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 additionally intended for use in transport situations within hospital environments.

The monitors are only for use on one patient at a time. 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 EC 11).

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

The transcutaneous gas measurement (tcGas) with the M1018A plug-in module is restricted to neonatal patients only.

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 noninvasive Masimo O3 Regional Oximeter System and accessories are intended for use as an adjunct monitor of absolute and trended regional hemoglobin oxygen saturation of blood (rSO2) in the cerebral region under the sensors. The Masimo O3 Regional Oximeter System and accessories are indicated for use on adults ≥40 kg and on pediatrics ≥5 kg and <40 kg, in healthcare environments.

Device Description

The IntelliVue Patient Monitors MX500 and MX550 acquire multiple physiological patient signals, display measurement values, waves and trends, generate physiological and technical alarms, provide data recording and support patient data management. The monitors support multiple non-invasive and invasive measurements such as ECG, arrhythmia, ST, QT, SpO2, respiration rate, pulse rate, invasive and noninvasive blood pressure, temperature, CO2, tcpO2/ tcpCO2, C.O., CCO, intravascular SO2, SvO2, ScvO2, spirometry, 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 at the patient bedside vicinity and can also be used during patient transport inside hospitals.

The monitors have a color display with touchscreen as a primary input device. They also support a specialized remote control, keyboard and pointing devices such as a mouse. External displays can be connected to a built-in video port to provide an adaptive duplicate image of the primary display.

The monitors can interact with several compatible external measuring and auxiliary devices locally at the bedside or in transport situations and with the Central Station via LAN or wireless link.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study information for the Philips IntelliVue Patient Monitors MX500 and MX550 based on the provided FDA 510(k) summary:

This submission is a 510(k) for modifications to an existing device, the IntelliVue Patient Monitors MX500 and MX550. The acceptance criteria and supporting studies primarily focus on demonstrating that the modifications do not introduce new questions of safety or effectiveness and that the modified device remains substantially equivalent to the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is an update to an existing device focusing on integrating new measurement modules (Masimo O3, IRMA CO2, ISA CO2) and updating EMC standards, the "acceptance criteria" are primarily related to meeting established performance standards for patient monitors and demonstrating that the new modules function as intended without compromising the overall device safety or efficacy. The document doesn't present specific numerical acceptance criteria for all physiological parameters of the overall monitor, but rather confirms compliance with recognized standards.

Acceptance Criteria Category	Details/Standard Adherence	Reported Device Performance
General Safety and Performance	Demonstrated compliance with harmonized standards.	Passed all safety tests for demonstrated compliance with harmonized standards.
Software Life Cycle Processes	IEC 62304:2015 Edition 1.1 (consolidated version) - Medical device software - software life cycle processes.	Complies. Software Verification and Validation testing was conducted, and documentation was provided as recommended by FDA guidance. Software Level of Concern determined to be Major.
Basic Safety and Essential Performance	AAMI/ANSI ES60601-1:2005/(R)2012 and A1:2012 (Ed. 3.1) - Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance.	Complies. Electrical safety testing conducted.
Electromagnetic Compatibility (EMC)	IEC 60601-1-2:2014 (Ed. 4.0) - Medical Electrical Equipment - Part 1-2: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Disturbances - Requirements And Tests.	Complies. EMC testing conducted. Note: The predicate device conformed to Ed. 3; the subject device updates to Ed. 4.
Alarm Systems	IEC 60601-1-8:2012 (Ed. 2.1) - Medical Electrical Equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral standard: General requirements, tests and guidance for alarm systems.	Device passed tests for this standard.
Respiratory Gas Monitors	ISO 80601-2-55:2011 (Ed. 1) - Medical Electrical Equipment - Part 2-55: Particular Requirements For The Basic Safety And Essential Performance Of Respiratory Gas Monitors.	Device passed tests for this standard.
System Level Device Specifications	Bench testing for system level device specifications.	Verified through bench testing.
Mechanical & Electrical Specifications	Bench testing for mechanical and electrical specifications.	Verified through bench testing.
Packaging Integrity	Bench testing for packaging integrity.	Verified through bench testing.
Shelf Life	Not applicable, as devices do not contain aging components.	No shelf life specified.
Sterility	Not applicable, as devices are not sterile.	Sterilization not evaluated.
Biocompatibility	Not applicable, as devices do not have patient contact.	Biocompatibility requirements are not applicable. Legally marketed medical accessories remain unchanged, so biocompatibility aspects are not affected.
Functionality of Added Masimo O3 Module	Intended use as an adjunct monitor of absolute and trended regional hemoglobin oxygen saturation of blood (rSO2) in the cerebral region for adults ≥40 kg and pediatrics ≥5 kg and <40 kg. (Reference Device: K162603)	The added Masimo O3 module's intended use fully aligns with the reference device, and its integration does not alter the substantial equivalence of the overall device. Received physiological data and forward it into existing SW infrastructure for presentation, data storage, user interface and alarming.
Functionality of Added Masimo IRMA/ISA CO2	Intended use as a gas analyzer for Carbon Dioxide. (Reference Devices: K123043, K171121)	The added IRMA/ISA CO2 measurements align with the reference devices and their integration does not alter the substantial equivalence of the overall device. Received physiological data and forward it into existing SW infrastructure for presentation, data storage, user interface and alarming.

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

The document explicitly states: "The IntelliVue Patient Monitors MX500 and MX550, like the predicate device, did not require clinical trials."

Therefore, there is no "test set" in the traditional sense of a clinical study involving patients or human readers. The evaluation was based on non-clinical bench testing and compliance with harmonized standards.

Sample Size for Test Set: Not applicable as no clinical test set was used.
Data Provenance: Not applicable. The data is from in-house bench testing and compliance evaluations against recognized standards.

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

Not applicable. As no clinical trials or human-in-the-loop performance studies were conducted for this submission, there was no need for experts to establish ground truth in the context of a test set involving patient data or diagnostic interpretations. The ground truth for the functionality of the integrated Masimo modules is established by their prior clearance as standalone devices (reference devices K162603, K123043, K171121).

4. Adjudication Method for the Test Set

Not applicable, as no clinical test set requiring adjudication was used.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The submission states, "The IntelliVue Patient Monitors MX500 and MX550, like the predicate device, did not require clinical trials." This indicates that there was no study involving human readers or AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

While there isn't an "algorithm only" study defined in the context of AI, the performance of the integrated components (Masimo O3, IRMA CO2, ISA CO2 modules) in receiving and forwarding physiological data was evaluated. This can be seen as a form of standalone testing of the integration without human interpretation. The original Masimo devices (reference devices) would have undergone their own standalone validation studies prior to their clearances (K162603, K123043, K171121), which are implicitly relied upon here. This submission focuses on the integration into the Philips monitor.

7. Type of Ground Truth Used

For the integrated measurement modules:

Previous FDA clearances of reference devices: The performance and safety of the Masimo O3 Regional Oximeter System, Masimo Infrared Mainstream Gas Analyzer CO2, and Masimo Infrared Sidestream Gas Analyzer CO2 were established during their original 510(k) clearances (K162603, K123043, K171121). This forms the "ground truth" for their individual measurement capabilities.
Compliance with harmonized standards: For the overall monitor and its specific functions (e.g., electrical safety, EMC, alarm systems), the ground truth is defined by meeting the requirements of internationally recognized standards (e.g., IEC 60601 series, ISO 80601-2-55).
Bench testing results: In-house bench testing validated the system-level specifications, mechanical/electrical aspects, and software functionality according to pre-defined internal test protocols and specifications derived from design requirements.

8. Sample Size for the Training Set

Not applicable. This device is a patient monitor with physiological measurement capabilities, not an AI/machine learning device that requires a training set in the typical sense. Its functionality is based on established engineering principles and validated measurement technologies.

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

Not applicable, as there is no training set for this device.

Summary

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September 11, 2020

Philips Medizin Systeme Boeblingen GmbH Stefan Breuer Senior Regulatory Affairs Engineer Hewlett-Packard-Str. 2 Boeblingen, 71034, Germany

Re: K192137

Trade/Device Name: IntelliVue Patient Monitor MX500, IntelliVue Patient Monitor MX550 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, DSI, MLD, DSJ, DSK, DXN, DXG, KRB, DRO, DRT, DPS, MLC, DRW, KRC, DRJ, DQA, DSB, DSH, DSF, DRS, DSA, MSX, DRG, MUD, CCK, CBQ, NHO, NHP, NHQ, CBS, CBR, CCL, BZC, BZQ, LKD, KLK, KOL, GWR, GWS, FLL Dated: August 12, 2020 Received: August 13, 2020

Dear Stefan Breuer:

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

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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 medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

for

Jennifer Shih Kozen Assistant Director DHT2A: Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Expiration Date: 06/30/2020 See PRA Statement below.

Form Approved: OMB No. 0910-0120

510(k) Number (if known) K192137

Device Name

IntelliVue Patient Monitor MX500, IntelliVue Patient Monitor MX550

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 additionally intended for use in transport situations within hospital environments.

The monitors are only for use on one patient at a time. 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 EC 11).

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

The transcutaneous gas measurement (tcGas) with the M1018A plug-in module is restricted to neonatal patients only.

(continued on next page)

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
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information unless it displays a currently valid OMB number."

FORM FDA 3881 (7/17)	Page 1 of 2	PSC Publishing Services (301) 443-6740 EF
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Indications for Use (continued)

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.

FORM FDA 3881 (7/17)	Page 2 of 2	PSC Publishing Services (301) 443-6740
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510(k) Summary 5

510(k) Summary
SUBMITTER
5.1	Date Prepared	August 12, 2020
5.2	Submitter/Owner	Philips Medizin Systeme Boeblingen GmbHFDA Establishment Registration Number 9610816Hewlett-Packard-Str. 271034 BoeblingenGermanyPhone: +49 151 1961 5514Fax: +49 7031 463 2202
5.3	Key Contact	Stefan BreuerSenior Regulatory Affairs EngineerStefan.Breuer@philips.com
5.4	510(k) Submission Type	Abbreviated 510(k)
DEVICE
5.5	Trade Name	IntelliVue Patient Monitors MX500 and MX550
5.6	Common Name	Multiparameter Patient Monitor
5.7	ClassificationName	Device Panel	Classification	ProCode	Description
CardiovascularDevices		§870.1025, II	MHX	Monitor, Physiological, Patient(with arrhythmia detection oralarms)
		§870.1025, II	DSI	Detector and alarm, arrhythmia
		§870.1025, II	MLD	Monitor, ST Segment withAlarm
		§870.1100, II	DSJ	Alarm, Blood Pressure
		§870.1110, II	DSK	Computer, Blood Pressure
		§870.1130, II	DXN	System, Measurement, Blood-Pressure, Non-Invasive
		§870.1435, II	DXG	Computer, Diagnostic, Pre-Programmed, Single-Function
		§870.1915, II	KRB	Probe, Thermodilution
		§870.2060, II	DRQ	Amplifier and SignalConditioner, Transducer Signal
		§870.2300, II	DRT	Monitor, Cardiac (incl.Cardiotachometer & Rate

Philips Monitoring & Analytics

8870.2340, II

PHILIPS

+49 151 1961 5514

Nancy.Annunziato@philips.com

DPS

MLC

Electrocardiograph

Monitor, ST Segment

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IntelliVue Patient Monitors MX500 and MX550

§870.2350, II	DRW	Electrocardiograph, LeadSwitching Adapter
§870.2370, II	KRC	Tester, Electrode, Surface,Electrocardiograph
§870.2600, I	DRJ	System, Signal Isolation
§870.2700, II	DQA	Oximeter
§870.2770, II	DSB	Plethysmograph, Impedance
§870.2800, II	DSH	Recorder, Magnetic tape,Medical
§870.2810, I	DSF	Recorder, Paper Chart
§870.2850, II	DRS	Extravascular Blood PressureTransducer
§870.2900, I	DSA	Cable, Transducer andElectrode, incl. PatientConnector
-	MSX	System, Network andCommunication, PhysiologicalMonitors
§870.2910, II	DRG	Transmitters and Receivers,Physiological Signal,Radiofrequency
§870.2700, II	MUD	Oximeter, Tissue Saturation
AnesthesiologyDevices	§868.1400, II	CCK	Analyzer, Gas, Carbon Dioxide,Gaseous-Phase
	§868.1500, II	CBQ	Analyzer, Gas, Enflurane,Gaseous-Phase (AnestheticConcentration)
	§868.1500, II	NHO	Analyzer, Gas, Desflurane,Gaseous-Phase (AnestheticConcentration)
	§868.1500, II	NHP	Analyzer, Gas, Sevoflurane,Gaseous-Phase (AnestheticConcentration)
	§868.1500, II	NHQ	Analyzer, Gas, Isoflurane,Gaseous-Phase (AnestheticConcentration)
	§868.1620, II	CBS	Analyzer, Gas, Halothane,Gaseous-Phase (AnestheticConcentration)
	§868.1700, II	CBR	Analyzer, Gas, Nitrous Oxide,Gaseous-Phase (AnestheticConcentration)
	§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 not under GasAnesthesia
	§868.2775 II	KOI	Electrical peripheral nervestimulator

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IntelliVue Patient Monitors MX500 and MX550

NeurologicalDevices	§882.1400, II	GWR	Electroencephalograph
	§882.1420, I	GWS	Analyzer, Spectrum,Electroencephalograph Signal
GeneralHospital andPersonal UseDevices	§880.2910, II	FLL	Thermometer, Electronic,Clinical

PREDICATE DEVICE

5.8 Predicate Devices		510(k) No.	Company Name Device Name	Product Code
	Primary Predicate	K161531	PhilipsIntelliVue Patient Monitors MX500 and MX550	See Section5.7
Reference Devices	Reference Device	K162603	Masimo O3 Regional Oximeter System	MUD
	Reference Device	K123043	Masimo Infrared Mainstream Gas Analyzer CO2	CCK, CBQ,CBR, CBS,NHO, NHP,NHQ
	Reference Device	K171121	Masimo Infrared Sidestream Gas Analyzer CO2	MWI, BZQ,CAT, CBQ,CBR, CBS,CCK, CCL,DPZ, DQA,DXN, FLL,GWQ, GXY,NHO, NHP,NHQ, OLT,OLW, OMC,ORT

The Philips IntelliVue Patient Monitor MX500 is substantially equivalent to the legally marketed Philips IntelliVue Patient Monitor MX500 (K161531).

The Philips IntelliVue Patient Monitor MX559 is substantially equivalent to the legally marketed Philips IntelliVue Patient Monitor MX550 (K161531).

DEVICE DESCRIPTION

5.9 Philips IntelliVue Patient Monitors MX500 and MX550 - description of the device per 21 CFR 807.92(a)(4)

Image /page/6/Picture/11 description: The image shows the Philips logo, which is a blue shield shape. Inside the shield, there are two wavy lines and two four-pointed stars. The word "PHILIPS" is written in blue at the top of the shield.

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The monitors can interact with several compatible external measuring and auxiliary devices locally at the bedside or in transport situations and with the Central Station via LAN or wireless link.

INDICATIONS FOR USE

5.10 Intended Use as required per 21 CFR 807.92(a)(5)

Image /page/7/Picture/8 description: The image shows the Philips logo, which consists of the word "PHILIPS" in a sans-serif font, positioned above a circular emblem. The emblem features two wavy lines and four stars, all rendered in a blue color. The logo is simple and recognizable, representing the brand's identity.

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PH

Image /page/8/Picture/4 description: The image features the Philips logo, which is a blue shield shape. Inside the shield, there are two wavy lines at the top and four stars at the bottom. The word "PHILIPS" is written in white at the top of the shield.

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PhilipsIntelliVuePatientMonitorsMX500 andMX550	The monitors are indicated for use by health care professionals whenever there is a needfor monitoring the physiological parameters of patients.
	The monitors are intended to be used for monitoring and recording of, and to generatealarms for, multiple physiological parameters of adults, pediatrics, and neonates. Themonitors are intended for use by trained healthcare professionals in a hospitalenvironment.
	The monitors are additionally intended for use in transport situations within hospitalenvironments.
	The monitors are only for use on one patient at a time. They are not intended for homeuse. Not therapeutic devices. The monitors are for prescription use only.
	The ECG measurement is intended to be used for diagnostic recording of rhythm anddetailed morphology of complex cardiac complexes (according to AAMI EC 11).
	ST segment monitoring is intended for use with adult patients only and is not clinicallyvalidated for use with neonatal and pediatric patients.
	The transcutaneous gas measurement (tcGas) with the M1018A plug-in module isrestricted to neonatal patients only.
	BIS is intended for use under the direct supervision of a licensed health care practitioneror by personnel trained in its proper use. It is intended for use on adult and pediatricpatients within a hospital or medical facility providing patient care to monitor the state ofthe brain by data acquisition of EEG signals. The BIS may be used as an aid in monitoringthe effects of certain anesthetic agents. Use of BIS monitoring to help guide anestheticadministration may be associated with the reduction of the incidence of awareness withrecall in adults during general anesthesia and sedation.
PrimaryPredicate	The SSC Sepsis Protocol, in the ProtocolWatch clinical decision support tool, is intendedfor use with adult patients only.
	The Integrated Pulmonary Index (IPI) is intended for use with adult and pediatric (1 to 12years) patients only. The IPI is an adjunct to and not intended to replace vital signmonitoring.
	The derived measurement Pulse Pressure Variation (PPV) is intended for use withsedated patients receiving controlled mechanical ventilation and mainly free from cardiacarrhythmia. The PPV measurement has been validated only for adult patients.
	The IntelliVue NMT Module is intended to be used as an objective neuromusculartransmission monitor, using accelerometry for measuring the muscle contraction followingan electrical stimulation of a peripheral nerve. The NMT Module is intended to be usedwith adult and pediatric patients.
	The Masimo rainbow SET measurement is indicated for the noninvasive monitoring offunctional oxygen saturation of arterial hemoglobin (SpO2), pulse rate,carboxyhemoglobin saturation (SpCO), methemoglobin saturation (SpMet), totalhemoglobin concentration (SpHb), and/or respiratory rate (RRac). The Masimo rainbowSET measurement is indicated for use during both no motion and motion conditions, andfor patients who are well or poorly perfused.

Philips Monitoring & Analytics Stefan.Breuer@philips.com Nancy.Annunziato@philips.com

Image /page/9/Picture/5 description: The image shows the Philips logo, which is a blue shield shape. Inside the shield, there are two wavy lines and two four-pointed stars. Above the shield, the word "PHILIPS" is written in blue.

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COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PRIMARY PREDICATE DEVICE

5.11 Predicate Device Comparison Table

Similarities
Feature of Comparison	Description of Feature
Indications for use	Indicated for use by health care professionals whenever there is a needfor monitoring the physiological parameters of patients.
Users	Healthcare professionals
Target patient population	Adult, pediatric, neonatal
Environment of use	In hospital environments
Monitor mechanical andelectrical/electronichardware, includingdimensions and weight	The proposed changes do not cause any changes to the monitors'electrical or mechanical hardware.
Human, device and systeminterfaces	The human, device and system interfaces of the monitors are not alteredby the proposed changes.
Electrical safety	ANSI/AAMI ES60601-1:2005/(R)2012, Ed.3 (cons.),IEC 60601-1, Ed.3.1:2012-08 (cons.)
Temperature/humidityspecifications	Temperature and humidity specifications are not affected by theproposed changes.
Biocompatibility	The devices do not have patient contact, therefore biocompatibilityaspects are not applicable.

Differences
Feature of Comparison	Description of Feature
Intended use	The intended use has been extended by the intended use of the addedMasimo O3 Regional Oximeter System:The noninvasive Masimo O3 Regional Oximeter System andaccessories are intended for use as an adjunct monitor of absolute andtrended regional hemoglobin oxygen saturation of blood (rSO2) in thecerebral region under the sensors. The Masimo O3 Regional OximeterSystem and accessories are indicated for use on adults ≥40 kg and onpediatrics ≥5 kg and <40 kg in healthcare environments.This added statement is unchanged from the reference device and doesnot alter the substantial equivalence of the devices.
Supported physiologicalmeasurements, includingall specifications andaccessories	Masimo O3, IRMA CO2 and ISA CO2 have been added to the otherwiseunchanged physiological measurements that the devices support.The added measurements do not alter the substantial equivalence of thedevices.
Electromagneticcompatibility	Subject devices conform to IEC 60601-1-2:2014 (Ed. 4); predicatedevices have conformed to IEC 60601-1-2:2007 (Ed. 3).This change is due to updated recognized consensus standards anddoes not alter the substantial equivalence of the devices.
Plug-in modules	Two plug-in modules are added:

Philips Monitoring & Analytics Stefan.Breuer@philips.com Nancy.Annunziato@philips.com

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Differences
Feature of Comparison	Description of Feature
	O3 plug-in module (867184) digital interface and isolating powersupply to external Masimo O3 measurement device CO2 plug-in module (867185) digital interface and isolatingpower supply to external Masimo IRMA CO2 or ISA CO2measurement devices The added plug-in modules do not alter the substantial equivalence ofthe devices.
Monitor software	Two software modules have been added: "Masimo O3" and "Masimo CO2" The added software modules communicate with external Masimomeasurement device via O3/CO2 plug-in module 867184/867185.The added software modules receive physiological data from externalMasimo measurement device and forward it into existing, unchangedSW infrastructure for presentation, data storage, user interface andalarming.This does not alter the substantial equivalence of the devices.

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5.12 Substantial Equivalence Summary

The technological characteristics of this 510(k), the IntelliVue Patient Monitors MX500/MX550 with Masimo O3, IRMA CO2 and ISA CO2, are equivalent to the predicate devices IntelliVue Patient Monitors MX500/MX550.

Philips has additionally identified three reference devices for comparison in order to demonstrate substantial equivalence of the modified IntelliVue Patient Monitors. The tables in this summary identify the predicate and reference devices and highlight a comparison between the IntelliVue Patient Monitors MX500/MX550 (K161531, cleared July 1, 2016), Masimo O3 Regional Oximeter System (K162603, cleared May 26, 2017), Masimo Infrared Mainstream Gas Analyzer CO2 (K123043, cleared October 25, 2012), Masimo Infrared Sidestream Gas Analyzer CO2 (K171121, cleared November 17, 2017) and the proposed modifications to the IntelliVue Patient Monitors MX500/MX550.

The changes described within this 510(k) do not raise different question of safety or effect the safety or effectiveness of the devices. The risks associated with the use of the device are well characterized and do not raise different questions of safety or effectiveness. Risk analysis was performed and no new questions that could affect safety or effectiveness have been identified. Therefore, the modified devices incorporating the Masimo 03, IRMA CO2 and ISA CO2 measurements are substantially equivalent to the predicate devices.

PERFORMANCE DATA

5.13 Non-Clinical Tests - Harmonized Standards

The IntelliVue Patient Monitors MX500 and MX550 has passed all safety tests for demonstrated compliance with the harmonized standards below.

Standard	FDA Recognition #	Title #
IEC 62304:2015Edition 1.1(consolidatedversion)	13-79	Medical device software - software life cycle processes
AAMI/ANSIES60601-1:2005/(R)2012and A1:2012 (Ed.3.1)	19-4	Medical Electrical Equipment - Part 1: General Requirements for Basic Safety andEssential Performance
IEC 60601-1-2:2014 (Ed. 4.0)	19-8	Medical Electrical Equipment - Part 1-2: General Requirements For Basic SafetyAnd Essential Performance - Collateral Standard: Electromagnetic Disturbances -Requirements And Tests
IEC 60601-1-8:2012 (Ed. 2.1)	5-76	Medical Electrical Equipment - Part 1-8: General requirements for basic safety andessential performance - Collateral standard: General requirements, tests andguidance for alarm systems in medical electrical equipment and medical electricalsystems
ISO 80601-2-55:2011 (Ed. 1)	1-96	Medical Electrical Equipment - Part 2-55: Particular Requirements For The BasicSafety And Essential Performance Of Respiratory Gas Monitors

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Philips Monitoring & Analytics Stefan.Breuer@philips.com Nancy.Annunziato@philips.com

FDA Registration Number: 9610816

+49 151 1961 5514

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5.14 Non-clinical Bench Tests

Bench Testing and Shelf life

Bench testing was performed to verify system level device specifications, mechanical and electrical specifications, and packaging integrity.

The subject devices do not contain any aging components, thus, the likelihood of time-dependent product degradation is low. For this reason, a shelf life for these devices is not needed and, therefore, not specified.

Consequently, performance data is not needed to establish that device performance is maintained for the entirety of the shelf life.

The devices are not sterile, are not re-processed single use not intended for sterilization. Therefore sterilization is not evaluated for the proposed changes.

Biocompatibility

The subject devices do not have any contact with patients. Therefore, biocompatibility requirements are not applicable.

This is unchanged from the legally marketed predicate devices.

The legally marketed medical accessories intended for use with the subject devices, as listed in Annex E of the original 510(k), remain all unchanged. Therefore, biocompatibility aspects are not affected.

Software Verification and Validation

Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff - Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (2005). The Philips IntelliVue Patient Monitors MX500/MX550 Software Level of Concern was determined to be Major, since a failure or latent flaw could indirectly result in death or serious injury of the patient or operator through incorrect or delayed information or through the action of a care provider.

Electromagnetic Compatibility and Electrical Safety

Electrical safety and electromagnetic compatibility (EMC) testing was conducted on the Philips IntelliVue Patient Monitors MX500/MX550. The device complies with the applicable requirements within the ANSI AAM ES60601-1 / IEC 60601-1 standards for safety and the IEC 60601-1-2 standard for EMC.

No new issues of safety or effectiveness are introduced as a result of using this device.

5.15 Clinical Studies

The IntelliVue Patient Monitors MX500 and MX550, like the predicate device, did not require clinical trials.

FDA recognized standards, FDA guidance documents, harmonized standards, verfication and validation, software validation, usability validation, and risk management activities have taken place for the IntelliVue Patient Monitors MX500 and MX550.

Based upon the design, intended use, indication, usability and safety testing the IntelliVue Patient Monitors MX500 and MX550 is substantially equivalent to the listed predicate device.

No new issues of safety or effectiveness are introduced as a result of using this device.

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Philips Monitoring & Analytics Stefan.Breuer@philips.com Nancy.Annunziato@philips.com

FDA Registration Number: 9610816

+49 151 1961 5514

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CONCLUSIONS

The results of the substantial equivalence assessment, taken together with non-clinical bench testing, electrical safety and electromagnetic compatibility, software verification and validation demonstrate that the IntelliVue Patient Monitors MX500 and MX550 do 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 IntelliVue Patient Monitors MX500 and MX550 predicate device.

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+49 151 1961 5514

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.