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 ECI1).

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

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

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

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.

Device Description

The IntelliVue Patient Monitor MX400 and MX450 is a modification of the legally marketed IntelliVue Patient Monitor MP30.

The MX400 and MX450 are display units with a TFT LCD flat panel display and built-in CPU. The models MX400 and MX450 differ only in the size of their flat panel displays: MX400 has a 9" and MX450 has a 12" display.

The MX400 and MX450 do not have any built-in measurements. They can be connected to one Philips M3001A Multi-Measurement Server, M3002A (X2) Multi-Measurement Module and any one of the M3012A, M3014A, M3015A/B or M3016A Measurement Server Extensions, as well as to the M1013A (G1) or M1019A (G5) Gas Modules. These external devices provide non-invasive and invasive measurements such as ECG with arrhythmia and ST, respiration, SpO2, NBP, invasive blood pressure, temperature, CO2, C.O., CCO.

The MX400 and MX450 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 MX400 and MX450 offer a monitoring solution optimized for the surgical, cardiac, medical and neonatal care environments. They are located in the patient vicinity either at the bedside or used mobile, during patient transport in the hospital.

The MX400 and MX450 have a color display with touch-screen as primary input device. They also support a specialized remote control, keyboard and pointing devices such as a mouse.

The MX400 and MX450 interact with the connected external measurement devices locally at the bedside or in transport situations and with the Central Station via LAN.

AI/ML Overview

This is a description of the acceptance criteria and study for the Philips IntelliVue Patient Monitor MX400 and MX450.

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary focuses on demonstrating substantial equivalence to a predicate device rather than presenting specific numerical performance metrics against predefined acceptance criteria for novel functionalities. The acceptance criteria described are broad and relate to safety, effectiveness, and adherence to established standards.

Acceptance Criteria Category	Reported Device Performance
Safety and General Performance
Adherence to IEC 60601-1-2:2001 +A1:2004 (EMC)	All applicable requirements have been met.
Adherence to IEC 60601-1:1988 +A1:1991+A2:1995 (General Safety)	All applicable requirements have been met.
Adherence to IEC 60601-1-8:2003 (Alarms)	All applicable requirements have been met.
Adherence to IEC 62304:2006 (Software life cycle processes)	All applicable requirements have been met.
Environmental testing (temperature, humidity, shock, vibration, free fall)	All specified test requirements have been met. The tests confirmed that the device worked safely and according to specifications and indicated claims during tests simulating general hospital conditions, handling, transport, and storage.
Functional Performance (Regression Testing)
Functionality of all physiological measurement parameters (unchanged from predicate)	All specified criteria have been met. The tests demonstrated that the device worked safely, effectively, and correctly in accordance with specifications and labeling claims.
Functionality of integrated recorder	All specified criteria have been met.
Functionality of display	All specified criteria have been met.
Functionality of battery (operating and charging time)	All specified criteria have been met.
Functionality of human interface	All specified criteria have been met.
Functionality of external interfaces	All specified criteria have been met.
Functionality of alarming system	All specified criteria have been met.
White box tests (identified by hazard analysis)	All specified criteria have been met.
Overall Equivalence to Predicate Device
Pass/Fail criteria based on specifications cleared for the predicate device	Test results showed substantial equivalence.
Meeting all defined reliability requirements and performance claims	The results demonstrate that the device meets all defined reliability requirements and performance claims.

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

The provided summary does not specify a "test set" in the context of patient data or clinical trials. The testing described primarily involves engineering and system-level verification and validation (V&V) activities. Therefore, there is no sample size for a test set of patient data, nor is there information on data provenance (e.g., country of origin, retrospective/prospective). The validation focuses on the device's adherence to technical standards and its functional performance when connected to existing, already cleared measurement modules.

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

This information is not applicable. The validation described is not a clinical study requiring expert interpretation of medical data to establish ground truth. It is a technical V&V process ensuring the device's proper functioning and adherence to standards.

4. Adjudication Method for the Test Set

This information is not applicable for the reasons mentioned in point 3.

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

No MRMC comparative effectiveness study was done. The submission is for a modification of an existing patient monitor, not an AI-assisted diagnostic tool that would involve human readers interpreting cases.

6. Standalone Performance

The concept of "standalone performance" (algorithm only without human-in-the-loop) is not directly applicable in the context of this traditional patient monitor device. The device itself is a monitor that displays physiological parameters measured by external modules. Its "performance" is evaluated based on its ability to accurately acquire, display, and manage data from these modules, and adhere to safety and functional standards. The summary details regression testing which essentially verifies the standalone functioning of the device's internal components, software, and interfaces according to its specifications.

7. Type of Ground Truth Used

The "ground truth" for the verification and validation activities described in the 510(k) summary are primarily:

Recognized consensus standards: IEC 60601-1-2, IEC 60601-1, IEC 60601-1-8, IEC 62304.
Specifications cleared for the predicate device: The MX400 and MX450's performance was compared against the established specifications and performance of the legally marketed IntelliVue Patient Monitor MP30.
Internal design specifications: The device's own defined specifications for its functions, such as battery operating time, display functionality, and interface performance.

There is no mention of expert consensus, pathology, or outcomes data being used as ground truth for this device's V&V.

8. Sample Size for the Training Set

This information is not applicable. The IntelliVue Patient Monitor MX400 and MX450 are hardware devices with software, not a machine learning or AI algorithm that requires a "training set" of data.

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

This information is not applicable for the reasons mentioned in point 8.

Summary

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510(k) Summary

JUN 1 4 2013

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.

l . 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 May 13, 2013.

1. The name and classification of the device
  Trade name: IntelliVue Patient Monitor MX400 and MX450 Common name: Multiparameter Patient Monitor

Classification:

Device Panel	Classification	ProCode	Description
CardiovascularDevices	§870.2300, II	DRT	Monitor, Cardiac (incl. Cardiotachometer& Rate Alarm)
	§870.1025, II	DSI	Detector and alarm, arrhythmia
	§870.1025, II	MLD	Monitor, ST Segment with Alarm
	§870.1025, II	MHX	Monitor, Physiological, Patient (witharrhythmia detection or alarms)
	§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
	§870.2340, 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
	§870.2800, II	DSH	Recorder, Magnetic tape, Medical
	§870.2810, I	DSF	Recorder, Paper Chart

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Image /page/1/Picture/1 description: The image shows the word "PHILIPS" in a bold, sans-serif font. The letters are large and black, contrasting with the white background. The font appears to be slightly distressed, giving it a textured look. The word is horizontally oriented and centered.

- Device Panel	Classification	ProCode·	Description: .
	8870.2850, II	DRS	Extravascular Blood Pressure Transducer
	8870.2900, I	DSA	Cable, Transducer and Electrode, incl.Patient Connector
		MSX	System, Network and Communication,Physiological Monitors

AnesthesiologyDevices	$868.1400, II	ССК	Analyzer, Gas, Carbon Dioxide, Gaseous-Phase
	$868.1500, II	сво	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)
	8868.1500, II	NHQ	Analyzer, Gas, Isoflurane, Gaseous-Phase(Anesthetic Concentration)
	8868.1620, II	CBS	Analyzer, Gas, Halothane, Gaseous-Phase(Anesthetic Concentration)
	8868.1700, 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
	8868.2500, II	KLK	Monitor, Oxygen, Cutaneous, for Infantnot under Gas Anesthesia
General Hospital andPersonal Use Devices	8880.2910, II	FLL	Thermometer, Electronic, Clinical

1. The subject devices Philips IntelliVue Patient Monitor MX400 and MX450, release K,00, are substantially equivalent to the previously cleared Philips Intelli Vue Patient Monitor MP30 marketed pursuant to K122439, K120366, K113657, K113441, K110622, K102562, . K093268, K083517, K082633, K071426, K063315, K062392, K062283, K061610, K060221, K060541, K061052, K052961, K052801, K050762, K050141, K042845, K041235.
Description of the device 4.

The IntelliVue Patient Monitor MX400 and MX450 is a modification of the legally marketed IntelliVue Patient Monitor MP30.

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devices provide non-invasive and invasive measurements such as ECG with arrhythmia and ST, respiration, SpO2, NBP, invasive blood pressure, temperature, CO2, C.O., CCO.

The MX400 and MX450 have a color display with touch-screen as primary input device. They also support a specialized remote control, keyboard and pointing devices such as a mouse.

The MX400 and MX450 interact with the connected external measurement devices locally at the bedside or in transport situations and with the Central Station via LAN.

న. Intended Use
The subject devices IntelliVue Patient Monitor MX400 and MX450 have the same intended use as the legally marketed predicate IntelliVue Patient Monitor MP30.

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 AAMIECII).

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

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

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

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6. Technological Characteristics

The subject devices IntelliVue Patient Monitors MX400 and MX450 have the same range of functions as the legally marketed predicate IntelliVue Patient Monitor MP30. MX400 and MX450 reuse unchanged external measurement modules and measurement accessories as already used by the predicate MP30.

MX400 and MX450 have the same relevant-technological characteristics as the predicate MP30 with regard to energy sources, portability, user interface, and robustness.

Compared to the predicate MP30, the MX400 and MX450 have modified technological characteristics with regard to the usage of state of the art hardware components such as widescreen display, CPU, memories and interfaces, regarding a more compact form factor, resulting in slightly different dimensions and weight, regarding environmental conditions and operating time with internal battery.

The housing of the MX400 and MX450 is made of plastic whereas the housing of the predicate IntelliVue Patient Monitor MP30 is made of plastic and partly of magnesium alloy. Biocompatibility aspects are not affected because the devices do not have contact with patients. The MX400 and MX450 reuse plastic materials of the predicate MP30.

The fundamental scientific technology of the new IntelliVue Patient Monitors MX400 and MX450 is the same as that of the predicate IntelliVue Patient Monitor MP30. The differences in technological characteristics between the subject devices MX400 and MX450 and the predicate device MP30 do not diminish safety or effectiveness.

1. Summary of V&V activities
- Testing according to the recognized consensus standards:
  - IEC 60601-1-2:2001 +A1:2004 (EMC) .
  - IEC 60601-1:1988 +A1:1991+A2:1995 (General Safety) .
  - . IEC 60601-1-8:2003 (Alarms)
  - IEC 62304:2006 (Software life cycle processes) .

All applicable requirements have been met.

-Environmental testing (temperature, humidity), mechanical testing (shock, vibration, and free fall).
All specified test requirements have been met. The tests confirmed that the Intelli Vue Patient Monitor MX400 and MX450 worked safely and according to their specifications and indicated claims during tests simulating general hospital conditions, handling and transport in hospital environments, and storage.
-Regression testing on the IntelliVue Patient Monitor MX400 and MX450. The performed regression testing comprised function tests of all physiological measurement parameters (which remain unchanged in this submission), integrated recorder, display, batterv functionality, battery operating and charging time, human interface, external interfaces, alarming system, and white box tests as identified by the hazard analysis. All specified criteria have been met. The tests demonstrated that the IntelliVue Patient Monitor MX400 and MX450 worked safely, effectively, and correctly in accordance with specifications and labeling claims in the intended environment of use.

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PHILIPS

8. Conclusion

Verification, validation, and testing activities establish the performance, functionality, and reliability characteristics of the modified devices with respect to the predicate.

Testing comprised regression tests, white box tests, electrical and mechanical safety tests, EMC tests, and environmental tests.

Pass/Fail criteria were based on the specifications cleared for the predicate device and test results showed substantial equivalence.

The results demonstrate that the Philips IntelliVue Patient Monitor MX400 and MX450 meet all defined reliability requirements and performance claims.

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Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus, a traditional symbol of medicine, with three wavy lines intersecting a staff-like element.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

June 14, 2013

Philips Medizinsysteme Boeblingen Gmbh c/o Markus Stacha Sr. Regulatory Affairs Engineer Hewlett-packard Str.2 71034 Boeblingen Germany

Re: K130849

Trade/Device Name: IntelliVue patient monitor mx400; IntelliVue patient monitor mx450

Regulation Number: 21 CFR 870.1250

Regulation Name: Multiparameter Patient Monitor

Regulatory Class: Class II

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

Dated: May 13, 2013 Received: May 16, 2013

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, 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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Page 2 - Markus Stacha

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 (reporting of medical device-related 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, Misbranding by reference to premarket notification (21CFR 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/ReportaProblem/default.htmfor 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours.

Owen-P.Faris-S

for Bram D. Zuckerman, M.D. Director

Division-of-Cardiovascular-Devices Office of Device Evaluation Center for Devices and Radiological Health

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Indications for Use

510(k) Number (if known):

Device Name: IntelliVue Patient Monitor MX400 and MX450

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 ECI1).

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

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

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

Prescription Use Yes Over-The-Counter Use 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)

Owen P. Faris -S
2013.06.13
15:50:16 -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.