(200 days)
BrainLAB's Kolibri spine 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 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 spine 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:
Spinal implant procedures such as pedicle screw placement Kyphoplasty and Vertebroplasty procedures Placement of temporary 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
Kolibri spine is a device that allows surgical planning and navigation. It links a surgical instrument, tracked by a passive marker sensor system to a virtual computer image, which is either based on patient's preoperative 3D data or based on online acquired intraoperative acquired 2D 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.
The provided document is a 510(k) Summary for the BrainLAB Kolibri spine, an image-guided surgery system. It describes the device's intended use and substantial equivalence to predicate devices but does not contain information regarding specific acceptance criteria, a detailed study proving performance against such criteria, or the methodology (e.g., sample sizes, expert qualifications, ground truth establishment) for any such study.
Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance, nor can I provide details on the study that proves the device meets acceptance criteria, as this information is not present in the provided text.
The document primarily focuses on the regulatory submission for clearance, outlining the device's description, intended use, and its substantial equivalence to previously cleared devices. It states that the device "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." However, it does not provide the specifics of this validation.
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APR ] 9 2005
KO49721 510 (k) Summary of Safety and Effectiveness for Kolibri spine
Manufacturer:
| Address: | BrainLAB AGAmmerthalstrasse 885551 HeimstettenGermanyPhone: +49 89 99 15 68 0Fax: +49 89 99 15 68 33 | |
|---|---|---|
| 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,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 (240) 276-0120 . 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 (800) 638-2041 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):
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
04272
§ 882.4560 Stereotaxic instrument.
(a)
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.(b)
Classification. Class II (performance standards).