M3290A INTELLIVUE INFORMATION CENTER SOFTWARE RELEASE G.00

K050742 · Philips Medical Systems · MHX · Apr 5, 2005 · Cardiovascular

Device Facts

• Record ID: K050742
• Device Name: M3290A INTELLIVUE INFORMATION CENTER SOFTWARE RELEASE G.00
• Applicant: Philips Medical Systems
• Product Code: MHX · Cardiovascular
• Decision Date: Apr 5, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1025
• Device Class: Class 2
• Attributes: Software as a Medical Device, Pediatric

Intended Use

Indicated 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 Story

M3290A IntelliVue Information Center Software Release G.00 is a central monitoring system for hospital use. It aggregates physiological data from multiple patients; processes cardiac arrhythmia and ST segment data; and provides alert data integration. The system enables clinicians to monitor patient status, assess treatment efficacy, and identify potential clinical issues. The primary modification in this release is the capability for alert data export via hospital LAN. It is operated by healthcare professionals in clinical settings to facilitate centralized patient surveillance.

Clinical Evidence

Bench testing only. Verification and validation activities included system-level tests, integration tests, environmental tests, and safety testing based on hazard analysis. Pass/Fail criteria were derived from predicate device specifications. Results demonstrated that the web software interface functionality meets all reliability requirements and performance claims.

Technological Characteristics

Software-based central monitoring system. Operates on a database server architecture. Features alert data integration and export capabilities via hospital LAN. Designed for network communication of physiological monitor data. No specific hardware materials or sterilization methods are applicable as this is a software release.

Indications for Use

Indicated for central monitoring of adult, pediatric, and neonatal patients; monitoring of cardiac arrhythmia (all ages) and ST segment (adults) for treatment guidance, monitoring treatment adequacy, or symptom exclusion.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• IntelliVue Information Center Software (K011093)
• IntelliVue Information Center Software (K031403)

Submission Summary (Full Text)

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summary of 510(k) safety and effectiveness information This i s 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:

Philips Medical Systems

This summary was prepared on 21 March, 2005.

- 2. The name of this device is the M3290A IntelliVue Information Center Software Release G.00 (for DataBase Server with Alert Data Integration). Classification names are as follows:

| Classification | ProCode | Description |
|----------------|---------|--------------------------------------------------------------|
| None | 74 MHX | Physiological Monitor, Patient<br>Monitor |
| 870.1025, II | 74 DSI | Arrhythmia Detector and Alarm |
| 870.1025, II | 74 MLD | Monitor, ST Alarm |
| 870.2800, II | 74 DSH | Recorder, Magnetic Tape, Medical |
| 870.2300, II | 74 MSX | System, Network and Communication,<br>Physiological Monitors |

- 3. The new device is substantially equivalent to the previously cleared IntelliVue Information Center Software cleared under K011093 and K031403.
- 4. The modification is a change that provides different alert data export via the hospital LAN.
- 5. 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 segment of adult patients to gain information for treatment, to monitor adequacy of treatment, or to exclude causes of symptoms .
- 6. The new device has the same technological characteristics as the legally marketed predicate device.
- 7. Verification, validation, and testing activities establish the performance, functionality, and reliability characteristics of the new device with respect to the predicate. Testing involved system level tests, integration tests, environmental 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 web software interface functionality meets all reliability requirements and performance claims.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of an eagle with three lines representing its wings.

APR - 5 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Phillips Medical Systems c/o Mr. Dave Osborn Quality Program Manager Cardiac & Monitoring Systems 3000 Minuteman Road Andover, MA 01810-1099

Re: K050742

R050142
Trade Name: M3290A Intellivue Information Center Software Release G.00 (for Database Server with Alert Data Integration) 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: March 21, 2005 Received: March 22, 2005

Dear Mr. Osborn:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bectorn 910(s) perceise is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosure) to regally the enactment date of the Medical Device Amendments, or to commerce price to May 20, 1978, in excordance with the provisions of the Federal Food, DNAA de vices that have been require approval of a premarket approval application (PMA). alle Cosmetic Act (Tec) that to not require to the general controls provisions of the Act. The I ou may, dicierore, market the act include requirements for annual registration, listing of general controls provisions of the rece 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 if your device is classified (see above) me existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulations FIA thay be subject to sueri additional controller , Title 21, Parts 800 to 898. In addition, FDA may oc found in the Oous overnming your device in the Federal Register.

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## Page 2 - Mr. Dave 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 [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

B Zimmerman 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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K050742

## Indications for Use

k050742 510(k) Number (if known):

M3290A IntelliVue Information Center Software Release G.00 Device Name: (for DataBase Server with Alert Data Integration)

Indications for Use:

Indicated 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.

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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

B/Hummerter

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