MODIFICATION TO VECTORVISION TRAUMA

K062358 · Brainlab AG · HAW · Jan 17, 2007 · Neurology

Device Facts

• Record ID: K062358
• Device Name: MODIFICATION TO VECTORVISION TRAUMA
• Applicant: Brainlab AG
• Product Code: HAW · Neurology
• Decision Date: Jan 17, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 882.4560
• Device Class: Class 2

Intended Use

BrainLAB VectorVision trauma is intended to be a pre- and intraoperative image quided 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 pre- or intraoperative 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 bone structure like tubular bones, pelvic, calcaneus and talus, or vertebra, can be identified relative to a CT, fluoroscopic, X-ray or MR based model of the anatomy. Example procedures include but are not limited to: Spinal procedures and spinal implant procedures such as pedicle screw placement. Pelvis and acetabular fracture treatment such as screw placement or illo-sacral screw fixation. Fracture treatment procedures, such as intramedullary nailing or screwing or external fixation procedures in the tubular bones.

Device Story

Image-guided localization system for minimally invasive surgery; links freehand surgical probes to virtual image space. Inputs: pre- or intraoperative patient image data (CT, fluoroscopic, X-ray, MR) and real-time tracking of surgical instruments via passive marker sensor system. Operation: workstation processes image data; correlates instrument position with patient anatomy; displays navigation in multiple views. Used in OR by surgeons to guide implant positioning, screw placement, and bone reduction. Benefits: enables precise navigation; reduces need for continuous intraoperative fluoroscopic radiation.

Clinical Evidence

Bench testing only; no clinical data provided. Safety and effectiveness verified through product design and development validation procedures.

Technological Characteristics

Image-guided surgery system; workstation-based; passive marker sensor system for instrument tracking. Compatible with CT, fluoroscopic, X-ray, and MR imaging modalities. Connectivity via workstation processing of image data.

Indications for Use

Indicated for patients requiring stereotactic surgery where rigid anatomical structures (skull, tubular bones, pelvis, calcaneus, talus, vertebra) can be referenced to CT, fluoroscopic, X-ray, or MR imaging. Applicable for spinal, pelvic, acetabular, and tubular bone fracture 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

• Vector Vision trauma (K012448)

Submission Summary (Full Text)

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# KO62358

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

#### Manufacturer:

| Address: | BrainLAB AG<br>Kapellenstrasse 12<br>85622 Feldkirchen<br>Germany<br>Phone: [phone]<br>Fax: [phone] |
|-----------------------------|--------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Mr. Rainer Birkenbach |
| Summary Date: | August 10, 2006 |
| Device Name: | |
| Trade name: | VectorVision trauma |
| Common/Classification Name: | VectorVision, BrainLAB Image Guided Surgery System / Instrument<br>Stereotaxic |

Predicate Device: Vector Vision trauma (K 012448)

Device Classification Name: Instrument, Stereotaxic Regulatory Class: Glass Il

#### Intended Use:

BrainLAB VectorVision trauma is intended to be a pre- and intraoperative image quided 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 pre- or intraoperative 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 bone structure like tubular bones, pelvic, calcaneus and talus, or vertebra, can be identified relative to a CT, fluoroscopic, X-ray or MR based model of the anatomy.

Example procedures include but are not limited to:

Spinal procedures and spinal implant procedures such as pedicle screw placement.

Pelvis and acetabular fracture treatment such as screw placement or illo-sacral screw fixation.

Fracture treatment procedures, such as intramedullary nailing or screwing or external fixation procedures in the tubular bones.

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#### Device Description:

BrainLAB VectorVision trauma is intended to enable operational navigation in spinal, orthopedic and traumatologic surgery. It links a surgical instrument, tracked by flexible passive markers to virtual computer image space on a patient's intraoperative image data being processed by a VectorVision workstation.

VectorVision trauma allows navigation of intraoperatively acquired images considering patient's movement in correlation to calibrated surgical instruments. This allows implant positioning, screw placement and bone reduction in different views and reduces the need for treatments under permanent fluoroscopic radiation.

#### Substantial equivalence:

VectorVision trauma has been verified and validated according to BrainLAB's procedures for product design and development. The validation proves the safety and effectiveness of the system. The information provided by BrainLAB in this 510 (k) application was found to be substantially equivalent with the predicate device VectorVision trauma (K012448).

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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features the department's name in a circular arrangement around a symbol. The symbol consists of a stylized caduceus, which is a staff with two snakes coiled around it, representing medicine and health. The seal is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

BrainLAB AG % Rainer Birkenbach Executive Vice President Kapellenstrasse 12 85662 Feldkirchen Germany

JAN 1 7 2007

Re: K062358

Trade/Device Name: VectorVision trauma Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: II Product Code: HAW Dated: December 26, 2006 Received: December 26, 2006

Dear Rainer 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 - 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]. 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 ours,

Mark N. Melkerson

Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## KO62358

### Indications for Use

510(k) Number (if known):

Device Name: VectorVision trauma

Indications For Use:

BrainLAB VectorVision Trauma is intended to be a pre- and 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 pre- or intraoperative 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 bone structure like tubular bones, pelvic, calcaneus and talus, or vertebra, can be identified relative to a CT, fluoroscopic, X-ray or MR based model of the anatomy.

Example procedures include but are not limited to:

Spinal procedures and spinal implant procedures such as pedicle screw placement. Pelvis and acetabular fracture treatment such as screw placement or ilio-sacral screw fixation.

Fracture treatment procedures, such as intramedullary nailing or screwing or external fixation procedures in the tubular bones.

Prescription Use (Per 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

P.S.B. m

Pastorative. and Neurological I

510(k) Number L062358