OEC 9900 ELITE

K082781 · Ge Healthcare Surgery · OWB · May 1, 2009 · Radiology

Device Facts

• Record ID: K082781
• Device Name: OEC 9900 ELITE
• Applicant: Ge Healthcare Surgery
• Product Code: OWB · Radiology
• Decision Date: May 1, 2009
• 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, vascular, cardiac, critical care and emergency room procedures. The system may be used for other imaging applications at the physician's discretion.

Device Story

Mobile fluoroscopic imaging system; consists of C-arm mainframe and mobile workstation. Mainframe houses high-voltage generator, x-ray control, x-ray tube, and image intensifier; supports linear/rotational motion for patient positioning. Workstation supports image display monitors, processing, and recording. Used in OR, clinic, or emergency settings by physicians/technicians to provide real-time fluoroscopic and spot-film images. Output viewed by clinicians to guide diagnostic, surgical, and interventional procedures; facilitates visualization of anatomy during complex interventions. Interfaces provided for optional peripheral devices like printers.

Clinical Evidence

Bench and animal performance testing conducted. Results demonstrate device is safe, effective, and performs equivalently to predicate devices.

Technological Characteristics

Mobile fluoroscopic x-ray system; consists of C-arm mainframe (high voltage generator, x-ray tube, image intensifier) and mobile workstation (monitors, image processing/recording). Supports linear and rotational motion. Interfaces for peripheral 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, vascular, cardiac, 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)
• OEC 9900 Elite (K073543)

Submission Summary (Full Text)

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K082781

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## Section 5 510(k) Summary

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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] Fax: [phone] |
| Preparation Date: | September 19, 2008 |
| 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<br>Mobile x-ray system. Product Code: 90.JAA and 90IZL. |
| Predicate Device: | K041932 OEC Olympus Fluoroscopic Imaging System,<br>K073543 OEC 9900 Elite |
| Device Description: | The OEC® 9900 Elite mobile fluoroscopy system is an image intensified fluoroscopic<br>system consisting of two mobile units: a Mainframe (C-Arm) and a Workstation. The<br>Mainframe (C-Arm) is comprised of a high voltage generator, x-ray control, and a "C"<br>shaped apparatus, which supports an X-ray tube and an image intensifier. The<br>Mainframe is designed to perform linear and rotational motions that allow the user to<br>position the x-ray imaging components at various angles and distances with respect to<br>the patient. The Workstation is a mobile platform that supports image display<br>monitors, image processing and recording devices. |
| Intended Use: | Interfaces are provided for optional peripheral devices such as thermal or instant film<br>printers.<br>The OEC® 9900 Elite mobile fluoroscopy system is designed to provide fluoroscopic<br>and spot-film images of the patient during diagnostic, surgical and interventional<br>procedures. Examples of clinical application may include cholangiography, endoscopy,<br>urologic, orthopedic, neurologic, vascular, cardiac, critical care and emergency room<br>procedures. The system may be used for other imaging applications at the physician's<br>discretion. |
| Technology:<br>Determination of<br>Substantial Equivalence: | The OEC® 9900 Elite employs the same fundamental scientific technology as the<br>predicate device(s).<br>The demonstration of substantial equivalence is based on a comparison of features to<br>the predicate device(s) and an assessment of non-clinical performance data.<br>Information is included with this 510(k) submission that supports this determination. |
| Conclusion: | Performance testing included in Section 18 Performance Testing – Bench and Section<br>19 Performance Testing - Animal of this 510(k) demonstrates that the OEC® 9900 Elite<br>is safe, effective and performs in an equivalent manner to the predicate device(s) and<br>in accordance with its labeling. |

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Image /page/1/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is a stylized symbol that resembles a caduceus, a traditional symbol of medicine.

## DEPARTMENT OF HEALTH & HUMAN SERVICES

## Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 .

MAY - 1 2009

Ms. Maria Frame Official Correspondent GE Healthcare 384 Wright Brothers Drive SALT LAKE CITY UT 84116

Re: K082781

Trade/Device Name: OEC® 9900 Elite Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: JAA Dated: January 9, 2009 Received: January 12, 2009

## Dear Ms. Frame:

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.

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

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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 at one of the following numbers, based on the regulation number at the top of this letter.

21 CFR 876.xxx 21 CFR 884.xxx 21 CFR 892.xxx Other

(Gastroenterology/Renal/Urology) (Obstetrics/Gynecology) (Radiology)

[phone] [phone] [phone] [phone]

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

[signature]

Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Section 4 Indications For Use

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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, urolagic, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures. The system may be used for other imaging applications at the physician's discretion.

Prescription Use_ > (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use _ (Per 21 CFR 801 Subpart C)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Iryen M. Whang
(Division Sign-Off)

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