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510(k) Data Aggregation
K Number
K242018Device Name
UbiqVue 2A Multi-parameter System (UX2550)
Manufacturer
LifeSignals, Inc.
Date Cleared
2024-11-12
(125 days)
Product Code
DRG, DQA, FLL, MHX
Regulation Number
870.2910Why did this record match?
Applicant Name (Manufacturer) :
LifeSignals, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The UbiqVue 2A Multiparameter System is a wireless remote patient monitoring system intended for use by healthcare professionals for continuous collection of physiological data at home and in healthcare settings. This shall include electrocardiography (2-Channel ECG), heart Rate, SpO2%, respiration rate, pulse Rate, photoplethysmography waveform, skin temperature, body posture, body motion, R-R Interval, heart Rate variability (HRV) and blood Pressure (optional). Data is transmitted wirelessly near real time from UbigVue 2A Wearable Biosensor and 3rd party device (for Blood Pressure only) to remote central server for display, storage, and analysis.
The UbiqVue 2A Multiparameter System is intended for non-critical, adult population.
The UbiqVue 2A Multiparameter System shall include the ability to notify healthcare professionals through alerts when physiological parameters fall outside the set limits, manual trigger by the patient and to display multiple patient's physiological data for remote monitoring at home and with visual alarm for active monitoring at hospitals and out-of-hospital patient care settings (such as clinics, outpatient surgery facilities, long-term care facilities and physician offices) in which care is administered by healthcare professionals.
Device Description
The UbiqVue™ 2A Multiparameter System is similar to LifeSignals Multiparameter Remote Monitoring Platform that is cleared under K202868 but upgraded with monitoring of additional physiological parameters, minor performance improvements and additional User Interface.
The UbiqVue™ 2A Multiparameter System consists of following components:
- 1) UbiqVue™ 2A Wearable Biosensor
- 2) UbigVue™ Single Patient Relay
- 3) UbiqVue™ Multi-Patient Relay
- 4) UbiqVue™ Central Server
- 5) UbiqVue™ Active Monitoring Portal
- 6) UbiqVue™ Relay Bridge Software (optional)
- 7) UbiqVue™ Bluetooth Gateway Software (optional)
- 8) Third-party Blood Pressure device (optional)
The UbigVue™ 2A Wearable Biosensor when attached to body acquires two channels of ECG signals, TTI respiration signals (one of the inputs for deriving Respiration Rate), resistance variation of a Thermistor attached to body (used for deriving Skin Temperature) & accelerometer data (input for deriving Respiration Rate & Posture), pre-processes them and wirelessly transmits to a paired Relay device, as cleared under K202868.
Following are additional features proposed in this submission:
- Ambient temperature sensor for Body temperature derivation.
- Acquisition of PPG (Photoplethysmography) signals using the integrated Optical sensor array.
- Derivation of SpO2% and Pulse Rate within the Biosensor, based on PPG signals acquired through the Optical sensor array.
Biosensor uses standard WLAN (802.11b) secured (AES) communication protocol for wireless data transmission to the Relay Device, as cleared under K202868. The Biosensor is also additionally integrated with BLE Radio for communication with Single Patient Relay device.
As cleared under K202868, when Relay device is available within the wireless range, the acquired data is continuously transmitted to the Relay device immediately. If Relay device is not available or if there is any interruption in the communication between Relay device and Biosensor, data shall be temporarily buffered locally in Biosensor till the wireless connection is re-established.
The UbigVue™ Single Patient Relay Device, a standard Mobile device or custom device that is installed with a UbigVue Single Patient Relay Application software, that receives the physiological data transmitted from any paired Biosensor. It shall transmit the data received from the Biosensor, immediately without any day to Central Server that is configured to receive, after necessary data encryption. The Single Patient Relay Device shall receive data from Biosensor either through WLAN or BLE and transmit it to Central Server using its mobile data network (3G, 4G, LTE, 5G, etc.)
Single Patient Relay Device function is identical to the one cleared under K202868, except it is upgraded to support additional parameters & also improvements in GUI as below:
- To handle additional data packets of Biosensor such as Ambient Temperature, PPG signals. SpO2% and Pulse Rate.
- Interactive GUI that provides feedback to Users about the signal quality of PPG signals to identify the optimal body location for affixing the Biosensor.
- Shall pair with a 3rd party Blood Pressure device using BLE and transfer the data to the Central Server.
- Allows User to enter Oral Temperature reading (for calibration) and/or manual Blood pressure data (optional if no 3td Party device is connected).
The UbiqVue™ Multi-Patient Relay Device (MPR) is an UbiqVue™ Multi-Patient Relay Application Software installed in a standard Linux platform (Physically or in cloud), that has ability to pair & receives data from multiple Biosensors, through wireless access points (WLAN) connected in its network. It shall transmit the received data from Biosensors to Central Server that is configured to receive through internet or private network (VPN), after necessary encryption & authentication. Multi-Patient Relay Device also receives data from multiple third-party Blood Pressure devices worn by the patients & connected to its network (through BLE gateway).
If the Central Server is not available or there is no connectivity, the data shall be temporarily buffered securely in the MPR device itself. There is no GUI component for this software application.
The UbigVue™ Central Server is UbiqVue™ Central Server Application software installed in a compatible Linux Server hardware Platform. The Central Server Application functions are also identical to Secure Server Application in LifeSignals Multi-parameter Remote Monitoring Platform (K202868), other than being upgraded to handle additional parameters. Also, the "Sensor Processing Library", the algorithm that derives various vital parameters is upgraded for performance improvements. The following are additional features:
- Extending the minimum skin temperature measurement capability from 32.0℃ (89.6 °F) to 15.0°C (59.0°F)
- Body Temperature estimation using Skin Temperature, Ambient temperature, Heart Rate (based on clinical condition) and Activity.
- Uses the Oral Temperature entered manually for initial / periodic calibration of derived Body temperature.
- Additional Posture classification & Body motion detection capabilities.
- Improvements in Respiration Rate & Heart Rate derivation algorithm.
- Integration with 3rd Party beat analysis & classification software for deriving Sinus Heart Rate, R-R Interval & Heart Rate Variability.
- The PPG Signal Quality Index (SQI) algorithm module for displaying the SQI on the Active Monitoring dashboard & to access the quality of SpO2 value derived by the Biosensor.
- Support for Early Warning Score (NEWS2) calculation.
Central Server shall have ability to send alert notifications to any configured one or more Users through E-mail, SMS or WhatsApp, for any Clinical, Technical or Manual Alert conditions, as cleared under K202868. However, this alert engine is upgraded to support additional parameters and improved configuration capabilities such as Acknowledgement, priority & condition delay time.
Active Monitoring Portal in UbiqVue™ 2A Multiparameter System is identical to Web UI in LifeSignals Multi-parameter Remote Monitoring Platform cleared under K202868. It is a browser-based User Interface Application that enables Clinical personnel to login to the Central server remotely and access the patient physiological data (Biosensor & derived data) and view/Acknowledge the Alert(s). The Clinical personnel, depending on the roles (normal or supervisory) can access data of multiple patients assigned to them and search them based on the recent alert status. This includes patients that are active (wearing Biosensor) and monitoring procedures completed.
It is in-built with a Monitoring Dashboard that continuously displays physiological parameters, waveforms & alert status of any assigned patients to any authenticated Clinical personnel for (quasi) real time Active Monitoring. It has the option for the User to select multiple patient tile view or Single Patient Zoom View/Hybrid view of any patient based on multiple available filter settings.
Following are the few changes in this 510(k):
- Additional parameters (SpO2%. PR, EWS, SYS, DIA, MAP, PPG, SQI, EWS).
- Visual alarm display for any Clinical, Technical, or manual alert/alarm.
- Hybrid tile view (Zoom View + Tile view) and Group tile view.
- Multi-level User Management, roles & privileges.
Note: Any Third-Party Application / Server may communicate with UbiqVue™ Central Server using a defined set of Application Programming Interface (API) for entering patient information, configuring & generating customized report or any other requirement that does not alter the intended use of the system (e.g., EMR/EHR, HIMS) or to meet the additional intended use claimed by the third-party application. UbigVue™ Active Monitoring Portal shall continue to be used for the claimed Active Monitoring intended use. However, UbiqVue™ Active Monitoring portal may be optional for integration with any other regulatory approved monitoring dashboard or different intended use claims.
Relay Bridge Software in UbiqVue™ 2A Multiparameter System when installed in a standard OpenWrt based routers, shall provide communication between Biosensor(s) & Multi-Patient Relay. Relay Bridge is an alternate for a standard access point and is intended when Multi-Patient Relay Software is hosted in the cloud. Similar to standard access point, the Relay Bridge communicates with multiple Biosensor and transfers the data to the Multi-Patient Relay without buffering the data. Since the Relay bridge transfers the data to the designated Multi-Patient Relay bridge in the cloud, it further encrypts the data for securely transmitting through the internet via ethernet, Wi-Fi or cellular network.
Bluetooth Gateway Software in UbigVue™ 2A Multiparameter System when installed in a standard OpenWrt based BLE gateway or BLE supported routers, shall provide communication between 3rd party BLE devices (e.g. BP device) & Multi-Patient Relay. Bluetooth Gateway communicates with multiple 3rd party devices and transfers the data to the Multi-Patient Relay without buffering.
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K Number
K202868Device Name
LifeSignals Multi-Parameter Remote Monitoring Platform
Manufacturer
LifeSignals, Inc.
Date Cleared
2021-07-21
(296 days)
Product Code
DRG, FLL, MHX
Regulation Number
870.2910Why did this record match?
Applicant Name (Manufacturer) :
LifeSignals, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The LifeSignals Multi-parameter Remote Monitoring Platform is a wireless remote monitoring system intended for use by healthcare professionals for continuous collection of physiological data at home and in healthcare settings. This shall include Electrocardiography (2-channel ECG), Heart Rate, Skin Temperature & Posture, Data is transmitted wirelessly from LifeSignals Biosensor to Remote secure server for display, storage & analysis.
The LifeSignals Multi-parameter Remote Monitoring Platform is intended for non-critical, adult population.
The LifeSignals Multi parameter Remote Monitoring Platform can include the ability to notify healthcare professionals when physiological parameters fall outside the set limits and to display multiple patient physiological data for remote monitoring.
Device Description
LifeSignals Multi-parameter Remote Monitoring Platform consists of four main components:
- (1) LifeSignals Multi-parameter Biosensor
- (2) LifeSignals Relay device (Software Application)
- (3) LifeSignals Secure Server (Software Application)
- (4) Web UI /Remote Monitoring Dashboard
- LifeSignals Multi-parameter Biosensor when attached body acquires two channel of ECG . signals, TTI respiration signals (one of the input for deriving Respiration Rate), resistance variation of a Thermistor attached to body (used for deriving Skin Temperature) & accelerometer data (input for deriving Respiration Rate & Posture), pre-processes them and wirelessly transmits to a paired Relay device (or any Receiver system). When Relay device is available within the wireless range, the acquired data is continuously transmitted to the Relay device immediately. If Relay device is not available or if there is any interruption in the communication between Relay device and Biosensor, data shall be temporarily buffered locally in Biosensor till the wireless connection is re-established.
Biosensor Patch uses standard WLAN (802.11b) secured (AES) communication protocol for wireless data transmission to the Relay Device.
- Relav Device manages wireless communication between LifeSignals Biosensor and ● LifeSignals Remote Secure Server. Relay device is a LifeSignals Relay Application software installed in a compatible commercial hardware platform, like a mobile phone or a tablet.
- LifeSignals Relay (Application) functions include: .
- . Manages secured wireless communication (WLAN 802.11b) between Relay device & Lifesignals Biosensor and encrypted communication between the Relay device and the LifeSignals Remote Secure Server.
- Receives physiological signals from the Biosensor and transmit them after encryption to Secure Server as quickly as possible. It manages the database in Relay device for buffering/storing the data securely, if there is any disruption in communication with the Secure Server.
- I Provides user interface for entering the Biosensor & Patient information and pairing & establishing connection with the Biosensor.
- . Provides User Interface to record any manual alert events by the patient.
- . Secure Server is a LifeSignals Secure Server Application software installed in Linuxcompatible Secure server hardware platform.
LifeSignals Secure Server Application manages the decryption, uploading and storage of Biosensor data received from multiple authenticated Relay devices. The "Sensor Processing Library" in LifeSignals Secure Server process, filter the received Biosensor data and derives Heart Rate, Respiration Rate, Skin Temperature & Posture before storing them in a secured location along with received Biosensor data, for access by Web UI or any 3rd-party applications for display or analysis purpose.
LifeSignals Secure Server Application shall have an optional ability to send alert notifications to any configured destination (email, SMS, WhatsApp), when the parameters (Heart Rate, Respiration Rate or Skin temperature) exceed the configured limits.
- . LifeSignals Web UI / Remote Monitoring dashboard is a web-browser User Interface Application that enable caregiver (Clinical personnel) to login to the LifeSignals Secure server remotely and access the patient physiological data (Biosensor & derived data) & Alert status. The caregiver (Clinical personnel) depending on the roles (normal or supervisory) can access multiple patient data and search them based on the recent alert status. This includes patients that are active (wearing Biosensor) and procedures completed.
Remote Monitoring Dashboard/Web UI shall also have an ability to continuously display physiological parameters (Heart Rate, Respiration Rate, Skin Temperature, Posture) & waveforms (ECG & Respiration) of multiple patients or single patient quasi-real time remotely on the screen for monitoring by caregiver (Clinical personnel).
This monitoring dashboard also has the ability for the caregiver (clinical personnel) to set the alert limits & notify address that configures the Secure server to send an alert notification to any Mobile Phone (SMS or WhatsApp) or Email ID of care giver, when parameters falls outside the set value.
Note: The Biosensor data may be accessible by a Third-Party Application installed in the Relay device using the Application Programming Interface (API) layer of the LifeSignal Relay Application Software, after suitable configuration and verification. In this configuration. LifeSignals Secure Server is optional and the data from Relay device shall be transmitted to a third-party server location. But the third-party server shall be installed with LifeSignals "Sensor Processing Library" for derivation Heart Rate, Respiration Rate, Skin Temperature & Posture.
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K Number
K200690Device Name
LifeSignals ECG Remote Monitoring Patch Platform
Manufacturer
LifeSignals, Inc.
Date Cleared
2020-07-15
(121 days)
Product Code
DRG, MWJ
Regulation Number
870.2910Why did this record match?
Applicant Name (Manufacturer) :
LifeSignals, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The LifeSignals ECG Remote Monitoring Patch Platform is a wireless remote monitoring system intended for use by healthcare professionals for continuous collection of Electrocardiography (ECG) and Heart Rate monitoring in home and healthcare settings. Data is transmitted wirelessly from LifeSignals Biosensor Patch to Remote Secure for storage and analysis.
The LifeSignals ECG Remote Monitoring Patch Platform is intended for non-critical, adult population, who are 18 years of age or older.
The LifeSignals ECG Remote Monitoring Patch Platform includes an ability to notify healthcare professionals when Heart Rate falls outside the set limits.
Device Description
LifeSignals ECG Remote Monitoring Patch Platform consists of three main components: (1) LifeSignals Biosensor Patch. (2) LifeSignals Relay device. (3) LifeSignals Remote Secure Server.
- LifeSignals Biosensor Patch acquires ECG signals from the body, pre-processes as two channels of ECG data and are wirelessly transmitted to the Relay device. Under normal operation, when the Relay Device is available within the wireless range, the acquired data is continuously transmitted to the Relay device immediately. If the Relay device is not available or if there is any interruption in the communication between the Relay device and the Biosensor Patch, data shall be buffered (stored) locally in the Biosensor Patch until the wireless connection is re-established.
Biosensor Patch uses standard WLAN (802.11b) secured (AES) communication protocol for wireless data transmission to the Relay Device.
- Relay Device manages wireless communication between LifeSignals Biosensor and LifeSignals Remote Secure Server. Relay device is a LifeSignals Relay Application Software-installed compatible commercial hardware platform, like a mobile phone or a tablet.
- LifeSignals Relay Application's functions:
- Manage secured wireless communication (WLAN 802.11b) between Relay device and Biosensor Patch and encrypts communication between the Relay device and the LifeSignals Remote Secure Server.
- Receive ECG signals from the Biosensor Patch and transmit them after encryption to Secure Server as quickly as possible. They manage the database in Relay device, for buffering/storing the data securely if there is any disruption in communication with the Secure Server.
- Provide user interface for selecting, pairing and establishing connection with Biosensor Patch.
- Display alert notifications received from the Secure Server when the Heart Rate of its associated Biosensor or of some other Biosensor in its network falls outside the configured range, when it is configured by the Secure Server to receive such notification.
- LifeSignals Secure Server consists of a hardware platform that is a Linux-compatible Secure server, LifeSignals Secure Server Application software that is installed in the hardware platform along with a Web UI, a browser-based application that interfaces with LifeSignals Secure Server Application.
LifeSignals Secure Server Application manages the decryption, uploading and storage of Biosensor data received from multiple authenticated Relay devices. The Signal Processing and Heart Rate Library in the LifeSignals Secure Server Application processes and filters the received ECG signals before storing them in a secured location. It also derives the Heart Rate from the ECG data and the Heart Rate value is appended to the filtered ECG Signals.
LifeSignals Secure Server Application can include the ability to send alert notifications to any configured Relay Device connected in its network, when Heart Rate value of any Biosensor falls outside the set range of values.
Web UI provides user interface for user (login) management, Relay management & Heart Rate Alert setting. It interfaces with Secure Server Application.
- The Secure Sever Application does not carry out any arrhythmia analysis of ECG data by itself. However, the ECG data received and stored by the LifeSignals Secure server is intended to be used with an approved third-party ECG analysis software. Based on the type of ECG analysis software, the LifeSignals ECG Remote Monitoring Platform can be used for a suitable clinical workflow such as a Remote Patient Monitoring, Mobile Cardiac Telemetry, Cardiac Event Monitor or Holter Monitoring system.
- The ECG data may be accessible by a Third-Party Application installed in the Relay device using the Application Programming Interface (API) layer of the Relay Application Software, after suitable configuration and verification. In this configuration, LifeSignals Secure Server is optional and the data from Relay device shall be transmitted to a server location configured by the third-party application. Also, in this configuration, Signal processing and Heart Rate processing Library shall be integrated in third-party secure server application or in third-party relay application.
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