Microscope Navigation Software

K172820 · Brainlab AG · HAW · Mar 1, 2018 · Neurology

Device Facts

• Record ID: K172820
• Device Name: Microscope Navigation Software
• Applicant: Brainlab AG
• Product Code: HAW · Neurology
• Decision Date: Mar 1, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4560
• Device Class: Class 2

Intended Use

The Brainlab Navigation System - Microscope Navigation Software module, that when used with a Brainlab navigation system and compatible instrument accessories, is intended as image guided planning and navigation system to enable open and minimally invasive surgery. It links an instrument and the view of the surgical field (e.g. video, view through surgical microscope) to a virtual computer image space on patient image data being processed by the navigation workstation. The system is indicated for any medical condition in which a reference to a rigid anatomical structure can be identified relative to images (CT, CTA, X-Ray, MR, MRA and ultrasound) of the anatomy

Device Story

Microscope Navigation Software is a module for Brainlab navigation systems (computer, display, IR tracking camera). It integrates with IGS software to provide image-guided navigation during open and minimally invasive surgeries. The device takes inputs from the surgical microscope's field of view, microscope position, and patient medical imaging data. It transforms these inputs by linking the surgical field view to a virtual computer image space, allowing surgeons to verify and correct patient registration. Used in the OR by surgeons, the output is displayed to the provider to assist in surgical navigation, tumor resection, and biopsies. It benefits patients by providing real-time navigation accuracy assessment and enabling registration updates to account for intra-operative deviations, potentially improving surgical precision.

Clinical Evidence

Bench testing only. Accuracy testing on phantoms demonstrated a focus point accuracy of 1.2 mm +/- 0.5 mm (99th percentile 2.4 mm) and a 3D error of 1.9 mm +/- 1.0 mm (99th percentile 4.6 mm). Navigation Update functionality was validated to improve registration errors with an accuracy of 0.8 mm +/- 0.3 mm (99th percentile 1.4 mm). Usability testing confirmed the user interface can be used safely and effectively.

Technological Characteristics

Software module running on Brainlab navigation platforms (Kick, Curve). Uses IR tracking camera for passive, reflective marker tracking. Interfaces with IGS software for registration. Operates on Windows 7/8.1. Provides microscope-specific views and registration update functionality. No specific material standards or sterilization methods listed as it is a software-only module.

Indications for Use

Indicated for patients requiring open or minimally invasive surgery where a reference to a rigid anatomical structure (e.g., skull, long bone, vertebra) can be identified relative to pre-operative or intra-operative imaging (CT, CTA, X-Ray, MR, MRA, ultrasound).

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

• VECTORVISION CRANIAL (K082060)

Submission Summary (Full Text)

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March 1, 2018

Brainlab AG Alexander Schwiersch Regulatory Affairs Manager Olof-Palme-Straße 9 81829 Munich, Germany

Re: K172820

Trade/Device Name: Microscope Navigation Software Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: HAW Dated: January 30, 2018 Received: February 2, 2018

Dear Alexander Schwiersch:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);

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and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# Michael J. Hoffmann -S

for

Carlos L. Peña. PhD. MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### Indications for Use

510(k) Number (if known) K172820

Device Name Microscope Navigation Software

#### Indications for Use (Describe)

The Brainlab Navigation System - Microscope Navigation Software module, that when used with a Brainlab navigation system and compatible instrument accessories, is intended as image guided planning and navigation system to enable open and minimally invasive surgery.

It links an instrument and the view of the surgical field (e.g. video, view through surgical microscope) to a virtual computer image space on patient mage data being processed by the navigation. The system is indicated for any medical condition in which a reference to a rigid anatomical structure can be identified relative to images (CT, CTA, X-Ray, MR, MRA and ultrasound) of the anatomy

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|--|
|-------------------------------------------------|--|

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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## 510(K) SUMMARY MICROSCOPE NAVIGATION 1.0

IN ACCORDANCE WITH REQUIREMENTS OF 21 CFR PART 807.92

| Manufacturer: | Brainlab AG<br>Olof-Palme-Straße 9<br>81829 Munich<br>Germany |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | Oliver Fleig |
| Contact person: | Alexander Schwiersch |
| Summary date | June 20, 2017 |
| Device | Microscope Navigation |
| Trade name | Microscope Navigation Software |
| Common name: | Frameless Stereotaxic Navigation System |
| Classification name: | Neurological Stereotaxic Instrument (21 CFR 882.4560, Product Code HAW) |
| Predicate Device: | K082060 VECTORVISION CRANIAL |
| Regulatory Class: | Class II |
| Regulation Number: | 882.4560 |
| Intended use: | The Brainlab Navigation System - Microscope Navigation Software is a software<br>module, that when used with a Brainlab navigation system and compatible instrument<br>accessories, is intended as image guided planning and navigation system to enable<br>open and minimally invasive surgery.<br><br>It links an instrument and the view of the surgical field (e.g. video, view through surgical<br>microscope) to a virtual computer image space on patient image data being processed<br>by the navigation workstation. The system is indicated for any medical condition in<br>which a reference to a rigid anatomical structure can be identified relative to images<br>(CT, CTA, X-Ray, MR, MRA and ultrasound) of the anatomy |

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| Device description: | The Microscope Navigation Software (also referred to as subject device or Microscope<br>App) is a software. It runs on a Brainlab navigation system consisting of a computer, a<br>display and an IR tracking camera (referred to as platform) and a Brainlab Image<br>Guided Surgery software (referred to as IGS software).<br>The Microscope Navigation encapsulates microscope specific functionality and<br>separates it from the IGS software.<br>The device interfaces with the IGS software and e.g. utilizes the registration provided<br>by the IGS software. |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| The device assists surgeries where a surgical microscope is used. It provides<br>information based on the field of view through the microscope, the microscope position<br>relative to the patient and the medical imaging data of the patient.<br>The subject device provides functionality to verify and correct a patient registration.<br>The Microscope Navigation does not provide its own registration. | |
| Reason for 510(k)<br>submission: | New device. |

#### Substantial Microscope Navigation has been verified and validated using non-clinical data equivalence: according to Brainlab procedures for product design and development. The information provided by Brainlab in this 510(k) application supports the claim of substantial equivalence to the predicate device VectorVision Cranial.

Microscope Navigation separates microscope specific functionality in an separate application. Microscope specific views are bundled in this application.

Comparison of Subject Device and Predicate Device

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| | Predicate Device<br>VectorVision Cranial K082060 | Subject Device<br>Microscope Navigation |
|------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The Brainlab Cranial IGS System is<br>intended to be an intra-operative image<br>guided localization system to enable<br>minimally invasive surgery. It links a<br>freehand probe, tracked by a magnetic<br>sensor system or a passive marker sensor<br>system to a virtual computer image space<br>on patient image data being processed by<br>the navigation workstation.<br><br>The system is indicated for any medical<br>condition in which the use of stereotactic<br>surgery may be appropriate and where a<br>reference to a rigid anatomical structure,<br>such as the skull, a long bone, or vertebra,<br>can be identified relative to a CT, CTA, X-<br>Ray, MR, MRA and ultrasound based<br>model of the anatomy.<br><br>Example procedures include but are not<br>limited to:<br><br>Cranial Procedures:<br>Tumor resections Skull base surgery Cranial biopsies Craniotomies/ Craniectomies | The Brainlab Navigation System -<br>Microscope Navigation Software is a<br>software module, that when used with a<br>compatible computer and compatible<br>instrument accessories, is intended as image<br>guided planning and navigation system to<br>enable open and minimally invasive surgery.<br><br>It links an instrument and the view of the<br>surgical field (e.g. video, view through<br>surgical microscope) to a virtual computer<br>image space on patient image data being<br>processed by the computer. The system is<br>indicated for any medical condition in which a<br>reference to a rigid anatomical structure can<br>be identified relative to images (CT, CTA, X-<br>Ray, MR, MRA and ultrasound) of the<br>anatomy |
| Brainlab<br>Platform | Brainlab Kolibri<br>Brainlab VectorVision | Brainlab Kick<br>Brainlab Curve |
| Operating<br>System | Windows XP | Windows 7<br>Windows 8.1 |
| Application(Use) | Cranial Procedures: Tumor resections Skull base surgery Cranial biopsies Craniotomies/ Craniectomies | Cranial Procedures: Tumor resections Skull base surgery Cranial biopsies Craniotomies/Craniectomies |
| GUI | Microscope functionality integrated in the<br>predicated device software | Microscope separated from predicated<br>device. Microscope specific views |
| Tracking<br>technology | passive, reflective markers | passive, reflective markers |
| | Predicate Device<br>VectorVision Cranial K082060 | Subject Device<br>Microscope Navigation |
| Changes to<br>Predicate<br>Device: | | Microscope Navigation separates microscope<br>specific functionality from the predicate<br>device.<br>Microscope Navigation adds a functionality to<br>adjust small deviations in patient to data set<br>registration (referred to as Registration<br>Update or Navigation Update in the technical<br>file). The adjustment is based on the<br>discrepancy between data to patient overlay |

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### Verification summary:

| Test | Test Method Summary | Results |
|------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Microscope focus<br>point accuracy | The focal point crosshair is aligned to a<br>landmark on a phantom for different<br>working distances. The distance<br>between landmark and focus point<br>measured by the IGS System. | The accuracy of the focus point in the focal<br>plane is 1.2 mm +/- 0.5 mm (99th percentile<br>2.4 mm).<br>The three-dimensional error including the<br>distance of the focus point is measured to<br>1.9 mm +/- 1.0 mm (99th percentile 4.6 mm). |
| Navigation<br>Update | The Navigation Update is performed on<br>a phantom for different initial registration<br>accuracies. The accuracy of the initial<br>accuracy is compared to the accuracy<br>after an update on landmarks on the<br>phantom. | The Navigation Update can improve<br>registration errors.<br>For translations and rotations parallel to the<br>focus plane the Navigation Update is accurate<br>up to 0.8 mm +/- 0.3 mm (99th percentile<br>1.4 mm). |

The subject device is part of a set of application of an IGS system. The errors above are measured under a OR setup conditions with optimal paired-point registrations. The ground accuracy provided by the subject device is sufficient to assess navigation accuracy repeatedly throughout a procedure and identify deviations.

The subject device uses identical calibration methods. The tracking method and algorithms are identical. Instrument design and marker geometry is unchanged. The subject device is substantial equivalent to its predecessor.

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#### Validation summary:

The validation comprises usability tests which to ensure that the user interface can be used safely and effectively. All tests were rated as successfully passed according to their acceptance criteria. The non-clinical validation has been performed with software and equipment that are identical or equivalent to the final version of the product.