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. 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 (tcp0 2 / tcpCO2) is restricted to neonatal patients only.

Device Description

The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90 IntelliVue Patient Monitors. The modification is the introduction of Release C.02 software for the IntelliVue patient monitor devices, which enhances the monitor to calculate and display a numeric for the Minimum Alveolar Concentration (MAC).

AI/ML Overview

The provided text describes a 510(k) summary for the Philips IntelliVue Patient Monitors (K052801), focusing on a software update (Release C.02) that enhances the monitor to calculate and display a numeric for the Minimum Alveolar Concentration (MAC).

Based on the provided information, here's an analysis of the acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance:

The document states that "Pass/Fail criteria were based on the specifications cleared for the predicate device and test results showed substantial equivalence." However, it does not explicitly list quantitative acceptance criteria or specific performance metrics. It generally states that the device "meets all reliability requirements and performance claims."

Acceptance Criteria (Stated/Implied)	Reported Device Performance
Reliability requirements met	Achieved
Performance claims met	Achieved
Functionality consistent with predicate device	Achieved
Safety consistent with predicate device	Achieved
Substantial equivalence to predicate device specifications	Achieved
Ability to calculate and display numeric MAC	Achieved (new feature)

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

The document does not provide a specific sample size for the test set used to demonstrate adherence to acceptance criteria. It mentions "Verification, validation, and testing activities," "system level tests, performance tests, and safety testing from hazard analysis."

Data Provenance: Not specified. The document does not indicate the country of origin of the data or whether it was retrospective or prospective.

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

The document does not mention the use of experts or a ground truth establishment process for the test set. The evaluation seems to rely on internal testing against existing specifications for predicate devices.

4. Adjudication Method for the Test Set:

Not applicable, as no external experts or adjudication process are mentioned. The testing appears to be internal verification and validation against established specifications.

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

No, an MRMC comparative effectiveness study was not conducted or mentioned in this submission. This type of study is typically performed to evaluate the impact of an AI-assisted device on human reader performance, which is not the focus of this 510(k) submission.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

The nature of the device (patient monitor with a software update for MAC calculation) implies that the "performance" is inherently standalone in terms of the algorithm generating the MAC numeric. The testing described focuses on the device's ability to accurately calculate and display this value as per its specifications. However, there isn't a specific section detailing a "standalone study" with explicit metrics in the way one might see for an AI diagnostic algorithm. The verification and validation activities essentially serve as the standalone performance evaluation of the new software functionality.

7. Type of Ground Truth Used:

The ground truth for the testing revolved around the specifications cleared for the predicate device and the accurate calculation of the MAC value based on established physiological principles and measurement inputs. It's not based on external expert consensus, pathology, or outcomes data in the typical sense of a diagnostic device. Instead, it's about the correct implementation of a physiological calculation within the monitor.

8. Sample Size for the Training Set:

Not applicable. This device is a patient monitor with a software update for a specific physiological calculation (MAC). There is no mention of a machine learning or AI algorithm that would require a "training set" in the conventional sense for image analysis or diagnostic prediction. The MAC calculation is based on established physiological formulas.

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

Not applicable, as there is no training set mentioned or implied for this device.

Summary

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K052801

510 (k) Summary

NOV - 2 2005

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 Tel: ++49 7031 463-2031 Fax: ++49 7031 463-2442 e-mail: hauke.schik@philips.com

This summary was prepared on September 30, 2005.

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
CirculatorySystem Devices(12625)	$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)
	$870.2300, II	MSX	System, Network andCommunication, PhysiologicalMonitors
	$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

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$870.2900, I	DSA	Cable, Transducer andElectrode, incl. PatientConnector
$870.2910, II	DRG	Transmitters and Receivers,Physiological Signal,Radiofrequency
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

1. The modified devices are substantially equivalent to previously cleared Philips devices marketed pursuant to K014159, K021778, K030038, K032858, K040304, K040183 and K040357, K041235, K41741, K042845, K050141, 050762 and ко51106.
1. The modification is the introduction of Release C.02 software for the IntelliVue patient monitor devices, which enhances the monitor to calculate and display a numeric for the Minimum Alveolar Concentration (MAC) .
1. The modified devices have the same intended use as the 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.

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1. The modified devices have the same technological characteristics as the legally marketed predicate devices.
1. Verification, validation, and testing activities establish 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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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV - 2 2005

Mr. Hauke Schik Senior Regulatory Affairs Engineer Philips Medizinsysteme Boeblingen GmbH Cardiac and Monitoring Systems Hewlett-Packard Str. 2, D-71034 Boeblingen, GERMANY

Re: K052801

Trade/Device Name: The Phillips MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90 IntelliVue Patient Monitors, Release C.02 Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia Detector and Alarm (including ST-segment measurement and alarm) Regulatory Class: II Product Code: MXH Dated: September 30, 2005 Received: November 2, 2005

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. 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 (OS) 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 vou 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,

Cluts

Chiu Lin, Ph.D. 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): ____________________________________________________________________________________________________________________________________________________

Device Name: The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90 IntelliVue Patient Monitors, Release C.02

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. 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 (tcp0 2 / tcpCO2) is restricted to neonatal patients only.

Prescription Use Over-The-Counter Use yes No AND/OR ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------(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)

Quen Suliom

sion of Anesthesiology, General Hospital, infoction Control, Dental Devices

(2(k) Number

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.