MODIFICATION TO: VECTORVISION FRAMELESS BIOPSY SYSTEM

K012564 · Brainlab AG · HAW · Sep 6, 2001 · Neurology

Device Facts

• Record ID: K012564
• Device Name: MODIFICATION TO: VECTORVISION FRAMELESS BIOPSY SYSTEM
• Applicant: Brainlab AG
• Product Code: HAW · Neurology
• Decision Date: Sep 6, 2001
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 882.4560
• Device Class: Class 2

Intended Use

The BrainLAB VectorVision Frameless Biopsy System 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 a patient's preoperative image data being processed by a VectorVision workstation. 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 or MR based model of the anatomy. Example procedures include but are not limited to: Cranial Procedures: Cranial biopsies. Tumor resections. Craniotomies/ Craniectomies. Skull base procedures. Thalamotomies/ Pallidotomies. Spinal Procedures: Spinal implant procedures such as pedicle screw placement. ENT Procedures: Transphenoidal procedures. Intranasal procedures. Sinus procedures, such as Maximillary antrostomies, Ethmoidectomies, Sphenoidotomies/Sphenoid explorations, Turbinate resections and Frontal sinusotomies

Device Story

VectorVision Frameless Biopsy System is an intraoperative image-guided localization system. Input: preoperative patient image data (CT, X-ray, MR) and real-time tracking of a freehand probe via a passive marker sensor system. Transformation: VectorVision workstation processes image data and maps tracked probe position into virtual computer image space. New features include a multiarticulated arm providing mechanical support to limit instrument degrees of freedom (zero or one), enhancing stability and efficiency for serial or multi-target approaches. Output: visual guidance on workstation display. Used in OR by surgeons to navigate instruments relative to patient anatomy. Benefit: simplified trajectory determination, increased surgical stability, and improved accuracy for minimally invasive procedures.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

System comprises a VectorVision workstation, passive marker sensor system, and a multiarticulated mechanical arm. Operates as an image-guided localization system using preoperative CT, X-ray, or MR data. Connectivity involves integration between the tracking sensor and the workstation. Software-based image processing maps physical probe position to virtual image space.

Indications for Use

Indicated for patients requiring stereotactic surgery where rigid anatomical structures (skull, long bone, vertebra) can be referenced to preoperative CT, X-ray, or MR imaging. Applicable for cranial, spinal, and ENT procedures including biopsies, resections, and implant placements.

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

• VectorVision2 System (K983831)
• VectorVision2 System (K003589)

Submission Summary (Full Text)

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# 510 (k) Summary of Safety and Effectiveness

Product; VectorVision Frameless Biopsy System

510 (k) application:

## Manufacturer:

BrainLAB AG Ammerthalstrasse 8 85551 Heimstetten Germany Phone: [phone] Fax: [phone]

#### What is new?

The Vector\/ision Frameless Biopsy System contains features to improve the support and guidance of surgical instruments. A multiarticulated arm facilitates the use of miscellaneous instruments for serial approaches along a determined trajectory to a specific target as well as the guidance of a single instrument to multiple targets along the same trajectory. Combined with the IGS features of VectorVision's software, the determination and repeated locating of trajectories is considerably simplified. By mechanical support, the degrees of freedom of the instrument can be limited either to zero or to one, thus giving the surgeon's hand mechanical support for increased stability, alleviating the surgeon's task of holding or inserting instruments and enhancing the efficiency of the surgery.

### Indications for use:

The BrainLAB VectorVision Frameless Biopsy System 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 a patient's preoperative image data being processed by a VectorVision workstation. 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 or MR based model of the anatomy.

Example procedures include but are not limited to:

Cranial Procedures: Cranial biopsies. Tumor resections. Craniotomies/ Craniectomies. Skull base procedures. Thalamotomies/ Pallidotomies.

Spinal Procedures: Spinal implant procedures such as pedicle screw placement.

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ENT Procedures: Transphenoidal procedures. Intranasal procedures. Sinus procedures, such as Maximillary antrostomies, Ethmoidectomies, Sphenoidotomies/Sphenoid explorations, Turbinate resections and Frontal sinusotomies

## Substantial equivalence

The information provided by BrainLAB in this 510 (k) application was found to be substantially equivalent with predicate devices such as the 510(k)-clearance of BrainLAB's VectorVision2 System (K983831, K003589).

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Image /page/2/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract symbol that resembles an eagle or a stylized human figure.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP = 6 2001

Mr. Stefan Vilsmeier President and CEO BrainLAB AG Ammerthalstrasse 8 85551 Heimstetten Germany

Re: K012564

Trade/Device Name: Modification to VectorVision Frameless Biopsy System Regulation Number: 882.4560 Regulatory Class: II Product Code: HAW Dated: July 31, 2001 Received: August 9, 2001

Dear Mr. Vilsmeier:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. Stefan Vilsmeier

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html".

Sincerely yours,

Susan Walker, MD

Fer 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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Page ot

510(k) Number (if known):

K012564

Device Name:

Vector Vision Frameless Biopsy System

Indications For Use:

The BrainLAB VectorVision Frameless Biopsy System is intended to be an intraoperative image I he Diami.AD v coon v sion Frances Drops, is your esurgery. It links a frechand probe, tracked by a guided localization system to virtual computer image space on a patient's preoperative image data passive marker school system to virtual beatle the system is indicated for any medical condition in being processed by a Vector vision workshately and where a reference to a rigid anatomical winch the use of stereoment dargery and, or vertebra, can be identified relative to a CT, X-ray or MR based model of the anatomy.

Example procedures include but are not limited to:

Cranial Procedures: Cranial biopsies. Tumor resections. Craniotomies/ Craniectomies. Skull base procedures. Thalamotomies/ Pallidotomies.

Spinal Procedures: Spinal implant procedures such as pedicle screw placement.

ENT Procedures:

Transphenoidal procedures.

Intranasal procedures.

Sinus procedures, such as Maximillary antrostomies, Ethmoidectomies, Sphenoidotomies/Sphenoid explorations, Turbinate resections and Frontal sinusotomies

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Lisa Wall

Division Sign-Off) Over-The-Counter Use _ Division of General, Restorative and Neurological Devices

(Optional Format I-2-96)

510(k) Number K612564