LifeSignals ECG Remote Monitoring Patch Platform

K200690 · Lifesignals, Inc. · DRG · Jul 15, 2020 · Cardiovascular

Device Facts

• Record ID: K200690
• Device Name: LifeSignals ECG Remote Monitoring Patch Platform
• Applicant: Lifesignals, Inc.
• Product Code: DRG · Cardiovascular
• Decision Date: Jul 15, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2910
• Device Class: Class 2

Intended 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) and Heart Rate monitoring in home and healthcare settings. Data is transmitted wirelessly from LifeSignals Biosensor Patch to Remote Secure for storage and analysis. The LifeSignals ECG Remote Monitoring Patch Platform is intended for non-critical, adult population, who are 18 years of age or older. The LifeSignals ECG Remote Monitoring Patch Platform includes an ability to notify healthcare professionals when Heart Rate falls outside the set limits.

Device Story

System collects ECG signals via wearable Biosensor Patch; transmits data wirelessly (WLAN 802.11b) to Relay device (mobile/tablet) or directly to Remote Secure Server. Biosensor buffers data locally if connection is lost. Relay device manages communication, encryption, and alert notifications. Remote Secure Server processes/filters ECG signals, derives Heart Rate, and stores data. Healthcare professionals access data via Web UI; system provides alerts when Heart Rate exceeds configured limits. Device does not perform arrhythmia analysis; intended for use with third-party analysis software. Benefits include continuous remote monitoring for non-critical patients, facilitating clinical workflows like Holter or cardiac telemetry.

Clinical Evidence

Bench testing only. Includes biocompatibility (ISO 10993-1), electrical safety/EMC (IEC 60601-1, -1-2, -1-11), performance (IEC 60601-2-47, -2-27), usability (IEC 60601-1-6), and wireless coexistence (ANSI/IEEE C63.27). Ambulatory performance of HR algorithm and ECG waveform quality verified via nonrandomized, self-control comparative on-body study. Adhesion verified per AAMI ANSI EC12.

Technological Characteristics

Biosensor Patch: 4 electrodes, hydrocolloid adhesive, Ag/AgCl eyelet, hydrogel electrolyte. Wireless: WLAN 802.11b, WPA2-PSK (AES 128). Energy: 2 Zinc-Air batteries. Applied part: Type CF. Connectivity: Wireless to Relay (mobile/tablet) or Secure Server. Software: Class B, moderate level of concern per IEC 62304.

Indications for Use

Indicated for continuous ECG and Heart Rate monitoring in non-critical adult patients (18+ years) in home and healthcare settings. Contraindicated for use with active implantable medical devices including pacemakers.

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

• Vital Connect Platform (K152139)

Reference Devices

• LifeSignals' WiPoint Biosensor iOS Receiver App System (K172011)
• H3+ Holter Recorder (K152626)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters.

July 15, 2020

LifeSignals, Inc. Saravanan Balasubramanian Vice President - Medical Systems & Regulatory Affairs 39355 California Street, Suite 305 Fremont, California 94538

Re: K200690

Trade/Device Name: Life Signal ECG Remote Monitoring Patch Platform Regulation Number: 21 CFR 870.2910 Regulation Name: Radiofrequency Physiological Signal Transmitter And Receiver Regulatory Class: Class II Product Code: DRG, MWJ Dated: June 11, 2020 Received: June 17, 2020

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 (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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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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 (OS) 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 (Acting) 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) K200690

Device Name

LifeSignals ECG Remote Monitoring Patch Platform

Indications for Use (Describe)

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) and Heart Rate monitoring in home and healthcare settings. Data is transmitted wirelessly from LifeSignals Biosensor Patch to Remote Secure for storage and analysis.

The LifeSignals ECG Remote Monitoring Patch Platform is intended for non-critical, adult population, who are 18 years of age or older.

The LifeSignals ECG Remote Monitoring Patch Platform includes an ability to notify healthcare professionals when Heart Rate falls outside the set limits.

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/1 description: The image shows the logo for LifeSignals. The logo consists of a blue square with white wave-like lines inside, followed by the word "LifeSignals" in blue. The word "LifeSignals" is written in a modern, sans-serif font.

## 510(k) Summary for LifeSignals ECG Remote Monitoring Patch Platform

| 5.1 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 |

- 5.2 Date prepared: July 15, 2020
## 5.3 Device

| Trade Name | : | LifeSignals ECG Remote Monitoring Patch Platform |
|-------------|---|--------------------------------------------------|
| Model Name | : | ECG Remote Monitoring Patch Platform |
| Common Name | : | Wireless ECG Remote Monitoring System |

# 5.4 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 |

## 5.5 Subsequent Product codes

| Device Panel | Regulation<br>Classification | Product<br>Code | Description |
|----------------|------------------------------|-----------------|-----------------------------------|
| Cardiovascular | 21 CFR 870.200<br>Class II | MWJ | Medical Magnetic Tape<br>Recorder |

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Image /page/4/Picture/1 description: The image shows the logo for LifeSignals. The logo consists of a blue square with a waveform inside, followed by the word "LifeSignals" in blue, sans-serif font. The waveform graphic is on the left side of the logo, and the text is on the right.

### 5.6 Predicate & Reference Devices

Predicate Device :

| 510(k) Number | : K152139 |
|---------------|----------------------------|
| Model | : Vital Connect Platform |
| Manufacturer | : Vital Connect, Inc., USA |

Reference Device - I (for technology comparison of Biosensor Patch) :

| 510(k) Number | : K172011 |
|---------------|----------------------------------------------------------|
| Model | : LifeSignals' WiPoint Biosensor iOS Receiver App System |
| Manufacturer | : LifeSignals, Inc., USA |

Reference Device - II (for ECG data acquisition - Secondary product code MWJ:

| 510(k) Number | : K152626 |
|---------------|----------------------------|
| Model | : H3+ Holter Recorder |
| Manufacturer | : Mortara Instrument, Inc. |

### 5.7 Device description

LifeSignals ECG Remote Monitoring Patch Platform consists of three main components: (1) LifeSignals Biosensor Patch. (2) LifeSignals Relay device. (3) LifeSignals Remote Secure Server.

- LifeSignals Biosensor Patch acquires ECG signals from the body, pre-processes as two . channels of ECG data and are wirelessly transmitted to the Relay device. Under normal operation, when the Relay Device is available within the wireless range, the acquired data is continuously transmitted to the Relay device immediately. If the Relay device is not available or if there is any interruption in the communication between the Relay device and the Biosensor Patch, data shall be buffered (stored) locally in the Biosensor Patch until 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 compatible commercial hardware platform, like a mobile phone or a tablet.

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Image /page/5/Picture/1 description: The image shows the logo for LifeSignals. The logo consists of a blue square with white sound wave-like lines inside, followed by the word "LifeSignals" in a stylized blue font. The font is modern and slightly rounded, giving the logo a clean and professional look.

- LifeSignals Relay Application's functions: .
- Manage secured wireless communication (WLAN 802.11b) between Relay device and Biosensor Patch and encrypts communication between the Relay device and the LifeSignals Remote Secure Server.
- . Receive ECG signals from the Biosensor Patch and transmit them after encryption to Secure Server as quickly as possible. They manage the database in Relay device, for buffering/storing the data securely if there is any disruption in communication with the Secure Server.
- Provide user interface for selecting, pairing and establishing connection with Biosensor Patch.
- . Display alert notifications received from the Secure Server when the Heart Rate of its associated Biosensor or of some other Biosensor in its network falls outside the configured range, when it is configured by the Secure Server to receive such notification.
- LifeSignals Secure Server consists of a hardware platform that is a Linux-compatible . Secure server, LifeSignals Secure Server Application software that is installed in the hardware platform along with a Web UI, a browser-based application that interfaces with LifeSignals Secure Server Application.

LifeSignals Secure Server Application manages the decryption, uploading and storage of Biosensor data received from multiple authenticated Relay devices. The Signal Processing and Heart Rate Library in the LifeSignals Secure Server Application processes and filters the received ECG signals before storing them in a secured location. It also derives the Heart Rate from the ECG data and the Heart Rate value is appended to the filtered ECG Signals.

LifeSignals Secure Server Application can include the ability to send alert notifications to any configured Relay Device connected in its network, when Heart Rate value of any Biosensor falls outside the set range of values.

Web UI provides user interface for user (login) management, Relay management & Heart Rate Alert setting. It interfaces with Secure Server Application.

- The Secure Sever Application does not carry out any arrhythmia analysis of ECG data by . itself. However, the ECG data received and stored by the LifeSignals Secure server is intended to be used with an approved third-party ECG analysis software. Based on the type of ECG analysis software, the LifeSignals ECG Remote Monitoring Platform can be used for a suitable clinical workflow such as a Remote Patient Monitoring, Mobile Cardiac Telemetry, Cardiac Event Monitor or Holter Monitoring system.

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- The ECG data may be accessible by a Third-Party Application installed in the Relay device ● using the Application Programming Interface (API) layer of the 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 server location configured by the third-party application. Also, in this configuration, Signal processing and Heart Rate processing Library shall be integrated in third-party secure server application or in third-party relay application.
#### 5.8 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) and Heart Rate monitoring in home and healthcare settings. Data is transmitted wirelessly from LifeSignals Biosensor Patch to Remote secure server for storage and analysis.

The LifeSignals ECG Remote Monitoring Patch Platform is intended for non-critical, adult population, who are 18 years of age or older.

The LifeSignals ECG Remote Monitoring Patch Platform includes an ability to notify healthcare professionals when Heart Rate falls outside the set limits.

| Comparison | Predicate (K152139) | Subject Device (K200690) |
|--------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Vital Connect, Inc. USA | LifeSignals, Inc., USA |
| Product Codes | DRG (Primary) , DSI , MHX | DRG (Primary), MWJ |
| Regulation Classification | 21 CFR 870.1025 | 21 CFR 870.1025 |
| (Primary) | Class II | Class II |
| Intended use /<br>Indications for use | The Vital Connect Platform is a wireless<br>remote monitoring system intended for use<br>by healthcare professionals for continuous<br>collection of physiological data in home and<br>healthcare settings. This can include heart<br>rate, electrocardiography (ECG), heart rate<br>variability, R-R interval, respiratory rate,<br>skin temperature, activity (including step<br>count), and posture (body position relative to<br>gravity including fall). Data are transmitted<br>wirelessly from the Vital Connect Sensor for<br>storage and analysis. The Vital Connect<br>Platform can include the ability to notify<br>healthcare professionals when physiological<br>data fall outside selected parameters. The<br>data from the Vital Connect Platform are<br>intended for use by healthcare professionals<br>as an aid to diagnosis and treatment. | The LifeSignals ECG Remote<br>Monitoring Patch Platform is a<br>wireless remote monitoring system<br>intended for use by healthcare<br>professionals for continuous<br>collection of Electrocardiography<br>(ECG) & Heart Rate monitoring in<br>home and healthcare settings. Data is<br>transmitted wirelessly from<br>LifeSignals Biosensor to Remote<br>secure server for storage and<br>analysis. The LifeSignals ECG<br>Remote Monitoring Patch Platform<br>includes an ability to notify<br>healthcare professionals when Heart<br>Rate falls outside the set limits. |
| Comparison | Predicate (K152139) | Subject Device (K200690) |
| Intended Population | General care patients who are 18 years or older | Non-critical, adult population, 18 years or older |
| Intended Use Environment | Home & Healthcare settings | Home & Healthcare settings |
| Monitored Parameters | | |
| ECG | ✓ (Single channel) | ✓ (Two channels) |
| Heart Rate | ✓ | ✓ |
| Heart Rate Variability | ✓ | x |
| Respiration | ✓ | x |
| Skin Temperature | ✓ | x |
| Activity & posture | ✓ | x |
| Continuous Physiological<br>data monitoring | ✓ | ✓ |
| Heart Rate Range &<br>accuracy (Stationary and<br>Ambulatory) | 30 – 200 BPM (Range)<br>± 5 or 10% whichever is greater | 30 – 250 BPM (Range)<br>± 3 or 10% whichever is<br>greater |
| Programmable Alert<br>Notification & Setting | ✓ | ✓ |
| "Alarm" Function<br>(to assist clinician for<br>immediate intervention ) | x | x |
| Sensor | | |
| Single Use | ✓ | ✓ |
| Wear Life | 72 hours | 72 hours |
| Data can be transferred &<br>Stored | ✓ | ✓ |
| Battery | Coin cell – Zinc Air (1 no) | Coin cell – Zinc Air ( 2 no) |
| 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) |
| 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 3rd party via API | ✓ | ✓ |
| Secure Server | Data is stored for access by any<br>3rd party software | Data is stored for access by<br>any 3rd party software |
| <b>Comparison</b> | <b>Predicate (K152139)</b> | <b>Subject Device (K200690)</b> |
| ECG analysis | No in-built arrhythmia analysis function and is intended to be used by any 3rd party arrhythmia analysis software | No in-built arrhythmia analysis function and is intended to be used by any 3rd party arrhythmia analysis software |

### 5.9 Substantial Equivalence comparison (Subject device & Predicate Device)

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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 (Respiration rate, temperature, HR variability) 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 two Zin-● Air battery. Additional Battery does not add any risk to the device.
- . 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 as it is intended for direct Cardiac Application.

#### 5.10 Technological Characteristics of Biosensor Patch (Subject Device & Reference Device - I )

The LifeSignals Biosensor Patch used in LifeSignals ECG Remote Monitoring Patch Platform is identical to the Biosensor Patch that is used in LifeSignals WiPoint Biosensor iOS Receiver App System, which is 510(k) cleared under K172011, except for firmware change to support different intended use and for additional memory to buffer the data in the Biosensor Patch, as explained in the following table :

| Comparison | Reference Device - I (K172011) | Subject Device (K200690) |
|--------------------------|--------------------------------|--------------------------|
| Manufacturer | LifeSignals, Inc. | LifeSignals, Inc. |
| Product Code | DRG (Primary), DRT, DRX | DRG (Primary), MWJ |
| General | | |
| Number of ECG Electrodes | Four Electrodes | Identical |
| Dimension (L x W x T) | 112 x 79 x 6 mm | Identical |
| Weight | 18 grams | Identical |

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| Comparison | Reference Device – I (K172011) | Subject Device (K200690) |
|-------------------------------|----------------------------------|--------------------------|
| Sensor & wireless Chip | Life Signal LC1110 (custom chip) | Identical |
| Battery | Zinc Air – 2 no – DC 2.8V | Identical |
| PCBA | Rigid - Flex | Minor changeNote1 |
| Top cover | Thermoformed Foam | Identical |
| User inputs | Switch & LED | Identical |
| <b>Body Contact Material</b> | | |
| Adhesive | Hydrocolloid | Identical |
| Electrode design | Ag/AgCl Eyelet | Identical |
| Electrolyte | Hydrogel | IdenticalNote2 |
| Wear Life | 72 hours | Identical |
| Electrical (Applied Part) | Type CF – Defibrillation proof | Identical |
| <b>Wireless Communication</b> | | |
| Protocol | WLAN-802.11b | Identical |
| Security | WPA2-PSK (AES 128) | Identical |

Note 1 : The Firmware & Memory chip are different from the Reference device-I to support the new intended use. Note 2 : Hydrogel part number is different. It is of same family & manufacturer. (Biocompatibility test is repeated)

| 5.11 Substantial Equivalence comparison ECG data acquisition performance – Secondary |
|--------------------------------------------------------------------------------------|
| product code (Subject device & Reference Device – II ) |

| Comparison | Reference Device - II<br>(K152626) | Subject Device<br>(K200690) |
|--------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Mortara Instrument, Inc., USA | LifeSignals, Inc., USA |
| Product Codes | MWJ…