THE PHILIPS MP20, MP30, MP40, MP50, MP60, MP70 AND MP90 INTELLIVUE PATIENT MONITORS by PHILIPS MEDIZINSYSTEME BOEBLINGEN 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. The MP20, MP30, MP40 and MP50 are intended for use in transport situations within additionally hospital environments.

ST Segment monitoring is restricted to adult patients only.

The transcutaneous gas measurement (tcp02 / tcpCO2) is restricted to neonatal patients only.

Device Description

The Philips MP20, MP30, MP40, MP50, MP60, MP70, and MP90 IntelliVue Patient Monitors. The modification is the introduction of Release B.1.2 software for the IntelliVue patient monitor devices and incorporating a ITS wireless interface.

AI/ML Overview

Here's an analysis of the provided text regarding acceptance criteria and the supporting study:

The provided document is a 510(k) summary for the Philips IntelliVue Patient Monitors, specifically for the introduction of Release B.1.2 software and a wireless interface. It focuses on demonstrating substantial equivalence to previously cleared devices rather than establishing novel performance claims with specific acceptance criteria that would require a detailed standalone study.

Key takeaway: This submission relies on proving the updated device functions similarly to its predicates, implying that the predicate devices already met established performance standards. Therefore, the information typically requested for a de novo device's acceptance criteria and studies (like specific accuracy metrics, sensitivity/specificity, etc.) is not explicitly present in this summary.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of numerical acceptance criteria (e.g., sensitivity, specificity, accuracy targets) or specific reported device performance metrics in the way a new device would for novel claims. Instead, it states that:

"Verification, validation, and testing activities establish the performance, functionality, and reliability characteristics of the modified device with respect to the predicate."
"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."

This means the "acceptance criteria" were essentially that the modified device performed at least as well as the predicate devices for their established specifications. The "reported device performance" is implicitly that it achieved this equivalence across all tested aspects.

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

The document does not specify a sample size for a test set in terms of patient data or specific clinical cases. The testing described is more focused on system-level validation and verification rather than clinical performance against a diagnostic gold standard in a typical study.

Sample Size: Not specified.
Data Provenance: Not specified. Since the testing is described as "system level tests, performance tests, and safety testing from hazard analysis," it's likely a mix of internal engineering tests, simulated data, and potentially some real-world operational testing, but not a large-scale clinical study with patient data.

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

Not applicable. This type of submission, focused on software and interface modifications for an existing patient monitor, primarily involves engineering and regulatory assessment, rather than expert clinical review of novel diagnostic outputs.

Number of Experts: Not specified.
Qualifications of Experts: Not specified.

4. Adjudication Method for the Test Set

Not applicable. As no human-in-the-loop diagnostic task or a specific clinical test set requiring expert adjudication is described, there's no mention of an adjudication method like 2+1 or 3+1.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. The document does not describe any study involving human readers or AI assistance, as the device is a patient monitor, not an AI-powered diagnostic tool.

6. If a Standalone Performance Study Was Done

A standalone performance study with explicit metrics (like sensitivity/specificity against a clinical gold standard) for a new algorithm was not performed or described. The performance assessment was centered on validating that the modified device maintains the performance, functionality, and reliability characteristics of its predicate devices. This includes "performance tests" at a system level.

7. The Type of Ground Truth Used

Given the nature of the device (patient monitor) and the submission's focus on substantial equivalence through software and interface updates:

Ground Truth Type: For the "performance, functionality, and reliability," the ground truth would be the specifications and established performance of the predicate devices. This implies that the internal workings and outputs (e.g., heart rate readings, blood pressure measurements, alarm triggers) of the modified device were compared against the known, validated behavior of the older versions. It's an engineering and functional ground truth rather than a clinical diagnostic ground truth like pathology or outcome data.

8. The Sample Size for the Training Set

Not applicable. This document describes a medical device (patient monitor) with software updates, not an AI/Machine Learning model that requires a training set.

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

Not applicable, as there is no mention of an AI/Machine Learning model or a training set.

Summary

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510 (k) Summary

This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of the Sate 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 January 21, 2005.

1. The names of the devices are the Philips MP20, MP30, MP40, MP50, MP60, MP70, 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

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 and K042845.
1. The modification is the introduction of Release B.1.2 software for the IntelliVue patient monitor devices and incorporating a ITS wireless interface.
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.
1. The modified devices have the same technological characteristics as the legally marketed predicate devices.

Electroencephalogram Signal

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K050141
P³/₃

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 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" around the edge. In the center of the seal is an abstract image of an eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 1 2005

Phillips Medizin Systeme Boeblingen GmbH c/o Mr. Hauke Schik Sr. Regulatory Affairs Engineer Hewlett-Packard Str. 2 D-71034 Boeblingen GERMANY

Re: K050141

Trade Name: The Phillips MP20, MP30, MP40, MP50, MP60, MP70 and MP90 Intellivue Patient Monitors, Release B.1.2. Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia Detector and Alarm (including ST-segment measurement and alarm) Regulatory Class: II (two) Product Code: MHX Dated: January 21, 2005 Received: January 24 2005

Dear Mr. Hauke Schik:

We have reviewed your Section 510(k) premarket notification of intent to market the device w & no re review a your we 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, de nees mat have been 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 (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 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 yours,

Brimmer 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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Indications for Use

510(k) Number (if known):_ Ko5o14 l

Device Name: The Philips MP20, MP30, MP40, MP50, MP60, MP70 and MP90 IntelliVue Patient Monitors, Release B.1.2.

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 intended for use in transport situations within additionally hospital environments.

ST Segment monitoring is restricted to adult patients only.

The transcutaneous gas measurement (tcp02 / tcpCO2) is restricted to neonatal patients only.

Prescription Use yes___________________________________________________________________________________________________________________________________________________________________________ Over-The-Counter Use _ No (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)

Blinums

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.