CIC PRO CLINICAL INFORMATION CENTER CENTRAL STATION

K032370 · Ge Medical Systems Information Technologies · DSI · Aug 13, 2003 · Cardiovascular

Device Facts

• Record ID: K032370
• Device Name: CIC PRO CLINICAL INFORMATION CENTER CENTRAL STATION
• Applicant: Ge Medical Systems Information Technologies
• Product Code: DSI · Cardiovascular
• Decision Date: Aug 13, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1025
• Device Class: Class 2
• Attributes: Software as a Medical Device, 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; collects physiological data, waveforms, and patient demographics from networked GE Medical Systems monitors and telemetry transmitters. Operates in hospital/clinical settings under licensed practitioner supervision. Displays up to four real-time waveforms per patient for up to 16 patients; supports web browser access to GE product information and Unity network server data. Clinicians use mouse, keyboard, or optional touch screen to view beat-to-beat data; optional writers/printers generate hard copies. Centralized display facilitates patient status assessment and clinical decision-making; provides continuous monitoring benefit for adult, pediatric, and neonatal populations.

Clinical Evidence

No clinical data. Evidence consists of bench testing, including requirements specification review, code inspections, software and hardware testing, safety testing, environmental testing, and final validation to demonstrate performance equivalent to the predicate.

Technological Characteristics

Standard PC platform; supports up to 16 patients with 4 waveforms each; connectivity via Unity network; input from GE monitors/telemetry; output via display, optional 2" Direct Digital Writer, or laser printer. Software-based monitoring system.

Indications for Use

Indicated for adult, pediatric, and neonatal patients in hospital or clinical environments requiring centralized monitoring of physiological data, waveforms, and patient demographics collected from bedside monitors and telemetry systems.

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

• Clinical Information Center (CIC) Central Station (K001112)

Submission Summary (Full Text)

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# AUG 1 3 2003

L032370

### 510(k) Summary of Safety and Effectiveness

| Date: | July 30, 2003 |
|--------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | GE Medical Systems Information Technologies<br>8200 West Tower Avenue<br>Milwaukee, WI 53223 USA |
| Contact Person: | Karen M. Lunde<br>Sr. 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: | K001112 Clinical Information Center (CIC) Central Station |
|-------------------|-----------------------------------------------------------|
|-------------------|-----------------------------------------------------------|

The CIC Pro Central Station is based on a standard PC platform and Device Description: 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.

The CIC Pro Clinical Information Central Station is intended for Intended Use: 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

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

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## Section 3 Proposed Labeling

#### 3.1 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 This data includes physiological, patient demographic and / or other non-medical data. 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.

The intended use has not changed as a result of the changes to the CIC Pro Central Station.

- 3.2 Proposed Operating Instructions
Refer to Appendix A for a copy of changes to the CIC Pro Central Station operating instructions.

- 3.3 Promotional Material (Device Claims)
Draft promotional information for the CIC Pro Central Station is provided in Appendix B.

- 3.4 Device and Package Labeling
Device label drawings associated with changes to the device are provided in Appendix C.

Reference the following documents:

| | Appendix |
|------------------------|----------|
| Operating Instructions | A |
| Promotional Material | B |
| Device Label Drawings | C |

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three wavy lines representing its wings.

AUG 1 3 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

GE Medical Systems Information Technologies c/o Ms. Karen M. Lunde Senior Regulatory Affairs Specialist 8200 West Tower Avenue Milwaukee, WI 53223

Re: K032370

Trade Name: CIC Pro Clinical Information Center Central Station Regulation Number: 21 CFR 870.2450, and 21 CFR 870.1025 Regulation Name: Medical cathode-ray tube display, and Arrhythmia detector and alarm. Regulatory Class: Class II (two), and III (three) Product Code: DXJ, and DSI Dated: July 30, 2003 Received: August 1, 2003

Dear Ms. Lunde:

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.

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

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Page 2 – Ms. Karen M. Lunde

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 (OS) 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/dsma/dsmamain.html

Sincerely yours,

Qalatiun

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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# 510(k) Number (if known): K032370

### Device Name: CIC Pro Clinical Information Center Central Station

Indications For Use:

The CIC Pro Clinical Information Central Station is intended 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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ncurrence of CDRH, Office of Device Evaluation (ODE)

N. Q. Th

(Division Sign-Off)
Division of Cardiovascular Devices
K032570

510(k) Number_

Prescription Use Only

(Optional Format 3-10-98)