MODIFICATION TO: CIC PRO CLINICAL INFORMATION CENTER CENTRAL STATION

K053356 · Ge Medical Systems Information Technologies · DXJ · Apr 19, 2006 · Cardiovascular

Device Facts

• Record ID: K053356
• Device Name: MODIFICATION TO: CIC PRO CLINICAL INFORMATION CENTER CENTRAL STATION
• Applicant: Ge Medical Systems Information Technologies
• Product Code: DXJ · Cardiovascular
• Decision Date: Apr 19, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2450
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The CIC Pro Clinical Information Center Central Station is intended for use under the direct supervision of a licensed healthcare practitioner. The intended use is to provide clinicians with adult, pediatric and neonatal patient data in a centralized location within a hospital or clinical environment. The CIC Pro Central Station is intended to collect information from a network and display this data. This data includes physiological, patient demographic and / or other non-medical information. Physiological parameters and waveforms from GE Medical Systems Information Technologies monitors and telemetry systems can be displayed and printed from the CIC Pro Central Station. Beat to beat patient information for all parameters and waveforms from the bedside and telemetry systems can be displayed. The CIC Pro Central Station supports the ability to access information from GE Medical Systems Information Technologies' products in a web browser format. Additionally, CIC Pro Central Station supports the ability to access patient information collected from the Unity network and stored on a network server.

Device Story

CIC Pro Central Station is a PC-based centralized monitoring system for hospital/clinical environments. It collects physiological data, waveforms, and patient demographics from bedside monitors and telemetry transmitters via a network. It displays up to four real-time waveforms per patient for up to 16 patients. Operators (clinicians) interact via mouse, keyboard, or optional touch screen. Output includes real-time waveform visualization, beat-to-beat parameter display, and printed reports via digital writer or laser printer. It also provides web-browser access to information from GE products and Unity network servers. By centralizing patient data, it enables clinicians to monitor multiple patients simultaneously, facilitating timely clinical decision-making and patient management.

Clinical Evidence

Bench testing only. The system underwent comprehensive quality assurance, including requirements specification review, code inspections, software and hardware testing, safety testing, environmental testing, and final validation to ensure performance equivalence to the predicate.

Technological Characteristics

Standard PC platform; supports up to 16 patients with 4 real-time waveforms each. Connectivity via network to bedside monitors and telemetry systems. Input/output interfaces include mouse, keyboard, optional touch screen, digital writer, and laser printer. Software-based centralized monitoring system.

Indications for Use

Indicated for adult, pediatric, and neonatal patients in hospital or clinical environments to provide centralized monitoring of physiological data, waveforms, and patient demographics under the supervision of a licensed healthcare practitioner.

Regulatory Classification

Identification

A medical cathode-ray tube display is a device designed primarily to display selected biological signals. This device often incorporates special display features unique to a specific biological signal.

Predicate Devices

• Clinical Information Center (CIC) Central Station (K032370)

Submission Summary (Full Text)

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K053356

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510(k) Summary of Safety and Effectiveness

| Date: | November 28, 2005 |
|-----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | GE Medical Systems Information Technologies<br>8200 West Tower Avenue<br>Milwaukee, WI 53223 USA |
| Contact Person: | Ronald N. Blaski<br>Regulatory Affairs Specialist<br>GE Medical Systems Information Technologies<br>8200 West Tower Avenue<br>Milwaukee, WI 53223 USA<br>Phone: [phone]<br>Fax: [phone] |
| Device: Trade Name: | CIC Pro Clinical Information Center Central Station |
| Common/Usual Name: | Central Station Monitoring System |
| Classification Names: | |
| 21 CFR 870.2450 | Display, Cathode-ray Tube, Medical DXJ |
| 21 CFR 870.1025 | Detector and Alarm, Arrhythmia DSI |
| Predicate Device: | K032370 Clinical Information Center (CIC) Central Station |
| Device Description: | The CIC Pro Central Station is based on a standard PC platform and provides centralized monitoring of all patients connected to GEMS IT monitors and telemetry transmitters. It may be configured to display up to four real-time waveforms per patient for up to 16 patients. |
| | Controls include the use of a computer mouse, keyboard and optional touch screen for precise touch control. Optional writers for the purpose of graphing waveforms and printing patient information include a 2" Direct Digital Writer or a laser printer. |
| Intended Use: | The CIC Pro Clinical Information Center Central Station is intended for use under the direct supervision of a licensed healthcare practitioner. The intended use is to provide clinicians with adult, pediatric and neonatal patient data in a centralized location within a hospital or clinical environment. |
| | The CIC Pro Central Station is intended to collect information from a network and display this data. This data includes physiological, patient demographic and / or other non-medical information. |
| | Physiological parameters and waveforms from GE Medical Systems Information Technologies monitors and telemetry systems can be displayed and printed from the CIC Pro Central Station. Beat to beat patient information for all parameters and waveforms from the bedside and telemetry systems can be displayed. |
| | The CIC Pro Central Station supports the ability to access information from GE Medical Systems Information Technologies' products in a web browser format. Additionally, CIC Pro Central Station supports the ability to access patient information collected from the Unity network and stored on a network server. |

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The CIC Pro Central Station employs the same functional technology Technology: as the predicate devices.

Test Summary: The CIC Pro platform and its applications comply with the voluntary standards as detailed in Section 9 of this submission. The following quality assurance measures were applied to the development of the system:

- . Requirements specification review
- . Code inspections
- . Software and hardware testing
- . Safety testing
- . Environmental testing
- . Final validation

## Conclusion:

The results of these measurements demonstrated that the CIC Pro Central Station is as safe, as effective, and performs as well as the predicate device.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 1 9 2006

GE Medical Systems Information Technologies c/o Mr. Ronald N. Blaski Regulatory Affairs Specialist 8200 West Tower Avenue Milwaukce, WI 53223

Re: K053356 Trade Name: CIC Pro Clinical Information Center Central Station, Version 5 Regulation Number: 21 CFR 870.2450 Regulation Name: Medical Cathode-Ray Tube Display Regulatory Class: Class II (two) Product Code: DXJ Dated: Undated Received: April 17, 2006

Dear Mr. Blaski:

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 10 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. Ronald N. Blaski

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,

Blummenhof

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: K053356

Device Name: CIC Pro Clinical Information Center Central Station

Indications for Use:

The CIC Pro Clinical Information Central Station is intended for use under the direct supervision of a licensed healthcare practitioner. The intended use is to provide clinicians with adult, pediatric and neonatal patient data in a centralized location within a hospital or clinical environment.

CIC Pro Clinical Information Central Station is intended to collect information from a network and display this data. This data includes physiological, patient demographic and / or other non-medical information.

Physiological parameters and waveforms from monitors and telemetry systems can be displayed and printed from the CIC Pro Clinical Information Central Station. Beat to beat patient information for all parameters and waveforms from the bedside and telemetry systems can be displayed.

The CIC Pro Clinical Information Center Central Station supports the ability to access information from CIC Pro Clinical Information Center Central Station' products in a web browser format. Additionally, CIC Pro Clinical Information Center Central Station supports the ability to access patient information collected from the Unity network and stored on a network server.

Prescription Use - -X (Part 21 CFR 801 Subpart D)

ANDAOR

(Over-The-Counter Use -(21 CFR 801 Subpart ( )

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

Concurrence of CDRH. Office of Device Evaluation (ODE)

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Bhemnnch

(Posted November 13, 2003)