(47 days)
Not Found
No
The description focuses on image guidance, localization systems (magnetic/optical), and patient registration using landmarks or fiducial markers. There is no mention of AI, ML, or related concepts like deep learning, neural networks, or algorithms that learn from data. The process described is based on established image processing and registration techniques, not AI/ML.
No.
The device is used for image-guided surgery, providing navigation and localization during surgical procedures rather than directly treating a medical condition.
No
Explanation: The device is described as an image-guided surgery system intended for intraoperative use, linking a probe to virtual images for surgical procedures. It uses pre-operative diagnostic images but does not perform diagnostic functions itself.
No
The device description explicitly states it is based on a "portable hardware platform with integrated touch screen monitor, 3D controller and computer workstation" and utilizes a "magnetic or optical 3D localization system." This indicates it includes significant hardware components beyond just software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections. They are used outside the body.
- Device Function: The BrainLAB Kolibri IGS System is an intraoperative image guided surgery system. It uses pre-operative imaging data (CT, X-ray, MR) and real-time tracking of instruments during surgery to help guide the surgeon.
- Intended Use: The intended use clearly states it's for "intraoperative image guided surgery" and "where a reference to a rigid anatomical structure... is identified relative to a CT, X-ray or MR based model of the anatomy." This describes a surgical navigation tool, not a diagnostic test performed on a sample.
- Device Description: The description details hardware for tracking instruments and patient anatomy in the operating field, not equipment for analyzing biological samples.
The system uses imaging data from diagnostic procedures (CT, X-ray, MR), but it doesn't perform the diagnostic test itself. It utilizes the results of those tests to aid in surgical planning and execution.
N/A
Intended Use / Indications for Use
The BrainLAB Kolibri IGS System is intended to be an intraoperative image guided surgery system to enable minimally invasive surgery. It links a freehand probe, tracked by a magnetic or optical localization system to a virtual computer image space on a patient 3D preoperative 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 vertebrae, is identified 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:
-
- Tumor resections
-
- Skull base surgery
-
- Cranial biopsies
-
- Craniotomies/Craniectomies
-
- Pediatric Catheter Shunt Placement (New)
-
- General Catheter Shunt Placement (New)
Example image guided ENT surgery procedures include, but are not limited to:
-
- Transphenoidal procedures
-
- Maxillary antrostomies
-
- Ethmoidectomies,
-
- Sphenoidotomies./sphenoid explorations,
-
- Turbinate resections
-
- Frontal sinusotomies
-
- Intranasal procedures
Product codes (comma separated list FDA assigned to the subject device)
HAW
Device Description
The Kolibri Image Guidance System is based on a portable hardware platform with integrated touch screen monitor, 3D controller and computer workstation. The localization of patient and surgical instruments 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 (e.g. via the hospital LAN network or an external storage media such as a cd-ROM) to the Kolibri workstation. Once the patient data is uploaded, 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 or model based registration with the use of a magnetic or optical tracked pointer. The surgeon can control all software functions of the navigation system via touch screen. Therefore the monitor of the Kolibri navigation system will be draped with a sterile drape during the procedure.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT, X-ray or MR based model
Anatomical Site
rigid anatomical structure, such as the skull, a long bone, or vertebrae.
cranial, ENT
Indicated Patient Age Range
Not Found
Intended User / Care Setting
intraoperative / operating field
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
K042391 1 of 2
510(k) Summary of Safety and Effectiveness for the Kolibri™ Image Guided Surgery System
| Manufacturer: | BrainLAB AG |
|---|---|
| Address: | Ammerthalstrasse 8 |
| 85551 Heimstetten | |
| Germany | |
| Phone: +49 89 99 15 68 0 | |
| Fax: +49 89 99 15 68 33 | |
| 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:
-
- Tumor resections
-
- Skull base surgery
-
- Cranial biopsies
-
- Craniotomies/Craniectomies
-
- Pediatric Catheter Shunt Placement (New)
-
- General Catheter Shunt Placement (New)
1
Example image guided ENT surgery procedures include, but are not limited to:
-
- Transphenoidal procedures
-
- Maxillary antrostomies
-
- Ethmoidectomies,
-
- Sphenoidotomies./sphenoid explorations,
-
- Turbinate resections
-
- Frontal sinusotomies
-
- 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).
2
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, which is a symbol often associated with medicine and healthcare. The caduceus is composed of three curved lines that resemble a bird in flight. The logo also includes the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular pattern around the caduceus.
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.
3
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 (240) 276-0115. 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 (800) 638-2041 or (301) 443-6597 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
4
510(k) Number (if known):
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:
-
- Tumor resections
-
- Skull base surgery
-
- Cranial biopsies
-
- Craniotomies/Craniectomies
-
- Pediatric Catheter Shunt Placement
-
- General Catheter Shunt Placement
Example image guided ENTsurgery procedures include but are not limited to:
510(k) Number_
-
- Transphenoidal procedures
-
- Maxillary antrostomies
-
- Ethmoidectomies,
-
- Sphenoidotomies./sphenoid explorations,
-
- Turbinate resections
-
- Frontal sinusotomies
-
- Intranasal procedures
| Prescription Use | X | OR | Over-The-Counter Use |
|---|---|---|---|
| (Per 21 CFR 801.109) | (Optional Format 1-2-96) | ||
| Miriam C. Provost | |||
| (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) |