VECTORVISION OSTEOTOMY

K042513 · Brainlab AG · HAW · Feb 10, 2005 · Neurology

Device Facts

• Record ID: K042513
• Device Name: VECTORVISION OSTEOTOMY
• Applicant: Brainlab AG
• Product Code: HAW · Neurology
• Decision Date: Feb 10, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4560
• Device Class: Class 2

Intended Use

BrainLAB VectorVision is intended to be an 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 an individual 3D-model of the patient's bone, which is generated through acquiring multiple landmarks on the bone surface. The system is indicated to assist a surgeon to perform one (open wedge) or two (closed wedge) cuts to achieve a leg angle correction. Example orthopedic surgical procedures include but are not limited to: Open wedge osteotomy for the lower limb Closed wedge osteotomy for the lower limb

Device Story

System provides intraoperative image-guided navigation for lower limb osteotomies. Inputs: physical landmarks on patient bone acquired via tracked freehand probe. Processing: system links tracked instrument to virtual 3D bone model generated from landmarks; calculates geometry for osteotomy planning. Output: real-time navigation of tibial cutting guides to preplanned positions; continuous tracking of leg geometry until osteosynthesis. Used in OR by surgeons. Benefits: enables minimally invasive approach; allows precise correction of leg alignment without additional intraoperative imaging; provides stability guidance for open/closed wedge procedures.

Clinical Evidence

No clinical data provided. Substantial equivalence based on bench testing and validation of software calculation accuracy compared to predicate device.

Technological Characteristics

Passive marker sensor system; freehand probe; 3D bone modeling via landmark acquisition; software-based navigation; standalone surgical navigation system.

Indications for Use

Indicated for patients undergoing lower limb osteotomy (open or closed wedge) requiring leg angle correction. Used by surgeons for intraoperative image-guided localization and navigation.

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® ct free knee (K 021306)

Submission Summary (Full Text)

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# FEB 1 0 2005

# KOUS 513 510 (k) Summary of Safety and Effectiveness for VectorVision® Osteotomy

| Manufacturer: | BrainLAB AG |
|-----------------------------|-----------------------------------------------------------------------------------------------------------|
| Address: | Ammerthalstrasse 8<br>85551 Heimstetten<br>Germany<br>Phone: [phone]<br>Fax: [phone] |
| Contact Person: | Mr. Rainer Birkenbach |
| Summary Date: | 26th August 2004 |
| Device Name:<br>Trade name: | VectorVision® Osteotomy |
| Common/Classification Name: | VectorVision, BrainLAB Image Guided Surgery System / Instrument, Stereotaxic |

# Predicate Device: Vector Vision® ct free knee (K 021306)

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

#### Intended Use:

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acquiring mailible lanamarke on the beneon to perform one (open wedge) or two (closed wedge) cuts to achieve a leq angle correction.

Example orthopedic surgical procedures include but are not limited to:

Open wedge osteotomy for the lower limb Closed wedge osteotomy for the lower limb

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### Device Description:

BrainLAB VectorVision®Osteotomy is intended to enable 3 dimensional correction planning and navigation for lower limb osteotomies. The SW links a surgical instrument tracked by passive markers to a model of the patient's bone geometry, which is generated by acquiring multiple landmarks on the bone surface. VectorVision® Osteotomy uses the registered landmarks tonavigate the tibial cutting guides to the preplanned position. Leg geometry correction can be tracked continuously until osteosynthesis.

High Tibial Osteotomy is like total and unicondylar knee arthroplasty a common therapy for osteoarthritis. Actually it obtains its relevance it seems more sensible to preserve nermal articular annuit.". long as possible instead of early joint replacement.

Two different kinds of operational procedure are in use. Open wedge osteotomy and closed wedge osteotomy. Open wedge osteotomy: One cut is performed on a planned level of the tibia and when spreadingt this cut open the leg geometry is changed. For the treatment of more common medial gonarthrosis the open wedge on is performed on the medial side of the tibia. The opened cut is fixed with a special plate designed for this treatment.

The open wedge technique provides an easier surgical approach, less vulnerable structures can interfere. But with great correction angles (>10°) the opened bone wedge gets unstable.

Closed wedge osteotomy: Two cuts with a certain angulation are peformed on the tibia. When the wedge, resulting from these two cuts, is removed a gap occurs which is closed by bringing both vutting hanes together. The fixation of this situation is less difficult as the situation bone on bone provides certain stability. The medial gonarthrosis is treated from the lateral side.

For greater correction angels the lateral closing wedge technique gives more stability. But the approach is more difficult and in most of the cases the fibular bone must be cut too.

The whole procedure can be performed without any additional imaging technique.

# Substantial equivalence:

VectorVision® Osteotomy has been verified and validated according to BrainLAB's procedures for product desig 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 510(k)clearance of VectorVision® CT-free knee (K 021306).

The VectorVision® CT-free knee software calculates all planning values based on the same registered landmark and parameters equally to the VectorVision® osteotomy software. The initial geometry of the legisted including in same way. For the knee software the registered leg geometry is used to calculate position and size of the used implants. In the osteotomy software the leg geometry itself is used to create the plan of treatment, as the geometry correction is the task. In summary it can be stated the both applications use the same calculation, th output of the VectorVision® CT-free knee software contains several continuative steps until planning result is completed.

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 0 2005

Mr. Rainer Birkenbach Executive Vice President BrainLAB AG Ammerthalstrasse 8 85551 Heimstetten Germany

Re: K042513

Trade/Device Name: VectorVision Osteotomy Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: II Product Code: HAW Dated: January 19, 2005 Received: January 24, 2005

Dear Mr. Birkenbach:

We have reviewed your Section 510(k) premarket notification of intent to market the device wo have reviewed 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 for use bated in the May 28, 1976, the enactment date of the Medical Device Amendments, or to econimer to from to rial as in accordance with the provisions of the Federal Food, Drug, de rioss marina ve over require approval of a premarket approval application (PMA). and Oosmeter For (110) respect 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 rr 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 or any I 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 Of It fart 6077; adoling (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) This letter whilanow you to begin manisting of substantial equivalence of your device to a legally premaired notification. "The Privating sification 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 If you ucsire specific acrite for Joan acc) 276-0115. Also, please note the regulation entitled, Comics the Office of Compilance an (21 t notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general informational 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 yours,
Mark A. Millan

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): | K042513 |
|---------------------------|------------------------|
| Device Name: | VectorVision Osteotomy |

Indications For Use:
BrainLAB VectorVision is intended to be an 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 an individual 3D-model of the patient's bone, which is generated through acquiring multiple landmarks on the bone surface. The system is indicated to assist a surgeon to perform one (open wedge) or two (closed wedge) cuts to achieve a leg angle correction.
Example orthopedic surgical procedures include but are not limited to:
Open wedge osteotomy for the lower limb
Closed wedge osteotomy for the lower limb

| Prescription Use<br>(Per 21 CFR 801 Subpart D) | X | AND/OR | Over-The-Counter Use<br>(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)

Mark N. Milkenson

(Division Sign-Off) (Division of General, Restorative, and Neurological Devices

510(k) Number_________________________________________________________________________________________________________________________________________________________________