THE PHILIPS INTELLIVUE MP40, MP50, MP60, MP70,AND MP90 PATIENT MONITORS, RELEASE B.O. by PHILIPS MEDIZINSYSTEME BOBLINGEN GMBH

Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. Intended for monitoring, recording and alarming of multiple physiological parameters of adults, pediatrics and neonates in hospital environments.

EASI 12-lead ECG is only for use on adult and pediatric patients.

ST Segment monitoring is restricted to adult patients only.

The transcutaneous gas measurement (tcpO2 / tcpCO2) is restricted to neonatal patients only.

Device Description

The Philips MP40, MP50, MP60, MP70, and MP90 IntelliVue Patient Monitor.

AI/ML Overview

The provided text describes a 510(k) summary for the Philips IntelliVue Patient Monitors, specifically focusing on the introduction of Release B.0 software and new models. However, it does not include the details typically found in a study proving a device meets specific acceptance criteria in the context of AI/ML or diagnostic performance. This document is a regulatory submission for a patient monitor, which is a hardware device with software, not a diagnostic AI algorithm.

Therefore, many of the requested categories related to AI/ML or diagnostic performance studies (like sample size for test/training sets, experts for ground truth, MRMC studies, standalone performance, etc.) are not applicable or not provided in this document.

Here's an attempt to answer the questions based only on the provided text, indicating where information is not available:

Acceptance Criteria and Device Performance Study for Philips IntelliVue Patient Monitors (K032858)

1. A table of acceptance criteria and the reported device performance

The document refers to acceptance criteria generally but does not provide a specific table of quantitative acceptance criteria or detailed performance metrics.

Acceptance Criteria Category	Reported Device Performance
System Level Tests	Pass/Fail criteria based on specifications cleared for the predicate device. Test results showed substantial equivalence.
Performance Tests	Pass/Fail criteria based on specifications cleared for the predicate device. Test results showed substantial equivalence.
Safety Testing	Based on hazard analysis. Test results showed substantial equivalence.
Reliability Requirements	"The results demonstrate that the Philips IntelliVue Patient Monitor meets all reliability requirements."
Performance Claims	"The results demonstrate that the Philips IntelliVue Patient Monitor meets all...performance claims."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size: Not specified. The document mentions "system level tests, performance tests, and safety testing" but does not detail the number of cases, patients, or data points used in these tests.
Data Provenance: Not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable/Not specified. This document is for a patient monitor (hardware and general software), not a diagnostic AI algorithm requiring expert-established ground truth for a test set in the typical sense of a diagnostic performance study. The "ground truth" for a patient monitor would be its accurate measurement and display of physiological parameters, which is validated through engineering tests against known standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable/Not specified. Adjudication methods like 2+1 or 3+1 are typically used in studies involving human interpretation (e.g., image reading) where multiple experts resolve disagreements to establish a ground truth. This is not the type of testing described for a patient monitor.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a patient monitor, and the testing described is not an MRMC comparative effectiveness study comparing human readers with and without AI assistance for interpretation.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. While the device contains algorithms for monitoring various physiological parameters (e.g., arrhythmia detection, ST segment monitoring), the document does not describe standalone algorithm performance testing in the context of an AI/ML diagnostic or predictive algorithm being evaluated against a ground truth as typically understood for this type of question. The "performance" mentioned refers to the overall device's ability to accurately measure and display parameters.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not specified in detail. For a patient monitor, the "ground truth" for performance testing would typically involve established reference standards, calibrated equipment, and simulated physiological signals to ensure accuracy of measurements (e.g., ECG, blood pressure, temperature, O2 saturation). The document states "Pass/Fail criteria were based on the specifications cleared for the predicate device," implying performance was compared against predetermined technical specifications.

8. The sample size for the training set

Not applicable/Not specified. The document describes a software release (Release B.0) for established patient monitors, not the development of a novel AI/ML algorithm that requires a "training set" in the context of machine learning.

9. How the ground truth for the training set was established

Not applicable/Not specified, as there is no mention of a "training set" in the context of machine learning for an AI algorithm.

Summary

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OCT 1 0 2003

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: Hauke Schik Philips Medizin Systeme Boeblingen GmbH Hewlett-Packard-Str. 2 D-71034 Boeblingen, Germany ++49 7031 463-2442 Tel: ++49 7031 463-2031 Fax: e-mail: hauke.schik@philips.com
  This summary was prepared on September 8, 2003.
1. The names of the devices are the Philips MP40, MP50, MP60, MP70, and MP90 IntelliVue Patient Monitor. Classification names are as follows:

Device Panel	Classification	ProCode	Description
CirculatorySystem Devices(12625)	$870.1025, III	DSI	Detector and alarm, arrhythmia
	$870.1025, III	MLD	Monitor, ST Segment with Alarm
	$870.1025, III	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
	$870.1915, II	KRB	Probe, Thermodilution
	$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
	$870.2900, I	DSA	Cable, Transducer andElectrode, incl. PatientConnector

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		MSX	System, Network andCommunication, PhysiologicalMonitors
Anesthesiologyand RespiratoryTherapy (12624)	$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
	$868.2375, 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)	$880.2910, II	FLL	Thermometer, Electronic,Clinical
Neurological(12513)	$882.1400, II	GWR	Electroencephalograph
	$882.1420, I	GWS	Analyzer, Spectrum,Electroencephalogram Signal

The new devices are substantially equivalent to previously 3. cleared Philips devices marketed pursuant to K001664, K021778, K030038 and K031481.
1. The modification is the introduction of Release B.0 software for the IntelliVue patient monitor devices, MP60, MP70 and MP90, and the introduction of the models MP40 and MP50.
1. The new devices have the same intended use as the leqally marketed predicate devices. When used in the hospital environment, they are intended for the monitoring, recording, and alarming of multiple physiological parameters of adults, pediatrics, and neonates.
1. The new devices have the same technoloqical characteristics as the legally marketed predicate devices.
1. Verification, validation, and testing activities establish the performance, functionality, and reliability characteristics of the new device with respect to the

10 3385

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Testing involved system level tests, performance predicate. 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 is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an abstract design that resembles an eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 1 0 2003

Philips Medizin Systeme Böblingen GmbH c/o Mr. Hauke Schik Sr. Regulatory Affairs Engineer Cardiac and Monitoring Systems Hewlett-Packard-Str. 2 71034 Böblingen GERMANY

Re: K032858

Trade Name: The Philips Intellivue M40, M50, MP60, MP70 and MP90 Patient Monitors, Release B.0. Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia Detector and Alarm Regulatory Class: Class III (three) Product Code: DSI Dated: September 9, 2003 Received: September 12, 2003

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.

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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 (301) 594-4646. 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 may be obtained 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/dsma/dsmamain.html

Sincerely vours.

Mefremyr

C. Peter R. Zohman, M.D.

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

Enclosure

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510(k) Number (if known):

Device Name: The Philips IntelliVue MP40, MP50, MP60, MP70, and MP90 Patient Monitors, Release B.0.

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, recording and alarming of multiple physiological parameters of adults, pediatrics and neonates in hospital environments.

EASI 12-lead ECG is only for use on adult and pediatric patients.

ST Segment monitoring is restricted to adult patients only.

The transcutaneous gas measurement (tcpO2 / tcpCO2) is restricted to neonatal patients only.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Mesa May

Prescription Use CFR 801.109)

Over-The-Counter (Per 21

510(K) Number K032856
(Optional Format 1-2-96)

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.