K Number

Device Name

INTELLIVUE PATIENT MONITORS ,MODELS MP40, MP50, MP60, MP70, MP80, MP90

Manufacturer

PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH, CARDIAC AN

Date Cleared

2009-11-03

(126 days)

Product Code

DSI DQE

Regulation Number

870.1025

Intended 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. Additionally the M1011A S02 module together with the Philips S02 optical module is indicated whenever there is a need for continuous and invasive monitoring of the venous oxygen saturation.

Device Description

The Philips 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 of adults, pediatrics and neonates in hospital environments. The MP40, and MP50 are additionally intended for use in transport situations within hospital environments. The monitors are not intended for home use. They are intended for use by health care professionals.

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

K021778, K030038, K032858, K033444, K033513, K040304, K040357, K041235, K042845, K050762, K051106, K052801, K053522, K060221, K060541, K061052, K061610, K062283, K063315, K062392, K063725, K071426, K082633, K083517

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a standard patient monitoring system and does not mention any AI or ML capabilities. The performance studies focus on traditional verification and validation against predicate devices.

Therapeutic

No
The device is described as a patient monitor for physiological parameters, which is a diagnostic/monitoring device, not a therapeutic one. It monitors and records data, and generates alarms, but does not provide any treatment or therapy.

Diagnostic

Yes

The device is indicated for monitoring and recording physiological parameters, which are used to assess a patient's health status, and the M1011A S02 module is specifically indicated for continuous and invasive monitoring of venous oxygen saturation, all of which fall under the scope of diagnostic activities.

SaMD (Software as a Medical Device)

The device description explicitly states "The Philips MP40, MP50, MP60, MP70, MP80, and MP90 IntelliVue Patient Monitors" which are physical hardware devices. The summary also mentions "system level and regression tests, safety and performance tests, EMC and environmental tests" which are typical for hardware devices.

IVD (In Vitro Diagnostic)

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

Here's why:

Intended Use/Indications for Use: The primary purpose is monitoring physiological parameters of patients in vivo (within the living body). This includes parameters like heart rate, blood pressure, oxygen saturation (measured invasively or non-invasively), etc.
Device Description: The description reinforces that it's a patient monitor for measuring physiological parameters directly from the patient.
Lack of IVD Characteristics: There is no mention of analyzing samples taken from the body (like blood, urine, tissue) in vitro (outside the body) to provide diagnostic information.

IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device is focused on real-time, direct measurement of physiological signals from the patient.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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.

Additionally the M1011A S02 module together with the Philips S02 optical module is indicated whenever there is a need for continuous and invasive monitoring of the venous oxygen saturation.

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 modification is the introduction of the M1011A Philips SO2 Module / Philips SO2 Optical Module and the introduction of software revision G.07 for the IntelliVue Patient Monitors models MP40, MP50, MP60, MP70, MP80, and MP90.

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 environments

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 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.

Key Metrics (Sensivity, 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.

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.

Not Found

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

ICO 9119227

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: NOV - 3 2009 Andreas Suchi Philips Medizin Systeme Boeblingen GmbH Hewlett-Packard-Str. 2 D-71034 Boeblingen, Germany Tel: ++49 7031 463-1291 Fax: ++49 7031 463-2442 e-mail: andreas.suchi@philips.com
  This summary was prepared on June 25, 2009.
1. The names of the devices are the Philips MP40, MP50, MP60, MP70, MP80, and MP90 IntelliVue Patient Monitors. 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

Device Panel	Classification	ProCode	Description
	$870.2910, II	DRG	Transmitters and Receivers,
Physiological Signal,
Radiofrequency
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
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 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, K071426, K082633, K083517.
1. The modification is the introduction of the M1011A Philips SO2 Module / Philips SO2 Optical Module and the introduction of software revision G.07 for the IntelliVue Patient Monitors models MP40, MP50, MP60, MP70, MP80, and MP90.
1. The modified devices have the same intended use as the legally marketed predicate devices. The Philips 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 of adults, pediatrics and neonates in hospital environments. The MP40, and MP50 are

additionally intended for use in transport situations within hospital environments. 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.

Image /page/3/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in all caps and is in a bold, sans-serif font. The text is centered on the image and is the only element present.

Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with its wings spread, representing the department's mission to protect the health of all Americans. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

Ms. Andreas Suchi Senior Regulatory Affairs Engineer Philips Medizin Systeme Boblingen GmbH Cardiac and Monitoring Systems Hewlett-Packard Strasse 2 Boblingen D-71034 GERMANY

NOV - 3 2009

Re: K091927

Trade/Device Name: Philips MP40, MP50, MP60, MP70, MP80, and MP90 Intelli Vue Patient Monitors, Software Revision G.07 Regulation Number: 21 CFR 870.1025

Regulation Name: Arrhythmia Detector and Alarm Regulatory Class: II Product Code: DSI, DQE

Dated: October 22, 2009

Received: October 26, 2009

Dear Ms. Suchi:

・・

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 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. Suchi

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/cdrh/mdr/ 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internét address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

far

Susan Runner, D.D.S., M.A. Acting Division Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

Indications for Use

510(k) Number (if known): _____________________

Philips MP40, MP50, MP60, MP70, MP80, and MP90 Device Name: IntelliVue Patient Monitors, Software Revision G.07.

Indicated for use by health care professionals Indications for Use: 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.

Additionally the M1011A S02 module together with the Philips S02 optical module is indicated whenever there is a need for continuous and invasive monitoring of the venous oxygen saturation.

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 IF

NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

L. Arbuthnot

(Division Sign-Off) Division of Anesthesiology. General Hospital Infection Control, Dental Devices

510(k) Number: _ K 09 ( 927