ECARE COORDINATOR (ECC)

K141706 · Visicu, Inc. · DRG · Sep 9, 2014 · Cardiovascular

Device Facts

• Record ID: K141706
• Device Name: ECARE COORDINATOR (ECC)
• Applicant: Visicu, Inc.
• Product Code: DRG · Cardiovascular
• Decision Date: Sep 9, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2910
• Device Class: Class 2
• Attributes: Software as a Medical Device, 3rd-Party Reviewed

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 (eCC) is a cloud-based, software-only telemedicine system for remote patient monitoring. Patients use the eCareCompanion (eCP) mobile application on a COTS Android tablet to manually input physiological measurements (weight, blood pressure, pulse, blood glucose, SpO2, temperature, PT/INR, transthoracic impedance) and respond to health surveys. The tablet transmits this data to the eCC cloud platform. Clinicians access a population management triage dashboard to review patient data and survey results. The system uses intervention rules to trigger flags for out-of-range or missed data, notifying clinicians who then review patient status and treatment plans. eCC does not provide real-time alarms or automated treatment decisions; it serves as an informational tool to support clinical decision-making and patient engagement in the home setting.

Clinical Evidence

Bench testing only. Verification testing confirmed system and sub-system requirements. Validation testing included formative and summative usability testing to validate the user interface and labeling. No clinical data provided.

Technological Characteristics

Software-only telemedicine system; cloud-based clinical interface; COTS Android tablet for patient interface. Connectivity via wireless networks. Rule-based intervention logic for flagging patient data. No hardware components; no sterilization required.

Indications for Use

Indicated for patients and care teams to collect and review patient data from patients capable and willing to engage in software use, to transmit medical and non-medical information via 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

• M3810A Philips Telemonitoring System (PTS) (K103214)
• M3810A Philips Telemonitoring System (PTS) (K041674)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's emblem, which is a stylized human figure with three faces in profile, representing health and well-being. The emblem is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The text is arranged in a circular fashion around the emblem.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

September 9, 2014

Visicu. Inc. c/o Mr. Mark Job Regulatory Technology Services LLC 1394 25th Street NW Buffalo, MN 55313

Re: K141706

Trade/Device Name: Visicu, Inc. eCareCoordinator Regulatory Number: 21 CFR 870.2910 Regulation Name: Radiofrequency Physiological Signal Transmitter and Receiver Regulatory Class: Class II (Two) Product Code: DRG Dated: August 26, 2014 Received: August 28, 2014

Dear Mr. Job:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. Isting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations. Title 21. Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical

{1}------------------------------------------------

Page 2 - Mr. Mark Job

device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [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" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

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

Sincerely vours.

Mitchell Stein

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

Enclosure

{2}------------------------------------------------

# Indications for Use

510(k) Number (if known) K141706

Device Name eCareCoordinator

Indications for Use (Describe)

eCareCoordinator and its accessories are indicated for use by patients and by care teams for collecting and reviewing patient data from patients who are capable and willing to engage in use of this software, to transmit medical and nonmedical information through integrated technologies.

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

_ Over-The-Counter Use (21 CFR 801 Subpart C)

# PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

#### FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

# TAB 6

# 510K SUMMARY

The Company's 510(k) Summary is provided on the following page.

{Please turn the page}

{4}------------------------------------------------

# 510(k) Summary

| Submitter | Chris Ferguson<br>Visicu, Inc.<br>217 E. Redwood Street, Suite 1900<br>Baltimore, MD 21202<br>Telephone: [phone]<br>Fax: [phone] |
|-------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|
| Date Prepared: | July 14, 2014 |
| Trade/Proprietary Name: | eCareCoordinator (eCC) |
| Common Name: | Telemedicine System |
| Classification Name: | Transmitters And Receivers, Physiological Signal, Radiofrequency<br>(21 CFR 870.2910, Product Code DRG) |

# Predicate Device

M3810A Philips Telemonitoring System (PTS) (K103214)

M3810A Philips Telemonitoring System (PTS) (K041674)

# Device Description

eCareCoordinator (eCC) is a software-only telemedicine system. eCareCoordinator (eCC) is a combination of technology and clinical programs designed to enable the support of patients in the home setting, eCC is intended to support the clinician with monitoring of remote patients. Clinicians use eCC to manage populations of ambulatory care patients, while keeping primary care physicians informed of patient status.

eCC is comprised of the following primary components:

- . eCareCoordinator (eCC): eCC is the platform supporting the Clinical User Interface. eCC is a cloud-based system, which is used to acquire patient data from home devices, as well as provide a population management triage dashboard to enable the clinician's team to prioritize and manage populations of patients.
- . eCareCompanion (eCP): eCP is a patient application element of eCareCoordinator used to engage patients in their own health. eCP is a mobile application which runs on an commercial off-the-shelf (COTS) Android tablet. Patients manually input measurements (including weight, blood pressure, pulse, blood glucose concentration, SpO2, temperature, prothrombin time (PT), coagulation ratio (INR), and transthoracic impedance) from measurement devices into the COTS tablet containing eCP. The COTS tablet wirelessly communicates with eCC to transmit the data stored by eCP to eCC.

{5}------------------------------------------------

# Accessories

The eCC Clinical User Interface is able to receive data from Philips Telehealth Solutions (PTS) Telestations.

#### Intended Use

eCareCoordinator is software intended for use in data aggregation, patient interaction facilitation, storage and clinical information management with independent physiological devices and ancillary systems that are connected either directly or through networks. The software is intended to provide patient information from the patient location through networking technology to a remote care team. eCareCoordinator does not send any real time alarms and is not intended to provide automated treatment decisions. This software is an informational tool only and is not to be used as a substitute for professional judgment of healthcare providers in diagnosing and treating patients.

#### Indications for Use

eCareCoordinator and its accessories are indicated for use by patients and by care teams for collecting and reviewing patient data from patients who are capable and willing to engage in use of this software, to transmit medical and non-medical information through integrated technologies.

#### Comparison of Indications for Use

Although the indications for use for the eCC and the PTS (K103214 / K041674) are not written identically, the stated indications for use are considered to be substantially equivalent, in that both devices are intended to be used in the data collection (aggregation)of patient measured physiological parameters (i.e., weight, blood pressure, etc.); both devices are intended to provide clinical information to a remote care team (i.e., clinical professional), both devices are not intended to be a substitute for professional judgment, and both devices do not send any real time alarms to the end user.

# Technological Characteristics

#### Clinical User Interface

Both eCC and PTS feature a clinical user interface (eCC Clinical User Interface and M3817B server with M3811B Clinical Review Software, for eCC and PTS, respectively) that allows clinical users to review patient measurement and survey data.

#### Patient User Interface

Both eCC and PTS feature a patient user interface (eCP and the PTS telestation, for eCC and PTS, respectively) that allows patients to respond to surveys or enter data from measurement devices. As compared to the predicate PTS, eCC allows for substantially equivalent means of data entry by allowing the patient to manually enter data read from measurement devices.

Surveys

{6}------------------------------------------------

Both eCC and PTS give clinical users the option of sending surveys to patients in order to determine additional information about their health status. Patient surveys are sets of questional materials, quizzes, or assessments that are sent to at-home users via the eCP app or the PTS telestation

# Protocols

Protocols are an option in eCC that allows the creation of patient tasks and intervention rules which trigger a flag. Both eCC and PTS present flags in the clinical application as a notification to clinical users that an item requires attention. In both eCC and PTS, flags are triggered by out-of-range patient data or missed patient data. Clinical users review flags and may take action, including review of individual patient treatment plans, as necessary.

# Performance Data

Bench tests were executed to verify and validate eCC. Verification testing consisted of verification of the system-level requirements and verification of the sub-system level requirements. Validation testing consisted of formative usability testing and summative usability testing. The verification and validation test results confirm that eCC performs as intended.

# Substantial Equivalence

Table 1 below summarizes the comparison of eCC and its predicate device, PTS. eCC and PTS have the same intended use and similar indications, technological characteristics and principles of operation. As discussed above, the technological differences do not change the intended use or present any new issues of safety or effectiveness. Software verification and validation testing, in addition to usability testing conducted to validate the user interface and labeling, demonstrate that the proposed device performs as intended. Thus, eCC is substantially equivalent to PTS.

| | eCareCoordinator (eCC) | M3810A Philips<br>Telemonitoring System (PTS) (K103214) | M3810A Philips<br>Telemonitoring System (PTS) (K041674) | Comparison |
|---------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------|
| Intended Use | Telemedicine system | Telemedicine system | Telemedicine system | Same |
| Indications for Use | eCareCoordinator and its accessories are indicated for use by patients and by care teams for collecting and reviewing patient data from patients who are capable and willing to | The M38IOA Philips TeleMonitoring System with eDevice BridgeD130 is indicated for patients at home, who are capable and willing to self | The M3810A is indicated for patients at home, who are capable and willing to self administrate this device, upon prescription of their healthcare provider, to | Substantially equivalent to K103214 and K041674 |

# Table 1. Substantial Equivalence Chart.

{7}------------------------------------------------

| engage in use of this<br>software, to transmit<br>medical and non-<br>medical information<br>through integrated<br>technologies. | administrate this<br>device, upon the<br>prescription of<br>their healthcare<br>provider, to<br>collect and<br>transmit medical<br>information such<br>as weight, blood<br>pressure<br>(including pulse<br>rate) and non-<br>diagnostic ECG<br>rhythm strip to<br>the healthcare<br>provider at<br>another location.<br>The patient takes<br>these<br>measurements,<br>typically once per<br>day, and the<br>information is<br>transmitted<br>automatically via<br>normal telephone<br>lines or cellular<br>connectivity to<br>the healthcare<br>provider. The<br>device may be<br>used for the<br>management of<br>congestive heart<br>failure,<br>hypertension,<br>ischemic heart<br>disease, weight<br>management,<br>cardiovascular<br>risk management,<br>post<br>cardiovascular<br>surgery, post<br>myocardial<br>infarction, and<br>other post cardiac | collect and<br>transmit medical<br>information, such<br>as weight, blood<br>pressure<br>(including pulse<br>rate) and non-<br>diagnostic ECG<br>rhythm strip to<br>the healthcare<br>provider at<br>another location.<br>The patient takes<br>these<br>measurements,<br>typically once per<br>day, and the<br>information is<br>transmitted<br>automatically via<br>normal telephone<br>time to the<br>healthcare<br>provider. The<br>device does not<br>send any real-<br>time alarms.<br>Clinical judgment<br>and experiences<br>are required to<br>check and<br>interpret the<br>information<br>delivered. |
|----------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

{8}------------------------------------------------

| | | events. The<br>device does not<br>send any real<br>time alarms.<br>Clinical judgment<br>and experience<br>are required to<br>check and<br>interpret the<br>information<br>delivered. | | |
|------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------|
| User<br>Population | Home users and<br>healthcare providers | Home users and<br>healthcare providers | Home users and<br>healthcare providers | Same |
| Measuring<br>devices and<br>functionality | Measurements are<br>entered manually<br>into eCP. | Measurements<br>are either entered<br>manually or<br>measurement<br>devices<br>wirelessly<br>communicate<br>with the PTS<br>telestation. | Measurements<br>are either entered<br>manually or<br>measurement<br>devices<br>wirelessly<br>communicate<br>with the PTS<br>telestation. | Substantially<br>equivalent to<br>K103214 and<br>K041674 |
| Alarm<br>functionality | None | None | None | Same |
| Connectivity<br>from patient<br>home to<br>clinical server | Wireless<br>connectivity | Wireless<br>connectivity or<br>telephone lines | Wireless<br>connectivity or<br>telephone lines | Substantially<br>equivalent to<br>K103214 and<br>K041674 |
| Patient data<br>review | Clinical users can<br>review patient<br>measurement data<br>and survey data | Clinical users can<br>review patient<br>measurement<br>data and survey<br>data | Clinical users can<br>review patient<br>measurement<br>data and survey<br>data | Same |
| Flags/Intervent<br>ion Rules | The clinical user<br>interface features<br>flags as a<br>notification to clinical<br>users that an item<br>requires attention.<br>Flags are triggered<br>by intervention rules<br>that determine that<br>patient data is out- | The clinical user<br>interface features<br>flags as a<br>notification to<br>clinical users that<br>an item requires<br>attention. Flags<br>are triggered by<br>intervention rules<br>that determine | The clinical user<br>interface features<br>flags as a<br>notification to<br>clinical users that<br>an item requires<br>attention. Flags<br>are triggered by<br>intervention rules<br>that determine | Substantially<br>equivalent to<br>K103214 and<br>K041674 |
| | of-range or that<br>there is missed<br>patient data, or that<br>a survey score is<br>out-of-range.<br>Clinical users review<br>flags and may take<br>action, as<br>necessary.<br>Intervention rules<br>can also send a<br>survey task to the<br>patient, send a<br>measurement task<br>to the patient, or<br>create a clinician<br>task. | that patient data<br>is out-of-range or<br>that there is<br>missed patient<br>data, or that a<br>survey score is<br>out-of-range.<br>Clinical users<br>review flags and<br>may take action,<br>as necessary.<br>Intervention rules<br>can also send a<br>survey task to the<br>patient. | that patient data<br>is out-of-range or<br>that there is<br>missed patient<br>data, or that a<br>survey score is<br>out-of-range.<br>Clinical users<br>review flags and<br>may take action,<br>as necessary.<br>Intervention rules<br>can also send a<br>survey task to the<br>patient. | |
| Surveys | Clinical users have<br>option to send<br>surveys to patients | Clinical users<br>have option to<br>send surveys to<br>patients | Clinical users<br>have option to<br>send surveys to<br>patients | Same |
| Protocols | Clinical users have<br>option of assigning<br>protocols (which are<br>a convenient way to<br>schedule patient<br>tasks to take<br>surveys and<br>measurements, as<br>well as define<br>intervention rules) to<br>patients. | Clinical users<br>have option of<br>assigning profiles<br>(which are a<br>convenient way<br>to schedule<br>patient tasks to<br>take surveys as<br>well as define<br>intervention rules)<br>to patients.<br>Clinical users<br>separately<br>schedule patient<br>tasks to take<br>measurements<br>and define<br>intervention rules. | Clinical users<br>have option of<br>assigning profiles<br>(which are a<br>convenient way<br>to schedule<br>patient tasks to<br>take surveys as<br>well as define<br>intervention rules)<br>to patients.<br>Clinical users<br>separately<br>schedule patient<br>tasks to take<br>measurements<br>and define<br>intervention rules. | Substantially<br>equivalent to<br>K103214 and<br>K041674 |

{9}------------------------------------------------