eCareManager 4.0.1

K153156 · Visicu, Inc. · MSX · Sep 30, 2016 · Cardiovascular

Device Facts

• Record ID: K153156
• Device Name: eCareManager 4.0.1
• Applicant: Visicu, Inc.
• Product Code: MSX · Cardiovascular
• Decision Date: Sep 30, 2016
• 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 4.0.1 is a telehealth software platform for enterprise-wide patient monitoring. It aggregates clinical data from electronic medical records (EMR), bedside monitors, and ancillary systems via network interfaces. The system provides a centralized dashboard for remote clinicians to view patient status, trends, and care plans. It includes a Sepsis Screening Prompt that automatically analyzes patient data against clinical criteria to identify potential sepsis risk. The device does not generate alarms or replace bedside monitoring; it serves as a clinical decision support tool to assist medical professionals in proactive care. It is operated by trained clinical staff in hospital or remote clinical settings. Output is displayed on a workstation, aiding clinicians in assessing patient condition and guiding clinical decision-making. The system benefits patients by facilitating early detection of clinical deterioration and supporting timely intervention by remote care teams.

Clinical Evidence

Clinical validation included model development and post-implementation studies evaluating the Sepsis Screening Prompt algorithm. Testing confirmed the algorithm's performance in identifying severe sepsis using 9 criteria based on the 2003 International Sepsis Definitions Conference. Results demonstrated that the eCareManager sepsis screening model yielded higher discrimination for identifying severe sepsis compared to traditional criteria used in the predicate IntelliVue SSC model. Verification and validation activities confirmed the system meets all specifications.

Technological Characteristics

Software-only platform; interfaces with hospital systems via HL-7; utilizes audio/video for remote communication. Features include patient census, profile, stroke profile, care plans, task lists, flowsheets, order entry, and sepsis screening. Employs user authentication, role-based access, and audit logging. Operates as a networked clinical decision support system.

Indications for Use

Indicated for use in hospital environments or remote locations by clinical professionals for 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

• Argus System (K012171)
• Philips IntelliVue Patient Monitors (K113657)

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

September 30, 2016

Visicu, Inc. Daniel Plonski Manager, Quality and Regulatory 217 East Redwood Street, Ste. 1900 Baltimore, Maryland 21202

Re: K153156

Trade/Device Name: eCareManager 4.0.1 Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (Including Cardiotachometer and Rate Alarm) Regulatory Class: Class II Product Code: MSX, PLB, OUG, NSX Dated: September 19, 2016 Received: September 19, 2016

Dear Daniel Plonski:

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 (reporting of medical devicerelated 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.

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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 [phone] or [phone] 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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

Mude Jellman
for

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### Indications for Use

510(k) Number (if known) K153156

Device Name eCareManager 4.0.1

#### 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 Philips logo in blue, with the text "K153156" above it. Below the logo, the text "eCareManager" and "Traditional 510(k)" are displayed. The text is centered and the Philips logo is in a bold, sans-serif font.

# 510(k) Summary eCareManager 4.0.1

This 510(k) summary of safety and effectiveness information is prepared in accordance with 21 CFR 807.92(c).

Date Prepared: September 22, 2016

#### 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: [phone]<br>Fax: [phone]<br>E-mail: [e-mail] |

#### II. Device information

| Device Name: | eCareManager 4.0.1 |
|-----------------------|---------------------|
| Common Name: | Telehealth Software |
| Classification panel: | Cardiovascular |

| Classification | ProCode | Description |
|---------------------|---------|-----------------------------------------------------------|
| 870.2300, II | PLB | Multivariate Vital Signs Index |
| 870.2450, Enf. Dis. | NSX | Software, Transmission and Storage, Patient Data |
| 870.2300, II | MSX | System, Network and Communication, Physiological Monitors |
| 880.6310, I | OUG | Medical Device Data System |

### III. Predicate device information

| Trade name: | Argus System |
|----------------------------|-----------------------------------------------------------|
| Manufacturer: | Visicu, Inc. |
| 510(k) clearance: | K012171 |
| Classification name: | System, network and communication, physiological monitors |
| Device class: | Class II |
| Classification regulation: | 21 CFR 892.2300 |
| Classification panel: | Cardiovascular |
| Product code: | MSX |

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Image /page/4/Picture/0 description: The image contains the Philips logo in blue, with the text "K153156" above it. Below the logo, the text "eCareManager" is displayed, followed by "Traditional 510(k)". The text is centered and appears to be part of a product or regulatory information.

| Trade name: | Philips IntelliVue Patient Monitors |
|---------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer: | Philips Medizin Systeme Boeblingen Gmbh |
| 510(k) clearance: | K113657 |
| Classification name<br>alarms)Device class: | Patient Physiological Monitor (with arrhythmia detection or<br>Class II |
| Classification regulation: | 21 CFR 892.2300 |
| Classification panel: | Cardiovascular |
| Product code: | MHX, DSI, MLD, DSJ, DSK, DXN, DXG<br>KRB, DRQ, DRT, DPS, MLC, DRW, KRC, DRJ, DQA, DSB,<br>DSH, DSF, DRS, DSA, MSX, DRG, CCK, CBQ, NHO, NHP,<br>NHQ, CBS, CBR, CCL, BZC, BZQ, LKD, KLK, KOI, GWR,<br>GWS, FLL |

### IV. Device Description

The eCareManager (eCM) system is a software platform that enables enterprise telehealth. The system includes an interface to acquire patient data from the electronic medical record and bedside devices. eCM provides a history of the patient population in clinic and provides a clinical decision support feature to aid in the proactive delivery of consultative care for the patient

#### V. 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.

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Image /page/5/Picture/0 description: The image shows the Philips logo in blue, with the text "eCareManager" and "Traditional 510(k)" below it. Above the logo is the text "K153156". The Philips logo is a simple, bold design, and the text is clear and easy to read. The image is likely from a product label or marketing material.

#### VI.Comparison of Technological Characteristics with the Predicate Device

The eCareManager software is Telehealth software. which employs and further builds on the same fundamental scientific technology as the Argus System software (K012171). The Sepsis Screening Prompt included in eCareManager has the same intended use and technological characteristics as the sepsis screening feature (Protocol Watch SSC) marketed with several models of the Philips IntelliVue Patient Monitors (K113657).

A comparison matrix (Table 5-1) shows the similarities and differences. The eCareManager software with the listed enhancements is substantially equivalent to the previously cleared Arqus System. 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. Table 5-2 presents a comparative summary of the sepsis screening features of eCareManager and the IntelliVue Patient Monitors with ProtocolWatch SSC.

| Specification /<br>Feature | eCareManager<br>(Subject Device) | Argus System<br>(Predicate device -<br>K012171) | 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. | The Argus System -<br>Continuous Expert Care<br>Network (CXCN) with Smart<br>Alarms enhancement is for<br>use in data collection,<br>storage and clinical<br>information management<br>with independent bedside<br>devices, and ancillary<br>systems that are connected<br>either directly or through<br>networks. It is also<br>intended to provide patient<br>information and surveillance<br>of monitored patients at the<br>point of care location and at<br>a remote supplementary<br>care location through wide<br>area networking technology<br>and dedicated telephone<br>lines. | Same intent, however,<br>language modified to clarify the<br>following with regard to<br>eCareManager:<br>• Intended for use by trained<br>medical staff<br>• Intended for supplemental<br>support of bedside care team<br>• Does not provide any alarms<br>• Does not replace bedside<br>vital sign alarms<br>• Does not replace proactive<br>clinical care<br>• Supports medical<br>judgement, does not replace it<br>• Not intended to be sole<br>source of information for<br>decision making. |
| Specification /<br>Feature | eCareManager<br>(Subject Device) | Argus System<br>(Predicate device -<br>K012171) | Comparison |
| | 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. | | |
| 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 Argus System is<br>intended to provide patient<br>information and surveillance<br>of monitored patients at the<br>point of care location and at<br>a remote supplementary<br>care location through wide<br>area networking technology<br>and dedicated telephone<br>lines. | Same but with eCareManager<br>emphasis on not for home use. |
| Target<br>population | In-hospital patients | In-hospital patients | Same |
| Technological Characteristics | | | |
| System<br>components | Software Only | Software Only | Same |
| 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 | Same |
| Graphical<br>Census | Graphical display of patient<br>status | None | Provides visual representation<br>of patient status |
| 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 but modifications to<br>screen layout |
| Stroke Profile | Summary of clinical data | None | Summary of patient data based<br>on NIHSS guidelines |
| Specification /<br>Feature | eCareManager<br>(Subject Device) | Argus System<br>(Predicate device -<br>K012171) | Comparison |
| Care Plan | Summary of clinical care<br>plan and therapeutic<br>objectives | Summary of clinical care<br>plan and therapeutic<br>objectives | Same but modifications to<br>screen layout |
| Task List | Communication and<br>tracking of clinical care<br>tasks | Communication and<br>tracking of clinical care<br>tasks…