(76 days)
Not Found
No
The summary describes a remote display and control portal for existing patient monitoring systems, with no mention of AI or ML capabilities.
No
The device is described as an "information portal" and a "remote monitor and remote control" that "displays the vital signs." It does not directly provide therapy or affect the body's structure or function; instead, it processes and displays data from other monitoring systems.
No
The device is described as an "information portal" that displays vital signs collected by other monitoring systems. It does not perform data collection or processing as a stand-alone patient monitoring system. Its primary function is to serve as a remote monitor and control interface, not to diagnose conditions.
No
The device description explicitly lists hardware components such as a "Desktop unit," "Radio Kit, USB," "Radio Cradle," and "Display, 18.5 inch," indicating it is not solely software.
Based on the provided information, the Philips MR Patient Care Portal 5000 is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In vitro diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
- Device Function: The MR Patient Care Portal 5000 is described as an "information portal" that displays vital signs data collected by a separate patient monitoring system. It acts as a remote display and control, not a device that analyzes biological samples.
- Intended Use: The intended use is to monitor vital signs of patients undergoing MRI procedures. This involves directly monitoring physiological parameters, not analyzing samples.
- Device Description: The description clearly states it "does not perform any data collection or processing of data as stand-alone patient monitoring system" and is a "remote monitor and remote control."
Therefore, the function and intended use of the Philips MR Patient Care Portal 5000 fall outside the scope of an in vitro diagnostic device. It is a patient monitoring accessory or component.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
MWI, DSF, DPS, DSJ, DXN, DSK, FLL, CBQ, CBR, CBS, CCL, NHO, NHQ, DOA, FLS
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;
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
The target patient population includes adult, pediatric, and neonatal patients that require monitoring during MRI procedures.
Intended User / Care Setting
healthcare professionals. The device is intended for use outside the MR Scanner room (i.e. Control Room, Induction Room, or Recovery Room).
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical performance data provided includes:
- Cleaning & Disinfecting: Tests support the use of listed cleaners and disinfectants during the device's lifetime.
- Shelf-Life: Tests support the storage conditions necessary to maintain performance, safety, and intended use.
- Lifetime: The device has a defined lifetime of "7" years, supported by accelerated testing under extreme conditions.
- Performance Testing - Bench: Functional and system-level testing conducted to validate safety and performance, according to applicable consensus standards and internal procedures.
- Performance Testing - Clinical (Human Factors and Usability): Tests performed under 'simulated-use' conditions to ensure implemented risk management measures were effective and to assess user interaction and interpretation of information. The device met performance, usability, and safety test acceptance criteria.
- Software Verification and Validation: Conducted per FDA guidance for medical device software. Software Level of Concern determined to be Major.
- Electromagnetic Compatibility and Electrical Safety: Tested against ANSI AAMI ES60601-1 and IEC 60601-1-2 standards, with additional wireless and co-existence testing per US FCC CFR 47 Part 15 and FDA guidance.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 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)
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)
| 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 32826 | |
| Tel.: 407-473-5510 | |
| Fax: 407-382-2707 | |
| OFFICIAL | |
| CORRESPONDENT | Maria Keelan |
| Regulatory Operations Specialist | |
| 12151 Research Parkway, Orlando, FL 32826 | |
| Tel.: 407-473-5510 | |
| Fax: 407-382-2707 | |
| maria.keelan@philips.com | |
| DEVICE INFORMATION | |
| TRADE NAME | Philips MR Patient Care Portal 5000 |
| COMMON NAME | Remote Display |
| CLASSIFICATION | Class II |
| 21 CFR 870.2300 Cardiac monitor (including | |
| cardiotachometer and rate alarm) | |
| PRODUCT CODE | MWI: Monitor, physiological, patient (without |
| arrhythmia 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 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.
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 Expression | ||||||||||||||||
| Information Portal (Model IP5) comply with FDA recognized | |||||||||||||||||
| consensus standards and industry recognized standards. | |||||||||||||||||
| Lifetime (aka | |||||||||||||||||
| Service Life) | Both the subject device and predicate device expected service life is | ||||||||||||||||
| "7" years from the date of manufacture. | |||||||||||||||||
| Host patient | |||||||||||||||||
| compatibility | Both the subject device and predicate device support the same host | ||||||||||||||||
| patient monitoring systems, the Expression Model MR400 MRI Patient | |||||||||||||||||
| Monitoring System or the Expression MR200 MRI Patient Monitoring | |||||||||||||||||
| System. | |||||||||||||||||
| Dimensions | The radio module dimensions are the same . | ||||||||||||||||
| Power | |||||||||||||||||
| requirements | AC mains to AC/DC power adapter rated 100-240 VAC at 50-60 Hz | ||||||||||||||||
| Operating | |||||||||||||||||
| Temperature | |||||||||||||||||
| range: | 15 to 35 SimilaritiesBoth the Philips MR Patient Care Portal 5000 and the Expression | ||||||||||||||||
| Information Portal (Model IP5) comply with FDA recognized | |||||||||||||||||
| consensus standards and industry recognized standards.Lifetime (aka | |||||||||||||||||
| Service Life)Both the subject device and predicate device expected service life is | |||||||||||||||||
| "7" years from the date of manufacture.Host patient | |||||||||||||||||
| compatibilityBoth the subject device and predicate device support the same host | |||||||||||||||||
| patient monitoring systems, the Expression Model MR400 MRI Patient | |||||||||||||||||
| Monitoring System or the Expression MR200 MRI Patient Monitoring | |||||||||||||||||
| System.DimensionsThe radio module dimensions are the same .Power | |||||||||||||||||
| requirementsAC mains to AC/DC power adapter rated 100-240 VAC at 50-60 HzOperating | |||||||||||||||||
| Temperature | |||||||||||||||||
| range:15 to 35℃ (59°F to 95°F)Material | |||||||||||||||||
| composition of | |||||||||||||||||
| radio and optional | |||||||||||||||||
| accessories and | |||||||||||||||||
| componentsThe material composition of the radio and optional accessories and | |||||||||||||||||
| components for both devices are the same.Mounting | |||||||||||||||||
| ConfigurationsDesktop mounted or Wall mounted |
Table 5-1. Comparison of Technological Features with the Primary Predicate Device
T
6
| Wireless
Communication
with the Host
Patient monitor | RF Output Power: +20 dBm Frequency Range: 2.4GHz band The radio module has FCC approval under identification number
HSW-2410NF. Radio frequency (RF) transceiver is the same The display provides visual indicators of communication status
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
power on if the subject and predicate device, host patient monitor,
wireless ECG module, and wireless SpO2 module are each set to
the same network (A, B, C, D, or E (for MR200) or 1-10 (for
MR400)). |
|-------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Vital signs
monitored | All vital signs are measured by and processed in the host patient
monitoring system. The host patient monitoring systems, either the
Expression Model MR400 MRI Patient Monitoring System or
Expression MR200 MRI Patient Monitoring System, transmit the
following 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 between
processing viewing at the modified display is less than one second. |
| Patient applied
parts | No patient applied parts |
| Environment of
Use | Both the subject device and the predicate device optional accessories
and components are intended for use outside the MR Scanner room
(i.e., within the MR control room, MR induction room, or MR recovery
room).
The Bar Code Scanner handheld, the same optional component used
with both the subject device and predicate device may be taken into the
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:
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
Information
System (HIS)
Interface | Both the subject device and predicate device can interface with the
Hospital 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 optional
accessories and
components | 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 and
dimensions between the subject device and the predicate device system
configuration does not affect the substantial equivalence of the device.
Both devices have the SAME principle and mode of operation and
condition of use. |
| Environmental
Specifications | While the subject device and predicate device have slight differences in
operating humidity ranges, transport and storage, and atmospheric
pressure temperatures the slight differences in environmental
specifications do not affect the substantial equivalence of the subject
device relative to the predicate. Both devices have the SAME principle
and mode of operation and condition of use. |
| Material
composition
primary
components | Although the material composition of the main components of the
subject device—Desktop Unit, Radio Cradle, and Display—and
predicate device (integrated touch screen display/ processing unit)
differ, neither device requires biocompatibility testing of the materials
since neither the subject nor predicate device come in direct or indirect
contact with the patient's body during use and the devices are not
intended by the user to be protective devices. The differences in
material composition do not affect the substantial equivalence of the
subject device relative to the predicate. |
| Operator Interface
(Touch screen
display) | There are some differences in technological characteristics of the
operator interface between the subject device and predicate device.
The technological characteristics remain the SAME with the exception
of the improved screen resolution, configuration with respect to the
processing unit (modular versus integrated), and the speaker. The
subject device Display has been evaluated by DIVA Laboratories and
certified 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 of
the completed Portal 5000 system. Although the subject device
includes one speaker, the subject device incorporates a built-in
diagnostic speaker test, power up tone, alarm plays during volume
adjustment, and visual alarm for redundancy. Performance testing and
risk assessment have verified the difference does not affect the
directional or average sound pressure level and does not affect the
substantial equivalence of the subject device relative to the predicate. |
| | The graphical user interface of the subject device was updated to better
align with other Philips patient monitors to provide a common look,
and feel, to improve clinician familiarity and ease of use. Caregivers
come from other areas of the hospital to monitor their patient
undergoing an MRI, so having a common graphical user interface
improves usability. The graphical user interface differences do not
affect the substantial equivalence of the subject device relative to the
predicate. |
| Radio Module | The subject device uses a radio module with the SAME radio
frequency (RF) transceiver as the predicate device. The difference in
the radio module is as follows:
an improved digital interface board that provides enhanced
electrical fast transient (EFT) and a coated housing that provides enhanced electromagnetic
compatibility (EMC) performance per the requirements of IEC
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
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
certification HSW-2410NF. The differences do to not affect the
substantial equivalence of the subject device relative to the
predicate.
The radio frequency (RF) transceiver is located within a radio
module and the 2 dBi antenna is mounted to the top of the radio
module. Although the radio module of the subject device is docked
on a radio cradle, and the radio module of the predicate device is
docked within the display's radio bay on the top rear of the display,
the subject device configuration has been tested for operating
performance and IEC 60601-1-2 Edition 4.0. The difference does
not affect the substantial equivalence of the subject device relative
to the predicate. The functionality, technology, and operating
performance of the wireless communication with the host patient
monitor are the SAME as the predicate device. |
| Display operating
system | Although the display operating system (software) is different between
the predicate and subject device, both the subject device and predicate
device implement a common system watchdog to identify processing
faults. Both devices have the SAME principle and mode of operation. |
| | The operating system differences do not affect the substantial
equivalence of the subject device relative to the predicate. |
| System optional
component | The “Mount, remote desktop wall” is an optional component for use
with the subject device only. The Desktop Unit Wall Mount is
evaluated for safety as part of the Philips MR Patient Care Portal 5000
system. The introduction of this optional component does not affect
the performance and substantial equivalence of the device relative to
the 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 of
these antennas does not affect the substantial equivalence and
performance 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.