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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
1. UbigVue™ Single Patient Relay
1. UbiqVue™ Multi-Patient Relay
1. UbiqVue™ Central Server
1. UbiqVue™ Active Monitoring Portal
1. UbiqVue™ Relay Bridge Software (optional)
1. UbiqVue™ Bluetooth Gateway Software (optional)
1. 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.

AI/ML Overview

LifeSignals, Inc. has developed the UbiqVue™ 2A Multiparameter System (UX2550), a wireless remote patient monitoring system. The device collects continuous physiological data including 2-Channel ECG, heart rate, SpO2%, respiration rate, pulse rate, photoplethysmography waveform, skin temperature, body temperature, body posture, body motion, R-R Interval, heart rate variability (HRV), and optionally blood pressure. The system transmits data wirelessly to a remote central server for display, storage, and analysis, and can notify healthcare professionals through alerts. It is intended for non-critical, adult populations in home and healthcare settings.

The following information describes the acceptance criteria and the study conducted to prove the device meets these criteria:

1. Acceptance Criteria and Reported Device Performance

Parameter	Acceptance Criteria	Reported Device Performance
Heart Rate	Range: 30 – 250 BPM
Accuracy: ± 3 BPM or 10% whichever is greater (Predicate-I)	Range: 30 – 250 BPM
Accuracy: ± 3 BPM or 5% whichever is greater
Respiration Rate	Range: 6-60 Breaths per Minute (Predicate-I); 4-40 Breaths per Minute (Predicate-II)
Accuracy: ≤ 1 Breath per minute (MAE simulation), ≤ 3 Breaths per minute (MAE clinical) (Predicate-I); ± 3 Breaths per Minute (Predicate-II)	Range: 5-60 Breaths per Minute
Accuracy: ≤ 1 Breath per minute (MAE simulation), ≤ 3 Breaths per minute (MAE clinical)
Skin Temperature	Range: 32.0°C – 43.0°C (89.6°F – 109.4°F)
Accuracy: As per ASTM E1112-00 (Predicate-I)	Range: 15.0°C – 43.0°C (59.0°F – 109.4°F)
Accuracy: As per ASTM E1112-00
Body Temperature	Range: 32.0°C – 43.0°C (89.6°F – 107.6°F) (Predicate-II)
Clinical Accuracy: ±0.3°C (Predicate-II)	Range: 32.0°C - 43.0°C (89.6°F - 109.4°F)
Clinical Accuracy: -0.27 °C (Clinical Bias), 1.01°C (Limits of agreement)
SpO2%	Range: 40 to 100% (Predicate-II)
Accuracy: ±2% (Predicate-II)	Range: 0 to 100%
Accuracy: ± 3 % (100 to 70%), Less than 70% unspecified
Pulse Rate	Range: 40 to 250 BPM (Predicate-II)
Accuracy: ± 3% (Predicate-II)	Range: 30 to 250 BPM
Accuracy: ± 3 or 5% whichever is greater
Wear Life	120 hours	120 hours
Alerts/Alarms	Compliance with IEC 60601-1-8 (Ed. 2.2) (validated for visual alarm, alerts via email/SMS for primary visual alarm indication)	Compliance with IEC 60601-1-8 (Ed. 2.2)
Biocompatibility	According to ISO 10993-1: 2018	Testing conducted according to ISO 10993-1:2018 (In-vitro cytotoxicity, skin irritation, skin sensitization)
Electrical Safety & EMC	Compliance with IEC 60601-1(Ed.3.2), IEC 60601-1-2 (Ed. 4.1), IEC 60601-1-11(Ed. 2.1)	Compliance achieved
Wireless Performance	Conformance to ANSI/IEEE C63.27:2017	Conformance achieved for Single Patient Relay System & Multi-Patient Relay System
Software	IEC 62304 & USFDA Guidance (Class B, Moderate-Enhanced documentation), IEC 81001-5-1	Designed, documented, verified & validated per specified standards
Shelf-life & Reliability	As per acceptance criteria	Testing conducted and verified
Packaging	As per ASTM D7386-16	Testing conducted
Usability	Compliance with IEC 60601-1-6 (Ed. 3.2) and "USFDA Guidance- Applying Human Factors and Usability Engineering to Medical Devices."	Study conducted

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the exact sample sizes for all test sets. However, it does mention specific studies:

SpO2% Accuracy: Clinical validation was performed to determine the accuracy of SpO2% with respect to SaO2 values from simultaneously drawn arterial blood as per ISO 80601-2-61 (Ed. 2.0). The specific sample size for this clinical validation is not provided in the summary.
Body Temperature Accuracy: Validated using "non-randomized, self-control comparative on-body comparative performance with oral digital thermometer on multiple subject populations" in accordance with ISO 80601-2-56 (Ed.2.0). The specific number of subjects or populations is not provided.
Wear-life Performance: Validated using "non-randomized, self-control comparative on-body comparative performance study for the wear period of 120 hours." The sample size for this study is not provided.
Respiration Algorithm Improvement: Validated by comparing against "clinician manually scored end tidal CO2 (EtCO2) capnography, under spontaneous breathing & metronome breathing during normal activity conditions as part of wearlife study." The sample size is part of the wear-life study, but not explicitly stated.

Data Provenance: The document does not explicitly state the country of origin for the clinical study data or whether studies were retrospective or prospective. Given the FDA 510(k) submission, it is implied that the data is acceptable for the US market.

3. Number of Experts Used to Establish the Ground Truth and Qualifications

The document indicates that for the respiration algorithm validation, the comparison was made against "clinician manually scored end tidal CO2 (EtCO2) capnography." This implies that clinicians (experts) were involved in establishing the ground truth. However, the exact number of experts and their specific qualifications (e.g., years of experience, specialty) are not provided.

4. Adjudication Method for the Test Set

The document does not explicitly describe an adjudication method (e.g., 2+1, 3+1, none) for the test sets. For the "clinician manually scored" data mentioned for respiration, it's not specified if multiple clinicians scored and how discrepancies were resolved.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

There is no mention of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study or any study evaluating the effect size of how much human readers (or healthcare professionals using the device) improve with AI vs without AI assistance. The device is a monitoring system that provides data and alerts, rather than an AI-driven diagnostic interpretation system typically evaluated with MRMC studies.

6. Standalone (Algorithm Only) Performance

The document describes specific performance tests for various parameters (e.g., heart rate, respiration rate, SpO2%, skin temperature, body temperature) that would inherently reflect the algorithm's performance in deriving these parameters from sensor data. For example:

SpO2% accuracy was proven through "clinical validation to determine the accuracy of SpO2% with respect to SaO2 values from simultaneously drawn arterial blood." This implies a comparison of the device's output (algorithm only) to a gold standard.
Body temperature accuracy was validated against an "oral digital thermometer."
Respiration algorithm validation was against "clinician manually scored end tidal CO2 (EtCO2) capnography."

These tests demonstrate standalone performance metrics against established reference standards.

7. Type of Ground Truth Used

The types of ground truth used include:

Physiological measurements from reference devices/standards:
- SaO2 values from simultaneously drawn arterial blood (for SpO2% accuracy).
- Oral digital thermometer (for Body Temperature accuracy).
- Bench testing standards (e.g., ASTM E1112-00 for skin temperature, ISO 80601-2-61 for Pulse Rate).
Clinician-established ground truth:
- Clinician manually scored end tidal CO2 (EtCO2) capnography (for Respiration Rate algorithm).

8. Sample Size for the Training Set

The document does not explicitly state the sample size used for training the algorithms within the UbiqVue™ 2A Multiparameter System. It discusses validation of improved algorithms and additional features, but provides no detail on the development or training phase data.

9. How the Ground Truth for the Training Set Was Established

As the document does not provide details on the training set, it does not describe how the ground truth was established for the training set. It primarily focuses on the verification and validation (testing) of the final device/algorithms.

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