M3290A INTELLIVUE INFORMATION CENTER SOFTWARE RELEASE F.O AND THE M4840A TELEMETRY MONITORING SYSTEM II

K040357 · Philips Medical Systems, Inc. · MHX · Mar 3, 2004 · Cardiovascular

Device Facts

• Record ID: K040357
• Device Name: M3290A INTELLIVUE INFORMATION CENTER SOFTWARE RELEASE F.O AND THE M4840A TELEMETRY MONITORING SYSTEM II
• Applicant: Philips Medical Systems, Inc.
• Product Code: MHX · Cardiovascular
• Decision Date: Mar 3, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1025
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

M3290A: 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. M4840A: For ambulatory and bedside monitoring of ECG and SpO2 parameters of adult and pediatric patients in healthcare facilities to gain information for treatment, to monitor adequacy of treatment, or to exclude causes of symptoms.

Device Story

System comprises M3290A IntelliVue Information Center Software and M4840A Telemetry System II (with TelePac+). Inputs: ECG and SpO2 signals from patients. Operation: Telemetry transmitters capture physiological signals; data transmitted to central station for processing/analysis. Modifications include updated ECG processing, 4 high-priority SpO2 limit alarms, waveform export, and new radio technology. Used in healthcare facilities by clinicians for bedside or central monitoring. Output: Real-time physiological waveforms and alarm notifications. Clinical utility: Enables continuous patient surveillance, treatment monitoring, and symptom exclusion. Benefits: Facilitates timely clinical intervention through automated arrhythmia and ST segment detection.

Clinical Evidence

Bench testing only. Verification and validation activities established performance, functionality, and reliability. No clinical data presented.

Technological Characteristics

Physiological monitoring system; ECG and SpO2 sensing; radiofrequency transmission; software-based arrhythmia and ST segment detection; networked communication; bedside and central station form factors.

Indications for Use

Indicated for adult, pediatric, and neonatal patients requiring cardiac arrhythmia monitoring (M3290A) or adult and pediatric patients requiring ambulatory/bedside ECG and SpO2 monitoring (M4840A) in healthcare facilities.

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 with ST/AR (K031403)
• IntelliVue Information Center Software with ST/AR (K021251)
• Philips Telemetry System (K993516)
• IntelliVue Patient Monitors (K021300)
• IntelliVue Patient Monitors (K030038)

Submission Summary (Full Text)

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## 510 (k) Summary 8.0

information i s safety and effectiveness 510 (k) of This summary accordance with the requirements of Safe Medical the submitted in Devices Act of 1990 and 21 C.F.R. §807.92.

1. The submitter of this premarket notification is:

| Dave Osborn<br>Quality Program Manager<br>Cardiac and Monitoring Systems<br>Philips Medical Systems<br>3000 Minuteman Road<br>Andover, MA 01810-1085 | Tel: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
|------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------|
| This summary was prepared on 12 February, 2004. | |

- 2. The name of this device is the M3290A IntelliVue Information Center Software Release F.0 and M4840A Telemetry System II with M4841A Classification names are as follows: TelePac+.

| Classification | | ProCode | Description |
|----------------|--|---------|---------------------------------------------------------------------------------|
| 870.1025, II | | 74 DSI | Arrhythmia Detector and Alarm |
| 870.1025, II | | 74 MHX | Physiological Monitor, Patient Monitor<br>(with arrhythmia detection or alarms) |
| 870.1025, II | | 74 MLD | Monitor, ST Alarm |
| 870.1130, II | | 74 DXN | System, Measurement, Blood-Pressure,<br>Non-Invasive |
| 870.2300, II | | 74 MSX | System, Network and Communication,<br>Physiological Monitors |
| 870.2700, II | | 74 DQA | Oximeter |
| 870.2800, II | | 74 DSH | Recorder, Magnetic Tape, Medical |
| 870.2910, II | | 74 DRG | Transmitters and Receivers,<br>Physiological Signal, Radiofrequency |

- The new device is substantially equivalent to the previously ന്ന cleared IntelliVue Information Center Software with ST/AR cleared under K031403 & K021251, the Philips Telemetry System under K993516, and IntelliVue Patient Monitors under K021300 & K030038.
- The modification is a change that modifies the ECG processing, adds 4 high priority SpO2 limit alarm conditions and waveform export, and changes the radio technology.
- The new device has the same Indications for Use as the legally ్ . marketed predicate device. M3290A: 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. M4840A: For creatment, or o do dside monitoring of ECG and Spo, parameters of adult and pediatric patients in healthcare facilities.

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- The new device has the same technological characteristics as the 6. legally marketed predicate device.
- 7. Verification, validation, and testing activities have successfully verification, Variablem.
established the performance, functionality, and reliability established the performance, and many and the predicates. Charactcriberob resting involved by bean _____________________________________________________________________________________________________________________________________________________ environmental ceseb, and based on the specifications cleared for the Pass/rail Criteria Were Dabstantial equivalential equivalence. predicate devices and cobs assessment monitoring system file resures backs all reliability requirements and performance runctionally mood ntially equivalent to the predicate devices.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features an eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The eagle is stylized with thick, black lines, and the text is in a simple, sans-serif font. The overall design is clean and professional.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR - 3 2004

Philips Medical Systems, Inc. c/o Mr. Dave Osborn Quality Program Manager 3000 Minuteman Road Andover, MA 01810

## Re: K040357

Trade Name: M3290A IntelliVue Information Center Software, Release F.0 and M4840A Philips Telemetry System II including M4841A TelePac+ Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia Detector and Alarm Regulatory Class: Class II (two) Product Code: MHX Dated: February 12, 2004 Received: February 13, 2004

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 may or saejoes to access will and 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 Please be advised that FDA \$ Issualite of a substance orgalies with other requirements of the Act
that FDA has made a determination that your device complies . You must that FDA has made a decernmanon ana Jour as Jour Second agencies. You must a or any Federal statutes and regulations adminitied to registration and listing (21
comply with all the Act's requirements, including, but not the newstige aget comply with an the Act 3 requirements, mercesses communicaturing practice requirements as set
CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice the elect CFR Part 807), labeling (21 CFR Part 801), good manart 820); and if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR Part 200), and 11 CFR 100 forth in the quality systems (Sections 531-542 of the Act); 21 CFR 100-1050.
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control provisions (occions of the as described in your Section 510(k)
This letter will allow you to begin marketing your device of your device to legal This letter will anow you to begin manketing of substantial equivalence of your device to a legally premarket notification. The FDA inding of substanted by and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our lated it (21 CFR Part 801), please If you desire specific advice for your ac not as a loo, please note the regulation entitled, contact the Office of Compliance at (501) 997 16 re (21CFR Part 807.97). You may obtain "Misbranding by reference to premarker its articlearences in the Division of Small other general information on your responsion.com its toll-free number [phone] or
Manufacturers, International and Consumer Assistance at its toll-idemamain http:// Manufacturers, International and Consumer Parssons Prists on Podrh/dsma/dsmamain.html

Sincerely yours,

MD

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

K040357 510(k) Number (if known):

M3290A IntelliVue Information Center Software, Device Name: Release F.0 and M4840A Philips Telemetry System II including M4841A TelePac+

M3290A: For central monitoring of multiple adult, Indications For Use: 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.

> M4840A: For ambulatory and bedside monitoring of ECG and SpO2 parameters of adult and pediatric patients in healthcare facilities to gain information for treatment, to monitor adequacy of treatment, or to exclude causes of symptoms.

X Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

| (Division Sign-Off) | |
|------------------------------------|----------|
| Division of Cardiovascular Devices | |
| 110(K) Number | K04 0357 |

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