(77 days)
Not Found
No
The description focuses on data collection, transmission, and a population management triage dashboard, with no mention of AI or ML algorithms for analysis or decision support.
No.
The device collects and reviews patient data for monitoring purposes, but it does not directly provide therapy or treatment.
No
The device collects and reviews patient data and supports clinician monitoring and population management, but it does not independently provide a diagnosis.
Yes
The device description explicitly states "eCareCoordinator (eCC) is a software-only telemedicine system." While it interacts with a COTS Android tablet and receives data from measurement devices, the core regulated component is described as software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for collecting and reviewing patient data from patients and transmitting medical and non-medical information. This is focused on remote patient monitoring and communication, not on performing diagnostic tests on samples taken from the human body.
- Device Description: The device is described as a software-only telemedicine system that supports clinicians with monitoring remote patients and managing patient populations. It facilitates the manual input of measurements from various devices and transmits this data.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening. The data collected is from external measurement devices or patient input, not from in vitro analysis of biological samples.
The device functions as a data collection, transmission, and management system for remote patient monitoring, which falls outside the scope of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
eCareCoordinator and its accessories are indicated for use by patients and by care teams for collecting and reviewing patient data from patients who are capable and willing to engage in use of this software, to transmit medical and non-medical information through integrated technologies.
Product codes
DRG
Device Description
eCareCoordinator (eCC) is a software-only telemedicine system. eCareCoordinator (eCC) is a combination of technology and clinical programs designed to enable the support of patients in the home setting, eCC is intended to support the clinician with monitoring of remote patients. Clinicians use eCC to manage populations of ambulatory care patients, while keeping primary care physicians informed of patient status.
eCC is comprised of the following primary components:
- . eCareCoordinator (eCC): eCC is the platform supporting the Clinical User Interface. eCC is a cloud-based system, which is used to acquire patient data from home devices, as well as provide a population management triage dashboard to enable the clinician's team to prioritize and manage populations of patients.
- . eCareCompanion (eCP): eCP is a patient application element of eCareCoordinator used to engage patients in their own health. eCP is a mobile application which runs on an commercial off-the-shelf (COTS) Android tablet. Patients manually input measurements (including weight, blood pressure, pulse, blood glucose concentration, SpO2, temperature, prothrombin time (PT), coagulation ratio (INR), and transthoracic impedance) from measurement devices into the COTS tablet containing eCP. The COTS tablet wirelessly communicates with eCC to transmit the data stored by eCP to eCC.
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
Not Found
Intended User / Care Setting
Home users and healthcare providers
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
Bench tests were executed to verify and validate eCC. Verification testing consisted of verification of the system-level requirements and verification of the sub-system level requirements. Validation testing consisted of formative usability testing and summative usability testing. The verification and validation test results confirm that eCC performs as intended.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench tests were executed to verify and validate eCC. Verification testing consisted of verification of the system-level requirements and verification of the sub-system level requirements. Validation testing consisted of formative usability testing and summative usability testing. The verification and validation test results confirm that eCC performs as intended.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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).
0
Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's emblem, which is a stylized human figure with three faces in profile, representing health and well-being. The emblem is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The text is arranged in a circular fashion around the emblem.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 9, 2014
Visicu. Inc. c/o Mr. Mark Job Regulatory Technology Services LLC 1394 25th Street NW Buffalo, MN 55313
Re: K141706
Trade/Device Name: Visicu, Inc. eCareCoordinator Regulatory Number: 21 CFR 870.2910 Regulation Name: Radiofrequency Physiological Signal Transmitter and Receiver Regulatory Class: Class II (Two) Product Code: DRG Dated: August 26, 2014 Received: August 28, 2014
Dear Mr. Job:
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. The general controls provisions of the Act include requirements for annual registration. Isting 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical
1
Page 2 - Mr. Mark Job
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely vours.
Mitchell Stein
forBram 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) K141706
Device Name eCareCoordinator
Indications for Use (Describe)
eCareCoordinator and its accessories are indicated for use by patients and by care teams for collecting and reviewing patient data from patients who are capable and willing to engage in use of this software, to transmit medical and nonmedical information through integrated technologies.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
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Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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TAB 6
510K SUMMARY
The Company's 510(k) Summary is provided on the following page.
{Please turn the page}
4
510(k) Summary
| Submitter | Chris Ferguson
Visicu, Inc.
217 E. Redwood Street, Suite 1900
Baltimore, MD 21202
Telephone: 410-276-1960
Fax: 410-276-1970 |
|-------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|
| Date Prepared: | July 14, 2014 |
| Trade/Proprietary Name: | eCareCoordinator (eCC) |
| Common Name: | Telemedicine System |
| Classification Name: | Transmitters And Receivers, Physiological Signal, Radiofrequency
(21 CFR 870.2910, Product Code DRG) |
Predicate Device
M3810A Philips Telemonitoring System (PTS) (K103214)
M3810A Philips Telemonitoring System (PTS) (K041674)
Device Description
eCareCoordinator (eCC) is a software-only telemedicine system. eCareCoordinator (eCC) is a combination of technology and clinical programs designed to enable the support of patients in the home setting, eCC is intended to support the clinician with monitoring of remote patients. Clinicians use eCC to manage populations of ambulatory care patients, while keeping primary care physicians informed of patient status.
eCC is comprised of the following primary components:
- . eCareCoordinator (eCC): eCC is the platform supporting the Clinical User Interface. eCC is a cloud-based system, which is used to acquire patient data from home devices, as well as provide a population management triage dashboard to enable the clinician's team to prioritize and manage populations of patients.
- . eCareCompanion (eCP): eCP is a patient application element of eCareCoordinator used to engage patients in their own health. eCP is a mobile application which runs on an commercial off-the-shelf (COTS) Android tablet. Patients manually input measurements (including weight, blood pressure, pulse, blood glucose concentration, SpO2, temperature, prothrombin time (PT), coagulation ratio (INR), and transthoracic impedance) from measurement devices into the COTS tablet containing eCP. The COTS tablet wirelessly communicates with eCC to transmit the data stored by eCP to eCC.
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Accessories
The eCC Clinical User Interface is able to receive data from Philips Telehealth Solutions (PTS) Telestations.
Intended Use
eCareCoordinator is software intended for use in data aggregation, patient interaction facilitation, storage and clinical information management with independent physiological devices and ancillary systems that are connected either directly or through networks. The software is intended to provide patient information from the patient location through networking technology to a remote care team. eCareCoordinator does not send any real time alarms and is not intended to provide automated treatment decisions. This software is an informational tool only and is not to be used as a substitute for professional judgment of healthcare providers in diagnosing and treating patients.
Indications for Use
eCareCoordinator and its accessories are indicated for use by patients and by care teams for collecting and reviewing patient data from patients who are capable and willing to engage in use of this software, to transmit medical and non-medical information through integrated technologies.
Comparison of Indications for Use
Although the indications for use for the eCC and the PTS (K103214 / K041674) are not written identically, the stated indications for use are considered to be substantially equivalent, in that both devices are intended to be used in the data collection (aggregation)of patient measured physiological parameters (i.e., weight, blood pressure, etc.); both devices are intended to provide clinical information to a remote care team (i.e., clinical professional), both devices are not intended to be a substitute for professional judgment, and both devices do not send any real time alarms to the end user.
Technological Characteristics
Clinical User Interface
Both eCC and PTS feature a clinical user interface (eCC Clinical User Interface and M3817B server with M3811B Clinical Review Software, for eCC and PTS, respectively) that allows clinical users to review patient measurement and survey data.
Patient User Interface
Both eCC and PTS feature a patient user interface (eCP and the PTS telestation, for eCC and PTS, respectively) that allows patients to respond to surveys or enter data from measurement devices. As compared to the predicate PTS, eCC allows for substantially equivalent means of data entry by allowing the patient to manually enter data read from measurement devices.
Surveys
6
Both eCC and PTS give clinical users the option of sending surveys to patients in order to determine additional information about their health status. Patient surveys are sets of questional materials, quizzes, or assessments that are sent to at-home users via the eCP app or the PTS telestation
Protocols
Protocols are an option in eCC that allows the creation of patient tasks and intervention rules which trigger a flag. Both eCC and PTS present flags in the clinical application as a notification to clinical users that an item requires attention. In both eCC and PTS, flags are triggered by out-of-range patient data or missed patient data. Clinical users review flags and may take action, including review of individual patient treatment plans, as necessary.
Performance Data
Bench tests were executed to verify and validate eCC. Verification testing consisted of verification of the system-level requirements and verification of the sub-system level requirements. Validation testing consisted of formative usability testing and summative usability testing. The verification and validation test results confirm that eCC performs as intended.
Substantial Equivalence
Table 1 below summarizes the comparison of eCC and its predicate device, PTS. eCC and PTS have the same intended use and similar indications, technological characteristics and principles of operation. As discussed above, the technological differences do not change the intended use or present any new issues of safety or effectiveness. Software verification and validation testing, in addition to usability testing conducted to validate the user interface and labeling, demonstrate that the proposed device performs as intended. Thus, eCC is substantially equivalent to PTS.
| | eCareCoordinator (eCC) | M3810A Philips
Telemonitoring System (PTS) (K103214) | M3810A Philips
Telemonitoring System (PTS) (K041674) | Comparison |
|---------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------|
| Intended Use | Telemedicine system | Telemedicine system | Telemedicine system | Same |
| Indications for Use | eCareCoordinator and its accessories are indicated for use by patients and by care teams for collecting and reviewing patient data from patients who are capable and willing to | The M38IOA Philips TeleMonitoring System with eDevice BridgeD130 is indicated for patients at home, who are capable and willing to self | The M3810A is indicated for patients at home, who are capable and willing to self administrate this device, upon prescription of their healthcare provider, to | Substantially equivalent to K103214 and K041674 |
Table 1. Substantial Equivalence Chart.
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| engage in use of this
software, to transmit
medical and non-
medical information
through integrated
technologies. | administrate this
device, upon the
prescription of
their healthcare
provider, to
collect and
transmit medical
information such
as weight, blood
pressure
(including pulse
rate) and non-
diagnostic ECG
rhythm strip to
the healthcare
provider at
another location.
The patient takes
these
measurements,
typically once per
day, and the
information is
transmitted
automatically via
normal telephone
lines or cellular
connectivity to
the healthcare
provider. The
device may be
used for the
management of
congestive heart
failure,
hypertension,
ischemic heart
disease, weight
management,
cardiovascular
risk management,
post
cardiovascular
surgery, post
myocardial
infarction, and
other post cardiac | collect and
transmit medical
information, such
as weight, blood
pressure
(including pulse
rate) and non-
diagnostic ECG
rhythm strip to
the healthcare
provider at
another location.
The patient takes
these
measurements,
typically once per
day, and the
information is
transmitted
automatically via
normal telephone
time to the
healthcare
provider. The
device does not
send any real-
time alarms.
Clinical judgment
and experiences
are required to
check and
interpret the
information
delivered. |
|----------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
8
| | | events. The
device does not
send any real
time alarms.
Clinical judgment
and experience
are required to
check and
interpret the
information
delivered. | | |
|------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------|
| User
Population | Home users and
healthcare providers | Home users and
healthcare providers | Home users and
healthcare providers | Same |
| Measuring
devices and
functionality | Measurements are
entered manually
into eCP. | Measurements
are either entered
manually or
measurement
devices
wirelessly
communicate
with the PTS
telestation. | Measurements
are either entered
manually or
measurement
devices
wirelessly
communicate
with the PTS
telestation. | Substantially
equivalent to
K103214 and
K041674 |
| Alarm
functionality | None | None | None | Same |
| Connectivity
from patient
home to
clinical server | Wireless
connectivity | Wireless
connectivity or
telephone lines | Wireless
connectivity or
telephone lines | Substantially
equivalent to
K103214 and
K041674 |
| Patient data
review | Clinical users can
review patient
measurement data
and survey data | Clinical users can
review patient
measurement
data and survey
data | Clinical users can
review patient
measurement
data and survey
data | Same |
| Flags/Intervent
ion Rules | The clinical user
interface features
flags as a
notification to clinical
users that an item
requires attention.
Flags are triggered
by intervention rules
that determine that
patient data is out- | The clinical user
interface features
flags as a
notification to
clinical users that
an item requires
attention. Flags
are triggered by
intervention rules
that determine | The clinical user
interface features
flags as a
notification to
clinical users that
an item requires
attention. Flags
are triggered by
intervention rules
that determine | Substantially
equivalent to
K103214 and
K041674 |
| | of-range or that
there is missed
patient data, or that
a survey score is
out-of-range.
Clinical users review
flags and may take
action, as
necessary.
Intervention rules
can also send a
survey task to the
patient, send a
measurement task
to the patient, or
create a clinician
task. | that patient data
is out-of-range or
that there is
missed patient
data, or that a
survey score is
out-of-range.
Clinical users
review flags and
may take action,
as necessary.
Intervention rules
can also send a
survey task to the
patient. | that patient data
is out-of-range or
that there is
missed patient
data, or that a
survey score is
out-of-range.
Clinical users
review flags and
may take action,
as necessary.
Intervention rules
can also send a
survey task to the
patient. | |
| Surveys | Clinical users have
option to send
surveys to patients | Clinical users
have option to
send surveys to
patients | Clinical users
have option to
send surveys to
patients | Same |
| Protocols | Clinical users have
option of assigning
protocols (which are
a convenient way to
schedule patient
tasks to take
surveys and
measurements, as
well as define
intervention rules) to
patients. | Clinical users
have option of
assigning profiles
(which are a
convenient way
to schedule
patient tasks to
take surveys as
well as define
intervention rules)
to patients.
Clinical users
separately
schedule patient
tasks to take
measurements
and define
intervention rules. | Clinical users
have option of
assigning profiles
(which are a
convenient way
to schedule
patient tasks to
take surveys as
well as define
intervention rules)
to patients.
Clinical users
separately
schedule patient
tasks to take
measurements
and define
intervention rules. | Substantially
equivalent to
K103214 and
K041674 |
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