eCareManager 4.1
Device Facts
| Record ID | K171322 |
|---|---|
| Device Name | eCareManager 4.1 |
| Applicant | Visicu, Inc. |
| Product Code | MSX · Cardiovascular |
| Decision Date | Aug 3, 2017 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.2300 |
| Device Class | Class 2 |
| Attributes | Software as a Medical Device |
Indications for Use
The eCareManager System is a software tool intended for use by trained medical staff providing supplemental remote support to bedside care teams in the management and care of in-hospital patients. The software collects, stores and displays clinical data obtained from the electronic medical record, patient monitoring systems and ancillary systems connected through networks. Using this data, clinical decision support notifications are generated that aid in understanding the patient's current condition and changes over time. The eCareManager System does not provide any alarms. It is not intended to replace bedside vital signs alarms or proactive patient care from clinicians. All information and notifications provided by the eCareManager System are intended to support the judgement of a medical professional and are not intended to be the sole source of information for decision making.
Device Story
eCareManager 4.1 is a telehealth software platform for enterprise-wide patient management; it aggregates clinical data from electronic medical records (EMR), bedside monitors, and ancillary systems via network interfaces. The system provides clinical decision support (CDS) by processing this data to generate visual cues and notifications regarding patient condition and trends. It features an automated acuity score, early warning scores, and discharge readiness assessments. The software is operated by trained medical staff in remote or hospital settings to support bedside care teams. It does not provide active alarms or replace bedside monitoring. Output is displayed on a dashboard for clinical review, aiding in proactive care delivery and patient status monitoring. The system includes patient census, flowsheets, order entry, and reporting tools to facilitate collaborative care.
Clinical Evidence
No human clinical trials were conducted. The device underwent observational, non-human subject evaluation using clinical data to validate changes to the Automated Acuity Score calculation. Verification and validation activities, including risk analysis, design reviews, and system-level testing, confirmed that the software meets all specifications and is substantially equivalent to the predicate.
Technological Characteristics
Software-only telehealth platform; operates on networked hospital systems. Interfaces via HL-7. Features include user authentication, role-based access control, and audit logging. CDS algorithms provide automated acuity scoring, early warning scores, and discharge readiness metrics. No hardware components, sensors, or active alarms.
Indications for Use
Indicated for use in hospital environments or remote locations by clinical professionals for the management and care of in-hospital patients. Not indicated for home use.
Regulatory Classification
Identification
A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.
Predicate Devices
- eCareManager 4.0 (K153156)
Submission Summary (Full Text)
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 3, 2017
Visicu. Inc. Milind Gramopadhye Director of Quality and Regulatory 217 East Redwood St. Suite 1900 Baltimore, Maryland 21202
Re: K171322
Trade/Device Name: eCareManager 4.1 Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (Including Cardiotachometer and Rate Alarm) Regulatory Class: Class II Product Code: MSX Dated: Mav 5. 2017 Received: Mav 5. 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
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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.A. Wilhelm
for 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) K171322
Device Name eCareManager 4.1
#### Indications for Use (Describe)
Intended Use Statement:
The eCareManager System is a software tool intended for use by trained medical staff providing supplemental remote support to bedside care teams in the management and care of in-hospital patients. The software collects, stores and displays clinical data obtained from the electronic medical record, patient monitoring systems and ancillary systems connected through networks. Using this data, clinical decision support notifications are generated that aid in understanding the patient's current condition and changes over time. The eCareManager System does not provide any alarms. It is not intended to replace bedside vital signs alarms or proactive patient care from clinicians.
All information and notifications provided by the eCareManager System are intended to support the judgement of a medical professional and are not intended to be the sole source of information for decision making.
Indications for Use Statement:
The eCareManager software is indicated for use in hospital environment or remote locations with clinical professionals. It is not indicated for home use.
Type of Use (Select one or both, as applicable)
| <span> <span style="font-size: 16px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> |
|-----------------------------------------------------------------------------------------------------------|
| <span> <span style="font-size: 16px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> |
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Image /page/3/Picture/1 description: The image shows the text "510(k) Summary" in bold black font. The text is centered and appears to be the title or heading of a document. The text is simple and straightforward.
Image /page/3/Picture/2 description: The image shows the Philips logo in blue, followed by the text "eCareManager 4.1" and "Traditional 510(k)" in black. The Philips logo is a simple, bold sans-serif typeface. The text below the logo is smaller and in a different font.
# 510(k) Summary eCareManager 4.1
This 510(k) summary of safety and effectiveness information is prepared in accordance with 21 CFR 807.92(c).
Date Prepared: May 5, 2017
#### l. Submitter's name and address
| Manufacturer: | Visicu, Inc.<br>217 East Redwood Street<br>Suite 1900<br>Baltimore, MD 21202 |
|-----------------|-----------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Daniel R. Plonski<br>Senior Manager, Quality and Regulatory<br>Phone: 410-246-5357<br>Fax: 410-276-1970<br>E-mail: daniel.plonski@philips.com |
### II. Device information
Device Name: eCareManager 4.1 Manufacturer: Visicu, Inc. Common Name: Telehealth Software System, network and communication, physiological monitors Classification name Device class: Class II Classification regulation: 21 CFR 870.2300 Classification panel: Cardiovascular Product Code: MSX
### III. Predicate device information
| Device Name: | eCareManager 4.0 (K153156) |
|----------------------------|-----------------------------------------------------------|
| Manufacturer: | Visicu, Inc. |
| Common Name: | Telehealth Software |
| Classification name | System, network and communication, physiological monitors |
| Device class: | Class II |
| Classification regulation: | 21 CFR 870.2300 |
| Classification panel: | Cardiovascular |
| Product Code: | MSX |
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Image /page/4/Picture/2 description: The image shows the Philips logo in blue, followed by the text "eCareManager 4.1" and "Traditional 510(k)". The Philips logo is a stylized version of the company's name. The text below the logo indicates that the image is related to Philips' eCareManager software and its regulatory status under the FDA's 510(k) clearance process.
### Device Description
The eCareManager system is a software platform that enables enterprise telehealth. The system includes interface features to acquire patient data from the electronic medical record and bedside devices which can be shared between the bedside and remote care teams. Population management and communication features facilitate a collaborative approach to delivery of in-patient care. The system's clinical decision support features further aid in the proactive delivery of care. Using data received from the hospital's systems, clinical decision support algorithms provide cues that assist in the early detection of changes in patient condition.
### IV.Intended use/ Indications for Use
#### Intended Use:
The eCareManager System is a software tool intended for use by trained medical staff providing supplemental remote support to bedside care teams in the management and care of in-hospital patients. The software collects, stores and displays clinical data obtained from the electronic medical record, patient monitoring systems and ancillary systems connected through networks. Using this data, clinical decision support notifications are generated that aid in understanding the patient's current condition and changes over time. The eCareManager System does not provide any alarms. It is not intended to replace bedside vital signs alarms or proactive patient care from clinicians.
All information and notifications provided by the eCareManager System are intended to support the judgement of a medical professional and are not intended to be the sole source of information for decision making.
### Indication for Use:
The eCareManager software is indicated for use in hospital environment or remote locations with clinical professionals. It is not indicated for home use.
### V. Comparison of Technological Characteristics with the Predicate Device
eCareManager 4.1 is an enhanced version of our previously cleared eCareManager 4.0 software product (K153156). While the intended use and technological characteristics remain the same, eCareManager 4.1 provides enhanced patient administration and clinical decision support features. Differences in the available features, summarized in table 5.1 below, do not present any new questions of safety or effectiveness.
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Image /page/5/Picture/2 description: The image shows the Philips logo in blue, followed by the text "eCareManager 4.1" 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 Philips' eCareManager software, version 4.1, and that it has received Traditional 510(k) clearance.
Table 5-1 Comparison Table
| Specification /<br>Feature | eCareManager 4.1<br>(Subject Device) | eCareManager 4.0<br>(Predicate device)<br>K153156 | Comparison |
|--------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------|
| Intended Use / Indications for Use / Target population | | | |
| Intended Use | The eCareManager System<br>is a software tool intended<br>for use by trained medical<br>staff providing supplemental<br>remote support to bedside<br>care teams in the<br>management and care of<br>in-hospital patients. The<br>software collects, stores<br>and displays clinical data<br>obtained from the electronic<br>medical record, patient<br>monitoring systems and<br>ancillary systems<br>connected through<br>networks. Using this data,<br>clinical decision support<br>notifications are generated<br>that aid in understanding<br>the patient's current<br>condition and changes over<br>time. The eCareManager<br>System does not provide<br>any alarms. It is not<br>intended to replace bedside<br>vital signs alarms or<br>proactive patient care from<br>clinicians.<br>All information and<br>notifications provided by the<br>eCareManager System are<br>intended to support the<br>judgement of a medical<br>professional and are not<br>intended to be the sole<br>source of information for<br>decision making. | The eCareManager System<br>is a software tool intended<br>for use by trained medical<br>staff providing supplemental<br>remote support to bedside<br>care teams in the<br>management and care of<br>in-hospital patients. The<br>software collects, stores<br>and displays clinical data<br>obtained from the electronic<br>medical record, patient<br>monitoring systems and<br>ancillary systems<br>connected through<br>networks. Using this data,<br>clinical decision support<br>notifications are generated<br>that aid in understanding<br>the patient's current<br>condition and changes over<br>time. The eCareManager<br>System does not provide<br>any alarms. It is not<br>intended to replace bedside<br>vital signs alarms or<br>proactive patient care from<br>clinicians.<br>All information and<br>notifications provided by the<br>eCareManager System are<br>intended to support the<br>judgement of a medical<br>professional and are not<br>intended to be the sole<br>source of information for<br>decision making. | Same |
| Indications for<br>Use | The eCareManager<br>software is indicated for use<br>in hospital environment or<br>remote locations with<br>clinical professionals. It is<br>not indicated for home use. | The eCareManager<br>software is indicated for use<br>in hospital environment or<br>remote locations with<br>clinical professionals. It is<br>not indicated for home use | Same |
| Target<br>population | In-hospital patients | In-hospital patients | Same |
| Technological Characteristics | | | |
| System<br>components | Software Only | Software Only | Same |
| Specification /<br>Feature | eCareManager 4.1<br>(Subject Device) | eCareManager 4.0<br>(Predicate device)<br>K153156 | Comparison |
| Interfaces to<br>hospital systems | HL-7 | HL-7 | Same |
| Bedside to<br>Remote<br>Communications | Audio/Video | Audio/Video | Same |
| Measurement<br>Features | None | None | Same |
| System Alarms | None | None | Same |
| Waveform<br>Transmission | None | None | Same |
| User Access and<br>Patient Data<br>Security | User Authentication<br>services, roles-based data<br>access, logging for audit<br>trail | User Authentication<br>services, roles-based data<br>access, logging for audit<br>trail | Same |
| Patient Administration Features | | | |
| Patient Census | Patient Census screen with<br>status indicators | Patient Census screen with<br>status indicators | Enhanced display |
| Graphical<br>Census | Graphical display of patient<br>status | Graphical display of patient<br>status | Enhanced display |
| Patient Profile | Summary of patient<br>information including<br>diagnosis, treatments, best<br>practices and trends | Summary of patient<br>information including<br>diagnosis, treatments, best<br>practices and trends | Same |
| Stroke Profile | Summary of clinical data<br>and workflow time tracking | Summary of clinical data<br>and workflow time tracking | Same |
| Care Plan | Summary of clinical care<br>plan and therapeutic<br>objectives | Summary of clinical care<br>plan and therapeutic<br>objectives | Same |
| Task List | Communication and<br>tracking of clinical care<br>tasks | Communication and<br>tracking of clinical care<br>tasks | Same |
| Flowsheets | Electronic charting of vital<br>signs and infusions, intake<br>and output, nursing<br>assessments and care,<br>respiratory therapy, and<br>lines, tubes and drains | Electronic charting of vital<br>signs and infusions, intake<br>and output, nursing<br>assessments and care,<br>respiratory therapy, and<br>lines, tubes and drains | Same |
| Order Entry | Medication and non-<br>medication orders. Drug<br>interaction and allergy<br>screening | Medication and non-<br>medication orders. Drug<br>interaction and allergy<br>screening | Same |
| Patient Notes | Supports entry of patient<br>notes with configurable<br>templates | Supports entry of patient<br>notes with configurable<br>templates | Same |
| Program Forms | Configurable data entry<br>forms for tracking clinical<br>program performance,<br>based on customer<br>initiatives | Configurable data entry<br>forms for tracking clinical<br>program performance,<br>based on customer<br>initiatives | Same |
| Reports | Operational, Clinical Care<br>and Billing reports provided | Operational, Clinical Care<br>and Billing reports provided | Same |
| Specification /<br>Feature | eCareManager 4.1<br>(Subject Device) | eCareManager 4.0<br>(Predicate device)<br>K153156 | Comparison |
| Clinical Decision Support Features | | | |
| Automated<br>Acuity Score | Provides a relative scoring<br>of patient condition | Provides a relative scoring<br>of patient condition | Modified parameters, to include<br>lab values and modified<br>graphical presentation |
| Pain, Agitation<br>and Delirium | Graphical summary of PAD<br>related issues | Graphical summary of PAD<br>related issues | Modified graphical presentation |
| Discharge<br>Readiness Score | Objective measurement of<br>risk of death or readmission…
