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 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.

AI/ML Overview

The document provided is a 510(k) premarket notification for a medical device called the "CIC Pro Clinical Information Center Central Station". This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel clinical efficacy through extensive studies with acceptance criteria, ground truth, and expert adjudication in the way new AI/ML medical devices often require.

As such, the information requested for a detailed study description with acceptance criteria and performance metrics (especially those involving AI/ML components, ground truth establishment, and multi-reader studies) is not present in this 510(k) summary.

Here's why and what information can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance:

No specific quantitative acceptance criteria or performance metrics (like sensitivity, specificity, AUC) are stated.
The overall "acceptance criteria" for this type of submission is demonstrating substantial equivalence to the predicate device in terms of safety and effectiveness.
The "reported device performance" is essentially that the device "is as safe, as effective, and performs as well as the predicate devices." This is a qualitative statement, not a quantitative one.

2. Sample Size Used for the Test Set and Data Provenance:

No specific test set or data provenance details are provided. The submission mentions "Software and hardware testing," "Safety testing," and "Environmental testing" as part of quality assurance measures, but does not quantify the data or cases used for these tests. The focus is on the process of testing and validation rather than the statistical results of a clinical trial.

3. Number of Experts Used to Establish Ground Truth and Their Qualifications:

Not applicable for this type of submission. The device is a central station for displaying patient data, not an AI diagnostic tool requiring expert-established ground truth for its analytical output.

4. Adjudication Method:

Not applicable. No expert adjudication process is described as there's no diagnostic output being evaluated against a ground truth.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No MRMC study was done or reported. The submission does not involve human readers interpreting output that would be assisted by AI.

6. Standalone (Algorithm Only) Performance:

Not applicable. The device is a display and information collection system, not an algorithm providing standalone diagnostic or analytical output.

7. Type of Ground Truth Used:

Not applicable. There's no "ground truth" in the diagnostic sense for this device. Its function is to accurately display physiological and patient data. The "truth" would be the real-time physiological signals from connected monitors, and the testing would focus on the fidelity and reliability of that display.

8. Sample Size for the Training Set:

Not applicable. The device does not employ machine learning or AI models that require a training set.

9. How Ground Truth for the Training Set Was Established:

Not applicable. (See point 8).

Summary of what the document does state regarding "testing" and "performance":

The device's performance, safety, and effectiveness are demonstrated through a suite of quality assurance measures applied during its development:

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

The conclusion derived from these activities is that "The CIC Pro Central Station is as safe, as effective, and performs as well as the predicate devices." The relevant predicate device identified is the "K001112 Clinical Information Center (CIC) Central Station."

In essence, this 510(k) submission establishes equivalence by asserting that the new device utilizes the "same functional technology" as its predicate and has undergone standard development and testing procedures, rather than by presenting a clinical study with detailed performance metrics against a defined ground truth.

Summary

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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 Technologies8200 West Tower AvenueMilwaukee, WI 53223 USA
Contact Person:	Karen M. LundeSr. Regulatory Affairs SpecialistGE Medical Systems Information Technologies8200 West Tower AvenueMilwaukee, WI 53223 USAPhone: 414-362-3329Fax: 414-918-8114
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.

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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 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.

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 (301) 594-4646. 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 (301) 443-6597 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.

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

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)

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.