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.

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.

AI/ML Overview

The provided document, a 510(k) Pre-Market Notification for eCareCoordinator 1.5, does not contain a typical "acceptance criteria" table with reported device performance in a quantitative manner as one might expect for a diagnostic or interventional device. This is likely because the device is a software-only telemedicine system for data aggregation and communication facilitation, rather than a device with direct physiological measurement or diagnostic capabilities requiring numerical performance metrics (e.g., sensitivity, specificity).

Instead, the document focuses on demonstrating substantial equivalence to a previously cleared predicate device (eCareCoordinator 1.0) through a comparison of technological characteristics and verification/validation activities.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

As mentioned, a specific table of quantitative acceptance criteria and performance metrics for the eCareCoordinator 1.5 is not provided in the document. The "performance" is demonstrated through verification and validation efforts, ensuring the device meets its specifications and user needs. The comparison table (Table 5-1 on pages 5-6) lists features and provides a categorical comparison (e.g., "Same", "Enhanced user interfaces", "Added video communications"), but not numerical performance.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify a "test set" in terms of patient data or clinical images for evaluating performance. The testing mentioned refers to:

"Philips verification and validation processes"
"detailed functional, system level and usability testing"

Given the nature of the device as a software-only telemedicine system for data aggregation and communication, a traditional test set with patient data provenance is not applicable in the way it would be for an AI diagnostic algorithm. The "test set" here would refer to the internal testing of the software's functionality and usability.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This information is not applicable and therefore not provided in the document. Since there's no clinical performance testing involving patient data for diagnostic or treatment decisions, there's no ground truth to be established by experts in the context of diagnostic accuracy. The device is described as an "informational tool only and is not to be used as a substitute for professional judgment of healthcare providers."

4. Adjudication Method for the Test Set

This information is not applicable and therefore not provided in the document for the reasons stated above.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A MRMC comparative effectiveness study was not done. The document states:

"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."

Therefore, there is no effect size reported for human readers improving with or without AI assistance, as the device is not an AI diagnostic tool and no such study was conducted.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

A standalone performance study of an "algorithm" in the typical sense (e.g., for diagnostic accuracy) was not done. The device is a "software-only telemedicine system" that facilitates data aggregation and communication for human care teams, not an autonomous algorithm making diagnostic or treatment decisions. The document explicitly states: "eCareCoordinator does not send any real time alarms and is not intended to provide automated treatment decisions. This software is an informational tool only..."

7. Type of Ground Truth Used

Not applicable/Not explicitly stated for clinical performance. The "ground truth" for this type of software would be its adherence to functional and user requirements during internal testing. For example, a ground truth for a communication feature would be "did the video call successfully connect and transmit audio/video as designed?" rather than "was the diagnosis correct?".

8. Sample Size for the Training Set

This information is not applicable and therefore not provided. The eCareCoordinator 1.5 is a traditional software system, not an AI/machine learning model that undergoes "training" on a dataset in the way a diagnostic algorithm would.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable as there is no training set mentioned for this traditional software.

Summary of Device Acceptance and Study:

The acceptance of eCareCoordinator 1.5 for 510(k) clearance is based on demonstrating substantial equivalence to its predicate device (eCareCoordinator 1.0). This was supported by:

Non-clinical testing: This involved internal "Philips verification and validation processes," including Risk Analysis, Product Specifications, Design Reviews, Verification & Validations.
Conclusion: "Test results demonstrated that eCareCoordinator 1.5 meets all specifications and user needs." This implies that the software functions as designed and fulfills its intended purpose as a telemedicine system for data aggregation and user communication.

The document emphasizes that the enhanced features (like two-way video communication and Bluetooth connectivity for measurements) do not change the intended use or introduce new questions of safety or effectiveness, thus obviating the need for clinical performance testing typically required for devices with direct clinical impact.

Summary

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Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or clothing.

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

July 14, 2017

Visicu Inc. Milind Gramopadhye Director of Quality and Regulatory 217 East Redwood St. Suite 1900 Baltimore, Maryland 21202

Re: K171029

Trade/Device Name: eCareCoordinator 1.5 Regulation Number: 21 CFR 870.2910 Regulation Name: Radiofrequency Physiological Signal Transmitter and Receiver Regulatory Class: Class II Product Code: DRG Dated: June 15, 2017 Received: June 16, 2017

Dear Milind Gramopadhye:

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

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

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

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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. 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)

Type of Use (Select one or both, as applicable)
☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/1 description: The image shows the Philips logo in blue, followed by the text "eCareCoordinator 1.5" and "Traditional 510(k)" in black. The Philips logo is in a bold, sans-serif font. The text below the logo is in a smaller, regular font. The image is likely a product label or advertisement.

510(k) Summary eCareCoordinator 1.5

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

Date Prepared: April 5, 2017

l. Submitter's name and address

Manufacturer:	Visicu, Inc.217 East Redwood StreetSuite 1900Baltimore, MD 21202
Contact Person:	Daniel R. PlonskiSenior Manager, Quality and RegulatoryPhone: 410-246-5357Fax: 410-276-1970E-mail: daniel.plonski@philips.com

II. Device information

Device Name:	eCareCoordinator 1.5
Common Name:	Telemedicine System
Classification panel:	Cardiovascular

Classification	ProCode	Description
870.2910	DRG	Radiofrequency physiological signal transmitterand 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

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 /Feature	eCareCoordinator 1.5(Subject Device)	eCareCoordinator(Predicate device –K141706)	Comparison
Intended Use	eCareCoordinator issoftware intended for use indata aggregation, patientinteraction facilitation,storage and clinicalinformation managementwith independentphysiological devices andancillary systems that areconnected either directly orthrough networks. Thesoftware is intended toprovide patient informationfrom the patient locationthrough networkingtechnology to a remote careteam. eCareCoordinatordoes not send any real timealarms and is not intendedto provide automatedtreatment decisions. Thissoftware is an informationaltool only and is not to beused as a substitute forprofessional judgment ofhealthcare providers indiagnosing and treatingpatients.	eCareCoordinator issoftware intended for use indata aggregation, patientinteraction facilitation,storage and clinicalinformation managementwith independentphysiological devices andancillary systems that areconnected either directly orthrough networks. Thesoftware is intended toprovide patient informationfrom the patient locationthrough networkingtechnology to a remote careteam. eCareCoordinatordoes not send any real timealarms and is not intendedto provide automatedtreatment decisions. Thissoftware is an informationaltool only and is not to beused as a substitute forprofessional judgment ofhealthcare providers indiagnosing and treatingpatients.	Same
Indications forUse	eCareCoordinator and itsaccessories are indicatedfor use by patients and bycare teams for collectingand reviewing patient datafrom patients who arecapable and willing toengage in use of thissoftware, to transmitmedical and non-medicalinformation throughintegrated technologies.	eCareCoordinator and itsaccessories are indicatedfor use by patients and bycare teams for managingpatients who are capableand willing to engage in useof this software, to transmitmedical and non-medicalinformation throughintegrated technologies.	Same – wording updated forclarity.
Targetpopulation	At home patients	At home patients	Same
Technological Characteristics
Systemcomponents	Software Only	Software Only	Same
User Interfaces	Clinical (eCC) andPatient (eCP)	Clinical (eCC) andPatient (eCP)	Enhanced user interfaces
Clinician-PatientCommunications	Two-way video	None	Added video communications
MeasurementFeatures	None	None	Same
Specification /Feature	eCareCoordinator 1.5(Subject Device)	eCareCoordinator(Predicate device –K141706)	Comparison
System Alarms	None	None	Same
WaveformTransmission	None	None	Same
User Access andPatient DataSecurity	User Authenticationservices, roles-based dataaccess, logging for audittrail, locked down tablet	User Authenticationservices, roles-based dataaccess, logging for audittrail, locked down tablet	Same
Clinical User Interface (eCC) Features
Population View	Population screen withmeasurement and surveyflags and other displayfields	Population screen withmeasurement and surveyflags and other displayfields	Same
Overall Score	Sum of weighted scores for:Measurements, surveyresponses, issues,readmission risk and dayssince discharge	Sum of weighted scores for:Measurements, surveyresponses, issues,readmission risk and dayssince discharge	Same
MeasurementsView	Display of patientmeasurements and surveyresponses	Display of patientmeasurements and surveyresponses	Same
Patient Chart	Graphical and tabulardisplays of patientinformation	Graphical and tabulardisplays of patientinformation	Same
InterventionRules	Used to trigger notifications(flags) to clinician.Customizable by institutionor clinician	Used to trigger notifications(flags) to clinician.Customizable by institutionor clinician	Same
Surveys	Clinical users haveoption to sendsurveys to patients	Clinical users haveoption to sendsurveys to patients	Same
Protocols	Used to set patient tasks,surveys and interventionrules. Customizable byinstitution or clinician	Used to set patient tasks,surveys and interventionrules. Customizable byinstitution or clinician	Same
Clinician Tasks	Communication andtracking of clinical caretasks	Communication andtracking of clinical caretasks	Same
Sticky Notes	Optionally added to patientcalendar	Optionally added to patientcalendar	Same
Reports	Hard copy patient recordreport and systemadministration reports	System administrationreports	Added patient record report
Patient User Interface (eCP) Features
Platform	Android Tablet and legacyTelestation	Android Tablet and legacyTelestation	Same
Measurementsfrom homedevices	Wireless Bluetooth andmanual entry	Manual entry	Bluetooth connectivityimplemented
Appointments	Scheduled by care provider,appear on patient's	Scheduled by care provider,appear on patient's	Same
Specification /Feature	eCareCoordinator 1.5(Subject Device)	eCareCoordinator(Predicate device –K141706)	Comparison
	calendar	calendar
Activities andReminders	Scheduled by care provider,appear on patient'scalendar	Scheduled by care provider,appear on patient'scalendar	Same
Surveys	Created and assigned topatients by the careprovider	Created and assigned topatients by the careprovider	Same
Video Calls	Capability to schedule andconduct video calls withcare providers	None	Added video call capability
EducationalVideos	Access to pre-installededucational 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.

Regulation Number and Section

§ 870.2910 Radiofrequency physiological signal transmitter and receiver.

(a)
Identification. A radiofrequency physiological signal transmitter and receiver is a device used to condition a physiological signal so that it can be transmitted via radiofrequency from one location to another, e.g., a central monitoring station. The received signal is reconditioned by the device into its original format so that it can be displayed.(b)
Classification. Class II (performance standards).