VECTORVISION TRAUMA

K012448 · Brainlab AG · HAW · Mar 14, 2002 · Neurology

Device Facts

• Record ID: K012448
• Device Name: VECTORVISION TRAUMA
• Applicant: Brainlab AG
• Product Code: HAW · Neurology
• Decision Date: Mar 14, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4560
• Device Class: Class 2

Intended 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.

Device Story

Image-guided localization system for minimally invasive surgery; utilizes VectorVision workstation to process pre- or intraoperative CT, fluoroscopic, X-ray, or MR images. System tracks freehand surgical probes via passive marker sensor system; correlates patient movement with calibrated instruments in virtual image space. Used in OR by surgeons to guide implant positioning, screw placement, and bone reduction. Reduces reliance on continuous fluoroscopic radiation; provides real-time visual feedback for surgical navigation.

Clinical Evidence

Bench testing and validation only; no clinical trial data provided.

Technological Characteristics

Image-guided navigation system; passive marker tracking; workstation-based processing; supports CT, fluoroscopic, X-ray, and MR data inputs. Class II stereotaxic instrument.

Indications for Use

Indicated for patients requiring stereotactic surgery where rigid anatomical structures (skull, tubular bones, pelvis, calcaneus, talus, vertebra) can be referenced against CT, fluoroscopic, X-ray, or MR imaging. Applicable for spinal, orthopedic, and traumatologic procedures including pedicle screw placement, pelvic/acetabular fracture treatment, and intramedullary nailing/fixation.

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

• VectorVision2 (K983831)
• VectorVision cranial, ENT, spine (K003589)

Submission Summary (Full Text)

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# MAR 1 4 2002

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

## Manufacturer:

BrainLAB AG Ammerthalstrasse 8 85551 Heimstetten Germany Phone: [phone] Fax: [phone]

#### Device Name:

Trade Name: Common/Classification Name: Vector Vision® Trauma VectorVision, BrainLAB Image Guided Surgery System / Instrument, Stereotaxic

#### Predicate Device:

VectorVision2® (K983831) VectorVision cranial, ENT, spine (K003589)

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

#### 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.

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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 patients intraoperative image data being processed by a VectorVision workstation.

Vector\/sion® Trauma allows navigation of intraopative acquired images considering patients 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 predicate devices such as the 510(k)-clearance of VectorVision2 (K983831),

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 4 2002

Mr. Rainer Birkenbach BrainLab AG Ammerthalstrasse 8 85551 Heimstetten Germany

Re: K012448

Trade/Device Name: VectorVision Trauma Regulation Number: 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: II Product Code: HAW Dated: December 20, 2001 Received: December 26, 2001

Dear Mr. Birkenbach:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becaon 310(x) presidentially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreative to regars) and entirent date of the Medical Device Amendments, or to conninered pror to May 20, 1978, as can and with the provisions of the Federal Food. Drug. de necs that have occh recuire approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The I ou may, dicrore, mailer of the Act include requirements for annual registration, listing of general controls provisions of ractice, 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 11 your device 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 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,

iriam C. Provost

for 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):

K012448

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 illo-sacral screw fixation. Fracture treatment procedures, such as intramedullary nailing or plating or external fixation procedures in the tubular bones.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Countor Use

(Optional Formar 1-2-96)

iriam C. Provost

al. Restorative

510(k) Number K012448