VECTORVISION HIP

K060468 · Brainlab AG · HAW · Mar 20, 2006 · Neurology

Device Facts

• Record ID: K060468
• Device Name: VECTORVISION HIP
• Applicant: Brainlab AG
• Product Code: HAW · Neurology
• Decision Date: Mar 20, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 882.4560
• Device Class: Class 2

Intended Use

BrainLAB VectorVision hip is intended to be an intraoperative image quided localization system. It links a freehand probe, tracked by a passive marker sensor system to virtual computer image space either on a patient's preoperative image data being processed by a VectorVision workstation or on an individual 3Dmodel of the patient's bone, which is generated through acquiring multiple landmarks on the bone surface. 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, MR based model of the system aids the surgeon to accurately navigate a hip endoprothesis to the preoperatively or intraoperatively planned position. Example orthopedic surgical procedures include but are not limited to: Total Joint Replacement (TJR) Revision surgery of TJR Tumor resection and bone/joint reconstruction

Device Story

Intraoperative image-guided localization system; tracks freehand probes and surgical instruments (reamers, rasps, saws) via passive marker sensor system. Transforms inputs (preoperative CT/X-ray/MR data or intraoperative bone surface landmarks) into 3D virtual models of patient anatomy. Used by surgeons in OR to navigate hip endoprosthesis placement. Software reconstructs mechanical axes/planes of femur and pelvis; aligns tools to planned positions. Benefits include improved surgical accuracy for joint replacement and reconstruction.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Stereotaxic instrument; passive marker tracking system; workstation-based software; 3D reconstruction of mechanical axes/planes; supports CT/X-ray/MR data integration; intraoperative landmark acquisition.

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. Used for orthopedic procedures including Total Joint Replacement (TJR), TJR revision, tumor resection, and bone/joint reconstruction.

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® Hip 3.0 (K040368)
• Navigation SW Hip 3.1 on CI (K052213)

Submission Summary (Full Text)

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MAR 2 0 2006

# KOGO468

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

#### Manufacturer:

| Manufacturer: | BrainLAB AG |
|---------------|--------------------------|
| Address: | Ammerthalstrasse 8 |
| | 85551 Heimstetten |
| | Germany |
| | Phone: [phone] |
| | Fax: [phone] |
| | Contact Person: |
| Summary Date: | December 28, 2005 |

#### Device Name:

Trade name:

VectorVision hip

Common/Classification Name:

VectorVision, BrainLAB Image Guided Surgery System / Instrument, Stereotaxic

Predicate Devices: Vector Vision® Hip 3.0(K 040368) Navigation SW Hip 3.1 on CI (K-052213)

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

#### Intended Use:

BrainLAB VectorVision hip is intended to be an intraoperative image quided localization system. It links a freehand probe, tracked by a passive marker sensor system to virtual computer image space either on a patient's preoperative image data being processed by a VectorVision workstation or on an individual 3Dmodel of the patient's bone, which is generated through acquiring multiple landmarks on the bone surface. 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, MR based model of the system aids the surgeon to accurately navigate a hip endoprothesis to the preoperatively or intraoperatively planned position.

Example orthopedic surgical procedures include but are not limited to:

Total Joint Replacement (TJR) Revision surgery of TJR Tumor resection and bone/joint reconstruction

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#### Device Description:

BrainLAB VectorVision® Hip is intended to enable operational planning and navigation in orthopedic 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 either based on a patients preoperative image data or generated through acquiring multiple landmarks on the bone surface. VectorVision® Hip uses the registered landmarks to navigate the needed surgical tools like cup reamer, cup inserter, stem rasp, bone saw and the implant to the planned position. 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.

VectorVision® Hip allows 3-dimensional reconstruction of the relevant mechanical axes and planes of femur and pelvis and alignment of the VectorVision® Hip 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. The VectorVision® Hip software registers the patient data needed for planning and navigating the surgery intra-operatively within the CT free module. The System can be used to generally align tool orientations according to the anatomy described and defined by the landmarks acquired by the surgeon. Using the CT based module the patient data can be used additionally for surgery, the patient data is then is provided by the CT data stored on a standard data storage media.

#### Substantial equivalence:

VectorVision® hip 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 devices Vector Vision® Hip 3.0 (K 040368) and Navigation SW Hip 3.1 on CI (K-052213).

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 0 2006

BrainLAB AG c/o Mr. Rainer Birkenbach Executive Vice President Ammerthalstrasse 8 85551 Heimstetten, Germany

Re: K060468

Trade/Device Name: VectorVision hip Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: II Product Code: HAW Dated: February 21, 2006 Received: February 23, 2006

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 10 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. Rainer Birkenbach

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.ida.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

elmel

Mark N. Melkerson Acting 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): KOGOY68_

Device Name: VectorVision hip

#### Indications For Use:

BrainLAB VectorVision hip is intended to be an intraoperative image guided localization system. It links a freehand probe, tracked by a passive marker sensor system to virtual computer image space either on a patient's preoperative image data being processed by a VectorVision workstation or on an individual 3D-model of the patient's bone, which is generated through acquiring multiple landmarks on the bone surface. 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, MR based model of the anatomy. The system aids the surgeon to accurately navigate a hip endoprothesis to the preoperatively or intraoperatively planned position.

Example orthopedic surgical procedures include but are not limited to:

- Total Joint Replacement (TJR) .
- Revision surgery of TJR
- Tumor resection and bone/joint reconstruction

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) { 0 9 00 Division of General, Restorative, and Neurological Devices

KOGO460 510(k) Number_

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