INTELLIVUE PATIENT MONITORS ,MODELS MP40, MP50, MP60, MP70, MP80, MP90 by PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH, CARDIAC AN

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.

AI/ML Overview

This 510(k) summary does not contain the specific details required to complete all sections of your request comprehensively. The document focuses on demonstrating substantial equivalence to predicate devices for patient monitors and the introduction of a new SO2 module and software revision. It largely relies on "verification, validation, and testing activities" without explicitly detailing the acceptance criteria, specific study design, or nuanced results you're asking for.

Here's an attempt to answer your questions based on the provided text, with significant caveats where information is not available:

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

The document does not provide a table with specific acceptance criteria (e.g., specific accuracy ranges for physiological parameters, alarm response times) or detailed reported device performance metrics in a quantitative manner.

Instead, it states: "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."

This means the acceptance criteria were implicitly those of the predicate devices, and the "reported performance" is a general statement of compliance rather than explicit numbers.

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

The document does not specify the sample size for any test set or the data provenance (country of origin, retrospective/prospective). It generally refers to "testing involved system level and regression tests, safety and performance tests, EMC and environmental tests."

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)

This information is not provided. The nature of the device (patient monitor) suggests that ground truth would likely be established through reference instruments or established clinical standards rather than expert consensus on interpretation of, for example, images.

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

This information is not provided.

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

A multi-reader multi-case (MRMC) comparative effectiveness study is not indicated in this document. This type of study is typically used for diagnostic or interpretive AI devices where human readers would be involved in interpreting outputs. The Philips IntelliVue Patient Monitors are monitoring devices, and the evaluation would focus on the accuracy and reliability of the physiological parameter measurements themselves and the associated alarms. There is no mention of "human readers" or "AI assistance" in this context.

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

The document describes testing of the "modified devices" (which include a new SO2 module and software revision G.07 for the patient monitors). The testing described ("system level and regression tests, safety and performance tests, EMC and environmental tests") would inherently be a standalone evaluation of the device's performance against its specifications without explicit human-in-the-loop performance being a primary evaluation point. The device itself is designed to perform monitoring functions independently.

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

The type of ground truth is not explicitly stated. For physiological monitors, ground truth would typically come from:

Reference standard instruments: Highly accurate and calibrated medical devices used to establish true physiological values.
Simulated physiological signals: Controlled inputs representing various patient conditions.
Clinical data paired with highly accurate manual measurements: In some cases, direct manual observation or measurement by trained clinicians using gold-standard techniques.

The document refers to "specifications cleared for the predicate devices," implying that the ground truth would be based on established measurements and performance expectations for the physiological parameters being monitored.

8. The sample size for the training set

This information is not provided. The document describes a "software revision G.07" but does not mention the use of machine learning or AI models that would typically require a training set in the way you might expect for an AI diagnostic device. The "software revision" is more likely related to traditional software engineering updates and bug fixes rather than an AI model requiring a training set of patient data.

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

Since the document does not indicate the use of a "training set" in the context of machine learning/AI, this question is not applicable based on the provided text. The ground truth for the testing, as inferred above, would be based on reference standards for physiological measurements.

Summary

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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
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
	$870.1915, 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
	$870.2600, 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
	-	MSX	System, Network andCommunication, PhysiologicalMonitors

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Device Panel	Classification	ProCode	Description
	$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
	$868.2480, II	LKD	Monitor, Carbon Dioxide,Cutaneous
	$868.2500, II	KLK	Monitor, Oxygen, Cutaneous, forInfant not under Gas Anesthesia
General Hospitaland Personal UseDevices	$880.2910, II	FLL	Thermometer, Electronic,Clinical
NeurologicalDevices	$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

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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.

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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.

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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

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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

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.