PHILIPS MP2 AND X2 INTELLIVUE PATIENT MONITORS by PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH, CARDIAC AN

Indicated for use by health care professionals whenever there is a need for monitoring and recording of, and to whenever enore 15 c, multiple physiological parameters of adults, gencrates and neonates in a hospital environment and during patient transport inside and outside of hospitals.

Device Description

The Philips MP2 and X2 IntelliVue Patient Monitors are devices for monitoring and recording of, and to generate alarms for, multiple physiological parameters. The modification adds the capability to function in transport environments outside of hospitals.

AI/ML Overview

The provided text describes the Philips MP2 and X2 IntelliVue Patient Monitors, specifically focusing on a modification that extends their use to transport environments outside of hospitals. However, the document does not contain a detailed study proving the device meets specific acceptance criteria in the format requested.

The document primarily focuses on establishing substantial equivalence to previously cleared predicate devices (K062392, K063725, K071426) for the new intended use.

Here's an analysis based on the provided text, addressing the requested information to the extent possible:

1. A table of acceptance criteria and the reported device performance

The document states: "Verification, validation, and testing activities establish the performance, functionality, and reliability characteristics of the modified devices with respect to the predicates. Testing involved environmental, EMC, safety and performance 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 modified Philips MP2 and X2 IntelliVue Patient Monitors meet all reliability requirements and performance claims."

This statement indicates that acceptance criteria existed and were met, but the specific criteria and corresponding performance metrics are not provided in a table within this summary. It refers to "specifications cleared for the predicate devices" as the basis for pass/fail criteria, but these specifications are not detailed.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify the sample size used for the test set, nor does it provide details on the data provenance (country of origin, retrospective or prospective). It broadly mentions "testing involved environmental, EMC, safety and performance tests."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided in the document. The type of testing described (environmental, EMC, safety, performance) suggests engineering and validation testing, not clinical studies requiring expert ground truth establishment for diagnostic purposes.

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

This information is not provided in the document. As mentioned above, the testing appears to be technical performance validation rather than clinical adjudication.

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

There is no indication of an MRMC comparative effectiveness study being performed. The device is a patient monitor, not an AI-assisted diagnostic tool for human readers. The document focuses on the device's ability to maintain its functionality and reliability in new environments.

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

The document describes "performance, functionality, and reliability characteristics of the modified devices." This implies that the device's standalone performance was evaluated against the predicate device's specifications. However, specific details of such a standalone study (e.g., specific metrics, quantitative results) are not provided. The monitors themselves are designed to operate standalone in terms of data acquisition and alarm generation, though they are used by healthcare professionals.

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

For the environmental, EMC, safety, and performance tests, the "ground truth" would likely be the established engineering specifications and regulatory standards relevant to patient monitors. The document states "Pass/Fail criteria were based on the specifications cleared for the predicate devices." It does not involve medical ground truth types like pathology or outcomes data.

8. The sample size for the training set

This information is not applicable/provided. The device is an updated version of existing patient monitors, not an AI algorithm that requires a "training set" in the machine learning sense. The testing focuses on hardware and software performance in new environments.

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

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

In summary:

The provided 510(k) summary focuses on demonstrating substantial equivalence of a modified patient monitor to its predicates for an expanded intended use (transport environments). While it asserts that testing was done and acceptance criteria based on predicate specifications were met, it does not provide the specific details of these criteria, performance results, test methodologies, sample sizes, or any clinical study information (like expert ground truth or MRMC studies) as would be expected for a diagnostic or AI-driven device. The evaluation appears to be based on engineering, safety, EMC, and environmental performance testing.

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.

AUG 1 0 2007 1. 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 July 27, 2007.
1. The names of the devices are the Philips MP2 and X2 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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072070

2/3

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
	$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
	$882.1420, I	GWS	Analyzer, Spectrum,Electroencephalogram Signal

1. The modified Philips MP2 and X2 IntelliVue Patient Monitors are substantially equivalent to the previously cleared Philips IntelliVue Patient Monitors MP2, X2, and MP5 marketed pursuant to K062392, K063725, K071426.
1. The modification adds to the MP2 and X2 IntelliVue Patient Monitors the capability to function in the transport environments outside of hospitals, such as a road ambulance, airplane or helicopter.
1. The modified Philips MP2 and X2 IntelliVue Patient Monitors are intended for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults, pediatrics and neonates in a hospital environment and during patient transport inside and outside of hospitals. The monitors are not intended for home use. They are intended for use by health care professionals.

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1. The modified devices have the same technological characteristics as the legally marketed predicate devices.
1. Verification, validation, and testing activities establish the performance, functionality, and reliability characteristics of the modified devices with respect to the predicates. Testing involved environmental, EMC, safety and performance 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 modified Philips MP2 and X2 IntelliVue Patient Monitors meet all reliability requirements and performance claims.

K072070 p3/3

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Public Health Service

Image /page/3/Picture/2 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with three stripes representing the three levels of government: federal, state, and local. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 0 2007

Philips Medizin Systeme Böblingen GmbH c/o Mr. Markus Stacha Senior Regulatory Affairs Engineer Hewlett-Packard - Str. 2 D - 71034 Boeblingen GERMANY

Re: K072070

Philips MP2 and X2 IntelliVue Patient Monitors 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: July 27, 2007 Received: July 30, 2007

Dear Mr. 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.

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.

Bhimamor 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 Namc: Philips MP2 and X2 IntelliVue Patient Monitors.

Indications for Use: Indicated for use by health care professionals whenever there is a need for monitoring and recording of, and to whenever enore 15 c, multiple physiological parameters of adults, gencrates and neonates in a hospital environment and during patient transport inside and outside of hospitals.

Over-The-Counter Use _ No Prescription Use yes -- AND/OR (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

B.Brumana

diovascular Devices

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.