K Number
K202868
Device Name
LifeSignals Multi-Parameter Remote Monitoring Platform
Manufacturer
Date Cleared
2021-07-21

(296 days)

Product Code
Regulation Number
870.2910
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The LifeSignals Multi-parameter Remote Monitoring Platform is a wireless remote monitoring system intended for use by healthcare professionals for continuous collection of physiological data at home and in healthcare settings. This shall include Electrocardiography (2-channel ECG), Heart Rate, Skin Temperature & Posture, Data is transmitted wirelessly from LifeSignals Biosensor to Remote secure server for display, storage & analysis. The LifeSignals Multi-parameter Remote Monitoring Platform is intended for non-critical, adult population. The LifeSignals Multi parameter Remote Monitoring Platform can include the ability to notify healthcare professionals when physiological parameters fall outside the set limits and to display multiple patient physiological data for remote monitoring.
Device Description
LifeSignals Multi-parameter Remote Monitoring Platform consists of four main components: - (1) LifeSignals Multi-parameter Biosensor - (2) LifeSignals Relay device (Software Application) - (3) LifeSignals Secure Server (Software Application) - (4) Web UI /Remote Monitoring Dashboard - LifeSignals Multi-parameter Biosensor when attached body acquires two channel of ECG . signals, TTI respiration signals (one of the input for deriving Respiration Rate), resistance variation of a Thermistor attached to body (used for deriving Skin Temperature) & accelerometer data (input for deriving Respiration Rate & Posture), pre-processes them and wirelessly transmits to a paired Relay device (or any Receiver system). When Relay device is available within the wireless range, the acquired data is continuously transmitted to the Relay device immediately. If Relay device is not available or if there is any interruption in the communication between Relay device and Biosensor, data shall be temporarily buffered locally in Biosensor till the wireless connection is re-established. Biosensor Patch uses standard WLAN (802.11b) secured (AES) communication protocol for wireless data transmission to the Relay Device. - Relav Device manages wireless communication between LifeSignals Biosensor and ● LifeSignals Remote Secure Server. Relay device is a LifeSignals Relay Application software installed in a compatible commercial hardware platform, like a mobile phone or a tablet. - LifeSignals Relay (Application) functions include: . - . Manages secured wireless communication (WLAN 802.11b) between Relay device & Lifesignals Biosensor and encrypted communication between the Relay device and the LifeSignals Remote Secure Server. - Receives physiological signals from the Biosensor and transmit them after encryption to Secure Server as quickly as possible. It manages the database in Relay device for buffering/storing the data securely, if there is any disruption in communication with the Secure Server. - I Provides user interface for entering the Biosensor & Patient information and pairing & establishing connection with the Biosensor. - . Provides User Interface to record any manual alert events by the patient. - . Secure Server is a LifeSignals Secure Server Application software installed in Linuxcompatible Secure server hardware platform. LifeSignals Secure Server Application manages the decryption, uploading and storage of Biosensor data received from multiple authenticated Relay devices. The "Sensor Processing Library" in LifeSignals Secure Server process, filter the received Biosensor data and derives Heart Rate, Respiration Rate, Skin Temperature & Posture before storing them in a secured location along with received Biosensor data, for access by Web UI or any 3rd-party applications for display or analysis purpose. LifeSignals Secure Server Application shall have an optional ability to send alert notifications to any configured destination (email, SMS, WhatsApp), when the parameters (Heart Rate, Respiration Rate or Skin temperature) exceed the configured limits. - . LifeSignals Web UI / Remote Monitoring dashboard is a web-browser User Interface Application that enable caregiver (Clinical personnel) to login to the LifeSignals Secure server remotely and access the patient physiological data (Biosensor & derived data) & Alert status. The caregiver (Clinical personnel) depending on the roles (normal or supervisory) can access multiple patient data and search them based on the recent alert status. This includes patients that are active (wearing Biosensor) and procedures completed. Remote Monitoring Dashboard/Web UI shall also have an ability to continuously display physiological parameters (Heart Rate, Respiration Rate, Skin Temperature, Posture) & waveforms (ECG & Respiration) of multiple patients or single patient quasi-real time remotely on the screen for monitoring by caregiver (Clinical personnel). This monitoring dashboard also has the ability for the caregiver (clinical personnel) to set the alert limits & notify address that configures the Secure server to send an alert notification to any Mobile Phone (SMS or WhatsApp) or Email ID of care giver, when parameters falls outside the set value. Note: The Biosensor data may be accessible by a Third-Party Application installed in the Relay device using the Application Programming Interface (API) layer of the LifeSignal Relay Application Software, after suitable configuration and verification. In this configuration. LifeSignals Secure Server is optional and the data from Relay device shall be transmitted to a third-party server location. But the third-party server shall be installed with LifeSignals "Sensor Processing Library" for derivation Heart Rate, Respiration Rate, Skin Temperature & Posture.
More Information

No
The summary describes standard signal processing and threshold-based alerting, with no mention of AI, ML, or related concepts like training/test sets for algorithms.

No.
This device is for monitoring physiological data and has no stated therapeutic function.

No

This device is described as a "wireless remote monitoring system intended for use by healthcare professionals for continuous collection of physiological data". While it collects and analyzes physiological data (ECG, Heart Rate, Skin Temperature, Posture) and can alert healthcare professionals to parameters falling outside set limits, its intended use is for monitoring, not for diagnosing a specific disease or condition. It explicitly states it is for "non-critical" populations and for "remote monitoring".

No

The device description explicitly includes a "LifeSignals Multi-parameter Biosensor" which is a hardware component that acquires physiological data. While the platform includes software components, it is not solely software.

Based on the provided information, this device is not an In Vitro Diagnostic (IVD).

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 data includes ECG, Heart Rate, Skin Temperature, and Posture. These are physiological measurements taken directly from the patient's body.
  • Device Description: The device components and their functions are described as acquiring, transmitting, processing, and displaying physiological signals from the body. There is no mention of analyzing samples of human origin (like blood, urine, tissue, etc.) outside of the body.
  • Lack of IVD Characteristics: The description does not include any elements typically associated with IVDs, such as reagents, assays, sample preparation, or analysis of biological samples.

In summary, the LifeSignals Multi-parameter Remote Monitoring Platform is a system for monitoring physiological parameters directly from the patient's body, which falls under the category of in vivo medical devices, not in vitro diagnostics.

N/A

Intended Use / Indications for Use

The LifeSignals Multi-parameter Remote Monitoring Platform is a wireless remote monitoring system intended for use by healthcare professionals for continuous collection of physiological data at home and in healthcare settings. This shall include Electrocardiography (2-channel ECG), Heart Rate, Skin Temperature & Posture, Data is transmitted wirelessly from LifeSignals Biosensor to Remote secure server for display, storage & analysis.

The LifeSignals Multi-parameter Remote Monitoring Platform is intended for non-critical, adult population.

The LifeSignals Multi parameter Remote Monitoring Platform can include the ability to notify healthcare professionals when physiological parameters fall outside the set limits and to display multiple patient physiological data for remote monitoring.

Product codes (comma separated list FDA assigned to the subject device)

DRG, MHX, FLL

Device Description

LifeSignals Multi-parameter Remote Monitoring Platform consists of four main components:

  • (1) LifeSignals Multi-parameter Biosensor
  • (2) LifeSignals Relay device (Software Application)
  • (3) LifeSignals Secure Server (Software Application)
  • (4) Web UI /Remote Monitoring Dashboard

LifeSignals Multi-parameter Biosensor when attached body acquires two channel of ECG . signals, TTI respiration signals (one of the input for deriving Respiration Rate), resistance variation of a Thermistor attached to body (used for deriving Skin Temperature) & accelerometer data (input for deriving Respiration Rate & Posture), pre-processes them and wirelessly transmits to a paired Relay device (or any Receiver system). When Relay device is available within the wireless range, the acquired data is continuously transmitted to the Relay device immediately. If Relay device is not available or if there is any interruption in the communication between Relay device and Biosensor, data shall be temporarily buffered locally in Biosensor till the wireless connection is re-established.

Biosensor Patch uses standard WLAN (802.11b) secured (AES) communication protocol for wireless data transmission to the Relay Device.

Relay Device manages wireless communication between LifeSignals Biosensor and LifeSignals Remote Secure Server. Relay device is a LifeSignals Relay Application software installed in a compatible commercial hardware platform, like a mobile phone or a tablet.
LifeSignals Relay (Application) functions include:

  • Manages secured wireless communication (WLAN 802.11b) between Relay device & Lifesignals Biosensor and encrypted communication between the Relay device and the LifeSignals Remote Secure Server.
  • Receives physiological signals from the Biosensor and transmit them after encryption to Secure Server as quickly as possible. It manages the database in Relay device for buffering/storing the data securely, if there is any disruption in communication with the Secure Server.
  • Provides user interface for entering the Biosensor & Patient information and pairing & establishing connection with the Biosensor.
  • Provides User Interface to record any manual alert events by the patient.

Secure Server is a LifeSignals Secure Server Application software installed in Linux-compatible Secure server hardware platform.
LifeSignals Secure Server Application manages the decryption, uploading and storage of Biosensor data received from multiple authenticated Relay devices. The "Sensor Processing Library" in LifeSignals Secure Server process, filter the received Biosensor data and derives Heart Rate, Respiration Rate, Skin Temperature & Posture before storing them in a secured location along with received Biosensor data, for access by Web UI or any 3rd-party applications for display or analysis purpose.
LifeSignals Secure Server Application shall have an optional ability to send alert notifications to any configured destination (email, SMS, WhatsApp), when the parameters (Heart Rate, Respiration Rate or Skin temperature) exceed the configured limits.

LifeSignals Web UI / Remote Monitoring dashboard is a web-browser User Interface Application that enable caregiver (Clinical personnel) to login to the LifeSignals Secure server remotely and access the patient physiological data (Biosensor & derived data) & Alert status. The caregiver (Clinical personnel) depending on the roles (normal or supervisory) can access multiple patient data and search them based on the recent alert status. This includes patients that are active (wearing Biosensor) and procedures completed.

Remote Monitoring Dashboard/Web UI shall also have an ability to continuously display physiological parameters (Heart Rate, Respiration Rate, Skin Temperature, Posture) & waveforms (ECG & Respiration) of multiple patients or single patient quasi-real time remotely on the screen for monitoring by caregiver (Clinical personnel).
This monitoring dashboard also has the ability for the caregiver (clinical personnel) to set the alert limits & notify address that configures the Secure server to send an alert notification to any Mobile Phone (SMS or WhatsApp) or Email ID of care giver, when parameters falls outside the set value.

Note: The Biosensor data may be accessible by a Third-Party Application installed in the Relay device using the Application Programming Interface (API) layer of the LifeSignal Relay Application Software, after suitable configuration and verification. In this configuration. LifeSignals Secure Server is optional and the data from Relay device shall be transmitted to a third-party server location. But the third-party server shall be installed with LifeSignals "Sensor Processing Library" for derivation Heart Rate, Respiration Rate, Skin Temperature & Posture.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Upper Left Chest

Indicated Patient Age Range

Adult population, 18 years or older

Intended User / Care Setting

Healthcare professionals for continuous collection of physiological data at home and in healthcare settings.

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 LifeSignals Multi-parameter Remote Monitoring Platform to demonstrate substantial equivalence to the predicate device:

  • Biocompatibility testing of In-vitro cytotoxicity, skin irritation, Intracutaneous reactivity and skin sensitization were conducted on the LifeSignals Multi-parameter Biosensor Patch, according to ISO 10993-1: 2009 Biological Evaluation of Medical Devices – Part 1 : Evaluation and Testing within a Risk Management Process.
  • Electrical Safety and electromagnetic compatibility testing were conducted on the Multi-parameter Biosensor Patch for compliance with ANSI AAMI ES60601-1:2005. ANSI AAMI IEC 60601-1-2:2014 and ANSI AAMI HA 60601-1-11:2015.
  • ECG Performance testing were repeated on the LifeSignals Multi-parameter Remote Monitoring Platform for compliance with ANSI AAMI IEC 60601-2-47:2012, IEC 60601-2-27:2011 & ANSI AAMI ISO 60601-2-25:2011.
  • Usability study was conducted on the LifeSignals Multi-parameter Remote Monitoring Platform for compliance with IEC 60601-1-6:2013 and "USFDA Guidance- Applying Human Factors and Usability Engineering to Medical Devices. "
  • Wear-life performance of ECG waveform quality, Heart Rate, Respiration Rate & Skin Temperature of LifeSignals Multi-parameter Remote Monitoring Patch Platform under normal use condition was validated using non-randomized, self-control comparative on-body comparative performance study for the wear period of 120 hours.
  • ECG & Heart Rate accuracy performance validation of LifeSignals ECG Remote Monitoring Patch Platform (Reference Device-II) under various conditions (normally activity, posture, etc.) using non-randomized, self-control comparative on-body comparative performance, is valid for LifeSignals Multiparameter Remote Monitoring Platform.
  • Respiration Rate performance under various postures & normal activity is validated through on-body comparative performance under spontaneous breathing & metronome breathing conditions and also by using bench testing.
  • Skin temperature accuracy performance of LifeSignals Multi-parameter Remote Monitoring Patch Platform was verified by using bench testing.
  • Wireless performance & coexistence testing conducted as per ANSI//EEE C63.27:2017. : American National Standard for Evaluation of Wireless coexistence on LifeSignals ECG Remote Monitoring Platform (Reference Device-II) is valid for Lifesignals Multiparameter Remote Monitoring Platform as both the Biosensors are based on LifeSignals proprietary Semiconductor platform which is integrated with multi-sensor subsvstem, signal processor subsystem and a multiband radio subsystem into a single chip.
  • Software in the ECG Remote Monitoring Platform 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" level of concern.
  • Shelf-life, Reliability and packaging transportation testing were conducted and verified on LifeSignals Multi-parameter Remote Monitoring Biosensor as per the acceptance criteria.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

  • Heart Rate Range & accuracy (Stationary and Ambulatory): 30 – 250 BPM (Range) ± 3 or 10% whichever is greater
  • Respiration Rate Range & accuracy:
    • 9-30 Breaths per Minute with a mean absolute error of less than 3 Breaths per Minute, validated by clinical studies.
    • 6-60 Breaths per Minute with a mean absolute error of less than 1 Breaths per Minute, validated by simulation studies
  • Skin Temperature Range & Accuracy (Laboratory): 32°C - 43°C (Accuracy as per ASTM E1112-00) Continuous measurement

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.

K163453

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.

K170973, K200690

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).

0

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July 21, 2021

LifeSignals, Inc. % Rita King Chief Executive Officer and Senior Regulatory Consultant MethodSense, Inc. One Copley Parkway, Suite 410 Morrisville, North Carolina 27560

Re: K202868

Trade/Device Name: LifeSignals Multi-Parameter Remote Monitoring Platform Regulation Number: 21 CFR 870.2910 Regulation Name: Radiofrequency Physiological Signal Transmitter And Receiver Regulatory Class: Class II Product Code: DRG, MHX, FLL Dated: July 15, 2021 Received: July 16, 2021

Dear Rita King:

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 (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 located at https://www.accessdata.fda.gov/scripts/cdrh/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.

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

1

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 803) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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 mediation-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-regulatoryassistance/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 Shih 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

2

Indications for Use

510(k) Number (if known)

K202868

Device Name

LifeSignals Multiparameter Remote Monitoring Platform

Indications for Use (Describe)

The LifeSignals Multi-parameter Remote Monitoring Platform is a wireless remote monitoring system intended for use by healthcare professionals for continuous collection of physiological data at home and in healthcare settings. This shall include Electrocardiography (2-channel ECG), Heart Rate, Skin Temperature & Posture, Data is transmitted wirelessly from LifeSignals Biosensor to Remote secure server for display, storage & analysis.

The LifeSignals Multi-parameter Remote Monitoring Platform is intended for non-critical, adult population.

The LifeSignals Multi parameter Remote Monitoring Platform can include the ability to notify healthcare professionals when physiological parameters fall outside the set limits and to display multiple patient physiological data for remote monitoring.

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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510(k) Summary for LifeSignals Multi-parameter Remote Monitoring Platform

1 Company name :LifeSignals, Inc.

| Address | :39355 California Street, Suite 305
Fremont, CA 94538.
USA |
|---------|-----------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact | :Saravanan Balasubramanian
Vice President – Medical Systems & Regulatory Affairs
Email: saravanan@lifesignals.com
Tel: 510.770.6412 Ext. 4 |

  • 2 Date prepared : July 20, 2021

3 Device

Trade Name: LifeSignals Multi-parameter Remote Monitoring Platform
Model Name: Multi-parameter Remote Monitoring Platform
Common Name: Wireless Multi-parameter Remote Monitoring System

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 |

4

6 Predicate & Reference Devices

Predicate Device :

510(k) Number: K163453
Model: VitalConnect Platform
Manufacturer: Vital Connect, Inc. USA

Reference Device – I ( for "Remote Monitoring Dashboard" only):

510(k) Number: K170973
Model: VitalWatch Software User Interface
Manufacturer: Vital Connect, Inc. USA

Reference Device - II (for technology comparison):

510(k) Number: K200690
Model: LifeSignals ECG Remote monitoring Patch Platform
Manufacturer: LifeSignals, Inc. USA

7 Device description

LifeSignals Multi-parameter Remote Monitoring Platform consists of four main components:

  • (1) LifeSignals Multi-parameter Biosensor
  • (2) LifeSignals Relay device (Software Application)
  • (3) LifeSignals Secure Server (Software Application)
  • (4) Web UI /Remote Monitoring Dashboard
  • LifeSignals Multi-parameter Biosensor when attached body acquires two channel of ECG . signals, TTI respiration signals (one of the input for deriving Respiration Rate), resistance variation of a Thermistor attached to body (used for deriving Skin Temperature) & accelerometer data (input for deriving Respiration Rate & Posture), pre-processes them and wirelessly transmits to a paired Relay device (or any Receiver system). When Relay device is available within the wireless range, the acquired data is continuously transmitted to the Relay device immediately. If Relay device is not available or if there is any interruption in the communication between Relay device and Biosensor, data shall be temporarily buffered locally in Biosensor till the wireless connection is re-established.

Biosensor Patch uses standard WLAN (802.11b) secured (AES) communication protocol for wireless data transmission to the Relay Device.

5

  • Relav Device manages wireless communication between LifeSignals Biosensor and ● LifeSignals Remote Secure Server. Relay device is a LifeSignals Relay Application software installed in a compatible commercial hardware platform, like a mobile phone or a tablet.
  • LifeSignals Relay (Application) functions include: .
    • . Manages secured wireless communication (WLAN 802.11b) between Relay device & Lifesignals Biosensor and encrypted communication between the Relay device and the LifeSignals Remote Secure Server.
    • Receives physiological signals from the Biosensor and transmit them after encryption to Secure Server as quickly as possible. It manages the database in Relay device for buffering/storing the data securely, if there is any disruption in communication with the Secure Server.
    • I Provides user interface for entering the Biosensor & Patient information and pairing & establishing connection with the Biosensor.
    • . Provides User Interface to record any manual alert events by the patient.
  • . Secure Server is a LifeSignals Secure Server Application software installed in Linuxcompatible Secure server hardware platform.

LifeSignals Secure Server Application manages the decryption, uploading and storage of Biosensor data received from multiple authenticated Relay devices. The "Sensor Processing Library" in LifeSignals Secure Server process, filter the received Biosensor data and derives Heart Rate, Respiration Rate, Skin Temperature & Posture before storing them in a secured location along with received Biosensor data, for access by Web UI or any 3rd-party applications for display or analysis purpose.

LifeSignals Secure Server Application shall have an optional ability to send alert notifications to any configured destination (email, SMS, WhatsApp), when the parameters (Heart Rate, Respiration Rate or Skin temperature) exceed the configured limits.

  • . LifeSignals Web UI / Remote Monitoring dashboard is a web-browser User Interface Application that enable caregiver (Clinical personnel) to login to the LifeSignals Secure server remotely and access the patient physiological data (Biosensor & derived data) & Alert status. The caregiver (Clinical personnel) depending on the roles (normal or supervisory) can access multiple patient data and search them based on the recent alert status. This includes patients that are active (wearing Biosensor) and procedures completed.

6

Remote Monitoring Dashboard/Web UI shall also have an ability to continuously display physiological parameters (Heart Rate, Respiration Rate, Skin Temperature, Posture) & waveforms (ECG & Respiration) of multiple patients or single patient quasi-real time remotely on the screen for monitoring by caregiver (Clinical personnel).

This monitoring dashboard also has the ability for the caregiver (clinical personnel) to set the alert limits & notify address that configures the Secure server to send an alert notification to any Mobile Phone (SMS or WhatsApp) or Email ID of care giver, when parameters falls outside the set value.

Note: The Biosensor data may be accessible by a Third-Party Application installed in the Relay device using the Application Programming Interface (API) layer of the LifeSignal Relay Application Software, after suitable configuration and verification. In this configuration. LifeSignals Secure Server is optional and the data from Relay device shall be transmitted to a third-party server location. But the third-party server shall be installed with LifeSignals "Sensor Processing Library" for derivation Heart Rate, Respiration Rate, Skin Temperature & Posture.

8 Indications for Use

  • . The LifeSignals Multi-parameter Remote Monitoring Platform is a wireless remote monitoring system intended for use by healthcare professionals for continuous collection of physiological data at home and in healthcare settings. This shall include Electrocardiography (2-channel ECG), Heart Rate, Respiration Rate, Skin Temperature & Posture. Data is transmitted wirelessly from LifeSignals Biosensor to Remote secure server for display, storage & analysis.
  • The LifeSignals Multi-Parameter Remote Monitoring Platform is intended for noncritical, adult population.
  • . The LifeSignals Multi-Parameter Remote Monitoring Platform can include the ability to notify healthcare professionals when Physiological parameters fall outside the set limits and to display multiple patient physiological data for remote monitoring.

7

ComparisonPredicate (K163453)Subject Device (K202868)
ManufacturerVital Connect, Inc. USALifeSignals, Inc., USA
Product CodesDRG (Primary) , DSI , MHXDRG (Primary), MHX, FLL
Regulation Classification
(Primary)21 CFR 870.2910
Class II21 CFR 870.2910
Class II
Intended use /
Indications for useThe Vital Connect 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, skin temperature, activity (including step count), and posture (body position relative to gravity including fall). Data are transmitted wirelessly from the Vital Connect 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 Vital Connect Platform are intended for use by healthcare professionals as an aid to diagnosis and treatment.The LifeSignals Multi-parameter Remote Monitoring Platform is a wireless remote monitoring system intended for use by healthcare professionals for continuous collection of physiological data at home and in healthcare settings. This shall include Electrocardiography (2-channel ECG), Heart Rate, Respiration Rate, Skin Temperature & Posture. Data is transmitted wirelessly from LifeSignals Biosensor to Remote secure server for display, storage & analysis. The LifeSignals Multi-parameter Remote Monitoring Platform is intended for non-critical, adult population. The LifeSignals Multi-parameter Remote Monitoring Platform can include the ability to notify healthcare professionals when physiological parameters falls outside the set limits and to display multiple patient physiological data for remote monitoring.
Intended PopulationGeneral care patients who are
18 years or olderNon-critical, adult
population, 18 years or older
Intended Use EnvironmentHome & Healthcare settingsHome & Healthcare settings
Monitored Parameters
ECG✓ (Single channel)✓ (Two channels)
Heart Rate
ComparisonPredicate (K163453)Subject Device (K202868)
Heart Rate Variability
Respiration
Skin Temperature
Posture
Activity×
Continuous Physiological
data monitoring
Heart Rate Range &
accuracy (Stationary and
Ambulatory)30 – 200 BPM (Range)
± 5 or 10% whichever is
greater30 – 250 BPM (Range)
± 3 or 10% whichever is
greater
Respiration Rate Range &
accuracy• 10-30 Breaths per Minute
with a mean absolute error of
less than 3 Breaths per
Minute, validated by clinical
studies.
• 4-42 Breaths per Minute with
a mean absolute error of less
than 1.5 Breaths per Minute,
validated by simulation
studies• 9-30 Breaths per Minute
with a mean absolute error
of less than 3 Breaths per
Minute, validated by
clinical studies.
• 6-60 Breaths per Minute
with a mean absolute error
of less than 1 Breaths per
Minute, validated by
simulation studies
Skin Temperature Range
& Accuracy (Laboratory)15°C - 50°C (≤ ± 0.3°C)
Continuous measurement32°C - 43°C (Accuracy as
per ASTM E1112-00)
Continuous measurement
Posture DetectionLying down, Upright,
Walking, Running, or LeaningLying down, Upright or
Inclined
Programmable Alert
Notification & Setting
"Alarm" Function
(to assist clinician for
immediate intervention )××
Sensor
Single Use
Wear Life120 hours120 hours
Data can be transferred &
Stored
BatteryCoin cell - Zinc Air (1 no)Li-MnO2 (Primary)
Applied part categoryType BFType CF
Communication protocolBluetooth (BT4.1)WLAN (802.11b)
Wireless Radio Frequency2.4 - 2.5 GHz2.4 - 2.4835 GHz
Communication SecurityAES-CCM 128WPA2-PSK (AES 128)
ComparisonPredicate (K163453)Subject Device (K202868)
Relay Device
Authentication from Server
Data transferred to Server
Data buffered if there is no
connection with Server
Data accessible from Relay
device by 3rd party via API
Secure ServerData is stored for access by 3rd
party softwareData is stored for access by
3rd party software
Note: ✓ - Feature is identical       x - Feature not available

9 Substantial Equivalence comparison (Subject device & Predicate Device)

8

9

Differences and Risks associated with that:

  • Predicate device has only one channel of ECG, whereas the proposed device has two channels of ECG. Additional ECG channel does not add any risk to the device.
  • The Predicate device has additional monitoring parameters (Heart Rate variability & Activity) ● compared to the proposed device. However, these parameters are not required for the claimed intended use of the proposed device.
  • The Predicate device has single Zinc-Air battery, whereas the Proposed device has one Li-MnO2 battery (Primary). This change in battery chemistry does not add any risk to the device. Li-MnO2 batteries are commonly used in Wearable Medical devices & tested for safety.
  • . The Predicate device uses BLE for wireless communication, whereas the Proposed device uses WLAN for wireless communication. The use of WLAN for wireless communication does not add any risk to the device.
  • The Applied Part classification of the Predicate device is "BF", whereas the Proposed device . Applied Part classification is "CF". Devices with CF classified Applied Part has a lower risk with lower leakage current.
  • . The Subject device has ability to display multiple patient data using a UI interface (Remote Monitoring Dashboard), while the predicate device does not have the ability. However, this does not add any risk, as this function / feature of predicate device is covered under separate 510(k) clearance (K170973). Please refer section 5.10 for further details.

10

| Comparison | Reference Device - I
(K170973) | Subject Device
(K202868) |
|---------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Vital Connect, Inc., USA | LifeSignals, Inc., USA |
| Product Codes | DRG | DRG (Primary), MHX |
| Regulation Classification | 21 CFR 870.2910
Class II | 21 CFR 870.2910
Class II |
| Intended use /
Indications for use | VitalWatch is a software user
interface intended for use by
healthcare professionals to
display physiological data
collected by the VitalConnect
Platform wireless remote
monitoring system in home
and healthcare settings.
VitalWatch is a secondary,
adjunct patient monitor and is
not intended to replace
existing standard-of-care
patient monitoring practices. | The LifeSignals Multi-
Parameter Remote Monitoring
Patch Platform (LX1550) is a
wireless remote monitoring
system intended for use by
healthcare professionals for
continuous collection of
physiological data at home and
in healthcare settings. This
shall include
Electrocardiography (2-
channel ECG), Heart Rate,
Respiration Rate, Skin
Temperature & Posture. Data
is transmitted wirelessly from
LifeSignals Biosensor to
Remote secure server for
display, storage & analysis.
The LifeSignals Multi-
Parameter Remote Monitoring
Platform is intended for non-
critical, adult population. The
LifeSignals Multi-Parameter
Remote Monitoring Platform
can include the ability to notify
healthcare professionals when
physiological parameters fall
outside the set limits and to
display multiple patient
physiological data for remote
monitoring. |
| Comparison | Reference Device – I
(K170973) | Subject Device
(K202868) |
| Physiological Data
Monitored | Electrocardiography (ECG),
Heart Rate, Heart rate
variability, R-R Interval,
Respiration rate, skin
temperature, activity
(including step count) and
posture | Electrocardiography (2-
channel ECG), Heart Rate,
Respiration Rate, Skin
Temperature & Posture. |
| Principles of Operations | Display of data from validated
Relay device using third-party
developed Graphical User
Interface, or VitalWatch, and
optional transmission of data
to Secure Server. | Display of data from validated
Secure server installed with
LifeSignals Secure Server
Application on any web-based
browser using LifeSignals
Remote Monitoring Dashboard
or any third-party developed
GUI. |
| Comparison | Reference Device II
(K200690) | Subject Device
(K202868) |
| Manufacturer | LifeSignals, Inc., USA | LifeSignals, Inc., USA |
| Product Codes | DRG (Primary), MWJ | DRG (Primary), MHX, FLL |
| Regulation Classification
(Primary) | 21 CFR 870.2910
Class II | 21 CFR 870.2910
Class II |
| Intended use /
Indications for use | The LifeSignals ECG Remote
Monitoring Patch Platform is a
wireless remote monitoring
system intended for use by
healthcare professionals for
continuous collection of
Electrocardiography (ECG) &
Heart Rate monitoring in home
and healthcare settings. Data is
transmitted wirelessly from
LifeSignals Biosensor to
Remote secure server for
storage and analysis. The
LifeSignals ECG Remote
Monitoring Patch Platform
includes an ability to notify
healthcare professionals when
Heart Rate falls outside the set
limits | The LifeSignals Multi-Parameter
Remote Monitoring Platform
(LX1550) is a wireless remote
monitoring system intended for
use by healthcare professionals
for continuous collection of
physiological data at home and in
healthcare settings. This shall
include Electrocardiography (2-
channel ECG), Heart Rate,
Respiration Rate, Skin
Temperature & Posture. Data is
transmitted wirelessly from
LifeSignals Biosensor to
Remote secure server for
display, storage & analysis. The
LifeSignals Multi-Parameter
Remote Monitoring Platform is
intended for non-critical, adult
population. The LifeSignals
Multi-Parameter Remote
Monitoring Platform can include
the ability to notify healthcare
professionals when physiological
parameters fall outside the set
limits and to display multiple
patient physiological data in for
remote monitoring. |
| Intended Population | 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 |
| Monitored Parameters | | |
| ECG | ✓ (Two channel) | ✓ (Two channels) |
| Heart Rate | ✓ | ✓ |
| Respiration | × | ✓ |
| Skin Temperature | × | ✓ |
| Posture | × | ✓ |
| Comparison | Reference Device II
(K200690) | Subject Device
(K202868) |
| Sensor | | |
| ECG Electrodes | Gel & Ag/AgCl Eyelet
(Four) | Gel & Ag/AgCl Eyelet
(Four) |
| Temperature sensing | x | Thermistor |
| Accelerometer | x | 3-axis |
| Dimension | | |
| Width | 112.0 mm | 105.0 mm |
| Length | 79.0 mm | 94.0 mm |
| Thickness | 6.0 mm | 12.0 mm |
| Weight | 18 grams | 28 grams |
| Electrode Distance | | |
| ECG-A (Diagonal) | 60.0 mm | 90.0 mm |
| ECG-B (Vertical) | 42.4 mm | 57.9 mm |
| Location of Body | Upper Left Chest | Upper Left Chest |
| | Life Signal LC1110 | Life Signal LC1110 |
| Sensor & wireless Chip | (custom chip) | (custom chip) |
| Battery | Zinc Air - 2 no - DC 2.8V | Li-MnO2 (1 no) |
| PCBA | Rigid - Flex | Rigid – Flex |
| Top cover | Thermoformed Foam | Thermoformed Foam |
| User inputs | Switch & LED | Switch & LED |
| Body Contact Material | | |
| Adhesive | Hydrocolloid | Acrylate |
| Electrode design | Ag/AgCl Eyelet | Ag/AgCl Eyelet |
| Electrolyte | Hydrogel | Hydrogel |
| Wear Life | 72 hours | 120 hours |
| Electrical (Applied Part) | Type CF - Defib. proof | Type CF - Defib. proof |
| Single Use | ✓ | ✓ |
| Wear Life | 72 hours | 120 hours |
| Data temporary buffered | ✓ | ✓ |
| Battery | Coin cell - Zinc Air (2 nos) | Li-MnO2 (Primary) |
| Applied part category | Type CF | Type CF |
| Communication protocol | WLAN (802.11b) | WLAN (802.11b) |
| Wireless Radio Frequency | 2.4 - 2.4835 GHz | 2.4 - 2.4835 GHz |
| Communication Security | WPA2-PSK (AES 128) | WPA2-PSK (AES 128) |
| Relay Device | | |
| Authentication from Server | ✓ | ✓ |
| Data transferred to Server | ✓ | ✓ |
| Data buffered if there is no
connection with Server | ✓ | ✓ |
| Comparison | Reference Device II
(K200690) | Subject Device
(K202868) |
| Data accessible from Relay
device by 3rd party via API | ✓ | ✓ |
| Secure Server | Data is stored for access by
3rd party software | Data is stored for access by
3rd party software |
| Note : ✓ - Feature is identical     ✗ - Feature not available | | |

10 Substantial Equivalence comparison Remote Monitoring Dashboard (one of the components of the Subject device) and Reference device I

11

Note : √ - Feature is identical × - Feature not available.

Differences and Risks associated with that :

  • . Predicate device has only one channel of ECG, whereas the proposed device has two channels of ECG. Additional ECG channel does not add any risk to the device.
  • The Predicate device has additional monitoring parameters (Heart Rate variability, R-R variability & Activity) compared to the proposed device. However, these parameters are not required for the claimed intended use of the proposed device.
  • In predicate device the display of data is from the validated relay device, while in the subject ● device the display of data is from the Secure Server. This allows either single or multiple patients data can be displayed on a standard desktop PC or tablet using web-based browser. This does not add any risk.

11 Comparison of previously cleared LifeSignals ECG Remote Monitoring Platform (Reference Device - II )

The LifeSignals Multi-parameter Remote Monitoring Platform is technologically identical to 510(k) cleared LifeSignals ECG remote monitoring Patch Platform with additional monitoring parameters & Remote Monitoring Dashboard

12

13

14

Differences and Risks associated with that:

  • The distance between electrodes of the Subject Device is different from the Reference ● Device-II and this may result in clinically significant differences in the acquired ECG signal. However, the increase in electrode distance reduces the risk. Increase in electrode distance substantially increases amplitude of QRS & P-wave amplitude and it helps 3rd party arrhythmia analysis software in improving the detection of arrhythmia.
  • Differences in the locations of the electrodes between Subject device & Reference Device-II may result in differences in the electrode placement on patients from a physiological perspective. However, the increase in the electrode distance have not substantially changed the overall dimension that could affect the intended location of the Biosensor (upper left chest). Further the Subject Device has improved design that allows the electrodes to move or flex independently compared to the Reference Device, that helps for better wearability, motion performance and increased wear-period (ability to withstand higher shear stress), which is confirmed through wear-period clinical performance study.

12 Summary of Performance Testing

Verification & Validation activities were performed on LifeSignals Multi-parameter Remote Monitoring Platform to demonstrate substantial equivalence to the predicate device:

  • Biocompatibility testing of In-vitro cytotoxicity, skin irritation, Intracutaneous ● reactivity and skin sensitization were conducted on the LifeSignals Multi-parameter Biosensor Patch, according to ISO 10993-1: 2009 Biological Evaluation of Medical Devices – Part 1 : Evaluation and Testing within a Risk Management Process.
  • Electrical Safety and electromagnetic compatibility testing were conducted on the Multi-parameter Biosensor Patch for compliance with ANSI AAMI ES60601-1:2005. ANSI AAMI IEC 60601-1-2:2014 and ANSI AAMI HA 60601-1-11:2015.

15

  • ECG Performance testing were repeated on the LifeSignals Multi-parameter Remote ● Monitoring Platform for compliance with ANSI AAMI IEC 60601-2-47:2012, IEC 60601-2-27:2011 & ANSI AAMI ISO 60601-2-25:2011.
  • . Usability study was conducted on the LifeSignals Multi-parameter Remote Monitoring Platform for compliance with IEC 60601-1-6:2013 and "USFDA Guidance- Applying Human Factors and Usability Engineering to Medical Devices. "
  • . Wear-life performance of ECG waveform quality, Heart Rate, Respiration Rate & Skin Temperature of LifeSignals Multi-parameter Remote Monitoring Patch Platform under normal use condition was validated using non-randomized, self-control comparative on-body comparative performance study for the wear period of 120 hours.
  • . ECG & Heart Rate accuracy performance validation of LifeSignals ECG Remote Monitoring Patch Platform (Reference Device-II) under various conditions (normally activity, posture, etc.) using non-randomized, self-control comparative on-body comparative performance, is valid for LifeSignals Multiparameter Remote Monitoring Platform.
  • Respiration Rate performance under various postures & normal activity is validated ● through on-body comparative performance under spontaneous breathing & metronome breathing conditions and also by using bench testing.
  • . Skin temperature accuracy performance of LifeSignals Multi-parameter Remote Monitoring Patch Platform was verified by using bench testing.
  • Wireless performance & coexistence testing conducted as per ANSI//EEE C63.27:2017 . : American National Standard for Evaluation of Wireless coexistence on LifeSignals ECG Remote Monitoring Platform (Reference Device-II) is valid for Lifesignals Multiparameter Remote Monitoring Platform as both the Biosensors are based on LifeSignals proprietary Semiconductor platform which is integrated with multi-sensor subsvstem, signal processor subsystem and a multiband radio subsystem into a single chip.
  • Software in the ECG Remote Monitoring Platform 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" level of concern.
  • . Shelf-life, Reliability and packaging transportation testing were conducted and verified on LifeSignals Multi-parameter Remote Monitoring Biosensor as per the acceptance criteria.

16

13 Conclusion

The LifeSignals Multi-parameter Remote Monitoring Platform is substantially equivalent with respect to safety and effectiveness to the legally marketed Predicate device for its intended use. Minor differences between LifeSignals Multi-parameter Remote Monitoring Platform and the predicate device & Reference devices have no significant effect on safety or effectiveness, as established through various performance tests. Further, LifeSignals Multi-parameter Biosensor used in LifeSignals Multi-parameter Remote Monitoring Platform is substantially equivalent with respect to technology & design to the legally marketed Reference Device.