M3290A INTELLIVUE INFORMATION CENTER SOFTWARE RELEASE E.1

K031403 · Philips Medical Systems, Inc. · MHX · May 30, 2003 · Cardiovascular

Device Facts

• Record ID: K031403
• Device Name: M3290A INTELLIVUE INFORMATION CENTER SOFTWARE RELEASE E.1
• Applicant: Philips Medical Systems, Inc.
• Product Code: MHX · Cardiovascular
• Decision Date: May 30, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1025
• Device Class: Class 2
• Attributes: Software as a Medical Device, Pediatric

Intended Use

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 E.1 functions as a central monitoring system for physiological data. Device receives patient data from bedside monitors; processes cardiac arrhythmia and ST segment information; enables alert data export via hospital LAN. Used in clinical settings by healthcare professionals for patient surveillance; treatment monitoring; symptom exclusion. Output provided to clinicians via central station interface to facilitate clinical decision-making. Modification from predicate involves enhanced alert data export capabilities.

Clinical Evidence

Bench testing only. Verification and validation activities included system-level, integration, environmental, and safety testing based on hazard analysis. Pass/Fail criteria were derived from predicate 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 hospital LAN for data export. Maintains same technological architecture as predicate device. Verification performed via system, integration, and environmental testing.

Indications for Use

Indicated for central monitoring of adult, pediatric, and neonatal patients; includes cardiac arrhythmia monitoring for all age groups and ST segment monitoring for adult patients.

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)

Submission Summary (Full Text)

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K031403

## 9.0 510 (k) Summary

safety and effectiveness information This summary of 510(k) is 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 1 May, 2003.

- 2. The name of this device is the M3290A IntelliVue Information Center Software Release E.1 (for DataBase Server with Alert Data Export). Classification names are as follows:

| Classification | ProCode | Description |
|----------------|---------|--------------------------------------------------------------|
| None | 74 MHX | Physiological Monitor, Patient<br>Monitor |
| 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 and Communication,<br>Physiological Monitors |

- 3. The new device is substantially equivalent to the previously cleared IntelliVue Information Center Software cleared under K011093.
- 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 leqally 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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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three lines forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 3 0 2003

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

Re: K031403

Trade Name: M3290A IntelliVue Information Center Software Release E. I (for DataBasc Server with Alert Data Export) Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia Detector Or Alarm Regulatory Class: Class III (three) Product Code: MHX Dated: May 2, 2003 Received: May 5, 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. 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 vours.

K. Quentin

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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Page ⊥ of ╱

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

M3290A IntelliVue DataBase Server Software for M3154 Device Name: with alert data export, Release E.1

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 | OR | Over-The-Counter Use |
|-----------------------|----|--------------------------|
| (Per 21 CFR 801, 109) | | (Optional Format 1-2-96) |

| (Division Sign-Off) | |
|------------------------------------|---------|
| Division of Cardiovascular Devices | |
| 510(k) Number | K031403 |