IPLAN

K101627 · Brainlab AG · HAW · Jun 3, 2011 · Neurology

Device Facts

• Record ID: K101627
• Device Name: IPLAN
• Applicant: Brainlab AG
• Product Code: HAW · Neurology
• Decision Date: Jun 3, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4560
• 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, shunt placement, minimal-invasive stereotactic interventions, biopsy, trajectory planning 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

Device Story

iPlan is a software-based surgical planning system for cranial, ENT, and spine procedures. It ingests medical imaging data (DICOM, CT, MRI, PET, SPECT) to provide visualization, image fusion, and segmentation. Users (surgeons/radiologists) perform tasks including anatomical landmark registration, BOLD MRI mapping, DTI fiber tracking, and trajectory planning for surgical instruments or electrodes. The system calculates stereotactic arc settings and generates 3D objects for surgical guidance. Output is exported to navigation systems or saved as DICOM/STL files. Used in clinical settings, it assists in pre-operative simulation and intraoperative planning, potentially improving surgical precision and patient outcomes by providing detailed anatomical and functional maps.

Clinical Evidence

Bench testing only. No clinical data presented. Performance was validated through module, subsystem, and system-level bench and integration tests, including conformance reports, environment compatibility, and interface testing. Comparison testing against the predicate device confirmed equivalent functionality.

Technological Characteristics

Software-based planning system; operates on dedicated Brainlab hardware or standard platforms meeting minimum requirements. Features include image fusion, segmentation, BOLD MRI mapping, and DTI fiber tracking. Connectivity via DICOM/STL export. Software-based processing; no specific hardware materials or energy sources defined.

Indications for Use

Indicated for medical professionals, including surgeons and radiologists, for viewing, processing, and planning surgical procedures. Procedures include cranial (tumor resection, shunt placement, biopsy, stimulation/electrode recording), ENT (sinus/tumor surgery), and spine (tumor surgery, pedicle screw/vertebroplasty planning).

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

• iPlan (K053127)

Submission Summary (Full Text)

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K101627

JUN - 3 2011

# 510 (k) Summary of Safety and Effectiveness for iPlan

### Manufacturer:

| Address: | Brainlab AG<br>Kapellenstrasse 12<br>85622 Feldkirchen<br>Germany |
|------------|-------------------------------------------------------------------|
| | Phone: [phone] |
| | Fax: [phone] |
| Submitter: | Mr. Rainer Birkenbach |

Contact Person: Mr. Alexander Schwiersch

Summary Date: April 21, 2011

# Device Name:

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

# Predicate Device:

iPlan (K053127)

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

# 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, trajectory planning 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

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

# Device Description

Following planning sub-modules are available in the functional applications:

| # | Sub-module | Changed<br>*) | iPlan<br>Cranial | iPlan<br>ENT | iPlan<br>Stereotaxy | iPlan<br>Spine | iPlan<br>View |
|----|-----------------------------|---------------|------------------|--------------|---------------------|----------------|---------------|
| 1 | Load and Import | yes | X | X | X | X | X |
| 2 | View and Adjustment | yes | X | X | | X | X |
| 3 | Registration Points | yes | X | X | X | X | |
| 4 | ACPC Localization | yes | | | X | | |
| 5 | Localization | yes | | | X | | |
| 6 | Image Fusion | yes | X | X | X | X | X |
| 7 | Object Creation | yes | X | X | X | X | |
| 8 | Advanced Object<br>Planning | yes | X | X | | | |
| 9 | BOLD MRI mapping | yes | X | | X | | |
| 10 | Fiber Tracking | yes | X | | X | | |
| 11 | Trajectory planning | yes | X | X | | X | |
| 12 | Stereotactic planning | yes | | | X | | |
| 13 | Electrode recording | yes | | | X | | |
| 14 | Save and Export | yes | X | X | X | X | |

*) changed compared to previous iPlan version

# Description of sub-modules:

.

| # | Sub-module | Description |
|----|--------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1 | Load and Import | Load existing treatment data from different data sources, Import patient data from DICOM or other archive types, manage (delete/copy/move) patient folders |
| 2 | View and Adjustment | Review patient data in various reconstructions or overlay, side-by-side comparison of different modalities, aligning the data set orientation, import or export screenshot images |
| 3 | Registration Points | Automatic detection of CT or MR registration markers for navigation, manual placement of markers and anatomical landmarks |
| 4 | ACPC Localization | This planning task allows the definition of AC/PC 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 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 various<br>ways to define and combine seed regions of 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 |

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The iPlan software can be used on a dedicated Brainlab system or other platforms with defined minimum requirements.

The iPlan software can be mainly used in combination with the Brainlab devices: iPlan Net, Digital Lightbox, VectorVision navigation, Kolibri navigation.

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K101627

# 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.

Side-by-side comparison testing of the new version of iPlan with it's predicate device was conducted to determine substantial equivalences of the new version of iPlan with it's predicate version.

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Image /page/4/Picture/1 description: The image shows the seal of the Department of Health & Human Services-USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" arranged around the top half of the circle. In the center of the seal is a stylized image of a bird, possibly an eagle, with its wings spread. The bird is composed of three curved lines, and below it are three wavy lines, possibly representing water.

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

JUN - 3 2011

BrainLab AG c/o Mr. Alexander Schwiersch Regulatory Affairs Manager Kapellenstrasse 12 Feldkirchen Germany 85622

Re: K101627

Trade/Device Name: iPlan Cranial, iPlan Stereotaxy, iPlan ENT, iPlan Spine, iPlan View Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: HAW Dated: May 13, 2011 Received: May 25, 2011

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. Iisting 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

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device-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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Q. Ci. Tim, m/

Malvina B. Evdelman. M.E Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

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K101627

# Indications for Use

510(k) Number (if known):

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

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

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)

tion Use

er 21 CFR 801.109)

(Division/Sign-Off)
Division of Ophthalmic, Neurological and Ear,
Throat Devices

Division of
Nose and Throat Devices

510(k) Number

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