INSTATRAK 3000

K983529 · Visualization Technology, Inc. · LLZ · Dec 31, 1998 · Radiology

Device Facts

• Record ID: K983529
• Device Name: INSTATRAK 3000
• Applicant: Visualization Technology, Inc.
• Product Code: LLZ · Radiology
• Decision Date: Dec 31, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2

Indications for Use

The InstaTrak 3000 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 rigid anatomical structures such as sinus, skull, cranial and axial skeletal visible on medical images such as CT or MR.

Device Story

InstaTrak 3000 is an image-guided surgical system; assists surgeons in locating anatomical structures during open or percutaneous procedures. Inputs: pre-operative CT or MR medical images; real-time electromagnetic tracking of surgical instruments. Operation: system registers patient anatomy to medical images via automatic or fiducial/surface registration; tracks instrument position relative to anatomy. Outputs: 2D/3D reconstructed models; planar images; oblique and trajectory views; surgical planning overlays. Used in OR by surgeons; provides visual feedback to avoid critical structures (nerves, etc.). Benefits: improved surgical precision; trajectory planning; real-time navigation relative to pre-operative scans.

Clinical Evidence

Bench testing only. Testing performed on new system components to verify accuracy and ensure performance within specifications.

Technological Characteristics

Electromagnetic position sensing; Sun computer workstation; monitor; hard disk storage. Supports CT and MR imaging. Includes surgical instruments (nasal specula, mouth gag, pharyngeal retractor, aspirator, pointer). Software provides 3D modeling, trajectory planning, and surface registration. System is networked/standalone workstation.

Indications for Use

Indicated for patients undergoing open or percutaneous stereotactic surgical procedures requiring navigation relative to rigid anatomical structures (sinus, skull, cranial, long bone, or vertebra) visible on CT or MR 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

• InstaTrak System (K960330)
• Pediatric InstaTrak System (K981998)
• Stealth Station (K954276)
• Viewing Wand (K911783)

Submission Summary (Full Text)

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K983529

DEC 31 1998

# 510(k) Summary VISUALIZATION TECHNOLOGY INC INSTATRAK 3000

#### 1. SPONSOR

Visualization Technology, Inc. 200 Research Drive Wilmington, MA 01887 Telephone: [phone]

..

Contact Person: Peter Ohanian

- 2. DEVICE NAME

| Proprietary Name: | InstaTrak 3000 |
|----------------------|------------------------------------------|
| Common/Usual Name: | Interactive Image Guided Surgical System |
| Classification Name: | Computed Tomography X-Ray System |

#### 3. PREDICATE DEVICES

InstaTrak System, subject of K960330,

Pediatric InstaTrak System, subject of K981998,

Stealth Station manufactured by Surgical Navigation Technologies, subject of K954276

Viewing Wand manufactured by ISG Technologies, Inc., subject of K911783.

#### DEVICE DESCRIPTION 4.

The InstaTrak System is an image guidance system indicated for use during sinus, skull base, cranial and axial skeletal procedures. The InstaTrak 3000 is essentially identical to the InstaTrak System cleared under K960330 and the Pediatric InstaTrak System cleared under K981998 which are both indicated for use during sinus surgery. The changes to the system include a computer upgrade, software enhancements, additional indications and the addition of several components. Using the InstaTrak 3000, the surgeon can readily identify the immediate location and position of the surgical instrument during the indicated procedure. The

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InstaTrak 3000 assists the surgeon in avoiding critical nerves and other anatomical structures.

The InstaTrak 3000 offers multiple modes of operation that includes sinus, skull base or axial skeletal, to the user based on the indications the user desires. Software is available to the user for using any one, two, or all three of the operational modes. A selection of the operational modes is made by the user prior to the procedure depending needs of the user.

The original InstaTrak System allows the user to view the reconstructed 2D 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 either an automatic or fiducial registration. The indications for use include sinus cleared under K960330 and pediatric sinus surgery (K981998). In all types of surgery the goal is the same, to indicate to the surgeon based on the pre-operative medical images, where the position of a tracked surgical tool is with regard to the patient's anatomy. The InstaTrak 3000 is based on the same hardware and software used in the original InstaTrak System and provides all of the above features. It utilizes the same clinically proven electromagnetic tracking technology as its predecessor. A newer version of a Sun computer has been substituted to provide 3D display capability which includes 3D models and planar images on top of 3D models, oblique and trajectory matching views. Additionally, a surgical planning capability has been added. This allows the surgeon to plan a trajectory prior to surgery and to observe the pre-surgical track in relation to the actual track during the surgical procedure. A new registration technique has been added whereby the surface of the anatomy can be registered to. New instruments have been added to which tracking sensors have been built in or may be attached. These, along with the surface registration and the new displays allow the system to be used in the proposed indications encompassing axial skeletal, and cranial surgery, in addition to the cleared and pending indications.

### 5. INTENDED USE

The InstaTrak 3000 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 rigid anatomical structures such as sinus, skull, cranial and axial skeletal visible on medical images such as CT or MR.

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## TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE 6.

The InstaTrak 3000 and the Stealth Station are similar in intended use in that they both are indicated for locating anatomical structures anywhere on the human body in open or percutaneous procedures. The InstaTrak 3000 is identical to both the original InstaTrak System the ISG Technologies Viewing Wand devices in that they are both intraoperative image-guidance systems intended for skull base surgery and sinus surgery.

The InstaTrak 3000 is essentially identical in technological characteristics to the InstaTrak System cleared under K960330 with the exception of computer and software enhancements and some additional components. The InstaTrak System uses the same electromagnetic position sensing, patient headset and automatic headset registration as the original InstaTrak System cleared under K960330.

The InstaTrak 3000, the original InstaTrak System and the ISG Viewing Wand all use a computer, monitor and hard disk storage system. All of the systems offer image guidance using CT or MR scans with the exception of the original InstaTrak System, which only offers CT scans.

There are several new components in the InstaTrak 3000 System. The new components include a nasal specula, mouth gag, pharyngeal retractor, straight extended aspirator, sterile disposable pointer, transmitter, receiver and a head frame. The new components used in the InstaTrak System have been added to accommodate the various applications.

The nasal speculum, mouth gag, and pharyngeal retractor are essentially identical to standard commercial devices and are exempt from the 510(k) premarket notification process. The extended straight aspirator and the disposable pointer are essentially identical to the aspirator and pointer described in the original 510(k) (K960330) for the InstaTrak System.

# 7. PERFORMANCE TESTING

Testing was performed using the new components of the InstaTrak 3000 System to determine if the new components affected device accuracy. The results showed that the device performed within the specification while using the new components.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 31 1998

Visualization Technology, Inc. C/o Mary McNamara-Cullinane Medical Device Consultants 49 Plain Street North Attleboro, MA 02760

Re:

K983529 Insta Trak 3000 Dated: October 7, 1998 Received: October 8, 1998 Regulatory class: II 21 CFR 892.1750/Procode: 90 LLZ

Dear Ms. McNamara-Cullinane:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 III (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [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"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone], or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Capt. Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): K98 35 d 9

Device Name: Visualization Technology, Inc. InstaTrak 3000

Indications For Use:

The InstaTrak 3000 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 rigid anatomical structures such as sinus, skull, cranial, a long bone or vertebra, visible on medical images such as CT or MR.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number K983529

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

(Optional Format 1-2-96)

Visualization Technology, Inc. 510(k) 10/7/98 CONFIDENTIAL

Skull Based InstaTrak System

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