The monitors are intended to be used for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults, pediatrics, and neonates. The monitors are intended for use by trained healthcare professionals in a hospital environment.

The monitors are only for use on one patient at a time. They are not intended for use in transport situations. They are not intended for home use. Not therapeutic devices. The monitors are for prescription use only.

The ECG measurement is intended to be used for diagnostic recording of rhythm and detailed morphology of complex cardiac complexes (according to AAMI EC11).

ST segment monitoring is intended for use with adult patients only and is not clinically validated for use with neonatal and pediatric patients.

BIS is intended for use under the direct supervision of a licensed health care practitioner or by personnel trained in its proper use. It is intended for use on adult and pediatric patients within a hospital or medical facility providing patient care to monitor the state of the brain by data acquisition of EEG signals. The BIS may be used as an aid in monitoring the effects of certain anesthetic agents. Use of BIS monitoring to help guide anesthetic administration may be associated with the reduction of the incidence of awareness with recall in adults during general anesthesia and sedation.

The SSC Sepsis Protocol in the ProtocolWatch clinical decision support tool, is intended for use with adult patients only.

The Integrated Pulmonary Index (IPI) is intended for use with adult and pediatric (1 to 12 years) patients only. The IPI is an adjunct to and not intended to replace vital sign monitoring.

The derived measurement Pulse Pressure Variation (PPV) is intended for use with sedated patients receiving controlled mechanical ventilation and mainly free from cardiac arrhythmia. The PPV measurement has been validated only for adult patients.

The IntelliVue NMT Module is intended to be used as an objective neuromuscular transmission monitor, using accelerometry for measuring the muscle contraction following an electrical stimulation of a peripheral nerve. The NMT Module is intended to be used with adult and pediatric patients.

The Masimo rainbow SET measurement is indicated for the noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate, carboxyhemoglobin saturation (SpCO), methemoglobin saturation (SpMet), total hemoglobin concentration (SpHb), and/or respiratory rate (RRac). The Masimo rainbow SET measurement is indicated for use during both no motion and motion conditions, and for patients who are well or poorly perfused.

The 4-Slot Module rack FMX-4 is intended to connect up to four particular plug-in physiological measurement modules to the dedicated host patient monitors.

Device Description

The IntelliVue Patient Monitors MX750 and MX850 acquire multiple physiological patient signals, display measurement values, waves and trends, generate physiological and technical alarms, provide data recording and support patient data management. They operate with the external Measurement Modules and the IntelliVue 4-Slot Module Rack FMX-4, which establishes the connection between the individual plug-in measurement modules and the MX750 and MX850 monitors.

The monitors support multiple non-invasive and invasive measurements such as ECG, arrhythmia, ST, QT, SpO2, respiration rate, pulse rate, invasive and non-invasive blood pressure, temperature, CO2, tcpO2/ tcpCO2, C.O., CCO, intravascular SO2, Sv02, ScvO2, EEG, BIS, NMT, and gas analysis.

The monitors offer a monitoring solution optimized for the surgical, cardiac, medical and neonatal care environments. They are located in the patient vicinity at the bedside. These devices have a color display with a touch-screen as a primary input device. They also support keyboard and pointing devices such as a mouse.

The monitor models MX750 and MX850 differ mainly in size. Whilst MX750 has a 19" flat panel display, MX850 has a 22" display.

The hardware of the new 4-Slot Module Rack FMX-4 is very similar to that of its 8 years old predicate 4-Slot Module Rack FMS-4. The new FMX-4 has the same housing, which is made of the same material as FMS-4 but has a slightly different shade of color (same shade of color as the new MX750 and MX850 monitors). The FMX-4 has a new Printed Circuit Assembly with standard hardware components like CPU and memory being replaced by state of the art electronic components.

The software modifications comprise the following changes:

Support of the new state-of-the-art electronic components.
Modified elements of the Graphical User Interface.
Implementation of a feature called Electronic Strip Recording. This feature allows electronic strips that can be reviewed on the monitor and printed out as a report on the printer.
Modification of the existing feature Remote Applications to support HTML5 and PDF format.

AI/ML Overview

This document is a 510(k) summary for the Philips IntelliVue Patient Monitors MX750 and MX850 and the IntelliVue 4-Slot Module Rack FMX-4. It states that these devices are substantially equivalent to previously cleared predicate devices (Philips IntelliVue Patient Monitor MX800 and Philips IntelliVue 4-Slot Module Rack FMS-4). The submission primarily focuses on hardware and software modifications to existing devices.

The information provided does not detail specific acceptance criteria and device performance in the format of a table with numerical values for metrics like sensitivity, specificity, or accuracy, as would be common for an AI/ML device study. Instead, it describes compliance with recognized consensus standards and general V&V activities. This is likely because the device is a patient monitor, and the modifications are primarily hardware updates and minor software changes to support the new hardware and improve existing functionalities, not a new AI/ML algorithm requiring extensive clinical performance validation against a pre-defined ground truth for diagnostic accuracy.

Therefore, many of the requested items (e.g., sample size for test set, number of experts for ground truth, adjudication method, MRMC comparative effectiveness study, standalone performance) are not explicitly addressed in the provided text as they pertain more to novel diagnostic or AI algorithms rather than general patient monitoring device updates.

I can, however, extract information about the types of tests conducted and general statements about meeting requirements.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a table with specific numerical acceptance criteria and corresponding device performance metrics (e.g., sensitivity, specificity, AUC) for the various physiological parameters monitored by the device. Instead, it states that "Test methods and acceptance criteria were the same as those for the predicate devices and test results showed substantial equivalence with respect to safety and effectiveness."

The V&V activities focused on compliance with various international standards:

Acceptance Criteria (Compliance with Standards)	Reported Device Performance
AAMI / ANSI ES60601-1:2005/(R)2012 and A1:2012 (Ed. 3.1) (Electrical Safety)	All applicable requirements have been met.
IEC 60601-1-2:2014 (Ed. 4) (EMC)	All applicable requirements have been met.
IEC 60601-2-23:2011 (Ed.3) (Non-invasive sphygmomanometers)	All applicable requirements have been met.
IEC 60601-2-25:2011 (Ed. 2) (Electrocardiographs)	All applicable requirements have been met.
IEC 60601-2-27:2011(Ed. 3) (Electrocardiographic monitoring equipment)	All applicable requirements have been met.
IEC 80601-2-30:2009 (Ed. 1.1) and A1:2013 (Automated non-invasive sphygmomanometers)	All applicable requirements have been met.
IEC 60601-2-34:2011(Ed.3) (Invasive blood pressure monitoring equipment)	All applicable requirements have been met.
ISO 80601-2-55:2018 (Ed. 2) (Respiratory gas monitors)	All applicable requirements have been met.
ISO 80601-2-56:2017 (Ed. 2) and A1:2018 (Clinical thermometers)	All applicable requirements have been met.
ISO 80601-2-61:2017 (Ed. 2) and Corr1:2018 (Pulse oximetry equipment)	All applicable requirements have been met.
IEC 60601-1-8:2006 (Ed. 2.1) and A1:2012 (Alarm systems)	All applicable requirements have been met.
IEC 62304:2006 (Ed. 1.1) and A1:2015 (Software lifecycle processes)	All applicable requirements have been met.
IEC 60601-1-6:2010 (Ed.3.1) and A1:2013 (Usability)	All applicable requirements have been met.
Environmental Testing (Mechanical: Shock, vibration, free fall; Climatic: Temp, humidity)	Specified test requirements have been met.
Human Factors Engineering Testing (GUI evaluation)	All specified test requirements have been met and no new hazards have been identified. User feedback led to iterative UI improvements.
WLAN Coexistence Testing	The specified pass/fail criteria has been met.
Software tests (Safety risk, Software specifications, Security risk)	All tests have been passed.
Overall Conclusion	The results demonstrate that the Philips IntelliVue Patient Monitors MX750, MX850 and the IntelliVue 4-Slot Module Rack FMX-4 meet all defined reliability requirements and performance claims.

2. Sample size used for the test set and the data provenance

The document does not specify a "test set" in terms of subject count or data record count for performance evaluation in the context of, for example, diagnostic algorithm accuracy. The studies described are primarily engineering validation and verification tests against established standards. Therefore, information regarding data provenance (e.g., country of origin, retrospective/prospective) is not provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

As there is no "test set" described for a diagnostic algorithm, this information is not applicable and not provided in the document. The human factors engineering testing involved "focus groups" and "expert reviews," but the number and qualifications of these experts are not specified, nor were they establishing ground truth for a diagnostic outcome.

4. Adjudication method for the test set

Not applicable, as no dedicated "test set" requiring adjudication for ground truth of a diagnostic outcome is described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done

No MRMC comparative effectiveness study is mentioned. The device is a patient monitor, and the submission concerns updates to an existing monitoring platform, not a new AI diagnostic aid that would typically warrant such a study.

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

This concept is less applicable to a patient monitoring device update. The performance evaluation focuses on the device's ability to accurately measure and display physiological parameters and generate alarms in compliance with safety and performance standards, rather than an autonomous diagnostic algorithm. The document states the monitors are "for use by trained healthcare professionals."

7. The type of ground truth used

For the various measurement parameters (ECG, SpO2, etc.), the "ground truth" implicitly aligns with the accuracy and performance specifications outlined in the referenced standards (e.g., AAMI EC11 for ECG, ISO 80601-2-61 for pulse oximetry). These standards define acceptable deviations from known physical or simulated physiological signals. The document does not describe the establishment of ground truth in the context of expert consensus, pathology, or outcomes data, as would be relevant for a diagnostic AI algorithm.

8. The sample size for the training set

This information is not provided. The document primarily describes hardware and software updates to an existing system, rather than the development and training of a new AI/ML algorithm.

9. How the ground truth for the training set was established

Not applicable, as the document does not describe the development or training of a new AI/ML algorithm.

Summary

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

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a seal with a stylized depiction of human faces. To the right of the seal, there is a blue square with the letters 'FDA' in white. Next to the blue square, the words 'U.S. FOOD & DRUG' are written in a bold, sans-serif font, with 'ADMINISTRATION' written in a smaller font below. The overall design is clean and professional, reflecting the FDA's role in regulating food and drugs.

October 7, 2021

Philips Medizin Systeme Boeblingen GmbH Monica Silva Sr. Regulatory Affairs Engineer Hewlett-Packard-Strasse 2 Boeblingen, Baden-Wuerttemberg 71034 Germany

Re: K210906

Trade/Device Name: IntelliVue Patient Monitors MX750 and IntelliVue 4-Slot Module Rack FMX-4 Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia Detector And Alarm (Including ST-Segment Measurement And Alarm) Regulatory Class: Class II Product Code: MHX Dated: September 3, 2021 Received: September 7, 2021

Dear Monica Silva:

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.

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

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about 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.

Jennifer Shih Kozen Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K210906

Device Name

IntelliVue Patient Monitors MX750 and MX850 and IntelliVue 4-Slot Module Rack FMX-4.

Indications for Use (Describe)

The monitors are indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients.

The monitors are intended to be used for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults, pediatrics, and neontors are intended for use by trained healthcare professionals in a hospital environment.

The ECG measurement is intended to be used for diagnostic recording of thythm and detailed morphology of complex cardiac complexes (according to AAMI EC11).

ST segment monitoring is intended for use with adult patients only and is not clinically validated for use with neonatal and pediatric patients.

BIS is intended for use under the direct supervision of a licensed health care practitioner or by personnel trained in its proper use. It is intended for use on adult and petiativ within a hospital or medical facility providing patient care to monitor the state of the brain by data acquisition of EEG signals. The BIS may be used as an aid in monitoring the effects of certain anesthetic agents. Use of BIS monitoring to help guide anesthetic administration may be associated with the reduction of the incidence of awareness with recall in adults during general anesthesia and sedation.

The SSC Sepsis Protocol in the ProtocolWatch clinical decision support tool, is intended for use with adult patients only.

The Integrated Pulmonary Index (IPI) is intended for use with adult and pediatric (1 to 12 years) patients only. The IPI is an adjunct to and not intended to replace vital sign monitoring.

The Masimo rainbow SET measurement is indicated for the nonitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate, carboxyhemoglobin saturation (SpCO), methemoglobin saturation (SpMet), total hemoglobin concentration (SpHb), and/or respiratory rate (RRac). The Masimo rainbow SET measurement is indicated for use during both no motion and motion conditions, and for patients who are well or poorly perfused.

{3}------------------------------------------------

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

X 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."

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

Image /page/4/Picture/1 description: The image shows the word "PHILIPS" in large, bold, blue letters. The font is sans-serif and the letters are evenly spaced. The background is plain white, which makes the blue letters stand out.

510(k) Summary

This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of the Safe Medical Devices Act of 1990 and 21 C.F.R. §807.92.

1. Submitter of this premarket notification
  Monica da Silva Philips Medizin Systeme Boeblingen GmbH Hewlett-Packard-Str. 2 D-71034 Boeblingen, Germany Tel: +49 151 4090 3561 e-mail: monica.dasilva(@philips.com

This summary was prepared on March 23, 2021.

1. The name and classification of the devices:
  Trade name: IntelliVue Patient Monitors MX750 and IntelliVue 4-Slot Module Rack FMX-4.

Common name: Multiparameter Patient Monitor.

Classification:

Device Panel	Classification	ProCode	Description
CardiovascularDevices	§870.1025, II	MHX	Monitor, Physiological, Patient (witharrhythmia detection or alarms)
	§870.1025, II	MLD	Monitor, ST Segment with Alarm
	§870.1100, II	DSJ	Alarm, Blood Pressure
	§870.1110, II	DSK	Computer, Blood Pressure
	§870.1130, II	DXN	System, Measurement, Blood-Pressure,Non-Invasive
	§870.2300, II	DRT	Monitor, Cardiac (incl. Cardiotachometer &Rate Alarm)
	§870.2340, II	DPS	Electrocardiograph
	§870.2700, II	DQA	Oximeter
Device Panel	Classification	ProCode	Description
	§870.2810, I	DSF	Recorder, Paper Chart
	§870.2300 II	MSX	System, Network and Communication,Physiological Monitors
AnesthesiologyDevices	§868.1400, II	CCK	Analyzer, Gas, Carbon Dioxide, Gaseous-Phase
	§868.1500, II	CBQ	Analyzer, Gas, Enflurane, Gaseous-Phase(Anesthetic Concentration)
	§868.1500, II	NHO	Analyzer, Gas, Desflurane, Gaseous-Phase(Anesthetic Concentration)
	§868.1500, II	NHP	Analyzer, Gas, Sevoflurane, Gaseous-Phase(Anesthetic Concentration)
	§868.1500, II	NHQ	Analyzer, Gas, Isoflurane, Gaseous-Phase(Anesthetic Concentration)
	§868.1620, II	CBS	Analyzer, Gas, Halothane, Gaseous-Phase(Anesthetic Concentration)
	§868.1700, II	CBR	Analyzer, Gas, Nitrous Oxide, Gaseous-Phase (Anesthetic Concentration)
	§868.1720, II	CCL	Analyzer, Gas, Oxygen, Gaseous-Phase
	§868.1880, II	BZC	Data calculator Pulmonary-function
	§868.2375, II	BZQ	Monitor, Breathing Frequency
	§868.2480, II	LKD	Monitor, Carbon Dioxide, Cutaneous
	§868.2500, II	KLK	Monitor, Oxygen, Cutaneous, for Infant notunder Gas Anesthesia
	§868.2775 II	KOI	Electrical peripheral nerve stimulator
NeurologicalDevices	§882.1400, II	GWQ	Electroencephalograph
	§882.1420, I	GWS	Analyzer, Spectrum, ElectroencephalographSignal
General Hospitaland Personal UseDevices	§880.2910, II	FLL	Thermometer, Electronic, Clinical

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

Image /page/5/Picture/1 description: The image shows the word "PHILIPS" in large, bold, blue letters. The font is sans-serif and the letters are evenly spaced. The background is white, which makes the blue letters stand out.

1. Philips IntelliVue Patient Monitors MX750, MX850 are substantially equivalent to the previously cleared, primary predicate device, Philips IntelliVue Patient Monitor MX800 marketed pursuant to K161531.
  Philips IntelliVue 4-Slot Module Rack FMX-4 is substantially equivalent to the previously cleared Philips IntelliVue 4-Slot Module Rack FMS-4 marketed pursuant to K110622.

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

Image /page/6/Picture/1 description: The image shows the word "PHILIPS" in large, bold, blue letters. The font is sans-serif and the letters are evenly spaced. The background is white, which makes the blue letters stand out. The logo is simple and modern.

Description of the device 4.

Hardware and software modifications carried out on the legally marketed device Intelli Vue Patient Monitor MX800 and its IntelliVue 4-Slot Module Rack FMS-4, resulted in new models, the IntelliVue Patient Monitors MX750, MX850 and their 4-Slot Module Rack FMX-4, the subject of this submission.

The monitor models MX750 and MX850 differ mainly in size. Whilst MX750 has a 19" flat

panel display, MX850 has a 22" display.

Modifications:

Standard hardware components of the almost 10 years old predicate MX800, like flat panel display, touch screen, CPU, video board, and memory have been replaced in the MX750 and MX850 by state of the art electronic components. Two additional features, the NFC reader and adaptive lighting through the Ambient Light Sensor, have been implemented into the new MX750 and MX850 monitors.

The software modifications comprise the following changes:

Support of the new state-of-the-art electronic components. -
-Modified elements of the Graphical User Interface.
-Implementation of a feature called Electronic Strip Recording. This feature allows electronic strips that can be reviewed on the monitor and printed out as a report on the printer.
-Modification of the existing feature Remote Applications to support HTML5 and PDF format.

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

Image /page/7/Picture/1 description: The image shows the word "PHILIPS" in large, bold, blue letters. The letters are evenly spaced and fill most of the frame. The background is white, providing a strong contrast to the blue text.

None of the described modifications represents any change to the fundamental technology of the predicate device.

1. Intended Use
  The intended use and indications for use of the Philips Intelli Vue Patient Monitors MX750, MX850 and their IntelliVue 4-Slot Module Rack FMX-4, have not changed from the legally marketed predicate device IntelliVue Patient Monitor MX800 and the respective IntelliVue 4-Slot Module Rack FMS-4 as a result of the modifications.

IntelliVue Patient Monitors MX750 and MX850 and IntelliVue 4-Slot Module Rack FMX-4.

The monitors are indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients.

The ECG measurement is intended to be used for diagnostic recording of rhythm and detailed morphology of complex cardiac complexes (according to AAMI EC11).

ST segment monitoring is intended for use with adult patients only and is not clinically validated for use with neonatal and pediatric patients.

The SSC Sepsis Protocol, in the ProtocolWatch clinical decision support tool, is intended for use with adult patients only.

The Integrated Pulmonary Index (IPI) is intended for use with adult and pediatric (1 to 12 years) patients only. The IPI is an adjunct to and not intended to replace vital sign monitoring.

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

Image /page/8/Picture/1 description: The image shows the word "PHILIPS" in large, bold, blue letters. The font is sans-serif and the letters are evenly spaced. The word is centered and takes up most of the frame.

IntelliVue 4-Slot Module Rack FMX-4

The 4-Slot Module rack FMX-4 is intended to connect up to four particular plug-in physiological measurement modules to the dedicated host patient monitors.

Comparison of Technological Characteristics with Predicate Device 6.

ComparativeCharacteristics	Primary Predicate DevicePhilipsIntelliVue Patient MonitorsMX800(K161531)	Subject DevicesPhilipsIntelliVue Patient MonitorsMX750 and MX850
Hardware Aspects
Hardware Design	Monitors with display and CPUintegrated in one housing andconnectable to dedicated externalmeasurement modules.	Same
Material	Housing: PC ABS + PCFront side: Glass with foilOn/Off Button: Silicone	Housing: PBT + PCFront side: Chemicallystrengthened GlassOn/Off Button: Same
Display	Size: 19"Resolution:WSXGA+ (1680 x 1050)	Size:MX750: 19"MX850: 22"Resolution:MX750: 1920 x 1080 (Full HD)MX850: 1920 x 1080 (Full HD)
TouchscreenTechnology	Resistive touchscreen	Capacitive touchscreen
Hardware VisualAlarm Indicators	Lamp indicators:1 color coded alarm indicator lamp(red, yellow, cyan)1 color coded alarm indicator lamp(red, yellow)	Same
	Primary Predicate Device	Subject Devices
ComparativeCharacteristics	PhilipsIntelliVue Patient MonitorsMX800(K161531)	PhilipsIntelliVue Patient MonitorsMX750 and MX850
Alarm Loudspeaker	1 color coded "alarms off" lamp(red, yellow)Loudspeaker technology: dynamicloudspeaker	Same
Energy Type	Powered by AC mains	Same
Physiological Measurements
Internal(built-in)PhysiologicalMeasurements	None	Same
Supported externalMeasurement Modules	Multi-Measurement Modules directly connected to the patient monitor (including) Measurement Extensions attached to the Multi-Measurement Modules Measurement Modules directly connected to the patient monitor Measurement Modules connected to a host patient monitor via the dedicated Flexible Module Racks.	Same
Supported dedicatedFlexible ModuleRacks	8-Slot Module Rack FMS-8 (M8048A) 4-Slot Module Rack FMS-4 (865243)	8-Slot Module Rack: not supported. Instead, supports two simultaneous 4-Slot Module Racks FMX-4 (866468). 4-Slot Module Rack FMS-4 (865243) not supported, substituted by FMX-4.
Connectivity features
Wireless Interfaces	WLAN 2.4 and 5 GHz, IEEE 802.11 a/b/g/nShort Range Radio (SRR) 2.4 GHz,ITS 2.4 GHz ISM, ITS 1.4 GHz WMTS Near Field Communication Interface (NFC): not supported	WLAN/Radio Module: SameShort Range Radio (SRR): not supportedITS 2.4 GHz ISM: not supportedITS 1.4 GHz WMTS: not supported
ComparativeCharacteristics	Primary Predicate DevicePhilipsIntelliVue Patient MonitorsMX800(K161531)	Subject DevicesPhilipsIntelliVue Patient MonitorsMX750 and MX850
		Near Field CommunicationInterface (NFC): Technology:NFCIP-1, NFCIP-2 protocol,ISO/IEC 14443A, ISO/IEC14443BFrequency: 13.56 MHz.FCC ID : PQC-NFCBV1
Wired Interfaces	LAN IEEE 802.3 100MBitRS232/MIB ISO/IEEE 11073-30200USB 2.0ECG-OutBasic Nurse Call RelayFlexible Nurse Call RelayProprietary measurement Link (MSL)Video Interface DVI analog & digital.	Same, except for not supportedVideo Interface DVI analog &digital.
Integrated PC	iPC (cleared with K101449)Feature that allows for a computerfunctionality within the monitor, sothat the user can use standardapplications as for i.e Web browser.	Same
Supported RemoteDisplay Application	Philips IntelliVue XDS solution	Same
Strip Recording	Paper-strip recorders M1116B andM1116C	Same, additionally electronic-strip recording in print database.
Remote Applications	Access to pre-configured applicationsmade available by hospital, hostedremotely on the Philips ApplicationServer utilizing Citrix PresentationServer™ and displayed and operatedon the MX800 patient monitor.	Same, but instead of CitrixPresentation Server™, Citrix®Xen App® and standard webapplication servers are used. Withthis modification the HTML5 andPDF format are provided.
Human Interface (HIF)
Elements thatprovide informationto the user	Indicator lights, display, visual andaudible alarms.	Same
Graphic userinterfaces of device	Selection of screen elementsUse touch screen to operate monitorMoving windowsUse of SmartKeys	Same
Hardwarecomponents that theuser handles tocontrol deviceoperation	Touchscreen: YesRemote control: YesUSB Pointing devices: mouse,trackball, keyboard, Barcode Reader	Same, except not supportedremote control.
ComparativeCharacteristics	Primary Predicate DevicePhilipsIntelliVue Patient MonitorsMX800(K161531)	Subject DevicesPhilipsIntelliVue Patient MonitorsMX750 and MX850
Robustness	Mechanical Strength testing as perIEC 60601-1: 1988 + A1: 1991 + A2:1995. Additionally mechanical Class7M1	Same
EnvironmentalSpecifications	- Operating Temperature Range: 0 to40°C (32 to 100 °F) or 0 to 35°C(32 to 95 °F) when equipped withthe iPC- Storage Temperature Range: -20 to60 °C (-4 to 140°F)- Operating Humidity Range: 15% to95% RH, non-condensing- Storage Humidity Range: 5% to95% RH- Operating Altitude Range: -500 to3000 m (-1600 to 10000 ft)- Storage Altitude Range: -500 to4600 m (-1600 to 15000 ft)- Ingress Protection: IPX1	Same environmentalspecifications.Ingress Protection: IP21
Biocompatibility	N/A, no patient contact	Same
EMC and ElectricalSafety	EMC: IEC 60601-1-2: 2014 (Ed.4)Safety: IEC 60601-1 (3rd Ed.) +Cor.1:2006 + Cor.2:2007 + A1:2012andANSI AAMI ES60601-1:2005/(R)2012 and A1:2012	EMC: SameSafety: Same

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

Image /page/9/Picture/1 description: The image shows the word "PHILIPS" in a bold, sans-serif font. The word is written in a bright blue color. The background is plain white, which makes the word stand out.

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

Image /page/10/Picture/1 description: The image shows the word "PHILIPS" in a bold, sans-serif font. The word is written in a bright blue color. The letters are large and evenly spaced.

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

Image /page/11/Picture/1 description: The image shows the word "PHILIPS" in large, bold, blue letters. The font is sans-serif and the letters are evenly spaced. The background is white, providing a strong contrast that makes the word stand out.

7. Summary of V&V activities

The modified IntelliVue Patient Monitors MX750, MX850 and the IntelliVue 4-Slot Module Rack FMX-4 with the current software Revision N.01 have been subject to the following V&V activities:

-Testing according to the recognized consensus standard:
- AAMI / ANSI ES60601-1:2005/(R)2012 and A1:2012 (Ed. 3.1)
- 트 IEC 60601-1-2:2014 (Ed. 4)
- I IEC 60601-2-23:2011 (Ed.3)
- I IEC 60601-2-25:2011 (Ed. 2)
- IEC 60601-2-27:2011(Ed. 3)
- l IEC 80601-2-30:2009 (Ed. 1.1) and A1:2013
- IEC 60601-2-34:2011(Ed.3)
- ' ISO 80601-2-55:2018 (Ed. 2)
- i ISO 80601-2-56:2017 (Ed. 2) and A1:2018

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

Image /page/12/Picture/1 description: The image shows the word "PHILIPS" in large, bold, blue letters. The font is sans-serif and the letters are evenly spaced. The background is white, providing a strong contrast that makes the word stand out. The overall impression is clean and professional, reflecting the brand's image.

I ISO 80601-2-61:2017 (Ed. 2) and Corr1:2018
트 IEC 60601-1-8:2006 (Ed. 2.1) and A1:2012 All applicable requirements have been met.
-Compliance with the recognized consensus process standards:
- IEC 62304:2006 (Ed. 1.1) and A1:2015 ■
- 트 IEC 60601-1-6:2010 (Ed.3.1) and A1:2013

All applicable requirements have been met.

· The determination of substantial equivalence is also based on an assessment of the following testing:
-Environmental Testing encompassing:
- I Mechanical Testing: Shock, vibration, and free fall to simulate the environment of use during stationary use and patient transport inside of hospitals, according to the IEC TR60721-4-7 Class 7M1 and IEC 60068-2-xx standard series.
- I Temperature and humidity testing to simulate the climatic conditions during device operation in hospital environments and during storage.
-Human Factors Engineering Testing

The modified Graphical User Interface elements were evaluated and improved iteratively during the design phase conducting several formative usability evaluations, as per FDA Guidance "Applying Human Factors and Usability Engineering to Medical Devices" issued on February 3, 2016. These included established usability engineering methods such as focus groups, expert reviews and usability tests using user interface prototypes. User feedback was translated into iterative user interface improvements. All specified test requirements have been met and no new hazards have been identified.

-WLAN Coexistence Testing
The specified pass/fail criteria has been met.
Software tests for: -
- Safety risk assessment requirements. 트
- I Software specifications requirements.
- 트 Security risk requirements.

All tests have been passed.

1. Conclusion
  Verification, validation, and testing activities establish the performance, functionality, and reliability characteristics of the modified devices with respect to the specific predicates.

V&V testing comprised well-established software tests, safety and essential performance tests, and human factors engineering tests.

{13}------------------------------------------------

Image /page/13/Picture/1 description: The image shows the word "PHILIPS" in large, bold, blue letters. The font is sans-serif and the letters are evenly spaced. The word is the only element in the image and it is centered.

Test methods and acceptance criteria were the same as those for the predicate devices and test results showed substantial equivalence with respect to safety and effectiveness.

The results demonstrate that the Philips IntelliVue Patient Monitors MX750, MX850 and the IntelliVue 4-Slot Module Rack FMX-4 meet all defined reliability requirements and performance claims.

Regulation Number and Section

§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).

(a)
Identification. The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.