(296 days)
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.
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.
1. Table of Acceptance Criteria and Reported Device Performance:
The provided text details performance testing but does not explicitly list quantitative acceptance criteria with corresponding reported values for all parameters in a single, clear table. However, the available information allows for a partial reconstruction of some performance aspects, particularly concerning accuracy for Heart Rate and Respiration Rate, and a general statement about meeting standards.
Based on the provided text, a table can be constructed for the most specific performance claims:
| Parameter | Acceptance Criteria (Stated) | Reported Device Performance (as validated) | Study Type Referenced |
|---|---|---|---|
| Heart Rate | 30 – 250 BPM (Range), ± 3 or 10% whichever is greater | (Implicitly meets stated criteria based on "accuracy performance validation") | On-body comparative performance ([K200690](https://510k.innolitics.com/search/K200690) validation applies) |
| Respiration Rate | Clinical: 9-30 Breaths/Minute with a mean absolute error of < 3 Breaths/Minute. Simulation: 6-60 Breaths/Minute with a mean absolute error of < 1 Breaths/Minute. | (Implicitly meets stated criteria based on "validated through on-body comparative performance" and "bench testing") | On-body comparative performance (spontaneous/metronome breathing), Bench testing |
| Skin Temperature | 32°C - 43°C (Accuracy as per ASTM E1112-00) | (Implicitly meets stated criteria based on "verified by using bench testing") | Bench testing |
| ECG Performance | Compliance with ANSI AAMI IEC 60601-2-47:2012, IEC 60601-2-27:2011 & ANSI AAMI ISO 60601-2-25:2011 | (Implicitly meets stated criteria based on "testing were repeated... for compliance") | Performance testing |
| Wear-life | 120 hours (for ECG waveform quality, Heart Rate, Respiration Rate & Skin Temperature) | (Implicitly confirmed through "validated using non-randomized, self-control comparative on-body comparative performance study for the wear period of 120 hours") | Clinical performance study |
| Biocompatibility | Compliance with ISO 10993-1: 2009 | (Implicitly confirmed through "testing were conducted... according to ISO 10993-1") | Biocompatibility testing |
| Electrical Safety & EMC | Compliance with ANSI AAMI ES60601-1:2005, ANSI AAMI IEC 60601-1-2:2014, and ANSI AAMI HA 60601-1-11:2015 | (Implicitly confirmed through "testing were conducted... for compliance") | Electrical Safety and EMC testing |
| Usability | Compliance with IEC 60601-1-6:2013 and USFDA Guidance | (Implicitly confirmed through "study was conducted... for compliance") | Usability study |
| Software | Compliance with IEC 62304 & USFDA Guidance | (Implicitly confirmed through "designed, documented, verified & validated as per...") | Software verification & validation |
| Wireless Performance & Coexistence | Compliance with ANSI//IEEE C63.27:2017 | (Implicitly confirmed through "testing conducted... is valid for Lifesignals Multiparameter Remote Monitoring Platform") | Testing conducted on Reference Device-II |
| Shelf-life, Reliability, Packaging | (Acceptance criteria implicit in "Shelf-life, Reliability and packaging transportation testing were conducted and verified... as per the acceptance criteria.") | Implicitly confirmed as "conducted and verified" | Testing |
2. Sample Size and Data Provenance:
- Test Set Sample Size: The document does not explicitly state the sample size used for the performance testing (test set). It mentions "non-randomized, self-control comparative on-body comparative performance study" for wear-life validation and for ECG & Heart Rate accuracy. For Respiration Rate, it mentions "on-body comparative performance" and "bench testing." No specific number of subjects or cases is provided.
- Data Provenance: The document does not specify the country of origin for the clinical study data. It refers to "clinical studies" and "on-body comparative performance," implying human subject data. It also mentions "bench testing" and "simulation studies." The nature of the studies ("comparative on-body comparative performance") suggests they are prospective, but this is not explicitly stated.
3. Number of Experts and Qualifications for Ground Truth:
The document does not provide any information regarding the number or qualifications of experts used to establish ground truth for the test set. It mentions "healthcare professionals" and "clinical personnel" in the context of device use, but not for ground truth establishment for the studies themselves.
4. Adjudication Method for the Test Set:
The document does not mention any adjudication method (e.g., 2+1, 3+1) used for establishing ground truth or evaluating the test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- The document does not describe a multi-reader multi-case (MRMC) comparative effectiveness study involving human readers with and without AI assistance.
- The device described is a remote monitoring platform that collects and transmits physiological data, offering parameters like ECG, Heart Rate, Respiration Rate, Skin Temperature, and Posture. Its primary function is data acquisition, transmission, display, storage, and analysis, with an optional alert notification system. It is not an AI-assisted diagnostic imaging device for which MRMC studies are typically performed to assess reader improvement.
- Therefore, an "effect size of how much human readers improve with AI vs without AI assistance" is not applicable in the context of the studies described for this device.
6. Standalone (Algorithm Only) Performance:
- The document describes performance testing for various physiological parameters (ECG, Heart Rate, Respiration Rate, Skin Temperature). These tests evaluate the device's ability to accurately measure and derive these parameters from raw biosensor data.
- Specifically, it states that the "Sensor Processing Library" in the LifeSignals Secure Server processes and filters biosensor data to derive Heart Rate, Respiration Rate, Skin Temperature & Posture.
- The performance validations conducted (e.g., for Heart Rate accuracy, Respiration Rate performance, Skin Temperature accuracy) essentially assess the "algorithm-only" or "device-only" performance in accurately capturing and processing physiological signals, as this is the core function of the device before human interpretation of the displayed data.
7. Type of Ground Truth Used:
The types of ground truth used can be inferred from the testing methods:
- Physiological Measurements: For Heart Rate, Respiration Rate, and Skin Temperature, the ground truth would likely be established through reference devices or highly accurate clinical measurement standards. For example, "on-body comparative performance" implies comparison against a gold standard in a clinical setting, and "bench testing" implies comparison against known, controlled inputs.
- ECG Waveform Quality: Ground truth would involve comparison against standard ECG recordings, likely by visual inspection or automated analysis according to established medical device standards (e.g., ANSI AAMI IEC 60601-2-47).
- Biocompatibility/Safety/Usability: Ground truth for these aspects is compliance with relevant national and international standards (ISO, ANSI AAMI, IEC, USFDA Guidance).
The document does not explicitly state "expert consensus," "pathology," or "outcomes data" as ground truth methods beyond the functional performance against established standards.
8. Sample Size for the Training Set:
The document does not provide any information regarding a training set sample size. This device is described as a physiological monitoring system that captures and processes signals, rather than a deep learning model that typically requires a large training dataset. While software is involved (Class B, "Moderate" level of concern), the text focuses on verification and validation of the software and derived parameters against known physical and physiological principles, rather than a machine learning training paradigm.
9. How Ground Truth for the Training Set was Established:
As no training set is mentioned in the context of machine learning, no information is provided on how its ground truth was established. The "Sensor Processing Library" mentioned suggests signal processing and derivation algorithms, which are typically validated through known physiological models, bench test data, or clinical reference measurements, rather than a large, retrospectively labeled training set in the AI sense.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.
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)
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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
510(k) Summary for LifeSignals Multi-parameter Remote Monitoring Platform
1 Company name :LifeSignals, Inc.
| Address | :39355 California Street, Suite 305Fremont, CA 94538.USA |
|---|---|
| Contact | :Saravanan BalasubramanianVice President – Medical Systems & Regulatory AffairsEmail: saravanan@lifesignals.comTel: 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
| RegulationClassification | ProductCode | Description | |
|---|---|---|---|
| Cardiovascular | 21 CFR 870.2910Class II | DRG | Transmitters and Receivers,Physiological Signal, Radiofrequency |
5 Subsequent Product code
| RegulationClassification | ProductCode | Description | |
|---|---|---|---|
| Cardiovascular | 21 CFR 870.1025Class II | MHX | Monitor, Physiological,Patient (With ArrhythmiaDetection Or Alarms) |
| General Hospital | 21 CFR 880.2910Class 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}------------------------------------------------
| 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(Primary) | 21 CFR 870.2910Class II | 21 CFR 870.2910Class II |
| Intended use /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 are18 years or older | Non-critical, adultpopulation, 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 Physiologicaldata monitoring | ✓ | ✓ |
| Heart Rate Range &accuracy (Stationary andAmbulatory) | 30 – 200 BPM (Range)± 5 or 10% whichever isgreater | 30 – 250 BPM (Range)± 3 or 10% whichever isgreater |
| Respiration Rate Range &accuracy | • 10-30 Breaths per Minutewith a mean absolute error ofless than 3 Breaths perMinute, validated by clinicalstudies.• 4-42 Breaths per Minute witha mean absolute error of lessthan 1.5 Breaths per Minute,validated by simulationstudies | • 9-30 Breaths per Minutewith a mean absolute errorof less than 3 Breaths perMinute, validated byclinical studies.• 6-60 Breaths per Minutewith a mean absolute errorof less than 1 Breaths perMinute, validated bysimulation studies |
| Skin Temperature Range& Accuracy (Laboratory) | 15°C - 50°C (≤ ± 0.3°C)Continuous measurement | 32°C - 43°C (Accuracy asper ASTM E1112-00)Continuous measurement |
| Posture Detection | Lying down, Upright,Walking, Running, or Leaning | Lying down, Upright orInclined |
| Programmable AlertNotification & Setting | ✓ | ✓ |
| "Alarm" Function(to assist clinician forimmediate intervention ) | × | × |
| Sensor | ||
| Single Use | ✓ | ✓ |
| Wear Life | 120 hours | 120 hours |
| Data can be transferred &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 noconnection with Server | ✓ | ✓ |
| Data accessible from Relaydevice by 3rd party via API | ✓ | ✓ |
| Secure Server | Data is stored for access by 3rdparty software | Data is stored for access by3rd 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 870.2910Class II | 21 CFR 870.2910Class II |
| Intended use /Indications for use | VitalWatch is a software userinterface intended for use byhealthcare professionals todisplay physiological datacollected by the VitalConnectPlatform wireless remotemonitoring system in homeand healthcare settings.VitalWatch is a secondary,adjunct patient monitor and isnot intended to replaceexisting standard-of-carepatient monitoring practices. | The LifeSignals Multi-Parameter Remote MonitoringPatch Platform (LX1550) is awireless remote monitoringsystem intended for use byhealthcare professionals forcontinuous collection ofphysiological data at home andin healthcare settings. Thisshall includeElectrocardiography (2-channel ECG), Heart Rate,Respiration Rate, SkinTemperature & Posture. Datais transmitted wirelessly fromLifeSignals Biosensor toRemote secure server fordisplay, storage & analysis.The LifeSignals Multi-Parameter Remote MonitoringPlatform is intended for non-critical, adult population. TheLifeSignals Multi-ParameterRemote Monitoring Platformcan include the ability to notifyhealthcare professionals whenphysiological parameters falloutside the set limits and todisplay multiple patientphysiological data for remotemonitoring. |
| Comparison | Reference Device – I(K170973) | Subject Device(K202868) |
| Physiological DataMonitored | Electrocardiography (ECG),Heart Rate, Heart ratevariability, R-R Interval,Respiration rate, skintemperature, activity(including step count) andposture | Electrocardiography (2-channel ECG), Heart Rate,Respiration Rate, SkinTemperature & Posture. |
| Principles of Operations | Display of data from validatedRelay device using third-partydeveloped Graphical UserInterface, or VitalWatch, andoptional transmission of datato Secure Server. | Display of data from validatedSecure server installed withLifeSignals Secure ServerApplication on any web-basedbrowser using LifeSignalsRemote Monitoring Dashboardor any third-party developedGUI. |
| 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 870.2910Class II | 21 CFR 870.2910Class II |
| Intended use /Indications for use | The LifeSignals ECG RemoteMonitoring Patch Platform is awireless remote monitoringsystem intended for use byhealthcare professionals forcontinuous collection ofElectrocardiography (ECG) &Heart Rate monitoring in homeand healthcare settings. Data istransmitted wirelessly fromLifeSignals Biosensor toRemote secure server forstorage and analysis. TheLifeSignals ECG RemoteMonitoring Patch Platformincludes an ability to notifyhealthcare professionals whenHeart Rate falls outside the setlimits | The LifeSignals Multi-ParameterRemote Monitoring Platform(LX1550) is a wireless remotemonitoring system intended foruse by healthcare professionalsfor continuous collection ofphysiological data at home and inhealthcare settings. This shallinclude Electrocardiography (2-channel ECG), Heart Rate,Respiration Rate, SkinTemperature & Posture. Data istransmitted wirelessly fromLifeSignals Biosensor toRemote secure server fordisplay, storage & analysis. TheLifeSignals Multi-ParameterRemote Monitoring Platform isintended for non-critical, adultpopulation. The LifeSignalsMulti-Parameter RemoteMonitoring Platform can includethe ability to notify healthcareprofessionals when physiologicalparameters fall outside the setlimits and to display multiplepatient physiological data in forremote 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 noconnection with Server | ✓ | ✓ |
| Comparison | Reference Device II(K200690) | Subject Device(K202868) |
| Data accessible from Relaydevice by 3rd party via API | ✓ | ✓ |
| Secure Server | Data is stored for access by3rd party software | Data is stored for access by3rd 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.
§ 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).