M3290A INTELLIVUE INFORMATION CENTER SOFTWARE, RELEASE J.00 (FOR M3140, M3145, M3150, M3151, M3154, M3155, M3169, M3170)

K062271 · Philips Medical Systems · MHX · Nov 30, 2006 · Cardiovascular

Device Facts

• Record ID: K062271
• Device Name: M3290A INTELLIVUE INFORMATION CENTER SOFTWARE, RELEASE J.00 (FOR M3140, M3145, M3150, M3151, M3154, M3155, M3169, M3170)
• Applicant: Philips Medical Systems
• Product Code: MHX · Cardiovascular
• Decision Date: Nov 30, 2006
• 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 J.00) functions as a central station for physiological patient monitoring. It aggregates data from connected bedside monitors (including MRx Monitor/Defibrillator and M3177 Trend Display) across a hospital network. The system provides clinicians with real-time visualization of patient vital signs, cardiac arrhythmia detection, and ST segment analysis. It is operated by healthcare professionals in clinical settings to facilitate patient assessment, treatment titration, and diagnostic exclusion. The software processes incoming physiological signals to generate alarms and trend displays, enabling centralized oversight of multiple patients simultaneously. This centralized monitoring capability assists clinicians in timely decision-making and improves patient safety by ensuring continuous surveillance of critical physiological parameters.

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, and results demonstrated that the web software interface functionality meets all reliability requirements and performance claims.

Technological Characteristics

Centralized physiological monitoring software. Operates on a networked system architecture. Features include arrhythmia detection and ST segment analysis. Connectivity supports integration with various bedside monitors (e.g., MRx, M3177). Software-based processing for alarm management and trend display.

Indications for Use

Indicated for central monitoring of adult, pediatric, and neonatal patients. Used for cardiac arrhythmia monitoring in all age groups and ST segment monitoring in adults to guide treatment, assess treatment adequacy, or exclude symptom causes.

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 (K050742, K041741, K040955, K040357, K031403, K023698, K021422, K011093, K001057, K993907, K993171, K964832)
• IntelliVue Patient Monitor (K053522, K051106, K041235, K032858)

Submission Summary (Full Text)

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K062271

## 8.0 510 (k) Summary

NOV 3 V 2006

510(k) safety and effectiveness information is This summary of 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 3 August, 2006.

- 2. The name of this device is the M3290A IntelliVue Information Center Software Release J.00 (for M3140, M3145, M3151, M3154, M3155, M3169, M3170, and M3177). 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 K050742, K041741, K040955, K040357, K031403, K023698, K021422, K011093, K001057, K993907, K993171, & K964832 and the IntelliVue Patient Monitor under K053522, K051106, K041235, & K032858.
- 4. The modification is a change that provides support for the MRx Monitor/Defibrillator and the M3177 Trend Display.
- 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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 3 U 2006

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

Re: K062271

Trade Name: M3290A IntelliVue Information Center Software, Release J.00 (for M3140, M3145, M3150, M3151, M3154, M3155, M3169, M3170, and M3177) Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia Detector and Alarm Regulatory Class: Class II (two) Product Code: MHX Dated: November 17, 2006 Received: November 20, 2006

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 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/industry/support/index.html.

Sincerely yours,

B/fimmman 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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## Indications for Use

510(k) Number (if known): K062271

M3290A IntelliVue Information Center Software Release J.00 Device Name: (for M3140, M3145, M3150, M3151, M3154, M3155, M3169, M3170, and M3177)

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 nond/or ST segment of adult patients to gain information for treatment, to monitor adequacy of treatment, or to exclude causes of symptoms.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ Over-The-Counter Use No____________________________________________________________________________________________________________________________________________________________________________ AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Blumunma

Division Slan-Off Division of Cardioy 510(k) Number

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