(99 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on data collection and monitoring, not advanced analytical capabilities.
No.
The device is described as a "software-only telemedicine system" intended to "support the clinician with monitoring of remote patients" and "manage populations of ambulatory care patients." It is not described as directly treating or diagnosing a medical condition.
No
The device is described as a "software-only telemedicine system, designed to enable the support of patients in the home setting" and "intended to support the clinician with monitoring of remote patients." It focuses on collecting and reviewing patient data and transmitting information, rather than providing a medical diagnosis. The "Intended Use / Indications for Use" mentions collecting and reviewing patient data, not diagnosing conditions.
Yes
The device description explicitly states that eCareCoordinator is a "software-only telemedicine system" and a "software-only device."
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 describes a system for remote patient monitoring and communication, not a test performed on biological samples to diagnose or monitor a disease or condition.
- Device Description: The description clearly states it is a "software-only telemedicine system" designed to support clinicians with monitoring remote patients. It explicitly mentions it "does not contain any patient-contacting components." IVD devices typically involve analyzing biological samples (blood, urine, tissue, etc.).
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, performing tests on specimens, or providing diagnostic information based on laboratory analysis.
Therefore, eCareCoordinator fits the description of a telemedicine or remote patient monitoring system, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for 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.
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 (comma separated list FDA assigned to the subject device)
DRG
Device Description
eCareCoordinator (eCC) is a software-only telemedicine system, 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 a software-only device and does not contain any patient-contacting components.
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
Intended for use in the home setting by patients and by care teams.
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)
The following performance data were provided in support of the substantial equivalence determination:
Summary of Non-clinical testing
No performance standards for telehealth systems or components have been issued under the authority of Section 514. eCareCoordinator was tested in accordance with Philips verification and validation processes. Quality Assurance measures were applied to the system design and development, including:
- Risk Analysis
- Product Specifications
- Design Reviews
- Verification & Validations
Summary of Clinical Testing
Clinical Performance testing for Philips eCareCoordinator 1.5 was not performed, as there were no new clinical applications that had hazards or risk mitigations that required clinical performance testing to support equivalence.
Conclusions drawn from the Non-clinical and Clinical testing
Verification validation activities have been conducted to establish the performance, functionality, and usability characteristics of the new device with respect to the predicate, intended use and defined requirements. Testing included detailed functional, system level and usability testing. Test results demonstrated that eCareCoordinator 1.5 meets all specifications and user needs.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or clothing.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 14, 2017
Visicu Inc. Milind Gramopadhye Director of Quality and Regulatory 217 East Redwood St. Suite 1900 Baltimore, Maryland 21202
Re: K171029
Trade/Device Name: eCareCoordinator 1.5 Regulation Number: 21 CFR 870.2910 Regulation Name: Radiofrequency Physiological Signal Transmitter and Receiver Regulatory Class: Class II Product Code: DRG Dated: June 15, 2017 Received: June 16, 2017
Dear Milind Gramopadhye:
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, 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device
1
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" (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 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.
M. G. Hillemann
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) K171029
Device Name eCareCoordinator 1.5
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 non-medical information through integrated technologies.
| 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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Image /page/3/Picture/1 description: The image shows the Philips logo in blue, followed by the text "eCareCoordinator 1.5" and "Traditional 510(k)" in black. The Philips logo is in a bold, sans-serif font. The text below the logo is in a smaller, regular font. The image is likely a product label or advertisement.
510(k) Summary eCareCoordinator 1.5
This 510(k) summary of safety and effectiveness information is prepared in accordance with 21 CFR 807.92(c).
Date Prepared: April 5, 2017
l. Submitter's name and address
| Manufacturer: | Visicu, Inc.
217 East Redwood Street
Suite 1900
Baltimore, MD 21202 |
|-----------------|-----------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Daniel R. Plonski
Senior Manager, Quality and Regulatory
Phone: 410-246-5357
Fax: 410-276-1970
E-mail: daniel.plonski@philips.com |
II. Device information
| Device Name: | eCareCoordinator 1.5 |
|---|---|
| Common Name: | Telemedicine System |
| Classification panel: | Cardiovascular |
| Classification | ProCode | Description |
|---|---|---|
| 870.2910 | DRG | Radiofrequency physiological signal transmitter |
| and receiver. |
III. Predicate device information
Trade name: eCareCoordinator Visicu, Inc. Manufacturer: 510(k) clearance: K141706 Classification name Radiofrequency physiological signal transmitter and receiver. Device class: Class II Classification regulation: 21 CFR 892.2910 Classification panel: Cardiovascular Product code: DRG
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Image /page/4/Picture/2 description: The image shows the Philips logo in blue, followed by the text "eCareCoordinator 1.5" and "Traditional 510(k)" in black. The Philips logo is a stylized wordmark with a distinctive design. The text below the logo appears to be related to the product or service offered by Philips.
IV.Device Description
eCareCoordinator (eCC) is a software-only telemedicine system, 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 a software-only device and does not contain any patient-contacting components.
V. Intended use/ Indications for Use
Intended Use:
eCareCoordinator is software intended for use in data aggregation, patient interaction facilitation, storage and clinical information management physiological devices and ancillary systems that are connected either directly or through networks. The software is intended to provide patient information from the pation 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.
Indication for Use:
eCareCoordinator and its accessories are indicated for use by patients and by care teams for collecting and reviewing patients who are capable and willing to engage in use of this software, to transmit medical and non-medical information through integrated technologies.
VI.Comparison of Technological Characteristics with the Predicate Device
eCareCoordinator 1.5 is an enhanced version of eCareCoordinator 1.0, originally cleared under K141706.
A comparison matrix (Table 5-1) shows the similarities and differences. The eCareCoordinator 1.5 software with the listed enhancements is substantially equivalent to the previously cleared eCareCoordinator 1.0. The Intended Use has been modified to clarify and modernize the wording, however, the concept has not changed. Technological characteristics and principles of operation remain the same, Differences in the available features, as discussed below, do not present any new questions of safety or effectiveness.
5
| Specification /
Feature | eCareCoordinator 1.5
(Subject Device) | eCareCoordinator
(Predicate device –
K141706) | Comparison |
|---------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------|
| 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. | 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. | 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
engage in use of this
software, to transmit
medical and non-medical
information through
integrated technologies. | eCareCoordinator and its
accessories are indicated
for use by patients and by
care teams for managing
patients who are capable
and willing to engage in use
of this software, to transmit
medical and non-medical
information through
integrated technologies. | Same – wording updated for
clarity. |
| Target
population | At home patients | At home patients | Same |
| Technological Characteristics | | | |
| System
components | Software Only | Software Only | Same |
| User Interfaces | Clinical (eCC) and
Patient (eCP) | Clinical (eCC) and
Patient (eCP) | Enhanced user interfaces |
| Clinician-Patient
Communications | Two-way video | None | Added video communications |
| Measurement
Features | None | None | Same |
| Specification /
Feature | eCareCoordinator 1.5
(Subject Device) | eCareCoordinator
(Predicate device –
K141706) | Comparison |
| System Alarms | None | None | Same |
| Waveform
Transmission | None | None | Same |
| User Access and
Patient Data
Security | User Authentication
services, roles-based data
access, logging for audit
trail, locked down tablet | User Authentication
services, roles-based data
access, logging for audit
trail, locked down tablet | Same |
| Clinical User Interface (eCC) Features | | | |
| Population View | Population screen with
measurement and survey
flags and other display
fields | Population screen with
measurement and survey
flags and other display
fields | Same |
| Overall Score | Sum of weighted scores for:
Measurements, survey
responses, issues,
readmission risk and days
since discharge | Sum of weighted scores for:
Measurements, survey
responses, issues,
readmission risk and days
since discharge | Same |
| Measurements
View | Display of patient
measurements and survey
responses | Display of patient
measurements and survey
responses | Same |
| Patient Chart | Graphical and tabular
displays of patient
information | Graphical and tabular
displays of patient
information | Same |
| Intervention
Rules | Used to trigger notifications
(flags) to clinician.
Customizable by institution
or clinician | Used to trigger notifications
(flags) to clinician.
Customizable by institution
or clinician | Same |
| Surveys | Clinical users have
option to send
surveys to patients | Clinical users have
option to send
surveys to patients | Same |
| Protocols | Used to set patient tasks,
surveys and intervention
rules. Customizable by
institution or clinician | Used to set patient tasks,
surveys and intervention
rules. Customizable by
institution or clinician | Same |
| Clinician Tasks | Communication and
tracking of clinical care
tasks | Communication and
tracking of clinical care
tasks | Same |
| Sticky Notes | Optionally added to patient
calendar | Optionally added to patient
calendar | Same |
| Reports | Hard copy patient record
report and system
administration reports | System administration
reports | Added patient record report |
| Patient User Interface (eCP) Features | | | |
| Platform | Android Tablet and legacy
Telestation | Android Tablet and legacy
Telestation | Same |
| Measurements
from home
devices | Wireless Bluetooth and
manual entry | Manual entry | Bluetooth connectivity
implemented |
| Appointments | Scheduled by care provider,
appear on patient's | Scheduled by care provider,
appear on patient's | Same |
| Specification /
Feature | eCareCoordinator 1.5
(Subject Device) | eCareCoordinator
(Predicate device –
K141706) | Comparison |
| | calendar | calendar | |
| Activities and
Reminders | Scheduled by care provider,
appear on patient's
calendar | Scheduled by care provider,
appear on patient's
calendar | Same |
| Surveys | Created and assigned to
patients by the care
provider | Created and assigned to
patients by the care
provider | Same |
| Video Calls | Capability to schedule and
conduct video calls with
care providers | None | Added video call capability |
| Educational
Videos | Access to pre-installed
educational videos | None | Educational videos added |
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Image /page/6/Picture/1 description: The image shows the logo for Philips, followed by the text "eCareCoordinator 1.5" and "Traditional 510(k)". The Philips logo is in blue, and the text is in black. The text "eCareCoordinator 1.5" appears to be the name of a software product, and "Traditional 510(k)" refers to a type of medical device clearance from the FDA.
7
Image /page/7/Picture/1 description: The image shows the Philips logo in blue, followed by the text "eCareCoordinator 1.5" and "Traditional 510(k)" in black. The Philips logo is a stylized version of the company's name. The text below the logo indicates that the image is related to the eCareCoordinator 1.5 software and the Traditional 510(k) regulatory pathway. The text is left-aligned and the font is sans-serif.
Table 5-1 Comparison Table
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Image /page/8/Picture/1 description: The image shows the logo for Philips, followed by the text "eCareCoordinator 1.5" and "Traditional 510(k)". The Philips logo is in blue, and the text is in black. The text is aligned to the left, and the logo is above the text. The image is likely a product label or advertisement.
Performance Data VII.
The following performance data were provided in support of the substantial equivalence determination:
Summary of Non-clinical testing
No performance standards for telehealth systems or components have been issued under the authority of Section 514. eCareCoordinator was tested in accordance with Philips verification and validation processes. Quality Assurance measures were applied to the system design and development, including:
- Risk Analysis
- Product Specifications
- Design Reviews
- Verification & Validations
Summary of Clinical Testing
Clinical Performance testing for Philips eCareCoordinator 1.5 was not performed, as there were no new clinical applications that had hazards or risk mitigations that required clinical performance testing to support equivalence.
Conclusions drawn from the Non-clinical and Clinical testing
Verification validation activities have been conducted to establish the performance, functionality, and usability characteristics of the new device with respect to the predicate, intended use and defined requirements. Testing included detailed functional, system level and usability testing. Test results demonstrated that eCareCoordinator 1.5 meets all specifications and user needs.
VIII. Conclusion
eCareCoordinator 1.5 is substantially equivalent to the previously cleared eCareCoordinator. Both devices have the same intended use, indications for use, technological characteristics and principles of operation. Differences in the available features, as discussed above, do not change the intended use or present any new questions of safety or effectiveness.