IPLAN (IPLAN CRANIAL, IPLAN STEREOTAXY, IPLAN ENT, IPLAN CMF, IPLAN VIEW, IPLAN SPINE)

K113732 · Brainlab AG · JAK · May 7, 2012 · Radiology

Device Facts

• Record ID: K113732
• Device Name: IPLAN (IPLAN CRANIAL, IPLAN STEREOTAXY, IPLAN ENT, IPLAN CMF, IPLAN VIEW, IPLAN SPINE)
• Applicant: Brainlab AG
• Product Code: JAK · Radiology
• Decision Date: May 7, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1750
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

iPlan's indications for use are the viewing, presentation and documentation of medical imaging, including different modules for image processing, image fusion, atlas assisted visualization and segmentation, intraoperative functional planning where the output can be used e.g. with stereotactic image guided surgery or other devices for further processing and visualization. Example procedures include but are not limited to: - Planning and simulation of cranial surgical procedures such as tumor resection, l shunt placement, minimal-invasive stereotactic interventions, biopsy, planning and simulation of trajectories for stimulation and electrode recording - ENT procedures such as sinus surgery, tumor surgery - -Spine procedures such as tumor surgery, pedicle screw planning, vertebroplasty planning - iPlan View is an application which is intended to be used for reviewing existing treatment plans - Planning and simulation of cranio-maxillofacial procedures - Typical users of iPlan are medical professionals, including but not limited to surgeons and radiologists.

Device Story

iPlan is a software-based treatment planning application for medical professionals (surgeons, radiologists). It imports medical imaging (DICOM) to perform image fusion, segmentation, and atlas-assisted visualization. Modules support cranial, ENT, spine, and CMF procedures. Key functions include: automatic/manual registration, BOLD MRI mapping, DTI fiber tracking, trajectory planning, and stereotactic arc calculation. Outputs are treatment plans, 3D models, and surgical trajectories used for image-guided surgery or further processing. The device aids clinical decision-making by providing anatomical visualization and surgical simulation, potentially improving surgical precision and patient outcomes.

Clinical Evidence

Clinical evaluation based on literature studies. No prospective clinical trials conducted. Performance validated via bench testing, integration testing, and usability workshops with prototype software. Compatibility with previous versions and predicate workflows documented in review protocols.

Technological Characteristics

Software-based planning application. Supports DICOM and STL data formats. Features include image fusion (CT, MRI, PET, SPECT), automatic/manual segmentation, DTI fiber tracking, BOLD MRI processing, and 3D volume rendering. Connectivity via standard DICOM/archive imports. Operates as a standalone planning workstation.

Indications for Use

Indicated for medical professionals (surgeons, radiologists) to view, present, and document medical imaging for surgical planning and simulation. Procedures include cranial (tumor resection, shunt, biopsy, stereotactic interventions, electrode recording), ENT (sinus/tumor surgery), spine (tumor, pedicle screw, vertebroplasty), and cranio-maxillofacial surgery.

Regulatory Classification

Identification

A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Predicate Devices

• iPlan (K101627)
• Maxilim (K052424)

Submission Summary (Full Text)

{0}------------------------------------------------

510(k) Summarv iPlan

MAY - 7 2012

K113732

# 510(k) Summary- iPlan

## 1. Manufacturer

| Address: | Brainlab AG |
|----------|--------------------|
| | Kapellenstrasse 12 |
| | 85622 Feldkirchen |
| | Germany |
| Phone: | [phone] |
| Fax: | [phone] |

Contact Person: Mr. Alexander Schwiersch

November 17, 2011 Summary Date:

## 2. Device Name

| Trade name (*): | iPlan Cranial, iPlan Stereotaxy<br>iPlan ENT, iPlan Spine, iPlan View, iPlan CMF |
|-----------------------------|----------------------------------------------------------------------------------|
| Common/Classification Name: | Planning System, Stereotactic Instrument |

# 3. Predicate Devices iPlan (K101627) Maxilim (K052424)

## 4. Device Description

iPlan is a software based treatment planning application providing functionalities like viewing, processing and documentation of medical data including different modules for image preparation, image fusion, image segmentation where the result is a treatment plan that can be used e.g. for stereotactic and/or image guided surgery.

#### 5. Intended use

iPlan's indications for use are the viewing, presentation and documentation of medical imaging, including different modules for image processing, image fusion, atlas assisted visualization and segmentation, intraoperative functional planning where the output can be used e.g. with stereotactic image guided surgery or other devices for further processing and visualization.

Example procedures include but are not limited to:

- Planning and simulation of cranial surgical procedures such as tumor resection, l shunt placement, minimal-invasive stereotactic interventions, biopsy, planning and simulation of trajectories for stimulation and electrode recording

{1}------------------------------------------------

- ENT procedures such as sinus surgery, tumor surgery -
- -Spine procedures such as tumor surgery, pedicle screw planning, vertebroplasty planning
- iPlan View is an application which is intended to be used for reviewing existing treatment plans
- Planning and simulation of cranio-maxillofacial procedures -

Typical users of iPlan are medical professionals, including but not limited to surgeons and radiologists.

| # | Sub-module | Changed<br>*) | iPlan<br>CMF | iPlan<br>Cranial | iPlan<br>ENT | iPlan<br>Stereotaxy | iPlan<br>Spine | iPlan<br>View |
|----|--------------------------|---------------|--------------|------------------|--------------|---------------------|----------------|---------------|
| 1 | Load and Import | No | X | X | X | X | X | X |
| 2 | View and Adjustment | No | X | X | X | | X | X |
| 3 | Registration Points | No | X | X | X | X | X | |
| 4 | ACPC Localization | No | | | | X | | |
| 5 | Localization | No | | | | X | | |
| 6 | Image Fusion | No | X | X | X | X | X | X |
| 7 | Object Creation | No | X | X | X | X | X | |
| 8 | Advanced Object Planning | No | X | X | X | | | |
| 9 | BOLD MRI mapping | No | | X | | X | | |
| 10 | Fiber Tracking | No | | X | | X | | |
| 11 | Trajectory planning | No | X | X | X | | X | |
| 12 | Stereotactic planning | No | | | | X | | |
| 13 | Electrode recording | No | | | | X | | |
| 14 | Save and Export | No | X | X | X | X | X | |
| 15 | 3D Functionalities | Yes | X | X | X | X | X | X |

# 6. Technological Characteristics

*) changed compared to iPlan K101627

#### Description of sub-modules:

| # | Sub-module | Description |
|----|-----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1 | Load and Import | Load existing treatment data from different data sources,<br>Import patient data from DICOM or other archive types,<br>manage (delete/copy/move) patient folders |
| 2 | View and Adjustment | Review patient data in various reconstructions or overlay,<br>side-by-side comparison of different modalities, aligning<br>the data set orientation, import or export screenshot<br>images |
| 3 | Registration Points | Automatic detection of CT or MR registration markers for<br>navigation, manual placement of markers and anatomical<br>landmarks |
| 4 | ACPC Localization | This planning task allows the definition of AC/PC<br>coordinate system |
| 5 | Localization | Assign a localizer frame for CT or MRI localization<br>Perform automatic detection of localizer rods |
| 6 | Image Fusion | Align available image sets automatically, manually or<br>using landmarks for various combinations of images sets<br>and modalities such as CT, MRI, PET and SPECT.<br>Visual verification of alignment. |
| 7 | Object Creation | Outline anatomical structures using manual or automatic<br>segmentation methods. Advanced manipulation for 3D<br>objects with scaling, logical operations and object<br>splitting.<br>Volumetric measurements based on the created 3D<br>objects |
| 8 | Advanced Object<br>Planning | Mirror and split segmented structures |
| 9 | BOLD MRI mapping | Processing of blood oxygen level dependent (BOLD) MRI<br>data<br>Definition of block design functional task, calculation of<br>activation areas based on BOLD MRI data, time series<br>view for activation signal, creation of 3D objects from<br>activation areas |
| 10 | Fiber Tracking | Processing of diffusion tensor imaging (DTI) using<br>various ways to define and combine seed regions of<br>interest.<br>Definition of multiple fiber bundles and creation of 3D<br>objects from fiber bundles.<br>Volumetric measurements and detailed fiber information |
| 11 | Trajectory planning | Plan pathways for surgical instruments or resection,<br>definition of entry, target points and diameter for<br>trajectories |
| 12 | Stereotactic planning | Planning of stereotactic trajectories<br>Usage of AC/PC coordinates and Schaltenbrandt-Wahren<br>atlas<br>Calculation of stereotactic arc settings for planned<br>trajectories |
| 13 | Electrode recording | Planning of parallel electrode tracks<br>Enter and display microelectrode recording and<br>stimulation results, display information stepwise along<br>tracks |
| 14 | Save and Export | Save the current treatment plan to the patient folder<br>Export the results to the navigation, as DICOM or STL<br>format |
| 15 | 3D Functionalities | Three-dimensional volume based rendering for different<br>image modalities and planning data.<br>Extension of standard view types and options with<br>structure specific view types |

{2}------------------------------------------------

i

·

{3}------------------------------------------------

## 7. Assessment of non-clinical performance data: non clinical tests

Usability workshops were performed with prototype versions of the software which has no relevant user interface differences to the final version and is therefore equivalent to the final version in respect to the usability validation.

Moreover an Expert Group Review has worked with Brainlab in order to tailor the existing iPlan planning functionalities to the specific needs of CMF surgeons.

#### 8. Clinical Evaluation/Validation

The clinical evaluation has been based on literature studies.

#### 9. Application performance testing

On different levels of development (module, subsystem, system) specific bench and integration tests were conducted. Internal standards were tested and documented as conformance report, environment compatibility and interfaces. Compatibility with previous version and comparable workflows to predicate devices were documented in corresponding review protocols.

#### 10. Conclusions

The submitted information in this premarket notification is complete and supports a substantial equivalence decision.

{4}------------------------------------------------

Image /page/4/Picture/0 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

# DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

MAY - 7 2012

Mr. Alexander Schwiersch Regulatory Affairs Manager Brainlab AG Kapellenstrasse 2 85622 Feldkirchen GERMANY

Re: K113732

Trade/Device Name: iPlan Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK, LLZ Dated: April 30, 2012 Received: May 4, 2012

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.

If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of

{5}------------------------------------------------

medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. 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/ReportalProblem/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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely Yours,

Janine M. Morris

Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

{6}------------------------------------------------

# Indications for Use

510(k) Number (if known): にいる732

Device Name: iPlan

#### Indications For Use:

iPlan's indications for use are the viewing, presentation and documentation of medical imaging, including different modules for image processing, image fusion, atlas assisted visualization and segmentation, intraoperative functional planning where the output can be used e.g. with stereotactic image guided surgery or other devices for further processing and visualization.

Example procedures include but are not limited to:

- Planning and simulation of cranial surgical procedures such as tumor resection, shunt placement, minimal-invasive stereotactic interventions, biopsy, planning and simulation of trajectories for stimulation and electrode recording
- ENT procedures such as sinus surgery, tumor surgery
- Spine procedures such as tumor surgery, pedicle screw planning, vertebroplasty planning
- iPlan View is an application which is intended to be used for reviewing existing treatment plans
- Planning and simulation of cranio-maxillofacial procedures

Typical users of iPlan are medical professionals, including but not limited to surgeons and radiologists.

Prescription Use _ X (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)

Marlon D. Kirk

Division Sign-Off Division of Radiological Devices Office of In Vitro Division of Raciologics Evaluation and Safety

K113732
510K

Page