MODIFICATION TO CIC PRO CLINICAL INFORMATION CENTER

K062976 · Ge Medical Systems Information Technologies · DSI · Mar 16, 2007 · Cardiovascular

Device Facts

• Record ID: K062976
• Device Name: MODIFICATION TO CIC PRO CLINICAL INFORMATION CENTER
• Applicant: Ge Medical Systems Information Technologies
• Product Code: DSI · Cardiovascular
• Decision Date: Mar 16, 2007
• 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. CIC Pro Clinical Information Center 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 Center 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 the CIC Pro Clinical Information Center central stations' products in a web browser format. Additionally, the 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.

Device Story

CIC Pro Clinical Information Center is a centralized monitoring station based on a standard PC platform; collects physiological data, waveforms, and patient demographics from bedside monitors and telemetry systems via a network. Displays up to four real-time waveforms per patient for up to 16 patients; supports web browser access and network server data retrieval. Operated by clinicians in hospital settings; provides centralized oversight of patient status. Output includes visual display of beat-to-beat parameters and waveforms; optional printing via laser printer or direct digital writer. Facilitates clinical decision-making by providing real-time patient information in a centralized location.

Clinical Evidence

Bench testing only. Quality assurance measures included risk analysis, requirements and design reviews, module verification, system integration testing, and final validation/performance/safety testing.

Technological Characteristics

Standard PC platform; network-based data collection; supports touch screen, mouse, and keyboard input; output via display, laser printer, or 2" direct digital writer. Connectivity via unity network. Software-based centralized monitoring.

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

• CIC Pro Clinical Information Center (K053356)

Submission Summary (Full Text)

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## Section 5 510(k) Summary of Safety and Effectiveness

1140

... ... ......................................................................................................................................................................

and the submit the state of the status of the security of the security

**MAR 1 6 2007**

| Date: | September 28, 2006 |
|------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | GE Medical Systems Information Technologies<br>8200 West Tower Avenue<br>Milwaukee, Wisconsin 53223 |
| Contact Person: | Lisa M. Baumhardt<br>Regulatory Affairs Program Manager<br>GE Medical Systems Information Technologies<br>Phone: [phone]<br>Fax: [phone] |
| Device:<br>Trade Name: | CIC Pro Clinical Information Center |
| Common/Usual Name: | Central Station |
| Classification Names: | The CIC Pro Clinical Information Center is classified as:<br>21 CFR 870.2450 Display, Cathode-ray Tube, Medical |
| Predicate Device: | K053356: CIC Pro Clinical Information Center |
| Device Description: | The CIC Pro Clinical Information Center is based on a standard PC platform<br>and provides centralized monitoring of all patients connected to GE Medical<br>Systems Information Technologies (GEMS-IT) monitors and telemetry<br>transmitters. It may be configured to display up to four real-time<br>waveforms per patient for up to 16 patients. |
| Intended Use: | Controls include the use of a computer mouse, keyboard and optional<br>touch screen for precise touch control. Optional writers for the purpose of<br>graphing waveforms and printing patient information include a 2" Direct<br>Digital Writer or a laser printer.<br>The CIC Pro Clinical Information Center central station is intended for use<br>under the direct supervision of a licensed healthcare practitioner. The<br>intended use is to provide clinicians with adult, pediatric and neonatal<br>patient data in a centralized location within a hospital or clinical<br>environment. |
| | CIC Pro Clinical Information Center central station is intended to collect<br>information from a network and display this data. This data includes<br>physiological, patient demographic and/or other non-medical information.<br>Physiological parameters and waveforms from monitors and telemetry<br>systems can be displayed and printed from the CIC Pro Clinical Information<br>Center central station. Beat to beat patient information for all parameters<br>and waveforms from the bedside and telemetry systems can be displayed. |
| | The CIC Pro Clinical Information Center central station supports the ability<br>to access information from the CIC Pro Clinical Information Center central<br>stations' products in a web browser format. Additionally, the CIC Pro<br>Clinical Information Center central station supports the ability to access<br>patient information collected from the unity network and stored on a<br>network server. |
| Technology: | The CIC Pro Clinical Information Center employs the same functional<br>scientific technology as its predicate devices. |
| Test Summary: | The CIC Pro Clinical Information Center and its applications comply with<br>voluntary standards as detailed in Section 9, 11 and 17 of this premarket |

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submission. The following quality assurance measures were applied to the development of the system:

- Risk Analysis .
- Requirements Reviews
- Design Reviews .
- Testing on unit level (Module verification) .
- Integration testing (System verification) .
- Final acceptance testing (Validation)
- Performance testing
- Safety testing

The results of these measures demonstrated that the CIC Pro Clinical Conclusion: Information Center is as safe, as effective, and performs as well as the predicate device.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name arranged in a circular pattern around an emblem. The emblem consists of a stylized caduceus, a symbol often associated with medicine and healthcare, with three intertwined snakes around a staff.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 6 2007

GE Medical Systems Information Technologies c/o Ms. Lisa M. Baumhardt Regulatory Affairs Program Manager 8200 West Tower Avenue Milwaukee, WI 53223

Re: K062976

Trade Name: CIC Pro Clinical Information Center Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia Detector and Alarm (including ST measurement and alarm) Regulatory Class: Class II (two) Product Code: DSI Dated: February 14, 2007 Received: February 15, 2007

Dear Ms. Baumhardt:

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. Lisa M. Baumhardt

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,

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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Page 1 of 1

510(k) Number (if known): Unknown;

510(k) filed on September 28, 2006

CIC Pro Clinical Information Center Device Name:

Indications for Use:

The CIC Pro Clinical Information Center central station is intended for use under the direct supervision of a licensed healthcare proctitioner. 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 Center 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 Center 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 the CIC Pro Clinical Information Center central stations' products in a web browser format. Additionally, the 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. .

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use X (Per 21 CFR 801.109) OR

Over-The-Counter Use_

(Optional Format 1-2-96)

Division Sign-Off
Division of Cardiovascular Devices
510(k) Number K062976