OEC OLYMPUS MOBILE FLUOROSCOPY SYSTEM WITH INTEGRATED NAVIGATION

K041931 · Ge Oec Medical Systems, Inc. · OWB · Aug 26, 2004 · Radiology

Device Facts

• Record ID: K041931
• Device Name: OEC OLYMPUS MOBILE FLUOROSCOPY SYSTEM WITH INTEGRATED NAVIGATION
• Applicant: Ge Oec Medical Systems, Inc.
• Product Code: OWB · Radiology
• Decision Date: Aug 26, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1650
• Device Class: Class 2

Intended Use

The OEC Olympus Mobile Fluoroscopy System with Integrated Navigation provides the physician with fluoroscopic images 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 fo any medical condition that may be benefit from the use of stereotactic surgery and which provides a reference to ridged anatomical structures such as sinus, cranial, long bone or vertebra visible on fluoroscopic images.

Device Story

Mobile C-arm fluoroscopy system with integrated electromagnetic surgical navigation. Inputs: real-time X-ray fluoroscopic images; electromagnetic tracking of surgical instruments. Operation: C-arm captures X-ray images; workstation processes and displays images; navigation system correlates tracked instrument position with preoperative medical images to provide 2D anatomical visualization. Used in OR/clinic by surgeons/physicians. Output: fluoroscopic images and navigation overlays on workstation monitors. Benefit: assists surgeon in precise localization of anatomical structures during stereotactic procedures.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Mobile C-arm with high-voltage generator, X-ray tube, and image intensifier. Workstation includes image display, processing, and recording. Electromagnetic tracking system for navigation. Complies with 21 CFR 1020.30-32, UL 60601, IEC 60601-1, 1-2, 1-3, 1-4, 2-7, 2-28, 2-32, and ANSI/NFPA 70/99.

Indications for Use

Indicated for patients requiring diagnostic, surgical, or interventional procedures where fluoroscopic imaging or stereotactic surgical navigation is beneficial. Applicable for locating anatomical structures (sinus, cranial, long bone, vertebra) during open or percutaneous 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 FluoroTrak 9800 Plus (K022069)
• OEC 9800 E/CV+ Digital Mobile System (K024012)

Submission Summary (Full Text)

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K041931
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# AUG 2 6 2004

#### 510(k) SUMMARY

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: | July 14, 2004 |
|--------------------------|-------------------------------------------------------------------------------------------------------------|
| Name of Submitter: | GE OEC Medical Systems, Inc.<br>384 Wright Brothers Drive<br>Salt Lake City, UT 84116<br>801-536-4668 |
| Corresponding Official: | Jeff Wagner<br>Manager, Regulatory Affairs |
| Device Proprietary Name: | OEC Olympus Mobile Fluoroscopy System with Integrated<br>Navigation. |
| 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 Olympus Mobile Fluoroscopy System with<br>Integrated Navigation is substantially equivalent to the: |
| | • OEC FluoroTrak 9800 Plus (K022069) marketed by GE<br>OEC Medical Systems, Inc. |
| | • OEC 9800 E/CV+ Digital Mobile System (K024012)<br>marketed by GE OEC Medical Systems, Inc. |

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#### Indications for Use

The OEC Olympus Mobile Fluoroscopy System with Integrated Navigation provides the physician with fluoroscopic images during diagnostic, surqical 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 be benefit from the use of stereotactic surgery and which provides a reference to ridged anatomical structures such as sinus, cranial, long bone or vertebra visible on fluoroscopic images.

#### General Description

The OEC Olympus Mobile Fluoroscopy System with Integrated Navigation is a fluoroscopic system with integrated surgical navigation capabilities.

The OEC Olympus Mobile Fluoroscopy System with Integrated Navigation is an image intensified fluoroscopic system consisting of a mobile C-arm and OEC Workstation. The C-arm supports the high-voltage 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-ray imaging components at various angles 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 integrated surgical navigation system allows the surgeon to view reconstructed two-dimensional images of the patient's anatomy in response to an electromagnetically tracked surgical instrument. This indicates the position of the tracked surgical instrument with regard to the patient's anatomy based on preoperative medical images.

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#### Product Standards

The OEC Olympus Mobile Fluoroscopy System with Integrated Navigation 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 60601 | Medical Electrical Equipment |
| CSA-C22.2 No. 601.1-<br>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<br>X-ray |
| IEC 60601-1-4 | Medical Electrical Equipment, Programmable Electrical Medical<br>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<br>Equipment |
| 93/42/EEC - Annex 1 | Essential Requirements of the Medical Devices Directive |

This concludes this 510(k) Summary.

GE OEC MEDICAL SYSTEMS, INC.

Jeff Wagner
Wagner

Jat Wagner Manager, Regulatory Affairs

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## AUG 2 6 2004

Mr. Jeff Wagner Manager. Regulatory Affairs GE OEC Medical Systems; Inc. General Electric Company 384 Wright Brothers Drive SLT LAKE CITY UT 84116-2862 Re: K041931

Trade/Device Name: OEC Olympus Mobile Fluoroscopy System with Integrated Navigation Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulation Number: 21 CFR 892.1720 Regulation Name: Mobile x-ray system Regulatory Class: II Product Code: 90 JAA and IZL Dated: July 14, 2004 Received: July 19, 2004

Dear Mr. Wagner:

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 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.

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); 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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This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will and w you've ought.
premarket notification. The FDA finding of substantial equivalence of your device to a legally premaired predicated 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 If you desire upositiv dompliance at one of the following numbers, based on the regulation number at the top of the letter:

| 8xx.1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [phone] |

Additionally, for questions on the promotion and advertising of your device, please contact the Additionally, for queeronis (1301) 594-4639. Also, please note the regulation entitled, "Misbranding Other of Compilarios as ( notification" (21CFR Part 807.97) you may obtain. Other general by Telect to premained nonitoation (er the Act may be obtained from the Division of Small Information on your responsional and Consumer Assistance at its toll-free number [phone] or Mandidolarerors, International and address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Nancy C. Boylen

Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications For Use Statement

| Applicant: | GE OEC Medical Systems, Inc. | | |
|------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|
| 510(k) No. (if known): | K041931 | | |
| Device name: | OEC Olympus Mobile Fluoroscopy System with Integrated<br>Navigation. | | |
| Indications for use: | The OEC Olympus Mobile Fluoroscopy System with Integrated<br>Navigation provides the physician with fluoroscopic images<br>during diagnostic, surgical and interventional procedures. The<br>surgical navigation feature is intended as an aid to the surgeon<br>for locating anatomical structures anywhere on the human body<br>during either open or percutaneous procedures. It is indicated fo<br>any medical condition that may be benefit from the use of<br>stereotactic surgery and which provides a reference to ridged<br>anatomical structures such as sinus, cranial, long bone or<br>vertebra visible on fluoroscopic images. | | |

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| Concurrence of CDRH Office of Device Evaluation (ODE) | |
|-------------------------------------------------------|--|
|-------------------------------------------------------|--|

| Prescription Use (Per 21 CFR 801.109) | ✓ | OR | Over-The-Counter ______ |
|---------------------------------------|---|----|-------------------------|
|---------------------------------------|---|----|-------------------------|

| | <i>Nancy C Brogdon</i> | | (Optional Format 1-2-96) |
|--|---------------------------------------------------------------|--|--------------------------|
| | (Division Sign-Off) | | |
| | Division of Reproductive, Abdominal, and Radiological Devices | | |

| 510(k) Number | <i>K041931</i> |
|---------------|----------------|
|---------------|----------------|

| GE OEC Medical Systems | Company Confidential | Page 5 |
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