(90 days)
Not Found
No
The document mentions "clinical decision support algorithms" but does not use terms like AI, ML, or deep learning, nor does it describe training or test sets typically associated with ML models. The performance studies focus on validation against a predicate device and changes to an "Automated Acuity Score calculation," which could be rule-based or algorithmic but doesn't necessarily imply AI/ML.
No
The device is a software tool that supports clinical decision-making and facilitates remote monitoring, but it does not directly treat or diagnose a disease or condition. It aids medical staff, rather than providing therapy itself.
No
The eCareManager System is a software tool that collects, stores, and displays clinical data to generate decision support notifications for trained medical staff, aiding in understanding a patient's condition. It does not provide a definitive diagnosis or interpret medical images. Instead, it supports the judgment of medical professionals by providing information and notifications.
Yes
The device description explicitly states that the eCareManager system is a "software platform" and the intended use and indications for use refer to "software tool" and "software". There is no mention of any hardware components being part of the device itself, only that it collects data from existing hardware (electronic medical record, patient monitoring systems, ancillary systems).
Based on the provided information, the eCareManager System is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- eCareManager Functionality: The eCareManager System collects, stores, and displays clinical data from existing sources like electronic medical records, patient monitoring systems, and ancillary systems. It uses this data to generate clinical decision support notifications.
- Lack of Sample Analysis: The system does not perform any analysis on biological samples taken from the patient. Its function is to aggregate and process data that has already been collected by other means.
- Intended Use: The intended use is to provide supplemental remote support to bedside care teams by displaying and analyzing existing clinical data, not to diagnose conditions based on in vitro testing.
Therefore, the eCareManager System falls outside the scope of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for 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 software is indicated for use in hospital environment or remote locations with clinical professionals. It is not indicated for home use.
Product codes (comma separated list FDA assigned to the subject device)
MSX
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained medical staff providing supplemental remote support to bedside care teams; hospital environment or remote locations with clinical professionals.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
No performance standards for telehealth systems or components have been issued under the authority of Section 514. eCareManager 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
Changes to the Automated Acuity Score calculation have been validated using clinical data collected under an observational, non-human subject evaluation. The evaluation demonstrated substantial equivalence of the modified calculation with the unmodified, predicate device version.
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 eCareManager software release 4.1 meets all device specifications and user needs.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).
(a)
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.(b)
Classification. Class II (performance standards).
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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" 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) |
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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 |
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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.
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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 | Objective measurement of
risk of death or readmission | Same |
| Early Warning
Score | Graphical summary of
physiological changes | Graphical summary of
physiological changes | Modified graphical presentation
and scoring range |
| Vital Signs
Monitoring | Retrospective | Retrospective | Same |
| Laboratory
Results | Received via hospital
system interface or manual
entry | Received via hospital
system interface or manual
entry | Same |
| Smart Alerts | Visual cues based on
automated assessment of
patient data. Patient
specific configuration | Visual cues based on
automated assessment of
patient data. Patient
specific configuration | Same |
6
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Image /page/7/Picture/1 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 in a bold, sans-serif font. The text below the logo is in a smaller, serif font. The image is simple and clean, with a focus on the text and logo.
VI.Performance Data
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. eCareManager 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
Changes to the Automated Acuity Score calculation have been validated using clinical data collected under an observational, non-human subject evaluation. The evaluation demonstrated substantial equivalence of the modified calculation with the unmodified, predicate device version.
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Image /page/8/Picture/1 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 wordmark with bold, blocky letters. The text below the logo appears to be related to the eCareManager software and its regulatory status.
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 eCareManager software release 4.1 meets all device specifications and user needs.
VII. Conclusion
eCareManager 4.1 is substantially equivalent to the predicate eCareManager 4.0 (K153156) in terms of design features, fundamental scientific technology, intended use, safety and effectiveness. Substantial equivalence has been demonstrated with non-clinical performance testing and validation using clinical datra. The verification results provided in this 510(k) premarket notification demonstrate that the subject device, CareManager 4.1, is as safe and effective as the predicate device without raising any new safety and/or effectiveness concerns.