eCareCoordinator

K171029 · Visicu, Inc. · DRG · Jul 14, 2017 · Cardiovascular

Device Facts

• Record ID: K171029
• Device Name: eCareCoordinator
• Applicant: Visicu, Inc.
• Product Code: DRG · Cardiovascular
• Decision Date: Jul 14, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2910
• Device Class: Class 2
• Attributes: Software as a Medical Device

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.

Device Story

eCareCoordinator 1.5 is a software-only telemedicine system for home-based patient monitoring. It facilitates data aggregation, patient interaction, and clinical information management. The system connects to independent physiological devices (via Bluetooth or manual entry) and ancillary systems to transmit patient data to a remote care team. Clinicians use the eCC interface to view population data, measurement trends, and survey responses, while patients use the eCP interface on Android tablets or legacy Telestations. Features include two-way video calls, educational videos, and customizable intervention rules that trigger clinician notifications. The device does not provide real-time alarms or automated treatment decisions; it serves as an informational tool to support clinical decision-making. It is intended for use by care teams and patients capable of engaging with the software.

Clinical Evidence

No clinical testing was performed. Substantial equivalence was supported by non-clinical verification and validation activities, including risk analysis, product specifications, design reviews, and functional/usability testing.

Technological Characteristics

Software-only telemedicine system. Operates on Android tablets and legacy Telestations. Connectivity via network and Bluetooth for physiological device data. Features include user authentication, role-based access control, audit logging, and locked-down tablet configuration. No patient-contacting components.

Indications for Use

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.

Regulatory Classification

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.

Predicate Devices

• eCareCoordinator (K141706)

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

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

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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 [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.

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

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### 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) | |
|----------------------------------------------------------------------------|---------------------------------------------------------------------------|
| <div> <span>☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> <span>☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </div> |

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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.<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: | eCareCoordinator 1.5 |
|-----------------------|----------------------|
| Common Name: | Telemedicine System |
| Classification panel: | Cardiovascular |

| Classification | ProCode | Description |
|----------------|---------|------------------------------------------------------------------|
| 870.2910 | DRG | Radiofrequency physiological signal transmitter<br>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.

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| Specification /<br>Feature | eCareCoordinator 1.5<br>(Subject Device) | eCareCoordinator<br>(Predicate device –<br>K141706) | Comparison |
|---------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------|
| Intended Use | eCareCoordinator is<br>software intended for use in<br>data aggregation, patient<br>interaction facilitation,<br>storage and clinical<br>information management<br>with independent<br>physiological devices and<br>ancillary systems that are<br>connected either directly or<br>through networks. The<br>software is intended to<br>provide patient information<br>from the patient location<br>through networking<br>technology to a remote care<br>team. eCareCoordinator<br>does not send any real time<br>alarms and is not intended<br>to provide automated<br>treatment decisions. This<br>software is an informational<br>tool only and is not to be<br>used as a substitute for<br>professional judgment of<br>healthcare providers in<br>diagnosing and treating<br>patients. | eCareCoordinator is<br>software intended for use in<br>data aggregation, patient<br>interaction facilitation,<br>storage and clinical<br>information management<br>with independent<br>physiological devices and<br>ancillary systems that are<br>connected either directly or<br>through networks. The<br>software is intended to<br>provide patient information<br>from the patient location<br>through networking<br>technology to a remote care<br>team. eCareCoordinator<br>does not send any real time<br>alarms and is not intended<br>to provide automated<br>treatment decisions. This<br>software is an informational<br>tool only and is not to be<br>used as a substitute for<br>professional judgment of<br>healthcare providers in<br>diagnosing and treating<br>patients. | Same |
| Indications for<br>Use | eCareCoordinator and its<br>accessories are indicated<br>for use by patients and by<br>care teams for collecting<br>and reviewing patient data<br>from patients who are<br>capable and willing to<br>engage in use of this<br>software, to transmit<br>medical and non-medical<br>information through<br>integrated technologies. | eCareCoordinator and its<br>accessories are indicated<br>for use by patients and by<br>care teams for managing<br>patients who are capable<br>and willing to engage in use<br>of this software, to transmit<br>medical and non-medical<br>information through<br>integrated technologies. | Same – wording updated for<br>clarity. |
| Target<br>population | At home patients | At home patients | Same |
| Technological Characteristics | | | |
| System<br>components | Software Only | Software Only | Same |
| User Interfaces | Clinical (eCC) and<br>Patient (eCP) | Clinical (eCC) and<br>Patient (eCP) | Enhanced user interfaces |
| Clinician-Patient<br>Communications | Two-way video | None | Added video communications |
| Measurement<br>Features | None | None | Same |
| Specification /<br>Feature | eCareCoordinator 1.5<br>(Subject Device) | eCareCoordinator<br>(Predicate device –<br>K141706) | Comparison |
| 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, locked down tablet | User Authentication<br>services, roles-based data<br>access, logging for audit<br>trail, locked down tablet | Same |
| Clinical User Interface (eCC) Features | | | |
| Population View | Population screen with<br>measurement and survey<br>flags and other display<br>fields | Population screen with<br>measurement and survey<br>flags and other display<br>fields | Same |
| Overall Score | Sum of weighted scores for:<br>Measurements, survey<br>responses, issues,<br>readmission risk and days<br>since discharge | Sum of weighted scores for:<br>Measurements, survey<br>responses, issues,<br>readmission risk and days<br>since discharge | Same |
| Measurements<br>View | Display of patient<br>measurements and survey<br>responses | Display of patient<br>measurements and survey<br>responses | Same |
| Patient Chart | Graphical and tabular<br>displays of patient<br>information | Graphical and tabular<br>displays of patient<br>information | Same |
| Intervention<br>Rules | Used to trigger notifications<br>(flags) to clinician.<br>Customizable by institution<br>or clinician | Used to trigger notifications<br>(flags) to clinician.<br>Customizable by institution<br>or clinician | Same |
| Surveys | Clinical users have<br>option to send<br>surveys to patients | Clinical users have<br>option to send<br>surveys to patients | Same |
| Protocols | Used to set patient tasks,<br>surveys and intervention<br>rules. Customizable by<br>institution or clinician | Used to set patient tasks,<br>surveys and intervention<br>rules. Customizable by<br>institution or clinician | Same |
| Clinician Tasks | Communication and<br>tracking of clinical care<br>tasks | Communication and<br>tracking of clinical care<br>tasks | Same |
| Sticky Notes | Optionally added to patient<br>calendar | Optionally added to patient<br>calendar | Same |
| Reports | Hard copy patient record<br>report and system<br>administration reports | System administration<br>reports | Added patient record report |
| Patient User Interface (eCP) Features | | | |
| Platform | Android Tablet and legacy<br>Telestation | Android Tablet and legacy<br>Telestation | Same |
| Measurements<br>from home<br>devices | Wireless Bluetooth and<br>manual entry | Manual entry | Bluetooth connectivity<br>implemented |
| Appointments | Scheduled by care provider,<br>appear on patient's | Scheduled by care provider,<br>appear on patient's | Same |
| Specification /<br>Feature | eCareCoordinator 1.5<br>(Subject Device) | eCareCoordinator<br>(Predicate device –<br>K141706) | Comparison |
| | calendar | calendar | |
| Activities and<br>Reminders | Scheduled by care provider,<br>appear on patient's<br>calendar | Scheduled by care provider,<br>appear on patient's<br>calendar | Same |
| Surveys | Created and assigned to<br>patients by the care<br>provider | Created and assigned to<br>patients by the care<br>provider | Same |
| Video Calls | Capability to schedule and<br>conduct video calls with<br>care providers | None | Added video call capability |
| Educational<br>Videos | Access to pre-installed<br>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.

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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.