M3290A INTELLIVUE INFORMATION CENTER SOFTWARE RELEASE E.O

K023698 · Philips Medical Systems · MHX · Nov 19, 2002 · Cardiovascular

Device Facts

• Record ID: K023698
• Device Name: M3290A INTELLIVUE INFORMATION CENTER SOFTWARE RELEASE E.O
• Applicant: Philips Medical Systems
• Product Code: MHX · Cardiovascular
• Decision Date: Nov 19, 2002
• 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.0 functions as a database and web server for physiological patient monitoring. It enables central monitoring of multiple patients across hospital networks via intra/internet systems. The device processes physiological data, including arrhythmia and ST segment information, to support clinical decision-making regarding treatment adequacy and symptom exclusion. It is intended for use by clinicians in hospital settings. The software provides near-realtime data export capabilities. Clinicians access the output via the web interface to view patient status and alarms, facilitating centralized oversight of patient physiological conditions.

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 the predicate device specifications. Results demonstrated that the web software interface functionality meets all reliability requirements and performance claims.

Technological Characteristics

Software-based database and web server for physiological monitoring. Operates on hospital intra/internet networks. Provides near-realtime data export. No hardware materials specified. Software-based arrhythmia and ST segment detection algorithms.

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

• VIC Web software (K993907)

Submission Summary (Full Text)

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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.

1. The submitter of this premarket notification is:

Philips Medical Systems

This summary was prepared on 1 November, 2002.

- 2. 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, 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<br>Communication, Physiological<br>Monitors |

- 3. The new device is substantially equivalent to the previously cleared VIC Web software cleared under K993907.
- 4. The modification is a software-based change that provides improved database server access via the hospital intra/internet system.
- 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 seqment 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

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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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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.

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### Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use | <span style="text-decoration: overline;">X</span> |
|----------------------|---------------------------------------------------|
| (Per 21 CFR 801.109) | |

OR

| Over-The-Counter Use | |
|----------------------|--|
|----------------------|--|

(Optional Format 1-2-96)

f Cardiovascular & Respiratory Devices
Number K023698
Date 11/18