VECTORVISION HIP AND HIP SR

K072573 · Brainlab AG · HAW · Oct 11, 2007 · Neurology

Device Facts

• Record ID: K072573
• Device Name: VECTORVISION HIP AND HIP SR
• Applicant: Brainlab AG
• Product Code: HAW · Neurology
• Decision Date: Oct 11, 2007
• Decision: SESE
• Submission Type: Special
• 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 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

Device Story

Intraoperative image-guided localization system; uses passive marker sensor system to track freehand probes/surgical instruments. Inputs: preoperatively-acquired patient images or intraoperatively acquired bone surface landmarks. Transformation: system generates 3D bone model; reconstructs anatomical axes/planes; aligns implants to planned positions. Output: visual navigation guidance on navigation station display. Used in OR by surgeons. Benefits: aids accurate navigation of hip endoprosthesis to planned position; enables non-CT-based intraoperative planning/navigation.

Clinical Evidence

No clinical data; bench testing and validation only.

Technological Characteristics

Intraoperative image-guided localization system; passive marker tracking; 3D bone modeling via surface landmark acquisition; software-based navigation; supports pre-calibrated drill guides.

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; specifically for orthopedic procedures including 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

• Vector Vision® Hip 3.0 (K040368)
• Vector Vision® Hip SR 1.0 (K063028)

Submission Summary (Full Text)

{0}------------------------------------------------

# K072573

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

### Manufacturer:

| Address: | BrainLAB AG<br>Kapellenstr. 12<br>85622 Feldkirchen<br>Germany | |
|-----------------|----------------------------------------------------------------|--|
| | Phone: [phone] | |
| | Fax: [phone] | |
| Contact Person: | Mr. Per Persson | |
| Summary Date: | August 30, 2007 | |

### Device Name:

Trade name:

Common/Classification Name:

VectorVision hip SR

VectorVision, BrainLAB Image Guided Surgery System / Instrument. Stereotaxic

Predicate Devices: Vector Vision® Hip 3.0 (K 040368) Vector Vision® Hip SR 1.0 (K 063028)

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 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

{1}------------------------------------------------

### 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 VectorVision® 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 the BrainLAB 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 devices Vector Vision® Hip 3.0 (K 040368) and Vector Vision® Hip SR 1.0 (K 063028).

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized emblem featuring three wavy lines that resemble a caduceus or a symbol of health and medicine.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 1 1 2007

BrainLAB AG % Mr. Benjamin Wagner Mechanical Design Engineer Kapellenstraß 12 85622 Feldkirchen Germany

Re: K072573 Trade/Device Name: VV hip SR Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: II Product Code: HAW Dated: September 10, 2007 Received: September 12, 2007

Dear Mr. Wagner:

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

{3}------------------------------------------------

Page 2 - Mr. Benjamin Wagner

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/industry/support/index.html.

Sincerely vor

For Polo Rms
Dep D.R
10/10/24
Mark N. Melkerson

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

Page 2011 - of of 1 - 1

| 510(k) Number (if known): | K072573 |
|---------------------------|---------|
|---------------------------|---------|

Device Name:

VV 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 endoprosthesis to the preoperatively or intraoperatively planned position.

Example orthopedic surgical procedures include but are not limited to:

· Partial/hemi-hip resurfacing

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

(PLEASE DO NOT WRITE BELOW THIS LINE CONTINUE ON ANOTHER PAGE IF NEEDED)

(Division Sign-Off)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division of General, Restorative, and Neurological Devices

| 510(k) Number | L072573 |
|---------------|---------|
|---------------|---------|