OEC FLUOROTRAK 9800 PLUS

K022069 · Ge Oec Medical Systems · OWB · Sep 17, 2002 · Radiology

Device Facts

• Record ID: K022069
• Device Name: OEC FLUOROTRAK 9800 PLUS
• Applicant: Ge Oec Medical Systems
• Product Code: OWB · Radiology
• Decision Date: Sep 17, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1650
• Device Class: Class 2

Intended Use

The OEC FluoroTrak 9800 Plus provides the physician with fluoroscopic imaging during diagnostic, surgical and interventional procedures. The surgical navigation feature is intended as an aid to the surgeon for locating anatomical structures anywhere on the human body during either open or percutaneous procedures. It is indicated for any medical condition that may benefit from the use of stereotactic surgery and which provides a reference to rigid anatomical structures such as sinus, skull, long bone or vertebra visible on fluoroscopic images.

Device Story

System integrates InstaTrak 3000 surgical navigation module into OEC 9800 mobile C-arm fluoroscopic workstation. C-arm captures X-ray images; workstation processes and displays fluoroscopic data. Navigation module uses electromagnetic tracking to monitor surgical instrument position relative to patient anatomy based on pre-operative images. Surgeon views reconstructed 2D images overlaid with instrument position to guide procedures. Used in clinical settings (OR/clinic) by physicians to improve anatomical localization during open or percutaneous surgeries; benefits include enhanced surgical precision and visualization of instrument trajectory relative to rigid structures.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on the mechanical integration of two legally marketed predicate devices with established safety and performance profiles. Bench testing was conducted to ensure compliance with recognized electrical and radiological safety standards.

Technological Characteristics

Mobile C-arm fluoroscopic system with integrated electromagnetic surgical navigation. Materials and components comply with 21 CFR 1020.30-32, UL 2601, CSA-C22.2 No. 601.1-M90, and IEC 60601 series (1, 1-2, 1-3, 1-4, 2-7, 2-28, 2-32). Features high-voltage generator, X-ray tube, image intensifier, and workstation for image processing/display. Connectivity via integrated workstation architecture.

Indications for Use

Indicated for patients requiring fluoroscopic imaging during diagnostic, surgical, or interventional procedures, and for patients undergoing stereotactic surgery where navigation of rigid anatomical structures (sinus, skull, long bone, vertebra) is required.

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 9800 Mobile Digital Imaging System (K974355)
• InstaTrak 3000 System with FluoroTrak Module (K994270)

Submission Summary (Full Text)

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# SEP 1 7 2002

# 510(k) SUMMARY

K022069

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: | June 21, 2002 |
|--------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Name of Submitter: | GE OEC Medical Systems<br>384 Wright Brothers Drive<br>Salt Lake City, UT 84116<br>801-874-778 |
| Corresponding Official: | BIII Gislason<br>Vice President, Quality Assurance, Requlatory and<br>Reliability |
| Device Proprietary Name: | OEC® FluoroTrak™ 9800 Plus |
| Classification Name: | Image Intensified Fluoroscopic X-ray System with image<br>Processing System |
| Common/Usual Names: | Fluoroscopic Imaging System with Interactive Image<br>Guided Surgical System |
| Substantial Equivalence: | The OEC FluoroTrak 9800 Plus is substantially equivalent<br>to the OEC 9800 Mobile Digital Imaging System<br>(K974355) marketed by GE OEC Medical Systems, Inc.<br>and the InstaTrak 3000 System with FluoroTrak Module<br>(K994270) marketed by Visualization Technology, Inc. |

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#### Indications for Use

The OEC FluoroTrak 9800 Plus provides the physician with fluoroscopic imaging during diagnostic, surgical and interventional procedures. The surgical navigation feature is intended as an aid to the surgeon for locating anatomical structures anywhere on the human body during either open or percutaneous procedures. It is indicated for any medical condition that may benefit from the use of stereotactic surgery and which provides a reference to rigid anatomical structures such as sinus, skull, long bone or vertebra visible on fluoroscopic images.

### General Description

The OEC FluoroTrak 9800 Plus is the result of mechanically integrating the Instatrak 3000 System with FluoroTrak Module (marketed by Visualization Technology, Inc.) into the workstation of the OEC 9800 Mobile Imaging System.

The 9800 Mobile Imaging System is an image intensified fluoroscopic system consisting of a mobile C-arm and OEC Workstation. The C-arm supports the highvoltage generator, x-ray tube, x-ray controls, and image intensifier. The C-arm is designed to perform linear and rotational motions that allow the user to position the x-rav imaging components at various andles and distances with respect to the patient. The OEC workstation is a mobile platform that supports image display monitors, image processing and recording devices.

The InstaTrak 3000 System is an image quidance system indicated for use during sinus, skull base, cranial and axial skeletal procedures. Using the InstaTrak 3000, the surgeon can readly identify the immediate location and position of the surgical instrument during the indicated procedure.

The InstaTrak 3000 System allows the surgeon to view reconstructed twodimensional images of the patient's analomy in response to an electromagnetically tracked surgical instrument. This indicates the position of the tracked surgical instrument with regard to the patient's analomy based on pre-operative medical images.

The InstaTrak 3000 System with FluoroTrak Module (K994270) is being mechanically integrated into the workstation of the OEC 9800 Mobile Imaging System (K974355) to form the system configuration marketed as the OEC FluoroTrak 9800 Plus. The intended use of both the InstaTrak 3000 System with FluoroTrak Module and the OEC 9800 Mobile Imaging System remains the same as described in their respective original 510(k)s.

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#### 510(k) Summary

## Product Standards

The OEC FluoroTrak 9800 Plus is designed in accordance with product safety and performance requirements established in the following standards:

| 21 CFR 1020.30-32 | Federal Performance Standard for Diagnostic X-ray Systems |
|-------------------------|------------------------------------------------------------------------|
| 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, Electromagnetic Compatibility |
| IEC 60601-1-3 | Medical Electrical Equipment, Radiation Protection in Diagnostic X-ray |
| IEC 60601-1-4 | Medical Electrical Equipment, Programmable Electrical Medical Systems |
| IEC 60601-2-7 | Medical Electrical Equipment, HV/X-ray Generators |
| IEC 60601-2-28 | Medical Electrical Equipment, X-ray Tube and Source Assemblies |
| IEC 60601-2-32 | Medical Electrical Equipment, Safety of Associated X-ray Equipment |
| 93/42/EEC - Annex 1 | Essential Requirements of the Medical Devices Directive |

This concludes this 510(k) Summary.

GE OEC MEDICAL SYSTEMS, INC.

Bill Dickson

Bill Gislason Vice President, Quality Assurance, Regulatory, and Reliability

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

Mr. Bill Gislason Vice President. Quality Assurance. Regulatory and Reliability GE OEC Medical Systems, Inc. 384 Wright Brothers Drive SALT LAKE CITY UT 84116-2862

MAY 22 2012

Re: K022069

Trade/Device Name: OEC FluoroTrak 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: June 24, 2002 Received: June 25, 2002

Dear Mr. Gislason:

This letter corrects our substantially equivalent letter of November 14, 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

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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

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#### Simplified 510(k)

#### Indications For Use Statement

GE OEC Medical Systems, Inc. Applicant:

510(k) No. (if known):

OEC FluoroTrak 9800 Plus Device name:

- The OEC FluoroTrak 9800 Plus Mobile Imaging System provides Indications for use: the physician with fluoroscopic imaging during diagnostic, surgical and interventional procedures. The Fluorotrak surgical navigation feature is intended as an aid to the surgeon for locating anatomical structures anywhere on the human body during either open or perculaneous procedures. It is indicated for any medical condition that may benefit from the use of stereotactic surgery and which provides a reference to rigid anatomical structures such as sinus, skull, long bone or vertebra visible on fluoroscopic images.
(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 Reproductive, Abdominal,
and Radiological Devices
510(k) Number K022069

Prescription Use *✓*
(Per 21 CFR 801.109)
OR
Over-The-Counter **__**

(Optional Format 1-2-96)

GE OEC Medical Systems