(121 days)
No
The document explicitly states that the Secure Server Application does not carry out any arrhythmia analysis by itself and is intended to be used with approved third-party ECG analysis software. There is no mention of AI or ML being used for any function within the described system components.
No.
The device is for monitoring and data collection, not for treating a condition or disease. It is explicitly stated that "The Secure Sever Application does not carry out any arrhythmia analysis of ECG data by itself." and the data is intended "to be used with an approved third-party ECG analysis software." for clinical workflow.
Yes
The device collects ECG and heart rate data, and can notify healthcare professionals when heart rate falls outside set limits, indicating its role in monitoring physiological parameters to inform medical decisions. Although it doesn't perform "arrhythmia analysis by itself," the data it collects is "intended to be used with an approved third-party ECG analysis software" for various clinical workflows, which are diagnostic in nature (e.g., Mobile Cardiac Telemetry, Cardiac Event Monitor, Holter Monitoring system).
No
The device description clearly outlines three main components: a Biosensor Patch (hardware), a Relay device (commercial hardware with software), and a Secure Server (hardware with software). The Biosensor Patch is explicitly described as acquiring and transmitting ECG signals, indicating it is a physical hardware component.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The LifeSignals ECG Remote Monitoring Patch Platform collects and transmits physiological signals (ECG and Heart Rate) directly from the body. It does not analyze samples taken from the body.
- Intended Use: The intended use is for continuous collection of ECG and Heart Rate monitoring, which are in-vivo measurements.
- Device Components: The components described (biosensor patch, relay device, secure server) are designed for acquiring, transmitting, and storing physiological data, not for analyzing biological samples.
While the data collected by this device can be used with third-party software for analysis that might contribute to a diagnosis, the device itself is focused on the acquisition and transmission of in-vivo physiological signals.
N/A
Intended Use / Indications for Use
The LifeSignals ECG Remote Monitoring Patch Platform is a wireless remote monitoring system intended for use by healthcare professionals for continuous collection of Electrocardiography (ECG) 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.
Product codes (comma separated list FDA assigned to the subject device)
DRG, MWJ
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.
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.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Adult population, who are 18 years of age or older.
Intended User / Care Setting
healthcare professionals / home and healthcare settings.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Verification & Validation activities were performed on LifeSignals ECG Remote Monitoring Patch Platform to demonstrate substantial equivalence to the predicate device:
- Biocompatibility testing of In-vitro cytotoxicity, skin irritation and skin sensitization were conducted on the LifeSignals 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 Biosensor Patch for compliance with IEC 60601-1, IEC 60601-1-2 and IEC 60601-1-11.
- Performance testing were conducted on the LifeSignals ECG Remote Monitoring Platform for compliance with IEC 60601-2-47 and IEC 60601-2-27.
- Usability study was conducted on the LifeSignals ECG Remote Monitoring Platform for compliance with IEC 60601-1-6 and "USFDA Guidance- Applying Human Factors and Usability Engineering to Medical Devices "
- Ambulatory performance of Heart Rate algorithm and ECG waveform quality of LifeSignals ECG Remote Monitoring Patch Platform was verified using nonrandomized, self-control comparative on-body comparative performance study. The adhesion (Wear-life) of LifeSignals Biosensor Patch was also verified in accordance to AAMI ANSI EC12.
- Wireless performance & coexistence testing was conducted as per ANSI/IEEE C63.27:2017 : American National Standard for Evaluation of Wireless coexistence. Also tested for compliance to FCC CFR47 Part 15 subpart C & ETSI EN 300 328
- 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 and packaging transportation testing were conducted and verified as per the acceptance criteria
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Heart Rate Range: 30 – 250 BPM (Range)
Heart Rate accuracy: ± 3 or 10% whichever is greater
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 870.2910 Radiofrequency physiological signal transmitter and receiver.
(a)
Identification. A radiofrequency physiological signal transmitter and receiver is a device used to condition a physiological signal so that it can be transmitted via radiofrequency from one location to another, e.g., a central monitoring station. The received signal is reconditioned by the device into its original format so that it can be displayed.(b)
Classification. Class II (performance standards).
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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
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
2
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 |
| Fremont, CA 94538. | |
| USA | |
| Contact | :Saravanan Balasubramanian |
| Vice President – Medical Systems & Regulatory Affairs | |
| Email: saravanan@lifesignals.com | |
| Tel: 510.770.6412 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
Classification | Product
Code | Description |
|----------------|------------------------------|-----------------|-------------------------------------------------------------------------|
| Cardiovascular | 21 CFR 870.2910
Class II | DRG | Transmitters and Receivers,
Physiological Signal, Radio
frequency |
5.5 Subsequent Product codes
| Device Panel | Regulation
Classification | Product
Code | Description |
|----------------|------------------------------|-----------------|-----------------------------------|
| Cardiovascular | 21 CFR 870.200
Class II | MWJ | Medical Magnetic Tape
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.
6
- 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 / | ||
| 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 ECG Remote | |
| Monitoring Patch Platform is a | ||
| wireless remote monitoring system | ||
| intended for use by healthcare | ||
| professionals for continuous | ||
| collection of Electrocardiography | ||
| (ECG) & Heart Rate monitoring in | ||
| home and healthcare settings. Data is | ||
| transmitted wirelessly from | ||
| LifeSignals Biosensor to Remote | ||
| secure server for storage and | ||
| analysis. The LifeSignals ECG | ||
| Remote Monitoring Patch Platform | ||
| includes an ability to notify | ||
| healthcare professionals when Heart | ||
| Rate falls outside the set limits. | ||
| 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 | ||
| data monitoring | ✓ | ✓ |
| Heart Rate Range & | ||
| accuracy (Stationary and | ||
| Ambulatory) | 30 – 200 BPM (Range) | |
| ± 5 or 10% whichever is greater | 30 – 250 BPM (Range) | |
| ± 3 or 10% whichever is | ||
| greater | ||
| Programmable Alert | ||
| Notification & Setting | ✓ | ✓ |
| "Alarm" Function | ||
| (to assist clinician for | ||
| immediate intervention ) | x | x |
| Sensor | ||
| Single Use | ✓ | ✓ |
| Wear Life | 72 hours | 72 hours |
| Data can be transferred & | ||
| 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 | ||
| connection with Server | ✓ | ✓ |
| Data accessible from Relay | ||
| device by 3rd party via API | ✓ | ✓ |
| Secure Server | Data is stored for access by any | |
| 3rd party software | Data is stored for access by | |
| any 3rd party software | ||
| Comparison | Predicate (K152139) | Subject Device (K200690) |
| 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)
7
8
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 |
9
| 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 |
| Body Contact Material | ||
| 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 |
| Wireless Communication | ||
| 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
(K152626) | Subject Device
(K200690) |
|--------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Mortara Instrument, Inc., USA | LifeSignals, Inc., USA |
| Product Codes | MWJ | DRG (Primary), MWJ |
| Regulation Classification
(All product codes) | 21 CFR 870.2800
Class II | 21 CFR 870.1025
21 CFR 870.2800
Class II |
| Intended use /
Indications for use | The H3+ Holter recorder is intended to
acquire, record and store continuous ECG
data as directed by a clinician from adult,
adolescent, pediatric, infant and neonate
patient populations for a maximum
recording time of 14 days in a hospital,
clinic or home environment. The H3+ is
intended to be used with a compatible
ambulatory ECG (Holter) analysis system
which will analyze the recorded data. The
H3+ data and the data analysis are then
reviewed by trained medical personnel for
the purpose of forming a clinical
diagnosis. The H3+ Holter Recorder is not
a life-supporting device. | LifeSignals
ECG
The
Remote
Monitoring Patch Platform is a wireless
remote monitoring system intended for
use by healthcare professionals for
continuous
collection
of
Electrocardiography (ECG) & Heart
Rate monitoring in home and healthcare
settings. Data is transmitted wirelessly
from LifeSignals Biosensor to Remote
secure server for storage and analysis.
LifeSignals
The
Remote
Monitoring Patch Platform includes an
ability to notify healthcare professionals
when Heart Rate falls outside the set
limits. |
| Intended Population | Adult, adolescent, pediatric,
Infant & Neonate Patient
population | Non-critical, adult population,
18 years or older |
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| Comparison | Reference Device – II
(K152626) | Subject Device
(K200690) |
|-----------------------|-------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Home & Healthcare settings | Home & Healthcare settings |
| Environment | | |
| Data type | Digital | Digital |
| Record Duration | Up to 14 days | Up to 72 hours in Biosensor patch,
when Relay device is not available
in wireless range & in Secure Server
when Relay device is available. |
| Record Medium | Internal Flash Memory | Internal Flash Memory (Biosensor)
or Hard disk (Secure Server) |
| Data Transfer Method | Via USB Port | Wireless |
| ECG Channels | 3 | 2 |
| Frequency Response | Meets the requirement of IEC
60601-2-47 | Meets the requirements of
IEC 60601-2-47 |
| Sampling Rate | 180 sps | 244.14 sps |
| Dynamic Range | 12-bit | 16-bit / ± 300 mV |
| Amplitude Resolution | 6.25 uV | 5.3 uV |
| Cable | 5-wires | Integrated Patch design |
| Impedance measurement | No | No |
| Pacemaker Detection | Yes | No |
| Time displayed | Yes | Yes (In Relay device) |
| Dimension | 64 x 25 x 19 mm | 112 x 79 x 6 mm |
| Weight | 28 grams | 18 grams |
| ECG analysis | No in-built arrhythmia analysis
function and is intended to be
used with a compatible
analysis software | No in-built arrhythmia
analysis function and is
intended to be used with a
compatible analysis software |
Differences and Risks associated with that :
- Reference device has three channels of ECG, whereas the proposed device has two channels . of ECG.
- Reference device uses 5-wires electrodes, while the proposed device has integrated patch ● design with four electrodes.
- . Reference device is intended for 14 days of recording, while the proposed device is intended for 72 hours. The recording period of more than 48 hours shall be considered to be extended cardiac monitoring. However, if there is a clinical requirement, multiple biosensor Patch can be worn by the patient to extend the monitoring period up to 14 days and the secure sever has ability to record more than 14 days of data simultaneously.
- . Reference device has a pacemaker detection capability, while the proposed device does not have pacemaker detection capability. The proposed device is contraindicated for use with active implantable medical devices including pacemakers.
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5.12 Summary of Performance Testing
Verification & Validation activities were performed on LifeSignals ECG Remote Monitoring Patch Platform to demonstrate substantial equivalence to the predicate device:
- Biocompatibility testing of In-vitro cytotoxicity, skin irritation and skin sensitization . were conducted on the LifeSignals 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 Biosensor Patch for compliance with IEC 60601-1, IEC 60601-1-2 and IEC 60601-1-11.
- Performance testing were conducted on the LifeSignals ECG Remote Monitoring Platform for compliance with IEC 60601-2-47 and IEC 60601-2-27.
- Usability study was conducted on the LifeSignals ECG Remote Monitoring Platform for compliance with IEC 60601-1-6 and "USFDA Guidance- Applying Human Factors and Usability Engineering to Medical Devices "
- Ambulatory performance of Heart Rate algorithm and ECG waveform quality of ● LifeSignals ECG Remote Monitoring Patch Platform was verified using nonrandomized, self-control comparative on-body comparative performance study. The adhesion (Wear-life) of LifeSignals Biosensor Patch was also verified in accordance to AAMI ANSI EC12.
- Wireless performance & coexistence testing was conducted as per ANSI/IEEE . C63.27:2017 : American National Standard for Evaluation of Wireless coexistence. Also tested for compliance to FCC CFR47 Part 15 subpart C & ETSI EN 300 328
- 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 and packaging transportation testing were conducted and verified as per the acceptance criteria
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5.13 Conclusion
The LifeSignals ECG Remote Monitoring Patch Platform is substantially equivalent with respect to safety and effectiveness to the legally marketed predicate device for its intended use. Minor differences between the LifeSignals ECG Remote Monitoring Patch Platform and the predicate device have no effect on safety or effectiveness, as established through various performance tests. Further, LifeSignals Biosensor Patch used in LifeSignals ECG Remote Monitoring Patch Platform is substantially equivalent with respect to technology & design to the legally marketed referenced devices.