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 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 transcutaneous gas measurement (tcGas) is restricted to neonatal patients only. 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.

Device Description

The subject devices Intelli Vue Patient Monitors MX400, MX450, MX500, and MX550 are display units with a TFT LCD flat panel display and built-in CPU. The specific models differ in the size of their flat panel displays and in the number of supported external measurement modules.

MX400 has a 9" display, MX450 and MX500 have a 12" display and MX550 has a 15" display. In addition to the MX400 and MX450, the MX500 and MX550 models have three integrated slots for use with the dedicated external plug-in modules.

The monitors do not have any built-in measurements. They are intended to be connected to any one of the external IntelliVue family physiological multi-measurement modules and/or (MX500/MX550 only) to the IntelliVue plug-in measurement modules.

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, C.O., CCO, intravascular SO2, spirometry, EEG, gas measurements, and NMT. The interaction with the patient depends on the monitored physiological parameter(s).

The monitors acquire multiple physiological patient signals (via connected external measurement modules), display measurement values, waves and trends, generate physiological and technical alarms, provide data recording and support patient data management.

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. The monitors can also be used mobile, during patient transport in a hospital setting.

The measurement sensors of the connected external measurement modules are applied at diverse bodily locations, depending on the actual physiological parameters monitored, e.g. on a patient's finger for the pulse oximetry or on a patient's upper arm for the non-invasive blood pressure.

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

The monitors interact with the connected external measurement devices locally at the bedside or in transport situations and with the Central Station via LAN or wireless link.

The modification, which is subject of this Premarket Notification, enables the IntelliVue Patient Monitors MX400, MX450, MX500, and MX550 via software update to support two additional features: Remote Display application and Remote Applications, The Remote Display application feature provides the possibility to view an independent monitor screen on an external display and to operate patient monitor from the external display.

The Remote Applications feature allows the user of the patient monitor to access remotely hosted, pre-configured applications made available by the hospital.

The added functionalities are the same as those already provided by other legally marketed Philips IntelliVue Patient Monitors, such as predicate model MX800. For access to the Remote Applications, the predicate Intelli Vue Patient Monitor MX800 supports commercial application server technology, whereas the modified IntelliVue Patient Monitors MX400, MX450, MX500, and MX550 support commercial application server technology as well as the HTML5 protocol for compatibility with standard web application servers

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Philips IntelliVue Patient Monitors MX400, MX450, MX500, and MX550, based on the provided 510(k) summary:

This submission describes a software update to existing patient monitors, adding "Remote Display application" and "Remote Applications" features. Therefore, the V&V activities primarily focus on confirming the correct functioning of these new software features and ensuring that previously cleared functionalities are not negatively impacted.

1. Table of Acceptance Criteria and Reported Device Performance

Since this submission is a software update for existing devices, the "acceptance criteria" are primarily related to the successful implementation and verification of the new features and the continued performance of existing features. The document highlights the meeting of existing specifications and "pass/fail criteria" from previous clearances.

Acceptance Criteria Category	Specific Criteria (Implicit/Explicit)	Reported Device Performance
New Features Functionality	Remote Display Application: - Correct presentation of parameter data on the Remote Display. - Correct presentation of alarm and/or INOP information on the Remote Display. - Correct presentation of operating windows on the Remote Display. - Ability to operate patient monitors from the Remote Display. Remote Applications: - Correct display of remote applications on the monitor screen. - Operability of remote applications with user input devices.	Remote Display Application: "The conducted tests demonstrate that parameter data, alarm and/ or INOP information and operating windows provided by the modified patient monitors are correctly presented on the Remote Display and that the patient monitors can be operated from the Remote Display." Remote Applications: "The conducted tests demonstrate that the remote applications are correctly shown on the display of the modified patient monitors and can be operated with user input devices."
Safety & Risk Mitigation	- All specified pass/fail criteria from Hazard Analysis met. - Effectiveness of implemented design risk mitigation measures.	"All specified pass/fail criteria have been met. The test results confirmed the effectiveness of the implemented design risk mitigation measures."
Regression/Non-Interference	Unchanged and unaffected functions from the previous software (Rev. K.10) continue to work correctly with the new software (Rev. K.20). - Safe, effective, and correct operation according to all specifications and labeling claims of the predicate devices.	"The regression tests demonstrate that the modified patient monitors work safely, effectively, and correctly in accordance with all specifications and labeling claims." "Pass/Fail criteria were based on the specifications cleared for the predicate devices and test results showed substantial equivalence."
General Reliability & Performance	Meeting all defined reliability requirements and performance claims.	"The results demonstrate that the Philips Intelli Vue Patient Monitors MX400, MX450, MX500, and MX550 meet all defined reliability requirements and performance claims."

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

The document does not explicitly state the "sample size" in terms of number of patients or cases for clinical data. Instead, the testing is described as functional and regression testing on the physical devices (monitors).

Sample Size: Not applicable in the context of clinical patient data. The "sample" would be the specific hardware models (MX400, MX450, MX500, MX550) with the updated software (Rev. K.20). The tests were conducted on these devices.
Data Provenance: Not applicable as it's not a clinical study involving patient data. The testing was an internal validation and verification (V&V) activity.

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

Not applicable. The ground truth for this type of V&V (functional and regression testing of software features on a patient monitor) is the expected behavior and output of the device as defined by its specifications and design documents. It does not involve expert clinical assessment of patient data.

4. Adjudication Method for the Test Set

Not applicable. This was internal engineering and software testing against predefined functional and non-functional requirements and previous device specifications. It does not involve adjudication of clinical findings.

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

Not applicable. This submission is for a software update to a patient monitor, adding features for remote display and remote application access. It does not involve an AI component for interpretation or diagnosis, nor does it involve human readers assessing cases.

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

Not applicable. The device is a patient monitor, which continuously collects and displays physiological parameters. The new features (Remote Display and Remote Applications) are functionalities that enhance how users interact with and access data from the monitor. There isn't a standalone "algorithm" in the diagnostic or interpretative sense tested separately.

7. The Type of Ground Truth Used

The ground truth used for this V&V was based on:

Device Specifications: The pre-defined expected outputs and behaviors of the patient monitor and its new features.
Predicate Device Performance: The established performance and specifications of the previously cleared IntelliVue Patient Monitors (Rev. K.10 and MX800 models).
Hazard Analysis Requirements: Safety criteria and risk mitigation effectiveness.

8. The Sample Size for the Training Set

Not applicable. This is not a machine learning or AI-based device that requires a training set of data. The "training" for the software involves its development, coding, and internal debugging processes, not a dataset in a machine learning context.

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

Not applicable, as there is no training set in the machine learning sense.

Summary

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510(k) Summary

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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
  Markus Stacha Philips Medizin Systeme Boeblingen GmbH Hewlett-Packard-Str. 2 D-71034 Boeblingen, Germany Tel: +49 7031 463-2840 Fax: +49 7031 463-2442 e-mail: markus.stacha@philips.com

This summary was prepared on April 16, 2014.

1. The name and classification of the devices:
  Trade name: IntelliVue Patient Monitors MX400, MX450, MX500, and MX550 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	DSI	Detector and alarm, arrhythmia
	§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
	§870.1435, II	DXG	Computer, Diagnostic, Pre-Programmed,Single-Function
	§870.1915, II	KRB	Probe, Thermodilution
	§870.2060, II	DRQ	Amplifier and Signal Conditioner,Transducer Signal
	§870.2300, II	DRT	Monitor, Cardiac (incl. Cardiotachometer& Rate Alarm)
	§870.2340, II	DPS	Electrocardiograph
	§870.2340, II	MLC	Monitor, ST Segment
	§870.2350, II	DRW	Electrocardiograph, Lead SwitchingAdapter
	§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

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PHILIPS

Device Panel	Classification	ProCode	Description
	§870.2800, II	DSH	Recorder, Magnetic tape, Medical
	§870.2810, I	DSF	Recorder, Paper Chart
	§870.2850, II	DRS	Extravascular Blood Pressure Transducer
	§870.2900, I	DSA	Cable, Transducer and Electrode, incl. Patient Connector
	-	MSX	System, Network and Communication, Physiological Monitors
		§870.2910, II	DRG
Anesthesiology Devices	§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 not under Gas Anesthesia
	§868.2775 II	KOI	Electrical peripheral nerve stimulator
Neurological Devices	§882.1400, II	GWR	Electroencephalograph
	§882.1420, I	GWS	Analyzer, Spectrum, Electroencephalograph Signal
General Hospital and Personal Use Devices	§880.2910, II	FLL	Thermometer, Electronic, Clinical

1. The modified devices Philips IntelliVue Patient Monitors MX400, MX450, MX500, and MX550 software Rev. K.20 are substantially equivalent to the previously cleared IntelliVue Patient Monitors MX400, MX450, MX500, and MX550 software Rev. K.10 marketed pursuant to K130849 and K131872 and the IntelliVue Patient Monitor MX800 marketed pursuant to K122439, K120366, K113441, K113657, K110474, K110622, K102562, K101449, and K100939. દ્

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4. Description of the device

The monitors interact with the connected external measurement devices locally at the bedside or in transport situations and with the Central Station via LAN or wireless link.

monitor screen on an external display and to operate patient monitor from the external display.

The Remote Applications feature allows the user of the patient monitor to access remotely hosted, pre-configured applications made available by the hospital.

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technology as well as the HTML5 protocol for compatibility with standard web application servers

5. Intended Use

The modified IntelliVue Patient Monitors MX400, MX450, MX500, and MX550 have the same intended use as the legally marketed predicate devices.

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. They are not intended for home use, Not therapeutic devices. The monitors are for prescription use 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.

6. Technological Characteristics

The modification to the Intelli Vue Patient Monitors MX400, MX450, and MX550 is limited to some minor software changes and does not affect technological characteristics of the devices. The devices software has slightly been modified in order to support the new features Remote Display application and Remote Applications. Design, materials, energy source, portability, user interface, radio technology, measurement principle, and all performance specifications of the devices remain all unchanged.

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7. Summary of V&V activities

The modified IntelliVue Patient Monitors MX400, MX450, and MX550 have been subject to the following V&V activities:

Tests as required by Hazard Analysis. All specified pass/fail criteria have been met. The test results confirmed the effectiveness of the implemented design risk mitigation measures.
-Functional tests of the modified patient monitors with the Remote Display application feature in order to verify support of the Intelli Vue XDS Remote Display. The conducted tests demonstrate that parameter data, alarm and/ or INOP information and operating windows provided by the modified patient monitors are correctly presented on the Remote Display and that the patient monitors can be operated from the Remote Display.
-Functional tests of the modified patient monitors with the Remote Applications feature in order to verify support of applications hosted on network servers. The conducted tests demonstrate that the remote applications are correctly shown on the display of the modified patient monitors and can be operated with user input devices.
-Regression Tests of the modified patient monitors to confirm that the unchanged and not affected functions of the previous software Rev. K.10 also work correctly with the new software Rev. K.20. The regression tests demonstrate that the modified patient monitors work safely, effectively, and correctly in accordance with all specifications and labeling claims.

8. Conclusion

Verification, validation, and testing activities establish the performance, functionality, and reliability characteristics of the modified devices with respect to the predicates. Testing comprised functionality and regression tests. Pass/Fail criteria were based on the specifications cleared for the predicate devices and test results showed substantial equivalence.

The results demonstrate that the Philips Intelli Vue Patient Monitors MX400, MX450, MX500, and MX550 meet all defined reliability requirements and performance claims.

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Public Health Service

Image /page/5/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three tail feathers. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circle around the eagle.

Food and Drug Administration 0903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

May 19, 2014

Philips Medizinsysteme Boeblingen Gmbh, Cardiac An Markus Stacha Sr. Regulatory Affairs Engineer Hewlett-Packard Str.2 Boeblingen, D 71034 GM

Re: K141015

Trade/Device Name: Intellivue Patient Monitor Mx400, Intellivue Patient Monitor Mx450, Intellivue Patient Monitor Mx500, Intellivue Patient Regulation Number: 21 CFR 870.1025 Regulation Name: Monitor, Physiological, Patient (with arrhythmia detection or alarms) Regulatory Class: II

Product Code: MHX, DSI, MLD, DSJ, DSK, DXN, DXG, KRB, DRQ, DRT, DPS, MLC, DRW, KRC, DRJ, DQA, DSB, DSH, DSF, DRS, DSA, MSX, DRG, CCK, CBQ, NHO, NHP, NHQ, CBS, CBR, CCL, BZC, BZQ, LKD, KLK, KOI, GWR, GWR, FLL

Dated: April 16, 2014 Received: April 21, 2014

Dear Markus Stacha.

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. The general controls provisions of the Act include requirements for annual registration. Iisting 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

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Page 2 - Markus Stacha

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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

Image /page/6/Picture/8 description: The image shows a black and white graphic that appears to be a logo or emblem. The central element is a stylized, possibly handwritten, word or name, with the letters overlapping and connected. The word is illegible due to the style and quality of the image. The word is surrounded by geometric shapes, including a triangle and a square, which are also stylized and have a textured appearance.

forBram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): K141015

Device Name: IntelliVue Patient Monitors MX400, MX450, MX500, and MX550

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 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 transcutaneous gas measurement (tcGas) is restricted to neonatal patients only.

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

The Integrated Pulmonary Index (1P1) 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.

Continued on next page

Over-The-Counter Use Prescription Use Yes No AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH. Office of Device Evaluation (ODE)

Image /page/7/Figure/15 description: The image shows a stamp with the word "Date:" on top. The date is "2014.05.19" and the time is "14:56:17". The time zone is "-04'00".

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.