MODIFICATION TO FLOUROLAB PLUS

K013025 · Z-Kat, Inc. · HAW · Oct 3, 2001 · Neurology

Device Facts

• Record ID: K013025
• Device Name: MODIFICATION TO FLOUROLAB PLUS
• Applicant: Z-Kat, Inc.
• Product Code: HAW · Neurology
• Decision Date: Oct 3, 2001
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 882.4560
• Device Class: Class 2

Intended Use

FluoroLab Plus will be used for navigational guidance to position instruments during surgical procedures. It will provide a method of navigational guidance of tools through the use of a standard C-arm fluoroscope to capture images and an optical camera for instrument tracking. This increase in control will free the surgeon from the iterative process conventionally used, reduce the length of the surgical procedure, and enable minimally invasive procedure. In addition, since only two fluoroscopic images are needed, the exposure to X-rays is greatly reduced.

Device Story

FluoroLab Plus is a stereotaxic surgical navigation system. It captures two fluoroscopic images via a standard C-arm; these images are displayed on a workstation monitor. Surgical instruments are equipped with LEDs or reflective markers. An optical camera tracks these markers in real-time, updating instrument position relative to the fluoroscopic images. Used in the OR by surgeons, the system provides continuous visual guidance for tool alignment. This replaces iterative manual positioning, potentially reducing procedure time, enabling minimally invasive techniques, and lowering X-ray exposure by requiring only two initial images.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

System components include a registration phantom, calibration grid, C-arm fluoroscope, computer workstation with monitor/video acquisition, ergonomic cart, optical camera with Tool Interface Unit (TIU), and instrumented surgical tools (LEDs/reflective markers). Operates via optical tracking of instrumented tools relative to registered fluoroscopic images. Standalone workstation configuration.

Indications for Use

Indicated for use by surgeons to assist in the alignment of surgical instruments (e.g., screws, nails, needles) via intraoperative navigational guidance based on pre-acquired fluoroscopic images.

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

• Fluorotactic Guidance System, Mk I (K984298)
• StealthStation (K954276)
• FluoroNav (K990214)
• The Voyager (K000310)
• VectorVision2 (K962939)

Submission Summary (Full Text)

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K0/3025

Image /page/0/Picture/1 description: The image shows the logo for "z-kat, inc.". The logo features a stylized letter "z" on the left side of the text. The text is in a simple, sans-serif font and is horizontally aligned.

OCT - 3 2001

2905 simms street hollywood florida 33020 tel [phone]

fax [phone]

zkatīzz-kat.com www.z.kat.com

## 510(K) SUMMARY

SUBMITTER: Z-KAT, Inc.

ADDRESS: 2903 Simms Street

Hollywood, FL 33020

PHONE NUMBER: 954-927-2044

FAX NUMBER: 954-927-0446

CONTACT PERSON: William F. Tapia

DATE PREPARED: August 23, 2001

TRADE NAME: FluoroLab Plus

COMMON NAME: Stereotaxic Instrument

CLASSIFICATION NAME: Class II

### SUBSTANTIAL EQUIVALENCE CLAIMED TO:

- The Fluorotactic Guidance System, Mk I, Z-KAT, Inc., K984298 1.
- 2. StealthStation, Sofamor Danek, K954276
- 3. FluoroNav, Sofamor Danek, K990214
- 4. The Voyager; Marconi Medical Systems, K000310
- 5. VectorVision2, BrainLab, K962939

## DESCRIPTION:

FluoroLab Plus is an integrated system that helps a surgeon more accurately position drill guides, screw drivers, needles, and other surgical instruments using at least two captured fluoroscopic images. The acquired images are displayed on a flat panel monitor. Surgical tools and accessories are instrumented with LEDs or small reflective markers. Their positions and orientations are continuously tracked by an optical camera and updated in reference to the fluoroscopic images to provide constant navigational guidance to the target.

#### SUMMARY OF TECHNOLOGICAL CHARACTERISTICS:

FluoroLab Plus will consist of following basic components:

- 1) Registration phantom

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- 2) Calibration grid
- 3) Fluoroscopic image intensifier system (C-arm)
- 4) Computer workstation with monitor and video acquisition box
- 5) Ergonomic cart
- FluoroLab Plus software application 6)
- Optical camera with Tool Interface Unit (TIU) 7)
- Tools and accessories surgical tools and accessories instrumented with LEDs or reflective 8) markers

## INTENDED USE:

FluoroLab Plus will be used for navigational guidance to position instruments during surgical procedures. It will provide a method of navigational guidance of tools through the use of a standard C-arm fluoroscope to capture images and an optical camera for instrument tracking. This increase in control will free the surgeon from the iterative process conventionally used, reduce the length of the surgical procedure, and enable minimally invasive procedure. In addition, since only two fluoroscopic images are needed, the exposure to X-rays is greatly reduced.

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, facing to the right.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT - 3 2001

William F. Tapia Z-KAT, Inc. 2903 Simms Street Hollywood, Florida 33020

Re: K013025

Trade/Device Name: FluoroLab Plus Regulation Number: 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: II Product Code: HAW Dated: August 23, 2001 Received: September 10, 2001

Dear Mr. Tapia:

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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Page 2 - Mr. William F. Tapia

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 and additionally 21 CFR Part 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" (21CFR Part 807.97). 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,

Susan Walker, MS

- J Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure

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Image /page/4/Picture/0 description: The image shows the logo for "z-kat, inc.". The logo features a stylized letter "z" on the left side of the text. The text is in a simple, sans-serif font and is black.

2903 simms street hollywood florida 33020 tel [phone] fax [phone]

**INDICATIONS FOR USE**

| 510(k) Number (if known): | K013025 |
|---------------------------|---------|
|---------------------------|---------|

Device Name: FluoroLab Plus

Indications for Use:

FluoroLab Plus will be used to assist in the alignment of surgical instruments by providing the surgeon with intraoperative navigational guidance based on pre-acquired fluoroscopic images.
Surgeon with intraoperative navigational guidance based on pre-acquired fluorosco Surgeon will use coordinated-fluoroscopy to allow intra-operative planning of the alignment of surgical tools such as a screw, nail, or needle.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use _____________________________________________________________________________________________________________________________________________________________

OR

Over-the-Counter Use

(Per 21 CFR 801.109)

Su Wor

(Division Sign-Off) (Division of General, Restorative and Neurological Devices

**510(k) Number** K013025