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 localization system to a virtual computer image space on a patient 3D 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 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

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 via the hospital LAN network or external media (e.g. a cd-ROM) to the Kolibri workstation. Once the data is loaded, 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 a tracked registration 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.

AI/ML Overview

The provided 510(k) summary for the Kolibri™ Image Guided Surgery System (K042391) does not contain detailed information about specific acceptance criteria or a dedicated study proving performance against these criteria. The submission mainly focuses on demonstrating substantial equivalence to predicate devices (K014256 and K022126) for existing functionalities and new indications.

Therefore, many of the requested details, such as specific performance metrics, sample sizes for test sets, expert qualifications, ground truth establishment methods, and MRMC study results, are not present in the provided document.

However, based on the available information, here's what can be inferred or explicitly stated:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not provided in the 510(k) summary. The document does not detail specific quantitative performance metrics (e.g., accuracy, precision, latency) or associated acceptance thresholds. The primary "performance" discussed is the technical equivalence to predicate devices.

2. Sample Size Used for the Test Set and Data Provenance

This information is not provided in the 510(k) summary. The document mentions that the application software automatically starts with the patient registration procedure, suggesting that testing would involve patient data, but does not specify the size or nature of any test set used in a formal study for this submission. There is no mention of country of origin or whether data was retrospective or prospective.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This information is not provided in the 510(k) summary. The document does not describe a study involving expert-established ground truth for performance evaluation related to the new indications or modifications.

4. Adjudication Method for the Test Set

This information is not provided in the 510(k) summary.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study is not mentioned in the 510(k) summary. The device is described as an image-guided surgery system, not an AI-assisted diagnostic tool that would typically involve human reader improvement studies.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

The 510(k) summary does not describe a standalone performance study. The device is referred to as an "Image Guided Surgery System," implying human interaction and control are inherent to its use. The mention of "patient to 3D data registration either by using anatomical landmarks or by a patient tracker with a fiducial marked registration pointer" directly involves human interaction in setting up the system for the procedure.

7. The Type of Ground Truth Used

The 510(k) summary does not explicitly state the type of ground truth used for any formal performance validation in the context of this submission. The system correlates surgical instruments to "patient's CT, MR or fluoroscopic images of the reference geometry," implying that the ground truth for instrument position would ideally be the actual physical placement validated against imaging. However, details of how this was formally assessed for the purpose of this 510(k) are absent.

8. The Sample Size for the Training Set

This information is not provided in the 510(k) summary. The document does not discuss a "training set" in the context of machine learning. The device is based on established image guidance technology, not a deep learning model requiring a large training dataset as often seen in AI/ML submissions.

9. How the Ground Truth for the Training Set Was Established

This information is not provided in the 510(k) summary, as there is no mention of a training set or machine learning components that would require such established ground truth. The system's functionality is described in terms of localization systems, data transfer, and patient registration procedures.

Summary of What is Available:

The K042391 submission is a 510(k) summary for extending the functionality of the Kolibri™ Image Guided Surgery System to include instruments for catheter placement, specifically targeting Pediatric Catheter Shunt Placement and General Catheter Shunt Placement. The basis for clearance is substantial equivalence to existing predicate devices (Kolibri™ Image Guided Surgery System K014256 and Catheter Introducer for the StealthStation System K022126). The applicant states that the "received option of the Kolibri system is technically equivalent" and provides "new indications that are substantially equivalent to the named predicate devices' indication for use." This type of submission relies on demonstrating that the new features or indications do not raise new questions of safety and effectiveness, leveraging the established safety and effectiveness of predicate devices, rather than presenting a de novo performance study with explicit acceptance criteria.

Summary

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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 885551 HeimstettenGermanyPhone: +49 89 99 15 68 0Fax: +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:

1. Tumor resections
1. Skull base surgery
1. Cranial biopsies
1. Craniotomies/Craniectomies
1. Pediatric Catheter Shunt Placement (New)
1. General Catheter Shunt Placement (New)

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

1. Transphenoidal procedures
1. Maxillary antrostomies
1. Ethmoidectomies,
1. Sphenoidotomies./sphenoid explorations,
1. Turbinate resections
1. Frontal sinusotomies
1. 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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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.

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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 (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

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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
1. Skull base surgery
1. Cranial biopsies
1. Craniotomies/Craniectomies
1. Pediatric Catheter Shunt Placement
1. General Catheter Shunt Placement

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

510(k) Number_

1. Transphenoidal procedures
1. Maxillary antrostomies
1. Ethmoidectomies,
1. Sphenoidotomies./sphenoid explorations,
1. Turbinate resections
1. Frontal sinusotomies
1. Intranasal procedures

Prescription Use	X	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)

K042391

Regulation Number and Section

§ 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).