For central monitoring of multiple adult, pediatric, and neonatal patients; and where the clinician decides to monitor cardiac arrhythmia of adult, pediatric, and neonatal patients and/or ST segment of adult patients to gain information for treatment, to monitor adequacy of treatment, or to exclude causes of symptoms.

Device Description

The name of this device is the M3290A IntelliVue Information Center Software Release E.0 (for DataBase Server with Web Server including Near-Realtime Export). The modification is a software-based change that provides improved database server access via the hospital intra/internet system.

AI/ML Overview

The PHILIPS MEDICAL SYSTEMS M3290A IntelliVue Information Center Software Release E.0 (for DataBase Server with Web Server including Near-Realtime Export) is a software-based modification designed to improve database server access via the hospital intra/internet system for central monitoring of multiple adult, pediatric, and neonatal patients. It also assists clinicians in monitoring cardiac arrhythmia and/or ST segments to inform treatment decisions.

Here's a breakdown of the acceptance criteria and the study conducted:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria / Performance Goal	Reported Device Performance
Reliability Requirements being met	Met all reliability requirements and performance claims.
Performance Claims being met	Met all reliability requirements and performance claims.
Functionality consistent with predicate	Functionality consistent with predicate.
Substantial Equivalence to predicate	Demonstrated substantial equivalence to the legally marketed predicate device (VIC Web software, K993907).

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

The document does not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It refers to "system level tests, integration tests, environmental tests, and safety testing."

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

The document does not mention the use of experts to establish ground truth for the test set. The validation appears to be based on engineering tests against predetermined specifications.

4. Adjudication Method for the Test Set:

The document does not describe an adjudication method. Pass/Fail criteria were based on predefined specifications from the predicate device and analysis of test results.

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

A multi-reader, multi-case (MRMC) comparative effectiveness study was not conducted. This device is a software modification for data access and monitoring, not an AI-assisted diagnostic tool that would typically involve human readers.

6. Standalone (Algorithm Only) Performance Study:

Yes, a standalone performance study was conducted in the form of "system level tests, integration tests, environmental tests, and safety testing" to establish the device's performance, functionality, and reliability. This testing assessed the algorithm's performance against predefined specifications, as it's a software-based system.

7. Type of Ground Truth Used:

The ground truth used for assessing the device's performance appears to be predefined technical specifications and functional requirements derived from the predicate device. The document states: "Pass/Fail criteria were based on the specifications cleared for the predicate device."

8. Sample Size for the Training Set:

The document does not mention a training set sample size because this device is a software modification and not a machine learning or AI model that requires a training phase with data for learning. Its functionality is based on established software logic and protocols.

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

As there is no mention or indication of a training set or machine learning components, there is no explanation of how a ground truth for a training set was established.

Summary

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NOV 1 9 2002

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:

Philips Medical Systems

This summary was prepared on 1 November, 2002.

1. The name of this device is the M3290A IntelliVue Information Center Software Release E.0 (for DataBase Server with Web Server including Near-Realtime Export). Classification names are as follows:

Classification	ProCode	Description
None	74 MHX	Physiological Monitor, PatientMonitor
870.1025, III	74 DSI	Arrhythmia Detector and Alarm
870.1025, III	74 MLD	Monitor, ST Alarm
870.2800, II	74 DSH	Recorder, Magnetic Tape, Medical
870.2300, II	74 MSX	System, Network andCommunication, PhysiologicalMonitors

1. The new device is substantially equivalent to the previously cleared VIC Web software cleared under K993907.
1. The modification is a software-based change that provides improved database server access via the hospital intra/internet system.
1. The new device has the same Indications for Use as the legally marketed predicate device. For central monitoring of multiple adult, pediatric, and neonatal patients; and where the clinician decides to monitor cardiac arrhythmia of adult, pediatric, and neonatal patients and/or ST seqment of adult patients to gain information for treatment, to monitor adequacy of treatment, or to exclude causes of symptoms.
1. The new device has 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 new device with respect to the

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Testing involved system level tests, integration predicate. tests, environmental tests, and safety testing from hazard Pass/Fail criteria were based on the analysis. specifications cleared for the predicate device and test results showed substantial equivalence. The results demonstrate that web software interface functionality meets all reliability requirements and performance claims.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Philins Medical Systems c/o Mr. David Osborn Ouality Program Manager 3000 Minuteman Road Andover, MA 01810

Re: K023698

Trade Name: M3290A IntelliVue DataBase Server Software for M3154 with Web Server including Near-Realtime export, Release E.0

Regulation Number: 21 CFR 870.1025

Regulation Name: Patient Physiological Monitor (with arrhythmia detection and alarms) Regulatory Class: Class III (three)

Product Code: MHX

Dated: November 1, 2002

Received: November 4, 2002

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 (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 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. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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,

Dma Sluschu for
Brand P. Zuckerman, M.D.

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

Enclosure

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Page : of

510(k) Number (if known):

Device Name: M3290A IntelliVue DataBase Server Software for M3154 with Web Server including Near-Realtime export, Release E.0

For central monitoring of multiple Indications for Use: . adult, pediatric, and neonatal patients; and where the clinician decides to monitor cardiac arrhythmia of adult, pediatric, and neonatal patients and/or ST segment of adult patients to gain information for treatment, to monitor adequacy of treatment, or to exclude causes of symptoms.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use	X
(Per 21 CFR 801.109)

Over-The-Counter Use
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(Optional Format 1-2-96)

f Cardiovascular & Respiratory Devices
Number K023698
Date 11/18

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.