OEC 9900 ELITE

K073543 · Ge Oec Medical Systems · OWB · May 2, 2008 · Radiology

Device Facts

• Record ID: K073543
• Device Name: OEC 9900 ELITE
• Applicant: Ge Oec Medical Systems
• Product Code: OWB · Radiology
• Decision Date: May 2, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1650
• Device Class: Class 2

Intended Use

The OEC® 9900 Elite Mobile Fluoroscopy System is designed to provide fluoroscopic and spot-film images of the patient during diagnostic, surgical and interventional procedures. Examples of clinical application may include cholangiography, endoscopy, urologic, orthopedic, neurologic, critical care and emergency room procedures. The system may be used for other imaging applications at the physician's discretion.

Device Story

OEC 9900 Elite is a mobile fluoroscopic imaging system consisting of a C-arm mainframe and a mobile workstation. The C-arm supports an X-ray tube and image intensifier, allowing for linear and rotational positioning relative to the patient. The workstation provides image display, processing, and recording capabilities. Used in clinical settings (OR, ER, etc.) by physicians and clinical staff to acquire real-time fluoroscopic and spot-film images. The system aids in visualization during diagnostic, surgical, and interventional procedures, supporting clinical decision-making by providing immediate anatomical feedback. Includes an uninterruptible power supply to protect image and demographic data during power outages.

Clinical Evidence

Bench testing only. Performance testing demonstrated the device is safe, effective, and performs equivalently to the predicate device.

Technological Characteristics

Mobile fluoroscopic X-ray system; C-arm configuration with high voltage generator, X-ray tube, and image intensifier. Includes workstation for image processing and display. Features an uninterruptible power supply for data protection. Interfaces provided for peripheral devices like printers.

Indications for Use

Indicated for patients undergoing diagnostic, surgical, and interventional procedures requiring fluoroscopic and spot-film imaging, including cholangiography, endoscopy, urologic, orthopedic, neurologic, critical care, and emergency room applications.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• OEC Olympus Fluoroscopic Imaging System (K041932)

Submission Summary (Full Text)

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. 2 MAY - 2 2008

## Section 5 510(k) Summary

.

Section 9 320(M Our Mr. J
The following information is being submitted in accordance with the requirements of 21 CFR 807.92.

| Company Name: | GE Healthcare Surgery |
|----------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Address: | 384 Wright Brothers Drive<br>Salt Lake City, UT 84116 |
| Contact Person: | Maria C. Frame<br>Vice President Quality Assurance and Regulatory Affairs<br>GE Healthcare Surgery<br>Phone: [phone]<br>Fax: [phone] |
| Preparation Date: | December 14, 2007 |
| Device (Trade Name): | OEC® 9900 Elite |
| Common/Usual Name: | Mobile Fluoroscopic Imaging System |
| Classification Names: | 21 CFR 892.1650 and 892.1720 (either) Image-intensified fluoroscopic x-ray system and Mobile x-ray system. Product Code: 90JAA and 90IZL. |
| Predicate Device: | K041932 OEC Olympus Fluoroscopic Imaging System |
| Device Description: | The OEC® 9900 Elite Mobile Fluoroscopy System is an image intensified fluoroscopic system consisting of two mobile units: a Mainframe (C-Arm) and a Workstation. The Mainframe (C-Arm) is comprised of a high voltage generator, x-ray control, and a "C" shaped apparatus, which supports an X-ray tube and an image intensifier. The Mainframe is designed to perform linear and rotational motions that allow the user to position the x-ray imaging components at various angles and distances with respect to the patient. The Workstation is a mobile platform that supports image display monitors, image processing and recording devices.<br>Interfaces are provided for optional peripheral devices such as thermal or instant film printers. |
| Intended Use: | The OEC® 9900 Elite Mobile Fluoroscopy System is designed to provide fluoroscopic and spot-film images of the patient during diagnostic, surgical and interventional procedures. Examples of clinical application may include cholangiography, endoscopy, urologic, orthopedic, neurologic, critical care and emergency room procedures. The system may be used for other imaging applications at the physician's discretion. |
| Technology: | The OEC® 9900 Elite employs the same fundamental scientific technology as its predicate device. An uninterruptible power supply was added to provide additional safety to image and demographic data in the event of a power outage. |
| Determination of Substantial<br>Equivalence: | The demonstration of substantial equivalence is based on a comparison of features to the predicate device and an assessment of non-clinical performance data. Information is included with this 510(k) submission that supports this determination. |
| Conclusion: | Performance testing included within this 510(k) demonstrates that the OEC® 9900 Elite is safe, effective and performs in an equivalent manner to the predicate device, with improved reliability and in accordance with its labeling. |

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle with three curved lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## MAY - 2 2008

Ms. Maria C. Frame Vice President Ouality Assurance and Regulatory Affairs GE Healthcare Surgery (GE OEC Medical Systems, Inc.) 384 Write Brothers Drive SALT LAKE CITY UT 84116

Re: K073543

Trade/Device Name: OEC® 9900 Elite Regulation Number: 21 CFR 892.1650 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: JAA Dated: December 14, 2007 Received: December 17, 2007

Dear Ms. Frame:

We have reviewed vour 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

Enclosure

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 nequirements 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 liating (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 100-1050.

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 logally 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance a one of the following numbers, based on the regulation number at the top of this letter.

| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|-----------------|----------------------------------|--------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, release contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 24/0276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You max 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/cdrb/industry/support/index.html of

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

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## Section 4 Indications For Use

Page 1 of 1

510(k) Number (if known):

OEC® 9900 Elite Device Name:

Indications for Use:

The OEC® 9900 Elite Mobile Fluoroscopy System is designed to provide fluoroscopic and spot-film images of the patient during diagnostic, surgical and interventional procedures. Examples of clinical application may include cholangiography, endoscopy, urologic, orthopedic, neurologic, critical care and emergency room procedures. The system may 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 Use _________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

ﻠﺴ

Tom Minter

(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number