(168 days)
Not Found
No
The document describes a central monitoring station that collects and displays patient data from various sources. There is no mention of AI, ML, or any related technologies in the intended use, device description, or performance studies sections. The focus is on data aggregation and display.
No.
The device is a central station for collecting and displaying patient data, including physiological information, but it does not directly provide therapy or therapeutic interventions.
No
Explanation: The device is a central station that collects and displays patient data (physiological parameters and waveforms) from other monitoring devices. It does not perform any analysis, interpretation, or diagnosis of the patient data itself, but rather provides the information for clinicians to review.
No
The device description explicitly states it is based on a "standard PC platform" and includes hardware components like a computer mouse, keyboard, optional touch screen, and optional writers (2" Direct Digital Writer or laser printer).
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is to collect, display, and centralize patient data (physiological, demographic, etc.) from monitors and telemetry systems. This is focused on presenting information gathered from the patient in vivo (within the body) or from devices monitoring the patient in vivo.
- Device Description: The device is a central station based on a PC platform that displays real-time waveforms and patient information from connected monitors and telemetry transmitters.
- Lack of IVD Characteristics: IVDs are typically used to examine specimens (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. This device does not perform any analysis on biological specimens.
The device is a clinical information system designed for centralized patient monitoring and data management within a healthcare setting.
N/A
Intended Use / Indications for 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.
Product codes
DSI
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
adult, pediatric and neonatal
Intended User / Care Setting
licensed healthcare practitioner; a hospital or clinical environment.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The CIC Pro Clinical Information Center and its applications comply with voluntary standards as detailed in Section 9, 11 and 17 of this premarket 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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K$\alpha$62976
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 |
| 8200 West Tower Avenue | |
| Milwaukee, Wisconsin 53223 | |
| Contact Person: | Lisa M. Baumhardt |
| Regulatory Affairs Program Manager | |
| GE Medical Systems Information Technologies | |
| Phone: (414) 362-3242 | |
| Fax: (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 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. | |
| Intended Use: | 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 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. | |
| Technology: | The CIC Pro Clinical Information Center employs the same functional |
| scientific technology as its predicate devices. | |
| Test Summary: | The CIC Pro Clinical Information Center and its applications comply with |
| voluntary standards as detailed in Section 9, 11 and 17 of this premarket |
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1
pg 2/2
9
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.
2
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.
3
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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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. .
(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