionals or researchers: Pulse Rate (PR), Respiratory Rate (RR), blood oxygen saturation (SpO2), peripheral skin temperature (TEMP), and electrodermal activity (EDA). Activity sensors are used to detect sleep periods and to monitor the activity associated with movement during sleep.

The TeleRehab® Aermos Cardiopulmonary Rehabilitation System is intended to acquire and condition the ECG signal from a patient so that it can be transmitted wirelessly from a radiofrequency transmitter to a workstation in a hospital or a clinical setting where the data is displayed and analyzed. This device also measures heart rate and provides visual and audible alarms if the patient's heart rate goes out of a prescribed range. This device is for use with ambulatory adult patients who need monitoring while undergoing cardiovascular and/or pulmonary rehabilitation. The physiological data from monitoring and other patient information (such as patient demographics, exercise protocol and medical information) is stored in a database for tracking and reporting of the patients' progress through rehabilitation.

The TeleRehab® Aermos Cardiopulmonary Rehabilitation System ("Aermos") provides the ECG monitoring functionality required for performing rehabilitation of cardiovascular and/or pulmonary patients. Patients' ECG may be monitored using the Aermos system during exercise under clinical supervision. During monitoring, Aermos provides both visual and audible alarms if the patient's heart rate goes out of a prescribed range. The heart rate alarm indication is one of multiple inputs a clinician may use to modify and adjust rehabilitation activities such as decreasing the patient's level of physical exertion or halting the exercise entirely. Aermos also provides the ability to plan a patient's rehabilitation program and document the patient's progress through the creation of various types of reports. The report types supported in Aermos include individual treatment plan reports, daily exercise session reports and various patient information reports. Additionally, the Aermos system provides the ability to transfer various report types to the hospital Electronic Medical Records system. The main components of Aermos are Argus ECG transmitters, the Aermos Workstation and associated networking equipment.

The Radius VSM and accessories are intended to be used as both a wearable multi-parameter patient monitor and an accessory to a multi-parameter patient monitor that is intended for multi-parameter physiological patient monitoring in hospital and healthcare facilities. The Radius VSM and accessories are indicated for the monitoring of hemodynamic (including ECG, arrhythmia detection, non-invasive blood pressure, SpO2, Pulse Rate, PVi, heart rate, and temperature), and respiratory (e.g., impedance, acoustic, and pleth-based respiration rate) physiological parameters along with the orientation and activity of adults. The Radius VSM and accessories are indicated for the non-invasive continuous monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and Pulse Rate (PR) of well or poorly perfused adults during both no motion and motion conditions. The Radius VSM and accessories are indicated for continuous monitoring of skin temperature of adults. The Radius VSM and accessories are indicated for monitoring of the orientation and activity of patients including those susceptible to pressure ulcers. The Radius VSM and accessories are indicated for the continuous non-invasive monitoring of PVi as a measure of relative variability of the photoplethysmograph (pleth) of adults during no motion conditions. PVi may be used as a noninvasive dynamic indicator of fluid responsiveness in select populations of mechanically ventilated adult patients. Accuracy of PVi in predicting fluid responsiveness is variable and influenced by numerous patient, procedure and device related factors. PVi measures the variation in the plethysmography amplitude but does not provide measurements of stroke volume or cardiac output. Fluid management decisions should be based on a complete assessment of the patient's condition and should not be based solely on PVi. Devices with Masimo technology are only indicated for use with Masimo accessories. **Radius VSM Accessories:** Radius VSM ECG Electrodes are disposable, single-patient use ECG electrodes intended to acquire ECG signals from the surface of the body. They are indicated for use on adults for up to 3 days of skin surface contact. Radius VSM Blood Pressure Cuffs are accessories intended to be used with a noninvasive blood pressure measurement system to measure blood pressure. They are indicated for use on adults during no motion conditions.

The Radius VSM and accessories are an FDA cleared (K223498), wearable, battery-operated, multi-modular patient monitoring platform that allows for the ability to scale and tailor the use of different monitoring technologies based upon the hospital and clinician's assessment of what technologies are appropriate. As part of this submission, a MAP feature is being added to the Radius VSM. The feature is a software feature that uses the previously cleared systolic and diastolic measurement capabilities to automate the calculation of MAP using the following formula: MAP = 1/3* Systolic + 2/3*Diastolic. The MAP is calculated by the Radius VSM NIBP Module and displayed on the Radius VSM Wearable Monitor. There were no other features added as part of this submission.

Avidhrt Sense is a handheld spot-checking measurement device, indicated to do the following: • Non-invasive spot checking of functional oxygen saturation of arterial hemoglobin (% SpO2) and pulse waveform (when prescribed by a physician). Avidhrt Sense SpO2 is intended for use in adult patients in the home environment. The Avidhrt Sense SpO2 is not for continuous monitoring, use during motion or for patients with low perfusion. The Avidhrt Sense SpO2 is not intended for pediatric use.

Avidhrt Sense SpO2 is a handheld spot-checking measurement device designed for non-invasive spot checking of functional oxygen saturation of arterial hemoglobin (% SpO2) and pulse waveform (when prescribed by a physician). Avidhrt Sense SpO2 is used in conjunction Avidhrt Sense SpO2 smart phone app that displays the SpO2.

Intended for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults and pediatrics in a hospital environment and during patient transport inside hospitals. Not intended for home use. Intended for use by health care professionals.

The Telemetry Monitor 5500 is a battery-operated patient worn monitor with a touchscreen display. The Telemetry Monitor 5500 is intended to monitor and record, and to generate alarms for, multiple physiological parameters like ECG, SpO2, and respiration rate. It is equipped with a 1.4 GHz radio to enable wireless bi-directional data flow with Philips' Patient Information Center (PIC) iX.

Airmod, when used in conjunction with Accursound Electronic Stethoscope AS-101, is a software as medical device intended to be used for the continuous, non-invasive monitoring of respiratory rate (RR) in adult patients who are subjected to procedural sedation and/or anesthesia. Airmod is intended for use by healthcare professionals in hospitals and healthcare facilities who are legally credentialed to perform procedural sedation and/or anesthesia. Airmod is intended for Android-based devices only.

Airmod 114 is an Android-based software application designed to aid healthcare professionals by monitoring a sedated and/or anesthetized patient's breathing in real time. The device has an AIbased algorithm that can detect inhalation acoustics and provides respiratory rates based on the analysis of the acoustic signals of breathing sounds collected by AccurSound Electronic Stethoscope AS-101. Airmodid for the continuous monitoring of respiratory rate (RR) in adults who are subjected to procedural sedation. Airmod™ is designed for use in hospitals and healthcare facilities performing procedural sedation/anesthesia. The device is not intended for patients who are not anesthetized/sedated.

The Pulse Oximeter is a non-invasive device indicated for use in measuring, displaying, storing and transmitting functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate for adult patients. It is intended for spot- check and/or continuous data collection, and not continuous monitoring. It can be used in sleep labs, long-term care, hospitals and home use.

The Pulse Oximeter is a lightweight, portable health finger ring oximeter for home or healthcare facilities. SpO2 measurement technology is based on the developed photoelectron method and circuit design, and Shenzhen Viatom Technology Co., Ltd. developed calculation software. The SpO2 sensor receives the optical signal from the red light and infrared light through the finger into the oximeter. Two emitting tubes (red light diodes and infrared diodes) are located on the inner right side of the sensor, and they can emit red light and infrared. The receiving end is located on the inner left side of the sensor, and it can receive the red light and infrared through the finger. The MCU receives the pulse signal, gets the frequency signal by counting, processes its digital signal, and finally gets the measured SpO2 value. The PR is calculated on average by the above peak intervals of the PR waveform.

The Aulisa Oximeter Module (2nd Gen.) is indicated for spot-checking and/or continuous monitoring SpO2 and pulse rate of adult and pediatric patients during non-motion and under well-perfused conditions in hospitals, medical facilities, home care, and subacute environments. The parameters derived by the Aulisa Oximeter Module (2nd Gen.) are transmitted to a commercially available mobile device that runs an Aulisa-developed application for display and review.

The Aulisa Oximeter Module (2nd Gen.) is a wireless, wrist-worn Sensor Module (SM) specifically designed to continuously measure and display a patient's pulse rate and oxygen saturation (SpO2). It uses non-invasive red and infrared technology to measure the vital signs and sends the data to an Aulisa-developed software application as cleared through previous Premarket Notification 510(k) submissions under Guardian Angel Rx GA1000 Series Digital Vital Sign Monitoring System (K162580) & Guardian Angel Rx GA2000 Series Digital Vital Sign Monitoring System (K203208) using Bluetooth technology. If the physiological data sent from the subject device to the software application falls outside of pre-set limits or when a technical error is detected, both auditory and visual alarm signals are generated through the software application while the subject device backlight of the vital sign will turn to RED colour as a visual alarm signal, to alert the caregiver. The sensor module uses Bluetooth technology to interact with a commercial, third-party mobile device whether under iOS or Android operating system, such as iPad, iPhone, Google Pixel ... etc. which is not part of this submission. The vital-signs are transmitted to mentioned mobile device that runs Aulisa-developed application for displayed and reviewed. The software application can be download from an official APP store, such as iOS APP store or Google Play.