(106 days)
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No
The document describes standard digital image processing but does not mention AI, ML, or related concepts like neural networks, training data, or performance metrics typically associated with AI/ML devices.
No
This device is an imaging system used for diagnostic purposes during various medical procedures, not for treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures." This directly indicates its use in diagnostic applications.
No
The device description explicitly states it is comprised of two mobile units: a C-arm stand and a workstation, which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is designed for "fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures." This describes an imaging system used on the patient, not a device used to examine samples from the patient (which is the core of IVD).
- Device Description: The description details a C-arm stand with an x-ray tube and image intensifier, and a workstation for image display and processing. This is consistent with an imaging system, not a device for analyzing biological samples.
- Input Imaging Modality: The input is "Fluoroscopic, spot-film imaging," which are imaging techniques applied to the patient.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any processes typically associated with in vitro diagnostics.
In summary, the OEC 9800 E/CV+ is a medical imaging system used for visualizing structures within the patient's body, which falls outside the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The OEC 9800 E/CV+ is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. The system includes features specifically designed for use in diagnostic and interventional cardiac imaging procedures, and is also intended for cholanqiography, endoscopic, urologic, orthopedic, neurologic, vascular, critical care and emergency room procedures. It may be used for other imaging applications at the physician's discretion.
Product codes (comma separated list FDA assigned to the subject device)
90 JAA and IZL
Device Description
The OEC 9800 E/CV+ is comprised of two mobile units: a C-arm stand and a workstation. The C-arm stand supports the high-voltage generator, x-ray controls, and a "C" shaped apparatus, which supports an x-ray tube on one end and an image intensifier on the other. The C-arm is designed to perform linear and rotational motions that allow the user to position the x-ray imaging components at various and distances with respect to the patient. The mobile workstation supports image display monitors, image processing and recording devices.
Interfaces are provided for optional peripheral devices such as thermal or laser printers and VCRs. Video outputs are compatible with RS-170 format for domestic markets. CCIR format for international markets, and DICOM 3.0. An auxiliary connection is provided for a Medrad angjographic injector system to facilitate synchronized acquisition of angiographic images during contrast media injection.
Mentions image processing
digital image processing
Mentions AI, DNN, or ML
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Input Imaging Modality
fluoroscopic imaging, x-ray
Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
The device is used by health care professionals such as physicians, surgeons, cardiologists, radiologists and technologists in hospitals, out-patient clinics and other clinical environments. It is expected that the device will be used on a daily basis. Users are trained in the proper use of the device by GE OEC applications specialists and/or qualified site personnel. The device labeling stipulates that only properly trained persons operate this equipment.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 892.1650 Image-intensified fluoroscopic x-ray system.
(a)
Identification. An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
0
MAR 2 0 2003
510(k) Summary
K0240/2
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.
Date:
November 27, 2002
Name of Submitter:
GE OEC Medical Systems, Inc. 384 Wright Brothers Drive Salt Lake City, UT 84116 801-328-9300
Corresponding Official:
Jeff Wagner. Manager, Regulatory Affairs
Device Proprietary Name:
OEC 9800 E/CV+ Digital Mobile Imaging System
Classification Name:
System, X-ray, Fluoroscopic, Image-Intensified - or System, X-ray, Mobile
1
Common/Usual Names:
Mobile C-arm, Fluoroscopic Imaging System
Substantial Equivalence:
The OEC 9800 E/CV+ is substantially equivalent to the following devices that are currently marketed:
- GE OEC Medical Systems OEC 9800 Plus Mobile Digital Imaging System .
- Siemens Medical Solutions Powermobil .
These devices are mobile C-arm type x-ray systems intended for fluoroscopic imaging. The systems all include a high-voltage x-ray generator and control, rotating anode x-ray tube, image intensifier, video image displays, digital image processing and image storage capability, as well as conventional spot-film capability.
Device Description:
Indications for Use
The OEC 9800 E/CV+ is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. The system includes features specifically designed for use in diagnostic and interventional cardiac imaging procedures, and is also intended for cholanqiography, endoscopic, urologic, orthopedic, neurologic, vascular, critical care and emergency room procedures. It may be used for other imaging applications at the physician's discretion.
User Characteristics
The device is used by health care professionals such as physicians, surgeons, cardiologists, radiologists and technologists in hospitals, out-patient clinics and other clinical environments. It is expected that the device will be used on a daily basis. Users are trained in the proper use of the device by GE OEC applications specialists and/or qualified site personnel. The device labeling stipulates that only properly trained persons operate this equipment.
General Description
The OEC 9800 E/CV+ is comprised of two mobile units: a C-arm stand and a workstation. The C-arm stand supports the high-voltage generator, x-ray controls, and a "C" shaped apparatus, which supports an x-ray tube on one end and an image intensifier on the other. The C-arm is designed to perform linear and rotational motions that allow the user to position the x-ray imaging components at various and distances with respect to the patient. The mobile workstation supports image display monitors, image processing and recording devices.
Interfaces are provided for optional peripheral devices such as thermal or laser printers and VCRs. Video outputs are compatible with RS-170 format for domestic markets. CCIR format for international markets, and DICOM 3.0. An auxiliary connection is provided for a Medrad angjographic injector system to facilitate synchronized acquisition of angiographic images during contrast media injection.
2
Standards:
The OEC 9800 E/CV+ is designed in accordance with product safety requirements established in the following standards:
- · Federal Performance Standard for Diagnostic X-ray Systems (21 CFR 1020.30-32)
- · ANSI/NFPA 70 & 99 National Electrical Code and Standard for Health Care Facilities
- · UL 2601 Medical Electrical Equipment
- · CSA-C22.2 No. 601.1-M90 Medical Electrical Equipment
- · IEC 60601-1, Medical Electrical Equipment, General Requirements for Safety
- · IEC 60601-1-2, Medical Electrical Equipment, General Requirements for Safety, Electromagnetic Compatibility
- · IEC 60601-1-3, Medical Electrical Equipment, Radiation Protection in Diagnostic X-ray Equipment
- · IEC 60601-1-4, General requirements for safety, Programmable electrical medical systems.
- · IEC 60601-2-7, Medical Electrical Equipment, Safety of HV/X-ray Generators
- · IEC 60601-2-32, Medical Electrical Equipment, Safety of Associated X-ray Equipment
- · IEC 60601-2-43 Particular requirements for safety of X-ray equipment for interventional procedures.
- · 93/42/EEC Annex 1 Essential Requirements of the Medical Devices Directive
3
Conclusion:
The OEC 9800 E/CV+ does not raise new questions of safety and effectiveness and is substantially equivalent to current legally marketed devices.
This concludes this 510(k) summary.
Jeff Wagner
Wagner. Manger, Regulatory Affairs GE OEC Medical Systems, Inc.
4
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles forming a bird-like shape.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Jeff Wagner Manager, Regulatory Affairs GE OEC Medical Systems, Inc. General Electric Company 384 Wright Brothers Drive SALT LAKE CITY UT 84116-2862
MAR 2 0 2003
Re: K024012 Trade/Device Name: OEC 9800 E/CV+ Digital Mobil Imaging System Regulation Number: 21 CFR 892.1650 Regulation Name: Image intensified fluoroscopic x-ray system Regulation Number: 21 CFR 892.1720 Regulation Name: Mobil x-ray system Regulatory Class: II Product Code: 90 JAA and IZL Dated: February 28, 2003 Received: March 3, 2003
Dear Mr. Wagner:
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 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 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.
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Page 2
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 one of the following numbers, based on the regulation number at the top of the letter:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 may be obtained 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,
Nancy C. Brogdon.
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Indications For Use Statement
| Applicant: | GE OEC Medical Systems, Inc. |
|---|---|
| 510(k) No. (if known): | K024012 |
| Device name: | OEC 9800 E/CV+ Digital Mobile Imaging System |
| Indications for use: | The OEC 9800 E/CV+ Digital Mobile Imaging System is designed to |
| provide fluoroscopic and spot-film imaging of the patient during | |
| diagnostic, surgical and interventional procedures. It includes features | |
| designed specifically for diagnostic and interventional cardiac imaging | |
| procedures, and is also intended for use in cholangiography, | |
| endoscopic, urologic, orthopedic, neurologic, vascular, critical care and | |
| emergency room procedures. It may also be used for other imaging | |
| applications at the physician's discretion. |
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter
(Optional Format 1-2-96)
Nancy C brogdon
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K024012