The MR Patient Care Portal 5000 is intended for use by healthcare professionals. The device is indicated for use to monitor vital signs of patients undergoing MRI procedures including ECG, pulse oximetry (SpO2), non-invasive blood pressure (NIBP), and optionally, invasive pressure (IP), carbon dioxide (CO2) and respiration rate, anesthetic agents, nitrous oxide (N2O), oxygen (O2), and/or temperature based on the configurations of the host patient monitor with which the MR Patient Care Portal 5000 is wirelessly communicating. The target patient population includes adult, pediatric, and neonatal patients that require monitoring during MRI procedures.

Device Description

The Philips MR Patient Care Portal 5000 is an information portal that serves as a remote monitor and remote control with electronic medical records capabilities outside the MR Scanner room (i.e. Control Room, Induction Room, or Recovery Room). The Philips MR Patient Care Portal 5000 displays the vital signs of a single patient monitoring system with which the device is communicating with from the MR control room.

The Philips MR Patient Care Portal 5000 is intended to replace the substantially equivalent device, the Expression Information Portal (Model IP5), cleared under 510(k) K121424 as a remote display and remote control for host patient monitoring systems, the Expression Model MR400 MRI Patient Monitoring System and Expression MR200 MRI Patient Monitoring System.

The Philips MR Patient Care Portal 5000 is not designed to be used in the MR Scanner room, does not perform any data collection or processing of data as stand-alone patient monitoring system, and it is not a central station.

The Philips MR Patient Care Portal 5000 system consists of the following primary components:

Desktop unit;
Radio Kit, USB;
. Radio Cradle:
Display, 18.5 inch;

AI/ML Overview

The provided document is a 510(k) summary for the Philips MR Patient Care Portal 5000. This type of submission focuses on demonstrating substantial equivalence to a previously cleared device, not necessarily on proving novel clinical effectiveness or "improvement" with quantifiable effect sizes from clinical studies. The device in question is a remote display and control unit for vital signs monitors during MRI procedures, not a diagnostic AI device.

Therefore, the acceptance criteria and supporting studies are focused on safety, performance, and functional equivalence, rather than clinical diagnostic accuracy or reader improvement. The document does not contain the kind of detailed information about acceptance criteria for AI performance (e.g., sensitivity, specificity, AUC), nor clinical study results (like MRMC studies for diagnostic accuracy, sample sizes for test sets in that context, ground truth establishment by expert consensus for diagnostic tasks) that your request implies.

Based on the provided document, here's an attempt to extract relevant information according to your template, acknowledging the differences in device type and regulatory pathway:

Device Name: Philips MR Patient Care Portal 5000
Device Type: Remote display and control for vital signs monitors (Cardiac Monitor)
Regulatory Pathway: 510(k) (Substantial Equivalence)

1. Table of Acceptance Criteria and Reported Device Performance

Since this is not an AI diagnostic device, the acceptance criteria are related to safety, functional performance, and equivalence to a predicate, not diagnostic metrics like sensitivity/specificity. The document states that the device "met performance, usability, and safety test acceptance criteria." Specific quantitative thresholds for these tests are not provided in this summary.

Acceptance Criterion (Implicitly Derived from Regulatory Standards & Equivalence)	Reported Device Performance (Summary from Document)
Functional Equivalence to Predicate	- Same intended use and indications for use.
(Display of Vital Signs & Alarms)	- Same operating principle and conditions of use.
	- Displays ECG, SpO2, NIBP, and optionally IP, CO2, respiration rate, anesthetic agents, N2O, O2, and temperature, matching what the host monitor transmits.
	- Time for vital sign information to be available between processing and viewing at the display is Less than one second.
	- Provides latched and unlatched visual and audible alarms compliant to IEC 60601-1-8.
	- Time for alarm conditions to be available between processing and viewing at the display is Two seconds.
Electrical Safety	- Complies with ANSI AAMI ES60601-1 standard for safety.
Electromagnetic Compatibility (EMC)	- Complies with IEC 60601-1-2 standard for EMC.
Wireless Communication Performance	- Wireless and co-existence testing per US FCC CFR 47 Part 15 and FDA guidance was conducted to ensure safe and effective use.
Software Verification & Validation	- Software verification and validation testing conducted, documented per FDA guidance.
	- Software Level of Concern: Major (due to vital signs/alarms for potentially life-threatening situations).
Human Factors & Usability	- Tests conducted under 'simulated-use' per recognized consensus standards, industry standards, and FDA guidance.
	- Evaluated user interaction, interpretation, and manipulation.
	- The graphical user interface (GUI) was updated to align with other Philips monitors for improved familiarity and ease of use, and this difference was determined not to affect substantial equivalence.
Cleaning & Disinfecting Durability	- Designed to be cleaned and disinfected. Accelerated cleaning tests utilized worst-case scenarios; results support use of listed cleaners/disinfectants during device lifetime.
Lifetime/Service Life	- Defined lifetime of "7" years. Supported by worst-case usability scenario and cleaning durability testing under extreme conditions.
Environmental Performance (Transport/Storage/Operation)	- Tests conducted against extreme conditions (worst-case usage scenario) for subject device, components, and accessories. Results applicable to transport and storage. Intended environmental usage conditions will not exceed tested ranges. Slight differences in operating humidity, transport/storage, and atmospheric pressure temperatures compared to predicate were deemed not to affect substantial equivalence.
Material Composition	- Differences in material composition of main components compared to predicate (modular vs. integrated design) were deemed not to affect substantial equivalence, as no direct/indirect patient contact requires biocompatibility testing.

2. Sample Size Used for the Test Set and Data Provenance

Test Set Sample Size: Not applicable in the context of diagnostic performance testing. The "test set" here refers to units of the device itself undergoing various non-clinical performance and safety tests. The document doesn't specify the number of physical devices or components tested for each non-clinical assessment (e.g., how many units were subjected to accelerated cleaning, or how many were involved in human factors testing).
Data Provenance: The data described is from non-clinical performance testing (bench, safety, EMC, software V&V, human factors, cleaning/disinfecting, lifetime) of the device itself. There is no mention of patient data or clinical images. The testing would have been conducted by Invivo Corporation (a division of Philips Medical Systems) or their designated testing facilities.
Retrospective/Prospective: All testing described is prospective as it's part of the development and verification/validation of the new device.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. This device is a monitor/display, not a diagnostic AI. There is no concept of "ground truth" (e.g., disease presence/absence in imaging) established by experts for a test set in the way you would for an AI diagnostic algorithm. The "truth" for functional tests is simply whether the device operates according to its specifications and regulatory standards.

4. Adjudication Method for the Test Set

Not applicable. This relates to diagnostic image interpretations, which is not what this device does or what this submission is about.

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. An MRMC study is not relevant for this type of device (a patient vital signs display) and was not conducted or required for this 510(k) submission. This type of study would be for evaluating diagnostic AI's impact on human reader performance.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

No, not applicable in the requested context. The device itself is a component in a human-in-the-loop system (healthcare professionals monitoring patients). There is no "standalone algorithm" in the diagnostic sense. The device's "performance" is its ability to accurately display information and meet safety standards.

7. The Type of Ground Truth Used

Not applicable in the requested context. The "ground truth" for this device's evaluation is primarily its adherence to engineering specifications, recognized safety and performance standards (e.g., IEC 60601 series, FCC), and functional equivalence to its predicate device. This is defined by technical standards and engineering verification, not by expert consensus on clinical cases, pathology, or outcomes data from patients the device is used on.

8. The Sample Size for the Training Set

Not applicable in the AI sense. This document does not describe an AI/machine learning model that requires a "training set" of data. The device is hardware and software designed to perform a specific data display and control function.

9. How the Ground Truth for the Training Set was Established

Not applicable. As there is no AI training set, there is no ground truth establishment for such a set described.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

September 30, 2021

Invivo Corporation Maria Keelan Regulatory Operations Specialist 12151 Research Parkway Orlando, Florida 32826

Re: K212227

Trade/Device Name: Philips MR Patient Care Portal 5000 Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (Including Cardiotachometer And Rate Alarm) Regulatory Class: Class II Product Code: MWI, DSF, DPS, DSJ, DXN, DSK, FLL, CBQ, CBR, CBS, CCL, NHO, NHQ, DOA. FLS Dated: July 15, 2021 Received: July 16, 2021

Dear Maria Keelan:

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

{1}------------------------------------------------

requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 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 (OS) 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 mediation-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,

LCDR Stephen Browning 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)

K212227

Device Name Philips MR Patient Care Portal 5000

Indications for Use (Describe)

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}------------------------------------------------

510(K) SUMMARY

The 510(k) summary was prepared in accordance with the requirements with CFR 807.92.

I. SUBMITTER

II.

III.

DATE PREPARED	July 15, 2021
APPLICANT	Invivo Corporation(Invivo, a division of Philips Medical Systems)12151 Research Parkway, Orlando, FL 32826Tel.: 407-473-5510Fax: 407-382-2707
OFFICIALCORRESPONDENT	Maria KeelanRegulatory Operations Specialist12151 Research Parkway, Orlando, FL 32826Tel.: 407-473-5510Fax: 407-382-2707maria.keelan@philips.com
DEVICE INFORMATION
TRADE NAME	Philips MR Patient Care Portal 5000
COMMON NAME	Remote Display
CLASSIFICATION	Class II21 CFR 870.2300 Cardiac monitor (includingcardiotachometer and rate alarm)
PRODUCT CODE	MWI: Monitor, physiological, patient (withoutarrhythmia detection or alarms)
SUB PRODUCT CODE	DSF; DRT; DPS; DSJ; DXN; DSK; FLL; CBQ; CBR;CBS; CCL; NHO; NHP; NHQ; DQA; FLS.
PREDICATE INFORMATION
PREDICATE DEVICE	Primary Predicate

Expression Information Portal (Model IP5) (K121424)

{4}------------------------------------------------

IV. DEVICE DESCRIPTION

The Philips MR Patient Care Portal 5000 system consists of the following primary components:

Desktop unit;
Radio Kit, USB;
. Radio Cradle:
Display, 18.5 inch;

V. INTENDED USE

The MR Patient Care Portal 5000 is intended to be used outside the MR Scanner room (i.e. Control Room, Induction Room, or Recovery Room) by healthcare professionals to monitor vital signs of a patient undergoing a MRI procedure. The device remotely monitors a patient's vital signs by wirelessly communicating with a patient monitoring system.

Indications for Use:

{5}------------------------------------------------

VI. Comparison of Technological Characteristics with the Predicate Device

The Philips MR Patient Care Portal 5000 has the following similarities to the legally marketed predicate device, the Expression Information Portal (Model IP5).

. Same intended use and indications for use
. Same operating principle
Same conditions of use .

Table 5-1 provides a high-level comparison of the technological characteristics between the Philips MR Patient Care Portal 5000 and the Expression Information Portal (Model IP5).

Similarities
General Safety	Both the Philips MR Patient Care Portal 5000 and the ExpressionInformation Portal (Model IP5) comply with FDA recognizedconsensus standards and industry recognized standards.
Lifetime (akaService Life)	Both the subject device and predicate device expected service life is"7" years from the date of manufacture.
Host patientcompatibility	Both the subject device and predicate device support the same hostpatient monitoring systems, the Expression Model MR400 MRI PatientMonitoring System or the Expression MR200 MRI Patient MonitoringSystem.
Dimensions	The radio module dimensions are the same .
Powerrequirements	AC mains to AC/DC power adapter rated 100-240 VAC at 50-60 Hz
OperatingTemperaturerange:	15 to 35 SimilaritiesBoth the Philips MR Patient Care Portal 5000 and the ExpressionInformation Portal (Model IP5) comply with FDA recognizedconsensus standards and industry recognized standards.Lifetime (akaService Life)Both the subject device and predicate device expected service life is"7" years from the date of manufacture.Host patientcompatibilityBoth the subject device and predicate device support the same hostpatient monitoring systems, the Expression Model MR400 MRI PatientMonitoring System or the Expression MR200 MRI Patient MonitoringSystem.DimensionsThe radio module dimensions are the same .PowerrequirementsAC mains to AC/DC power adapter rated 100-240 VAC at 50-60 HzOperatingTemperaturerange:15 to 35℃ (59°F to 95°F)Materialcomposition ofradio and optionalaccessories andcomponentsThe material composition of the radio and optional accessories andcomponents for both devices are the same.MountingConfigurationsDesktop mounted or Wall mounted

Table 5-1. Comparison of Technological Features with the Primary Predicate Device

{6}------------------------------------------------

WirelessCommunicationwith the HostPatient monitor	RF Output Power: +20 dBm Frequency Range: 2.4GHz band The radio module has FCC approval under identification numberHSW-2410NF. Radio frequency (RF) transceiver is the same The display provides visual indicators of communication statusbetween the following components: Subject and predicate device and host patient monitor, Host patient monitor and its wireless ECG module, and Host patient monitor and its wireless SpO2 module. Communication status is established within a few seconds uponpower on if the subject and predicate device, host patient monitor,wireless ECG module, and wireless SpO2 module are each set tothe same network (A, B, C, D, or E (for MR200) or 1-10 (forMR400)).
Vital signsmonitored	All vital signs are measured by and processed in the host patientmonitoring system. The host patient monitoring systems, either theExpression Model MR400 MRI Patient Monitoring System orExpression MR200 MRI Patient Monitoring System, transmit thefollowing data to the subject or predicate device for viewing:ECG (MR200 and MR400)SPO2 (MR200 and MR400)NIBP (MR200 and MR400)IP (MR400 only)CO2 (MR200 and MR400)O2 (MR400 only)Anesthetic agents (MR400 only)N2O (MR400 only)Respiration (MR200 and MR400)The time for making patient vital sign information available betweenprocessing viewing at the modified display is less than one second.
Patient appliedparts	No patient applied parts
Environment ofUse	Both the subject device and the predicate device optional accessoriesand components are intended for use outside the MR Scanner room(i.e., within the MR control room, MR induction room, or MR recoveryroom).The Bar Code Scanner handheld, the same optional component usedwith both the subject device and predicate device may be taken into theMB scanner room in a location at or outside the 2000 (2.000 or less)
Gauss (0.2T) field line, as measured from the center line of the MR bore, but in no case closer than 3 feet (1 meter) from the MR system.
Display operating platform	PC based
Alarms	Both the subject device and the predicate device provide:latched and unlatched alarms. visual (flashing text, numerics, and waveforms) and audible alarms. alarm system compliant to IEC 60601-1-8. time for making alarm conditions available between processing and viewing at the display is two seconds
HospitalInformationSystem (HIS)Interface	Both the subject device and predicate device can interface with theHospital Information System (HIS) as follows:HIS interface is available when operating outside the MR System room. Connect to HIS via standard Ethernet cable connected to the Ethernet port on the rear of the display, or optionally via the RS232 port on the rear of the device. Data output is in HL7 format and output at a rate specified by the user. Data output is compliant to HL7 messaging standard version 2.6. Data output via the RS232 port is serial No data input from the HIS to the subject and predicate device with the exception of time sync. No internet connection
System optionalaccessories andcomponents	Optional medical device accessories:Thermal Printer, USB Optional non-medical accessories and components:Bar code scanner with base Wireless keyboard and mouse Wall Arm, 16" Wall Channel, Polymount, 19" Arm Extension, Strip Chart Printer
Differences
Assembly	The difference in assembly between the subject device and the predicate device is that the subject device is designed in a modular fashion where the display/touch screen is separate from the processing unit while the predicate device is designed in an integrated fashion where the display/touch screen and processing unit are one. This difference in modular construction does not affect the substantial equivalence of the subject device relative to the predicate since both
	devices have the SAME principle and mode of operation and
	conditions of use.
Dimensions	The difference in configuration (modular versus integrated) design anddimensions between the subject device and the predicate device systemconfiguration does not affect the substantial equivalence of the device.Both devices have the SAME principle and mode of operation andcondition of use.
EnvironmentalSpecifications	While the subject device and predicate device have slight differences inoperating humidity ranges, transport and storage, and atmosphericpressure temperatures the slight differences in environmentalspecifications do not affect the substantial equivalence of the subjectdevice relative to the predicate. Both devices have the SAME principleand mode of operation and condition of use.
Materialcompositionprimarycomponents	Although the material composition of the main components of thesubject device—Desktop Unit, Radio Cradle, and Display—andpredicate device (integrated touch screen display/ processing unit)differ, neither device requires biocompatibility testing of the materialssince neither the subject nor predicate device come in direct or indirectcontact with the patient's body during use and the devices are notintended by the user to be protective devices. The differences inmaterial composition do not affect the substantial equivalence of thesubject device relative to the predicate.
Operator Interface(Touch screendisplay)	There are some differences in technological characteristics of theoperator interface between the subject device and predicate device.The technological characteristics remain the SAME with the exceptionof the improved screen resolution, configuration with respect to theprocessing unit (modular versus integrated), and the speaker. Thesubject device Display has been evaluated by DIVA Laboratories andcertified to IEC 60601-1 Edition 3.1 as a medical device component,and verified and certified again to IEC 60601-1 Edition 3.1 as part ofthe completed Portal 5000 system. Although the subject deviceincludes one speaker, the subject device incorporates a built-indiagnostic speaker test, power up tone, alarm plays during volumeadjustment, and visual alarm for redundancy. Performance testing andrisk assessment have verified the difference does not affect thedirectional or average sound pressure level and does not affect thesubstantial equivalence of the subject device relative to the predicate.
	The graphical user interface of the subject device was updated to betteralign with other Philips patient monitors to provide a common look,and feel, to improve clinician familiarity and ease of use. Caregiverscome from other areas of the hospital to monitor their patientundergoing an MRI, so having a common graphical user interfaceimproves usability. The graphical user interface differences do notaffect the substantial equivalence of the subject device relative to thepredicate.
Radio Module	The subject device uses a radio module with the SAME radiofrequency (RF) transceiver as the predicate device. The difference inthe radio module is as follows:an improved digital interface board that provides enhancedelectrical fast transient (EFT) and a coated housing that provides enhanced electromagneticcompatibility (EMC) performance per the requirements of IEC60601-1-2 Edition 4.0. The 3 dBi antenna has been replaced with a 2 dBi antenna. In addition, there are two optional accessories that are intended tomitigate any signal integrity issues: Control room flex antenna and Advanced Communications Option (ACO) passive antenna. The additional antennas are also permitted under the FCCcertification HSW-2410NF. The differences do to not affect thesubstantial equivalence of the subject device relative to thepredicate.The radio frequency (RF) transceiver is located within a radiomodule and the 2 dBi antenna is mounted to the top of the radiomodule. Although the radio module of the subject device is dockedon a radio cradle, and the radio module of the predicate device isdocked within the display's radio bay on the top rear of the display,the subject device configuration has been tested for operatingperformance and IEC 60601-1-2 Edition 4.0. The difference doesnot affect the substantial equivalence of the subject device relativeto the predicate. The functionality, technology, and operatingperformance of the wireless communication with the host patientmonitor are the SAME as the predicate device.
Display operatingsystem	Although the display operating system (software) is different betweenthe predicate and subject device, both the subject device and predicatedevice implement a common system watchdog to identify processingfaults. Both devices have the SAME principle and mode of operation.
	The operating system differences do not affect the substantialequivalence of the subject device relative to the predicate.
System optionalcomponent	The “Mount, remote desktop wall” is an optional component for usewith the subject device only. The Desktop Unit Wall Mount isevaluated for safety as part of the Philips MR Patient Care Portal 5000system. The introduction of this optional component does not affectthe performance and substantial equivalence of the device relative tothe predicate.The Control room flex antenna and the advance communication option(ACO) antenna are optional non-medical components of the Radio Kit,USB and are intended to mitigate any signal integrity issue. The use ofthese antennas does not affect the substantial equivalence andperformance of the subject device relative to the predicate.

{7}------------------------------------------------

{8}------------------------------------------------

{9}------------------------------------------------

{10}------------------------------------------------

{11}------------------------------------------------

VII. NON-CLINICAL PERFORMANCE DATA

The following non-clinical performance data is not applicable:

Sterilization .
Biocompatibility ●
Performance testing-Animal .

The following non-clinical performance data was provided in support of the substantial equivalence determination:

Cleaning & Disinfecting

The Philips MR Patient Care Portal 5000 is designed to be cleaned and disinfected as encountered in the intended use environment. A list of disinfectants and cleaners were compiled using input from customer surveys and complaint data based on legacy devices. The accelerated cleaning test utilized worst-case scenario of daily and monthly cleaning cycles. Results of the test support the use of the listed cleaners and disinfectants during the lifetime of the device.

Shelf-Life

The Philips MR Patient Care Portal 5000 does not have a defined shelf life. Tests were conducted against these extreme conditions as worst-case usage scenario for the subject device, its components, and/or accessories. Although these tests were performed as part of the lifetime of the device, the results are applicable to transport and storage conditions that may be encountered when the device is not in use. Tests results support the storage conditions necessary to maintain the performance, safety and intended use of the subject device.

Lifetime

The lifetime (also referred to as service life) of the device has been defined as "7" years. This is based on the combination of worst-case usability scenario and cleaning durability testing using accelerated testing under extreme conditions. Although tests were conducted under extreme environmental conditions, these test results are still applicable. The intended environmental usage conditions will not exceed test ranges that were used to challenge the subject device. The extreme testing conditions encompassed actual use environmental conditions that would be encountered in the intended use environment. Test results support the lifetime claim of "7" years for the Philips MR Patient Care Portal 5000 when used within operating conditions and as defined by the manufacturer.

Performance Testing - Bench

To establish substantial equivalence of the Philips MR Patient Care Portal 5000, functional and system level testing was conducted to validate the safety and performance of the device. The use of mechanical and engineering testing supports the safety and performance of the subject device under the intended use environment. Tests were performed according to applicable consensus standards and internal procedures/protocols. Conducted tests focused on the integrity and durability of the device to meet specific design requirements to ensure its safety and efficacy.

{12}------------------------------------------------

Performance Testing - Clinical (Human Factors and Usability)

The Philips MR Patient Care Portal 5000 is designed to be used in a controlled environment. Tests were performed to ensure implemented risk management measures were effective. Conducted tests focused on the interactions between the user and the Philips MR Patient Care Portal 5000 and its proposed labeling (i.e. IFU, Quick Reference Guide) under 'simulated-use' and were completed according to recognized consensus standards, industry standards, and FDA guidance documents regarding Human Factors/Usability. User specific data collected included the user receiving information from the device, user interpretation of information to make decisions, and user manipulation of the device/component or controls. Conducted usability tests support the safety and efficacy of the Philips MR Patient Care Portal 5000. The subject device met performance, usability, and safety test acceptance criteria.

Software Verification and Validation

Software verification and validation testing was conducted and documentation was provided per FDA's Guidance for Industry and FDA Staff "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices. The Philips MR Patient Care Portal 5000 Software Level of Concern was determined to be Major since the Philips MR Patient Care Portal 5000 provides vital signs monitoring and alarms for potentially life-threatening situations in which medical intervention is necessary.

Electromagnetic Compatibility and Electrical Safety

Electrical safety and electromagnetic compatibility (EMC) testing was conducted on the Philips MR Patient Care Portal 5000. The device complies with the applicable requirements within the ANSI AAMI ES60601-1 standard for safety and the IEC 60601-1-2 standard for EMC. Additional wireless and co-existence testing per US FCC CFR 47 Part 15 and FDA guidance was conducted to ensure safe and effective use of the Philips MR Patient Care Portal 5000 radio frequency wireless technology features.

VIII. SUMMARY/CONCLUSIONS

The results of the substantial equivalence assessment, taken together with non-clinical bench testing, electrical safety and electromagnetic compatibility, software verification and validation, human factors and usability demonstrate that the Philips MR Patient Care Portal 5000 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 Expression Information Portal (Model IP5) predicate device.

Regulation Number and Section

§ 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).