VECTORVISION HIP 3.0

K040368 · Brainlab AG · HAW · Aug 23, 2004 · Neurology

Device Facts

• Record ID: K040368
• Device Name: VECTORVISION HIP 3.0
• Applicant: Brainlab AG
• Product Code: HAW · Neurology
• Decision Date: Aug 23, 2004
• 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. 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 Vector vision workstation 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

Device Story

VectorVision Hip is an intraoperative image-guided surgery system. It tracks surgical instruments (cup reamer, cup inserter, stem rasp, bone saw) using a passive marker sensor system. Inputs include preoperative patient image data (CT, X-ray, MR) or intraoperatively generated 3D bone models via landmark acquisition. The system reconstructs 3D mechanical axes and planes of the femur and pelvis, allowing surgeons to navigate implants to planned positions. Used in OR by surgeons for orthopedic procedures like TJR and tumor resection. Output is visual navigation data on a workstation, aiding accurate implant placement. Benefits include improved surgical precision and alignment.

Clinical Evidence

No clinical data provided. Substantial equivalence is supported by bench testing and validation of product design according to manufacturer procedures.

Technological Characteristics

Stereotaxic instrument system; passive marker tracking; workstation-based; 3D reconstruction of mechanical axes; software-based registration of patient anatomy; CT/X-ray/MR data integration.

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. Applicable for Total Joint Replacement (TJR), revision TJR, 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

• VectorVision Hip (K010602)
• Vector Vision CT-free Knee (K021306)

Submission Summary (Full Text)

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# 510 (k) Summary of Safety and Effectiveness for VectorVision® Hip (K040368)

### Manufacturer:

| Address: | BrainLAB AG |
|-----------------|--------------------------|
| | Ammerthalstrasse 8 |
| | 85551 Heimstetten |
| | Germany |
| | Phone: [phone] |
| | Fax: [phone] |
| Contact Person: | Mr. Rainer Birkenbach |
| Summary Date: | August 13, 2004 |

# Device Name:

Trade name:

VectorVision® Hip

Common/Classific:stion Name:

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

# Predicate Device Vector Vision® Hip (K010602)

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

## intended Use:

BrainLAB VectorV sion is intended to be an intraoperative image guided localization system. It links a freehand probe, tr:cked by a passive marker sensor system to virtual computer image space either on a patients preoperat ve image data being processed by a Vector vision 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 anatomy. The system aids the surgeon to accuralely 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:

Device Description.
BrainLAB VectorV sion® Hip is intended to enable operational planning and navigation in orthopedic and Brainced vectory sion "The Is inched to bhable passive markers to virtual computer image space on an ilt lifes a surgical mistrument, traokou by ilohino passed on a patients preoperative image data or midwiddler SD-modil of the patient 3 band, while bone sufface. Vector Vision of Hip uses the registered generated through acquinny multiple lanathans the 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 implant to the plainted position. If he implant and the bone orientation as defined by the operating surgeon.

VectorVision® Hip allows 3-dimensional reconstruction of the relevant mechanical axes and planes of femur vector vision " hip allows of almendiation" Hip software has been designed to read in data and pervis and to:).ment of the implanter manufacturer and offers to individually choose the of miplants and tonio if provided by the ctorVision® Hip software registers the patient data needed for prosulesis uning :ach Surgery. The Toster New within the CT free module. The system can be used to planning and navillating the Surgery intre Sperial of William of the landman and any and generally and too "onemations as overing to the patient data can be used additionally for surgery, the patient data is then provided by the CT data stored on a standard data storage media.

#### Substantial equiv alence:

Substantial Cquit Inonoor
VectorVision® Hip has been verified and validated according to BrainLAB's procedures for product design violor video. This has bettle and effectiveness of the system. The information and devolopmont. The valication was found to be substantially equivalent with predicate devices such as the 510(k)-clearance of:

- VectorVision® Hip (K 010602) -
- Vector Vision® CT-free Knee (K 021306) -

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#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 2 3 2004

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

Re: K040368

Trade/Device Name: VectorVision® Hip 3.0 Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: II Product Code: HAW Dated: June 23, 2004 Received: June 28, 2004

Dear Mr. Birkenbach:

We have reviewed your Section 510(k) premarket notification of intent to market the device wt nave reviewed your becamed 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 commerce prior to May 20, 1978, tive eccordance with the provisions of the Federal Food. Drug. de vices that have been recidentive require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may, mereleve, mains of the Act include requirements for annual registration, listing of general controlly profitering 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 If your device is olasbirred (overal 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 I lease be advised that the researce complies with other requirements of the Act that I 127 Has made a and regulations administered by other Federal agencies. You must or any I edena satisfer and see is 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 (QS) regulation (21 CFR Part 820); and if applicable, the electronic foruit in the quant) of the (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 with anow You to oegin mailing of substantial equivalence of your device to a legally premarket notification. The 717A midning of the more of the and thus, permits your device to proceed to the market.

ff you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire specific acrite for your as 1) 594-4659. Also, please note the regulation entitled, Colliation of Compullios as (ot (on the motification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general information on your responser Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Miriam C. Provost

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): | K040368 |
|---------------------------|-------------------------------|
| Device Name: | VectorVision ^® Hip |

Indications For Use:

BrainLAB VectorVision 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 Vector vision workstation 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<br>(Per 21 CFR 801.109) | X | OR | Over-The-Counter Use ______ |
|------------------------------------------|---|----|-----------------------------|
|------------------------------------------|---|----|-----------------------------|

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Muriam C Provost
(Division Sign-Off)

Division of General, Restorative, and Neurological Devices

**510(k) Number** K040368