GE HEALTHCARE INSTA TRAK 3500PLUS/ FLUORO TRAK 9800 PLUS SYSTEM WITH AXCESS BONE PIN, MODEL PART # 1006955

K051734 · Ge Healthcare Technologies · HAW · Nov 23, 2005 · Neurology

Device Facts

• Record ID: K051734
• Device Name: GE HEALTHCARE INSTA TRAK 3500PLUS/ FLUORO TRAK 9800 PLUS SYSTEM WITH AXCESS BONE PIN, MODEL PART # 1006955
• Applicant: Ge Healthcare Technologies
• Product Code: HAW · Neurology
• Decision Date: Nov 23, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4560
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

The GE Healthcare Navigation and Visualization System [InstaTrak® 3500 Plus System or FluoroTrak™ 9800 Plus System] together with the Axcess™ Bone Pin, 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 stereotaxic surgery and which provides a reference to rigid structures such as sinus, skull, long bone or vertebra visible on medical images such as CT, MR or x-ray, The Axcess™ Bone Pin is to be used where rigid fixation of a tracking device to bone is required.

Device Story

System provides image-guided surgical navigation; utilizes Axcess Bone Pin for rigid fixation of tracking devices to patient bone. Inputs include pre-operative or intra-operative medical images (CT, MR, x-ray). System transforms image data and real-time tracking signals into visual navigation aids for surgeons. Used in clinical settings (OR) by surgeons to precisely locate anatomical structures. Output displayed to surgeon to guide surgical instruments; facilitates minimally invasive procedures; improves surgical accuracy by correlating patient anatomy with imaging data.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and intended use compared to legally marketed predicate devices.

Technological Characteristics

Stereotaxic instrument and image processing system. Components include Axcess Bone Pin for rigid fixation. System integrates with fluoroscopic x-ray and image processing hardware. Connectivity supports image data import (CT/MR/x-ray).

Indications for Use

Indicated for patients undergoing stereotaxic surgery requiring precise anatomical localization of rigid structures (sinus, skull, long bone, vertebra) visible on CT, MR, or x-ray imaging during open or percutaneous procedures.

Regulatory Classification

Identification

A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.

Predicate Devices

• LandmarX™ Image Guided Surgical System (K992927)
• Framelock™ (K022370)
• VectorVision Cranial/ENT (K023651)

Reference Devices

• InstaTrak 3500 Plus System (K040050)
• OEC FluoroTrak 9800 Plus (K022069)

Submission Summary (Full Text)

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NOV 2 3 2005

# KOSIT 34 510(K) STATEMENT / SUMMARY AS REQUIRED BY SECTION 807.92(c)

# GE HEALTHCARE TECHNOLOGIES INSTATRAK® 3500 PLUS/FLUOROTRAK™ 9800 PLUS SYSTEM WITH AXCESS™ BONE PIN

# 1. SUBMITTED BY:

GE Healthcare Technologies 439 South Union Street, 3rd Floor Lawrence, MA 01843 Tel [phone] Fax [phone]

# 2. DEVICE NAME:

GE Healthcare InstaTrak® 3500Plus or FluoroTrak™ 9800 Plus System with Axcess™ Bone Pin

| | Systems | Instrument |
|---------------------|--------------------------------------------------------------------------------------------------------------------------|------------------------|
| Proprietary Name | InstaTrak 3500 Plus System<br>OEC FluoroTrak 9800 Plus System | Axcess Cranial Pin* |
| Common/Usual Name | Interactive Image Guided Surgical System<br>Fluoroscopic Imaging System with Interactive<br>Image Guided Surgical System | Stereotaxic Instrument |
| Classification Name | Image Processing System<br>Image-intensified Fluoroscopic x-ray System<br>with Image Processing System | Stereotaxic Instrument |

#### Table 1: System and Instrument Names

*Note that the Axcess™ Cranial Pin is one example of the Axcess™ Bone Pin.

### 3. DEVICE CLASSIFICATION:

Stereotaxic Instrument (21CFR 882.4560 Product Code HAW) has been classified under section 513 of the Act as Class II by the Neurology Devices Panel.

Image Processing System (21CFR 892.2050 Product Code LLZ) has been classified under section 513 of the Act as Class II by the Radiology Devices Panel.

Image-intensified Fluoroscopic x-ray System with Image Processing System (21CFR 892.1650 Product Code 90 JAA and 21CFR 892.1720 Product Code IZL) has been classified under section 533 of the Act as Class II by the Radiology Devices Panel.

GE Healthcare Technologies

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### 4. INTENDED USE / INDICATIONS FOR USE:

The GE Healthcare Navigation and Visualization System [InstaTrak® 3500 Plus System or FluoroTrak™ 9800 Plus System] together with the Axcess™ Bone Pin, 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 stereotaxic surgery and which provides a reference to rigid structures such as sinus, skull, long bone or vertebra visible on medical images such as CT, MR or x-ray,

The Axcess™ Bone Pin is to be used where rigid fixation of a tracking device to bone is required.

#### 5. SUBSTANIAL EQUIVALENCE:

The GE Healthcare InstaTrak 3500 Plus System with Axcess Bone Pin is substantially equivalent to the following:

- LandmarX™ Image Guided Surgical System (K992927) when used with Framelock™ . (K022370), the transmitter rigid fixation device - both manufactured by Medtronic Xomed, Inc.
- . VectorVision Cranial/ENT (K023651) system, which contains a proprietary transmitter rigid fixation device (Skull Reference Array)- manufactured by BrainLAB AG.

Each predicate device offers a minimally invasive means of direct and rigid fixation to bone. The GE Healthcare InstaTrak 3500 Plus System with Axcess Bone Pin has a similar intended use as the predicate devices. There are no new questions of safety and effectiveness when compared to the predicate devices.

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# NOV 2 3 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

GE Healthcare Technologies c/o Tamas Borsai Program Manager, Third Party Review Program TUV Rheinland of North America, Inc. 12 Commerce Road Newton. Connecticut 06470

Re: K051734

Trade/Device Name: GE Healthcare Technologies' InstaTrak® 3500 Plus System or OEAC FluoroTrak™ 9800 Plus with the new Axcess " Bone Pin Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: II Product Code: HAW Dated: November 7, 2005 Received: November 14, 2005

Dear Mr. Borsai:

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) 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 [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 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,

Barbara Buechner

Mark N. M elkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### Attachment 1b

#### Page 1 of 1

#### 510(k) Number (if known): K051734

Device Name: GE Healthcare Technologies' InstaTrak® 3500 Plus System or OEC FluoroTrak™ 9800 Plus with the new Axcess TM Bone Pin

Indications For Use:

The GE Healthcare Navigation and Visualization System [InstaTrak 3500 Plus System (K040050) or OEC FluoroTrak 9800 Plus (K022069)] together with the Axess Bone Pin, is intended as an aid to the surgeon for precisely 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 stereotaxic surgery and which provides a reference to rigid structures such as sinus, skull, long bone or vertebra visible on medical images such as CT, MR or x-ray.

The Axess Bone Pin is intended to be used where rigid fixation of a tracking device to bone is required.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) OR

Over-The Counter Use

(Optional Format 1-2-96)

Barbara Buehns

(Division Sign-C Division of General, Restorative, and Neurological Devices

510(k) Numbe