(90 days)
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.
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.
The provided document is a 510(k) premarket notification for a software device called eCareManager 4.1. It details the device's intended use, comparison with a predicate device (eCareManager 4.0), and summarizes performance testing. However, this document does not contain the specific acceptance criteria or detailed results of a study proving the device meets those criteria, as typically found in a clinical study report for an AI/ML medical device.
The eCareManager system described is a "telehealth software system" that provides "clinical decision support notifications" based on collected clinical data. It is explicitly stated that the system "does not provide any alarms" and "is not intended to replace bedside vital signs alarms or proactive patient care from clinicians," nor is it "intended to be the sole source of information for decision making." This suggests its role is primarily informational and supportive, not diagnostic or a direct intervention.
Given the nature of the device as clinical decision support software without direct diagnostic or therapeutic action, the FDA submission focuses on showing substantial equivalence to a previous version and that the changes do not raise new safety or effectiveness concerns, rather than proving a specific performance metric against a "ground truth" as would be done for an AI diagnostic device.
Therefore, much of the requested information regarding detailed acceptance criteria, specific performance metrics (like sensitivity, specificity, AUC), sample sizes for test sets, data provenance, expert adjudication, MRMC studies, standalone performance, and ground truth establishment is not present in this 510(k) summary.
The document states:
- "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."
- "Test results demonstrated that eCareManager software release 4.1 meets all device specifications and user needs."
This indicates that some form of validation was done, but the specifics of how "substantial equivalence" was demonstrated in terms of precise metrics for the "Automated Acuity Score" or what "device specifications and user needs" were measured are not provided in this public summary.
Based on the available information:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table of explicit acceptance criteria with numerical performance targets and corresponding reported device performance values (e.g., sensitivity, specificity, accuracy, etc.) for AI/ML performance. Instead, it states that "Test results demonstrated that eCareManager software release 4.1 meets all device specifications and user needs" and that the "evaluation demonstrated substantial equivalence of the modified calculation with the unmodified, predicate device version." These are high-level conclusions without quantified metrics for specific performance criteria.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified. The document mentions "clinical data collected under an observational, non-human subject evaluation" was used to validate changes to the Automated Acuity Score.
- Data Provenance: Not specified (e.g., country of origin).
- Retrospective or Prospective: "Retrospective" is mentioned for "Vital Signs Monitoring" under "Clinical Decision Support Features" in Table 5-1, but it's unclear if this refers to the data used for the validation study or just a general characteristic of how vital signs are handled by the system. The validation itself is described as "observational, non-human subject evaluation," which typically implies retrospective analysis of existing data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable/Not specified. Given the device's function as clinical decision support that generates "notifications" and "cues" to "aid in understanding the patient's current condition," and explicitly "not intended to be the sole source of information for decision making," the ground truth wouldn't typically be established by expert consensus on, for example, image interpretation, but rather on the clinical condition of the patient as recorded in their EMR or other systems. The validation focused on the "Automated Acuity Score," and it's not clear that human experts were involved in establishing a "ground truth" for this algorithm's output, beyond perhaps verifying consistency with existing clinical assessments or outcomes data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable/Not specified. There's no indication of any expert adjudication process for the "clinical data" used in validation.
5. 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 such study appears to have been performed or reported in this summary. The device is a "telehealth software system" providing "clinical decision support notifications," not an AI diagnostic tool intended to assist human readers differentiate between medical conditions from images or other complex data. The validation focused on the "substantial equivalence of the modified calculation with the unmodified, predicate device version."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The "Automated Acuity Score" calculation was validated using "clinical data." This suggests a standalone evaluation of the algorithm's output against some measure (likely derived from the clinical data it processes or against the predicate's output), although the specific metrics used are not stated. The device functions as a software tool that generates notifications, meaning its core function is algorithm-driven, so an algorithm-only evaluation of its calculations (like the Acuity Score) would be inherent to its validation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not explicitly stated. For the "Automated Acuity Score," the validation aimed to demonstrate "substantial equivalence... with the unmodified, predicate device version." This implies that the "ground truth" for the new version's performance was its consistency or agreement with the predicate's output or a clinical outcome measure derived from the "clinical data" itself that the score is meant to reflect (e.g., patient condition changes, length of stay, etc.). The summary only states "clinical data collected under an observational, non-human subject evaluation."
8. The sample size for the training set
Not applicable/Not specified. The document describes the device validation for a new version (eCareManager 4.1) against a predicate (eCareManager 4.0). It validates "changes to the Automated Acuity Score calculation." This would typically involve re-training or fine-tuning the algorithm, but the size of any training data used for the development of this calculation (or the updated parameters) is not disclosed in this summary, which focuses on validation of the product.
9. How the ground truth for the training set was established
Not applicable/Not specified. As mentioned, the document describes product validation for an updated version, not the initial development or training process.
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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
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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.A. Wilhelm
for 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) 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 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: 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 Systemis a software tool intendedfor use by trained medicalstaff providing supplementalremote support to bedsidecare teams in themanagement and care ofin-hospital patients. Thesoftware collects, storesand displays clinical dataobtained from the electronicmedical record, patientmonitoring systems andancillary systemsconnected throughnetworks. Using this data,clinical decision supportnotifications are generatedthat aid in understandingthe patient's currentcondition and changes overtime. The eCareManagerSystem does not provideany alarms. It is notintended to replace bedsidevital signs alarms orproactive patient care fromclinicians.All information andnotifications provided by theeCareManager System areintended to support thejudgement of a medicalprofessional and are notintended to be the solesource of information fordecision making. | The eCareManager Systemis a software tool intendedfor use by trained medicalstaff providing supplementalremote support to bedsidecare teams in themanagement and care ofin-hospital patients. Thesoftware collects, storesand displays clinical dataobtained from the electronicmedical record, patientmonitoring systems andancillary systemsconnected throughnetworks. Using this data,clinical decision supportnotifications are generatedthat aid in understandingthe patient's currentcondition and changes overtime. The eCareManagerSystem does not provideany alarms. It is notintended to replace bedsidevital signs alarms orproactive patient care fromclinicians.All information andnotifications provided by theeCareManager System areintended to support thejudgement of a medicalprofessional and are notintended to be the solesource of information fordecision making. | Same |
| Indications forUse | The eCareManagersoftware is indicated for usein hospital environment orremote locations withclinical professionals. It isnot indicated for home use. | The eCareManagersoftware is indicated for usein hospital environment orremote locations withclinical professionals. It isnot indicated for home use | Same |
| Targetpopulation | In-hospital patients | In-hospital patients | Same |
| Technological Characteristics | |||
| Systemcomponents | Software Only | Software Only | Same |
| Specification /Feature | eCareManager 4.1(Subject Device) | eCareManager 4.0(Predicate device)K153156 | Comparison |
| Interfaces tohospital systems | HL-7 | HL-7 | Same |
| Bedside toRemoteCommunications | Audio/Video | Audio/Video | Same |
| MeasurementFeatures | None | None | Same |
| System Alarms | None | None | Same |
| WaveformTransmission | None | None | Same |
| User Access andPatient DataSecurity | User Authenticationservices, roles-based dataaccess, logging for audittrail | User Authenticationservices, roles-based dataaccess, logging for audittrail | Same |
| Patient Administration Features | |||
| Patient Census | Patient Census screen withstatus indicators | Patient Census screen withstatus indicators | Enhanced display |
| GraphicalCensus | Graphical display of patientstatus | Graphical display of patientstatus | Enhanced display |
| Patient Profile | Summary of patientinformation includingdiagnosis, treatments, bestpractices and trends | Summary of patientinformation includingdiagnosis, treatments, bestpractices and trends | Same |
| Stroke Profile | Summary of clinical dataand workflow time tracking | Summary of clinical dataand workflow time tracking | Same |
| Care Plan | Summary of clinical careplan and therapeuticobjectives | Summary of clinical careplan and therapeuticobjectives | Same |
| Task List | Communication andtracking of clinical caretasks | Communication andtracking of clinical caretasks | Same |
| Flowsheets | Electronic charting of vitalsigns and infusions, intakeand output, nursingassessments and care,respiratory therapy, andlines, tubes and drains | Electronic charting of vitalsigns and infusions, intakeand output, nursingassessments and care,respiratory therapy, andlines, tubes and drains | Same |
| Order Entry | Medication and non-medication orders. Druginteraction and allergyscreening | Medication and non-medication orders. Druginteraction and allergyscreening | Same |
| Patient Notes | Supports entry of patientnotes with configurabletemplates | Supports entry of patientnotes with configurabletemplates | Same |
| Program Forms | Configurable data entryforms for tracking clinicalprogram performance,based on customerinitiatives | Configurable data entryforms for tracking clinicalprogram performance,based on customerinitiatives | Same |
| Reports | Operational, Clinical Careand Billing reports provided | Operational, Clinical Careand Billing reports provided | Same |
| Specification /Feature | eCareManager 4.1(Subject Device) | eCareManager 4.0(Predicate device)K153156 | Comparison |
| Clinical Decision Support Features | |||
| AutomatedAcuity Score | Provides a relative scoringof patient condition | Provides a relative scoringof patient condition | Modified parameters, to includelab values and modifiedgraphical presentation |
| Pain, Agitationand Delirium | Graphical summary of PADrelated issues | Graphical summary of PADrelated issues | Modified graphical presentation |
| DischargeReadiness Score | Objective measurement ofrisk of death or readmission | Objective measurement ofrisk of death or readmission | Same |
| Early WarningScore | Graphical summary ofphysiological changes | Graphical summary ofphysiological changes | Modified graphical presentationand scoring range |
| Vital SignsMonitoring | Retrospective | Retrospective | Same |
| LaboratoryResults | Received via hospitalsystem interface or manualentry | Received via hospitalsystem interface or manualentry | Same |
| Smart Alerts | Visual cues based onautomated assessment ofpatient data. Patientspecific configuration | Visual cues based onautomated assessment ofpatient data. Patientspecific configuration | Same |
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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.
§ 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).