PHILIPS MP60, MP70 AND MP90 INTELLIVUE PATIENT MONITORS WITH PORTAL TECHNOLOGY AND M3185 OPT C41 WIRELESS BEDSIDE ADAPTR by PHILIPS MEDICAL SYSTEMS, INC.

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.

Device Description

The Philips MP60, MP70, and MP90 IntelliVue Patient Monitor with Portal Technology and Wireless LAN. The modification is primarily a hardware based change that offers, as an option, the addition of an externally mounted wireless network connection to the Philips Medical System MP60, MP70 and MP90 IntelliVue patient monitor devices.

AI/ML Overview

The provided text is a 510(k) summary for the Philips MP60, MP70, and MP90 IntelliVue Patient Monitors with Portal Technology and Wireless LAN. It describes the device, its classification, and asserts substantial equivalence to previously cleared devices. However, it does not contain detailed information about specific acceptance criteria or a study proving the device meets those criteria in the way a clinical performance study would.

Instead, the summary focuses on verification testing activities to establish performance and reliability characteristics, and safety testing from the risk analysis. This type of submission (510(k)) for a patient monitor and its wireless adapter typically relies on demonstrating substantial equivalence to existing devices through engineering and functional testing, rather than a clinical efficacy study with specific performance metrics against a ground truth as one might expect for an AI/ML diagnostic device.

Therefore, many of the requested fields cannot be filled from the provided text because such a study was not described.

Here's a breakdown based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document states: "Verification testing activities were conducted to establish the performance and reliability characteristics of the new device. Testing involved functional level tests and safety testing from the risk analysis."

However, no specific quantitative acceptance criteria (e.g., sensitivity, specificity, accuracy for a particular physiological parameter) or their corresponding performance results are reported in this 510(k) summary. The submission focuses on demonstrating substantial equivalence to predicate devices, implying that if the new device performs similarly and meets safety standards, it is acceptable.

2. Sample size used for the test set and the data provenance

Not applicable. The document describes "functional level tests and safety testing," which are typically internal engineering and validation tests, not clinical studies with a "test set" in the context of diagnostic performance. There is no mention of patient data being used for a performance evaluation in this summary.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. No "ground truth" derived from expert consensus for a clinical performance study is described.

4. Adjudication method for the test set

Not applicable. No clinical performance study requiring adjudication is described.

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 with a wireless adapter, not an AI-based diagnostic tool. No MRMC study or AI-assistance evaluation is mentioned.

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

Not applicable. This device is a patient monitor, and its "performance" is inherent to its sensors and measurement capabilities, not a standalone algorithm in the sense of an AI/ML product.

7. The type of ground truth used

Not applicable. For this type of device (patient monitor), "ground truth" would generally refer to highly accurate reference measurements from calibrated equipment during functional testing, or clinical reference standards for physiological parameters. The summary doesn't detail the specifics of such ground truth used in their verification activities.

8. The sample size for the training set

Not applicable. This document pertains to a medical device (patient monitor with wireless capabilities), not an AI/ML model that requires a training set.

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

Not applicable. As above, this document does not describe an AI/ML model with a training set.

Summary

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MAR 1 2 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.

The submitter of this premarket notification is: David Osborn Philips Medical Systems 3000 Minuteman Road Andover, MA 01810-1099 Tel: 978 659 3178 Fax: 978 685 5624 e-mail: d.g.osborn@ieee.org

This summary was prepared on December 31, 2002.

1. The names of the devices are the Philips MP60, MP70, and MP90 IntelliVue Patient Monitor with Portal Technology and Wireless LAN. 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	Monotor, 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
	-	MSX	System, Network andCommunication, PhysiologicalMonitors

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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 new devices are substantially equivalent to previously cleared Philips devices marketed pursuant to K001664, K021778, and ко23871.
The modification is primarily a hardware based change that offers, as 4 . an option, the addition of a an externally mounted wireless network connection to the Philips Medical System MP60, MP70 and MP90 IntelliVue patient monitor devices.
1. The new devices have the same intended use as the legally 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 technological characteristics as the leqally marketed predicate devices.
1. Verification testing activities were conducted to establish the performance and reliability characteristics of the new device. Testing involved functional level tests and safety testing from the risk analysis.

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Public Health Service

Image /page/2/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three swooping lines forming its body and wings. The eagle is enclosed in a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper half of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 2 2003

Phillips Medical Systems, Inc. c/o Mr. David Osborn Ouality Program Manager 3000 Minuteman Road Andover, MA 01810-1099

Re: K030038

Trade/Device Name: IntelliVue Models MP60, MP70 and MP90 Patient Monitors with Portal Technology and M3185 opt. C41 Wireless Bedside Adapter Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia detector and alarm Regulatory Class: Class III (three) Product Code: MHX Dated: February 24, 2003 Received: February 25, 2003

Dear Mr. Osborn:

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. David Osborn

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 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,

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

Page

KO30038 510(k) Number (if known):

Device Name: The Philips IntelliVue MP60, MP70, and MP90 Patient Monitors with Portal Technology and M3185 opt C41 Wireless Bedside Adapter.

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.

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

Prescription Use
(Per 21 CFR 801.109)

(Optional Format 1-2-96)

Over-The-Counter

VCelkatil

(Division Sign-Off)
Division of Cardiovascular Devices

510(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.