(421 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 connected through networks. Using this data, clinical decisions 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 solely indicated for use in hospital environment or remote locations with clinical professionals. It is not indicated for home use.
The eCareManager System is a collection of software applications designed to facilitate the delivery of high-quality critical care services with the assistance of a Telehealth Center Program (THC). The THC provides an organizational and technology platform to transform critical care by redesigning the way critical care is structured and managed. The THC Care Team is a multi-professional team that includes both bedside and THC remote clinicians working together to ensure the best care is provided. The eCareManager System provides a robust toolset that helps ICU and Acute Care clinicians plan, document, and standardize care around best practices.
Population management and communications facilitate a collaborative approach to delivery of in-patient care. The system's clinical decision support applications 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 Visicu, Inc. eCareManager 4.5 is a software tool intended for use by trained medical staff to provide supplemental remote support to bedside care teams in the management and care of in-hospital patients. This device generates clinical decision support notifications to aid in understanding the patient's current condition and changes over time, using clinical data from electronic medical records, patient monitoring systems, and ancillary systems. It is not intended to provide alarms or replace bedside vital signs alarms or proactive patient care from clinicians. The information and notifications are meant to support the judgment of a medical professional and are not the sole source for decision-making. The software is indicated for use in hospital environments or remote locations with clinical professionals and is not for home use.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance:
The provided document does not explicitly state quantitative acceptance criteria for device performance in a table format. Instead, it relies on a qualitative assessment of successful completion of verification and validation activities. The "Reported Device Performance" is implied by the statement "All predetermined acceptance criteria were met, demonstrating that the device performs appropriately per defined specifications, and correctly incorporates all required safety mitigations."
However, the document mentions two key device functions under review: Automated Acuity and Discharge Readiness Score, suggesting these would have had specific performance requirements, though not detailed here. The "Comparisons of Technological Characteristics" section also outlines new features and enhancements, and their successful implementation implies they met their intended design specifications.
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify a separate "test set" sample size in terms of patient data. The non-clinical testing described focuses on software verification and validation activities. It states that "eCareManager was tested in accordance with Philips verification processes" and "Software verification and validation tests were successfully executed on the eCareManager." This implies that the validation was conducted on the software itself rather than a specific patient data set. There is no mention of the country of origin of data or whether it was retrospective or prospective, as the testing was primarily on the software functionality.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
The document does not mention the use of experts to establish a "ground truth" for a patient-data-based test set, as the testing described is primarily software verification and validation. While the device's purpose is to aid medical professionals, the validation focuses on the software's functional correctness rather than the accuracy of its clinical decision support against expert consensus in a clinical setting.
4. Adjudication Method for the Test Set:
No adjudication method is described, as the non-clinical testing detailed does not involve human readers evaluating output against a ground truth from patient data. The testing was focused on software functionality and compliance with specifications.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No MRMC comparative effectiveness study is mentioned. The document primarily reports on software verification and validation activities, not a study involving human readers with and without AI assistance to assess improved effectiveness.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
Yes, the testing described appears to be primarily stand-alone algorithm performance. The "Non-Clinical Testing" section details "Software verification and validation activities" including "Unit Testing, Integration Testing and System Level Testing (Functional and Regression Testing, Migration Testing, Localization Testing, Performance/Load Testing and Compatibility Testing included the following System Level Testing: User/Commercial Requirements Validation, Essential Performance Testing and Human Factors/Usability Testing." This indicates that the software's functionality was evaluated independently to ensure it performed according to its defined specifications and safety mitigations.
7. The Type of Ground Truth Used:
For the software verification and validation, the "ground truth" would be the defined specifications and requirements for the eCareManager 4.5 software. The success of the testing means that the software's outputs and behaviors matched these predetermined specifications.
8. The Sample Size for the Training Set:
The document does not provide information about a "training set" sample size. The eCareManager system uses clinical data from electronic medical records and patient monitoring systems to generate clinical decision support notifications. While this implies underlying algorithms that may have been trained, the regulatory submission documentation focuses on the verification and validation of the software system as a whole, rather than the development and training of specific AI/ML models within it. Thus, a training set is not mentioned.
9. How the Ground Truth for the Training Set Was Established:
Since no training set is described in the provided document, there is no information on how its ground truth was established.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
June 3, 2022
Visicu, Inc. Janine Treter Regulatory Affairs Specialist 217 East Redwood Street Baltimore, Maryland 21202
Re: K211046
Trade/Device Name: eCareManager 4.5 Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (Including Cardiotachometer And Rate Alarm) Regulatory Class: Class II Product Code: MSX Dated: May 4, 2022 Received: May 6, 2022
Dear Janine Treter:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for
Jennifer Shih Kozen Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K211046
Device Name eCareManager 4.5
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 connected through networks. Using this data, clinical decisions 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 solely 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/0 description: The image shows the word "PHILIPS" in large, bold, blue letters. The font is sans-serif and the letters are evenly spaced. The background is white, which makes the blue letters stand out.
510(k) Summary
| 510(k) Summary | |
|---|---|
| I. SUBMITTER | |
| Date Prepared | 03-June-2022 |
| Submitter/Owner | Visicu, Inc.Site Number: 1125873217 East Redwood St. Suite 1900Baltimore, MD 21202Business Trade Names:(1) Philips (2) Philips Visicu Inc. |
| Key Contact | Janine TreterRegulatory Affairs Managerjanine.treter@philips.com |
| 510(k) Submission Type | Traditional 510(k) |
| II. DEVICE | |
| Trade Name | eCareManager 4.5 |
| Common Name | Telehealth Software |
| Classification Name | Class IIPart 870 CardiovascularSubpart C Cardiovascular Monitoring DevicesSec. 870.2300 Cardiac monitor (including cardiotachometer andrate alarm).Product Code: MSX Description: System, Network andCommunication, Physiological Monitors |
Image /page/3/Picture/6 description: The image shows the Philips logo, which is a blue shield shape. Inside the shield, the word "PHILIPS" is written in white at the top. Below the text, there are two wavy lines and two four-pointed stars, also in white. The overall design is simple and clean, with a focus on the brand name and a stylized representation of light or energy.
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| III. PREDICATE DEVICE | |||
|---|---|---|---|
| Predicate Device | 510(k) No. | Company NameDevice Name | Product Code |
| K171322 | Visicu, Inc.eCareManager 4.1 | MSX |
The eCareManager 4.5 is substantially equivalent in intended use and technological characteristics to the eCareManager 4.1 (K171322).
IV. DEVICE DESCRIPTION
eCareManager 4.5 - description of the device per 21 CFR 807.92(a) (4)
The eCareManager System is a collection of software applications designed to facilitate the delivery of high-quality critical care services with the assistance of a Telehealth Center Program (THC). The THC provides an organizational and technology platform to transform critical care by redesigning the way critical care is structured and managed. The THC Care Team is a multi-professional team that includes both bedside and THC remote clinicians working together to ensure the best care is provided. The eCareManager System provides a robust toolset that helps ICU and Acute Care clinicians plan, document, and standardize care around best practices.
Population management and communications facilitate a collaborative approach to delivery of in-patient care. The system's clinical decision support applications 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.
V. INDICATIONS FOR USE
Intended Use as required per 21 CFR 807.92(a)(5)
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.
Image /page/4/Picture/13 description: The image shows the Philips logo, which is a blue shield shape. Inside the shield, the word "PHILIPS" is written in blue at the top. Below the word, there are two wavy lines and two four-pointed stars, all in blue. The logo is simple and recognizable, representing the brand's identity.
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Image /page/5/Picture/0 description: The image shows the word "PHILIPS" in large, bold, blue letters. The font is sans-serif and the letters are evenly spaced. The background is white, which makes the blue letters stand out. The word is horizontally oriented and takes up most of the image.
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
The eCareManager software is solely indicated for use in hospital environment or remote locations with clinical professionals. It is not indicated for home use.
| Name | Indications for Use/Intended Use |
|---|---|
| Subject DeviceeCareManager 4.5 | Intended UseThe eCareManager System is a software tool intended for use by trained medicalstaff providing supplemental remote support to bedside care teams in themanagement and care of in-hospital patients. The software collects, stores anddisplays clinical data obtained from the electronic medical record, patientmonitoring systems and ancillary systems connected through networks. Usingthis data, clinical decision support notifications are generated that aid inunderstanding the patient's current condition and changes over time. TheeCareManager System does not provide any alarms. It is not intended to replacebedside vital signs alarms or proactive patient care from clinicians. |
| All information and notifications provided by the eCareManager System areintended to support the judgement of a medical professional and are notintended to be the sole source of information for decision making. | |
| Indications for Use | |
| The eCareManager software is solely indicated for use in hospital environmentor remote locations with clinical professionals. It is not indicated for home use | |
| Predicate DeviceK171322eCareManager 4.1 | The Intended Use is the same of the predicate device. The indication for usestatement is equivalent to the predicate device. the word "solely" was added togive emphasis to the exclusive use which is in-hospital patients. |
Comparison of Intended Uses for Subject Device and Predicate
Image /page/5/Picture/8 description: The image shows the Philips logo, which is a blue shield shape. Inside the shield, the word "PHILIPS" is written in white at the top. Below the word, there are two wavy lines and two four-pointed stars, also in white. The logo is simple and recognizable, representing the brand's identity.
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| VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE | |
|---|---|
| Similarities | |
| Item of Comparison | Description/Rationale |
| Technological Characteristics | |
| System components | Software as a medical device (SaMD) |
| Interfaces to hospital systems | HL-7 |
| Bedside to Remote Communications (bilateral exchange) | Patient sign-out tool for written communication/ task assignmentAudio/Video - Vidyo, Proconnections |
| Measurement Features | None |
| System Alarms | None |
| Waveform Transmission | None |
| Deployment | On premise |
| Population Health Applications | |
| Graphical Census | Graphical display of patient status |
| Patient Profile | Summary of key clinical data regarding patient information includingdiagnosis, treatments, best practices and trends |
| Watchlist | Graphical display of patient status based on clinical decision support tools;companion tool of the Graphical Census |
| Patient Administration | Provides Admit, Discharge and Transfer (ADT) functions for managementof patient flow. Received via hospital system interface or manual entry |
| Care Plan | Summary of clinical care plan and therapeutic objectives |
| Task List | Communication and tracking of clinical care tasks |
| Quick Entry | Alternative data entry form for documenting patient clinical status toclinical decision support functionalities. |
| External Links | Allows the user to access external websites from a Patient Chart (PACSimaging studies, microbiology results, etc) |
| Lines, Tubes, and Drains(LTD) | Allows clinicians to document and manage various types of lines, tubes,and drains used for treating patients |
| Active Diagnoses &Treatment (Dx/Rx) | Allows clinicians to enter active diagnoses and treatments without havingto create a note |
| Patient Registry | Alternative data display and edition capabilities outside of the mainapplication areas. |
| eLerts and Notifications | Displays eLert messages and Task reminders for clinical users. |
| Patient Notes | Supports entry of patient notes with configurable templates |
| Flowsheets | Electronic charting of vital signs and infusions, intake and output, nursingassessments and care, respiratory therapy |
| Labs and Radiology | Results received via hospital system interface or manual entry |
| Microbiology | Displays patient microbiology information received via hospital systeminterface or manual entry |
| Reports | Operational, Clinical Care and Billing reports provided |
| Clinical Decision Support Applications | |
| Automated Acuity Score | Provides a relative scoring of patient condition - improving or worseningdata for rapid identification and assessment |
| Pain, Agitation and Delirium | Graphical summary of PAD related issues |
| Early Warning Score | Graphical summary of physiological changes to identify signs of earlydeterioration |
| Discharge Readiness Score | Objective measurement of risk of death or readmission within 48 hoursfrom discharge |
| Order & Medications | Enables physicians to create orders that screen medications for druginteractions and patient allergies |
| Telestroke | Consultative care module in evaluating patients with suspected stroke andcare management through tasks, timing, and workflow activities. |
| Differences | |
| Indications for Use | |
| The Indication for use statement is equivalent to the predicate device. The word "solely" was added togive emphasis to the exclusive use. | |
| Technological Characteristics | |
| Bedside to RemoteCommunications (bilateralexchange) | Audio/Video - Addition of Univago HE as another optional third-partyvideo solution. It is equivalent to existing third-party solutions.Compatibility testing was performed and no unanticipated issues inperformance resulted from the verification. |
| User Access and PatientData Security | User Authentication services, roles-based data access, logging for audittrail are equivalent to the predicate device containing additionalcybersecurity features including improved auditing capabilities, FIPScompliant encryption, and compliance with the Department of Defense(DoD) Risk Management Framework (RMF). |
| Deployment | Hosted beyond on premise deployment. The code and server deploymentstructure in the hosted environment is the same to the on premiseenvironment. Successful essential performance testing was performed inthe hosted and on premise environment. No unanticipated issues inperformance resulted from validation. |
| Population Health Applications | |
| Patient Census | Patient Census screen with status indicators for management as apopulation with cosmetic enhancement for identification of when a videosession is in progress and addition of a column. No new risks of safety andefficacy were identified. |
| Ventilation Patient Census | New application which is a consolidated view of patients receiving invasivemechanical ventilation for management as a population. Same data sourcefrom respiratory flowsheet. Software verification and validation of the |
| change did not result in any unintended changes to the software orunexpected results. No new risks of safety and efficacy were identified. | |
| Vital Signs | Displays near real-time vital sign data, including the last 15 minutes of vitalsigns at 1-minute intervals, and historical vital sign data (over the last 24hours). An additional Inbound Field was included following the principlesof other existing Inbound Fields. |
| Program Form | Configurable data entry forms for tracking clinical program performance,based on customer initiatives. New form option was included to allowremote clinicians to document specific clinical interventions. |
| Clinical Decision Support | |
| SpontaneousTrials orSpontaneous AwakeningBreathing Trial (SAT/SBT) | Visual cues for patients which fits the established criteria for earlyidentification of patients ready to SAT/SBT. New application using samedata source from respiratory flowsheet. SAT/SBT screen was utilized as aperformance and preferential benchmark with users. Display ofinformation following the same principles of other existing CDSapplications. |
| APACHE AdmissionDiagnosis | Provides retrospective scoring on severity-of-disease classification tocompare populations of patients. A consolidated view of patient APACHEday in one screen highlighting missing data was added. Bench verificationsupporting the change. |
| Smart Alerts | Visual cues based on automated assessment of patient data displayedaccording to a set of pre-defined events. Patient specific configuration.Sentry Alerts have been enhanced to allow default settings at the unit leveland introduce a more intuitive user interface to allow for configuration.Previously these default settings were set for the entire population orcould be customized at an individual level. Users can still keep the defaultsettings or change if individual patient condition warrants the change.Permissions for alert settings remain unchanged. |
| Sepsis Prompt | Visual cue based on automated assessment of abnormalities as perinflammation signs. Philips Sepsis Prompt has been updated to align withthe new sepsis definition established Third International ConsensusConference. |
Image /page/6/Picture/5 description: The image shows the Philips logo, which is a blue shield shape. Inside the shield, there are two wavy lines and two four-pointed stars. The word "PHILIPS" is written in white at the top of the shield.
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Image /page/7/Picture/5 description: The image shows the Philips logo, which is a blue shield shape. Inside the shield, there are two wavy lines and two four-pointed stars. The word "PHILIPS" is written in white at the top of the shield.
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Image /page/8/Picture/0 description: The image shows the word "PHILIPS" in large, bold, blue letters. The font is sans-serif and the letters are evenly spaced. The word is centered and takes up most of the frame. The background is white.
Image /page/8/Picture/5 description: The image shows the Philips logo, which is a blue shield shape. Inside the shield, there are two wavy lines and two four-pointed stars. The word "PHILIPS" is written in white at the top of the shield.
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Substantial Equivalence Summary
Image /page/9/Picture/6 description: The image shows the Philips logo, which is a blue shield shape. Inside the shield, the word "PHILIPS" is written in white at the top. Below the word, there are two wavy lines and two four-pointed stars, also in white. The logo is simple and recognizable, representing the brand's identity.
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Operational and technological characteristics form the basis for the determination of substantial equivalence of the eCareManager 4.5 with the legally marketed predicate devices (K171322). The eCareManager 4.5 is substantially equivalent to the predicate devices.
PERFORMANCE DATA VII.
Non-Clinical Testing
No performance standards for telehealth software systems or components have been issued under the authority of Section 514.
eCareManager was tested in accordance with Philips verification processes. Quality Assurance measures were applied to the system design and development, including Device Hazard Analysis; Product Specifications; Design Change Controls and Maintenance; Verification and Validations; and Cybersecurity Risk Assessment and Testing.
Verification and validation activities have been conducted to establish the performance, functionality, and usability characteristics of the enhanced eCareManager version with respect to the predicate, intended use and defined requirements. Verification testing included Unit Testing, Integration Testing and System Level Testing (Functional and Regression Testing, Migration Testing, Localization Testing, Performance/Load Testing and Compatibility Testing included the following System Level Testing: User/Commercial Requirements Validation, Essential Performance Testing and Human Factors/Usability Testing.
Software verification and validation tests were successfully executed on the eCareManager. The testing suite included functional and non-functional testing including security and load testing. All predetermined acceptance criteria were met, demonstrating that the device performs appropriately per defined specifications, and correctly incorporates all required safety mitigations. Results of the software verification and validation testing suite demonstrate substantial equivalence to the predicate system.
VIII. CONCLUSION
eCareManager 4.5 was established as a Multiple Function device product based on the Agency current thinking, where two applications were identified as the device functions under review which are Automated Acuity and Discharge Readiness Score.
The results of the substantial equivalence assessment, taken together with non-clinical bench testing, software verification and validation demonstrate that the eCareManager 4.5 does not raise different questions of safety and effectiveness when compared to the predicate, performs as intended, and has performance characteristics that are substantially equivalent to the eCareManager 4.1 predicate device.
Image /page/10/Picture/13 description: The image shows the Philips logo, which is a blue shield shape. Inside the shield, there are two wavy lines and two four-pointed stars. The word "PHILIPS" is written in blue at the top of the shield.
§ 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).