BrainLAB's NaviVision is an add-on system for the Siemens mobile x-ray system Siemens Arcadis Orbic, including the 3D option Arcadis Orbic3D, and the Siemens mobile x-ray system Siemens Arcadis Varic. The NaviVision system is intended as 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 or intraoperative image data. The system is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, for which imaging using the Siemens mobile x-ray system has been cleared, and where a reference to a rigid anatomical structure, such as the skull, the pelvis, a long bone or vertebra can be identified relative to the acquired image and/or image data-based model of the anatomy.

Device Description

NaviVision is a device that allows surgical planning and navigation on datasets acquired with digital Siemens Carms. No extra navigation platform is required in the surgical theatre, since the BrainLAB navigation computer is built in the Siemens C-arm trolley. NaviVision links a surgical instrument, (tracked by passive marker sensor system) to a virtual computer image, which is either based on an intraoperative patient's intraoperatively acquired 2D fluoro image with a digital Siemens C-arm. The device enables the navigation based on 3D scan data and / or based on acquired fluoro images. Based on 2D fluoro images, the registration is done automatically by using the exact spatial position information of the intra-operatively acquired fluoro images. Based on 3D data, the registration is also done automatically by using the exact spation information of the start position of the scan. Beforehand, the 3D Siemens C-arm has to be calibrated in combination with the navigation system. For 3D data, the paired point matching is also available as a re-registration method. Re-registration is a method to regain the navigation accuracy in case of a movement of the patient's reference. By using this option, another 3D scan is not necessary.

AI/ML Overview

The provided text describes the NaviVision system, but it does not contain a detailed study report that includes specific acceptance criteria and a demonstration of how the device meets those criteria with performance metrics.

The document primarily focuses on:

Device identification and classification: Trade name, common name, predicate device identification, regulatory class, and product codes.
Intended Use/Indications for Use: What the device is designed to do and for what medical conditions it's appropriate.
Device Description: How the device works (linking surgical instruments to image data, auto-registration based on 2D fluoro or 3D data).
Substantial Equivalence Statement: A general declaration that the device has been verified and validated according to BrainLAB's procedures and found substantially equivalent to predicate devices. This statement implies that safety and effectiveness have been proven, but doesn't present the evidence.
FDA Correspondence: The FDA's letter confirming substantial equivalence.

Therefore, I cannot extract the requested information regarding acceptance criteria, reported performance, sample sizes, ground truth establishment, expert qualifications, or MRMC study details from the provided text.

The closest the document comes to "acceptance criteria" is the general statement about "verification and validation according to BrainLAB's procedures for product design and development," which "proves the safety and effectiveness of the system." However, the specific metrics and thresholds for "safety and effectiveness" are not listed.

Summary

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SEP 2 0 2006

KO62086 510 (k) Summary of Safety and Effectiveness for NaviVision

Manufacturer: BrainLAB AG Address: Kapellenstraße 12 85622 Feldkirchen Germany Phone: +49 89 99 15 68 0 Fax: +49 89 99 15 68 33 Contact Person: Mr. Rainer Birkenbach Summary Date: July 06, 2006

Device Name:

Trade name:

NaviVision

Common/Classification Name:

NaviVision, BrainLAB Image Guided Surgery System / Instrument, Stereotaxic

Predicate Device:

BrainLAB VectorVision fluoro 30 (K024192) BrainLAB Kolibri spine (K042721)

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

Intended Use:

Indications For Use:

The system is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, for which imaging using the Siemens mobile x-ray system has been cleared, and where a reference to a rigid anatomical structure, such as the skull, the pelvis, a long bone or vertebra can be identified relative to the acquired image and/or image data-based model of the anatomy.

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Device Description:

NaviVision links a surgical instrument, (tracked by passive marker sensor system) to a virtual computer image, which is either based on an intraoperative patient's intraoperatively acquired 2D fluoro image with a digital Siemens C-arm.

The device enables the navigation based on 3D scan data and / or based on acquired fluoro images.

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

Based on 3D data, the registration is also done automatically by using the exact spation information of the start position of the scan. Beforehand, the 3D Siemens C-arm has to be calibrated in combination with the navigation system.

For 3D data, the paired point matching is also available as a re-registration method. Re-registration is a method to regain the navigation accuracy in case of a movement of the patient's reference. By using this option, another 3D scan is not necessary.

The C- Arm and its components are manufactured by Siemens AG Medical Solutions. BrainLAB AG manufactures the integrated NaviVision Platform and its components. The components of the NaviVision platform and the C- Arm are delivered by Siemens. On site installation and customer training is performed by a qualified BrainLAB support engineer.

Substantial equivalence:

( : NaviVision 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. The information provided by BrainLAB in this 510 (k) application was found to be substantially equivalent with the predicate device BrainLAB VectorVision fluoro 30 (K024192) and BrainLAB Kolibri spine (K042721).

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 0 2006

BrainLAB AG % Mr. Rainer Birkenbach Executive Vice President Kappellenstraße 12 85622 Feldkirchen Germany

Re: K062086

Trade/Device Name: Navi Vision Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: II Product Code: HAW Dated: July 17, 2006 Received: July 21, 2006

Dear Mr. Birkenbach:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976. 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, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing 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 be found in the Code 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. Rainer Birkenbach

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 marketed predicate device results in a classification for your device 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 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 Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

for

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): KO62086

Device Name: NaviVision

Indications For Use:

Prescription Use × (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)

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

12062086 510(k) Number_

Page 1 of 1

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).