KOLIBRI SPINE

K042721 · Brainlab AG · HAW · Apr 19, 2005 · Neurology

Device Facts

• Record ID: K042721
• Device Name: KOLIBRI SPINE
• Applicant: Brainlab AG
• Product Code: HAW · Neurology
• Decision Date: Apr 19, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4560
• Device Class: Class 2

Intended Use

BrainLAB's Kolibri spine is intended to be an intraoperative image-guided localization system to virtual computer image space on a patient's preoperative image data being processed by a Kolibri 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 of the cranium or vertebra can be identified relative to a CT, X-ray or MR-based model of the anatomy.

Device Story

Kolibri spine is an intraoperative image-guided surgery system for surgical planning and navigation. It tracks a freehand probe using a passive marker sensor system. Inputs include preoperative 3D image data (CT, X-ray, or MR) or intraoperatively acquired 2D fluoro images from a C-arm. The system registers the surgical instrument to the virtual computer image space; 3D data registration uses specific methods, while 2D fluoro registration is performed automatically using spatial position information from the C-arm. The workstation displays the tracked instrument relative to the patient's anatomy. Surgeons use this visual feedback to guide minimally invasive procedures, such as pedicle screw placement or tumor surgery. The device assists in precise instrument positioning, potentially improving surgical accuracy and patient outcomes.

Clinical Evidence

Bench testing only. The device was verified and validated according to manufacturer procedures for product design and system use.

Technological Characteristics

Stereotaxic instrument; passive marker sensor system; workstation-based; supports 3D (CT/MR) and 2D (fluoro) imaging; registration via spatial position information or 3D registration methods.

Indications for Use

Indicated for patients requiring stereotactic surgery where rigid anatomical structures of the cranium or vertebra can be identified relative to CT, X-ray, or MR-based models. Procedures include spinal implant placement (e.g., pedicle screws), Kyphoplasty, Vertebroplasty, placement of k-wires, needles, catheters, electrodes, thoracic spine surgery, tumor surgery, and placement of acetabular and SI screws.

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

• BrainLAB VV CT / Fluoro (K010968)
• BrainLAB Kolibri™ Image Guided Surgery System (K014256)

Submission Summary (Full Text)

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## APR ] 9 2005

# KO49721 510 (k) Summary of Safety and Effectiveness for Kolibri spine

#### Manufacturer:

| Address: | BrainLAB AG<br>Ammerthalstrasse 8<br>85551 Heimstetten<br>Germany<br>Phone: [phone]<br>Fax: [phone] | |
|-----------------------------|--------------------------------------------------------------------------------------------------------------------------|--|
| Contact Person: | Mr. Rainer Birkenbach | |
| Summary Date: | March 8, 2004 | |
| Device Name: | | |
| Trade name: | Kolibri spine | |
| Common/Classification Name: | Kolibri spine, BrainLAB Image Guided Surgery System / Instrument,<br>Stereotaxic | |

## Predicate Device:

## BrainLAB VV CT / Fluoro (K010968) BrainLAB Kolibri™ Image Guided Surgery System (K014256)

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

## Intended Use:

BrainLAB's Kolibri spine is intended to be an intraoperative image-guided localization system to virtual ogmuter BrainLAB S Kolibr Spile is mended to be an midded to marker sensor system to virtual computer invasive surgery. It ifiks a trendlid proc, truckod by a Kolibri workstation. The system is
image space on a patient's preoperative image data being processed by a parentiate image space on a patient's preoperative image aathing provins be appropriate and where a indicated for ally theilean condition in whilen the sould be of other or vertebra can be identified relative to a CT, X-ray or MR-based model of the anatomy.

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Example procedures include but are not limited to:

Spinal implant procedures such as pedicle screw placement Kyphoplasty and Vertebroplasty procedures Ryphopiasty and votobrophory or permanent devices such as k-wires, needles, catheters or electrodes Thoracic spine surgery Tumor surgery on the spinal column and adjacent soft tissue Placement of acetabular and SI screws on the pelvis

#### Device Description:

Kolibri spine is a device that allows surgical planning and navigation. It links a surgical instrument, (tracked by Rulpir Spille is a doviou that allette caration on a virtual computer image, which is either based on patient's passive municil of online of a looking to a looking intraoperative acquired 20 fluoro image(s) of a c-arm.

The device enables the navigation based on 3D data and/or based on acquired fluoro images (Fluoro only).

Based on 3D data, the procedure of linking the surgical instrument to the virtual computer image is achieved by performing certain registration methods.

Based on 2D fluoro images, the registration is done automatically by using the exact spatial position information of the intra-operatively acquired fluoro images.

After registration, the device assists the surgeon in performing certain surgical procedures as described in the indications for use.

## Substantial equivalence:

Substantial equivalence.
Kolibri spine has been verified and validated according to BrainLAB's procedures for product design and Kolibil Spire nas been velifica and validated use of the system. The information provided by development. The valuation provos the barety and on the substant with the predicate device BrainLAB
BrainLAB in this 510 (k) application was found to be substantially (401185 BrailLAB In this 910 (K) uppliodition Was found to Brided Surgery System (K014256)
VV CT / Fluoro (K010968) and BrainLAB Kolibri™ Image Guided Surgery System (K014256)

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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 caduceus symbol, which is a staff with two snakes entwined around it. Above the caduceus, the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern.

## APR 1 9 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Per Persson Quality Manager BrainLab AG Ammerthalstraße 8 85551 Heimstetten, Germany

Re: K042721

Trade/Device Name: Kolibri spine Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: II Product Code: HAW Dated: March 18, 2005 Received: March 21, 2005

Dear Mr. Persson:

We have reviewed your Section 510(k) premarket notification of intent to market the device indicati We have reviewed your Section >10(x) prematice is substantially equivalent (for the indications referenced above and nave ucternined the article of the article devices marketed in interstate for use stated in the encrosule) to regally manated povice Americal Device Ameralments, or to commerce prior to May 26, 1770, the enactions with the provisions of the Federal Food, Drug, devices that have been reclassified in accered in of a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premarket of the Act . T and Cosment Act (Act) that to not require approval controls provisions of the Act. The You may, dierefore, market the devices, bacycles of the more
general controls provisions of the Act include requirements for annual registration, listing of general controls provisions of the Fiel hereas sand 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 EDA it may be subject to such addinonal control - na Title 21, Parts 800 to 898. In addition, FDA can be found in the Code of Feaster concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issualies of a succession of the requirements of the Act
that FDA has made a determination that your device complies . You must that FDA has made a decertimation that Jour acered by other Federal agencies. You must or any Federal statutes and regulations damanistered by not limited to: registration and listing (21 comply with all the Act s requirements, merceded wantice requirements as set CFR Part 807), iabening (21 CFR Fart 800); and if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR Part 820); and if and 1050 forum in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 – Mr. Per Persson

This letter will allow you to begin marketing your device as described in your Section 510(k)
The supply of the supply of any first of the sixplanes of your device to a legal This letter will allow you to begin marketing your advice of your device of your device to a legally
premarket notification. The FDA finding of substantial equivaleon this p premarket noutication. The PDA Intuing of Subscannal square 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
rs the results of the more 10, 276, 0100 - Alge seculation entitled If you desire specific advice iol your uc-nec on on accesses not the regulation entitled,
contact the Office of Compliance at [phone] . Also, please note the regulati contact the Office of Compliatics at (240) 270 - 12 (217) Part 807.97). You may obtain
"Misbranding by reference to premarket notification (21 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - "Misbranding by reference to premarket nonlineation (1) + + + ct from the Division of Small other general information on your responsion its toll-live number [phone] or
Manufacturers, International and Consumer Assistance at its toll-firences/support/index.ht Manufacturers, International and Consumer Assistance at to to to to to to the manufactures html.

Sincerely yours,

signature

Miriam C. Provost, Ph.D. Acting 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):

K042721

Device Name:

Kolibri spine

Indications For Use:

BrainLAB's Kolibri spine is intended to be an intraoperative image-guided localization system BrainLAD > Konon spine is mened it outs a freehand probe, tracked by a passive marker to enable inimilally invasive surger ; ? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . sensor system to Virtual compact mage space on indicated for any medical condition in which processed by a Kombir worksmation: '110 by online and where a reference to a rigid anatomical the use of stereotactic surgery may be appropriate and be identified relative to a CT, X-ray or MR-based model of the anatomy.

Example procedures include but are not limited to:

Spinal implant procedures such as pedicle screw placement Kyphoplasty and Vertebroplasty procedures Kyploplasty and verceoropias) processions devices such as k-wires, needles, catheters or electrodes Thoracic spine surgery Thoracle spino bargery on the spinal column and adjacent soft tissue Placement of acetabular and SI screws on the pelvis

Prescription Use X (Per 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use _ (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Signature

ACTIVE

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