Elements Image Fusion, Elements Cranial Distortion Correction, Elements Spine Curvature Correction, Elements TRAM

K170816 · Brainlab AG · LLZ · Sep 26, 2017 · Radiology

Device Facts

• Record ID: K170816
• Device Name: Elements Image Fusion, Elements Cranial Distortion Correction, Elements Spine Curvature Correction, Elements TRAM
• Applicant: Brainlab AG
• Product Code: LLZ · Radiology
• Decision Date: Sep 26, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

The Image Fusion Element is an application for the co-registration of image data within medical procedures by using rigid and deformable registration methods. It is intended to align anatomical structures between data sets.

Device Story

Software application for co-registering volumetric medical image data (e.g., MR, CT). Inputs: two or more volumetric datasets. Transformation: rigid registration to adjust spatial position/orientation; deformable registration to compensate for distortion or spatial deviation. Outputs: co-registered datasets, visualization of corresponding anatomical planes, and processed data highlighting differences between scanning sequences or treatment response. Used in hospital offices, operating rooms, or surgical suites. Operated by medical professionals (neurosurgery, traumatology, radiotherapy planning) and assistants. Healthcare providers use output to visualize planning content (objects, points, trajectories) across datasets, aiding surgical navigation and treatment planning. Benefits: improved anatomical alignment for surgical guidance and radiotherapy accuracy.

Clinical Evidence

Bench testing only. Verification and validation performed according to internal processes and 21 CFR 820.30(g). Usability testing conducted to ensure safe operation and risk mitigation.

Technological Characteristics

Software-based image processing system. Features rigid and deformable registration algorithms. Operates on standard computer hardware in clinical environments. Connectivity via import/export of medical data. No specific hardware materials or energy sources defined as it is a software application.

Indications for Use

Indicated for clinical workflows benefiting from co-registration of image data, including navigation systems, medical data information terminals for image-guided surgery, and treatment planning software for radiosurgery and radiotherapy. No specific patient population limitations (age, gender, disease state).

Regulatory Classification

Identification

A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.

Special Controls

*Classification.* Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).

Predicate Devices

• Mirada XD (K101228)
• iPlan (K113732)

Submission Summary (Full Text)

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

September 26, 2017

Brainlab AG % Mr. Alexander Schwiersch Regulatory Affairs Manager Olof-Palme-Str. 9 Munchen 81829 GERMANY

Re: K170816

Trade/Device Name: Image Fusion Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ, JAK Dated: September 15, 2017 Received: September 21, 2017

Dear Mr. 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 (reporting of medical device-

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related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education (DICE) at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education (DICE) at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

Michael D. O'Hara For

Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known)

K170816

Device Name Image Fusion

Indications for Use (Describe)

The Image Fusion Element can be used in clinical workflows that benefit from the co-registration of image data. For example, this applies to navigation systems or medical data information terminals for image guided surgery in general as well as for treatment planning software for radiotherapy. The device itself does not have specific clinical indications.

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

| <div> <span style="font-size:16px">☒</span> Prescription Use (Part 21 CFR 801 Subpart D) </div> |
|---------------------------------------------------------------------------------------------------|
| <div> <span style="font-size:16px">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </div> |

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# 510 (K) SUMMARY OF SAFETY AND EFFECTIVENESS FOR IMAGE FUSION

| Manufacturer: | Brainlab AG<br>Olof-Palme-Str. 9<br>81829 München<br>Germany<br><br>Phone: [phone]<br>Fax: [phone] |
|---------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | Rainer Birkenbach |
| Contact person: | Alexander Schwiersch |
| Summary date: | 9/15/2017 |
| Device: | Image Fusion |
| Trade name: | Elements Image Fusion<br>Elements Cranial Distortion Correction<br>Elements Spine Curvature Correction<br>Elements Contrast Clearance Analysis |
| Common/Classification Name: | System, Image Processing, Radiological |
| Main Predicate Device: | Mirada XD (K101228) |
| Secondary Predicate Device: | iPlan (K113732) |
| Device classification name: | Picture archiving and communications system |
| Regulatory Class: | Class II |
| Regulation Number: | 21 CFR 892.2050 |
| Product Code: | LLZ |
| Intended use: | The Image Fusion Element is an application for the co-registration of image<br>data within medical procedures by using rigid and deformable registration<br>methods. It is intended to align anatomical structures between data sets. |
| Indications for use: | The Image Fusion Element can be used in clinical workflows that benefit<br>from the co-registration of image data. For example, this applies to<br>navigation systems or medical data information terminals for image<br>processing or image guided surgery in general as well as for treatment<br>planning software for radiosurgery and radiotherapy. The device itself does<br>not have specific clinical indications. |
| Device description: | The Image Fusion Element is intended to co-register volumetric medical<br>image data (e.g. MR, CT). It allows rigid image registration to adjust<br>different spatial position and orientation of two data sets. It also offers<br>deformable registration to compensate image distortion or spatial deviation<br>between image acquisitions. |
| | The Image Fusion Element gives the possibility to show basic planning<br>content (e.g. objects, points, trajectories) defined from one dataset on<br>another dataset and to display datasets of corresponding anatomic planes<br>simultaneously. Further it could process co-registered data to highlight<br>differences between distinct scanning sequences or to assess the response<br>to a treatment. |
| | Operator Profile<br>The application is intended to be used by medical professionals and their<br>assistants working in the field of neurosurgery, traumatology or radiotherapy<br>planning. |
| | Patient Population<br>There are no demographic, regional or cultural limitations for patients. |
| | Conditions of use<br>The Image Fusion Element is designed to be used<br>- in a hospital office environment or at any other location offering a<br>computer<br>- in an operating room / suite or in rooms appropriate for surgical<br>interventions |
| Substantial<br>equivalence: | Image Fusion is part of a new software generation at Brainlab. It contains<br>features for rigid fusion (co-registration) of medical image data, verification<br>of such calculation results as well as a user interface which is substantially<br>equivalent to the reference predicate device iPlan 3.0 (K113732). Further it<br>contains features for deformable registration (elastic fusion) of cranial or<br>spinal image data as well as tools for assessing results of a treatment,<br>which are substantially equivalent to the primary predicate device Mirada<br>XD (K101228). |
| Conclusion: | Functionality and features considered as substantially equivalent have been<br>verified and validated. The system Image Fusion with its set of<br>functionalities is substantially equivalent to its predicate devices. |
| Changes to Predicate<br>Device: | The new Image Fusion 3.0 Element enlarges the portfolio of already cleared<br>Brainlab Elements. Central changes compared to the main predicate device<br>iPlan 3.0 are based in focusing on image fusion functionality in general (co-<br>registration and deformable registration). |

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# Technological Characteristics:

| | Cleared device<br>feature/specifications<br>Mirada XD (K101228) | Modified device<br>feature/specifications<br>Image Fusion 3.0 |
|-------------------------------------------------------|------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|
| Characteristics | | |
| Starting of a<br>deformation<br>calculation | Yes | Yes |
| Verification of<br>deformation<br>(correction) result | Yes | Yes |
| | Cleared device<br>feature/specifications | Modified device<br>feature/specifications |
| | iPlan 3.0.6 (K113732):<br>- Cranial<br>- ENT<br>- CMF<br>- Stereotaxy<br>- Spine<br>- Flow<br>- View | Image Fusion 3.0:<br>- Image Fusion<br>- Cranial Distortion<br>Correction<br>- Spine Curvature<br>Correction<br>- Contrast Clearance<br>Analysis |
| Characteristics | | |
| Selection of intended<br>application container | Yes | Yes |
| Import/export of<br>medical data | Yes | Yes |
| Display of data,<br>Switching of view<br>orientation | Yes | Yes |
| Starting of a rigid<br>fusion calculation | Yes | Yes |
| Verification of rigid<br>fusion result | Yes | Yes |

Verification/validation summary:

# Verification

Verification has been performed according to the Verification Plan and following internal processes to demonstrate that design specifications are met by the device.

# Validation

Validation of the functionalities has been performed in accordance with the Validation Plan and following internal processes. Usability tests have been performed as well to ensure that the device can be used safely and that measures against potential use related risks are effective. The validation has been performed with software and units that are considered equivalent to the final version of the product (in terms of functionality and user interface), as demanded by 21 CFR 820.30 (g).