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. 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.

AI/ML Overview

Here's an analysis of the acceptance criteria and study information based on the provided text, focusing on the eCareCoordinator (eCC) device:

Important Note: The provided document is a 510(k) Summary, which primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, not necessarily extensive performance validation against strict clinical acceptance criteria with statistical power. Therefore, some of the requested information (like specific effect sizes for MRMC studies, detailed sample sizes for "test sets" in a diagnostic accuracy sense, or specific ground truth methodologies for training data) are typically not found in such summaries for devices of this nature. The "studies" described here are mainly for verification and validation of the software's functionality and usability.

Acceptance Criteria and Reported Device Performance

The document does not explicitly list "acceptance criteria" for diagnostic performance in the way one might expect for an AI diagnostic device (e.g., sensitivity, specificity thresholds). Instead, the performance objective is to demonstrate that the eCareCoordinator (eCC) performs "as intended" and is "substantially equivalent" to its predicate devices. The "performance data" section states: "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."

The acceptance criteria are implicitly tied to the functional and usability requirements, ensuring the system reliably collects, transmits, and presents patient data, and facilitates patient/clinician interaction as designed.

Acceptance Criteria (Implied)	Reported Device Performance
Functional Verification: System-level requirements met.	"Verification testing consisted of verification of the system-level requirements and verification of the sub-system level requirements."
Functional Verification: Sub-system level requirements met.	"Verification testing consisted of verification of the system-level requirements and verification of the sub-system level requirements."
Usability Validation: Formative usability testing successful.	"Validation testing consisted of formative usability testing..."
Usability Validation: Summative usability testing successful.	"...and summative usability testing."
Overall Performance: Performs as intended.	"The verification and validation test results confirm that eCC performs as intended."
Substantial Equivalence: Similar intended use, indications, technological characteristics, and principles of operation to predicate devices (K103214 and K041674).	Document claims substantial equivalence, stating: "eCC and PTS have the same intended use and similar indications, technological characteristics and principles of operation."
Safety and Effectiveness: Technological differences do not raise new issues.	"As discussed above, the technological differences do not change the intended use or present any new issues of safety or effectiveness."

Additional Information:

Sample size used for the test set and the data provenance:
- The document mentions "bench tests" and "usability testing." It does not specify a "test set" in terms of a dataset for diagnostic accuracy, nor does it provide a sample size for data points or patients used in these tests.
- Data provenance (country of origin, retrospective/prospective) is not mentioned for validation testing. Given the nature of a telemedicine system for data aggregation, the "data" itself might be simulated or test data for functional verification, and participants for usability studies.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided. The device is a "telemedicine system" for data aggregation and communication, not a diagnostic AI that generates a "ground truth" to be compared against expert readings. The "ground truth" for its type of validation would likely be correct data transmission, correct display, and appropriate user interaction as per design specifications, rather than a clinical diagnosis.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable as this is not a diagnostic performance study requiring adjudication of expert readings against an AI output.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No MRMC study was conducted or mentioned. The device is not presented as an AI-assisted diagnostic tool for human readers. It's a system to facilitate data collection and communication.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The "bench tests" and "verification testing" would likely constitute a standalone evaluation of the software's functionality. However, the device's purpose inherently involves human interaction (patients entering data, clinicians reviewing it), so a complete "standalone" clinical performance evaluation without any human interaction would not be meaningful for this device type. The document states it's an "informational tool only and is not to be used as a substitute for professional judgment of healthcare providers."
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the functional aspects (data aggregation, transmission, display), the "ground truth" would be the expected system behavior and correct data handling as defined by the software requirements and design specifications.
- For usability, the "ground truth" would be successful completion of tasks by users and positive feedback on the user experience without critical errors. This is not a clinical ground truth in the diagnostic sense.
The sample size for the training set:
- Not applicable. The eCareCoordinator is described as a "software-only telemedicine system" and a "platform supporting the Clinical User Interface," and "engages patients in their own health" by having them manually input measurements. It does not appear to employ machine learning that would require a "training set" of data to develop algorithms for diagnostic or predictive purposes.
How the ground truth for the training set was established:
- Not applicable, as there is no mention of a training set or machine learning algorithms in the traditional sense described for this device.

Summary

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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

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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 (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" (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 (800) 638-2041 or (301) 796-7100 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

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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)

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FOR FDA USE ONLY

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

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TAB 6

510K SUMMARY

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

{Please turn the page}

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510(k) Summary

Submitter	Chris FergusonVisicu, Inc.217 E. Redwood Street, Suite 1900Baltimore, MD 21202Telephone: 410-276-1960Fax: 410-276-1970
Date Prepared:	July 14, 2014
Trade/Proprietary Name:	eCareCoordinator (eCC)
Common Name:	Telemedicine System
Classification Name:	Transmitters And Receivers, Physiological Signal, Radiofrequency(21 CFR 870.2910, Product Code DRG)

Predicate Device

M3810A Philips Telemonitoring System (PTS) (K103214)

M3810A Philips Telemonitoring System (PTS) (K041674)

Device Description

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.

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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

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

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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 PhilipsTelemonitoring System (PTS) (K103214)	M3810A PhilipsTelemonitoring 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.

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engage in use of thissoftware, to transmitmedical and non-medical informationthrough integratedtechnologies.	administrate thisdevice, upon theprescription oftheir healthcareprovider, tocollect andtransmit medicalinformation suchas weight, bloodpressure(including pulserate) and non-diagnostic ECGrhythm strip tothe healthcareprovider atanother location.The patient takesthesemeasurements,typically once perday, and theinformation istransmittedautomatically vianormal telephonelines or cellularconnectivity tothe healthcareprovider. Thedevice may beused for themanagement ofcongestive heartfailure,hypertension,ischemic heartdisease, weightmanagement,cardiovascularrisk management,postcardiovascularsurgery, postmyocardialinfarction, andother post cardiac	collect andtransmit medicalinformation, suchas weight, bloodpressure(including pulserate) and non-diagnostic ECGrhythm strip tothe healthcareprovider atanother location.The patient takesthesemeasurements,typically once perday, and theinformation istransmittedautomatically vianormal telephonetime to thehealthcareprovider. Thedevice does notsend any real-time alarms.Clinical judgmentand experiencesare required tocheck andinterpret theinformationdelivered.

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		events. Thedevice does notsend any realtime alarms.Clinical judgmentand experienceare required tocheck andinterpret theinformationdelivered.
UserPopulation	Home users andhealthcare providers	Home users andhealthcare providers	Home users andhealthcare providers	Same
Measuringdevices andfunctionality	Measurements areentered manuallyinto eCP.	Measurementsare either enteredmanually ormeasurementdeviceswirelesslycommunicatewith the PTStelestation.	Measurementsare either enteredmanually ormeasurementdeviceswirelesslycommunicatewith the PTStelestation.	Substantiallyequivalent toK103214 andK041674
Alarmfunctionality	None	None	None	Same
Connectivityfrom patienthome toclinical server	Wirelessconnectivity	Wirelessconnectivity ortelephone lines	Wirelessconnectivity ortelephone lines	Substantiallyequivalent toK103214 andK041674
Patient datareview	Clinical users canreview patientmeasurement dataand survey data	Clinical users canreview patientmeasurementdata and surveydata	Clinical users canreview patientmeasurementdata and surveydata	Same
Flags/Intervention Rules	The clinical userinterface featuresflags as anotification to clinicalusers that an itemrequires attention.Flags are triggeredby intervention rulesthat determine thatpatient data is out-	The clinical userinterface featuresflags as anotification toclinical users thatan item requiresattention. Flagsare triggered byintervention rulesthat determine	The clinical userinterface featuresflags as anotification toclinical users thatan item requiresattention. Flagsare triggered byintervention rulesthat determine	Substantiallyequivalent toK103214 andK041674
	of-range or thatthere is missedpatient data, or thata survey score isout-of-range.Clinical users reviewflags and may takeaction, asnecessary.Intervention rulescan also send asurvey task to thepatient, send ameasurement taskto the patient, orcreate a cliniciantask.	that patient datais out-of-range orthat there ismissed patientdata, or that asurvey score isout-of-range.Clinical usersreview flags andmay take action,as necessary.Intervention rulescan also send asurvey task to thepatient.	that patient datais out-of-range orthat there ismissed patientdata, or that asurvey score isout-of-range.Clinical usersreview flags andmay take action,as necessary.Intervention rulescan also send asurvey task to thepatient.
Surveys	Clinical users haveoption to sendsurveys to patients	Clinical usershave option tosend surveys topatients	Clinical usershave option tosend surveys topatients	Same
Protocols	Clinical users haveoption of assigningprotocols (which area convenient way toschedule patienttasks to takesurveys andmeasurements, aswell as defineintervention rules) topatients.	Clinical usershave option ofassigning profiles(which are aconvenient wayto schedulepatient tasks totake surveys aswell as defineintervention rules)to patients.Clinical usersseparatelyschedule patienttasks to takemeasurementsand defineintervention rules.	Clinical usershave option ofassigning profiles(which are aconvenient wayto schedulepatient tasks totake surveys aswell as defineintervention rules)to patients.Clinical usersseparatelyschedule patienttasks to takemeasurementsand defineintervention rules.	Substantiallyequivalent toK103214 andK041674

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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).