INSTATRAK SYSTEM WITH MULTIPLE DATASET NAVIGATION, MODEL IT3500

K040050 · Ge Medical Systems Navigation and Visualization IN · LLZ · Mar 24, 2004 · Radiology

Device Facts

• Record ID: K040050
• Device Name: INSTATRAK SYSTEM WITH MULTIPLE DATASET NAVIGATION, MODEL IT3500
• Applicant: Ge Medical Systems Navigation and Visualization IN
• Product Code: LLZ · Radiology
• Decision Date: Mar 24, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2

Indications for Use

The InstaTrak 3500 Plus System (K983529, originally cleared under the product name InstaTrak 3000) is intended as an aid to the surgeon for precisely 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 medical images such as CT, MR, or X-ray.

Device Story

InstaTrak 3500 Plus is an image-guided surgical system; provides real-time visualization of tracked surgical instruments relative to patient anatomy. Input: pre-operative medical images (CT, MR, X-ray) and real-time electromagnetic tracking data from surgical instruments. Operation: system registers patient anatomy to image datasets; allows co-registration (fusion) of multiple datasets (e.g., CT and MR) to enhance visualization. Output: visual display of instrument position overlaid on fused medical images. Used in OR by surgeons for intra-operative guidance; assists in precise localization of anatomical structures. Benefits: improved surgical planning and navigation accuracy during open or percutaneous procedures.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and software functionality compared to predicate devices.

Technological Characteristics

Electromagnetic position sensing system; software-based image fusion module. Compatible with CT, MR, and X-ray imaging modalities. Operates as an add-on to the existing InstaTrak 3500 Plus platform. Complies with CENELEC EN 55011, EN 60601-1-2, EN 60601-1, UL2601, and CSA601 standards.

Indications for Use

Indicated for patients undergoing open or percutaneous surgical procedures requiring stereotactic navigation; applicable to conditions involving rigid anatomical structures (sinus, skull, long bone, vertebra) visible on CT, MR, or X-ray imaging.

Regulatory Classification

Identification

A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.

Special Controls

*Classification.* Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).

Predicate Devices

• Vectorvision iPlan (K020631)
• StealthStation (K954276)

Submission Summary (Full Text)

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K040050
Page 21 of 3

## 510(k) SUMMARY

# GE MEDICAL SYSTEMS NAVIGATION AND VISUALIZATION INSTATRAK 3500 PLUS WITH MULTIPLE DATASET NAVIGATION

#### SUBMITTED BY: ﮩ

GE Medical Systems Navigation and Visualization

| Primary Contact: | Jeff Wagner |
|------------------|---------------------------|
| | GE OEC Medical Systems |
| | 384 Wright Brothers Drive |
| | Salt Lake City, UT 84116 |
| | Tel [phone] |

#### DEVICE NAME 2.

| Proprietary Name: | InstaTrak with Multiple Dataset Navigation |
|----------------------|--------------------------------------------|
| Common/Usual Name: | Interactive Image Guided Surgical System |
| Classification Name: | Image Processing System |

#### DEVICE CLASSIFICATION 3.

Image Processing Systems (21 CFR 892.2050 Product Code LLZ) and Computed Tomography Systems (21 CFR 892.1750 Product Code JAK) have been classified under Section 513 of the Act as Class II by the Radiology Devices Panel.

#### PERFORMANCE STANDARDS 4.

No performance standards applicable to this device have been adopted under Section 514 of the Act. The InstaTrak system complies with the following:

CENELEC EN 55011 CENELEC EN 60601-1-2 CENELEC EN 60601-1 UL2601 CSA601

#### DEVICE DESCRIPTION 5.

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K040050
Page 2 of 3

## Intended Use

The InstaTrak 3500 Plus System (K983529, originally cleared under the product name InstaTrak 3000) is intended as an aid to the surgeon for precisely 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 medical images such as CT, MR, or X-ray.

### General Description

The InstaTrak system with Multiple Dataset Navigation provides the same capability as the existing system, with the additional functionality of utilizing two sets of medical images instead of one. By providing information from multiple datasets, the user can locate and visualize anatomical structures using different imaging modalities.

The InstaTrak 3500 Plus System allows the user to view the medical images of the patient's anatomy in response to the mouse or the tracked surgical instrument. Alignment of the patient and medical images is accomplished through the registration process. In all types of surgery the goal is the same, to display to the surgeon based on the medical images, where the position of a tracked surgical tool is with regard to the patient's anatomy. With the additional capability of multiple dataset navigation, the surgeon can now view the position of the tracked instrument using two sets of medical images instead of one.

The Multiple Dataset Navigation will provide the user with the ability to co-reqister (fuse) images from multiple datasets such as CT and MR. Using the existing InstaTrak 3500 Plus System software, the user will register one of the datasets, referred to as the Reference Dataset, to the patient. Navigation is then possible on the fused images, with secondary (registered) dataset(s) acting as a visualization enhancement for both surgical planning and intra-operative quidance. The sensors and instruments used for navigation are identical to those utilized by the existing InstaTrak system. Navigation will be disabled until the datasets have been successfully co-registered.

Patient registration is the process by which the coordinate systems of the medical images and the pointing instrument are aligned. This is performed on the primary (reference) dataset. Both the method of registration on the primary (reference) dataset and the resulting accuracy are identical to that described in K983529.

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K040050
page 3 of 3

The current system provides displays for a single set of medical images. The Multiple Dataset Navigation option will provide displays for multiple sets of medical images. The addition of the Multiple Dataset Navigation operating mode does not change any of the major components of the InstaTrak System. There are no new receivers, transmitters, or instrument attachment configurations associated with this operational mode. Addition of the Multiple Dataset Navigation mode is a software change only.

#### 7. SUBSTANTIAL EQUIVALENCE

The GE Medical Systems Navigation and Visualization Multiple Dataset Navigation option on the InstaTrak system is substantially equivalent to the Image Composer application on the Vectorvision iPlan (K020631), manufactured by BrainLAB, and the StealthStation (K954276) with StealthMerge application, manufactured by Medtronic. Each predicate device also offers the capability to fuse multiple data sets from different imaging modalities. The GE Medical Systems Multiple Dataset Navigation application has the same intended use and utilizes images from the same modalities as the predicate devices. There are no new questions of safety and effectiveness when compared to the predicate devices. The technological platform (InstaTrak, K983529) is unchanged, using the same electromagnetic position sensing and registration process as described in K983529, Except for the Multiple Dataset Navigation function, the InstaTrak system specifications and operating parameters will remain unchanged.

#### 8. CONCLUSION

Based on the above discussion, GE Medical Systems Visualization and Navigation believes that the Multiple Dataset Navigation module is substantially equivalent to the predicate devices.

This concludes this 510(k) summary

lac ti

Jackie Magno Vice President, Regulatory and Six Sigma GE OEC Medical Systems

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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged around the symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 4 2004

Mr. Jackie Magno Vice President, Regulatory Affairs and Six Sigma GE OEC Medical Systems, Inc. General Electric Company 384 Write Brothers Drive SALT LAKE CITY UT 84116-2862

Re: K040050 Trade/Device Name: Insta Trak 3500 Plus with Multiple Dataset Navigation Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: 90 LLZ Dated: December 22, 2003 Received: January 15, 2004

### Dear Mr. Magno:

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 intestste 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, Or ug, 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, I isting 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, TDA 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) 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 Part 801), please contact the Office of Compliance 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 Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html.

Sincerely yours.

Nancy C. Brogdon

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

Enclosure

Page 2

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510(k) Number (if known): K 0 400 50

Device Name: GE Medical Systems Visualization and Navigation InstaTrak System with Multiple Dataset Navigation

Indications For Use:

The system is intended as an aid to the surgeon for precisely 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 anatomical structures such as sinus, skull, long bone, or vertebra, visible on medical images such as CT, MR, or X-ray.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

L Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use __

David A. Lynn
(Division Sign-Off)
Division of Reproductive, Abdominal

Reproductive, Abdominal,