KOLIBRI IMAGE GUIDED SURGERY SYSTEM

K042391 · Brainlab AG · HAW · Oct 19, 2004 · Neurology

Device Facts

• Record ID: K042391
• Device Name: KOLIBRI IMAGE GUIDED SURGERY SYSTEM
• Applicant: Brainlab AG
• Product Code: HAW · Neurology
• Decision Date: Oct 19, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4560
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The BrainLAB Kolibri IGS System is intended to be an intraoperative image guided surgery. It links a freehand probe, tracked by a magnetic sensor system or a passive marker system to a virtual computer image space on a patient 3D 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 other anatomical structure can be identified relative to a CT, X-ray or MR based model of the anatomy.

Device Story

Kolibri Image Guided Surgery System is a portable workstation for intraoperative navigation. Inputs include pre-operative CT, MR, or fluoroscopic image data (transferred via CD-ROM or hospital network) and real-time tracking data from magnetic or optical 3D localization sensors. The system correlates tracked surgical instruments (e.g., catheter stylets) with the patient's virtual anatomical model. The surgeon operates the system via a touch-screen monitor, which is draped for sterility. Output is a real-time visual representation of instrument position relative to patient anatomy, assisting the surgeon in minimally invasive procedures. Benefits include improved spatial orientation and precision during cranial and ENT surgeries. Used in the operating room by surgeons.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and design verification/validation procedures.

Technological Characteristics

Portable hardware platform with integrated touch-screen monitor and computer workstation. Employs magnetic or optical 3D localization systems for instrument tracking. Supports passive reflective or magnetic surgical instruments. Connectivity via hospital LAN or external media (CD-ROM). Software-based registration of patient anatomy to 3D image data.

Indications for Use

Indicated for patients undergoing image-guided cranial or ENT surgery, including tumor resections, skull base surgery, cranial biopsies, craniotomies/craniectomies, and pediatric or general catheter shunt placement. ENT procedures include transphenoidal procedures, maxillary antrostomies, ethmoidectomies, sphenoidotomies/explorations, turbinate resections, frontal sinusotomies, and 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

• Kolibri™ Image Guided Surgery System (K014256)
• Catheter Introducer for the StealthStation System (K022126)

Submission Summary (Full Text)

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K042391 1 of 2

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

| Manufacturer: | BrainLAB AG |
|-----------------------------|-----------------------------------------------------------------------------------------------------------|
| Address: | Ammerthalstrasse 8<br>85551 Heimstetten<br>Germany<br>Phone: [phone]<br>Fax: [phone] |
| Contact Person: | Mr. Per Person |
| Summary Date: | October 06, 2004 |
| Device Name: | |
| Trade name: | Kolibri™ Image Guided Surgery System (K042391) |
| Common/Classification Name: | Image Guided Surgery System / Instrument, Stereotaxic |
| Product Code: | HAW CFR 882.4560 |

#### Predicate Devices:

### Kolibri™ Image Guided Surgery System (K014256)

## Catheter Introducer for the StealthStation System (K022126)

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 The BlainLAD Konon 105 System is minimally invasive surgery. It links a freehand probe, tracked by localization System to endore minimally areasor system to a virtual computer image space a magnetic sonsor system or a passive image data set being processed by the Kolibri computer on a patient 3 prooperative anage many medical condition in which the use of stereotactic workstation. The 35thin is marcare a reference to a rigid anatomical structure, such as the surger y may be appropriate and mises dentified relative to a CT, X-ray or MR based model of the anatomy.

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

- 1. Tumor resections
- 2. Skull base surgery
- 3. Cranial biopsies
- 4. Craniotomies/Craniectomies
- 5. Pediatric Catheter Shunt Placement (New)
- 6. General Catheter Shunt Placement (New)

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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 The Nonon'i muge Gataanse of Sontroller and computer workstation. The localization of patient screen momor, 5D that in the operating field will be performed by a magnetic or optical 3D localization system. All patient data needed for the image guided surgery procedure will be transferred focatization system. An patient assame as a cd-ROM) to the Kolibri workstation. Once the via the nospital LTN network of external the application software automatically starts with the patient registration procedure. The user may perform the patient to 3D data registration either by using pattent registration procedure. The assn. Inc. The patient registration will be performed by allatined handinarias, nodelar marked registration pointer. The surgeon can control all software functions use of a magication system via touch screen. Therefore the monitor of the Kolibri navigation system will be draped with a sterile drape during the procedure.

#### Description of Device Modifications:

This submission extends the Kolibri Image Guided Surgery System functionality with instruments to I his submission extends the received option of the Kolibri system is technically equivalent to the place catheter since of the StealthStation System. All Kolibri systems use either passive reflective Cancel Introducer for the becamels surgical instruments (e.g. the catheter stylet) in relation to reference geometry. This information is correlated to the patient's CT, MR or fluoroscopic images of the reference geomed y . This moomatics. This submission provides new indications that are substantially equivalent to the named predicate devices' indication for use.

#### Substantial equivalence:

Substantal equivalencer The Konor - Image Galace Bargery Jildsted according to BrainLAB's procedures for product design and apprications nas over verried and ranews of the system. The information provided by BrainLAB in this 510 (k) application was found to be substantially equivalent with the predicate by Drames in introducer for the SteathStation System (K022126) and Kolibri Image Guided Surgery System (K014256).

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 1 9 2004

Mr. Jens Witte BrainLab AG Ammerthalstrasse 8 85551 Heimstetten, Germany

Re: K042391

Trade/Device Name: Kolibri Image Guided Surgery System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: II Product Code: HAW Dated: August 25, 2004 Received: September 2, 2004

Dear Mr Witte:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your becaused in (d the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreations of 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, de need mat have act (Act) that do not require approval of a premarket approval application (PMA). and Cosmetic Free (110) his the device, subject to the general controls provisions of the Act. The r ou may, aterere, mains of the Act include requirements for annual registration, listing of general obtable provisions 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 may or day 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 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. Jens Witte

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 premated notification " west " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " 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 Mace Eacturers, 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,

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):

K042391

Kolibri Image Guided Surgery System Device Name:

Indications For Use:

#### General description:

General description.
The BrainLAB Kolibri IGS System is intended to be an intraoperative image guided The BrainLAB Konori IGS System is intenate to or argery. It links a freehand probe, localization system to enable inimmally invasive marker sensor system to a virtual tracked by a magnetic school system or aparentive diagnostic image data set being computer image space on a panent 3 proopers is indicated for any processed by the Ronori compater werkbants. In surgery may be appropriate and medical condition in which the use of between the skull, a long bone, or
where a reference to a rigid anatomical structure, such as the skull, af the where a reference to a figid anatonined. Butters, or MR based model of the anatomy.

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

- 1. Tumor resections
- 2. Skull base surgery
- 3. Cranial biopsies
- 4. Craniotomies/Craniectomies
- 5. Pediatric Catheter Shunt Placement
- 6. General Catheter Shunt Placement

Example image guided ENTsurgery procedures include but are not limited to:

510(k) Number_

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

| Prescription Use | X | OR | Over-The-Counter Use |
|----------------------|---------------------------------------------------------------------------|----|--------------------------|
| (Per 21 CFR 801.109) | | | (Optional Format 1-2-96) |
| | <i>Miriam C. Provost</i> | | |
| | (Division Sign-Off) | | |
| | (PLEASE DO NOT WRITE Division of General, Restorative, ER PAGE IF NEEDED) | | |
| | and Neurological Devices | | |
| | Concurrence of CDRH, Office of Device Evaluation (ODE) | | |

K042391