LifeSignals Multi-Parameter Remote Monitoring Platform

K202868 · Lifesignals, Inc. · DRG · Jul 21, 2021 · Cardiovascular

Device Facts

• Record ID: K202868
• Device Name: LifeSignals Multi-Parameter Remote Monitoring Platform
• Applicant: Lifesignals, Inc.
• Product Code: DRG · Cardiovascular
• Decision Date: Jul 21, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2910
• Device Class: Class 2

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, 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.

Device Story

System collects physiological data via wearable biosensor patch; inputs include 2-channel ECG, thermistor-based skin temperature, and 3-axis accelerometer data (for respiration/posture). Biosensor pre-processes signals and transmits via WLAN (802.11b) to a relay device (mobile/tablet app) or directly to a secure server. Relay device manages encrypted communication and local buffering. Secure server processes/filters data using 'Sensor Processing Library' to derive heart rate, respiration rate, skin temperature, and posture. Caregivers access data via web-based dashboard for quasi-real-time monitoring and alert management. System notifies clinicians via email/SMS/WhatsApp if parameters exceed set limits. Benefits include continuous remote patient monitoring, enabling timely clinical intervention for non-critical adults.

Clinical Evidence

Bench testing included biocompatibility (ISO 10993-1), electrical safety (ANSI AAMI ES60601-1), and EMC. Wear-life performance (120 hours) validated via non-randomized, self-control comparative on-body study. ECG/Heart Rate accuracy validated via reference device (K200690) data. Respiration rate validated via on-body comparative performance (spontaneous/metronome breathing) and bench testing. Skin temperature accuracy verified via bench testing.

Technological Characteristics

Biosensor uses proprietary semiconductor platform with multi-sensor subsystem and multiband radio. Materials: Acrylate adhesive, hydrogel electrodes, thermoformed foam cover. Sensing: 2-channel ECG (Ag/AgCl eyelet), thermistor, 3-axis accelerometer. Connectivity: WLAN 802.11b (WPA2-PSK/AES 128). Power: Li-MnO2 primary battery. Form factor: Rigid-flex PCBA. Sterilization: Not specified. Software: Class B, Moderate level of concern.

Indications for Use

Indicated for non-critical adult patients (18+ years) for continuous remote monitoring of 2-channel ECG, heart rate, respiration rate, skin temperature, and posture 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

• VitalConnect Platform (K163453)

Reference Devices

• VitalWatch Software User Interface (K170973)
• LifeSignals ECG Remote monitoring Patch Platform (K200690)

Submission Summary (Full Text)

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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

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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 ([e-mail]) or phone [phone] 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

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## 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)

| <span style="font-size: 10pt;"> <span style="text-decoration: overline;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> |
|------------------------------------------------------------------------------------------------------------------------------------------|
| <span style="font-size: 10pt;"> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </span> |

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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<br>Fremont, CA 94538.<br>USA |
|---------|-----------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact | :Saravanan Balasubramanian<br>Vice President – Medical Systems & Regulatory Affairs<br>Email: [e-mail]<br>Tel: [phone] 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<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 |

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## 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.

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- 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.

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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.

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| Comparison | Predicate (K163453) | Subject Device (K202868) |
|--------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Vital Connect, Inc. USA | LifeSignals, Inc., USA |
| Product Codes | DRG (Primary) , DSI , MHX | DRG (Primary), MHX, FLL |
| Regulation Classification<br>(Primary) | 21 CFR 870.2910<br>Class II | 21 CFR 870.2910<br>Class II |
| Intended use /<br>Indications for use | The 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 Population | General care patients who are<br>18 years or older | Non-critical, adult<br>population, 18 years or older |
| Intended Use Environment | Home & Healthcare settings | Home & Healthcare settings |
| Monitored Parameters | | |
| ECG | ✓ (Single channel) | ✓ (Two channels) |
| Heart Rate | ✓ | ✓ |
| Comparison | Predicate (K163453) | Subject Device (K202868) |
| Heart Rate Variability | ✓ | |
| Respiration | ✓ | ✓ |
| Skin Temperature | ✓ | ✓ |
| Posture | ✓ | |
| Activity | ✓ | × |
| Continuous Physiological<br>data monitoring | ✓ | ✓ |
| Heart Rate Range &<br>accuracy (Stationary and<br>Ambulatory) | 30 – 200 BPM (Range)<br>± 5 or 10% whichever is<br>greater | 30 – 250 BPM (Range)<br>± 3 or 10% whichever is<br>greater |
| Respiration Rate Range &<br>accuracy | • 10-30 Breaths per Minute<br>with a mean absolute error of<br>less than 3 Breaths per<br>Minute, validated by clinical<br>studies.<br>• 4-42 Breaths per Minute with<br>a mean absolute error of less<br>than 1.5 Breaths per Minute,<br>validated by simulation<br>studies | • 9-30 Breaths per Minute<br>with a mean absolute error<br>of less than 3 Breaths per<br>Minute, validated by<br>clinical studies.<br>• 6-60 Breaths per Minute<br>with a mean absolute error<br>of less than 1 Breaths per<br>Minute, validated by<br>simulation studies |
| Skin Temperature Range<br>& Accuracy (Laboratory) | 15°C - 50°C (≤ ± 0.3°C)<br>Continuous measurement | 32°C - 43°C (Accuracy as<br>per ASTM E1112-00)<br>Continuous measurement |
| Posture Detection | Lying down, Upright,<br>Walking, Running, or Leaning | Lying down, Upright or<br>Inclined |
| Programmable Alert<br>Notification & Setting | ✓ | ✓ |
| "Alarm" Function<br>(to assist clinician for<br>immediate intervention ) | × | × |
| Sensor | | |
| Single Use | ✓ | ✓ |
| Wear Life | 120 hours | 120 hours |
| Data can be transferred &<br>Stored | ✓ | ✓ |
| Battery | Coin cell - Zinc Air (1 no) | Li-MnO2 (Primary) |
| Applied part category | Type BF | Type CF |
| Communication protocol | Bluetooth (BT4.1) | WLAN (802.11b) |
| Wireless Radio Frequency | 2.4 - 2.5 GHz | 2.4 - 2.4835 GHz |
| Communication Security | AES-CCM 128 | WPA2-PSK (AES 128) |
| Comparison | Predicate (K163453) | Subject Device (K202868) |
| Relay Device | | |
| Authentication from Server | ✓ | ✓ |
| Data transferred to Server | ✓ | ✓ |
| Data buffered if there is no<br>connection with Server | ✓ | ✓ |
| Data accessible from Relay<br>device by 3r…