PATIENTNET MONITORING SYSTEM

K020524 · General Electric Medical Systems Information Techn · MSX · Mar 20, 2002 · Cardiovascular

Device Facts

• Record ID: K020524
• Device Name: PATIENTNET MONITORING SYSTEM
• Applicant: General Electric Medical Systems Information Techn
• Product Code: MSX · Cardiovascular
• Decision Date: Mar 20, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.2300
• Device Class: Class 2

Intended Use

The PatientNet™ System is intended to collect and analyze patient data from ECG ambulatory The Pational - Syctorn - Jeading manufacturers' bedside monitors and ventilators anywhere in a healthcare facility and distributes the data to locations throughout the facility.

Device Story

PatientNet™ Monitoring System collects and analyzes physiological data from patients; inputs include ECG signals from ambulatory transmitters, digital outputs from bedside monitors, and ventilator data. System transmits data via hardwire or RF (174-216 MHz) to a central monitoring station within a healthcare facility. Designed for use in clinical environments by healthcare professionals to facilitate patient monitoring. Output allows clinicians to view patient status centrally, supporting clinical decision-making and patient management. System functions as a network and communication infrastructure for physiological monitoring.

Clinical Evidence

No clinical data. Safety and effectiveness demonstrated through risk analysis and verification and validation testing.

Technological Characteristics

Networked physiological monitoring system; utilizes hardwire or RF (174-216 MHz) communication; interfaces with ECG ambulatory transmitters, bedside monitors, and ventilators; Class II device.

Indications for Use

Indicated for patients connected via ambulatory ECG transmitters, bedside monitors, or ventilators in clinical settings with hardwire or RF (174-216 MHz) communication infrastructure to a central monitoring station.

Regulatory Classification

Identification

A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.

Predicate Devices

• VitalCom Networked Monitoring System (K962473)

Submission Summary (Full Text)

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K020524

MAR 2 0 2002

# 510(k) Summary

This 510(k) Summary is submitted in accordance with 21 CFR 807.92.

| Submitter's Name:<br>Submitter's Address: | GE Medical Systems Information Technologies<br>15222 Del Amo Avenue<br>Tustin, CA 92780 |
|----------------------------------------------------------|-----------------------------------------------------------------------------------------|
| Telephone :<br>Fax:<br>Contact Person:<br>Date Prepared: | [phone]<br>[phone]<br>Diana M. Thorson<br>January 14, 2002 |
| Device Trade Name: | PatientNet™ Monitoring System |
| Device Classification Name: | System, Network and Communication, Physiological Monitors |
| Device Classification: | Class II |
| Predicate Device(s): | VitalCom Networked Monitoring System<br>K962473 |

### Device Description:

The modified PatientNet™ Monitoring System performs patient monitoring using PatientNet™ rne moulhou Patient for radio transmitters connected directly to bedside monitors or athbuittory fudio transmitors with similar physiological parameters, and to ventilators that have digital outputs.

### Intended Use:

The PatientNet™ System is intended to collect and analyze patient data from ECG ambulatory The Pational - Syctorn - Jeading manufacturers' bedside monitors and ventilators anywhere in a healthcare facility and distributes the data to locations throughout the facility.

### Performance Data:

The safety and effectiveness of the modified PatientNet™ Monitoring System described in this r roo salety and been demonstrated through risk analysis and verification and validation testing. Test results demonstrated that the functionality and safety characteristics of the modified PatientNet™ Monitoring System are to the predicate device.

### Conclusions:

Based on the information provided in this submission, the modified PatientNet™ Monitoring System is substantially equivalent to the predicate device and does not raise new issues of safety and effectiveness.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## MAR 2 0 2002

Ms. Diana M. Thorson Regulatory Affairs Manager GE Medical Systems Information Technology General Electric Company 15222 Del Amo Avenue Tustin, CA 92780

Re: K020524

Trade Name: PatientNet™ Monitoring System Regulation Name: Arrhythmia Detector and Alarm Regulation Number: 21 CFR 870.1025 Regulatory Class: Class III (three) Product Code: MHX Dated: February 15, 2002 Received: February 19, 2002

Dear Ms. Thorson:

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 - Ms. Diana M. Thorson

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), 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,

Dala Tulla

Bram D. Zuckerman, M.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# INDICATIONS FOR USE STATEMENT

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**Device Name:** Patient Net
Monitoring System

# Indications for Use:

## Monitoring of Recognized Conditions:

-An environmentally controlled clinical setting that has multiple patients using any combination of ECG leads, bedside monitors, or ventilators.

-Hospital areas that have the capability of installing hardwire paths to the Central Monitoring Station from the rooms or areas where bedside monitors or ventilators operate.

-Clinical areas that have the capability of installing 174-216 MHz radio systems (or alternate frequency bands approved by the FCC) to communicate via RF. The information from the ECG leads, bedside monitors or ventilators is transferred via an RF transmitter to the Central Monitoring Station.

## Target Population:

Those patients who are connected through PatientNet™ Monitoring System via ambulatory ECG transmitters, bedside monitors, or ventilators.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Division of Cardiovascular & Respiratory Devices
510(k) Number K020504

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use

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