The devices are intended to be used for monitoring and recording of, and to generate alarms for multiple physiological parameters of adults, pediatrics, and neonates.

Indications for Use:

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 only for use on one patient at a time.

The monitors are 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.

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 quide 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 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.

The SedLine Sedation Monitor is intended to monitor the state of the brain by real-time data acquisition and processing of EEG signals. The system includes the Patient State Index (PSI), a proprietary computed EEG variable that is related to the effect of anesthetic agents. The agents include: Alfentanil. Desflurane. Fentanyl. Isoflurane. Nitrous Oxide. Propofol. Remifentanil. and Sevoflurane. The SedLine Sedation Monitor is intended for use with adult patients (18 years of age and older) in the operating room (OR), intensive care unit (ICU), and clinical research laboratory.

The monitors are intended for use by trained healthcare professionals in a hospital environment. They are not intended for use in transport situations.

They are not intended for home use.

Device Description

All features and technological characteristics of the primary predicate IntelliVue Patient Monitors MX750 (866471), MX850 (866470) and IntelliVue 4-Slot Module Rack FMX-4 (866468) remain unchanged and are still applicable to the IntelliVue Patient Monitors, subject of this submission.

The proposed modifications for the IntelliVue Patient Monitors MX750/MX850 and IntelliVue 4-Slot Module Rack FMX-4 include:

1. A new software version, designated as IntelliVue Software P.01. The new software version introduces following new features:
- . New alarm sounds designated as "Philips 2021" sounds, based on a joint development of Philips and Sen Sound researchers who focus on transforming the experience of sound in healthcare.
- . New Visual Patient feature, which displays patients's vital signs in an animated patient avatar alongside the conventional vital sign waveforms and numerics.
- . configurable alarm management, limiting changes in alarm settings to pre-defined authorized personnel.

It further enhances following existing features

Manual Selection of QRS /Pulse Tone
Introduction of Lead Diagram for ECG
. Enhancement of Visual Presentation for "Global Alarm Off" State

AI/ML Overview

This document describes the Philips IntelliVue Patient Monitor MX750/MX850 and IntelliVue 4-Slot Module Rack FMX-4. The submission references a prior clearance (K221348) as the primary predicate device, indicating that the current submission is for modifications to an existing device.

Here's the breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" for performance in a table format with numerical values. Instead, it details that the device passed various tests related to electrical safety, EMC, wireless coexistence, software integration, software functionality within the system, essential performance, and human factors. The acceptance criterion for each of these tests is implied to be "PASSED" against recognized consensus standards and internal requirements.

Test Name	Test Description	Acceptance Criteria (Implied)	Reported Device Performance
Electrical Safety Testing	Tested to recognized consensus standards: IEC 60601-1, IEC 60601-1-8, IEC 62304	PASSED	PASSED
EMC Testing	Tested to recognized consensus standard: IEC 60601-1-2; Tested against common EM emitters	PASSED	PASSED
Wireless Coexistence	Test sensitivity of patient monitors to common interferers	PASSED	PASSED
Software Integration Testing	Test of new functionality integration into existing software infrastructure	PASSED	PASSED
Software Testing	Test of new software functionality ("Test Report for System Requirements Testing," "Test Report for Safety Risk Assessment," "Test Report for Regression Testing," "Test Report for Security Risk Assessment," "Test Report for Compatibility Testing")	PASSED	PASSED
Essential Performance Testing	Tests verifying that essential performance requirements are met (for Patient Monitors)	PASSED	PASSED
Human Factors	Test of device usability	PASSED	PASSED

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

The document does not specify the sample sizes used for any of the tests mentioned (e.g., how many devices were tested for electrical safety, or how many users were involved in human factors testing). It also does not specify the data provenance (e.g., country of origin, retrospective or prospective) for any of these non-clinical tests.

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

This information is not provided in the document. The tests described are primarily engineering and software validation tests rather than clinical studies requiring expert ground truth for interpretation. For "Human Factors," it would involve users, but their qualifications and numbers are not detailed.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

This information is not provided. The nature of the tests (compliance with standards, software functionality) suggests that a formal adjudication method like 2+1 or 3+1 for ground truth establishment, typical in clinical studies, would not be applicable here.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

A multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. This device is a patient monitor with software enhancements, not an AI-assisted diagnostic tool that would typically involve human readers interpreting output.

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

The document indicates "Software Testing" was performed, which would involve testing the algorithms and functionalities of the software in a standalone manner. However, it's not a standalone diagnostic algorithm in the typical sense; it's the core operating software of the patient monitor. The new features like "new alarm sounds," "Visual Patient feature," and "configurable alarm management" were tested for their functionality and integration.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The "ground truth" for the tests described is primarily based on:

Recognized consensus standards: For electrical safety (IEC 60601-1, IEC 60601-1-8, IEC 62304), EMC (IEC 60601-1-2).
System requirements/specifications: For software integration, software functionality, and essential performance.
Usability principles: For Human Factors testing.

There is no mention of expert consensus, pathology, or outcomes data being used as ground truth, as these are non-clinical hardware and software validation tests.

8. The sample size for the training set:

This information is not applicable as this document does not describe an AI or machine learning model that requires a training set. The changes described are software updates for existing functionalities and introduction of new display/alarm features, not the development of a predictive algorithm from data.

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

This information is not applicable for the same reason as point 8.

Summary

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December 19, 2023

Philips Medizin Systeme Boeblingen GmbH Siegfried Breitling Regulatory Affairs Specialist Hewlett-Packard-Strasse 2 Boeblingen, BW 71034 Germany

Re: K231671

Trade/Device Name: IntelliVue Patient Monitor MX750 (866471), Intelli Vue Patient Monitor MX850 (866470), IntelliVue 4-Slot Module Rack FMX-4 (866468) 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, BZC, BZQ, CBQ, CBR, CBS, CCK, CCL, DPS, DQA, DRT, DSF, DSJ, DSK, DXN, FLL, GWQ, GWS, KLK, KOI, LKD, MLD, MSX, NHO, NHP, NHQ Dated: November 17, 2023 Received: November 17, 2023

Dear Siegfried Breitling:

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 (the 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 available 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.

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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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).

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Sincerely,

Jennifer W. Shih -S

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

Enclosure

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Indications for Use

Submission Number (if known)

K231671

Device Name IntelliVue Patient Monitor MX750 (866471); IntelliVue Patient Monitor MX850 (866470);

IntelliVue 4-Slot Module Rack FMX-4 (866468)

Indications for Use (Describe)

Intended Use:

The devices are intended to be used for monitoring and recording of, and to generate alarms for multiple physiological parameters of adults, pediatrics, and neonates.

Indications for Use:

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 only for use on one patient at a time.

The monitors are not therapeutic devices.

The monitors are for prescription use only.

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

The Masimo rainbow SET measurement is indicated for the noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate, carboxyhemoglobin saturation (SpCO),

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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 monitors are intended for use by trained healthcare professionals in a hospital environment. They are not intended for use in transport situations.

They are not intended for home use.

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)

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K231671 510(k) Summary

Submitter/Owner	Philips Medizin Systeme Böblingen GmbHFDA Establishment Number 9610816Hewlett-Packard-Str. 271034 BöblingenGermany
	Phone: +49 151 40903561
Trade Name	IntelliVue Patient Monitor MX750IntelliVue Patient Monitor MX850IntelliVue 4-Slot Module Rack FMX-4
Common Name	Multiparameter Patient Monitor
Classification Name	Panel & Name: Cardiovascular DevicesSubpart & Division: 21 CFR §870.1025Regulatory Class: IIProduct Code: MHX
Predicate Device	510(k) No.	Company	Device Name	ProductCode
K221348 is the primarypredicate device.	K221348	Philips	IntelliVue Patient Monitor MX750IntelliVue Patient Monitor MX850IntelliVue 4-Slot Module Rack FMX-4	MHX

Intended Use andIndications for Use	Intended Use:
The modified IntelliVuePatient Monitors MX750and MX850 have the sameintended use andindications as the legallymarketed predicate device.	The devices are intended to be used for monitoring and recording of, and togenerate alarms for multiple physiological parameters of adults, pediatrics,and neonates.
	Indications for Use:
	The monitors are indicated for use by health care professionals wheneverthere is a need for monitoring the physiological parameters of patients.
	The monitors are only for use on one patient at a time.
	The monitors are not therapeutic devices.
	The monitors are for prescription use only.
	The ECG measurement is intended to be used for diagnostic recording ofrhythm and detailed morphology of complex cardiac complexes (accordingto AAMI EC 11).
	ST segment monitoring is intended for use with adult patients only and isnot clinically validated for use with neonatal and pediatric patients.

BIS is intended for use under the direct supervision of a licensed healthcare practitioner or by personnel trained in its proper use. It is intendedfor use on adult and pediatric patients within a hospital or medical facilityproviding patient care to monitor the state of the brain by data acquisitionof EEG signals. The BIS may be used as an aid in monitoring the effects ofcertain anesthetic agents. Use of BIS monitoring to help guide anestheticadministration may be associated with the reduction of the incidence ofawareness with recall in adults during general anesthesia and sedation.
The SSC Sepsis Protocol, in the ProtocolWatch clinical decision supporttool, is intended for use with adult patients only.
The Integrated Pulmonary Index (IPI) is intended for use with adult andpediatric (1 to 12 years) patients only. The IPI is an adjunct to and notintended to replace vital sign monitoring. The IPI is an adjunct to and notintended to replace vital sign monitoring.
The derived measurement Pulse Pressure Variation (PPV) is intended foruse with sedated patients receiving controlled mechanical ventilation andmainly free from cardiac arrhythmia. The PPV measurement has beenvalidated only for adult patients.
The IntelliVue NMT Module is intended to be used as an objectiveneuromuscular transmission monitor, using accelerometry for measuringthe muscle contraction following an electrical stimulation of a peripheralnerve. The NMT Module is intended to be used with adult and pediatricpatients.
The Masimo rainbow SET measurement is indicated for the noninvasivemonitoring of functional oxygen saturation of arterial hemoglobin (SpO2),pulse rate, carboxyhemoglobin saturation (SpCO), methemoglobinsaturation (SpMet), total hemoglobin concentration (SpHb), and/orrespiratory rate (RRac). The Masimo rainbow SET measurement isindicated for use during both no motion and motion conditions, and forpatients who are well or poorly perfused.
The noninvasive Masimo O3 Regional Oximeter System and accessoriesare intended for use as an adjunct monitor of absolute and trendedregional hemoglobin oxygen saturation of blood (rSO2) in the cerebralregion under the sensors. The Masimo O3 Regional Oximeter System andaccessories are indicated for use on adults ≥40 kg and on pediatrics >5 kgand <40 kg in healthcare environments.
The SedLine Sedation Monitor is intended to monitor the state of the brainby real-time data acquisition and processing of EEG signals. The systemincludes the Patient State Index (PSI), a proprietary computed EEG variable
that is related to the effect of anesthetic agents. The agents include:Alfentanil, Desflurane, Fentanyl, Isoflurane, Nitrous Oxide, Propofol,Remifentanil, and Sevoflurane. The SedLine Sedation Monitor is intendedfor use with adult patients (18 years of age and older) in the operatingroom (OR), intensive care unit (ICU), and clinical research laboratory.
The monitors are intended for use by trained healthcare professionals in ahospital environment.They are not intended for use in transport situations.They are not intended for home use.

Image /page/5/Picture/6 description: The image shows the Philips logo, which is a blue shield shape. Inside the shield, there are two wavy lines that resemble water or sound waves. Above and below the waves, there are two four-pointed stars. The word "PHILIPS" is written in white at the top of the shield.

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Image /page/6/Picture/4 description: The image shows the Philips logo, which is a blue shield shape. Inside the shield is a white circle with two wavy lines across the middle. There are also two four-pointed stars, one above the wavy lines and one below. The word "PHILIPS" is written in white at the top of the shield.

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Summary of Reason forNotification
The reason for this traditional 510(k) submission is to:
Notify FDA on modifications carried out on the IntelliVue Software,
	which is the software platform common to the legally marketed Philips
	IntelliVue Patient Monitors MX750/MX850 and their designated FMX-4
	(K221348). The software changes resulted in a new IntelliVue Software
	version, bringing these devices to software version P.01.

Image /page/7/Picture/5 description: The image shows the Philips logo, which is a blue shield shape. Inside the shield are two wavy lines and four stars. The word "PHILIPS" is written in white at the top of the shield.

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1. Description of the Subject Devices: IntelliVue Patient Monitors MX750/MX850 and IntelliVue 4-Slot Module Rack FMX-4

The proposed modifications for the IntelliVue Patient Monitors MX750/MX850 and IntelliVue 4-Slot Module Rack FMX-4 include:

1. A new software version, designated as IntelliVue Software P.01. The new software version introduces following new features:
- . New alarm sounds designated as "Philips 2021" sounds, based on a joint development of Philips and Sen Sound researchers who focus on transforming the experience of sound in healthcare.
- . New Visual Patient feature, which displays patients's vital signs in an animated patient avatar alongside the conventional vital sign waveforms and numerics.
- . configurable alarm management, limiting changes in alarm settings to pre-defined authorized personnel.

It further enhances following existing features

Manual Selection of QRS /Pulse Tone
Introduction of Lead Diagram for ECG
. Enhancement of Visual Presentation for "Global Alarm Off" State

Model Number	Product Name / Description
866471	IntelliVue Patient Monitor MX750
866470	IntelliVue Patient Monitor MX850
866468	IntelliVue 4-Slot Module Rack FMX-4

Table 1 - Device Identifying Information

Image /page/8/Picture/16 description: The image shows the Philips logo. The logo is blue and white. The word "PHILIPS" is in blue at the top of the logo. Below the word is a white shield shape with two wavy lines and four stars inside.

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1.1 Discussion of Similarities and Differences

Intended Use and Indications for Use

Intended use and indications for use of the modified IntelliVue Patient Monitors MX750/MX850 and their designated FMX-4 are the same as those of the primary predicate IntelliVue Patient Monitors MX750/MX850 and their designated FMX-4 .

Environment of Use, Intended Users

All subject and predicate devices are intended for use inside hospital environments.

All subject and predicate devices are for use by trained healthcare professionals.

In summary, the environment of use and intended users of the subject devices IntelliVue Patient Monitors MX750/MX850 and their designated FMX-4 is the same as those of their predicate devices.

Technological Characteristics

The device design, materials and energy sources of the modified IntelliVue Patient Monitors MX750/MX850 and their designated FMX-4 are the same as those of their predicate IntelliVue Patient Monitors MX750/MX850 and their designated FMX-4.

The software of the IntelliVue Patient Monitors MX750/MX850 and their designated FMX-4 was slightly changed in order to:

further enhance some of the existing functionalities, i.e re-design of existing alarm sounds o (adding the Philips 2021 sounds), enabling the user authentication capability, limiting the access to Early Warning Score (EWS) data and allow for user validation of the data by means of authentication, additional configuration for manual selection of QRS /Pulse Tone, additional lead diagram for ECG and the enhanced presentation of the "Global Alarm off" state.
o include an additional form of vital signs presentation, which presents physiological parameters in a more intuitive way, by means of an animated patient avatar i.e Visual Patient feature.

Other key technological features

The proposed modification does not introduce any new hardware features.

Operating principle, mechanisms of action and human interface are unchanged from the predicate devices.

All accessories of the legally marketed predicate devices IntelliVue Patient Monitors MX750/MX850 and their designated FMX-4 are re-used without any change.

The physiological measurements of the legally marketed IntelliVue Patient Monitors MX750/MX850 and their designated FMX-4 remain unchanged.

Image /page/9/Figure/20 description: The image shows the Philips logo, which is a blue shield shape. Inside the shield, there are two wavy lines that resemble water. Above and below the wavy lines, there are four-pointed stars. The word "PHILIPS" is written in blue at the top of the shield.

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Performance specifications of all supported measurements remain unchanged by the proposed modification.

In summary, key technological features are mostly unchanged, and the modifications do not raise any different questions of safety and effectiveness as compared to the predicate device.

Image /page/10/Picture/5 description: The image shows the Philips logo, which consists of the word "PHILIPS" in a white, sans-serif font above a blue shield-like shape. Inside the blue shape, there is a white background with two wavy lines and four stars. The wavy lines are arranged horizontally, and the stars are positioned above and below the lines.

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2. Summary of Performance Testing

The following table provides an overview how the proposed modification has been verified:

Table 1 - Summary of Performance Testing

Test Name	Test Description	Attachments	Result
Electrical Safety Testing	Tested to recognized consensus standardsIEC 60601-1IEC 60601-1-8IEC 62304	"IEC 60601-1 Test Report"TR: 282234-TL4-1"IEC 60601-1-8 Test Report"TR: 291778-TL4-16“IEC 62304 Test Report"TR: 291778-TL4-20	PASSED
EMC Testing	Tested to recognized consensus standardIEC 60601-1-2Tested against common EM emitters	"EMC Test Report"TR: 2021113-02-I	PASSED
Wireless Coexistence	Test sensitivity of patient monitors tocommon interferers	"Wireless Coexistence Test Report"	PASSED
Software Integration Testing	Test of new functionality integration intoexisting software infrastructure	"Test Report for Integration Testing"	PASSED
Software Testing	Test of new software functionality	"Test Report for System Requirements Testing""Test Report for Safety Risk Assessment""Test Report for Regression Testing""Test Report for Security Risk Assessment""Test Report for Compatibility Testing"	PASSED
Essential PerformanceTesting	Tests verifying that essential performancerequirements are met.	For Patient Monitors:“Monitor EP Verification Report1""Monitor EP Verification Report2"	PASSED
Human Factors	Test of device usability	"Human Factors Engineering Report"	PASSED

Image /page/11/Picture/7 description: The image shows the Philips logo. The logo is a blue shield shape with the word "PHILIPS" written at the top. Inside the shield is a white circle with two wavy lines and two stars.

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Table 3 - Summary of non-clinical and clinical testing

Non-clinical Bench Tests
No new issues of safety or effectiveness as compared to the predicate are introduced because of using this device.
Clinical Studies
The subject devices, like the primary predicate devices, did not require clinical trials.
Compliance to the FDA Quality System Regulations, FDA recognized standards, FDA guidance documents, harmonized standards, verificationand validation, software validation, usability validation, and risk management activities have taken place for the subject devices.
Based upon the design, intended use, indications for use, classification, usability and safety testing, the subject devices are substantiallyequivalent to the listed predicate devices.
No new issues of substantial equivalence are introduced as a result of using this device.

Image /page/12/Picture/5 description: The image contains the Philips logo. The logo is a blue oval with the word "PHILIPS" written in white at the top. Inside the oval, there are two wavy lines and four stars. The stars are arranged in a diamond shape, with one star at the top, one at the bottom, and one on each side.

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.