MODIFICATION TO CIC PRO CLINICAL INFORMATION CENTER by GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES

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 Description

The CIC Pro Clinical Information Center is based on a standard PC platform and provides centralized monitoring of all patients connected to GE Medical Systems Information Technologies (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.

AI/ML Overview

The provided text does not contain specific acceptance criteria or a detailed study proving the device meets acceptance criteria in the format requested. The document is a 510(k) summary for the CIC Pro Clinical Information Center, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed performance metrics against pre-defined acceptance criteria.

The "Test Summary" section broadly mentions various quality assurance measures applied to the development of the system, including risk analysis, requirements reviews, design reviews, and different levels of testing (unit, integration, final acceptance, performance, safety). It concludes that these measures demonstrated the device is "as safe, as effective, and performs as well as the predicate device." However, it does not provide:

A table of acceptance criteria and reported device performance: No specific performance metrics (e.g., accuracy, sensitivity, specificity, or response times for displaying data) are presented alongside acceptance criteria.
Sample size, data provenance, number of experts, adjudication method, MRMC study, standalone performance, or ground truth details for any test set: These details are entirely absent from the provided text. The document is a regulatory submission summary, not a detailed technical study report.
Training set sample size or how its ground truth was established: Similar to the test set, no information about training data is provided as the focus is on validation against the predicate.

In summary, based only on the provided text:

Acceptance Criteria and Reported Device Performance: Not explicitly stated in a quantifiable manner. The general acceptance criterion is that the device is "as safe, as effective, and performs as well as the predicate device."
Sample size used for the test set and data provenance: Not mentioned.
Number of experts used to establish the ground truth for the test set and their qualifications: Not mentioned.
Adjudication method for the test set: Not mentioned.
Multi-reader multi-case (MRMC) comparative effectiveness study: Not mentioned.
Standalone (i.e. algorithm only without human-in-the-loop performance) study: Not mentioned.
Type of ground truth used: Not mentioned.
Sample size for the training set: Not mentioned.
How the ground truth for the training set was established: Not mentioned.

The document primarily relies on demonstrating compliance with voluntary standards and various software development lifecycle testing phases to assert equivalence to a predicate device (K053356: CIC Pro Clinical Information Center).

Summary

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K$\alpha$62976

Section 5 510(k) Summary of Safety and Effectiveness

1140

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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 Technologies8200 West Tower AvenueMilwaukee, Wisconsin 53223
Contact Person:	Lisa M. BaumhardtRegulatory Affairs Program ManagerGE Medical Systems Information TechnologiesPhone: (414) 362-3242Fax: (414) 362-2585
Device:Trade Name:	CIC Pro Clinical Information Center
Common/Usual Name:	Central Station
Classification Names:	The CIC Pro Clinical Information Center is classified as: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 platformand provides centralized monitoring of all patients connected to GE MedicalSystems Information Technologies (GEMS-IT) monitors and telemetrytransmitters. It may be configured to display up to four real-timewaveforms per patient for up to 16 patients.
Intended Use:	Controls include the use of a computer mouse, keyboard and optionaltouch screen for precise touch control. Optional writers for the purpose ofgraphing waveforms and printing patient information include a 2" DirectDigital Writer or a laser printer.The CIC Pro Clinical Information Center central station is intended for useunder the direct supervision of a licensed healthcare practitioner. Theintended use is to provide clinicians with adult, pediatric and neonatalpatient data in a centralized location within a hospital or clinicalenvironment.
	CIC Pro Clinical Information Center central station is intended to collectinformation from a network and display this data. This data includesphysiological, patient demographic and/or other non-medical information.Physiological parameters and waveforms from monitors and telemetrysystems can be displayed and printed from the CIC Pro Clinical InformationCenter central station. Beat to beat patient information for all parametersand waveforms from the bedside and telemetry systems can be displayed.
	The CIC Pro Clinical Information Center central station supports the abilityto access information from the CIC Pro Clinical Information Center centralstations' products in a web browser format. Additionally, the CIC ProClinical Information Center central station supports the ability to accesspatient information collected from the unity network and stored on anetwork server.
Technology:	The CIC Pro Clinical Information Center employs the same functionalscientific technology as its predicate devices.
Test Summary:	The CIC Pro Clinical Information Center and its applications comply withvoluntary 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 (240) 276-0120. 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 (800) 638-2041 or (240) 276-3150 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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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.

(Please DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

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

Regulation Number and Section

§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).

(a)
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.(b)
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.