Predicate Devices

K120366, K113657, K113441, K110474, K110622, K102562, K101449, K100939, K093268, K091927, K083517, K082633, K081793, K072070, K071426, K063725, K063315, K062283, K062392, K061610, K061052, K060541, K060221, K053522, K052801, K051106, K050762, K050141, K042845, K041235, K040304, K033513, K033444, K032858, K031481, K030038, K023871, K021778

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on standard physiological monitoring and communication capabilities.

Therapeutic

No
The "Intended Use / Indications for Use" section explicitly states, "Not therapeutic devices."

Diagnostic

Yes

The device "monitors and records" physiological parameters and helps "generate alarms" for them, which are functions commonly associated with diagnostic devices, as they provide information about a patient's health status.

SaMD (Software as a Medical Device)

No

The device description explicitly states that the device comprises "display units including built-in or separate flat panel displays and central processing units (CPU) and physiological measurement modules," indicating it includes significant hardware components beyond just software.

IVD (In Vitro Diagnostic)

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

Here's why:

IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
Device Function: The description clearly states that the Philips IntelliVue Patient Monitors measure and monitor physiological parameters of patients directly. This includes things like ECG, invasive and non-invasive pressure, etc. The NMT module measures muscle contraction following electrical stimulation. These are all measurements taken in vivo (within the living body), not in vitro (in a test tube or laboratory setting).
Intended Use: The intended use is for monitoring patients in a hospital setting by healthcare professionals. This aligns with the function of a patient monitor, not an IVD.

The device is a patient monitor used for real-time physiological monitoring, which is distinct from in vitro diagnostic testing.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The monitor is indicated for use by healthcare professionals whenever there is a need for monitoring the physiological parameters of patients.

The monitor is intended to be used for monitoring and recording and to generate alarms, for, multiple physiological parameters of adults, pediatrics, and neonates. The monitor is intended for use by trained healthcare professionals in a hospital environment.

The monitor is also intended for use during patient transport inside and outside of the hospital environment.

The monitor is only for use on one patient at a time. It is not intended for home use. Not a therapeutic device. The monitor is 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 EC 11).

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

The MP5, MP5SC and MP5T monitors are also intended for use during patient transport inside the hospital environment; only the MP5 monitor is for use during patient transport outside of the hospital environment. The MP5, MP5SC and MP5T when used with the TRx4841A/TRx4851A IntelliVue Telemetry System Transceiver or with the IntelliVue Cableless Measurement Devices, are intended for use in a hospital environment and during patient transport inside the hospital environment.

The Predictive Temperature unit is intended for use with adult and pediatric patients in a hospital environment.

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

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

The MP20/MP30/MP40/MP50 monitors are additionally intended for use in transport situations within hospital environments.

The transcutaneous gas measurement (tcGas) is restricted to neonatal patients only.

BIS is intended for use under the direct supervision of a licensed health care practitioner or by personnel trained in its proper use. It is intended for use on adult and pediatric patients within a hospital or medical facility providing patient care to monitor the state of the brain by data acquisition of EEG signals. The BIS may be used as an aid in monitoring the effects of certain anesthetic agents.

Use of BIS monitoring to help quide anesthetic administration may be associated with the reduction of the incidence of awareness with recall in adults during general anesthesia and sedation.

The IntelliVue NMT Module is intended to be used as an objective neuromuscular transmission monitor, using accelerometry for measuring the muscle contraction following an electrical stimulation of a peripheral nerve. The NMT Module is intended to be used with adult and pediatric patients.

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, KOI, FLL, GWR, GWS

Device Description

The Philips IntelliVue Patient Monitor family comprises the multi-parameter patient monitor models: X2, MP2, MP5, MP5T, MP5SC, MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90, MX600, MX700 and MX800 IntelliVue Patient Monitors that consist of display units including built-in or separate flat panel displays and central processing units (CPU) and physiological measurement modules. All monitors share the same system architecture and exactly the same software is executed on each monitor.

The IntelliVue Patient Monitors measure multiple physiological parameters such as surface ECG; invasive and non-invasive generate alarms, record physiological pressure, etc., signals, store derived data, and communicate derived data and central stations via the IntelliVue Clinical Network.

The subject modification extends the capability of IntelliVue MP40, MP50, MP60, MP70, MP80, MP90, and MX600, MX700 and MX800' patient monitors to communicate with the new NMT module.

The IntelliVue NMT Module is intended to be used as an objective neuromuscular transmission monitor, using accelerometry for measuring the muscle contraction following an electrical stimulation of a peripheral nerve. The NMT Module is intended to be used with adult and pediatric patients. The NMT has been added to list for MP20 - MP90, and MX600 -MX800 IntelliVue Patient Monitors

Additionally the software revision J.08 is made available for the entire IntelliVue Patient Monitors family.

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.
ST segment monitoring is intended for use with adult patients only and is not clinically validated for use with neonatal and pediatric patients.
The Predictive Temperature unit is intended for use with adult and pediatric patients in a hospital environment.
The SSC Sepsis Protocol, in the ProtocolWatch clinical decision support tool, is intended for use with adult patients only.
The derived measurement Pulse Pressure Variation (PPV) is validated only for adult patients.
The Integrated Pulmonary Index (IPI) is intended for use with adult and pediatric (1 to 12 years) patients only.
The transcutaneous gas measurement (tcGas) is restricted to neonatal patients only.
BIS is intended for use on adult and pediatric patients.
The IntelliVue NMT Module is intended to be used with adult and pediatric patients.

Intended User / Care Setting

Healthcare professionals in a hospital environment.
Also intended for use during patient transport inside and outside of the hospital environment.
Not intended for home use.
For prescription use only.

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 as well 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 (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.

K120366, K113657, K113441, K110474, K110622, K102562, K101449, K100939, K093268, K091927, K083517, K082633, K081793, K072070, K071426, K063725, K063315, K062283, K062392, K061610, K061052, K060541, K060221, K053522, K052801, K051106, K050762, K050141, K042845, K041235, K040304, K033513, K033444, K032858, K031481, K030038, K023871, K021778

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

0

K122439
p1/7

510 (k) Summary

This summary of 510(k) safety and effectiveness information is
submitted in accordance with the requirements of the Safe Medical AUG 29 2012 Devices Act of 1990 and 21 C.F.R. §807.92.

The submitter of this premarket notification is:

Herbert van Dyk Philips Medizin Systeme Boeblingen GmbH Hewlett-Packard-Str. 2 D-71034 Boeblingen, Germany Tel: ++49 7031 463-1734 Fax: ++49 7031 463-2442 e-mail: herbert.van dyk@philips.com

This summary was prepared on August 07, 2012.

1. The names of the devices are the Philips X2, MP2, MP5, MP5T, MP5SC, MP20, MP30, MP40, MP50, MP70, MP80, MP90, MX600, MX700 and MX800 patient monitors, Revision J.08.
  Common name: Patient Monitoring Devices

Classification names are as follows:

Device Panel	Classification	ProCode	Device 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
Device Panel	Classification	ProCode	Device Description
	§870.2900, I	DSA	Cable, Transducer and Electrode, incl. Patient Connector
	-	MSX	System, Network and Communication, Physiological Monitors
	§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
General Hospital
and Personal Use
Devices	§868.2500, II	KLK	Monitor, Oxygen, Cutaneous, for Infant not under Gas Anesthesia
	§868.2775, II	KOI	Electrical peripheral nerve Stimulator
	§880.2910, II	FLL	Thermometer, Electronic, Clinical
Neurological
Devices	§882.1400, II	GWR	Electroencephalograph
	§882.1420, I	GWS	Analyzer, Spectrum, Electroencephalogram Signal

1

K122439
P2/7

1. The modified devices are substantially equivalent to previously cleared Philips patient monitors marketed pursuant to K120366, K113657, K113441, K110474, K110622, K102562, ' K101449, K100939, K093268, K091927, K083517, K082633, K081793, . K072070, K071426, K063725, K063315, K062283, K062392, K061610, K061052, K060541, K060221, K053522, K052801, K051106, K050762,
  K050141, K042845, K041235, K040304, K033513, K033444, K032858, K031481, K030038, K023871, and K021778

2

Description of the Devices

The Philips IntelliVue Patient Monitor family comprises the multi-parameter patient monitor models: X2, MP2, MP5, MP5T, MP5SC, MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90, MX600, MX700 and MX800 IntelliVue Patient Monitors that consist of display units including built-in or separate flat panel displays and central processing units (CPU) and physiological measurement modules. All monitors share the same system architecture and exactly the same software is executed on each monitor.

The IntelliVue Patient Monitors measure multiple physiological parameters such as surface ECG; invasive and non-invasive generate alarms, record physiological pressure, a etc., signals, store derived data, and communicate derived data and central stations via the IntelliVue Clinical alarms to Network.

The subject modification extends the capability of IntelliVue MP40, MP50, MP60, MP70, MP80, MP90, and MX600, MX700 and MX800' patient monitors to communicate with the new NMT module.

The IntelliVue NMT Module is intended to be used as an objective neuromuscular transmission monitor, using accelerometry for measuring the muscle contraction following an electrical stimulation of a peripheral nerve. The NMT Module is intended to be used with adult and pediatric patients. The NMT has been added to list for MP20 - MP90, and MX600 -MX800 IntelliVue Patient Monitors

Additionally the software revision J.08 is made available for the entire IntelliVue Patient Monitors family.

Intended Use

The Intended Use and Indications for Use of the subject Philips IntelliVue Patient Monitors X2, MP2, MP5, MP5T, MP5SC, MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90, MX600, MX700, and MX800 have not changed as a result of the device modification. The devices have the following detailed Indications for Use Statements in their Instructions for Use:

MP2 IntelliVue Patient monitor:

The monitor is indicated for use by healthcare professionals whenever there is a need for monitoring the physiological parameters of patients.

The monitor is intended to be used for monitoring and recording and to generate alarms, for, multiple physiological of, parameters of adults, pediatrics, and neonates. The monitor is intended for use by trained healthcare professionals in a hospital environment.

The monitor is also intended for use during patient transport inside and outside of the hospital environment.

The monitor is only for use on one patient at a time. It is not intended for home use. Not a therapeutic device. The monitor is 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 EC 11).

3

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

MP5, MP5T and MP5SC IntelliVue Patient Monitor:

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 intended to be used for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults, pediatrics, and neonates. monitors are intended for use by trained healthcare The professionals in a hospital environment.

The MP5, MP5SC and MP5T monitors are also intended for use during patient transport inside the hospital environment; only the MP5 monitor is for use during patient transport outside of the hospital environment. The MP5, MP5SC and MP5T when used with the TRx4841A/TRx4851A IntelliVue

Telemetry System Transceiver or with the IntelliVue Cableless Measurement Devices, are intended for use in a hospital environment and during patient transport inside the hospital environment.

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 EC 11).

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

The Predictive Temperature unit is intended for use with adult and pediatric patients in a hospital environment.

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

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

MP20 - MP90 IntelliVue Patient Monitor:

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 intended to be used for monitoring and of, recording and to generate alarms for, multiple physiological parameters of adults, pediatrics, and neonates. monitors are intended for use by trained healthcare The professionals in a hospital environment.

4

The MP20/MP30/MP50 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 EC 11).

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

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. The transcutaneous gas measurement (tcGas) is restricted to neonatal patients only.

BIS is intended for use under the direct supervision of a licensed health care practitioner or by personnel trained in its proper use. It is intended for use on adult and pediatric patients within a hospital or medical facility providing patient care to monitor the state of the brain by data acquisition of EEG signals. The BIS may be used as an aid in monitoring the effects of certain anesthetic agents.

Use of BIS monitoring to help quide anesthetic administration may be associated with the reduction of the incidence of awareness with recall in adults during general anesthesia and sedation.

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 adjunct to and not intended to replace vital sign an monitoring.

The IntelliVue NMT Module is intended to be used as an objective neuromuscular transmission monitor, using

accelerometry for measuring the muscle contraction following an electrical stimulation of a peripheral nerve. The NMT Module is intended to be used with adult and pediatric patients.

MX600, MX700 and MX800 IntelliVue Patient Monitor:

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 intended to be used for monitoring and to generate alarms for, multiple of, and recording physiological parameters of adults, pediatrics, and neonates. monitors are intended for use by trained healthcare The professionals in a hospital environment.

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 EC 11).

5

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

The transcutaneous gas measurement (toGas) is restricted to neonatal patients only.

BIS is intended for use under the direct supervision of a licensed health care practitioner or by personnel trained in its proper use. It is intended for use on adult and pediatric patients within a hospital or medical facility providing patient care to monitor the state of the brain by data acquisition of EEG signals. The BIS may be used as an aid in monitoring the effects of certain anesthetic agents.

Use of BIS monitoring to help guide anesthetic administration may be associated with the reduction of the incidence of awareness with recall in adults during general anesthesia and sedation.

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

derived measurement Pulse Pressure Variation (PPV) The រន 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. The Integrated Pulmonary Index (IPI) is intended for use with adult and pediatric (1 to 12 years) patients only. The IPI is adjunct to and not intended to replace vital an siqn monitoring.

The IntelliVue NMT Module is intended to be used as an objective neuromuscular transmission monitor, using

accelerometry for measuring the muscle contraction following an electrical stimulation of a peripheral nerve. The NMT Module is intended to be used with adult and pediatric patients.

X2 Multi-Measurement Module:

The monitor is indicated for use by healthcare professionals whenever there is a need for monitoring the physiological parameters of patients.

The monitor is intended to be used for monitoring and recording and to generate alarms, for, multiple physiological of, parameters of adults, pediatrics, and neonates. The monitor is intended for use by trained healthcare professionals in a hospital environment.

The monitor is also intended for use during patient transport inside and outside of the hospital environment.

The monitor is only for use on one patient at a time. It is not intended for home use. Not a therapeutic device. The monitor is 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 EC 11) .

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

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

K122439 pp17

6

1. Technological Characteristics
  The modified devices have the same technological characteristics as the legally marketed predicate device.
1. Summary of Verification & Validation Activities and Conclusion 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 as well 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.

7

Image /page/7/Picture/1 description: The image is a circular seal for the Department of Health & Human Services - USA. The seal features a stylized eagle with its wings spread, facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the perimeter of the circle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

AUG 2 9 2012

Philips Medizin Systeme Boeblingen GmbH c/o Mr. Herbert van Dyk Quality and Regulatory Function Manager Hewlett-Packard Str. 2 Boeblingen 71034 GERMANY

Re: K122439

Trade/Device Name: Philips MP2, MP5, MP5T, MP5SC, MP20, MP30, MP50, MP60, MP70, MP80, MP90, MX600, MX700 and MX800 IntelliVue patient monitors and IntelliVue X2 Multi-Measurement Module

Regulatory Number: 21 CFR 870.1025

Regulation Name: Patient Physiological Monitor (with arrhythmia detection or alarms) Regulatory Class: II (two)

Product Code: MHX. DSI. MLD, DSJ, DSK, DXN, DXG, KRB, DRO, DRT, DPS, MLC, DRW, KRC, DRI, DQA, DSB, DSH, DSF, DRS, DSA, MSX, DRG, CCK, CBQ, NHO, NHP, NHQ, CBS, CBR, CCL, BZC, BZQ, LKD, KLK, KOI, FLL, GWR, GWS

Dated: August 7, 2012 Received: August 10, 2012

Dear Mr. van Dyk:

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.

8

Page 2 - Mr. Herbert van Dyk

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.

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.htm 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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor_You/Industry/default.htm.

Sincerely yours,

Tom D. Zukauskas, M.D.

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

Enclosure

9

3.1 Indications Statement

Indications for Use MP2

510(k) Number (if known):

Philips MP2 IntelliVue patient monitor, software Device Name: revision J.08.

MP2 IntelliVue Patient monitor:

monitor is indicated for use by healthcare professionals The whenever there is a need for monitoring the physiological parameters of patients.

The monitor is intended to be used for monitoring and recording of, and to generate alarms, for, multiple physiological parameters of adults, pediatrics, and neonates. The monitor is intended for use by trained healthcare professionals in a hospital environment.

The monitor is also intended for use during patient transport inside and outside of the hospital environment.

The monitor is only for use on one patient at a time. It is not intended for home use. Not a therapeutic device. The monitor is 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 EC 11).

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

Over-The-Counter Use Yes___________________________________________________________________________________________________________________________________________________________________________ Prescription Use No 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)

Division Sign Off

diovascular Devices

510(k) Number K122435

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Indications for Use MP5, MP5T and MP5SC

510 (k) Number (if known) : _

Philips MP5, MP5T and MP5SC IntelliVue patient Device Name: monitors, software revision J.08.

and MP5SC IntelliVue Patient Monitor: MP5, MP5T

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 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 MP5, MP5SC and MP5T monitors are also intended for use during patient transport inside the hospital environment; only the MP5 monitor is for use during patient transport outside of the hospital The MP5, MP5SC and MP5T when used the with environment. TRx4841A/TRx4851A IntelliVue

Telemetry System Transceiver or with the IntelliVue Cableless Measurement Devices, are intended for use in a hospital environment and during patient transport inside the hospital environment.

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 EC 11) .

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

The Predictive Temperature unit is intended for use with adult and pediatric patients in a hospital environment.

The SSC Sepsis Protocol, in the Protocol Watch 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.

Prescription Use _Yes_ AND/OR Over-The-Counter Use _No_
(Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Offic

510(k) Number K122437

11

Indications for Use MP20-90

510 (k) Number (if known) :

Device Name: Philips MP20, MP30, MP50, MP60, MP70, MP80 and MP90 IntelliVue patient monitors, software revision J.08.

MP20 - MP90 IntelliVue Patient Monitor:

monitors are indicated for use by health care professionals The whenever there is a need for monitoring the physiological parameters of patients.

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 MP20/MP30/MP40/MP50 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 EC 11). ST segment monitoring is intended for use with adult patients only

and is not clinically validated for use with neonatal and pediatric patients.

The derived measurement Pulse Pressure Variation (PPV) is intended use with sedated patients receiving controlled mechanical for mainly free from cardiac arrhythmia. The PPV ventilation and measurement has been validated only for adult patients: The transcutaneous gas measurement (tcGas) is restricted to neonatal patients only.

BIS is intended for use under the direct supervision of a licensed health care practitioner or by personnel trained in its proper use. It is intended for use on adult and pediatric patients within a hospital or medical facility providing patient care to monitor the state of the brain by data acquisition of EEG signals. The BIS may be used as an aid in monitoring the effects of certain anesthetic agents.

Use of BIS monitoring to help guide anesthetic administration may be associated with the reduction of the incidence of awareness with recall in adults during general anesthesia and sedation.

SSC Sepsis Protocol, in the ProtocolWatch clinical decision The 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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K122439

The IntelliVue NMT Module is intended to be used as an objective neuromuscular transmission monitor, using accelerometry for measuring the muscle contraction following an electrical stimulation of a peripheral nerve. The NMT Module is intended to be used with adult and pediatric patients.

Over-The-Counter Use Prescription Use AND/OR. No Yes (Part 21 CFR 801 Subpart D) (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)

Division Sign-Off) Division of Cardiovascular Devices

510(k) Number

13

Indications for Use MX600-MX800

510(k) Number (if known) :

Philips MX600, MX700 and MX800 IntelliVue patient Device Name: monitors, software revision J.08.