Z KAT FLUROTACTIC GUIDANCE SYSTEM MKI

K984298 · Z-Kat, Inc. · HAW · Jun 23, 1999 · Neurology

Device Facts

• Record ID: K984298
• Device Name: Z KAT FLUROTACTIC GUIDANCE SYSTEM MKI
• Applicant: Z-Kat, Inc.
• Product Code: HAW · Neurology
• Decision Date: Jun 23, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4560
• Device Class: Class 2

Intended Use

The Fluorotactic Guidance System Mk. I will be used to assist in the accurate placement of a guiding device for surgery in which a linear trajectory insertion or placement is required. This system will use coordinated-fluoroscopy to allow intra-operative planning of the precise insertion point and angle of a device such as a screw, nail, or needle. The surgeon will place a registration artifact over the desired surgical area and capture two fluoroscopic images, which will then be displayed on two computer screens. The surgeon will manipulate a virtual guidewire on the screens, until the desired angle and placement is achieved. The system will then output 3D coordinates to the robot arm which will move the drill guide to a precise position.

Device Story

System assists surgeons in precise placement of surgical instruments (screws, nails, needles) requiring linear trajectory. Inputs: two orthogonal fluoroscopic images captured via C-arm; registration artifact with eight steel balls provides fiducial shadows for spatial calibration. Processing: PC software processes image data, displays on dual monitors; surgeon manipulates virtual guidewire on screen to plan entry point and trajectory. Output: 3D coordinates sent to electromechanical robot arm; arm positions drill guide over surgical site. Used in OR; operated by surgeon. Benefits: improved accuracy for instrument positioning during surgery.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

System components: electromechanical robot arm, registration/drill guide artifact (with embedded steel balls), fluoroscopic C-arm, PC with image acquisition card and dual monitors. Sensing: fiducial-based registration using X-ray shadows. Connectivity: PC-based image acquisition. Software: image processing and coordinate calculation for robotic positioning.

Indications for Use

Indicated for surgical procedures requiring linear trajectory insertion or placement of instruments (e.g., screws, nails, needles). Intended for use by surgeons to assist in accurate intra-operative positioning of drill guides.

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

• StealthStation (K954276)
• Radionics Operating Arm & OTS System/StereoPlan (K961844)
• Picker International Viewpoint System (K970604)
• Fischer Imaging AutoGuide (Part of Mammotest Mammography System) (K861692)

Submission Summary (Full Text)

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## JUN 2 3 1999

K984298

11645 Biscayne Blvd. Suite 308 Miami, FL 33181-3139 Tel [phone] Fax [phone] [e-mail]

## 510(k) Summary

Submitter: Z-KAT, Inc.

Address: 11645 Biscayne Blvd. Suite 304 Miami, FL 33181

Phone number: [phone]

Fax number: [phone]

Contact person: Rony Abovitz

Date prepared: November 18, 1998

Trade name: Z-KAT Fluorotactic ™ Guidance System

Common name: Stereotaxic Instrument

Classification name: Class II

Substantial equivalence claimed to:

- 1. StealthStation, Surgical Navigation Technologies, Inc., K954276
- 2. Radionics Operating Arm & OTS System/StereoPlan, K961844
- 3. Picker International Viewpoint System, K970604
- 4. Fischer Imaging AutoGuide (Part of Mammotest Mammography System), K861692

Description:

The Fluorotactic Guidance System Mk. I is an integrated system that enables a surgeon to more accurately position drill guides, screw drivers, needles, and other surgical instruments using two captured fluoroscopic images. An electromechanical arm is used to accurately position an end-effector over the desired surgical area, and two approximately orthogonal images are captured with a standard flouroscope. The two images are displayed on computer monitors and used to perform accurate intra-operative planning. The plan consists of specifying the instrument entry point, and sagittal and transverse orientations. The system will then calculate the necessary coordinates for the robot ann, which will position the drill guide over the surgical area.

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Summary of technological characteristics:

The Fluorotactic Guidance System Mk. I system will consist of four components:

- 1) Robot arm
- 2) Registration/drill guide artifact
- 3) Fluoroscopic image intensifier system (C-arm)
- 4) Personal computer (PC) with a Data Translation image acquisition card and two monitors

The robot arm will hold a registration artifact which is transparent to X-rays over the patient in proximity to the desired surgical area. This artifact has eight steel balls embedded such that when the C-arm is used to capture images of the area, the balls will create fiducial shadows on the image. Two images will be required, an Anterior/Posterior (A/P) view and a Sagittal view.

The PC will receive the image data from the C-Arm and display it on two monitors. The surgeon will indicate the desired positioning of the drill by manipulating a virtual guidewire on the screens. The software will then use the fiducial location information to calculate the coordinates for the positioning of the drill guide, and the robot arm will move to the new orientation.

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Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a stylized image of an eagle with three stripes extending from its back, representing the department's mission to protect the health of all Americans and provide essential human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle image.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 3 1999

Mr. Rony Abovitz Mr. Rony Aboviz
Vice President, Biomedical Research and Development Z-KAT, Inc. 11645 Biscayne Boulevard, Suite 304 Miami, Florida 33181

K984298 Re: K984298
Trade Name: Z-KAT Fluorotactic™ Guidance System Regulatory Class: II Product Code: HAW Dated: March 30, 1999 Received: March 31, 1999

Dear Mr. Abovitz:

We have reviewed your Section 510(k) notification of intent to market the device referenced
in the indication in the best in the increases tiglizent (for the indications for We have reviewed your Securit is tu(K) notified to wivalent (for the indications for
above and we have determined the device is substantially equivalent (for the indications above and we have determined the devices marketed in interstate commerce prior to the use stated in the enclosure) to devices marketed be simments, or to devices that
May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that May 28, 1976, the enactment date of the Messions of the Federal Food, Drug, and
have been reclassified in accordance with the provisions of the Federal Food, Drug, and have been reclassified in accordance with the provisions of the general controls
Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls Cosmetic Act (Act). You may, therelore, inaractions of the Act include requirements for provisions of the Act. The general connolo provincial in the more of actice, labeling, and annual 10gistrations against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III
nd in the same of the collection of the diditional controls. Existing major If your device is classified (see above) into such additions controls. Existing major (Premarket Approval), it may be subject to such addition of Federal Regulations, Title 21,
regulations affecting your device can be found in the commencembiance with the regulations aftecting your device can be tound in the occase assumes compliance with the Parts 800 to 895. A substantially equivalia as set forth in the Quality System
current Good Manufacturing Practice requirement, as set forth in the Part 870) and the current Good Manufacturing Fractice requiation (21 CFR Part 820) and that,
Regulation (QS) for Medical Devices: General Instituction (EDA) will verif Regulation (QS) for Medical Devices. General IDBut Administration (FDA) will verify
through periodic (QS) inspections, the AM samation may result in regulatory through periodic (QS) Inspections, the I ook and Drag Presult in regulation may result in regulatory such assumptions. Failure to comply with in Girli regencents concerning your device in the action. In addition, FDA may publish nuture announcemarket notification submission does
Federal Register. Please note: this response to your premarket notification in the A Federal Register. Please note: tills response to Jour pros. 53 through 542 of the Act for not affect any obligation you might have under socked by on other Federal laws or regulations.

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Page 2 -- Mr. Rony Abovitz

This letter will allow you to begin marketing your device as described in your 510(k) This letter will anow you to begin mainer 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 and additionally 6097794-4595. Additionally, for questions on the promotion and Compliance at [phone]. Financially , 1997. Inchience at [phone] Also, please note the regulation entitled, "Misbranding by reference to premarket Also, prease note the regulation only see are al information on your responsibilities under the notification (21 CFTC 007.97). Only getting of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

a M. Witten, Ph.D., M.D Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K984298 510(k) Number (if known):_

Device Name: Z-KAT Fluorotactic ™ Guidance System Mk. I

Indications for Use:

The Fluorotactic Guidance System Mk. I will be used to assist in the accurate placement of a guiding device for surgery in which a linear trajectory insertion or placement is required. This system will use coordinated-fluoroscopy to allow intra-operative planning of the precise insertion point and angle of a device such as a screw, nail, or needle.

The surgeon will place a registration artifact over the desired surgical area and capture two fluoroscopic images, which will then be displayed on two computer screens. The surgeon will manipulate a virtual guidewire on the screens, until the desired angle and placement is achieved. The system will then output 3D coordinates to the robot arm which will move the drill guide to a precise position.

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| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|--------------------------------------------------------|----------------------|
| (Division Sign-Off) | |
| Division of General Restorative Devices | |
| 510(k) Number | K984298 |
| Prescription Use<br>(Per 21 CFR 801.109) | X |
| | OR |
| | Over-the-Counter Use |