(165 days)
No
The description focuses on data collection, storage, display, and simple threshold-based notifications. There is no mention of AI/ML algorithms for interpretation, prediction, or complex analysis. The document explicitly states it is "not interpretive".
No.
The Comarch e-Care Platform is a software platform for remote patient monitoring that collects and displays physiological measurement data; it is not described as providing any therapeutic intervention or treatment.
No
The "Intended Use / Indications for Use" section explicitly states, "The Comarch e-Care Platform is not interpretive, nor is it intended for diagnosis or as a substitute for medical care..." This clearly indicates it is not a diagnostic device.
Yes
The device description explicitly states that the Comarch e-Care Platform is "a software intended for use in remote patient monitoring" and lists its components as software applications and servers. While it connects to external physiological measurement devices, the platform itself is described solely as software.
Based on the provided information, the Comarch e-Care Platform 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.
- Comarch e-Care Platform's Function: The Comarch e-Care Platform collects and displays physiological measurements (weight, blood pressure, pulse oximetry, peak flow, temperature, glucose) from external, FDA-cleared devices. It does not perform any tests on samples taken from the body.
- Intended Use: The intended use is for remote patient monitoring of vital signs, not for diagnostic testing of biological samples.
- Device Description: The device description focuses on software components and the collection of vital signs, not on the analysis of biological samples.
Therefore, the Comarch e-Care Platform falls under the category of a remote patient monitoring system that utilizes data from other medical devices, rather than being an in vitro diagnostic device itself.
N/A
Intended Use / 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, 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.
Product codes
DRG
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.
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
Medical device is intended for adult users.
Intended User / Care Setting
Home users and healthcare providers.
Healthcare related environment or home.
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)
Non-Clinical Tests: 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.
Clinical Tests: No new hazards to safety or effectiveness are presented by Comarch e-Care Platform, therefore, no clinical tests were conducted.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
FORA IR21b K090395, WristOx2 K052829, Onyx II K051107, UC-351PBT-Ci Exempt, UC-355PBT-Ci Exempt, UA-767PBT-Ci K043217, Asma-1 K073155, Lung Monitor K073155, COPD K073155, Spirobank II K061712, TD-4277 K100322
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 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) |
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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.
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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 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):
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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.
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.