VECTORVISION HIP SR

K063028 · Brainlab AG · HAW · Dec 12, 2006 · Neurology

Device Facts

• Record ID: K063028
• Device Name: VECTORVISION HIP SR
• Applicant: Brainlab AG
• Product Code: HAW · Neurology
• Decision Date: Dec 12, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4560
• Device Class: Class 2

Intended Use

BrainLAB's VectorVision® hip SR is intended as an intraoperative image-guided localization system. It links a freehand probe, tracked by a passive marker sensor system to virtual computer image space on a VectorVision® navigation station. The image data is provided either in the form of preoperatively-acquired patient images or in the form of an individual 3D model of the patient's generated by acquiring multiole landmarks on the bone surface. The system is indicated for any medical condition in which the use of stereotactic surgery may be considered to 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. The system aids the surgeon in accurately navigating a hip endoprothesis to the preoperatively or intraoperatively planned position. Example orthopedic surgical procedures include but are not limited to: · Partial/hemi-hip resurfacing

Device Story

VectorVision® hip SR is an intraoperative image-guided localization system for orthopedic surgery. It tracks surgical instruments (freehand probe, drill guide) using a passive marker sensor system. Input data consists of preoperatively acquired patient images (CT, X-ray, MR) or an intraoperatively generated 3D bone model created by digitizing surface landmarks. The system reconstructs 3D anatomical axes and planes to guide implant alignment. Used in the OR by surgeons, the system provides real-time navigation on a workstation, allowing surgeons to align tools and implants relative to patient anatomy. It facilitates accurate pin insertion and prosthesis placement, potentially improving surgical precision in hemi-hip resurfacing procedures.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Stereotaxic instrument; passive marker sensor system; workstation-based navigation; 3D bone modeling via landmark acquisition; software-based 3D reconstruction of anatomical axes; supports integration of manufacturer-specific implant data.

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-based models. Used for intraoperative navigation of hip endoprosthesis, specifically partial/hemi-hip resurfacing.

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

• VectorVision® hip (K040368)
• VectorVision® osteotomy (K042513)

Submission Summary (Full Text)

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# ® BrainLAB

BrainLAB AG Kapellenstraße 12 · 85622 Feidkirchen · Germany

phone: · 49 89 99 15 68 - 0 • 49 89 99 15 68 - 33

brainlab.com

OEC 1 2 2006

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

KO63028

| Manufacturer: | BrainLAB AG |
|-----------------|-----------------------------------------------------------------------------------------------------------|
| Address: | Kapellenstrasse 12<br>85622 Feldkirchen<br>Germany<br>Phone: [phone]<br>Fax: [phone] |
| Contact Person: | Mr. Per Persson |
| Summary Date: | September 26th, 2006 |
| Device Name: | |
| Trade name: | VectorVision® hip SR |

Common/Classification Name:

VectorVision®, BrainLAB Image Guided Surgery System / Instrument, Stereotaxic

Predicate Device: VectorVision® hip (K 040368) VectorVision® osteotomy (K042513)

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

### Intended Use:

BrainLAB's VectorVision® hip SR is intended as an intraoperative image-guided localization system. It links a freehand probe, tracked by a passive marker sensor system to virtual computer image space on a VectorVision® navigation station. The image data is provided either in the form of preoperatively-acquired patient images or in the form of an individual 3D model of the patient's generated by acquiring multiole landmarks on the bone surface. The system is indicated for any medical condition in which the use of stereotactic surgery may be considered to 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. The system aids the surgeon in accurately navigating a hip endoprothesis to the preoperatively or intraoperatively planned position.

Example orthopedic surgical procedures include but are not limited to:

- · Partial/hemi-hip resurfacing

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Image /page/1/Picture/0 description: The image shows the logo for BrainLAB. The logo consists of a caduceus symbol on the left, followed by the word "Brain" in bold, and then the word "LAB" with a striped pattern. The logo is in black and white.

### 14063098

#### Device Description:

BrainLAB's VectorVision® hip SR is intended to enable operational planning and navigation in orthopedic hemi resurfacing surgery. It links a surgical instrument, tracked by flexible passive markers to virtual computer image space on an individual 3D-model of the patient's bone, which is generated through acquiring multiple landmarks on the bone surface. VectorVision® hip SR uses the registered landmarks to navigate the initial pin insertion into the femur with a pre-calibrated drillguide to the planned position.

VectorVision® hip SR allows 3-dimensional reconstruction of the relevant anatomical axes and planes of the femur and alignment of the implants. The Vector\/sion® hip SR software has been designed to read in data of implants and tools if provided by the implant manufacturer and offers to individually choose the prosthesis during each surgery. If no implant data is available it is possible to provide information in order to achieve a generally targeted alignment relative to the bone orientation as defined by the operating surgeon. The VectorVision® hip SR software registers the patient data needed for planning and navigating the surgery intraoperatively without CT-based imaging. The system can be used to generally align tool orientations according to the anatomy described and defined by the landmarks acquired by the surgeon.

#### Substantial equivalence:

VectorVision® hip SR 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 Vector Vision® hip (K 040368) and Vector Vision® osteotomy (K042513).

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Public Health Service

Image /page/2/Picture/11 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES, USA" is arranged in a circular pattern around the eagle. The eagle is black, and the text is in a smaller, sans-serif font.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

BrainLAB AG % Rainer Birkenbach Executive Vice President Kapellenstrasse 12 85622 Feldkirchen Germany

DEC 1 2 2006

Re: K063028 Trade/Device Name: VectorVision® hip SR Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: II Product Code: HAW Dated: September 28, 2006 Received: October 2, 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 (OS) 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 vo

for Pedro V
Mark N. Melkerson
DEPUTY
DIRECTOR

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): KO6 3028

Device Name: VectorVision® hip SR

Indications For Use:

BrainLAB's VectorVision® hip SR is intended as an intraoperative image-guided localization system. It links a freehand probe, tracked by a passive marker sensor system to virtual computer image space on a VectorVision® navigation station. The image data is provided either in the form of preoperatively-acquired patient images or in the form of an individual 3D model of the patient's bone, which is generated by acquiring multiple landmarks on the bone surface. The system is indicated for any medical condition in which the use of stereotactic surgery may be considered to 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. The system aids the surgeon in accurately navigating a hip endoprothesis to the preoperatively or intraoperatively planned position.

Example orthopedic surgical procedures include but are not limited to:

· Partial/hemi-hip resurfacing

| Prescription Use<br>(Per 21 CFR 801 Subpart D) | X | AND/OR | Over-The-Counter Use<br>(21 CFR 801 Subpart C) | |
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Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of General, Restorative, and Neurological Devices

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510(k) Number K063028