VECTORVISION FLUORO3D

K024192 · Brainlab AG · HAW · Jun 11, 2003 · Neurology

Device Facts

• Record ID: K024192
• Device Name: VECTORVISION FLUORO3D
• Applicant: Brainlab AG
• Product Code: HAW · Neurology
• Decision Date: Jun 11, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4560
• Device Class: Class 2

Intended Use

BrainLAB VectorVision® Fluoro3D is intended to be an intraoperative image guided localization system to enable minimally invasive surgery. It links a freehand probe, tracked by a passive marker sensor system to virtual computer image space on a patient's preoperative image data being processed by a VectorVision workstation. The system is indicated for any medical condition in which the use of stereotactic surgery may be appropriate and where a reference to a rigid anatomical structure, such as the skull, a long bone, or vertebra, can be identified relative to a CT, X-ray or MR based model of the anatomy.

Device Story

VectorVision Fluoro3D is an intraoperative image-guided surgery system. It uses a passive marker sensor system to track a freehand probe in real-time. The system processes preoperative image data (CT, X-ray, MR) and intraoperatively acquired volume data (calculated from X-ray sets) on a workstation. It enables 'touchless' patient registration for surgical planning and navigation. Surgeons use the system in the OR to visualize the probe position relative to patient anatomy, facilitating minimally invasive procedures like pedicle screw placement. The output provides real-time navigation, assisting the surgeon in precise instrument placement, potentially reducing invasiveness and improving surgical accuracy.

Clinical Evidence

No clinical data provided. Substantial equivalence was established through product design, verification, and validation procedures.

Technological Characteristics

System consists of a workstation, passive marker sensor system, and freehand probe. Utilizes image-guided localization technology to link physical instruments to virtual image space. Supports CT, X-ray, and MR-based anatomical models. Software-based registration of intraoperative X-ray volume data. Class II stereotaxic instrument.

Indications for Use

Indicated for patients requiring stereotactic surgery where rigid anatomical structures (skull, long bone, vertebra) can be referenced to CT, X-ray, or MR models. Applicable for minimally invasive procedures, including spinal implant placement (e.g., pedicle screws).

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

• Vector Vision® 2 (K983831)
• Vector Vision® Spine (K981508)
• Vector Vision® CT/Fluoro (K010968)

Submission Summary (Full Text)

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K024192

## JUN 1 1 2003

# 510 (k) Summary of Safety and Effectiveness for VectorVision® Fluoro3D

### Manufacturer:

| Address: | BrainLAB AG<br>Ammerthalstrasse 8<br>85551 Heimstetten<br>Germany<br>Phone: [phone]<br>Fax: [phone] |
|-----------------|--------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Mr. Rainer Birkenbach |
| Summary Date: | February 12, 2003 |

### Device Name:

Trade name:

Common/Classification Name:

VectorVision® Fluoro3D

VectorVision, BrainLAB Image Guided Surgery System / Instrument, Stereotaxic

### Predicate Device:

Vector Vision® 2 (K983831) Vector Vision® Spine (K981508) Vector Vision® CT/Fluoro (K010968)

Device Classification Name: Instrument, Stereotaxic Regulatory Class: Class II

### Intended Use:

BrainLAB VectorVision® Fluoro3D is intended to be an intraoperative image guided localization system to enable minimally invasive surgery. It links a freehand probe, tracked by a passive marker sensor system to virtual computer image space on a patient's preoperative image data being processed by a VectorVision workstation. The system is indicated for any medical condition in which the use of stereotactic surgery may be appropriate and where a reference to a rigid anatomical structure, such as the skull, a long bone, or vertebra, can be identified relative to a CT, X-ray or MR based model of the anatomy.

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Example procedures include but are not limited to:

Spinal Procedures:

- Spinal implant procedures as pedicle screw placement. -
### Device Description:

VectorVision® Fluoro3D intends to enable "touchless" patient registration for operational planning and navigation in surgery. It allows using automatic registered intra-operatively acquired image modalities (e.g. volume data calculated from a set of x-ray images) processed by a VectorVision workstation.

#### Substantial equivalence:

VectorVision® Fluoro3D Module has been verified and validated according to BrainLAB's procedures for product design and development. The validation proves the safety and effectiveness of the information provided by BrainLAB in this 510 (k) application was found to be substantially equivalent with the predicate device VectorVision® (K983831), VectorVision® Spine Software (K981508), Vector Vision® (K010968

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of a stylized caduceus, which is a symbol of medicine and healing. The caduceus is composed of three lines that form the shape of a human profile.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 1 1 2003

Mr. Rainer Birkenbach Executive Vice President BrainLAB AG Ammerthalstrasse 8 85551 Heimstetten Germany

Re: K024192

Trade/Device Name: VectorVision Fluoro3D Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: II Product Code: HAW Dated: April 2, 2003 Received: April 8, 2003

Dear Mr. Birkenbach:

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. Rainer Birkenbach

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]. 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.

Miriam C. Provost

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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| 510(k) Number (if known): | K024192 |
|---------------------------|---------|
|---------------------------|---------|

Device Name:

VectorVision Fluoro3D

Indications For Use:

BrainLAB VectorVision® Fluoro3D is intended to be an intraoperative image guided localization system to enable minimally invasive surgery. It links a freehand probe, tracked by a passive marker sensor system to virtual computer image space on a patient's preoperative image data being processed by a VectorVision workstation. The system is indicated for any medical condition in which the use of stereotactic surgery may be appropriate and where a reference to a rigid anatomical structure, such as the skull, a long bone, or vertebra, can be identified relative to a CT, X-ray or MR based model of the anatomy.

Example procedures include but are not limited to:

Spinal Procedures:

Spinal implant procedures such as pedicle screw placement. -

Miriam C. Provost

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

024192 510(k) Number.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Format I-2-96)