K Number

Device Name

MP5 INTELLIVUE PATIENT MONITOR

Manufacturer

PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH, CARDIAC AN

Date Cleared

2007-02-08

(55 days)

Product Code

MHX

Regulation Number

870.1025

Intended Use

Indicated for use by health care professionals whenever there is a need for monitoring and recording of and to generate alarms for multiple physiological parameters of adults, pediatrics and neonates in a hospital environment and during transport situations within and outside of hospital environment.

Device Description

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K062392, K971910, K992273, K030973

Reference Devices

K031740

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on hardware modifications and interfacing with existing modules.

Therapeutic

No
Explanation: The intended use of the device is for monitoring and recording physiological parameters and generating alarms, not for treating or providing therapy.

Diagnostic

The device is described as a patient monitor for "monitoring and recording of and to generate alarms for multiple physiological parameters," which is indicative of a monitoring device rather than a diagnostic one that aims to identify the nature of a disease or condition.

SaMD (Software as a Medical Device)

The device description explicitly states it is a modified patient monitor and interfaces with a thermometer module, indicating it is a hardware device with software components, not a software-only device.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is for "monitoring and recording of and to generate alarms for multiple physiological parameters". This describes a device that measures vital signs directly from the patient's body, not from samples taken from the body.
Device Description: The description mentions monitoring physiological parameters and interfacing with a thermometer module. These are typical functions of a patient monitor, which is an in vivo device.
Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), reagents, or any other components typically associated with in vitro diagnostics.

IVD devices are designed to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device's function is to monitor the patient's physiological state directly.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Product codes (comma separated list FDA assigned to the subject device)

DSI, MLD, MHX, 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, FLL, GWR, GWS

Device Description

The modified Philips MP5 IntelliVue Patient Monitor is substantially equivalent to previously cleared Philips MP5 IntelliVue Patient Monitor marketed pursuant to K062392, the M3/M3046A Compact Portable Patient Monitor marketed pursuant to K971910, K992273, K030973, and the Welch Allyn SureTemp® Plus thermometer module marketed pursuant to K031740.
The modification adds the capability to the MP5 patient monitor to interface to the legally marketed Welch Allyn SureTemp® Plus thermometer module. The modification also adds the capability to the MP5 patient monitor to function in a transport environment outside of hospitals, such as a road ambulance, airplane or helicopter.
The modified Philips MP5 IntelliVue Patient Monitor is 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 hospital environment. It is not intended for home use. The monitor is intended for use by health care professionals. The MP5 monitor with interfaced Welch Allyn SureTemp® Plus thermometer module is intended for use with adult and pediatric patients in a hospital environment.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

adults, pediatrics and neonates

Intended User / Care Setting

health care professionals / hospital environment and during patient transport inside and outside of hospital environment.

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Verification, validation, and testing activities establish the performance, functionality, and reliability characteristics of the modified device with respect to the predicate. Testing involved system level tests, performance tests, EMC, safety and environmental testing from 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 modified Philips MP5 IntelliVue Patient Monitor meets all reliability requirements and performance claims.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K062392, K971910, K992273, K030973

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

K031740

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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.

Summary

K063725

.510 (k) Summary ·

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. The submitter of this premarket notification is: Markus Stacha Philips Medizin Systeme Boeblingen GmbH FEB 8 2007 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 December 13, 2006.
1. The names of the device is the Philips MP5 IntelliVue Patient Monitor
  Classification names are as follows:

Device Panel	Classification	ProCode	Description
Cardiovascular
Devices	$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 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
	$870.2300, 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
Switching 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 Pressure
Transducer
	$870.2900, I	DSA	Cable, Transducer and
Electrode, incl. Patient
Connector
	-	MSX	System, Network and
Communication, Physiological
Monitors

Page 1 OF 3

Device Panel	Classification	ProCode	Description
Anesthesiology
Devices	$870.2910, II	DRG	Transmitters and Receivers,
Physiological Signal,
Radiofrequency
	$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
General Hospital
and Personal Use
Devices	$880.2910, II	FLL	Thermometer, Electronic,
Clinical
Neurological
Devices	$882.1400, II	GWR	Electroencephalograph
	$882.1420, I	GWS	Analyzer, Spectrum,
Electroencephalogram Signal

1. The modified Philips MP5 IntelliVue Patient Monitor is substantially equivalent to previously cleared Philips MP5 IntelliVue Patient Monitor marketed pursuant to K062392, the M3/M3046A Compact Portable Patient Monitor marketed pursuant to K971910, K992273, K030973, and the Welch Allyn SureTemp® Plus thermometer module marketed pursuant to K031740.
1. The modification adds the capability to the MP5 patient monitor to interface to the legally marketed Welch Allyn SureTemp® Plus thermometer module. The modification also adds the capability to the MP5 patient monitor to function in a transport environment outside of hospitals, such as a road ambulance, airplane or helicopter.
The modified Philips MP5 IntelliVue Patient Monitor is intended 5. for monitoring and recording of and to generate alarms for, multiple physiological parameters of adults, pediatrics and

PAGE 2 OF 3

neonates in a hospital environment and during patient transport inside and outside of hospital environment. It is not intended for home use. The monitor is intended for use by health care professionals. The MP5 monitor with interfaced Welch Allyn SureTemp® Plus
thermometer module is intended for use with adult and pediatric patients in a hospital environment.
1. The modified device has 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 device with respect to the predicate. Testing involved system level tests, performance tests, EMC, safety and environmental testing from 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 modified Philips MP5 IntelliVue Patient Monitor meets all reliability requirements and performance claims.

PAGE 3 OF 3

Image /page/3/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS) in the USA. The logo features a stylized eagle with three heads, representing the department's focus on health, human services, and science. The eagle is encircled by the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA".

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 8 2007

Philips Medizin Systeme Boeblingen GmbH Cardiac and Monitoring Systems c/o Markus Stacha Hewlett-Packard-Str. 2 D-71034 Boeblingen, GERMANY

Re: K063725

Trade Name: Philips MP5 Intelli Vue Patient Monitor Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia Detector and Alarm Regulatory Class: Class II Product Code: MHX Dated: December 13, 2006 Received: December 15, 2006

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.

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,

Bhimmarfor

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

Enclosure

Indications for Use

510(k) Number (if known): JKD (63725

Device Name: Philips MP5 IntelliVue Patient Monitor.

Indications for Use: Indicated for use by health care professionals whenever there is a need for monitoring and recording of and to generate alarms for multiple physiological parameters of adults, pediatrics and neonates in a hospital environment and during transport situations within and outside of hospital environment.

Use (Part 21 CFR 801 Subpart D)

Prescription

AND/OR

Over-The-Counter Use (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)

Bl.Zimmerman
Division Sign-Off

Division of Cardiovascular Devices
510(k) Number K063205

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