OEC 9900 ELITE

K122234 · Ge Healthcare Surgery GE Oec Medical Systems, Inc. · OWB · Aug 16, 2012 · Radiology

Device Facts

• Record ID: K122234
• Device Name: OEC 9900 ELITE
• Applicant: Ge Healthcare Surgery GE Oec Medical Systems, Inc.
• Product Code: OWB · Radiology
• Decision Date: Aug 16, 2012
• Decision: SESE
• Submission Type: Special
• 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.

Device Story

OEC 9900 Elite is a mobile fluoroscopic X-ray system used by physicians to visualize patient anatomy during surgical and interventional procedures. It provides real-time X-ray imaging and records of pre-surgical, intra-operative, and post-surgical anatomy. The system assists in localizing surgical regions of interest and visualizing pathology. Modifications include an alternative X-ray tube, alternative radiological imaging unit (RIU/image intensifier), optional wireless connectivity to hospital PACS, consolidated printed circuit board assemblies, and optional wireless foot/hand switches. The device is operated by trained clinicians in clinical settings such as ORs, critical care, and emergency rooms. Output is displayed for physician review to guide clinical decision-making and surgical intervention.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing and verification activities confirming that modified components (X-ray tube, RIU, wireless platform, PCB, switches) meet the same specifications as the predicate device.

Technological Characteristics

Mobile fluoroscopic X-ray system. Components: X-ray tube, radiological imaging unit (image intensifier). Connectivity: Optional wireless platform for PACS integration. Control: Optional wireless foot/hand switches. Hardware: Consolidated printed circuit board assemblies. Compliance: Voluntary standards as detailed in submission.

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 procedures.

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 (K120613)

Submission Summary (Full Text)

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K122234

AUG 16 2012

GE Healthcare 510(k) Premarket Notification Submission

### 510(k) Summary

In accordance with 21 CFR 807.92 the following summary of information is provided:

Date: August 3, 2012

Submitter:

GE Healthcare Surgery 384 Wright Brothers Drive Salt Lake City, UT 84116

Primary Contact Person:

Gerald Buss Director Regulatory Affairs GE Healthcare Surgery Phone: [phone] Fax: [phone]

Secondary Contact Person:

Karen Russell Regulatory Affairs Leader GE Healthcare Surgery Phone: [phone] Fax: [phone]

Device: (Trade Name): Common/Usual Name: Classification Names:

Mobile Fluoroscopic Imaging System

K120613 OEC® 9900 Elite

OEC® 9900 Elite

21 CFR 892.1650 Image-intensified fluoroscopic x-ray system

Product Code: 900XO, 90JAA, and OWB

Predicate Device(s):

Device Description:

The OEC® 9900 Elite is a system used to assist trained physicians. The system is used to provide X-Ray images while the physician performs a medical procedure. Images from the system help the physician to visualize the patients' anatomy. This visualization helps to localize surgical regions of interest and The images provide real-time visualization and pathology. records of pre-surgical anatomy, in vivo-surgical activity and post-surgical outcomes.

The proposed device will add an alternative supplier for the X-Ray The current tube and the proposed tube have the same Tube. specifications and will be interchangeable. Verification activities confirmed that the proposed tube meets the same specification as the current supplier's tube.

The proposed device will add an alternative supplier for the Radiological Imaging Unit (RIU) or Image Intensifier. The

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# GE Healthcare

## 510(k) Premarket Notification Submission

current RIU and the proposed RIU have the same specifications and will be interchangeable. Verification activities confirmed that the alternate RIU meets the same specification as the current supplier's RIU.

The proposed device will provide an optional wireless service platform to allow the user to connect to hospital intranet PACS system. The predicate product features a hard-wired connection. Verification testing confirmed that all specifications, including data security, were met.

Two printed circuit board assemblies have been combined into a single board in the proposed device. Both the proposed and predicate assemblies share common specifications as confirmed through verification testing.

The proposed device will provide an optional wireless foot switch and hand switch. The new option is equivalent to the predicate in that functionality is identical. The wireless option provides placement flexibility and reduced cable clutter.

#### Intended Use:

Technology:

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 OEC® 9900 Elite Mobile Fluoroscopy System is designed to

The modified OEC® 9900 Elite device employs the same fundamental scientific technology as the predicate device. The comparison chart reveals that functions performed by the predicate device are performed by the proposed device.

Verification testing has confirmed that the OEC® 9900 Elite and its application comply with voluntary standards as detailed in Section 9, of this premarket submission. The modifications from the predicate device OEC® 9900 Elite were completed in accordance with GE Healthcare Surgery's quality management system design controls. Engineering testing and standards compliance testing were successfully conducted and did not raise any new safety questions or concerns or identify new risks. Information is included with this 510(k) submission that supports this determination.

GE Healthcare considers the modified GE OEC® 9900 Elite to be Conclusion: as safe, as effective, and perform substantially equivalent to the predicate device OEC® 9900 Elite (K 120613).

Determination of Substantial Equivalence:

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes extending from its wing, representing service to the people. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

# DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002

AUG 16 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: K122234

Trade/Device Name: GE OEC 9900 Elite Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: OWB. OXO. and JAA Dated: July 20, 2012 Received: July 26, 2012

Dear Mr. Buss:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your Section >><(x) promation is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the Caclosure) to 1egarry mannet date of the Medical Device Amendments, or to commerce province to May 26, 1976, the encomment with the provisions of the Federal Food, Drug, devices that have been recuire approval of a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premarket approval application (PM and Cosment Act (Act) that to not require apple to the general controls provisions of the Act. The 1 ou may, merciole, market the device, ecolde requirements for annual registration, listing of general controls provisions of the rice 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 II your device is Classificu (sec above) into exase fr (sign your device can be found in Title 21, additional controls. Existing major regulations and to 895. In addition, FDA may publish further Code of Poderal Free ming your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issuance of a subsidination with other requirements of the Act that FDA has made a dectrimation that your as receiner Federal agencies. You must of ally Federal statutes and regulations and limited to: registration and listing (21 Comply with an the 11et 5 requirements 801 and 809); medical device reporting (reporting of

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medical device-related adverse events) (21 CFR 803); and good manufacturing practices and Incurements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket witi anow you to oogin finding of substantial equivalence of your device to a legally marketed nouthoution. The FDF imally of fication 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 II you desire specific an rice for your ac-receive ex-res-evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket 9 150. Thise, process not 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 Tou may other belief one general management and Consumer Assistance at its toll-free number [phone] of [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

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Image /page/4/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' intertwined and enclosed within a circle. The letters and the circle are in black, contrasting with the white background.

# GE Healthcare 510(k) Premarket Notification Submission

## INDICATIONS FOR USE

510(k) Number (if known):

Device Name: GE OEC 9900 Elite

Indications for Use:

The OEC® 9900 Elite 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, vascular, cardiac, critical care and emergency room procedures.

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

Over-The-Counter Use_ (Part 21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Radiological Devices
K122234

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