Philips MR Patient Care Portal

K212227 · Invivo Corporation · MWI · Sep 30, 2021 · Cardiovascular

Device Facts

• Record ID: K212227
• Device Name: Philips MR Patient Care Portal
• Applicant: Invivo Corporation
• Product Code: MWI · Cardiovascular
• Decision Date: Sep 30, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2300
• Device Class: Class 2
• Attributes: Software as a Medical Device, Pediatric

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.

Device Story

The Philips MR Patient Care Portal 5000 is a remote display and control system for MRI patient monitoring. It receives vital sign data wirelessly from a host patient monitor (Expression MR200 or MR400) located in the MR scanner room. The device is used by healthcare professionals in the MR control, induction, or recovery rooms. It displays real-time waveforms and numerics, and provides visual and audible alarms for patient status. The system consists of a desktop unit, display, and USB radio kit. It does not perform primary data collection or processing; it acts as a remote interface. By allowing clinicians to monitor patients from outside the scanner room, it facilitates continuous observation during MRI procedures, enabling timely clinical intervention if vital signs deviate from expected ranges.

Clinical Evidence

No clinical data. Bench testing included functional and system-level verification, software validation, electrical safety (ANSI AAMI ES60601-1), EMC (IEC 60601-1-2), and human factors/usability testing under simulated-use conditions to confirm safety and efficacy.

Technological Characteristics

Modular system with desktop unit, 18.5-inch display, and USB radio module. PC-based platform. Wireless communication via 2.4GHz RF (FCC ID: HSW-2410NF). Complies with IEC 60601-1 (safety) and IEC 60601-1-2 (EMC). Connectivity includes Ethernet/RS232 for HL7 data output. Service life: 7 years.

Indications for Use

Indicated for monitoring vital signs of adult, pediatric, and neonatal patients undergoing MRI procedures. Parameters include ECG, SpO2, NIBP, and optionally IP, CO2, respiration rate, anesthetic agents, N2O, O2, and temperature, based on host patient monitor configuration.

Regulatory Classification

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.

Predicate Devices

• Expression Information Portal (Model IP5) (K121424)

Submission Summary (Full Text)

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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

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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 ([e-mail]) or phone [phone] 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

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# Indications for Use

510(k) Number (if known)

K212227

Device Name Philips MR Patient Care Portal 5000

#### Indications for Use (Describe)

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.

Type of Use (Select one or both, as applicable)

| <span></span> <span></span> Prescription Use (Part 21 CFR 801 Subpart D) |
|--------------------------------------------------------------------------|
| <span></span> <span></span> Over-The-Counter Use (21 CFR 801 Subpart C) |

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# 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<br>(Invivo, a division of Philips Medical Systems)<br>12151 Research Parkway, Orlando, FL 32826<br>Tel.: [phone]<br>Fax: [phone] |
| OFFICIAL<br>CORRESPONDENT | Maria Keelan<br>Regulatory Operations Specialist<br>12151 Research Parkway, Orlando, FL 32826<br>Tel.: [phone]<br>Fax: [phone]<br>[e-mail] |
| DEVICE INFORMATION | |
| TRADE NAME | Philips MR Patient Care Portal 5000 |
| COMMON NAME | Remote Display |
| CLASSIFICATION | Class II<br>21 CFR 870.2300 Cardiac monitor (including<br>cardiotachometer and rate alarm) |
| PRODUCT CODE | MWI: Monitor, physiological, patient (without<br>arrhythmia detection or alarms) |
| SUB PRODUCT CODE | DSF; DRT; DPS; DSJ; DXN; DSK; FLL; CBQ; CBR;<br>CBS; CCL; NHO; NHP; NHQ; DQA; FLS. |
| PREDICATE INFORMATION | |
| PREDICATE DEVICE | Primary Predicate |

Expression Information Portal (Model IP5) (K121424)

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#### IV. 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;

#### 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:

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.

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## 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 Expression<br>Information Portal (Model IP5) comply with FDA recognized<br>consensus standards and industry recognized standards. | | | | | | | | | | | | | | | | |
| Lifetime (aka<br>Service Life) | Both the subject device and predicate device expected service life is<br>"7" years from the date of manufacture. | | | | | | | | | | | | | | | | |
| Host patient<br>compatibility | Both the subject device and predicate device support the same host<br>patient monitoring systems, the Expression Model MR400 MRI Patient<br>Monitoring System or the Expression MR200 MRI Patient Monitoring<br>System. | | | | | | | | | | | | | | | | |
| Dimensions | The radio module dimensions are the same . | | | | | | | | | | | | | | | | |
| Power<br>requirements | AC mains to AC/DC power adapter rated 100-240 VAC at 50-60 Hz | | | | | | | | | | | | | | | | |
| Operating<br>Temperature<br>range: | 15 to 35 SimilaritiesBoth the Philips MR Patient Care Portal 5000 and the Expression<br>Information Portal (Model IP5) comply with FDA recognized<br>consensus standards and industry recognized standards.Lifetime (aka<br>Service Life)Both the subject device and predicate device expected service life is<br>"7" years from the date of manufacture.Host patient<br>compatibilityBoth the subject device and predicate device support the same host<br>patient monitoring systems, the Expression Model MR400 MRI Patient<br>Monitoring System or the Expression MR200 MRI Patient Monitoring<br>System.DimensionsThe radio module dimensions are the same .Power<br>requirementsAC mains to AC/DC power adapter rated 100-240 VAC at 50-60 HzOperating<br>Temperature<br>range:15 to 35℃ (59°F to 95°F)Material<br>composition of<br>radio and optional<br>accessories and<br>componentsThe material composition of the radio and optional accessories and<br>components for both devices are the same.Mounting<br>ConfigurationsDesktop mounted or Wall mounted | | | | | | | | | | | | | | | | |

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

T

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| Wireless<br>Communication<br>with the Host<br>Patient monitor | RF Output Power: +20 dBm Frequency Range: 2.4GHz band The radio module has FCC approval under identification number<br>HSW-2410NF. Radio frequency (RF) transceiver is the same The display provides visual indicators of communication status<br>between 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 upon<br>power on if the subject and predicate device, host patient monitor,<br>wireless ECG module, and wireless SpO2 module are each set to<br>the same network (A, B, C, D, or E (for MR200) or 1-10 (for<br>MR400)). |
|-------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Vital signs<br>monitored | All vital signs are measured by and processed in the host patient<br>monitoring system. The host patient monitoring systems, either the<br>Expression Model MR400 MRI Patient Monitoring System or<br>Expression MR200 MRI Patient Monitoring System, transmit the<br>following data to the subject or predicate device for viewing:<br>ECG (MR200 and MR400)<br>SPO2 (MR200 and MR400)<br>NIBP (MR200 and MR400)<br>IP (MR400 only)<br>CO2 (MR200 and MR400)<br>O2 (MR400 only)<br>Anesthetic agents (MR400 only)<br>N2O (MR400 only)<br>Respiration (MR200 and MR400)<br>The time for making patient vital sign information available between<br>processing viewing at the modified display is less than one second. |
| Patient applied<br>parts | No patient applied parts |
| Environment of<br>Use | Both the subject device and the predicate device optional accessories<br>and components are intended for use outside the MR Scanner room<br>(i.e., within the MR control room, MR induction room, or MR recovery<br>room).<br>The Bar Code Scanner handheld, the same optional component used<br>with both the subject device and predicate device may be taken into the<br>MB 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:<br>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 |
| Hospital<br>Information<br>System (HIS)<br>Interface | Both the subject device and predicate device can interface with the<br>Hospital Information System (HIS) as follows:<br>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 optional<br>accessories and<br>components | Optional medical device accessories:<br>Thermal Printer, USB Optional non-medical accessories and components:<br>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 and<br>dimensions between the subject device and the predicate device system<br>configuration does not affect the substantial equivalence of the device.<br>Both devices have the SAME principle and mode of operation and<br>condition of use. |
| Environmental<br>Specifications | While the subject device and predicate device have slight differences in<br>operating humidity ranges, transport and storage, and atmospheric<br>pressure temperatures the slight differences in environmental<br>specifications do not affect the substantial equivalence of the subject<br>device relative to the predicate. Both devices have the SAME principle<br>and mode of operation and condition of use. |
| Material<br>composition<br>primary<br>components | Although the material composition of the main components of the<br>subject device—Desktop Unit, Radio Cradle, and Display—and<br>predicate device (integrated touch screen display/ processing unit)<br>differ, neither device requires biocompatibility testing of the materials<br>since neither the subject nor predicate device come in direct or indirect<br>contact with the patient's body during use and the devices are not<br>intended by the user to be protective devices. The differences in<br>material composition do not affect the substantial equivalence of the<br>subject device relative to the predicate. |
| Operator Interface<br>(Touch screen<br>display) | There are some differences in technological characteristics of the<br>operator interface between the subject device and predicate device.<br>The technological characteristics remain the SAME with the exception<br>of the improved screen resolution, configuration with respect to the<br>processing unit (modular versus integrated), and the speaker. The<br>subject device Display has been evaluated by DIVA Laboratories and<br>certified to IEC 60601-1 Edition 3.1 as a medical device component,<br>and verified and certified again to IEC 60601-1 Edition 3.1 as part of<br>the completed Portal 5000 system. Although the subject device<br>includes one speaker, the subject device incorporates a built-in<br>diagnostic speaker test, power up tone, alarm plays during volume<br>adjustment, and visual alarm for redundancy. Performance testing and<br>risk assessment have verified the difference does not affect the<br>directional or average sound pressure level and does not affect the<br>substantial equivalence of the subject device relative to the predicate. |
| | The graphical user interface of the subject device was updated to better<br>align with other Philips patient monitors to provide a common look,<br>and feel, to improve clinician familiarity and ease of use. Caregivers<br>come from other areas of the hospital to monitor their patient<br>undergoing an MRI, so having a common graphical user interface<br>improves usability. The graphical user interface differences do not<br>affect the substantial equivalence of the subject device relative to the<br>predicate. |
| Radio Module | The subject device uses a radio module with the SAME radio<br>frequency (RF) transceiver as the predicate device. The difference in<br>the radio module is as follows:<br>an improved digital interface board that provides enhanced<br>electrical fast transient (EFT) and a coated housing that provides enhanced electromagnetic<br>compatibility (EMC) performance per the requirements of IEC<br>60601-1-2 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 to<br>mitigate any signal integrity issues: Control room flex antenna and Advanced Communications Option (ACO) passive antenna. The additional antennas are also permitted under the FCC<br>certification HSW-2410NF. The differences do to not affect the<br>substantial equivalence of the subject device relative to the<br>predicate.<br><br>The radio frequency (RF) transceiver is located within a radio<br>module and the 2 dBi antenna is mounted to the top of the radio<br>module. Although the radio module of the subject device is docked<br>on a radio cradle, and the radio module of the predicate device is<br>do…