KOLIBRI IGS SYSTEMS

K014256 · Brainlab AG · HAW · Jul 19, 2002 · Neurology

Device Facts

• Record ID: K014256
• Device Name: KOLIBRI IGS SYSTEMS
• Applicant: Brainlab AG
• Product Code: HAW · Neurology
• Decision Date: Jul 19, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4560
• Device Class: Class 2

Intended Use

The BrainLAB Kolibri IGS System is intended to be an intraoperative image guided localization system to enable minimally invasive surgery. It links a freehand probe, tracked by a magnetic sensor system or a passive marker sensor system to a virtual computer image space on a patient's preoperative diagnostic image data set being processed by the Kolibri computer 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 image quided cranial surgery procedures include but are not limited to: 1. Tumor resections 2. Skull base surgery 3. Cranial bionsies 4. Craniotomies/Craniectomies. Example image guided ENT surgery procedures include, but are not limited to: 1. Transphenoidal procedures 2. Maxillary antrostomies 3. Ethmoidectomies. 4. Sphenoidotomies./sphenoid explorations, 5. Turbinate resections 6. Frontal sinusotomies 7. Intranasal procedures

Device Story

Kolibri IGS is a portable workstation with touch screen monitor for intraoperative navigation. System tracks freehand probes using magnetic or optical 3D localization sensors. Preoperative diagnostic images (CT, X-ray, MR) are transferred to the workstation via LAN or external media. Software performs patient registration using anatomical landmarks, fiducial markers, or surface matching via tracked pointer. Surgeon operates system via touch screen (draped for sterility). System provides real-time visualization of surgical tools relative to patient anatomy, assisting in minimally invasive procedures. Benefits include improved surgical precision and localization for cranial and ENT interventions.

Clinical Evidence

Bench testing only. The system underwent verification and validation according to BrainLAB's product design and development procedures to confirm safety and effectiveness.

Technological Characteristics

Portable hardware platform with integrated touch screen; magnetic or optical 3D localization system; navigation software delivered via external memory modules; connectivity via hospital LAN or external media drives; sterile draping for touch screen interface.

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 procedures (tumor resection, skull base surgery, biopsies, craniotomies) and ENT procedures (transphenoidal, antrostomies, ethmoidectomies, sphenoidotomies, turbinate resections, sinusotomies, intranasal procedures).

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

• Medtronic StealthStation® System Goldeneye™ Micro-Magnetic Tracking Option (K001284)
• COMPASS Regulus™ Navigator (K964229)
• BrainLAB VectorVision (Cranial/ENT/Spinal) (K003589)
• BrainLAB VectorVision2 (K983831)

Submission Summary (Full Text)

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# 510(k) Summary of Safety and Effectiveness for the Kolibri Image Guided Surgery System

### Manufacturer:

| Address: | BrainLAB AG<br>Ammerthalstrasse 8<br>85551 Heimstetten<br>Germany<br>Phone: [phone]<br>Fax: [phone] |
|-----------------|--------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Mr. Stefan Vilsmeier, President & CEO |
| Summary Date: | July 15, 2002 |
| Device Name: | |

| Trade name: | Kolibri™ Image Guided Surgery System (K014256) |
|-----------------------------|-------------------------------------------------------|
| Common/Classification Name: | Image Guided Surgery System / Instrument, Stereotaxic |
| Product Code: | HAW CFR 882.4560 |

#### Predicate Devices:

Medtronic StealthStation® System Goldeneye™ Micro-Magnetic Tracking Option (K001284)

#### COMPASS Regulus™ Navigator (K964229)

#### BrainLAB VectorVision (Cranial/ENT/Spinal) (K003589) BrainLAB VectorVision2 (K983831)

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

#### Indications for use:

The BrainLAB Kolibri IGS System is intended to be an intraoperative image guided localization system to enable minimally invasive surgery. It links a freehand probe, tracked by a magnetic sensor system or a passive marker sensor system to a virtual computer image space on a patient's preoperative diagnostic image data set being processed by the Kolibri computer 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 image quided cranial surgery procedures include but are not limited to:

- 1. Tumor resections
- 2. Skull base surgery
- Cranial bionsies 3.
- Craniotomies/Craniectomies 4.

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Example image guided ENT surgery procedures include, but are not limited to:

- 1. Transphenoidal procedures
- 2. Maxillary antrostomies
- 3. Ethmoidectomies.
- 4. Sphenoidotomies./sphenoid explorations,
- 5. Turbinate resections
- 6. Frontal sinusotomies
- 7. Intranasal procedures

#### Device Description:

The Kolibri Image Guidance System is based on a portable hardware platform with integrated touch screen monitor. 3D tracking system controller and computer workstation. The navigation software won't be installed on the system hard disk but will be delivered on "memory modules that will be externally plugged into the system platform according to the current intended kind of surgery. The localization of patient position and surgical tools within the operating field will be performed by a magnetic or optical 3D localization system. All patient data needed for the image quided surgery will be transferred via the hospital LAN network or external media drives to the Kolibri workstation. Once the patient data is transferred to the Kolibri system, the application software automatically starts with the patient registration procedure. The user may perform the patient to 3D data registration either by using anatomical landmarks, fiducial markers or surface matching. The patient registration will be performed by use of a magnetic or optically tracked registration pointer. The surgeon can control all software functions of the Kollbri navigation system via touch screen. Therefore the monitor of the Kolibri navigation system will be draped with a sterile drape.

#### Substantial equivalence:

The Kolibri™ Image Guides Surgery System incl. application software for Cranial and ENT applications 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 device StealthStation® System Goldeneye™ Micro-Magnetic Tracking (K001284), the Requlus™ Navigator and the BrainLAB VectorVison (Cranial/ENT/Spinal) (K003589) / BrainLAB VectorVision2 (K983831).

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle or bird with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the bird symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## JUL 1 9 2002

Mr. Stefan Vilsmeier BrainLab AG Ammerthalstrasse 8 Heimstetten Germany 85551

Re: K014256

Trade/Device Name: Kolibri IGS System Regulation Number: 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: II Product Code: HAW Dated: April 16, 2002 Received: April 24, 2002

Dear Mr. Vilsmeier:

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. Iisting 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 mav 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 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.

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Page 2 -- Mr. Stefan Vilsmeier

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 and additionally 21 CFR Part 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 Part 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.

Stipt Rurdu

elia 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 1 of i

510(k) Number (if known):

Device Name:

K014256

Kolibri Image Guided Surgery System Device Name: Came

Indications For Use:

General description:

The BrainLAB Kolibri IGS System is intended to be an intraoperative image guided localization system to enable minimally invasive surgery. It links a freehand probe, tracked by a magnetic sensor system or a passive marker sensor system to a virtual computer image space on a patient's preoperative diagnostic image data set being processed by the Kolibri computer workstation. The system is indicated for any medical condition in which the use of sterectactic 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 image quided cranial surgery procedures include but are not limited to:

- 1. Tumor resections
- Skull base surgery 2.
- 3. Cranial biopsies
- 4. Craniotomies/Craniectomies

Example image guided ENT surgery procedures include, but are not limited to:

- 1. Transphenoidal procedures
- Maxillary antrostomies in
- Ethmoidectomies, కా
- র্বা Sphenoidotomies./sphenoid explorations,
- Turbinate resections ട്.
- 6. Frontal sinusotomies
- 7. Intranasal procedures

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

OR
Stuptl Rudie
Over-The-Counter Usc
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(Division Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number_