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 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.

AI/ML Overview

The Comarch e-Care Platform is a software intended for use in remote patient monitoring outside of traditional healthcare settings (e.g. at home). It connects with physiological measurement devices (weight scales, blood pressure meters, pulse oximeters, peak flow meters, thermometers, spirometers, glucometers) and sends the measurement results to a central server. The platform displays collected measurements on a web application, securely stores them, and allows caregivers to view and analyze them, leave comments, and contact patients. Caregivers can set individual thresholds for each patient, and the platform notifies the caregiver if a measurement result is beyond the set threshold. The device is not interpretive, not intended for diagnosis or as a substitute for medical care, and does not provide real-time data. It is for patients who are able and willing to manage its use, and clinical judgment by a caregiver is required to interpret the information.

Here's an analysis of the acceptance criteria and supporting study information:

1. Table of Acceptance Criteria and Reported Device Performance:

The provided document does not explicitly present a table of quantitative acceptance criteria for device performance. Instead, the substantial equivalence determination for the Comarch e-Care Platform is based on similarities to predicate devices in terms of:

Feature	Acceptance Criteria (Implied)	Reported Device Performance (Comarch e-Care Platform)
Indications for Use	Collect physiological measurements from home-use devices, transmit results to a central server, display measurements on a web application, securely store data, allow caregivers to view/analyze results, comment, and contact patients, enable setting of individual thresholds, and notify caregivers if thresholds are exceeded. Not interpretive, not for diagnosis, not real-time, for patients managing its use, and requiring caregiver judgment for interpretation.	Intended to connect with physiological measurement devices (glucose meters, weight scales, blood pressure meters, pulse oximeters, peak flow meters, thermometers, spirometers) for home use and send results to a central server. Displays collected measurements on a web application and securely stores them. Caregiver can view, analyze, comment, and contact patient. Caregivers can set individual thresholds, and receive notifications if results are beyond thresholds. Not interpretive, not for diagnosis/substitute for medical care, not real-time. For patients willing and capable of managing its use; clinical judgment by caregiver required.
Intended Use	Telemedicine system	Telemedicine system
Intended Users	Home users and healthcare providers	Home users and healthcare providers
Patient Population	Adult users	Adult users
Site of Use	Healthcare related environment or home	Healthcare related environment or home
Rx/OTC	Prescription Use (Rx)	Prescription Use (Rx)
Data Collection Software	Software application for collecting, displaying, and transmitting vital sign measurements from home monitoring devices.	Comarch e-Care software application; Comarch SMA software application. Intended to collect, display, and transmit vital sign measurements captured from commercially available home monitoring devices.
Data Collection Software Functionality	Transmit data from measuring devices and store data in a central database.	Transmit data from measuring devices and store data in a central database.
Communication Method of Hub with Central Server	Internet access method (e.g., Ethernet, Wi-Fi, 3G/4G network)	Any Internet access method with Ethernet or Wi-Fi 802.11 b/g/n interface or 3G/4G network.
Types of Measuring Devices Interfaced	Glucose meters, weight scales, blood pressure meters, pulse oximeters, peak flow meters, thermometers, spirometers (FDA-cleared devices for home use).	Glucose meters, weight scales, blood pressure meters, pulse oximeters, peak flow meters, thermometers, spirometers (from a list of FDA cleared devices for home use).
Implementation Method of Collecting Data from Measuring Devices	Short range radio system using Bluetooth (v2.0 and v4.0).	Short range radio system using Bluetooth (v2.0 and v4.0).
Measuring Device Software	Unchanged	Unchanged
Measuring Devices Communication Frequency	Bluetooth 2.4 GHz	Bluetooth 2.4 GHz
Power Source	Wall power plug (120 VAC/50-60)	Wall power plug (120 VAC/50-60)
Display	On devices and hub, and monitors connected to central server	On devices and hub, and monitors connected to central server
Communications with Patients	Visual reading and feedback on display, phone call/email messages from caregiver.	Visual reading and feedback on hub's screen. Phone call and email messages from caregiver.
Use of Thresholds/Algorithms	Thresholds set by healthcare professionals in server software, and sent to the hub for analysis, with results sent back to 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.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document states that "no clinical tests were conducted." Therefore, there is no specific test set or data provenance mentioned for clinical performance evaluation. The evaluation was based on non-clinical verification and validation.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Since no clinical tests were conducted and no specific test set-based ground truth was established, this information is not applicable and not provided in the document.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Since no clinical tests were conducted and no test set ground truth was established by experts, this information is not applicable and not provided.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

The document explicitly states "no clinical tests were conducted." Therefore, no MRMC comparative effectiveness study was done, and no effect size regarding human reader improvement with/without AI assistance is provided.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

The substantial equivalence is based on the device's functional similarities to predicate devices in remote patient monitoring, data transmission, storage, and caregiver notification, rather than a standalone performance evaluation of a diagnostic algorithm. The device itself is described as "not interpretive" and "not intended for diagnosis." The non-clinical verification and validation focused on the software's functionality and adherence to design specifications. Therefore, a standalone performance study in the context of diagnostic accuracy was not performed for this device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

As no clinical tests were performed, there was no "ground truth" derived from patient data, expert consensus, pathology, or outcomes data for the purpose of validating diagnostic or interpretive accuracy. The "ground truth" for the non-clinical verification and validation would have been the design specifications and requirements of the software.

8. The sample size for the training set

The document states "no clinical tests were conducted." This implies that the device did not undergo a process involving a "training set" for machine learning model development in the context of clinical performance. The platform's functionality is about data handling and alerts based on pre-set thresholds, not on learning from a dataset to perform interpretations. Therefore, this information is not applicable and not provided.

9. How the ground truth for the training set was established

As no training set was used for clinical performance evaluation, this information is not applicable and not provided.

In summary, the Comarch e-Care Platform's acceptance was based on a demonstration of substantial equivalence to existing predicate devices through comprehensive non-clinical verification and validation testing, ensuring the software's functionality, adherence to design specifications, and addressing identified risks. No clinical studies or performance evaluations requiring test sets, ground truth establishment, or expert adjudication were conducted, as the device is not interpretive and does not provide diagnostic insights.

Summary

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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

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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

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Indications for Use

510(k) Number (if known) K181248

Device Name Comarch e-Care Platform

Indications for Use (Describe)

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)

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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:

The following vital signs are collected: temperature, glucose, noninvasive blood pressure, pulse oximetry, weight and spirometry.

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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 pressuremonitor	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.

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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 PredicateIntel ® HealthGuide Express(K103276)	Reference PredicateHealthInterlinkBeacon (K133252)	Reference PredicateMedApps 2.0 RemotePatient Monitoringsystem(K124000)	Subject DeviceComarch e-CarePlatform (Pending)
Indication forUse	The Intel® HealthGuide Express isintended to collectvital signsmeasurements fromphysiologicalmeasurement devicesintended for use athome. Patients canreview the storedvital signsmeasurementinformation andreceive educationaland motivationalcontent fromcaregivers. Patientscan also engage invideo conferenceswith caregivers andanswer thecaregivers' questionsby participating insurveys.	The HealthInterlinkBeacon device is for useby patients to collect andtransmit generalhealth information,physiologicalmeasurements such asblood pressure,temperature,weight, glucose andSpO2 usingcommercially availableFDA cleared wirelessmedicaldevices designed forhome use, and other databetween themselves anda caregiver.	The MedApps 2.0 - RemotePatient Monitoring Systemis intended to connect tocommercially availableglucose meters, scales,blood pressure monitors andpulse oximeters then receiveand store data collectedfrom measurements thentransmit. Healthcareprofessionals can review thetransmitted information.	Comarch e-CarePlatform is intended toconnect withphysiologicalmeasurement devices(glucose meters weightscales, blood pressuremeters, pulse oximeters,peak flow meters,thermometers andspirometers) intended touse at home and send themeasurement results tocentral server. Comarche-Care Platform displaysthe collectedmeasurements on theWeb application andsecurely stores them in adatabase server, wherethe caregiver can viewthe results, analyze them,leave comments andcontact patient ifnecessary.
Intended use	Telemedicine system	Same	Same	Same
Intended users	Home users andhealthcare providers.	Same	Same	Same
Patientpopulation	Medical device isintended for adultusers.	Same	Same	Same
Site of use	Healthcare relatedenvironment orhome	Same	Same	Same
OTC and/or Rx	Rx	OTC and Rx	OTC	Rx
Feature	Primary PredicateIntel ® HealthGuide Express(K103276)	Reference PredicateHealthInterlinkBeacon (K133252)	Reference PredicateMedApps 2.0 RemotePatient Monitoringsystem(K124000)	Subject DeviceComarch e-CarePlatform (Pending)
Data collectionsoftware	• Intel® Health CareManagement Suitesoftwareapplication• Intel® HealthGuide Expresssoftwareapplication	• HealthInterlinkBeacon Softwareapplication	• MedApps proprietarysoftware application	• Comarch e-Caresoftware application• Comarch SMAsoftware application
Data collectionsoftwarefunctionality	Transmit data frommeasuring devicesand store data in acentral database.	Same	Same	Same
Communicationmethod of hubwith centralserver	Connection viaInternet usinginterface providedby „commercial offthe shelf" PC	Via publictelecommunicationsnetwork.	Via embedded cellulartechnology.	Any Internet accessmethod with Ethernet orWi-Fi 802.11 b/g/ninterface or 3G/4Gnetwork.
Types ofmeasuringdevices whichcan be interfacedto receiver hub	Medical Devicesdesigned for homeuse:glucose meters,weight scales,blood pressuremeters,pulse oximeters,peak flow meters	Medical Devicesdesigned for home use:glucose meters,weight scales,pulse oximeters,thermometers,spirometers	Medical Devices designedfor home use:glucose meters,weight scales,blood pressure meters,pulse oximeters,peak flow meters	Medical Devicesdesigned for home use:glucose metersweight scales,blood pressure meters,pulse oximeters,peak flow meters,thermometers,spirometers
Implementationmethod ofcollecting datafrom measuringdevices	Short range radiosystem usingBluetooth andtethered cables	Short range radio systemusing Bluetooth	Short range radio systemusing Bluetooth andtethered cables	Short range radio systemusing Bluetooth
Measuringdevice software	Measuring devicesoftware unchanged	Same	Same	Same
Connectivity	Short range radiosystem usingBluetooth andtethered cables	Short range radio systemusing Bluetooth	Short range radio systemusing Bluetooth andtethered cables	Short range radio systemusing Bluetooth
Communicationmethod of hubwith measuringdevices	Short range radiosystem usingBluetooth andtethered cables	Short range radio systemusing Bluetooth	Short range radio systemusing Bluetooth andtethered cables	Short range radio systemusing Bluetooth
Feature	Primary PredicateIntel ® HealthGuide Express(K103276)	Reference PredicateHealthInterlinkBeacon (K133252)	Reference PredicateMedApps 2.0 RemotePatient Monitoringsystem(K124000)	Subject DeviceComarch e-CarePlatform (Pending)
Implementationmethod ofcollecting datafrom measuringdevices.	Wireless (Bluetooth)V2.0 & Wired(Tethered)	Bluetooth v2.0 andBluetooth v4.0	Wireless(Bluetooth) V2.0 &Wired (Tethered)	Bluetooth v2.0 andBluetooth v4.0
Measuringdevicescommunicationfrequency	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 monitorsconnected to centralserver	Same	Same	Same
Communicationswith patients	On screen display.	On screen display.Text/Interactive VoiceResponse	Audio/visual readingfeedback on screen and byspeaker and InteractiveVoice Response (IVR)System for patient contact	Visual reading andfeedback on hub'sscreen. Phone call andemail messages fromcaregiver
Use ofthresholds/algorythms fordetermining howthresholds areset and changed	Thresholds are set byHealthcareprofessionals inserver software	N.D.	Thresholds are set byHealthcare professionals inserver software	Thresholds are set byHealthcare professionalsin server software andsent to the hub. Hubperforms the analysisand sends it back withresults to serversoftware

6. Comparison to the 510(k) Cleared Devices (Predicate Devices):

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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.

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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.

Regulation Number and Section

§ 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).