Indicated for use by health care professionals whenever there is a need for monitoring, recording and alarming of multiple physiological parameters of patients. Intended for monitoring, of multiple physiological parameters of adults, pediatrics and neonates in hospital environments. The MP20, MP30, MP40 and MP50 are additionally intended for use in transport situations within hospital environments.

ST Segment monitoring is restricted to adult patients only.

The transcutaneous gas measurement (tcp02 / tcpCQ2) is restricted to neonatal patients only.

Device Description

The names of the devices are the Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90 IntelliVue Patient Monitors.

AI/ML Overview

The provided text is a 510(k) summary for the Philips IntelliVue Patient Monitors, specifically for the introduction of Release D.04 software, which includes the calculation of Pulse Pressure Variation.

Here's an analysis of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Acceptance Criteria (Implicit)	Reported Device Performance
Equivalence to Predicate	Substantial equivalence to previously cleared Philips devices (K021778, K030038, etc.)	The modified devices have the same intended use and technological characteristics as the legally marketed predicate devices.
Performance & Functionality	Meet specifications cleared for the predicate device.	"Test results showed substantial equivalence." "The results demonstrate that the Philips IntelliVue Patient Monitor meets all reliability requirements and performance claims."
Reliability	Meet reliability requirements.	"The results demonstrate that the Philips IntelliVue Patient Monitor meets all reliability requirements and performance claims."
Safety	Address hazards identified in hazard analysis.	"Safety testing from hazard analysis" was performed, implying that safety criteria were met.

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). It generally refers to "system level tests, performance tests, and safety testing."

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

The document does not mention the use of experts to establish a ground truth for a test set, nor does it specify their number or qualifications. The evaluation appears to be based on engineering-level testing against predetermined specifications rather than clinical expert review.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method. The testing seems to be based on pass/fail criteria against specifications.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not mentioned. The device is a patient monitor with software for physiological parameter calculation (Pulse Pressure Variation), not an imaging or diagnostic device typically evaluated with MRMC studies involving human readers.

6. Standalone (Algorithm Only) Performance Study

A standalone performance evaluation was done in the sense that the device's performance (specifically the Release D.04 software including Pulse Pressure Variation calculation) was tested against "specifications cleared for the predicate device." However, the term "standalone" usually implies an AI algorithm's performance independent of human input, and this document describes the overall system's performance. The "algorithm" itself (Pulse Pressure Variation calculation) was implicitly evaluated as part of the overall performance tests.

7. Type of Ground Truth Used

The ground truth for the performance evaluation appears to be based on:

Specifications: "Pass/Fail criteria were based on the specifications cleared for the predicate device." This implies engineering and technical specifications for accuracy and functionality.
Predicate Device Performance: The primary method of demonstrating substantial equivalence relies on showing the device performs similarly to or within the established range of the predicate device.

8. Sample Size for the Training Set

The document does not mention a training set. This is not a machine learning model in the modern sense that typically requires a separate training set. The "software" likely refers to deterministic algorithms and calculations.

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

Since there is no mention of a training set, the establishment of ground truth for it is not applicable.

Summary

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510 (k) Summary

MAY 26 2006

· Comments of Submittee Barner Station Comments of Children Comments of Children States March 14-

K061052

+1/3

How we well be procession

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: Hauke Schik Philips Medizin Systeme Boeblingen GmbH Hewlett-Packard-Str. 2 D-71034 Boeblingen, Germany Fax: ++49 7031 463-2442 Tel: ++49 7031 463-2031 e-mail: hauke.schik@philips.com

This summary was prepared on April 13, 2006.

1. The names of the devices are the Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90 IntelliVue Patient Monitors. Classification names are as follows:

Device Panel	Classification	ProCode	Description
Circulatory	s870.1025, II	DSI	Detector and alarm, arrhythmia
System Devices	$870.1025, II	MLD	Monitor, ST Segment with Alarm
(12625)	$870.1025, II	MHX	Monitor, Physiological, Patient
			(with arrhythmia detection or
			alarms)
	5870.1100,II	DSI	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
	5870.1915, II	KRB	Probe, Thermodilution
	5870.2060, II	DRQ	Amplifier and Signal
			Conditioner; Transducer Signal
	5870.2300, II	DRT	Monitor, Cardiac (incl.
			Cardiotachometer & Rate Alarm)
	$870.2300, II	MSX	System, Network and
			Communication, Physiological
			Monitors
	$870.2340, II	DES	Electrocardiograph
	$870.2340, II	MLC	Monitor, ST Segment
	$870.2350, II	DRW	Electrocardiograph, Lead
			Switching Adapter
	$870.2370, II	KRC	Tester, Electrode, Surface,
			Electrocardiograph
	$870.2450, II	DXJ	Display, Cathode-Ray Tube,
			Medical
	$870.2600,I	DRJ	System, Signal Isolation
	5870.2700,	DQA	Oximeter
	$370.0770,!	DSB	Plethysmograph, Impedance
	8330.1400,	DSH	Recorder, Magnetic tape,
			Medical
	$800.0810,	DSFF	Recorder, Paper Chart
	$672.0450, 11	DRS	Extravascular Blood Pressure
			Transducer

	$870.2900, I	DSA	Cable, Transducer andElectrode, incl. PatientConnector
	$870.2910,II	DRG	Transmitters and Receivers,Physiological Signal,Radiofrequency
Anesthesiologyand Respiratory	$868.1400,II	CCK	Analyzer, Gas, Carbon Dioxide,Gaseous-Phase
Therapy (12624)	5868.1500, II	СВО	Analyzer, Gas, Enflurane,Gaseous-Phase (AnestheticConcentration)
	$868.1500, II	NHQ	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)
	5868.1620,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
	$868.2375.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 Use(12520)	5880.2910,II	FLL	Thermometer, Electronic,Clinical
Neurological	$882.1400,II	GWR	Electroencephalograph
(12513)	5882.1420,I	GMS	Analyzer, Spectrum,Electroencephalogram Signal

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comments of the consistent of the count

1. The modified devices are substantially equivalent to previously cleared Philips devices marketed pursuant to, K021778, K030038, K032858, K033513, K040304, K041235, K042845, K050141, 050762, K051106, K052801, K053522, K060221 and K060541
1. The modification is the introduction of Release D.04 software for the IntelliVue patient monitor devices including the calculation of the Pulse Pressure Variation.
The modified devices have the same intended use as the 5. legally marketed predicate devices. They are intended for the monitoring, recording, and alarming of multiple physiological parameters of adults, pediatrics, and neonates in hospital environment and during transport within hospital environments .

4 o

KO61052

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

The modified devices have the same technological 6. characteristics as the leqally marketed predicate devices.

3/3

! こ

Verification, validation, and testing activities establish 7. the performance, functionality, and reliability characteristics of the modified device with respect to the predicate. 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 Patient Monitor meets all reliability requirements and performance claims.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the Department of Health and Human Services, USA. The logo features a stylized caduceus symbol, which is a traditional symbol of medicine, with three lines representing the branches of government. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged in a circular pattern around the caduceus.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Phillips Medical Systems North America, Inc. c/o Mr. Hauke Schik Sr. Regulatory Affairs Engineer Hewlett-Packard Str. 2 Boeblingen, Germany D-71034

Re: K061052

Trade Name: The Phillips MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue Patient Monitors, Models Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia detector and alarm Regulatory Class: Class II (two) Product Code: MHX Dated: May 9, 2006 Received: May 12, 2006

Dear Mr. Schik:

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.

MAY 26 2006

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Page 2 - Mr. Hauke Schik

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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Bhimman 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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K061052

Indications for Use

510(k) Number (if known): KobloS2

The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80 Device Name: and MP90 IntelliVue Patient Monitors, Release D.04

Indications for Use: Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters recording and alarming patients. Intended for monitoring, of of multiple physiological parameters of adults, pediatrics and neonates environments. The MP20, MP30, MP40 and MP50 hospital in are use in transport situations additionally intended for within hospital environments.

ST Seqment monitoring is restricted to adult patients only.

The transcutaneous gas measurement (tcp02 / tcpCQ2) is restricted to neonatal patients only.

Prescription Use yes (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use No (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF

NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Abimema

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.