Who is the manufacturer of eCareManager 4.1?

Visicu, Inc. submitted the Traditional clearance for eCareManager 4.1 (K171322).

What is the FDA product code for eCareManager 4.1?

MSX. It is classified under 21 CFR 870.2300 as a Class 2 device in the Cardiovascular panel.

What is the regulatory pathway for eCareManager 4.1?

510(k) clearance (submission type: Traditional).

eCareManager 4.1

K171322 · Visicu, Inc. · MSX · Aug 3, 2017 · Cardiovascular

Device Facts

Record ID	K171322
Device Name	eCareManager 4.1
Applicant	Visicu, Inc.
Product Code	MSX · Cardiovascular
Decision Date	Aug 3, 2017
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 870.2300
Device Class	Class 2
Attributes	Software as a Medical Device

Intended Use

The eCareManager System is a software tool intended for use by trained medical staff providing supplemental remote support to bedside care teams in the management and care of in-hospital patients. The software collects, stores and displays clinical data obtained from the electronic medical record, patient monitoring systems and ancillary systems connected through networks. Using this data, clinical decision support notifications are generated that aid in understanding the patient's current condition and changes over time. The eCareManager System does not provide any alarms. It is not intended to replace bedside vital signs alarms or proactive patient care from clinicians. All information and notifications provided by the eCareManager System are intended to support the judgement of a medical professional and are not intended to be the sole source of information for decision making.

Device Story

eCareManager 4.1 is a telehealth software platform for enterprise-wide patient management; it aggregates clinical data from electronic medical records (EMR), bedside monitors, and ancillary systems via network interfaces. The system provides clinical decision support (CDS) by processing this data to generate visual cues and notifications regarding patient condition and trends. It features an automated acuity score, early warning scores, and discharge readiness assessments. The software is operated by trained medical staff in remote or hospital settings to support bedside care teams. It does not provide active alarms or replace bedside monitoring. Output is displayed on a dashboard for clinical review, aiding in proactive care delivery and patient status monitoring. The system includes patient census, flowsheets, order entry, and reporting tools to facilitate collaborative care.

Clinical Evidence

No human clinical trials were conducted. The device underwent observational, non-human subject evaluation using clinical data to validate changes to the Automated Acuity Score calculation. Verification and validation activities, including risk analysis, design reviews, and system-level testing, confirmed that the software meets all specifications and is substantially equivalent to the predicate.

Technological Characteristics

Software-only telehealth platform; operates on networked hospital systems. Interfaces via HL-7. Features include user authentication, role-based access control, and audit logging. CDS algorithms provide automated acuity scoring, early warning scores, and discharge readiness metrics. No hardware components, sensors, or active alarms.

Indications for Use

Indicated for use in hospital environments or remote locations by clinical professionals for the management and care of in-hospital patients. Not indicated for home use.

Regulatory Classification

Identification

A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.

Predicate Devices

eCareManager 4.0 (K153156)

Related Devices

K211046 — eCareManager 4.5 · Visicu, Inc. · Jun 3, 2022
K153156 — eCareManager 4.0.1 · Visicu, Inc. · Sep 30, 2016
K171029 — eCareCoordinator · Visicu, Inc. · Jul 14, 2017
K161767 — Philips IntelliVue GuardianSoftware · Philips Medizin Systeme Boeblingen GmbH · Jan 27, 2017
K141706 — ECARE COORDINATOR (ECC) · Visicu, Inc. · Sep 9, 2014

Submission Summary (Full Text)

{0}------------------------------------------------ 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" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other, creating a sense of depth and unity. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 August 3, 2017 Visicu. Inc. Milind Gramopadhye Director of Quality and Regulatory 217 East Redwood St. Suite 1900 Baltimore, Maryland 21202 Re: K171322 Trade/Device Name: eCareManager 4.1 Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (Including Cardiotachometer and Rate Alarm) Regulatory Class: Class II Product Code: MSX Dated: Mav 5. 2017 Received: Mav 5. 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 {1}------------------------------------------------ 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.A. Wilhelm for 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) K171322 Device Name eCareManager 4.1 #### Indications for Use (Describe) Intended Use Statement: The eCareManager System is a software tool intended for use by trained medical staff providing supplemental remote support to bedside care teams in the management and care of in-hospital patients. The software collects, stores and displays clinical data obtained from the electronic medical record, patient monitoring systems and ancillary systems connected through networks. Using this data, clinical decision support notifications are generated that aid in understanding the patient's current condition and changes over time. The eCareManager System does not provide any alarms. It is not intended to replace bedside vital signs alarms or proactive patient care from clinicians. All information and notifications provided by the eCareManager System are intended to support the judgement of a medical professional and are not intended to be the sole source of information for decision making. Indications for Use Statement: The eCareManager software is indicated for use in hospital environment or remote locations with clinical professionals. It is not indicated for home use. Type of Use (Select one or both, as applicable) | ☑ Prescription Use (Part 21 CFR 801 Subpart D) | |-----------------------------------------------------------------------------------------------------------| | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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}------------------------------------------------ Image /page/3/Picture/1 description: The image shows the text "510(k) Summary" in bold black font. The text is centered and appears to be the title or heading of a document. The text is simple and straightforward. Image /page/3/Picture/2 description: The image shows the Philips logo in blue, followed by the text "eCareManager 4.1" and "Traditional 510(k)" in black. The Philips logo is a simple, bold sans-serif typeface. The text below the logo is smaller and in a different font. # 510(k) Summary eCareManager 4.1 This 510(k) summary of safety and effectiveness information is prepared in accordance with 21 CFR 807.92(c). Date Prepared: May 5, 2017 #### l. Submitter's name and address | Manufacturer: | Visicu, Inc. 217 East Redwood Street Suite 1900 Baltimore, MD 21202 | |-----------------|-----------------------------------------------------------------------------------------------------------------------------------------------| | Contact Person: | Daniel R. Plonski Senior Manager, Quality and Regulatory Phone: 410-246-5357 Fax: 410-276-1970 E-mail: daniel.plonski@philips.com | ### II. Device information Device Name: eCareManager 4.1 Manufacturer: Visicu, Inc. Common Name: Telehealth Software System, network and communication, physiological monitors Classification name Device class: Class II Classification regulation: 21 CFR 870.2300 Classification panel: Cardiovascular Product Code: MSX ### III. Predicate device information | Device Name: | eCareManager 4.0 (K153156) | |----------------------------|-----------------------------------------------------------| | Manufacturer: | Visicu, Inc. | | Common Name: | Telehealth Software | | Classification name | System, network and communication, physiological monitors | | Device class: | Class II | | Classification regulation: | 21 CFR 870.2300 | | Classification panel: | Cardiovascular | | Product Code: | MSX | {4}------------------------------------------------ Image /page/4/Picture/2 description: The image shows the Philips logo in blue, followed by the text "eCareManager 4.1" and "Traditional 510(k)". The Philips logo is a stylized version of the company's name. The text below the logo indicates that the image is related to Philips' eCareManager software and its regulatory status under the FDA's 510(k) clearance process. ### Device Description The eCareManager system is a software platform that enables enterprise telehealth. The system includes interface features to acquire patient data from the electronic medical record and bedside devices which can be shared between the bedside and remote care teams. Population management and communication features facilitate a collaborative approach to delivery of in-patient care. The system's clinical decision support features further aid in the proactive delivery of care. Using data received from the hospital's systems, clinical decision support algorithms provide cues that assist in the early detection of changes in patient condition. ### IV.Intended use/ Indications for Use #### Intended Use: The eCareManager System is a software tool intended for use by trained medical staff providing supplemental remote support to bedside care teams in the management and care of in-hospital patients. The software collects, stores and displays clinical data obtained from the electronic medical record, patient monitoring systems and ancillary systems connected through networks. Using this data, clinical decision support notifications are generated that aid in understanding the patient's current condition and changes over time. The eCareManager System does not provide any alarms. It is not intended to replace bedside vital signs alarms or proactive patient care from clinicians. All information and notifications provided by the eCareManager System are intended to support the judgement of a medical professional and are not intended to be the sole source of information for decision making. ### Indication for Use: The eCareManager software is indicated for use in hospital environment or remote locations with clinical professionals. It is not indicated for home use. ### V. Comparison of Technological Characteristics with the Predicate Device eCareManager 4.1 is an enhanced version of our previously cleared eCareManager 4.0 software product (K153156). While the intended use and technological characteristics remain the same, eCareManager 4.1 provides enhanced patient administration and clinical decision support features. Differences in the available features, summarized in table 5.1 below, do not present any new questions of safety or effectiveness. {5}------------------------------------------------ Image /page/5/Picture/2 description: The image shows the Philips logo in blue, followed by the text "eCareManager 4.1" 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 Philips' eCareManager software, version 4.1, and that it has received Traditional 510(k) clearance. Table 5-1 Comparison Table | Specification / Feature | eCareManager 4.1 (Subject Device) | eCareManager 4.0 (Predicate device) K153156 | Comparison | |--------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------| | Intended Use / Indications for Use / Target population | | | | | Intended Use | The eCareManager System is a software tool intended for use by trained medical staff providing supplemental remote support to bedside care teams in the management and care of in-hospital patients. The software collects, stores and displays clinical data obtained from the electronic medical record, patient monitoring systems and ancillary systems connected through networks. Using this data, clinical decision support notifications are generated that aid in understanding the patient's current condition and changes over time. The eCareManager System does not provide any alarms. It is not intended to replace bedside vital signs alarms or proactive patient care from clinicians. All information and notifications provided by the eCareManager System are intended to support the judgement of a medical professional and are not intended to be the sole source of information for decision making. | The eCareManager System is a software tool intended for use by trained medical staff providing supplemental remote support to bedside care teams in the management and care of in-hospital patients. The software collects, stores and displays clinical data obtained from the electronic medical record, patient monitoring systems and ancillary systems connected through networks. Using this data, clinical decision support notifications are generated that aid in understanding the patient's current condition and changes over time. The eCareManager System does not provide any alarms. It is not intended to replace bedside vital signs alarms or proactive patient care from clinicians. All information and notifications provided by the eCareManager System are intended to support the judgement of a medical professional and are not intended to be the sole source of information for decision making. | Same | | Indications for Use | The eCareManager software is indicated for use in hospital environment or remote locations with clinical professionals. It is not indicated for home use. | The eCareManager software is indicated for use in hospital environment or remote locations with clinical professionals. It is not indicated for home use | Same | | Target population | In-hospital patients | In-hospital patients | Same | | Technological Characteristics | | | | | System components | Software Only | Software Only | Same | | Specification / Feature | eCareManager 4.1 (Subject Device) | eCareManager 4.0 (Predicate device) K153156 | Comparison | | Interfaces to hospital systems | HL-7 | HL-7 | Same | | Bedside to Remote Communications | Audio/Video | Audio/Video | Same | | Measurement Features | None | None | Same | | System Alarms | None | None | Same | | Waveform Transmission | None | None | Same | | User Access and Patient Data Security | User Authentication services, roles-based data access, logging for audit trail | User Authentication services, roles-based data access, logging for audit trail | Same | | Patient Administration Features | | | | | Patient Census | Patient Census screen with status indicators | Patient Census screen with status indicators | Enhanced display | | Graphical Census | Graphical display of patient status | Graphical display of patient status | Enhanced display | | Patient Profile | Summary of patient information including diagnosis, treatments, best practices and trends | Summary of patient information including diagnosis, treatments, best practices and trends | Same | | Stroke Profile | Summary of clinical data and workflow time tracking | Summary of clinical data and workflow time tracking | Same | | Care Plan | Summary of clinical care plan and therapeutic objectives | Summary of clinical care plan and therapeutic objectives | Same | | Task List | Communication and tracking of clinical care tasks | Communication and tracking of clinical care tasks | Same | | Flowsheets | Electronic charting of vital signs and infusions, intake and output, nursing assessments and care, respiratory therapy, and lines, tubes and drains | Electronic charting of vital signs and infusions, intake and output, nursing assessments and care, respiratory therapy, and lines, tubes and drains | Same | | Order Entry | Medication and non- medication orders. Drug interaction and allergy screening | Medication and non- medication orders. Drug interaction and allergy screening | Same | | Patient Notes | Supports entry of patient notes with configurable templates | Supports entry of patient notes with configurable templates | Same | | Program Forms | Configurable data entry forms for tracking clinical program performance, based on customer initiatives | Configurable data entry forms for tracking clinical program performance, based on customer initiatives | Same | | Reports | Operational, Clinical Care and Billing reports provided | Operational, Clinical Care and Billing reports provided | Same | | Specification / Feature | eCareManager 4.1 (Subject Device) | eCareManager 4.0 (Predicate device) K153156 | Comparison | | Clinical Decision Support Features | | | | | Automated Acuity Score | Provides a relative scoring of patient condition | Provides a relative scoring of patient condition | Modified parameters, to include lab values and modified graphical presentation | | Pain, Agitation and Delirium | Graphical summary of PAD related issues | Graphical summary of PAD related issues | Modified graphical presentation | | Discharge Readiness Score | Objective measurement of risk of death or readmission…