LifePath Remote Patient Monitoring Platform
Device Facts
| Record ID | K211822 |
|---|---|
| Device Name | LifePath Remote Patient Monitoring Platform |
| Applicant | Elastic Care Incorporated |
| Product Code | DRG · Cardiovascular |
| Decision Date | Feb 3, 2022 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.2910 |
| Device Class | Class 2 |
| Attributes | Software as a Medical Device, 3rd-Party Reviewed |
Indications for Use
The LifePath Remote Patient Monitoring Platform connects with compatible physiological measurement devices (blood pressure meters, pulse oximeters, thermometers, glucometers) to collect vital sign using a Patient App and securely transmit them, unaltered, to LifePath servers. The LifePath Platform is intended to be used at home or in healthcarerelated environments such as long-term care facilities or clinics, nursing homes and hospitals. The LifePath Remote Patient Monitoring Platform serves as Software as a Medical Device and can be used only with specific FDA cleared third-party measurement devices. The LifePath Remote Patient Monitoring Platform securely stores the collected information on LifePath servers and make it available for viewing by remotely located clinician App installed on their smartphones. The clinician can analyze the data, prescribe medications or contact the patient if needed. Clinicians can set thresholds individually for each patient; notifications are sent to the clinician for threshold breaches. The LifePath Platform does not interpret, make diagnoses or serve as a substitute for medical care. It is not intended to provide real time data. The LifePath Platform is contraindicated for use in high-acuity environments, such as the ICU or operating rooms, and is not intended for use on acutely or critically ill patients or those requiring time-critical or emergency intervention. It is intended for patients who are willing and capable of managing its use or where its operations can be performed by a caregiver. Clinical judgment and experience of a Clinician are required to check and interpret the information delivered.
Device Story
LifePath RPM Platform is a software-based telemedicine system; collects vital signs from FDA-cleared third-party Bluetooth-enabled devices (pulse oximeters, thermometers, glucometers, BP monitors). Patient App on mobile device receives data via Bluetooth LE; transmits encrypted, unmodified data to central LifePath server. Clinician App on mobile device allows remote viewing of stored data, threshold setting, and communication (chat/video). Clinicians use output to monitor patient status, prescribe medications, or contact patients. System provides notifications for threshold breaches. Used in home or clinical settings by patients/caregivers and clinicians. Does not provide real-time data, diagnosis, or interpretation. Benefits include remote patient management and improved clinician-patient communication.
Clinical Evidence
No clinical data. Safety and performance established via software verification and validation testing per FDA guidance.
Technological Characteristics
Software as a Medical Device (SaMD). Connectivity: Bluetooth LE (2.4 GHz) for device-to-app; Wi-Fi/cellular for app-to-server. Platform: Android (v8+), mobile smartphones. Security: HIPAA-compliant encryption. Data processing: Central server-based storage and threshold analysis. No hardware components; utilizes COTS third-party medical devices.
Indications for Use
Indicated for adult patients with non-critical conditions requiring remote monitoring of vital signs (pulse rate, SpO2, skin temperature, blood pressure, blood glucose) at home or in healthcare facilities. Contraindicated for high-acuity environments (ICU, OR), acutely/critically ill patients, or those requiring time-critical/emergency intervention.
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
- Comarch e-Care Platform (K181248)
Submission Summary (Full Text)
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February 3, 2022
Elastic Care Incorporated % Prithul Bom Most Responsible Person Regulatory Technology Services, LLC 1000 Westgate Drive, Suite 510k Saint Paul, Minnesota 55114
Re: K211822
Trade/Device Name: LifePath Remote Patient Monitoring Platform Regulation Number: 21 CFR 870.2910 Regulation Name: Radiofrequency physiological signal transmitter and receiver Regulatory Class: Class II Product Code: DRG Dated: January 4, 2022 Received: January 5, 2022
#### Dear Prithul Bom:
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
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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 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 Kozen Assistant Director Division of Cardiac Electrophysiology. Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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#### Indications for Use
510(k) Number (if known) K211822
Device Name LifePath Remote Patient Monitoring Platform
#### Indications for Use (Describe)
The LifePath Remote Patient Monitoring Platform connects with compatible physiological measurement devices (blood pressure meters, pulse oximeters, thermometers, glucometers) to collect vital sign using a Patient App and securely transmit them, unaltered, to LifePath servers. The LifePath Platform is intended to be used at home or in healthcarerelated environments such as long-term care facilities or clinics, nursing homes and hospitals. The LifePath Remote Patient Monitoring Platform serves as Software as a Medical Device and can be used only with specific FDA cleared third-party measurement devices.
The LifePath Remote Patient Monitoring Platform securely stores the collected information on LifePath servers and make it available for viewing by remotely located clinician App installed on their smartphones. The clinician can analyze the data, prescribe medications or contact the patient if needed. Clinicians can set thresholds individually for each patient; notifications are sent to the clinician for threshold breaches.
The LifePath Platform does not interpret, make diagnoses or serve as a substitute for medical care. It is not intended to provide real time data.
The LifePath Platform is contraindicated for use in high-acuity environments, such as the ICU or operating rooms, and is not intended for use on acutely or critically ill patients or those requiring time-critical or emergency intervention. It is intended for patients who are willing and capable of managing its use or where its operations can be performed by a caregiver. Clinical judgment and experience of a Clinician are required to check and interpret the information delivered.
| Type of Use (Select one or both, as applicable) |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| <div> <span> <span style="text-decoration: underline;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> <span> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |
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Image /page/3/Picture/0 description: The image shows the logo for Elastic Care. The logo consists of a stylized letter "E" in black, with a red line extending from the "E" to a partial circle on the right, resembling an electrocardiogram (ECG) waveform. Below the logo are the words "ELASTIC" and "CARE" stacked vertically in a simple, sans-serif font.
# 510(k) Summary
[As per the requirements of 21 CFR Part 807.92]
# 1 SUBMITTER IDENTIFICATION
| Company name: | ELASTIC CARE INCORPORATED |
|------------------|---------------------------|
| Company Address: | 95 Apple Creek Blvd., |
| | Markham, Ontario L3R 1C7 |
| | Canada |
| Phone: | (416)-704-5141 |
| Fax: | (416)-214-6238 |
| Contact Person: | Ashok Kalle |
| Contact Email: | ashok.kalle@pathcom.com |
| Date Prepared: | 17 May 2021 |
## 2 SUBMITTER CORRESPONDENT
| Contact Person: | Prithul Bom |
|-----------------|------------------------------------------------------------------------------------------|
| Address: | Regulatory Technology Services, 1000 Westgate Drive,<br>Suite #510k Saint Paul, MN 55114 |
| Phone: | 612-963-0379 |
| Contact Email: | prithul.bom@rts3pro.com |
## 3 DEVICE IDENTIFICATION
| Trade Name: | LifePath Remote Patient Monitoring Platform |
|-----------------------------------|--------------------------------------------------------------|
| Common Name: | LifePath RPM Platform |
| Device Class: | II |
| Classification Regulation Number: | 870.2910 |
| Classification Name: | Radiofrequency physiological signal transmitter and receiver |
| Product Code: | DRG |
| Classification Panel: | Cardiovascular |
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Image /page/4/Picture/0 description: The image shows the logo for Elastic Care. The logo features the letters 'EC' in a stylized design. The 'E' is formed by a black line with a red horizontal line running through it. The 'C' is a black circle with a red line that resembles an electrocardiogram (ECG) tracing. Below the symbol are the words 'ELASTIC CARE' stacked vertically in a simple, sans-serif font.
## 4 LEGALLY MARKETED PREDICATE DEVICE(S)
Predicate Device: Comarch e-Care Platform, K181248
# 5 DEVICE DESCRIPTION
The LifePath Remote Patient Monitoring Platform (the "LifePath RPM Platform") is a software application. It is used in conjunction only with FDA cleared Commercial, Off-The-Shelf (COTS) Third-Party Medical Devices (TPDs). These TPDs are with Bluetooth functionality to collect, aggregate, and present, without modification, vital signs and symptoms required by clinicians to assess a patient's health. The device is intended for patients who have non-critical conditions and are located either in their own homes or in professional healthcare facilities such as hospitals, skilled nursing facilities, nursing homes, or long-term care facilities. The LifePath RPM Platform constitutes a telemedicine system for remote monitoring of patients with the connected Clinician. Both the Patient App and Clinician App are accessed via authentication using a one-time security code by the respective users.
Image /page/4/Figure/6 description: The image shows a diagram of the LifePath Processing Software system. The system includes third-party devices such as a blood pressure meter, pulse oximeter, glucometer, and thermometer. These devices connect to the LifePath Patient App, which then connects to the LifePath Clinician App. The LifePath Processing Software includes features such as authentication/authorization, vital data processing and storage, appointments booking, video call and chat functions, alerts, prescriptions creation/storage, notifications handling, and patient data storage.
The LifePath Patient App connects through a short-range radio system using Bluetooth to FDA 510(k) cleared devices (listed in Table 1 below) to measure physiological parameters of adult patients and securely transmit unmodified data to the LifePath Processing Software residing on the LifePath Server (or central server) for storage, formatting, remote display, and download. The information is available for secure viewing by remotely-located healthcare professionals (eg.
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Image /page/5/Picture/1 description: The image shows a logo for a company called "ELASTIC CARE". The logo features the letters "EC" in a stylized font, with the "E" in black and the "C" formed by a black outline and a red heartbeat line. The words "ELASTIC CARE" are written in a simple, sans-serif font below the letters.
Clinicians). The data may be retrieved and viewed via the Clinician App and Patient App on smartphones through internet access using local Wi-Fi 802.11 or a 3G/4G/LTE cellular network. By using the Clinician App a Clinician can view the vital signs of the connected patient, analyze the data, and prescribe medications. Clinicians will also be able to set thresholds for each patient such that notifications will be sent to the Clinician in the event of any threshold breach. The LifePath RPM Platform will be prescribed by the Clinician to the patient as per the need to remotely monitor the patient. The patient, using the Patient App, can book appointments with the Clinician. The Patient App also has the provision for the patient to respond to the Clinician's questions on their prior health conditions, medical conditions, any allergic conditions, etc., that will enable Clinicians to get a clear medical status of the patient. The patient and the Clinician can interact through chats and video calls using their respective apps.
The LifePath RPM Platform is not intended for use in high-acuity environments, such as the ICU or operating rooms, and is not intended for use on acutely or critically ill patients or those requiring time-critical or emergency intervention.
## 5.1 Physiological Parameters from Third-Party Medical Devices
The LifePath RPM Platform gathers physiological parameter readings transmitted by Third-Party Medical Devices ("TPDs") using Bluetooth LE. These third-party bedside or mobile devices shall each have individually received FDA 510k clearance and the LifePath RPM Platform will have been configured to receive physiological parameter readings from them by integrating the device-specific software(s). Physiological vital signs and parameters measured include the following medical devices:
- Pulse rate from a Pulse Oximeter ●
- Peripheral oxygen saturation (SpO2) from a Pulse Oximeter ●
- Skin temperature from a digital thermometer ●
- Systolic and diastolic blood pressure from a non-invasive BP Monitor ●
- Blood sugar (glucose) from a Glucometer
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Image /page/6/Picture/0 description: The image contains a logo for a company called "ELASTIC CARE". The logo features the letters "EC" in a stylized design. The "E" is a square shape, and the "C" is a curved shape. A red line runs through the middle of the "E" and continues into the "C", forming a heartbeat symbol. Below the logo, the words "ELASTIC CARE" are written in a simple, sans-serif font.
#### The following table lists the FDA 510k cleared third-party medical devices from which the LifePath RPM Platform receives physiological parameters:
| Physiological<br>Parameters | Device | Manufacturer | Model | 510 (k)<br>number | Date cleared<br>(MM/DD/YYYY) |
|-------------------------------------------------------|---------------------------------------------------------|-------------------------------------------------------------|-----------|-------------------|------------------------------|
| Pulse rate,<br>Peripheral oxygen<br>saturation (SpO2) | Pulse Oximeter | Shanghai Berry<br>Electronic Tech<br>Co., Ltd | BMC1000C | K172141 | 04/04/2018 |
| Skin temperature | Clinical Electronic<br>Thermometer | Shenzhen Jumper<br>Medical Equipment<br>Co., Ltd. | JPD-FR400 | K172795 | 03/14/2018 |
| Blood sugar<br>(glucose) | Blood Glucose<br>Monitoring<br>System | Tyson Bio | HT100B | K170079 | 10/06/2017 |
| | | All Medicus Co.,<br>Ltd. | ABM-513S | K170241 | 10/13/2017 |
| Systolic and<br>diastolic blood<br>pressure | Non-invasive<br>Blood Pressure<br>Measurement<br>System | Shenzhen Belter<br>Health<br>Measurement And<br>Analysis TE | ePA-46B4 | K134029 | 07/25/2014 |
Table 1
## 5.2 LifePath RPM Platform - MAJOR COMPONENTS
The LifePath RPM Platform consists of the following:
- a) The LifePath Patient Application ("Patient App"). This is downloaded and installed on a mobile phone which is in the proximity of the person whose vital signs are being monitored. The patient may seek assistance from a caregiver in operating the App and collecting vital signs.
The Patient App receives the vital signs data from the third-party medical devices over Bluetooth LE and transmits them, encrypted and unmodified, over the Internet to the "LifePath Processing Software" installed on a secure, remote central server. The Patient App must be turned on and be available within Bluetooth range of the third-party devices at the location of the individual(s) whose vital signs and parameters are being monitored.
- b) The LifePath Processing Software ("Processing Software") receives, stores, formats, and makes the vital signs information accessible for viewing by Clinicians. Notifications will be sent to the Clinician for any threshold breaches
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Image /page/7/Picture/0 description: The image shows the logo for Elastic Care. The logo consists of a stylized letter "E" in black, with a red line extending from the right side of the "E" that forms a heart rate waveform. The waveform ends inside a black circle that is connected to the "E". Below the symbol are the words "ELASTIC" and "CARE" stacked on top of each other in a sans-serif font.
set by the Clinician. The Processing Software resides in the central server (LifePath Server).
- c) A LifePath Clinician Application ("Clinician App"). This is downloaded and installed on a mobile phone used by the Clinician who is monitoring the patient. The Clinician App is an interface to observe physiological parameters, to view and respond to alerts, and to perform other administrative functions that do not involve vital signs.
Elastic Care onboards healthcare professionals such as Clinicians bv background verification of their credentials. They are required to have skills to interpret physiological parameters and vital signs.
### 5.3 LifePath RPM Platform Feature Summary
The LifePath RPM Platform includes the following features and functions:
- a. Creation of a master patient record on the central server which contains patient information.
- b. Setting of individual thresholds by a Clinician for each vital sign or parameter, and for sending alerts to the Clinician when these thresholds are crossed.
- c. The ability for the reviewing clinician to add annotations and notes to the patients' record.
- d. Reminders and alerts for patients and Clinicians related to medical and nonmedical activities.
- e. Scheduling of appointments by the patient with the Clinician using the Patient App.
- f. Issue of secure electronic prescriptions by the supervising Clinician from the Clinician App in conformance to legal requirements.
- g. Communications between the Clinician and the patient via video and chat.
- h. The ability for the clinicians and patients to manually enter patients' vital signs and symptoms into the patient records using the Patient App.
- i. Storage and display of historical patient vital signs.
- i. Maintenance of records of consultation for Clinician billing and audit.
## 5.4 Mode of Operation
The LifePath RPM Platform is a software application constituting a telemedicine system for remote monitoring of patients with the connected Clinician. It is used in
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Image /page/8/Picture/1 description: The image is a logo for a company called "Elastic Care". The logo features the letters "EC" in a stylized design. The "E" is a black square with an open side, and the "C" is a black arc. A red line runs horizontally through the "E" and continues into the "C", where it becomes a red heartbeat symbol. Below the letters, the words "ELASTIC" and "CARE" are stacked on top of each other in a simple, sans-serif font.
combination with FDA cleared TPDs with Bluetooth functionality to collect, aggregate, and present, without modification, vital signs and symptoms required by clinicians to assess a patient's health. The Patient's vital sign data can be viewed by the Clinician using the Clinician App over cellular or Wi-Fi networks to analyze and prescribe medications or provide medical advice. Clinicians can also set thresholds for individual patients and receive notifications for any breach. The LifePath RPM Platform also provides the capability for the patient to book consultations with the Clinician and interact using either chat or video call facility. All patients shall have non-critical conditions and shall not require in-person emergency medical care.
The proposed conditions for use of the LifePath RPM Platform are listed below.
#### 5.4.1 Hardware hosts for Patient and Clinician Applications:
- a. Android (version 8 and above).
- b. Smartphones with screen sizes equal to, or greater than, 5.7 inches diagonally.
- c. Processor: 2 core 1.2 GHz or faster processor.
- d. RAM: Minimum 2 GB or more.
- e. ROM: Minimum 2 GB or more.
- f Network Bandwidth: More than 1 MBPS (Internet access using local Wi-Fi 802.11 or 3G/4G/LTE cellular.
- g. Bluetooth: version 2.0 and higher and operating frequency of 2.4 GHz.
The LifePath RPM Platform ensures the security of transmitted data via encryption in compliance with HIPAA requirements.
## 6 INDICATION FOR USE
The LifePath Remote Patient Monitoring Platform connects with compatible physiological measurement devices (blood pressure meters, pulse oximeters, thermometers, glucometers) to collect vital sign using a Patient App and securely transmit them, unaltered, to LifePath servers. The LifePath Platform is intended to be used at home or in healthcare-related environments such as long-term care facilities or clinics, nursing homes and hospitals. The LifePath Remote Patient Monitoring Platform serves as Software as a Medical Device and can be used only with specific FDA cleared third-party measurement devices.
The LifePath Remote Patient Monitoring Platform securely stores the collected information on LifePath servers and make it available for viewing by remotely located clinicians using a Clinician App installed on their smartphones. The clinician can analyze the data, prescribe medications or contact the patient if needed. Clinicians can set thresholds individually for
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Image /page/9/Picture/0 description: The image contains a logo for Elastic Care. The logo features the letters 'EC' in a stylized design, with the 'E' in black and the 'C' formed by a black arc. A red line runs horizontally through the letters, forming a heartbeat waveform in the middle. Below the letters, the words 'ELASTIC CARE' are stacked vertically in a simple, sans-serif font.
each patient; notifications are sent to the clinician for threshold breaches.
The LifePath Platform does not interpret, make diagnoses or serve as a substitute for medical care. It is not intended to provide real time data.
The LifePath Platform is contraindicated for use in high-acuity environments, such as the ICU or operating rooms, and is not intended for use on acutely or critically ill patients or those requiring time-critical or emergency intervention.
It is intended for patients who are willing and capable of managing its use or where its operations can be performed by a caregiver. Clinical judgment and experience of a Clinician are required to check and interpret the information delivered.
# 7 COMPARISON OF TECHNOLOGICAL
## 7.1 Characteristics with Legally Marketed Predicate Device
Table 2: The table below describes the similarities and differences with respect to the intended use, principle of operation, and technological characteristics between the subject device and the predicate device.
| SI<br># | Feature | Predicate Device<br>Comarch E-Care Platform<br>(K181248) | Subject Device<br>Lifepath Remote Patient<br>Monitoring Platform (Pending) |
|---------|-------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Device<br>Classification | II | II |
| | Product Code | DRG | DRG |
| | Regulation<br>Number | 870.2910 | 870.2910 |
| 1. | Indications for<br>Use | The Comarch e-Care Platform is<br>intended to connect with<br>physiological measurement devices<br>(weight scales, blood pressure<br>meters, pulse oximeters, peak flow<br>meters, thermometers, spirometers,<br>glucometers) intended to use at<br>home and send the measurement<br>results to central server. Comarch | The LifePath<br>Remote Patient<br>Monitoring Platform connects with<br>compatible<br>physiological<br>measurement devices to collect<br>vital sign measurements intended<br>to be used at home or<br>healthcare-related environments and<br>securely transmit them unaltered to<br>the LifePath server. LifePath<br>Remote Patient Monitoring Platform |
| 2. | Intended use | | |
| | | e-Care Platform serves as Software as a Medical Device and can be used only with FDA cleared measurement devices.<br><br>Comarch e-Care Platform displays the collected measurements on the Web application and securely stores them in a database server, where the caregiver can view the results, analyze them, leave comments and contact patient if necessary. Caregivers are able to set thresholds individually for each patient. Measurement results sent to e-Care Platform from connected devices are analyzed and if result is beyond the threshold, caregiver gets the notification.<br><br>The Comarch e-Care Platform is not interpretive, nor is it intended for diagnosis or as a substitute for medical care, and it is not intended to provide real-time data. It is made available to patients when time-critical care is not required.<br><br>The Comarch e-Care Platform is contraindicated for patients requiring direct medical supervision or emergency intervention. It is intended for patients who are willing and capable of managing its use. Clinical judgment and experience by a caregiver are required to check and interpret the information delivered. | serves as Software as a Medical Device and can be used only with specific FDA cleared third-party measurement devices.<br><br>The LifePath server securely stores the collected information and makes it available for viewing to remotely located clinicians using the Clinician App installed on their smartphones. The clinician can analyze the data, prescribe medications or contact the patient if needed. Clinicians can set thresholds individually for each patient and for any threshold breach, notification is sent to the clinician.<br><br>The LifePath RPM Platform does not interpret, make diagnoses nor serve as a substitute for medical care.<br><br>The LifePath RPM Platform is contraindicated for use in high-acuity environments, such as the ICU or operating rooms, and is not intended for use on acutely or critically ill patients or those requiring time-critical or emergency intervention.<br><br>It is intended for patients who are willing and capable of managing its use or can be assisted by a caregiver. Clinical judgment and experience by a Clinician are required to check and interpret the information delivered. |
| | | Telemedicine system | Telemedicine system |
| 3. | Intended<br>users | Home users and healthcare<br>providers. | Home users and healthcare providers. |
| 4. | Site of Use | Healthcare related environment or<br>home | Healthcare-related environment or<br>home |
| 5. | Patient<br>population | The medical device is intended for<br>adult users. | The medical device is intended for<br>adult users. |
| 6. | OTC and/or Rx | Rx | Rx |
| 7. | Contraindicati<br>on | The Comarch e-Care Platform is<br>contraindicated for patients<br>requiring direct - medical<br>supervision or emergency<br>intervention. | The LifePath RPM Platform is not<br>intended for use in high-acuity<br>environments, such as the ICU or<br>operating rooms, and is not intended<br>for use on acutely or critically ill<br>patients or those requiring time-critical<br>or emergency intervention. |
| 8. | Data<br>collection<br>software | Comarch e-Care software<br>application, Comarch SMA software<br>application | LifePath proprietary server software,<br>LifePath Patient Software Application |
| 9. | Data<br>collection<br>software<br>functionality | Transmit data from measuring<br>devices and store data in a central<br>database. | Collect data from measuring devices<br>and transmit them to a central server<br>(LifePath Server). |
| 10. | Communicati<br>on method of<br>hub with<br>central server | Any Internet access method with<br>Ethernet or Wi-Fi 802.11 b/g/n<br>interface or 3G/4G network. | Internet access using local Wi-Fi<br>802.11 or 3G/4G/LTE cellular network. |
| 11. | Types of<br>measuring<br>devices which<br>can be<br>interfaced to<br>receiver hub | Medical devices designed for home<br>use: glucose meters weight scales,<br>blood pressure meters, pulse<br>oximeters, peak flow meters,<br>thermometers, spirometers. | Medical Devices designed for home<br>use: FDA 510K cleared glucometers,<br>pulse oximeters, blood pressure<br>meters, and thermometers |
| 12. | Measuring<br>device<br>software | Measuring device software<br>unchanged | Measuring device software unchanged |
| 13. | Communicati<br>on with | Short-range radio system using<br>Bluetooth | Short-range radio system using<br>Bluetooth |
| | measuring<br>devices | | |
| 14. | Method<br>implemented<br>for collecting data<br>from<br>measuring<br>devices | Bluetooth v2.0 and Bluetooth v4.0 | Bluetooth v2.0 and higher |
| 15. | Measuring<br>devices<br>communicatio<br>n frequency | Bluetooth 2.4 GHz…
