Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. Intended for monitoring and recording of and to generate alarms for multiple physiological parameters of adults, pediatrics and neonates in hospital environments. The MP2, X2, MP20, MP30, MP40, and MP50 are additionally intended for use in transport situations within hospital environments. The MP5 is also intended for use during patient transport outside of a hospital environment.

Device Description

The Philips MP2, X2, MP5, MP20, MP30, MP40, MP50, MP60, MP70, MP80, and MP90 IntelliVue Patient Monitors. The modification is the introduction of the models MP2 and X2 IntelliVue Patient Monitors and the introduction of software release F.00 for the entire IntelliVue Patient Monitors family, models MP2, X2, MP5, MP20, MP30, MP40, MP50, MP60, MP70, MP80, and MP90.

AI/ML Overview

The Philips IntelliVue Patient Monitors (models MP2, X2, MP5, MP20, MP30, MP40, MP50, MP60, MP70, MP80, and MP90, with software release F.00) are intended for monitoring and recording multiple physiological parameters and generating alarms for adults, pediatrics, and neonates in hospital environments. Some models (MP2, X2, MP20, MP30, MP40, MP50) are also for hospital transport, and the MP5 is for transport outside the hospital. They are intended for use by healthcare professionals.

Acceptance Criteria and Device Performance:

The provided 510(k) summary states that "Pass/Fail criteria were based on the specifications cleared for the predicate devices." However, it does not provide specific quantitative acceptance criteria or detailed reported device performance metrics in a table. It generally states that "test results showed substantial equivalence" and that the "results demonstrate that the Philips IntelliVue Patient Monitors meet all reliability requirements and performance claims."

Acceptance Criteria (Generic as specific criteria are not provided)	Reported Device Performance (Generalized as specific metrics are not provided)
Device functions as intended without hazardous failures.	Testing established performance, functionality, and reliability.
Meets safety and performance requirements.	Test results showed substantial equivalence to predicate devices.
Conforms to EMC and environmental standards.	EMC and environmental test results were satisfactory.
Maintains reliability.	Meets all reliability requirements.

Study Details:

Sample size for the test set and data provenance:
The document does not specify the sample size for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It only mentions "system level and regression tests, safety and performance tests, EMC and environmental tests, such as testing from the hazard analysis."
Number of experts used to establish the ground truth for the test set and qualifications:
This information is not provided in the document.
Adjudication method for the test set:
This information is not provided in the document.
Multi-reader multi-case (MRMC) comparative effectiveness study:
No MRMC comparative effectiveness study is mentioned. The submission focuses on demonstrating substantial equivalence to predicate devices through technical verification and validation, not comparative effectiveness with human readers.
Standalone (algorithm only without human-in-the-loop performance) study:
The submission describes testing activities for the device itself ("Verification, validation, and testing activities establish the performance, functionality, and reliability characteristics of the modified devices"). This implies standalone performance testing of the device's functions, but details on specific standalone performance metrics or a study explicitly labeled as such are not provided. The device is a patient monitor, implying continuous monitoring of physiological parameters by the device itself before human interpretation.
Type of ground truth used:
The document does not explicitly state the type of ground truth used for performance evaluation, beyond stating that "Pass/Fail criteria were based on the specifications cleared for the predicate devices." For physiological monitoring, ground truth would typically come from calibrated reference measurements or expert clinical assessment for phenomena like arrhythmia detection.
Sample size for the training set:
This information is not provided. The document describes verification and validation activities for the device, but does not mention "training sets," which implies that this device might not incorporate machine learning or AI that requires a distinct training phase in the way a diagnostic imaging AI would.
How the ground truth for the training set was established:
As no training set is explicitly mentioned or implied to be relevant to the device's development as described, this information is not provided.

Summary

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K071426
p1/3

510 (k) Summary

JUN 1 3 2007

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. The submitter of this premarket notification is: 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 16, 2007.
1. The names of the devices are the Philips MP2, X2, MP5, MP20, MP30, MP40, MP50, MP60, MP70, MP80, and MP90 IntelliVue Patient Monitors. Classification names are as follows:

Device Panel	Classification	ProCode	Description
CardiovascularDevices	$870.1025, II	DSI	Detector and alarm, arrhythmia
	$870.1025, II	MLD	Monitor, ST Segment with Alarm
	$870.1025, II	MHX	Monitor, Physiological, Patient(with arrhythmia detection oralarms)
	$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 Alarm)
	$870.2340, II	DPS	Electrocardiograph
	$870.2340, II	MLC	Monitor, ST Segment
	$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

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Device Panel	Classification	ProCode	Description
	$870.2910, II	DRG	Transmitters and Receivers,Physiological Signal,Radiofrequency
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, forInfant not under Gas Anesthesia
General Hospitaland Personal UseDevices	$880.2910, II	FLL	Thermometer, Electronic,Clinical
NeurologicalDevices	$882.1400, II	GWR	Electroencephalograph
Devices	$882.1420, I	GWS	Analyzer, Spectrum,Electroencephalogram Signal

1. The modified devices are substantially equivalent to previously cleared Philips IntelliVue Patient Monitors marketed pursuant to K021778, K030038, K032858, K033444, K033513, K040304, K040357, K041235, K042845, K050762, K051106, K052801, K053522, K060221, K060541, K061052, K061610, K062283, K063315, K062392, K063725.
1. The modification is the introduction of the models MP2 and X2 IntelliVue Patient Monitors and the introduction of software release F.00 for the entire IntelliVue Patient Monitors family, models MP2, X2, MP5, MP20, MP30, MP40, MP50, MP60, MP70, MP80, and MP90.
1. The modified devices have the same intended use as the legally marketed predicate devices. The Philips MP2, X2, MP5, MP20, MP30, MP40, MP50, MP60, MP70, MP80, and MP90 IntelliVue Patient Monitors are intended for monitoring and recording of and to generate alarms for, multiple physiological parameters

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of adults, pediatrics and neonates in hospital environments. The MP2, X2, MP5, MP20, MP30, MP40, and MP50 are additionally intended for use in transport situations within hospital environments. The MP5 is also intended for use during patient transport outside of a hospital environment. The monitors are not intended for home use. They are intended for use by health care professionals.

1. The modified devices have the same technological characteristics as the legally marketed predicate device.
1. Verification, validation, and testing activities establish the performance, functionality, and reliability characteristics of the modified devices with respect to the predicate. Testing involved system level and regression tests, safety and performance tests, EMC and environmental tests, such as testing from the hazard analysis. 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 IntelliVue Patient Monitors meet all reliability requirements and performance claims.

K071426 4 3/3

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 1 3 2007

Philips Medizin Systeme Bobligen GmbH c/o Mr. Markus Stacha Senior Regulatory Affairs Engineer, Cardiac and Monitoring Systems Postfach 1471 71004 Böblingen, Germany

Re: K071426

Philips MP2, X2, MP5, MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90 IntelliVue Patient Monitors, Software Revision F.00. Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia detector and alarm (including ST-segment measurement and alarm) Regulatory Class: Class II (two) Product Code: MHX Dated: May 23, 2007 Received: May 23, 2007

Dear Mr. Markus:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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- Mr. 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); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Blyminima for

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

Enclosure

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Indications for Use

510(k) Number (if known):

Device Name: Philips MP2, X2, MP5, MP20, MP30, MP40, MP50, MP60, MP70, MP80, and MP90 IntelliVue Patient Monitors, Software Revision F.00.

Indications for Use: Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. Intended for monitoring and recording of and to generate alarms for multiple physiological parameters of adults, pediatrics and neonates in hospital environments. The MP2, X2, MP20, MP30, MP40, and MP50 are additionally intended for use in transport situations within hospital environments. The MP5 is also intended for use during patient transport outside of a hospital environment.

Prescription (Part 21 CFR 801 Subpart D)

yes

Use

AND/OR

Over-The-Counter Use No (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Blumuma

(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number k71424

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.