PHILIPS INTELLIVUE MP5 PATIENT MONITOR by PHILIPS MEDIZIN SYSTEME BOBLINGEN GMBH

Indicated for use whenever there is a need for monitoring, transport monitoring, recording, and alarming of multiple physiological parameters of adult, pediatric and neonatal patients in a hospital environment and during transport inside and outside of hospital environment by health care professionals.

Device Description

The modified device Philips IntelliVue MP5 Patient Monitor with Microstream Side Stream CO2 Measurement Module. The modification consists of the integration of the Microstream CO2 Measurement Module, which is substantial equivalent to the legally marketed Philips M3015A Measurement Server Extension (K993383) and to the Oridion Capnostream2o with A2 Adaptive Averaging Software and Extended CO2 Measurement Range (K072295).

AI/ML Overview

The provided text describes the Philips IntelliVue MP5 Patient Monitor with an integrated Microstream Side Stream CO2 Measurement Module. The document focuses on showing substantial equivalence to predicate devices rather than providing a detailed acceptance criteria table with specific performance metrics and their verification.

Here's a breakdown of the information that can be extracted, acknowledging the limitations of the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a table with explicit acceptance criteria (e.g., minimum accuracy rates, sensitivity, specificity) for specific physiological parameters. Instead, it states that the device was validated according to ISO 21647 for accuracy and that "Pass/Fail criteria were based on the specifications cleared for the predicate device." It also claims that "test results showed substantial equivalence" and that the device "meets all reliability requirements and performance claims."

Therefore, based on the provided text, a detailed table cannot be constructed. The implicit acceptance criteria are that the device performs equivalently to the predicate devices and meets relevant ISO standards.

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective nature of the study). It generically mentions "system level tests, performance tests, and safety testing from hazard analysis."

3. Number of Experts Used to Establish Ground Truth and Their Qualifications

This information is not provided in the document.

4. Adjudication Method

This information is not provided in the document.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC study is mentioned in the document. The study described is not focused on human reader performance with or without AI assistance, but rather on the technical performance and equivalence of the device itself.

6. Standalone Performance

The description of "system level tests, performance tests, and safety testing" implies that standalone (algorithm only without human-in-the-loop) performance testing was conducted to demonstrate the device's functional integrity and equivalence to predicate devices. However, specific metrics of this standalone performance are not provided beyond the general statement of meeting "all reliability requirements and performance claims."

7. Type of Ground Truth Used

The document does not explicitly state the type of ground truth used. Given the context of monitoring physiological parameters (like CO2 measurement accuracy), the ground truth would likely be established through highly accurate reference measurement devices or laboratory-grade instruments. The validation against ISO 21647 suggests adherence to established standards for verifying accuracy against a known truth.

8. Sample Size for the Training Set

No information about a "training set" or its sample size is provided. This is expected as the device in question is a patient monitor with an integrated CO2 module, not typically an AI/machine learning algorithm requiring a distinct training set in the modern sense. The "training" for such devices involves calibration and validation against known standards.

9. How the Ground Truth for the Training Set Was Established

Since no training set is mentioned, this information is not available.

Summary of Study Information:

Study Type: Verification, validation, and testing activities focused on demonstrating substantial equivalence to predicate devices.
Key Validation Standard: Accuracy was validated according to ISO 21647.
Comparison: The modified device (Philips IntelliVue MP5 Patient Monitor with Microstream CO2) was compared to its legally marketed predicate device (IntelliVue MP5 Patient Monitor (K063725, K081793)) and the Microstream CO2 module was compared to the Philips M3015A Measurement Server Extension (K993383) and the Oridion Capnostream2o (K072295).
Conclusion: "Test results showed substantial equivalence" and "The results demonstrate that the Philips IntelliVue MP5 Patient Monitor meets all reliability requirements and performance claims."

In conclusion, while the document confirms that a study was conducted to demonstrate the device's performance and substantial equivalence according to ISO 21647 and predicate device specifications, it lacks the detailed quantitative acceptance criteria and specific study metrics (like sample sizes, expert details, or ground truth establishment methods) that would typically be associated with modern AI/ML device studies.

Summary

{0}------------------------------------------------

NOV 2 4 2008

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.

The submitter of this premarket notification is:

Dr. Jens-Peter Seher Philips Medizin Systeme Böblingen GmbH Hewlett-Packard-Str. 2 D-71034 Böblingen, Germany

Tel: ++49 7031 463-2086 Fax: ++49 7031 463-2442 e-mail: jens-peter.seher@philips.com

This summary was prepared on October 29, 2008.

1. The name of the device is the Philips IntelliVue MP5 Patient Monitor with Microstream Side Stream CO2 Measurement Module.
  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
	$870.2060, 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
	$870.2450, II	DXJ	Display, Cathode-Ray Tube,Medical
	$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

{1}------------------------------------------------

Device Panel	Classification	ProCode	Description
	$870.2900, I	DSA	Cable, Transducer andElectrode, incl. PatientConnector
	-	MSX	System, Network andCommunication, PhysiologicalMonitors
	$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
General Hospitaland Personal UseDevices	$880.2910, II	FLL	Thermometer, Electronic,Clinical

1. Indicated for use whenever there is a need for monitoring, transport monitoring, recording, and alarming of multiple physiological parameters of adult, pediatric and neonatal patients in a hospital environment and during transport inside and outside of hospital environment by health care professionals.
1. The modified device Philips IntelliVue MP5 Patient Monitor is substantially equivalent to the legally marketed IntelliVue MP5 Patient Monitor (K063725, K081793). The modification consists of the integration of the Microstream CO2 Measurement Module, which is substantial equivalent to the legally marketed Philips M3015A Measurement Server Extension (K993383) and to the Oridion Capnostream2o with A2 Adaptive Averaging Software and Extended CO2 Measurement Range (K072295).

{2}------------------------------------------------

1. The modified device has the same intended use as the legally marketed predicate device. The device is intended for monitoring, transport monitoring, recording, and alarming of multiple physiological parameters of adult, pediatric and neonatal patients in a hospital environment and during transport inside and outside of hospital environment by health care professionals.
1. The modification is the integration of the Microstream CO2 measurement module into the MP5 with minor hardware and software adaptations. The modification leads to a compact patient monitor with integrated side stream CO2 measurement and reduces manufacturing costs.
1. The accuracy of the device was validated according to ISO 21647.
1. Verification, validation, and testing activities establish the performance, functionality, and reliability characteristics of the modified device with respect to the predicate device. Testing involved system level tests, performance tests, and safety testing from hazard analysis. Pass/Fail criteria were based on the specifications cleared for the predicate device and test results showed substantial equivalence. The results demonstrate that the Philips IntelliVue MP5 Patient Monitor meets all reliability requirements and performance claims.

{3}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/2 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with three legs, representing health, services, and people. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 2 4 2008

Philips Medizin Systeme Boblingen GMBH Dr. Jens-Peter Seher Senor Regulatory Affairs Engineer Cardiac and Monitoring Systems Hewlett-Packard -Str. 2 D-71034 Boblingen, Germany

Re: K083228

Trade/Device Name: Philips IntelliVue MP5 Patient Monitor 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: October 29, 2008 Received: November 3, 2008

Dear Dr. Seher:

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 intentate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendinents, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Orug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (DMA), You may, therefore, market the device, subject to the general controls provisions of the 11th general controls provisions of the Act include requirements for annual registration, isting of devices, good manufacturing practice, labeling, and prohibitions against misbaranding 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 11 vire can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition JFDA may publish further announcements concerning your device in the Federal Register. Nexe oc advised that FDA's issuance of a substantial equivalence determination docs not mean that FDA has made a determination that your device complies with other requirements of the Act array

{4}------------------------------------------------

Page 2 - Dr. Jens-Peter Seher

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 (2) 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

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

Enclosure

{5}------------------------------------------------

Indications for Use

510(k) Number (if known): K083228

Device Name: Philips IntelliVue MP5 Patient Monitor.

Indications for Use: Indicated for use whenever there is a need for monitoring, transport monitoring, recording, and alarming of multiple physiological parameters of adult, pediatric and neonatal patients in a hospital environment and during transport inside and outside of hospital environment by health care professionals.

Prescription Use (Part 21 CFR 801 Subpart D)	yes	AND/OR	Over-The-Counter Use (21 CFR 807 Subpart C)	No
----------------------------------------------	-----	--------	---------------------------------------------	----

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Signature

(Division Sign-Off)
Division of Cardiovascular Devices
	11/24/05
510(k) Number	K083228

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.