(421 days)
Not Found
No
The summary mentions "clinical decision support algorithms" but does not explicitly state or imply the use of AI or ML. The description of testing focuses on traditional software verification and validation, not AI/ML specific performance metrics or training/test data.
No
The device is a software tool for clinical data management and decision support, not for direct treatment or therapy.
No
The device is described as a software tool that collects, stores, and displays clinical data to aid in understanding a patient's condition and changes over time, and provides clinical decision support algorithms for early detection of changes. It explicitly states it "does not provide any alarms" and is "not intended to replace bedside vital signs alarms or proactive patient care from clinicians" and "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." This indicates it is for managing existing clinical data and supporting clinical judgment rather than directly diagnosing a condition.
Yes
The device description explicitly states that the eCareManager System is a "collection of software applications" and the summary focuses entirely on software verification and validation activities, with no mention of hardware components or their testing.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide supplemental remote support to bedside care teams in managing in-hospital patients. It collects and displays clinical data from existing sources (EMR, patient monitoring systems) and generates clinical decisions to aid in understanding the patient's condition.
- Nature of Data: The data used is clinical data from patient monitoring systems and the electronic medical record. This is not data derived from in vitro examination of specimens from the human body.
- Function: The software is a tool for managing and displaying existing clinical data and providing decision support based on that data. It does not perform any tests or analyses on biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens (blood, urine, tissue, etc.), performing tests on these specimens, or providing results related to the diagnosis of diseases based on such tests.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device does not fit that description.
N/A
Intended Use / Indications for Use
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.
Product codes
MSX
Device Description
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.
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 in the management and care of in-hospital patients.
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
Non-Clinical Testing:
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.
Key Results: 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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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).
0
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
1
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
2
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) |
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/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: 1125873 | |
| 217 East Redwood St. Suite 1900 | |
| Baltimore, MD 21202 |
Business Trade Names:
(1) Philips (2) Philips Visicu Inc. |
| Key Contact | Janine Treter
Regulatory Affairs Manager
janine.treter@philips.com |
| 510(k) Submission Type | Traditional 510(k) |
| II. DEVICE | |
| Trade Name | eCareManager 4.5 |
| Common Name | Telehealth Software |
| Classification Name | Class II
Part 870 Cardiovascular
Subpart C Cardiovascular Monitoring Devices
Sec. 870.2300 Cardiac monitor (including cardiotachometer and
rate alarm).
Product Code: MSX Description: System, Network and
Communication, 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.
4
Image /page/4/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 plain white.
| III. PREDICATE DEVICE | |||
|---|---|---|---|
| Predicate Device | 510(k) No. | Company Name | |
| Device 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.
5
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 Device | |
| eCareManager 4.5 | 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. | |
| 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 | |
| Predicate Device | |
| K171322 | |
| eCareManager 4.1 | The Intended Use is the same of the predicate device. The indication for use |
| statement is equivalent to the predicate device. the word "solely" was added to | |
| give 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.
6
Image /page/6/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 the only element in the image and it is centered.
| 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 assignment |
| Audio/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 including |
| diagnosis, 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 management |
| of 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 to |
| clinical decision support functionalities. | |
| External Links | Allows the user to access external websites from a Patient Chart (PACS |
| imaging 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 having |
| to create a note | |
| Patient Registry | Alternative data display and edition capabilities outside of the main |
| application 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, nursing |
| assessments and care, respiratory therapy | |
| Labs and Radiology | Results received via hospital system interface or manual entry |
| Microbiology | Displays patient microbiology information received via hospital system |
| interface 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 worsening |
| data 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 early |
| deterioration | |
| Discharge Readiness Score | Objective measurement of risk of death or readmission within 48 hours |
| from discharge | |
| Order & Medications | Enables physicians to create orders that screen medications for drug |
| interactions and patient allergies | |
| Telestroke | Consultative care module in evaluating patients with suspected stroke and |
| care 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 to | |
| give emphasis to the exclusive use. | |
| Technological Characteristics | |
| Bedside to Remote | |
| Communications (bilateral | |
| exchange) | Audio/Video - Addition of Univago HE as another optional third-party |
| video solution. It is equivalent to existing third-party solutions. | |
| Compatibility testing was performed and no unanticipated issues in | |
| performance resulted from the verification. | |
| User Access and Patient | |
| Data Security | User Authentication services, roles-based data access, logging for audit |
| trail are equivalent to the predicate device containing additional | |
| cybersecurity features including improved auditing capabilities, FIPS | |
| compliant encryption, and compliance with the Department of Defense | |
| (DoD) Risk Management Framework (RMF). | |
| Deployment | Hosted beyond on premise deployment. The code and server deployment |
| structure in the hosted environment is the same to the on premise | |
| environment. Successful essential performance testing was performed in | |
| the hosted and on premise environment. No unanticipated issues in | |
| performance resulted from validation. | |
| Population Health Applications | |
| Patient Census | Patient Census screen with status indicators for management as a |
| population with cosmetic enhancement for identification of when a video | |
| session is in progress and addition of a column. No new risks of safety and | |
| efficacy were identified. | |
| Ventilation Patient Census | New application which is a consolidated view of patients receiving invasive |
| mechanical ventilation for management as a population. Same data source | |
| from respiratory flowsheet. Software verification and validation of the | |
| change did not result in any unintended changes to the software or | |
| unexpected 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 vital |
| signs at 1-minute intervals, and historical vital sign data (over the last 24 | |
| hours). An additional Inbound Field was included following the principles | |
| of 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 allow | |
| remote clinicians to document specific clinical interventions. | |
| Clinical Decision Support | |
| Spontaneous | |
| Trials or | |
| Spontaneous Awakening | |
| Breathing Trial (SAT/SBT) | Visual cues for patients which fits the established criteria for early |
| identification of patients ready to SAT/SBT. New application using same | |
| data source from respiratory flowsheet. SAT/SBT screen was utilized as a | |
| performance and preferential benchmark with users. Display of | |
| information following the same principles of other existing CDS | |
| applications. | |
| APACHE Admission | |
| Diagnosis | Provides retrospective scoring on severity-of-disease classification to |
| compare populations of patients. A consolidated view of patient APACHE | |
| day in one screen highlighting missing data was added. Bench verification | |
| supporting the change. | |
| Smart Alerts | Visual cues based on automated assessment of patient data displayed |
| according to a set of pre-defined events. Patient specific configuration. | |
| Sentry Alerts have been enhanced to allow default settings at the unit level | |
| and introduce a more intuitive user interface to allow for configuration. | |
| Previously these default settings were set for the entire population or | |
| could be customized at an individual level. Users can still keep the default | |
| settings 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 per |
| inflammation signs. Philips Sepsis Prompt has been updated to align with | |
| the new sepsis definition established Third International Consensus | |
| Conference. |
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.
7
Image /page/7/Picture/0 description: The image shows the word "PHILIPS" in a bold, sans-serif font. The word is written in a bright blue color. The background is white, which makes the blue text stand out.
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.
8
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.
9
Image /page/9/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.
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.
10
Image /page/10/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 plain white.
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.