OEC(R) 9800, OEC(R) 9800 PLUS

K111551 · Ge Oec Medical Systems, Inc. · OWB · Oct 4, 2011 · Radiology

Device Facts

• Record ID: K111551
• Device Name: OEC(R) 9800, OEC(R) 9800 PLUS
• Applicant: Ge Oec Medical Systems, Inc.
• Product Code: OWB · Radiology
• Decision Date: Oct 4, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1650
• Device Class: Class 2

Intended Use

The OEC 9800 Plus is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. Clinical applications may include cholangiography, endoscopic, urologic, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures.

Device Story

Mobile fluoroscopic imaging system; consists of C-arm gantry and workstation. Uses X-ray generator to emit X-rays directed at patient; X-rays captured by image intensifier; camera converts to digital images displayed on workstation monitor. Operated by trained physicians/technicians in clinical environments (OR, ER, etc.). Physician directs operator to adjust C-arm position, X-ray technique, image size, and orientation based on anatomy. Provides real-time visualization and records of pre-surgical, in-vivo, and post-surgical anatomy to assist in localization of surgical regions and pathology. Benefits include improved visualization for procedures like hip replacements, fracture reconstruction, blood flow studies, and cardiac artery blockage assessment.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Mobile fluoroscopic X-ray system. Components: C-arm gantry, workstation, X-ray generator, X-ray tube, image intensifier, camera, and display monitors. Imaging technology: X-ray. Connectivity: Workstation-based image storage and display. Sterilization: Not applicable (device is capital equipment).

Indications for Use

Indicated for patients requiring fluoroscopic and spot-film imaging during diagnostic, surgical, and interventional procedures, including cholangiography, endoscopic, 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® 9900 Elite (K082781)

Submission Summary (Full Text)

{0}------------------------------------------------

OCT - 4 2011

KIIISS

P. I of

## Section 5 510(k) Summary

The following information is being submitted in accordance with the requirements of 21 CFR 807.92.

| Company Name: | GE Healthcare Surgery |
|-----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | 384 Wright Brothers Drive |
| Address: | Salt Lake City, UT 84116 |
| Contact Person: | Gerald Buss |
| | Director Regulatory Affairs |
| | GE Healthcare Surgery |
| | Phone: [phone] Fax: [phone] |
| Preparation Date: | November 9, 2010 |
| Device (Trade Name): | OEC® 9800 / OEC® 9800 Plus |
| Common/Usual Name: | Mobile Fluoroscopic Imaging System |
| Classification Names: | 21 CFR 892.1650 and 892.1720 (either) Image-intensified fluoroscopic X-<br>Ray system and Mobile X-Ray system. Product Code: 90JAA and 90IZL. |
| Predicate Device: | K082781 OEC® 9900 Elite |
| Device Description: | The Series OEC® 9800 is a System used to assist trained Physicians. The<br>system is used to provide X-Ray images while the Physician performs<br>medical procedure. Images from the system help the Physician to visualize |

the patients' anatomy. This visualization helps to localize surgical regions of interest and pathology. The images provide real-time visualization and records of pre-surgical anatomy, in vivo-surgical activity and post surgical outcomes.

The system is composed of two primary physical elements. The first is referred to as the "C-Arm" because of its "C" shaped image gantry; the second referred to as the "Workstation" because this is the primary user interface to the system.

The system is used in different surgical procedures. Orthopedic Physicians may use the system to help perform hip replacements and reconstructions of badly fractured bones. Vascular Physicians may use the system to perform blood flow studies. Cardiologists may use the system to help see if there are blockages in some of the key arteries supplying blood to the heart. The procedures that these physicians perform are broadly referred to as "Clinical Applications". The system is controlled and run in a clinical environment.

The system employs X-Rays as its imaging tcchnology. An X-Ray Generator located in the base of the C-Arm creates high voltage. High voltage is carried to the X-Ray tube across a set of cables. The X-Ray tube emits X-Rays that are directed toward the patient under the control of the operator. The Physician defines the desired view for the specific clinical procedure and directs the operator. The X-Rays pass through the patient and are captured by the image intensifier (II). Image intensifier images are

{1}------------------------------------------------

K111551
P. 2 of 2

captured by a camera and displayed on the image monitor located on the Workstation. The system operator and/or Physician view the images as they are displayed and they may choose to store the images for later review.

In order to perform these procedures different views of the human anatomy are required, so the system is designed with the ability to rotate and translate the C-Arm's image gantry to obtain different viewing angles. In addition since there is variation in thickness and density of the anatomy the operator has the ability to adjust the X-Ray Generator technique, image size and orientation to account for the anatomical differences.

- Intended Use: The OEC 9800 Plus is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. Clinical applications may include cholangiography, endoscopic, urologic, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures.
The OEC® 9800 / OEC® 9800 Plus employs the same fundamental Technology: scientific technology as the predicate device.

Determination of Substantial 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.

Performance testing included in Section 18 Performance Testing - Bench of Conclusion: this 510(k) demonstrates that the OEC® 9800 / OEC® 9800 Plus is safe. effective and performs in an equivalent manner to the predicate device and in accordance with its labeling.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image contains the logo for the U.S. Department of Health and Human Services. The logo features the department's emblem, which consists of a stylized caduceus-like symbol with three figures representing health, services, and human aspects. The emblem is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.

Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993

MAY - 7 2012 Mr. Gerald Buss Director, Regulatory Affairs GE Healthcare Surgery (GE OEC Medical Systems, Inc.) 384 Wright Brothers Drive SALT LAKE CITY UT 84116

Re: K111551

Trade/Device Name: OEC® 9800 / OEC® 9800 Plus Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: OWB, JAA and OXO Dated: August 26, 2011 Received: August 29, 2011

Dear Mr. Buss:

This letter corrects our substantially equivalent letter of October 4, 2011.

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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of

{3}------------------------------------------------

medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820). 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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,

Janine M. Morris

Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

KIIISSI
P. I al

Section 4 Indications For Use

510(k) Number (if known):

OEC® 9800 / OEC® 9800 Plus Device Name:

Indications for Use: The OEC 9800 Plus is designed to provide fluoroscopic and spotfilm imaging of the patient during diagnostic, surgical and interventional procedures. Clinical applications may include cholangiography, endoscopic, urologic, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures.

Prescription Use __ V __ V __ AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (Per 21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Device (OIVD)

Mary S Patil

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K////55/