M3290A INTELLIVUE INFORMATION CENTER SOFTWARE RELEASE F.0 AND M4840A PHILIPS TELEMETRY SYSTEM II INCLUDING M4841A PATIEN

K041741 · Philips Medical Systems, Inc. · MHX · Jul 21, 2004 · Cardiovascular

Device Facts

• Record ID: K041741
• Device Name: M3290A INTELLIVUE INFORMATION CENTER SOFTWARE RELEASE F.0 AND M4840A PHILIPS TELEMETRY SYSTEM II INCLUDING M4841A PATIEN
• Applicant: Philips Medical Systems, Inc.
• Product Code: MHX · Cardiovascular
• Decision Date: Jul 21, 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

Philips M3290A IntelliVue Information Center and M4840A Telemetry System II provide centralized and bedside patient monitoring. System inputs include ECG signals (via additional chest lead/vector support) and SpO2 parameters. Device processes physiological data to detect arrhythmias and ST segment changes; generates alarms for NBP limits. Used in healthcare facilities by clinicians to monitor patient status, assess treatment efficacy, and identify symptoms. Output displayed at central station or bedside monitor; informs clinical decision-making regarding patient care and treatment adjustments.

Clinical Evidence

Bench testing only. Verification and validation activities included system-level tests, integration tests, environmental tests, and safety testing based on hazard analysis. Results demonstrated that functionality meets reliability requirements and performance claims equivalent to the predicate.

Technological Characteristics

Patient monitoring system comprising software (IntelliVue Information Center) and telemetry hardware (M4841A patient device). Features include ECG, SpO2, and NBP monitoring. Connectivity via network. Software-based arrhythmia and ST segment detection. Sterilization not applicable (electronic equipment).

Indications for Use

Indicated for adult, pediatric, and neonatal patients requiring cardiac arrhythmia monitoring and/or ST segment monitoring (adults only) and ECG/SpO2 monitoring 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

• M3290A IntelliVue Information Center Software (K040357)
• M4840A Philips Telemetry System II (K040357)

Submission Summary (Full Text)

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K041741
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## JUL 2 1 2004

## 8.0 510(k) Summary

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:

| Barry Wyshogrod<br>Regulatory Engineer<br>Philips Medical Systems<br>Cardiac and Monitoring Systems<br>3000 Minuteman Road<br>Andover, MA 01810 | Tel: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
|-------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------|
| This summary was prepared on June 25, 2004. | |

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

| Classification | ProCode | Description |
|----------------|---------|---------------------------------------------------------------------------------|
| 870.1025, II | 74 DSI | Arrhythmia Detector and Alarm |
| 870.1025, II | 74 MHX | Physiological Monitor, Patient Monitor (with arrhythmia detection<br>or alarms) |
| 870.1025, II | 74 MLD | Monitor, ST Alarm |
| 870.1130, 11 | 74 DXN | System, Measurement, Blood-Pressure, Non-Invasive |
| 870.2300, II | 74 MSX | System, Network and Communication, 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, Physiological Signal,<br>Radiofrequency |

- The new device is substantially equivalent to the previously cleared M3290A IntelliVue Information 3. Center Software and M4840A Philips Telemetry System II, cleared under K040357.
- The modification is a change that adds support for an additional ECG chest lead (vector), adds NBP 4. limit alarms, and adds support for additional network functionality.
- The new device has the same Indications for Use as the legally marketed predicate devices: 5.

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.

- The new device has the same technological characteristics as the legally marketed predicate device. റ്.
- Verification, validation, and testing activities have successfully established the performance, 7. functionality, and reliability characteristics of the new devices with respect to the predicates. 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 devices and test results showed substantial equivalence. The results successfully demonstrate that patient monitoring system functionality meets all reliability requirements and performance claims and is substantially equivalent to the predicate devices.

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Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health and 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 an abstract symbol that resembles a stylized caduceus or a representation of the human form.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 2 1 2004

Phillips Medical Systems c/o Mr. Barry Wyshogrod Regulatory Engineer Cardiac and Monitoring Systems 3000 Minuteman Road Andover, MA 01810

Re: K041741

K04771
Trade Name: M3290A Intellivue Information Center Software Release F.0 and M4840A Phillips Telemetry System II including M4841A Patient Device Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia Detector and Alarm Regulatory Class: II (two) Product Code: MHX Dated: July 8, 2004 Received: July 9, 2004

Dear. Mr. Wyshogrod:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becalled is (2) for the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for ass surfal in the May 28, 1976, the enactment date of the Medical Device Amendments, or to conninered pror to this 2011-07-11 accordance with the provisions of the Federal Food, Drug, devices mat nave been require approval of a premarket approval application (PMA). The Cobinete Free ( 100 ( 100 ) was the device, subject to the general controls provisions of the Act. The r ou may, diererere, mains 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. Barry Wyshogrod

Please be advised that FDA's issuance of a substantial equivalence determination does not mean i lease of action that I Dr wines on that your device complies with other requirements of the Act that I Dri has made a actor regulations administered by other Federal agencies. You must or uny I edelar sthates 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 Of that 0077, incenting (21 CFR Part 820); and if applicable, the electronic form in the quality by brovisions (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation comiter provisions (seting your device as described in your Section 510(k) This lotter will and in your your finding of substantial equivalence of your device to a legally premaince notinetatem " mesults 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 If you dome office of Compliance at [phone]. Also, please note the regulation entitled, Connect the Office of Come to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Other general 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,

Neil R.T. Ogden

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):

Device Name:

Indications For Use:

M3290A IntelliVue Information Center Software Release F.0 and M4840A Philips Telemetry System II including M4841A patient 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 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.

Neil RP Ogden
Sign on

(Division Sian-Off Division of Cardiovascular

510(k) Number K041741

AND/OR

Prescription Use Yes (Part 21 CFR 801 Subpart D) Over-The-Counter Use No (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)

(Optional Format 1-2-96)