VECTORVISION SPINE

K053159 · Brainlab AG · HAW · Jun 6, 2006 · Neurology

Device Facts

• Record ID: K053159
• Device Name: VECTORVISION SPINE
• Applicant: Brainlab AG
• Product Code: HAW · Neurology
• Decision Date: Jun 6, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4560
• Device Class: Class 2

Intended Use

BrainLAB's VectorVision spine is intended for use as an intraoperative image-quided localization system for 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 that is 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, the pelvis, 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: - Navigated spinal procedures in support of standard approaches (e.g. anterior, lateral, oblique) - Spinal implant procedures such as - Pedicle screw placement - Anterior plating - Kyphoplasty and vertebroplasty procedures - Placement of other temporary or permanent devices such as k-wires, needles, catheters or electrodes - Thoracic spine surgerv - Tumor surgery on the spinal column and adjacent soft tissue - Placement of acetabular and SI screws on the pelvis

Device Story

VectorVision spine is an intraoperative image-guided localization system; assists surgeons in minimally invasive spinal and pelvic procedures. Inputs: preoperative 3D CT/MR datasets or intraoperative 2D fluoroscopic images. Operation: links tracked freehand surgical instruments to virtual image space via passive marker sensor system. Registration methods: paired point matching, surface matching, region matching, or CT-fluoro matching. Output: real-time navigation visualization on workstation display. Usage: OR environment; operated by surgeons. Benefit: provides spatial orientation for precise instrument placement during spinal implants, tumor surgery, or device insertion; improves accuracy of minimally invasive approaches.

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; passive marker sensor tracking; workstation-based processing. Supports 3D (CT/MR) and 2D (fluoroscopy) data integration. Registration algorithms include paired point, surface, region, and CT-fluoro matching. Connectivity via workstation interface. Sterilization requirements for surgical instruments apply.

Indications for Use

Indicated for patients requiring stereotactic surgery where rigid anatomical structures (skull, pelvis, long bone, vertebra) can be referenced to CT, X-ray, or MR-based models. Applicable for spinal navigation, implant placement (pedicle screws, anterior plating), kyphoplasty, vertebroplasty, and placement of temporary/permanent devices (k-wires, needles, catheters, electrodes) in spinal or pelvic 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

• BrainLAB VectorVision CT / Fluoro (K010968)
• BrainLAB Kolibri spine (K042721)

Submission Summary (Full Text)

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# KOS 3159 510 (k) Summary of Safety and Effectiveness for VectorVision spine

| Manufacturer: | BrainLAB AG |
|-----------------------------|---------------------------------------------------------------------------------------|
| Address: | Ammerthalstrasse 8<br>85551 Heimstetten<br>Germany |
| Phone: | [phone] |
| Fax: | [phone] |
| Contact Person: | Mr. Rainer Birkenbach |
| Summary Date: | September 13, 2005 |
| Device Name: | |
| Trade name: | VectorVision spine |
| Common/Classification Name: | VectorVision spine, BrainLAB Image Guided Surgery System /<br>Instrument, Stereotaxic |

#### Predicate Device:

BrainLAB VectorVision CT / Fluoro (K010968) BrainLAB Kolibri spine (K042721)

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

## Intended Use:

BrainLAB's VectorVision spine is intended for use as an intraoperative image-quided localization system for 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 that is 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, the pelvis, 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:

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- · Navigated spinal procedures in support of standard approaches (e.g. anterior, lateral, oblique)
- · Spinal implant procedures such as
- · Pedicle screw placement
- · Anterior plating
- · Kyphoplasty and vertebroplasty procedures
- · Placement of other temporary or permanent devices such as k-wires, needles, catheters or electrodes
- · Thoracic spine surgerv
- · Tumor surgery on the spinal column and adjacent soft tissue
- Placement of acetabular and SI screws on the pelvis

# Device Description:

VectorVision spine is a device that allows surgical planning and navigation. It links a surgical instrument. (tracked by passive marker sensor system) to a location on a virtual computer image, which is either based ou patient's preoperative 3D information of a CT or MR dataset or based on patient's intraoperative acquired 2D fluoro image(s) of a c-arm.

The device enables the navigation based on 3D data and / or based on acquired fluoro images,

Based on 2D fluoro images, the registration is done automatically by using the exact spatial position informat. of the intra-operatively acquired fluoro images.

Based on 3D data, the procedure of linking the surgical instrument to the virtual computer image is achieved by performing registration methods as paired point matching, surface matching, region matching or CT fluoro matching. The last registration method uses 2D fluoro images to register the previously acquired 3D dataset. Thus, CT fluoro matching combines 2D fluoro imaging with 3D datasets,

After registration, the device assists the surgeon in performing certain surgical procedures as described in the indications for use.

## Substantial equivalence:

VectorVision spine 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 BrainLAB VectorVision CT / Fluoro (K010968) and BrainLAB Kolibri spine (K042721).

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo features a stylized caduceus, a symbol often associated with healthcare, with three abstract human figures intertwined within it. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN - 6 2006

BrainLAB AG % Mr. Martin Ringholz Project Engineer IGS Spine Ammerthalstrasse 8 Heimstetten, Germany 85551

Re: K053159

Trade/Device Name: Vector Vision spine Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulation Class: II Product Code: HAW Dated: May 23, 2006 Received: May 25, 2006

Dear Mr. Ringholz:

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

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Page 2 - Mr. Martin Ringholz

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. 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/dsma/dsmamain.html

Sincerely yours.

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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# Indications for Use

510(k) Number (if known): K053159

Device Name: Vector Vision spine

Indications For Use:

BrainLAB's VectorVision spine is intended for use as an intraoperative image-quided localization system for 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 that is 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, the pelvis, 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:

- · Navigated spinal procedures in support of standard approaches (e.g. anterior, lateral. oblique)
- · Spinal implant procedures such as
- · Pedicle screw placement
- · Anterior plating
- · Kyphoplasty and vertebroplasty procedures
- · Placement of other temporary or permanent devices such as k-wires, needles, catheters or electrodes
- · Thoracic spine surgery
- · Tumor surgery on the spinal column and adjacent soft tissue
- · Placement of acetabular and SI screws on the pelvis

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) | |
|---------------------------------------------------------------|---------|
| (Division Sign-Off) | |
| Division of General, Restorative,<br>and Neurological Devices | |
| 510(k) Number | K053159 |