Who is the manufacturer of Comarch e-Care Platform?

Comarch Healthcare SA filed the 510(k) submission for Comarch e-Care Platform (K181248).

What is the FDA product code for Comarch e-Care Platform?

DRG. It is classified under 21 CFR 870.2910 as a Class 2 device in the Cardiovascular panel.

What is the regulatory pathway for Comarch e-Care Platform?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like Comarch e-Care Platform?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Comarch e-Care Platform

Q: What are the predicate devices for Comarch e-Care Platform?

Intel® Health Guide Express (K103276).

K181248 · Comarch Healthcare SA · DRG · Oct 22, 2018 · Cardiovascular

Device Facts

Record ID	K181248
Device Name	Comarch e-Care Platform
Applicant	Comarch Healthcare SA
Product Code	DRG · Cardiovascular
Decision Date	Oct 22, 2018
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 870.2910
Device Class	Class 2
Attributes	Software as a Medical Device

Intended Use

The Comarch e-Care Platform is intended to connect with physiological measurement devices (weight scales, blood pressure meters, pulse oximeters, peak flow meters, thermometers, glucometers) intended to use at home and send the measurement results to central server. Comarch e-Care Platform serves as Software as a Medical Device and can be used only with FDA cleared measurement devices. 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 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. 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. 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.

Device Story

Comarch e-Care Platform is a remote patient monitoring system; collects vital sign data (temperature, glucose, blood pressure, pulse oximetry, weight, spirometry) from FDA-cleared home-use devices via Bluetooth. System components include Comarch SMA (patient-facing app), Comarch e-Care application, application server, and database server. Data transmits to a central server for caregiver review. Caregivers set individual patient thresholds; system analyzes incoming measurements against these thresholds and notifies the caregiver if results exceed limits. Used in home settings by patients; caregivers (healthcare providers) view data, leave comments, and contact patients. Device is not interpretive, does not provide real-time data, and is not for emergency intervention. Benefits include facilitating remote patient management and communication between patients and caregivers.

Clinical Evidence

No clinical data; bench testing only. Verification and validation testing performed on all executable code and functionality to confirm design specifications and risk analysis requirements were met.

Technological Characteristics

Software as a Medical Device (SaMD). Connectivity via Bluetooth (v2.0/v4.0) for device data collection; Internet/Wi-Fi/3G/4G for server communication. Operates on application/database servers. Threshold-based analysis logic. No specific hardware materials or sterilization required as it is a software platform.

Indications for Use

Indicated for adult patients at home requiring remote monitoring of vital signs (weight, blood pressure, SpO2, peak flow, temperature, glucose, spirometry). Contraindicated for patients requiring direct medical supervision or 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

Intel® Health Guide Express (K103276)

Reference Devices

HealthInterlink Beacon (K133252)
MedApps 2.0 Remote Patient Monitoring System (K124000)

Related Devices

K211822 — LifePath Remote Patient Monitoring Platform · Elastic Care Incorporated · Feb 3, 2022
K132930 — MYHEALTHPOINT TELEHEALTH MANAGER · Entra Health Systems · Apr 14, 2014
K130290 — MODIFICATION TO INTEL-GE CARE IINOVATIONS GUIDE · Intel-Ge Care Innovations, LLC · Jun 4, 2013
K101178 — MODIFICATION TO INTEL HEALTH GUIDE PHS6000 · Intel Corp. · Jun 29, 2010
K134004 — VERIZON WIRELESS CONVERGED HEALTH MANAGEMENT DEVICE · Cellco Partnership D/B/A Verizon Wireless · Feb 14, 2014

Submission Summary (Full Text)

{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 is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. October 22, 2018 Comarch Healthcare SA % Jigar Shah Consultant mdi Consultants. Inc. 55 Northern Blvd. Suite 200 Great Neck. New York 11021 Re: K181248 Trade/Device Name: Comarch e-Care Platform Regulation Number: 21 CFR 870.2910 Regulation Name: Radiofrequency Physiological Signal Transmitter and Receiver Regulatory Class: Class II Product Code: DRG Dated: September 18, 2018 Received: September 19, 2018 Dear Jigar Shah: 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 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE(@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely. # Jessica E. Paulsen -S for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K181248 Device Name Comarch e-Care Platform #### Indications for Use (Describe) The Comarch e-Care Platform is intended to connect with physiological measurement devices (weight scales, blood pressure meters, pulse oximeters, peak flow meters, thermometers, glucometers) intended to use at home and send the measurement results to central server. Comarch e-Care Platform serves as Software as a Medical Device and can be used only with FDA cleared measurement devices. 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 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. 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. 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. | 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 The assigned 510(k) number is: K181248 #### 1. Submitter's Identification: #### COMARCH HEALTHCARE SA al. Jana Pawla II 39a. 31 - 864 Kraków, Poland Phone +48 12 646 10 00 Fax +48 12 646 11 00 Date Summary Prepared: September 18, 2018 Contact: Irmina Serafin, COMARCH HEALTHCARE SA #### 2. Name of the Device: Comarch e-Care Platform Regulation Number: 870.2910 Regulation Name: Radiofrequency physiological signal transmitter and receiver Regulatory Class: II Product Code: DRG Common or Usual Name: Remote Patient Monitoring System #### 3. Information for the 510(k) Cleared Device (Predicate Device): Primary Predicate: Intel® Health Guide Express, K103276 Reference Predicates: HealthInterlink Beacon, K133252 MedApps 2.0 Remote Patient Monitoring System, K124000 #### 4. Device Description: Comarch e-Care Platform is a software intended for use in remote patient monitoring outside of traditional healthcare settings (e.g. at home). Components of Comarch e-Care Platform are: Comarch SMA application, Comarch e-Care application, application server, database server. Comarch SMA is a software application intended to use by patients. It is designed to collect, display and transmit vital sign measurements captured from commercially available home monitoring devices. The following vital signs are collected: temperature, glucose, noninvasive blood pressure, pulse oximetry, weight and spirometry. {4}------------------------------------------------ | Device type | Manufacturer | Model | 510(K) Number | |---------------------------|-------------------------|------------------|------------------| | Ear thermometer | ForaCare Suisse AG | FORA IR21b | K090395 | | Pulse oximeter | Nonin Medical, Inc. | WristOx2 | K052829 | | Pulse oximeter | Nonin Medical, Inc. | Onyx II | K051107 | | Scale | A&D Medical | UC-351PBT- Ci | Exempt | | Scale | A&D Medical | UC-355PBT- Ci | Exempt | | Blood pressure monitor | A&D Company Limited | UA-767PBT- Ci | K043217 | | Spirometer | Vitalograph | Asma-1 | K073155 | | Spirometer | Vitalograph | Lung Monitor | K073155 | | Spirometer | Vitalograph | COPD | K073155 | | Spirometer | MIR | Spirobank II | K061712 | | Glucometer | TaiDoc Technology Corp. | TD-4277 | K100322 | The list of the FDA cleared devices that the Comarch SMA receives readings from: ## 5. Indications for Use: The Comarch e-Care Platform is intended to connect with physiological measurement devices (weight scales, blood pressure meters, pulse oximeters, peak flow meters, thermometers, spirometers, glucometers) intended to use at home and send the measurement results to central server. Comarch e-Care Platform serves as Software as a Medical Device and can be used only with FDA cleared measurement devices. 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. 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. {5}------------------------------------------------ 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. | Feature | Primary Predicate Intel ® Health Guide Express (K103276) | Reference Predicate HealthInterlink Beacon (K133252) | Reference Predicate MedApps 2.0 Remote Patient Monitoring system (K124000) | Subject Device Comarch e-Care Platform (Pending) | |-------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Indication for Use | The Intel® Health Guide Express is intended to collect vital signs measurements from physiological measurement devices intended for use at home. Patients can review the stored vital signs measurement information and receive educational and motivational content from caregivers. Patients can also engage in video conferences with caregivers and answer the caregivers' questions by participating in surveys. | The HealthInterlink Beacon device is for use by patients to collect and transmit general health information, physiological measurements such as blood pressure, temperature, weight, glucose and SpO2 using commercially available FDA cleared wireless medical devices designed for home use, and other data between themselves and a caregiver. | The MedApps 2.0 - Remote Patient Monitoring System is intended to connect to commercially available glucose meters, scales, blood pressure monitors and pulse oximeters then receive and store data collected from measurements then transmit. Healthcare professionals can review the transmitted information. | Comarch e-Care Platform is intended to connect with physiological measurement devices (glucose meters weight scales, blood pressure meters, pulse oximeters, peak flow meters, thermometers and spirometers) intended to use at home and send the measurement results to central server. 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. | | Intended use | Telemedicine system | Same | Same | Same | | Intended users | Home users and healthcare providers. | Same | Same | Same | | Patient population | Medical device is intended for adult users. | Same | Same | Same | | Site of use | Healthcare related environment or home | Same | Same | Same | | OTC and/or Rx | Rx | OTC and Rx | OTC | Rx | | Feature | Primary Predicate Intel ® Health Guide Express (K103276) | Reference Predicate HealthInterlink Beacon (K133252) | Reference Predicate MedApps 2.0 Remote Patient Monitoring system (K124000) | Subject Device Comarch e-Care Platform (Pending) | | Data collection software | • Intel® Health Care Management Suite software application • Intel® Health Guide Express software application | • HealthInterlink Beacon Software application | • MedApps proprietary software application | • Comarch e-Care software application • Comarch SMA software application | | Data collection software functionality | Transmit data from measuring devices and store data in a central database. | Same | Same | Same | | Communication method of hub with central server | Connection via Internet using interface provided by „commercial off the shelf" PC | Via public telecommunications network. | Via embedded cellular technology. | Any Internet access method with Ethernet or Wi-Fi 802.11 b/g/n interface or 3G/4G network. | | Types of measuring devices which can be interfaced to receiver hub | Medical Devices designed for home use: glucose meters, weight scales, blood pressure meters, pulse oximeters, peak flow meters | Medical Devices designed for home use: glucose meters, weight scales, pulse oximeters, thermometers, spirometers | Medical Devices designed for home use: glucose meters, weight scales, blood pressure meters, pulse oximeters, peak flow meters | Medical Devices designed for home use: glucose meters weight scales, blood pressure meters, pulse oximeters, peak flow meters, thermometers, spirometers | | Implementation method of collecting data from measuring devices | Short range radio system using Bluetooth and tethered cables | Short range radio system using Bluetooth | Short range radio system using Bluetooth and tethered cables | Short range radio system using Bluetooth | | Measuring device software | Measuring device software unchanged | Same | Same | Same | | Connectivity | Short range radio system using Bluetooth and tethered cables | Short range radio system using Bluetooth | Short range radio system using Bluetooth and tethered cables | Short range radio system using Bluetooth | | Communication method of hub with measuring devices | Short range radio system using Bluetooth and tethered cables | Short range radio system using Bluetooth | Short range radio system using Bluetooth and tethered cables | Short range radio system using Bluetooth | | Feature | Primary Predicate Intel ® Health Guide Express (K103276) | Reference Predicate HealthInterlink Beacon (K133252) | Reference Predicate MedApps 2.0 Remote Patient Monitoring system (K124000) | Subject Device Comarch e-Care Platform (Pending) | | Implementation method of collecting data from measuring devices. | Wireless (Bluetooth) V2.0 & Wired (Tethered) | Bluetooth v2.0 and Bluetooth v4.0 | Wireless(Bluetooth) V2.0 & Wired (Tethered) | Bluetooth v2.0 and Bluetooth v4.0 | | Measuring devices communication frequency | Bluetooth 2.4 GHz | Bluetooth 2.4 GHz | Bluetooth 2.4 GHz | Bluetooth 2.4 GHz | | Power source | Wall power plug (120 VAC/50-60) | Same | Same | Same | | Display | On devices and hub, and monitors connected to central server | Same | Same | Same | | Communications with patients | On screen display. | On screen display. Text/Interactive Voice Response | Audio/visual reading feedback on screen and by speaker and Interactive Voice Response (IVR) System for patient contact | Visual reading and feedback on hub's screen. Phone call and email messages from caregiver | | Use of thresholds/algor ythms for determining how thresholds are set and changed | Thresholds are set by Healthcare professionals in server software | N.D. | Thresholds are set by Healthcare professionals in server software | Thresholds are set by Healthcare professionals in server software and sent to the hub. Hub performs the analysis and sends it back with results to server software | # 6. Comparison to the 510(k) Cleared Devices (Predicate Devices): {6}------------------------------------------------ {7}------------------------------------------------ ### 7. Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence are as follows: The submitted Comarch e-Care Platform has undergone design control verification and validation testing. Comarch e-Care Platform validation testing of all executable code and functionality and confirmation that all identified risks have been adequately addressed by software functionality, the user interface, documentation or user SOP. Comarch e-Care Platform verification and validation activities as part of the design control process include testing of all Design Specifications (Design Control Inputs) based on risk analysis and Verification plans. Comarch e-Care Platform Verification Plan execution ensures the system works with each type of user accessory medical device as part of the Comarch e-Care Platform system. The output of these design control verification analysis documents for the Comarch e-Care Platform system shall meet its requirements and design specifications as intended. {8}------------------------------------------------ ### 8. Discussion of Clinical Tests Performed: No new hazards to safety or effectiveness are presented by Comarch e-Care Platform, therefore, no clinical tests were conducted. ### 9. Conclusions: Comarch Healthcare SA considers Comarch e-Care Platform to be equivalent to the predicate devices listed above. This conclusion is based upon the devices' similarities in principles of operation, technology, materials and indications for use.