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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 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.

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 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.

FH Vitals SDK-RR is a software-only respiratory rate measurement tool intended to be integrated into third-party software applications on compatible mobile devices, laptops, or computers. It is intended for spot checking of Respiration Rate (RR) in an automatic contactless manner by analyzing chest wall movement from video input when the subject is still and properly positioned in front of the camera in a well-lit environment. FH Vitals SDK-RR is intended for use under the supervision of a healthcare professional, either in clinical or home environments, and is not intended for continuous monitoring, apnea detection, or as the sole method for evaluating physical health. It is intended to serve as a supplemental tool to assist in the overall assessment of the patient. The software is indicated for use on individuals aged 18 years and older who do not require critical care or continuous vital sign monitoring.

The FaceHeart Vitals Software Development Kit (FH Vitals SDK-RR) is a software product designed for integration into various software applications, such as those on mobile devices, laptops, or computers. This SDK is strictly a software-only product and is compatible with the following operating systems: Windows 10, Android 14, and iOS 17. It has been tested and is currently only compatible with the following cameras: - Logitech C930 webcam - Samsung S24+, S24+ smartphone front-facing cameras - iPhone 15 Pro, and iPhone 15 Pro Max front-facing cameras The SDK is non-contact and designed to measure the respiratory rate in breaths per minute based on facial video streams. When the SDK receives a video stream, it first identifies and tracks the face within the video, ensuring consistent positioning of the face. Based on the tracked facial region, the system identifies the chest as the region of interest (RoI) and locates reliable key points. The system then focuses on the movement of the chest within the RoI to further determine the number of respiratory cycles. By analyzing the frequency of chest elevation and depression, the SDK calculates the respiratory rate in breaths per minute. FH Vitals SDK-RR is designed for non-invasive respiratory rate measurement with a validated measurement range of 5-36 bpm. The SDK is not intended for apnea monitoring or detecting the cessation of breathing. FH Vitals SDK-RR is a prescription-use software device that must be used under the clinical supervision or instruction of a licensed healthcare professional (HCP).

VitalSigns Camera Medical Library is a software library that can be integrated into a customer application for use during virtual consults or health screening. It is intended for spot checking of Respiration Rate (RR) in an automatic contactless manner as a data point in the overall assessment of the patient. It is used under the supervision of a health care professional, either in the home or in a clinical environment when the subject is still and positioned properly in front of the camera (Samsung Galaxy A20e), which is placed on a stable surface in an adequately lit environment. It is intended to be used on patients aged 22 years and older that classify as ASA I (American Society of Anesthesiologists), which is defined as a normal healthy patient, non-smoking and no or minimal alcohol use. It is not intended for continuous patient monitoring system or as the sole method of checking the physical health of the patient, nor as an apnea monitor, but as a part of a framework which mandates periodic checks by a health care professional to ensure appropriate clinical diagnosis and treatment can be reached.

The Philips VitalSigns Camera Medical Library (hereafter known as Philips VSC-MEDlib) is a software library that shall be used in conjunction with a camera which can be part of another platform or as part of a medical device. The Philips VSC-MEDlib incorporates an algorithm which allow for automatic, contactless measuring of Respiration Rate (RR). Philips VSC-MEDlib utilizes the video stream of an unobstructed view of the subject's torso captured from a camera to calculate the RR from torso motion. The video stream can be captured during a video consult or health screening which should always be conducted in the presence of a physician or other Health Care Professional (HCP). The patient must be properly positioned in front of the camera, sitting still and in an adequately lit environment. From a video stream that typically lasts 60 seconds or less, a spot measurement is taken.

The Makani Science™ Respiration Monitoring System is indicated for continuous, non-invasive, and real-time monitoring of a patient's breathing. It graphically displays respiration versus time and reports the respiratory rate value. The Makani Science™ Respiration Monitoring System is intended to be used by healthcare professionals in healthcare facilities and dental offices on adult patients aged 22 or older. It is not intended to be used as an apnea monitor.

The Makani Science™ Respiration Monitoring System (Makani Science RMS) is a respiration rate (RR) monitoring system that consists of a pair of identical, battery-powered, wireless, Makani Science Ahe™ Respiration Sensors (Ahe Sensors - piezo-resistive strain sensors) and the Makani Science Ahe™ App (Ahe App), which is deployed and runs on an Apple® iPad®. The two (2) small and lightweight Ahe Sensors are paired to the Ahe App using Bluetooth Low Energy (BLE) 5.0 technology. The Makani Science RMS is intended to be used by trained healthcare providers (HCPs) in the management of their patients. The Ahe Sensors are single-patient use sensors and can be used up to 24 hours of continuous use. The sensors are applied to the patient's intact skin using an adhesive tape built into the sensors and are made to be retained on the skin in nonambulatory use situations, such as supine on a procedure room table or semi-recumbent in a dental chair. One sensor is applied to the patient's thoracic region and the other sensor is applied to the abdomen region. Correct placement of these sensors is important to the effectiveness of the device, and specific guidance is provided to the user in the labeling on where to place the sensors. The Ahe App is a software application, which guides the user through system setup and monitoring using display screens. During use, the iPad is forced into guided access, or "kiosk" mode, which prevents the user from using any other applications during the monitoring session. Once setup is complete and monitoring initiated, the Ahe App displays a graphical rendition and numerical value of the patient's RR. Low and high RR alarm thresholds provide a visual and audible notification if the patient's RR violates the user-determined alarm thresholds. Monitoring continues until the user terminates the monitoring session, at which time the Ahe App can save a report of the monitoring session to an external memory card, if desired by the user. No patient health information (PHI) is retained by the Ahe App after completion of the monitoring session. The Makani Science RMS does not interact with any third-party medical or non-medical devices other than a memory card that is used to store a report of the patient's monitoring session.

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.

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 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.