UbiqVue™ 2A Multi-parameter System (UX2550)

K242018 · Lifesignals, Inc. · DRG · Nov 12, 2024 · Cardiovascular

Device Facts

Record IDK242018
Device NameUbiqVue™ 2A Multi-parameter System (UX2550)
ApplicantLifesignals, Inc.
Product CodeDRG · Cardiovascular
Decision DateNov 12, 2024
DecisionSESE
Submission TypeTraditional
Regulation21 CFR 870.2910
Device ClassClass 2

Intended Use

The UbiqVue 2A Multiparameter System is a wireless remote patient monitoring system intended for use by healthcare professionals for continuous collection of physiological data at home and in healthcare settings. This shall include electrocardiography (2-Channel ECG), heart rate, SpO2%, respiration rate, pulse rate, photoplethysmography waveform, skin temperature, body 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.

Device Story

Wireless remote patient monitoring system; collects physiological data via wearable biosensor (chest-worn) and optional 3rd-party BP device. Biosensor acquires 2-channel ECG, PPG, skin temperature, and accelerometer data; transmits via WLAN/BLE to relay devices (single-patient mobile app or multi-patient Linux-based server). Central server processes data; derives vitals (SpO2, HR, respiration, body temperature, HRV, posture, motion); manages alerts (clinical/technical/manual) via SMS/email/WhatsApp. Healthcare professionals access data via browser-based Active Monitoring Portal for real-time dashboard viewing, trend analysis, and alarm management. System supports NEWS2 early warning scores. Benefits include continuous, non-critical patient monitoring in hospitals, clinics, and home settings, enabling timely clinical intervention.

Clinical Evidence

Clinical validation included SpO2 accuracy testing (hypoxia study vs. arterial blood gas) per ISO 80601-2-61, body temperature accuracy vs. oral digital thermometer per ISO 80601-2-56, and wear-life performance (120 hours) for ECG, HR, respiration, and temperature. Respiration algorithm validated against clinician-scored EtCO2. Usability study conducted per IEC 60601-1-6.

Technological Characteristics

Wearable biosensor (Type CF applied part) with 2-channel ECG, spectral optical sensor (Red/IR/White), thermistor, and accelerometer. Connectivity: WLAN (802.11b) and BLE 5.2. Data transmission: AES-encrypted. Dimensions: 116x91x17mm. Power: Li-MnO2 primary battery. Software: Class B (Moderate-Enhanced). Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, ISO 80601-2-61, ISO 80601-2-56, ANSI AAMI IEC 60601-2-47.

Indications for Use

Indicated for non-critical adult patients (18+ years) for continuous remote monitoring of physiological data (ECG, HR, SpO2, respiration, pulse, temperature, posture, motion, HRV, R-R interval, BP) in home and healthcare settings.

Regulatory Classification

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.

Predicate Devices

Reference Devices

Related Devices

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol representing the Department of Health & Human Services on the left, and the text "FDA U.S. FOOD & DRUG ADMINISTRATION" on the right. The text is in a sans-serif font, with "FDA" in a blue square and the rest of the text in blue as well. 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) K242018 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) ## CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ## *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {4}------------------------------------------------ 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<br>Classification | Product<br>Code | Description | |----------------|------------------------------|-----------------|-------------------------------------------------------------------------| | Cardiovascular | 21 CFR 870.2910<br>Class II | DRG | Transmitters and Receivers,<br>Physiological Signal, Radio<br>frequency | ### 5 Subsequent Product code | | Regulation<br>Classification | Product<br>Code | Description | |------------------|------------------------------|-----------------|-----------------------------------------------------------------------------| | Cardiovascular | 21 CFR 870.1025<br>Class II | MHX | Monitor, Physiological,<br>Patient (With Arrhythmia<br>Detection Or Alarms) | | General Hospital | 21 CFR 880.2910<br>Class II | FLL | Thermometer, Electronic,<br>Clinical | {5}------------------------------------------------ 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<br>Classification | Product<br>Code | Description | |----------------|------------------------------|-----------------|-------------| | Anesthesiology | 21 CFR 870.2700<br>Class II | DQA | Oximeter | ### 6 Predicate & Reference Devices | <b>Primary Predicate Device:</b> | | |----------------------------------|---------------------------------------------------------| | 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 | {6}------------------------------------------------ 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: - 1) UbiqVue™ 2A Wearable Biosensor - 2) UbigVue™ Single Patient Relay - 3) UbiqVue™ Multi-Patient Relay - 4) UbiqVue™ Central Server - 5) UbiqVue™ Active Monitoring Portal - 6) UbiqVue™ Relay Bridge Software (optional) - 7) UbiqVue™ Bluetooth Gateway Software (optional) - 8) Third-party Blood Pressure device (optional) - The UbigVue™ 2A Wearable Biosensor when attached to body acquires two channels of ● ECG signals, TTI respiration signals (one of the inputs for deriving Respiration Rate), resistance variation of a Thermistor attached to body (used for deriving Skin Temperature) & accelerometer data (input for deriving Respiration Rate & Posture), pre-processes them and wirelessly transmits to a paired Relay device, as cleared under K202868. Following are additional features proposed in this submission: - Ambient temperature sensor for Body temperature derivation. 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<br>display<br>patient<br>physiological data for remote<br>monitoring. | hospitals, clinics, long-term care,<br>and at home . The data from the<br>Biobeat Platform are intended for<br>use by healthcare professionals as<br>an aid to diagnosis and treatment.<br>The device is not intended for use<br>on critical care patients. | healthcare<br>professionals<br>notify<br>through alerts when Physiological<br>parameters fall outside the set limits,<br>manual trigger by patient and<br>to<br>multiple<br>display<br>patient's<br>physiological data for remote<br>monitoring at home and with visual<br>alarm for active monitoring at<br>hospitals and out of hospital patient<br>settings (such as clinics,<br>care<br>outpatient surgery facilities, long-<br>term care facilities and physician<br>which<br>care<br>offices)<br>in<br>is<br>administered<br>healthcare<br>by<br>professionals. | | Intended Population | Non-critical, adult population,<br>18 years or older | Non-critical, adult population,<br>18 years or older | Non-critical, adult population, 18<br>years or older | | Intended Use<br>Environment | Home & Healthcare settings | Home & Healthcare settings | Home & Healthcare settings | | Monitored Parameters | | | | | ECG (Two Channel) | V<br>============================================================================================================================================================================== | × | V | | Heart Rate<br> | V<br>. | × | イ | | Heart Rate Variability | × | ਮ | イ | | R-R Interval | メ | × | イ | | Respiration Rate | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | 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<br>data monitoring | ✓ | x<br>(Spot check only) | ✓ | | Heart Rate<br>Range | 30 – 250 BPM | x | 30 – 250 BPM | | Accuracy | ± 3 BPM or 10% whichever<br>is greater | x | ± 3 BPM or 5% whichever is<br>greater | | Respiration Rate<br>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<br>Simulation study)<br>≤ 3 Breaths per minute (Mean Absolute Error based on Clinical<br>study) | ± 3 Breaths per Minute | ≤ 1 Breath per minute (Mean Absolute Error based on Simulation study)<br>≤ 3 Breaths per minute (Mean Absolute Error based on Clinical<br>study) | | Method | Trans-thoracic Impedance (TTI),<br>ECG Derived Respiration (EDR)<br>based on RS Amplitude and<br>Accelerometer data. | Derived from<br>photoplethysmogram | Trans-thoracic Impedance (TTI),<br>ECG Derived Respiration (EDR)<br>based on RS Amplitude &<br>Respiratory Sinus arrhythmia<br>(RSA) and Accelerometer data. | | Skin Temperature<br>Range | 32.0°C – 43.0°C<br>89.6°F – 109.4°F | x | 15.0°C – 43.0°C<br>59.0°F – 109.4°F | | Accuracy | As per ASTM E1112-00 | x | As per ASTM E1112-00 | | Body Temperature<br>Range | x | 32.0°C – 43.0°C<br>89.6°F – 107.6°F | 32.0°C - 43.0°C<br>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)<br>1.01°C (Limits of agreement) | | Method | × | Adjusted mode (with Skin<br>Temperature & Ambient<br>Temperature) | Adjusted mode (with Skin<br>Temperature, Ambient<br>Temperature, Heart Rate &<br>Activity) | | Posture Detection | Lying down, Upright or<br>Inclined | × | Supine, Prone, Lying- Left/Right,<br>Reclining, Reclining-Left/Right,<br>Leaning Forward, Upright, Upside<br>down | | SpO2% | | | | | Range | × | 40 to 100% | 0 to 100% | | Accuracy | × | ±2% | ± 3 % (100 to 70%),<br>Less than 70% unspecified | | PPG | × | ✓ | ✓ | | Signal Strength Indicator | × | × | ✓ | | Measurement Site | × | Chest | Chest | | Optical Sensor | × | 880nm (IR), 650nm (Red) | Spectral Sensor | | Pulse Rate | | |…
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510(k) Summary
Decision Summary
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