(125 days)
No
The document describes algorithms for deriving physiological parameters and calculating scores (like NEWS2), but it does not explicitly mention the use of AI or ML techniques. The "Sensor Processing Library" and other algorithms are described as being upgraded or improved, but not as incorporating AI/ML.
No.
This device is a remote patient monitoring system intended for continuous collection of physiological data. It provides alerts to healthcare professionals but does not provide any direct therapy or treatment.
Yes
The device is described as a "Multiparameter System" that collects physiological data (e.g., ECG, SpO2, respiration rate, temperature) and has the ability to notify healthcare professionals through alerts when "physiological parameters fall outside the set limits" and display "multiple patient's physiological data for remote monitoring." This continuous collection, monitoring, and alerting based on physiological changes indicate its use in identifying and characterizing health conditions or risks related to these parameters, which aligns with the definition of a diagnostic device.
No
The device description explicitly lists hardware components such as the "UbiqVue™ 2A Wearable Biosensor," "UbigVue™ Single Patient Relay," and "UbiqVue™ Multi-Patient Relay," which are physical devices used for data acquisition and transmission. The performance studies also include testing on the "UbiqVue™ 2A Wearable Biosensor," indicating it is a tangible hardware component.
Based on the provided information, the UbiqVue 2A Multiparameter System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the system is for the "continuous collection of physiological data at home and in healthcare settings." This involves monitoring vital signs directly from the patient's body (ECG, SpO2, temperature, etc.).
- Device Description: The device components and their functions are described as acquiring and transmitting physiological signals from the body. There is no mention of analyzing samples taken from the body (like blood, urine, tissue, etc.).
- Performance Studies: The performance studies focus on the accuracy of physiological measurements (SpO2, temperature, heart rate, respiration rate) and the system's safety and usability in a clinical setting. There are no studies related to the analysis of biological samples.
- Key Metrics: The key metrics are related to the accuracy of the physiological parameters being measured directly from the patient.
In Vitro Diagnostic (IVD) devices are defined as those intended for use in the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The UbiqVue 2A system does not perform this type of analysis. It is a patient monitoring system that collects data from the body, not from a specimen.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
DRG, MHX, FLL, DQA
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:
-
- UbiqVue™ 2A Wearable Biosensor
-
- UbigVue™ Single Patient Relay
-
- UbiqVue™ Multi-Patient Relay
-
- UbiqVue™ Central Server
-
- UbiqVue™ Active Monitoring Portal
-
- UbiqVue™ Relay Bridge Software (optional)
-
- UbiqVue™ Bluetooth Gateway Software (optional)
-
- 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. O
- Acquisition of PPG (Photoplethysmography) signals using the integrated Optical o sensor array.
- Derivation of SpO2% and Pulse Rate within the Biosensor, based on PPG signals o 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 O signals. SpO2% and Pulse Rate.
- Interactive GUI that provides feedback to Users about the signal quality of PPG O 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 о to the Central Server.
- Allows User to enter Oral Temperature reading (for calibration) and/or manual o 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℃ o (89.6 °F) to 15.0°C (59.0°F)
-
Body Temperature estimation using Skin Temperature, Ambient temperature, о Heart Rate (based on clinical condition) and Activity.
-
Uses the Oral Temperature entered manually for initial / periodic calibration of O derived Body temperature.
-
Additional Posture classification & Body motion detection capabilities. O
-
Improvements in Respiration Rate & Heart Rate derivation algorithm. O
-
Integration with 3rd Party beat analysis & classification software for deriving Sinus O Heart Rate, R-R Interval & Heart Rate Variability.
-
The PPG Signal Quality Index (SQI) algorithm module for displaying the SQI on O the Active Monitoring dashboard & to access the quality of SpO2 value derived by the Biosensor.
-
Support for Early Warning Score (NEWS2) calculation. o
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):
- 0 Additional parameters (SpO2%. PR, EWS, SYS, DIA, MAP, PPG, SQI, EWS).
- Visual alarm display for any Clinical, Technical, or manual alert/alarm. O
- Hybrid tile view (Zoom View + Tile view) and Group tile view. O
- o 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Upper Center Chest or Upper Left Chest (for Biosensor attachment)
Indicated Patient Age Range
Adult population, 18 years or older
Intended User / Care Setting
Healthcare professionals for use at home and in healthcare settings (hospitals, clinics, outpatient surgery facilities, long-term care facilities, and physician offices).
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Verification & Validation activities were performed on UbiqVue™ 2A Multiparameter System to demonstrate substantial equivalence to the predicate device:
- Biocompatibility testing of In-vitro cytotoxicity, skin irritation and skin sensitization were conducted on UbiqVue™ 2A Wearable Biosensor, according to ISO 10993-1: 2018 Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing within a Risk Management Process.
- Electrical Safety and electromagnetic compatibility testing were conducted on UbiqVue™ 2A Multiparameter System with UbiqVue™ 2A Wearable Biosensors for compliance with IEC 60601-1(Ed.3.2), IEC 60601-1-2 (Ed. 4.1) and IEC 60601-1-11(Ed. 2.1).
- UbiqVue™ 2A Multiparameter System with UbiqVue™ 2A Wearable Biosensors (at Upper Center Chest location & Upper Left Chest location) were verified & validated for compliance with ISO 80601-2-61(Ed. 2.0) standard including clinical validation to determine the accuracy of SpO2% with respect to SaO2 values from simultaneously drawn arterial blood.
- The Pulse Rate accuracy performance of UbiqVue™ 2A Multiparameter System was verified by using bench testing, as per ISO 80601-2-61(Ed. 2.0) and through clinical validation by a reference device.
- Body temperature accuracy performance of UbiqVue™ 2A Multiparameter System was validated using non-randomized, self-control comparative on-body comparative performance with oral digital thermometer on multiple subject populations in accordance with the ISO 80601-2-56 (Ed.2.0).
- The Skin temperature accuracy performance of Ubiq Vuelle 2A Multiparameter System was reverified by using bench testing, as per ASTM E1112-00 & ISO80601-2-56 (Ed. 2.0).
- ECG & Heart Rate Performance testing was repeated on the UbiqVue™ 2A Multiparameter System for compliance with ANSI AAMI IEC 60601-2-47:2012, IEC 60601-2-27(Ed.3.0) & IEC 60601-2-25 (Ed. 2.0).
- Wear-life performance of ECG waveform quality, Heart Rate, Respiration Rate, Skin Temperature, and SpO2% of UbiqVue™ 2A Multiparameter System under normal use condition was validated using non-randomized, self-control comparative on-body comparative performance study for the wear period of 120 hours.
- Improvement in the Respiration algorithm was 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 Alert system & Visual alarm display on UbiqVue™ 2A Multiparameter System was validated for compliance with IEC 60601-1-8 (Ed. 2.2).
- Usability study was conducted on UbiqVue™ 2A Multiparameter System for compliance with IEC 60601-1-6 (Ed. 3.2) and "USFDA Guidance- Applying Human Factors and Usability Engineering to Medical Devices."
- Wireless performance & coexistence testing conducted as per ANSI/IEEE C63.27:2017: American National Standard for Evaluation of Wireless coexistence on Ubig Vue™ 2A Multiparameter System for both Single Patient Relay System & Multi-Patient Relay System.
- Software in the UbiqVue™ 2A Multiparameter System was designed, documented, verified & validated as per the IEC 62304: Medical device Software - Software Life Cycle Process and USFDA Guidance for the content of premarket submissions for Software contained in medical device. The Software for this device is determined as Class B. "Moderate-Enhanced documentation" level of concern.
- Software in the UbiqVue™ 2A Multiparameter System was securely designed by conforming to IEC 81001-5-1 Health software and health IT systems safety, effectiveness and security – Activities in the product life cycle.
- Shelf-life & Reliability and testing were conducted and verified on UbiqVue™ 2A Wearable Biosensor, as per the acceptance criteria.
- Packaging test conducted on the packaged Ubiq Vue™ 2A Wearable Biosensors as per ASTM D7386-16.
Key results:
- Heart Rate Accuracy: ± 3 BPM or 5% whichever is greater
- Respiration Rate Accuracy: ≤ 1 Breath per minute (Mean Absolute Error based on Simulation study) ≤ 3 Breaths per minute (Mean Absolute Error based on Clinical study)
- Skin Temperature Accuracy: As per ASTM E1112-00
- Body Temperature Clinical Accuracy: -0.27 °C (Clinical Bias), 1.01°C (Limits of agreement)
- SpO2% Accuracy: ± 3 % (100 to 70%), Less than 70% unspecified
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
K183078, K200160, K160951, K203215
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 870.2910 Radiofrequency physiological signal transmitter and receiver.
(a)
Identification. A radiofrequency physiological signal transmitter and receiver is a device used to condition a physiological signal so that it can be transmitted via radiofrequency from one location to another, e.g., a central monitoring station. The received signal is reconditioned by the device into its original format so that it can be displayed.(b)
Classification. Class II (performance standards).
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November 12, 2024
LifeSignals, Inc. Saravanan Balasubramanian Vice President - Global, Medical Technology & Regulatory Operations 426 S Hillview Dr. Milpitas, California 95035
Re: K242018
Trade/Device Name: UbiqVue™ 2A Multi-parameter System (UX2550) Regulation Number: 21 CFR 870.2910 Regulation Name: Radiofrequency Physiological Signal Transmitter And Receiver Regulatory Class: Class II Product Code: DRG, MHX, FLL, DQA Dated: October 10, 2024 Received: October 10, 2024
Dear Saravanan Balasubramanian:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrb/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (OS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatory
2
assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Jennifer W. Shih -S
Jennifer Kozen Assistant Director Division of Cardiac Electrophysiology, Diagnostics, and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
Submission Number (if known)
Device Name
UbiqVue™ 2A Multiparameter System (UX2550)
Indications for Use (Describe)
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.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/4/Picture/1 description: The image contains the logo for LifeSignals. The logo consists of a blue square with a white waveform inside, followed by the text "LifeSignals" in blue. The waveform graphic is on the left side of the logo, and the text is on the right.
510(k) Summary for UbiqVue™ 2A Multiparameter System
1 Company name : LifeSignals, Inc.
-
Address :426 S Hillview Drive Milpitas, CA 95035. USA
Contact : Saravanan Balasubramanian Vice President - Global, Medical Technology & Regulatory Operations Email: saravanan@lifesignals.com Tel: 510.770.6412 Ext. 4 -
2 Date prepared : October 07, 2024
3 Device
| Trade Name | : UbiqVue™ 2A Multiparameter System |
|---|---|
| Model Name | : 2A Multiparameter System |
| Common Name | : Transmitters and Receivers, Physiological Signal, Radio Frequency |
4 Classification Product code
| | Regulation
Classification | Product
Code | Description |
|----------------|------------------------------|-----------------|-------------------------------------------------------------------------|
| Cardiovascular | 21 CFR 870.2910
Class II | DRG | Transmitters and Receivers,
Physiological Signal, Radio
frequency |
5 Subsequent Product code
| | Regulation
Classification | Product
Code | Description |
|------------------|------------------------------|-----------------|-----------------------------------------------------------------------------|
| Cardiovascular | 21 CFR 870.1025
Class II | MHX | Monitor, Physiological,
Patient (With Arrhythmia
Detection Or Alarms) |
| General Hospital | 21 CFR 880.2910
Class II | FLL | Thermometer, Electronic,
Clinical |
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Image /page/5/Picture/1 description: The image contains the logo for LifeSignals. The logo consists of a blue square on the left side, which contains a white waveform graphic. To the right of the square is the text "LifeSignals" in a blue sans-serif font. The logo is simple and modern, and the waveform graphic suggests that the company is involved in healthcare or technology.
| | Regulation
Classification | Product
Code | Description |
|----------------|------------------------------|-----------------|-------------|
| Anesthesiology | 21 CFR 870.2700
Class II | DQA | Oximeter |
6 Predicate & Reference Devices
| Primary Predicate Device: | |
|---|---|
| 510(k) Number | : K202868 |
| Model | : LifeSignals Multiparameter Remote Monitoring Platform |
| Manufacturer | : LifeSignals, Inc. USA |
| Secondary Predicate (for SpO2 , Pusle Rate & Body temperature intended use) | |
|---|---|
| 510(k) Number | : K212153 |
| Model | : Biobeat Platform, BB-613WP Patch |
| Manufacturer | : Biobeat Technologies Ltd. Israel |
| Reference Device-I (for Body temperature, HRV, RR Interval, EWS Intended Use) | |
|---|---|
| 510(k) Number | : K183078 |
| Model | : Vitalconnect Platform, VitalPatch Biosensor |
| Manufacturer | : Vital Connect, Inc. USA |
| Reference Device -II (for SpO2, Pulse Rate, PPG & SQI technology): | |
|---|---|
| 510(k) Number | : K200160 |
| Model | : 740 SafeSAT |
| Manufacturer | : Zoe Medical, Inc. USA |
| Reference Device-III (for Visual Alarm & Active Monitoring Intended Use): | |
| 510(k) Number | : K160951 |
| Model | : Philips Efficia CMS200 Central Monitoring System |
| Manufacturer | : Philips Medical Systems, USA |
| Reference Device-IV (for Body Temperature accuracy claim): |
| 510(k) Number | : K203215 |
|---|---|
| Model | : Radius T Wearable Thermometer |
| Manufacturer | : Masimo Corporation, USA |
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Image /page/6/Picture/1 description: The image contains the logo for LifeSignals. The logo consists of a blue square with a white waveform inside, followed by the text "LifeSignals" in blue. The waveform is a series of vertical lines that vary in height, resembling a signal. The text is in a sans-serif font and is aligned to the right of the square.
7 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:
-
- UbiqVue™ 2A Wearable Biosensor
-
- UbigVue™ Single Patient Relay
-
- UbiqVue™ Multi-Patient Relay
-
- UbiqVue™ Central Server
-
- UbiqVue™ Active Monitoring Portal
-
- UbiqVue™ Relay Bridge Software (optional)
-
- UbiqVue™ Bluetooth Gateway Software (optional)
-
- 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. O
- Acquisition of PPG (Photoplethysmography) signals using the integrated Optical o sensor array.
- Derivation of SpO2% and Pulse Rate within the Biosensor, based on PPG signals o 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.
7
"In LifeSignals
-
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 O signals. SpO2% and Pulse Rate.
-
Interactive GUI that provides feedback to Users about the signal quality of PPG O 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 о to the Central Server.
-
Allows User to enter Oral Temperature reading (for calibration) and/or manual o 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℃ o (89.6 °F) to 15.0°C (59.0°F)
8
"It" LifeSignals
- Body Temperature estimation using Skin Temperature, Ambient temperature, о Heart Rate (based on clinical condition) and Activity.
- Uses the Oral Temperature entered manually for initial / periodic calibration of O derived Body temperature.
- Additional Posture classification & Body motion detection capabilities. O
- Improvements in Respiration Rate & Heart Rate derivation algorithm. O
- Integration with 3rd Party beat analysis & classification software for deriving Sinus O Heart Rate, R-R Interval & Heart Rate Variability.
- The PPG Signal Quality Index (SQI) algorithm module for displaying the SQI on O the Active Monitoring dashboard & to access the quality of SpO2 value derived by the Biosensor.
- Support for Early Warning Score (NEWS2) calculation. o
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):
- 0 Additional parameters (SpO2%. PR, EWS, SYS, DIA, MAP, PPG, SQI, EWS).
- Visual alarm display for any Clinical, Technical, or manual alert/alarm. O
- Hybrid tile view (Zoom View + Tile view) and Group tile view. O
- o 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
9
Image /page/9/Picture/1 description: The image contains the logo for LifeSignals. The logo consists of a blue square with a white waveform inside, followed by the text "LifeSignals" in blue. The waveform graphic is on the left side of the logo, and the text is on the right.
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.
8 Indications for 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 temperature, body posture, body motion, R-R Interval, heart Rate Variability (HRV) and Blood Pressure (optional). Data is transmitted wirelessly near real time from Ubiq Vue 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.
10
Image /page/10/Picture/0 description: The image shows the LifeSignals logo. The logo consists of a blue square with white sound wave-like lines on the left side. To the right of the square is the word "LifeSignals" in blue, with the "L" being slightly larger than the rest of the letters. The logo is simple and modern, and the sound wave-like lines suggest that the company is involved in some kind of technology or communication.
Predicate-I (K202868) Predicate-II (K212153) Subject Device Comparison Manufacturer Biobeat Technologies Ltd. LifeSignals, Inc., USA LifeSignals, Inc., USA DRG, MHX, FLL, DQA Product Codes DRG, MHX, FLL DQA, DRG, BZQ, DXG, FLL Regulation Classification 21 CFR 870.2910 21 CFR 870.2700 21 CFR 870.2910 (Primary) Class II Class II Class II The LifeSignals Multi-Parameter The Biobeat Platform is a wireless The UbiqVue™ 2A Multiparameter noninvasive remote monitoring System is a wireless remote patient Remote Monitoring Platform is a remote monitoring system intended for use by monitoring system intended for use by wireless system intended for use healthcare professionals for spotbv healthcare professionals for professionals continuous collection of physiological of healthcare for checking collection continuous collection of physiological data in home and data at home and in healthcare physiological data at home and in healthcare settings. This shall include This can settings. healthcare settings. This shall functional electrocardiography, heart include. oxygen rate. include Electrocardiography (2 saturation of arterial hemoglobin SpO2%, respiration rate, pulse rate, channel ECG), Heart Rate, (%SpO2), pulse rate, blood photoplethysmography waveform, Respiration Rate, Skin pressure, respiration rate (RRp), skin temperature, body temperature, Temperature & Posture. Data is and body temperature. body posture, body motion, R-R Intended use / Interval, heart rate variability transmitted wirelessly from The Biobeat Platform tracks Indications for use LifeSignals Biosensor to Remote changes in blood pressure based on (HRV) and Blood Pressure (optional). secure server for display, storage Pulse Wave Transit Time (PWTT) Data is transmitted wirelessly near & analysis. The LifeSignals which is obtained utilizing real time from Ubiq Vue 2A Wearable Multi-Parameter Remote pulsemeasurements from Biosensor and 3rd party device (for Monitoring Platform is intended Blood Pressure only) to Remote the integrated SpO2 sensor. for non-critical, adult population. following a calibration process Central server for display, storage, The LifeSignals Multi-Parameter using an FDA-cleared and analysis. The UbiqVue™ 2A Multiparameter Remote Monitoring Platform can oscillometric blood pressure include the ability to notify System is intended for non-critical, monitor. healthcare professionals when The Biobeat Platform is intended adult population. for spot- checking and tracking The UbiqVue™ 2A Multiparameter physiological parameters fall outside the set limits and to changes of adult patients in System shall include the ability to
ல் Substantial Equivalence comparison (Subject device & Predicate Device)
11
Image /page/11/Picture/0 description: The image contains the logo for LifeSignals. The logo consists of a blue square with a white waveform pattern on the left, followed by the word "LifeSignals" in a bold, blue sans-serif font. The waveform pattern is stylized and represents the company's focus on biosensors and remote monitoring.
K242018 510(k) Summary
| Comparison | Predicate-I (K202868) | Predicate-II (K212153) | Subject Device |
|---|---|---|---|
| multiple | |||
| display | |||
| patient | |||
| physiological data for remote | |||
| monitoring. | hospitals, clinics, long-term care, | ||
| and at home . The data from the | |||
| Biobeat Platform are intended for | |||
| use by healthcare professionals as | |||
| an aid to diagnosis and treatment. | |||
| The device is not intended for use | |||
| on critical care patients. | healthcare | ||
| professionals | |||
| notify | |||
| through alerts when Physiological | |||
| parameters fall outside the set limits, | |||
| manual trigger by patient and | |||
| to | |||
| multiple | |||
| display | |||
| patient's | |||
| physiological data for remote | |||
| monitoring at home and with visual | |||
| alarm for active monitoring at | |||
| hospitals and out of hospital patient | |||
| settings (such as clinics, | |||
| care | |||
| outpatient surgery facilities, long- | |||
| term care facilities and physician | |||
| which | |||
| care | |||
| offices) | |||
| in | |||
| is | |||
| administered | |||
| healthcare | |||
| by | |||
| professionals. | |||
| Intended Population | Non-critical, adult population, | ||
| 18 years or older | Non-critical, adult population, | ||
| 18 years or older | Non-critical, adult population, 18 | ||
| years or older | |||
| Intended Use | |||
| Environment | Home & Healthcare settings | Home & Healthcare settings | Home & Healthcare settings |
| Monitored Parameters | |||
| ECG (Two Channel) | V | ||
| ============================================================================================================================================================================== | × | V | |
| Heart Rate |
| V
. | × | イ |
| Heart Rate Variability | × | ਮ | イ |
| R-R Interval | メ | × | イ |
| Respiration Rate | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | V | V |
| Skin Temperature | V | × | イ |
| Body Temperature | × | V | イ |
| Body Posture | V | × | V |
| Body Motion | × | × | イ |
| SpO2% | × | V | V |
| Comparison | Predicate-I (K202868) | Predicate-II (K212153) | Subject Device |
| Pulse Rate | x | ✓ | ✓ |
| PPG Waveform | x | ✓ | ✓ |
| Blood Pressure | x | ✓ | ✓ (using 3rd party device) |
| Continuous Physiological
data monitoring | ✓ | x
(Spot check only) | ✓ |
| Heart Rate
Range | 30 – 250 BPM | x | 30 – 250 BPM |
| Accuracy | ± 3 BPM or 10% whichever
is greater | x | ± 3 BPM or 5% whichever is
greater |
| Respiration Rate
Range | 6-60 Breaths per Minute | 4-40 Breaths per Minute | 5-60 Breaths per Minute |
| Accuracy | ≤ 1 Breath per minute (Mean Absolute Error based on
Simulation study)
≤ 3 Breaths per minute (Mean Absolute Error based on Clinical
study) | ± 3 Breaths per Minute | ≤ 1 Breath per minute (Mean Absolute Error based on Simulation study)
≤ 3 Breaths per minute (Mean Absolute Error based on Clinical
study) |
| Method | Trans-thoracic Impedance (TTI),
ECG Derived Respiration (EDR)
based on RS Amplitude and
Accelerometer data. | Derived from
photoplethysmogram | Trans-thoracic Impedance (TTI),
ECG Derived Respiration (EDR)
based on RS Amplitude &
Respiratory Sinus arrhythmia
(RSA) and Accelerometer data. |
| Skin Temperature
Range | 32.0°C – 43.0°C
89.6°F – 109.4°F | x | 15.0°C – 43.0°C
59.0°F – 109.4°F |
| Accuracy | As per ASTM E1112-00 | x | As per ASTM E1112-00 |
| Body Temperature
Range | x | 32.0°C – 43.0°C
89.6°F – 107.6°F | 32.0°C - 43.0°C
89.6°F - 109.4°F |
| Comparison | Predicate-I (K202868) | Predicate-II (K212153) | Subject Device |
| Clinical Accuracy | × | ±0.3°C | -0.27 °C (Clinical Bias)
1.01°C (Limits of agreement) |
| Method | × | Adjusted mode (with Skin
Temperature & Ambient
Temperature) | Adjusted mode (with Skin
Temperature, Ambient
Temperature, Heart Rate &
Activity) |
| Posture Detection | Lying down, Upright or
Inclined | × | Supine, Prone, Lying- Left/Right,
Reclining, Reclining-Left/Right,
Leaning Forward, Upright, Upside
down |
| SpO2% | | | |
| Range | × | 40 to 100% | 0 to 100% |
| Accuracy | × | ±2% | ± 3 % (100 to 70%),
Less than 70% unspecified |
| PPG | × | ✓ | ✓ |
| Signal Strength Indicator | × | × | ✓ |
| Measurement Site | × | Chest | Chest |
| Optical Sensor | × | 880nm (IR), 650nm (Red) | Spectral Sensor |
| Pulse Rate | | | |
| Range | × | 40 to 250 BPM | 30 to 250 BPM |
| Accuracy | × | ± 3% | ± 3 or 5% whichever is greater |
| R-R Interval | × | × | ✓ |
| Beat Classification | × | × | ✓ |
| Sinus Heart Rate | × | × | ✓ |
| Heart Rate Variability
(HRV) | | | ✓ |
| SDNN | × | × | |
| SDANN | × | × | ✓ |
| Comparison | Predicate-I (K202868) | Predicate-II (K212153) | Subject Device |
| ASDNN | × | × | ✓ |
| RMSSD | × | × | ✓ |
| VLF Band | × | × | ✓ |
| LF Band | × | × | ✓ |
| HF Band | × | × | ✓ |
| Body Motion | × | × | No Body Motion, Mild Body
Motion, Moderate Body Motion,
Severe Body Motion |
| Sensor | | | |
| Single Use | ✓ | ✓ | ✓ |
| Wear Life | 120 hours | 120 hours | 120 hours |
| Dimension | 105 x 94 x 12 mm | Monitor enclosure - 38 x 38 x 15 mm.
Adhesive unit - 85 x 85 x 12 mm | 116 x 91 x17 mm |
| Weight | 28 g | 14g | 35 g |
| ECG Electrode distance | | | |
| ECG-A | 90.0 mm | × | 90.0 mm |
| ECG-B | 57.9 mm | | 73.0 mm |
| Location of Body | Upper Left Chest | Chest-patch attached to the skin
& Wrist device | Upper Center Chest or
Upper Left Chest |
| Data can be transferred &
temporarily stored | ✓ | ✓ | ✓ |
| Battery | Li-MnO2 (Primary) | Li-MnO2 (Primary) | Li-MnO2 (Primary) |
| Applied part category | Type CF | Type BF | Type CF |
| Defibrillation Proof | ✓ | × | ✓ |
| HF Surgical equipment
compatibility | ✓ | × | ✓ |
| Communication protocol | WLAN (802.11b) | BLE 4.2 | WLAN (802.11b), BLE 5.2 |
| Wireless Radio Frequency | 2.4 - 2.4835 GHz | 2.402-2.480 GHz | 2.4 - 2.4835 GHz |
| Comparison | Predicate-I (K202868) | Predicate-II (K212153) | Subject Device |
| Communication Security | WPA2-PSK/CCMP | AES-CCM 128 | WPA2-PSK /CCMP
AES-CCM 128 |
| Patient Relay Device | | | |
| Authentication from Server | ✓ | - | ✓ |
| Data transferred to Server | ✓ | - | ✓ |
| Data buffered if there is no
connection with Server | ✓ | ✓ | ✓ |
| GUI for Patient admission
(Only for Single Patient Relay) | ✓ | - | ✓ |
| GUI for PPG signal quality
(Only for Single Patient Relay) | × | - | ✓ |
| Secure Server | Data is stored for access by
Active Monitoring Portal &
any 3rd party server (through
API) | - | Data is stored for access by
Active Monitoring Portal & any
3rd party server (through API) |
| Programmable Alert | | | |
| Notification & Configurable | ✓ (Clinical, Technical, Manual) | - | ✓ (Clinical, Technical, Manual) |
| Early Warning Score
(NEWS2) | × | - | ✓ |
| Active Monitoring Portal | | | |
| Multi-patient Tile view | ✓ | - | ✓ |
| Single Patient Zoom view | ✓ | - | ✓ |
| Visual Alarm Indication | × | - | ✓ |
| Early Warning score | × | - | ✓ |
12
Image /page/12/Picture/0 description: The image contains the logo for LifeSignals. The logo consists of a blue square with a white waveform graphic inside, followed by the text "LifeSignals" in a bold, blue font. The waveform graphic appears to represent a life signal or vital sign, aligning with the company's name.
13
Image /page/13/Picture/0 description: The image shows the logo for LifeSignals. The logo consists of a blue square with a white waveform inside, followed by the word "LifeSignals" in blue, sans-serif font. The waveform graphic is on the left side of the logo, and the text is on the right.
14
Image /page/14/Picture/0 description: The image contains the logo for LifeSignals. The logo consists of a blue square on the left side, which contains a waveform graphic. To the right of the square is the company name, "LifeSignals", in a bold, blue font.
15
Image /page/15/Picture/0 description: The image shows the logo for LifeSignals. The logo consists of a blue square with a white waveform inside, followed by the word "LifeSignals" in blue, sans-serif font. The waveform graphic is on the left side of the logo, and the text is on the right.
Note: ✔ Feature is identical
× Feature not available - Feature Unknown
16
Image /page/16/Picture/1 description: The image contains the logo for LifeSignals. The logo consists of a blue square with a white waveform graphic on the left, followed by the word "LifeSignals" in a bold, blue font. The waveform graphic appears to represent a signal or wave pattern, possibly related to health or technology. The overall design is clean and modern.
Differences and Risks associated with that:
- The Subject device has additional physiological data monitoring capabilities of, R-R interval, Heart Rate Variability & Body . motion in the system, compared the Predicate device(s). However, performance of these parameters is validated & the technology to measure these parameters is equivalent to other 510(k) cleared device which is included as Reference Device-I under Section #10 below (K183978). Hence, these additional parameters do not affect the intended use of the Proposed device.
- The Subject device has an Early Warning Score display in the Active Monitoring dashboard as an added feature, compared to ● the Predicate Device(s). However, this does not add any risk, as Early Warning Score is based on well-known NEWS2 (National Early Warning Score by Royal College of Physicians, UK) adopted by other 510(k) cleared device which is included as Reference Device-I section #10 (K183078) and the integration of which is validated.
- The Subject device has improved algorithms to derive Respiration Respiratory Sinus arrhythmia (RSA) . based EDR, derive Heart Rate from either of the two channels dynamically & extended Skin temperature compared to the Predicate device. However, performance of improved Respiration Rate, Skin temperature algorithm is validated and hence does not add any risk.
- The Subject device has a Visual Alarm indication and intended for Active monitoring at hospitals patient care ● settings (such as clinics, outpatient surgery facilities and physician offices) in which care is administered by healthcare professionals, using the updated Active Monitoring portal. However, this does not add any risk, as the Visual Alarm indication is in compliance with IEC 60601-1-8 and Intended use is equivalent to other 510(k) cleared device which is included as Reference Device-III under Section #10 (K160951)
- The Subject Device uses IR/Red/White LED and Spectral sensor for continuous SpO2% & Pulse rate derivation compared to . the standard IR/Red LED/sensor used in the Predicate device. However, performance of these parameters is validated & the technology to measure these parameters is equivalent to other 510(k) cleared device which is included as Reference Device-II under Section #10 (K200160).
- The Body temperature accuracy claim of the predicate device is different from the subject device. However, the acuracy claims ● of the Reference Device-IV (K203215) that is included under Section #10 is same as the subject device.
17
Image /page/17/Picture/1 description: The image contains the logo for LifeSignals. The logo consists of a blue square with a white waveform graphic inside, followed by the company name "LifeSignals" in blue text. The waveform graphic is a series of vertical lines of varying heights, resembling a signal or sound wave.
10 Comparison with Reference devices for additional physiological monitoring parameters & Technology.
| Comparison | Reference Device -
I (K183078) | Reference Device
- II (K200160) | Reference Device-
III (K160951) | Reference Device-
IV (K203215) | Subject Device |
|------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Vital Connect, Inc. | Zoe Medical, Inc. | Philips Medical Systems | Masimo Corporation | LifeSignals, Inc., USA |
| Product Codes | DRG, MHX, DSI | MWI, DQA, DXN | MSX | FLL | DRG, MHX, FLL, DQA |
| Regulation | 21 CFR 870.2910 | 21 CFR 870.2300 | 21 CFR 870.2300 | 21 CFR 880.2910 | 21 CFR 870.2910 |
| Classification (Primary) | Class II | Class II | Class II | Class II | Class II |
| Intended use /
Indications for use | The VitalConnect
Platform is a wireless
remote monitoring
system intended for
use by healthcare
professionals for
continuous collection
of physiological data
in home and
healthcare settings.
This can include heart
rate,
electrocardiography
(ECG), heart rate
variability, R-R
interval, respiratory
rate, body
temperature, skin
temperature, activity | The 740 SafeSAT is
indicated for use as
a bedside, portable
device for use by
health care
professionals,
clinicians and
medically qualified
personnel for spot
checking,
continuous
monitoring and
recording of adult
and pediatric
patients,
excluding neonates.
The Monitor
features technology
to facilitate the | The Efficia CMS200
central monitoring
system is intended for
use by healthcare
professionals for
central viewing of
physiologic waves,
parameters, and trends
from other networked
medical devices
(patient monitors and
vital signs
monitors) for multiple
patients. It provides
secondary operator
notification of alarms
from other networked
medical devices. It
provides for the | Radius T wearable
thermometer is
intended for single-
use, continuous
noninvasive
measurement of body
temperature on the
upper chest via
wireless
communication to a
smart device
application or
compatible patient
monitor (i.e., Masimo
Root, Masimo Rad-
97).
The Radius T is
indicated for single-
use, continuous body | The UbiqVue™ 2A
Multiparameter System 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, 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 Blood Pressure
(optional). Data is transmitted |
| Comparison | Reference Device -
I (K183078) | Reference Device - II (K200160) | Reference Device-
III (K160951) | Reference Device-
IV (K203215) | Subject Device |
| | (including
step
count), and posture
(body
position
relative to gravity
including fall). Data
are
transmitted wirelessly
from
the
VitalConnect Sensor
for
storage
and
analysis. The Vital
Connect Platform can
include the ability to
notify
healthcare
professionals
when
physiological data fall
outside
selected
parameters. The data
from
the
VitalConnect
Platform are intended
for use by healthcare
professionals as an
aid to diagnosis and
treatment. | monitoring of non-
invasive
blood
pressure, pulse rate
and
functional
arterial
oxygen
saturation (SpO2) in
a variety of clinical
environments. | retrospective review of
alarm
conditions,
physiologic waves and
parameters
from
multiple patients. The
intended use of the
printer, when present,
is to provide hardcopy
text, graphics,
and
wave data. The Efficia
CMS200 may provide
for connection and
information exchange
to external systems.
The Efficia CMS200 is
intended for use in
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. | temperature
measurements
of
persons 5 years of age
or
older in hospitals,
hospital-type
facilities, and home
environments. | wirelessly near real time from
UbiqVue
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. |
| Comparison | Reference Device -
I (K183078) | Reference Device - II (K200160) | Reference Device-
III (K160951) | Reference Device-
IV (K203215) | Subject Device |
| Intended Population | General care
patients who are 18
years or older | General & Acute
care
Adult and
Pediatric Patients | General patients | 5 years or older | Non-critical, adult
population, 18 years or
older |
| Intended Use
Environment | Home & Healthcare
settings | Healthcare
Settings | Healthcare Settings | Home &
Healthcare settings | Home & Healthcare
settings |
| Monitored Parameters | | | | | |
| ECG | ✓ (Single
Channel) | × | ✓ | × | ✓ (Two Channels) |
| Heart Rate | ✓ | × | ✓ | × | ✓ |
| Heart Rate Variability | ✓ | × | ✓ | × | ✓ |
| R-R Interval | ✓ | × | ✓ | × | ✓ |
| Respiration Rate | ✓ | × | ✓ | × | ✓ |
| Skin Temperature | ✓ | × | × | × | ✓ |
| Body Temperature | ✓ | × | ✓ | ✓ | ✓ |
| Body Posture | ✓ | × | × | × | ✓ |
| Activity / Body Motion | ✓ (Activity) | × | × | × | ✓ (Body motion) |
| SpO2% | × | × | ✓ | × | ✓ |
| Pulse Rate | × | × | ✓ | × | ✓ |
| PPG Waveform | × | × | ✓ | × | ✓ |
| Blood Pressure | × | × | ✓ | × | ✓ (using 3rd party
device) |
| Continuous
Physiological data
monitoring | ✓ | ✓ | ✓ | ✓ | ✓ |
| Comparison | Reference Device -
I (K183078) | Reference Device -
II (K200160) | Reference Device-
III (K160951) | Reference Device-
IV (K203215) | Subject Device |
| Body Temperature
Range | 32.0°C - 43.0°C
89.6°F - 109.4°F | × | - | 25.0°C – 43.0°C
77.0°F - 109.4°F | 32.0°C - 43.0°C
89.6°F - 109.4°F |
| Clinical Accuracy | ≤ 1°C (Mean
absolute error) | × | - | -0.27 °C
(Clinical Bias)
≤1.0°C
(Limits of agreement) | -0.27 °C (Clinical Bias)
1.01°C (Limits of agreement) |
| Method | Adjusted mode
(with Skin
Temperature &
Ambient
Temperature) | × | - | Adjusted mode
(surface
temperature) | Adjusted mode (with
Skin Temperature,
Ambient Temp, Heart
Rate & Activity) |
| SpO2%
Range | × | 0 to 100% | - | × | 0 to 100% |
| Accuracy | × | ± 2 % (100 to
70%),
Less than 70%
unspecified | - | × | ± 3 % (100 to 70%),
Less than 70% unspecified |
| PPG | × | ✓ | - | × | ✓ |
| Signal Strength Indicator | × | ✓ | - | × | ✓ |
| Method | × | LED - Red, IR &
White
Two Photo sensor | - | × | LED - Red, IR & White
Two Photo sensor |
| Pulse Rate
Range | × | 30 to 250 BPM | - | × | 30 to 250 BPM |
| Accuracy | × | ± 3 or 5%
whichever is
greater | - | × | ± 3 or 5% whichever is
greater |
| R-R Interval | ✓ | × | - | × | ✓ |
| Comparison | Reference Device -
I (K183078) | Reference Device - II (K200160) | Reference Device-
III (K160951) | Reference Device-
IV (K203215) | Subject Device |
| Beat Classification | ✓ | × | - | × | ✓ |
| Sinus Heart Rate | ✓ | × | - | × | ✓ |
| Heart Rate Variability
(HRV) | ✓ | × | - | × | ✓ |
| Monitoring Dashboard | | | | | |
| Multi-patient Tile view | ✓ | × | ✓ | × | ✓ |
| Single Patient Zoom
view | ✓ | ✓ | ✓ | × | ✓ |
| Visual Alarm Indication | × | × | ✓ | × | ✓ |
| Viewing the Trend | ✓ | × | ✓ | × | ✓ |
| Early Warning Score
(NEWS2) | ✓ | × | × | × | ✓ |
18
Image /page/18/Picture/0 description: The image contains the logo for LifeSignals. The logo consists of a blue square with a waveform graphic on the left and the word "LifeSignals" in blue on the right. The waveform graphic is made up of several vertical lines of varying heights, resembling a signal or sound wave.
K242018 510(k) Summary
19
Image /page/19/Picture/0 description: The image shows the LifeSignals logo. The logo consists of a blue square with a white waveform inside, followed by the word "LifeSignals" in blue. The waveform is a series of vertical lines of varying heights, resembling a sound wave or a heartbeat signal. The text "LifeSignals" is written in a bold, sans-serif font.
20
Image /page/20/Picture/0 description: The image contains the logo for LifeSignals. The logo consists of a blue square with white signal wave patterns on the left, followed by the text "LifeSignals" in blue. The text is in a sans-serif font, with the word "Life" slightly larger than "Signals".
21
Image /page/21/Picture/0 description: The image contains the logo for LifeSignals. The logo consists of a blue square with a white waveform inside, followed by the word "LifeSignals" in blue. The waveform is a series of vertical lines that vary in height, resembling a signal or sound wave.
K242018 510(k) Summary
Note: ✔ Feature is identical × Feature not available - Feature Unknown
22
Image /page/22/Picture/1 description: The image shows the logo for LifeSignals. The logo consists of a blue square with a white waveform inside, followed by the word "LifeSignals" in blue. The waveform is a stylized representation of a life signal, such as an electrocardiogram (ECG) or electroencephalogram (EEG). The logo is simple and modern, and it conveys the company's focus on life science.
- The function of Active Monitoring portal of the Subject device at hospitals & 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 is equivalent to the Reference device-III. The Reference device-III obtains data from networked patient monitors, while the subject device obtains data from the networked Biosensors. Both Subject device & Reference device-III provide centralized viewing of waveforms, numeric data and alarms from all the connected beds. Both Reference Device-III & Subject device allow for retrospective data review and can transfer data to an electronic medical record system (EMR).
- One main difference between the Reference Device-III & Subject device is that the O Reference Device-III provides secondary alarm notification (both audio & visual), while the Subject device provides primary visual alarm notification. The Subject device Portal does not have the claims of audio alarm. The Reference Device-III software is intended to be installed in a dedicated PC that meets the audio alarm specification, while the subject device is browser-based solution & not specific to any specific hardware (PC). However, the alert notification (e.g. Email or SMS) by the Subject device can be configured to be an audible one and further not intended for critical patients. Hence, this does not add any risk.
- The Subject device uses the same technology of three LED & two photosensors used in ● Reference device-II. However, the location of SpO2 monitoring in Subject device is on "Chest", while it is "Finger" in the Reference device-II. However, the sensor design is suitably modified for the "Chest" based measurement and the performance of SpO2% & Pulse Rate on "Chest" is validated through hypoxia tests as per ISO80601-2-61. Further, the subject device has additional controls for Chest-based measurement, such as providing visual guidance to the User to identify suitable location on the Chest for affixing the Biosensor. All the subject device has an in-built algorithm to invalidate or discard the derived SpO2% & Pulse rate value if there is a severe body motion or heavy respiration, by accessing the PPG signal & accelerometer data. Hence, this does not add any risk.
11 Summary of Performance Testing
Verification & Validation activities were performed on UbiqVue™ 2A Multiparameter System to demonstrate substantial equivalence to the predicate device:
- Biocompatibility testing of In-vitro cytotoxicity, skin irritation and skin sensitization ● were conducted on UbiqVue™ 2A Wearable Biosensor, according to ISO 10993-1: 2018 Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing within a Risk Management Process.
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Image /page/23/Picture/1 description: The image contains the logo for LifeSignals. The logo consists of a blue square with a white waveform inside of it. To the right of the square is the word "LifeSignals" in a blue sans-serif font.
- Electrical Safety and electromagnetic compatibility testing were conducted on . UbiqVue™ 2A Multiparameter System with UbiqVue™ 2A Wearable Biosensors for compliance with IEC 60601-1(Ed.3.2), IEC 60601-1-2 (Ed. 4.1) and IEC 60601-1-11(Ed. 2.1).
- UbiqVue™ 2A Multiparameter System with UbiqVue™ 2A Wearable Biosensors (at ● Upper Center Chest location & Upper Left Chest location) were verified & validated for compliance with ISO 80601-2-61(Ed. 2.0) standard including clinical validation to determine the accuracy of SpO2% with respect to SaO2 values from simultaneously drawn arterial blood.
- The Pulse Rate accuracy performance of UbiqVue™ 2A Multiparameter System was . verified by using bench testing, as per ISO 80601-2-61(Ed. 2.0) and through clinical validation by a reference device.
- Body temperature accuracy performance of UbiqVue™ 2A Multiparameter System ● was validated using non-randomized, self-control comparative on-body comparative performance with oral digital thermometer on multiple subject populations in accordance with the ISO 80601-2-56 (Ed.2.0).
- The Skin temperature accuracy performance of Ubiq Vuelle 2A Multiparameter System ● was reverified by using bench testing, as per ASTM E1112-00 & ISO80601-2-56 (Ed. 2.0).
- ECG & Heart Rate Performance testing was repeated on the UbiqVue™ 2A . Multiparameter System for compliance with ANSI AAMI IEC 60601-2-47:2012, IEC 60601-2-27(Ed.3.0) & IEC 60601-2-25 (Ed. 2.0).
- . Wear-life performance of ECG waveform quality, Heart Rate, Respiration Rate, Skin Temperature, and SpO2% of UbiqVue™ 2A Multiparameter System under normal use condition was validated using non-randomized, self-control comparative on-body comparative performance study for the wear period of 120 hours.
- Improvement in the Respiration algorithm was 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 Alert system & Visual alarm display on UbiqVue™ 2A Multiparameter System . was validated for compliance with IEC 60601-1-8 (Ed. 2.2).
- Usability study was conducted on UbiqVue™ 2A Multiparameter System for . compliance with IEC 60601-1-6 (Ed. 3.2) and "USFDA Guidance- Applying Human Factors and Usability Engineering to Medical Devices."
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Image /page/24/Picture/1 description: The image contains the logo for LifeSignals. The logo consists of a blue square with a white waveform inside of it. To the right of the square is the word "LifeSignals" in blue, sans-serif font. The logo is simple and modern, and the waveform suggests that the company is involved in the medical or healthcare industry.
- Wireless performance & coexistence testing conducted as per ANSI/IEEE . C63.27:2017: American National Standard for Evaluation of Wireless coexistence on Ubig Vue™ 2A Multiparameter System for both Single Patient Relay System & Multi-Patient Relay System.
- Software in the UbiqVue™ 2A Multiparameter System was designed, documented, ● verified & validated as per the IEC 62304: Medical device Software - Software Life Cycle Process and USFDA Guidance for the content of premarket submissions for Software contained in medical device. The Software for this device is determined as Class B. "Moderate-Enhanced documentation" level of concern.
- . Software in the UbiqVue™ 2A Multiparameter System was securely designed by conforming to IEC 81001-5-1 Health software and health IT systems safety, effectiveness and security – Activities in the product life cycle.
- Shelf-life & Reliability and testing were conducted and verified on UbiqVue™ 2A Wearable Biosensor, as per the acceptance criteria.
- Packaging test conducted on the packaged Ubiq Vue™ 2A Wearable Biosensors as per ● ASTM D7386-16.
12 Conclusion
The UbiqVue 2A Multiparameter System is substantially equivalent in indications for use & intended use to the legally marketed Predicate Device(s) & Reference Device(s). The Technology adopted for additional physiological parameters in UbiqVue 2A Multiparameter System is substantially equivalent to the technology adopted in the Reference Device(s). Minor differences between UbiqVue 2A Multiparameter System and the Predicate & Reference devices have no significant effect on safety or effectiveness, as established through various performance tests. Thus, the proposed device/system is substantially equivalent to the legally marketed predicate & reference devices.