IPLAN

K053127 · Brainlab AG · HAW · Feb 9, 2006 · Neurology

Device Facts

• Record ID: K053127
• Device Name: IPLAN
• Applicant: Brainlab AG
• Product Code: HAW · Neurology
• Decision Date: Feb 9, 2006
• 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 is to prepare and present patient and image data based on CT, MR, Xray(Fluoro), including - image preparation . - image fusion . - image segmentation . where the result is used for the creation of treatment plans for Stereotactic Surgery: - Surgery Planning The Surgery Planning is a tool for pre- and intraoperative stereotactic surgery planning based on stereotactic systems. Multiple graphical display functions and 3-dimensional views of anatomical structures offer effective and efficient means of presenting the anatomical data for diagnostic and surgical planning. Computer-graphic simulation in various views of a chosen probe path can help prevent probe intersections with unwanted, critical structures or vessels. The surgeon can interactively change a probe path simulation through the image slices in the software with online calculation of the accompanying arc settings and graphical manipulation to aid in optimizing his approach. - BrainMAP The BrainMAP module is a tool, which defines two and three-dimensional information about anatomical structures of the human brain for pre- and intraoperative planning of stereotactic procedures. These contours are defined and described by TalairactyTournoux and/or Schaltenbrand/Wahren based brain atlases. The user is provided with information about the various functional and anatomical areas of the brain. These positions of the structures have to be correlated with every patients brain data. The correlation is defined by a procedure defined by Talairach/Tournoux. Using their grid system to divide the brain in particular areas, the program will be able to provide matching data for different patient data. BrainMAP may be used alone or in conjunction with neurosurgery. - Functional Planning The Functional Planning is based on Surgery Planning, which gives two- and three dimensional online information of a stereotactical surgical instrument (electrodes) for a neurosurgical functional treatment using a stereotactic arc. The user is provided with information by numerical results and by various displays and reconstruction planes based on patient images (CT, MRI, PET, SPECT) about the position and orientation relative to the patient of his surgical instrument to perform stimulation and treatment on to a preplanned trajectory . The software is capable of displaying the trajectory and functional areas of the brain based on BrainMAP online on the screen and recording the stimulations by storing positions of the electrodes. The Functional Planning is intended to be used with patients where measurement, stimulation and placement of electrodes in the brain (pallidotomy) are part of the treatment. The stereotactic arc system is useful for placing these electrodes or using the instruments during the treatment and in the planning phases of the functional treatment. In addition iPlan's indications for use is to prepare and present patient and image data based on CT, MR, Xray(Fluoro) including - image preparation . - image fusion . - image segmentation . where the result is preplanned data to be used by other BrainLAB medical devices such as VectorVision (for performing the planned treatment) where these medical devices are used for: - Image Guided Surgery BrainLAB's Image Guided Surgery system is intended to be an intraoperative image quided localization system to enable minimally invasive surgery where the image guided surgery system is indicated for any medical condition in which the use of stereotactic surgery may be considered to be appropriate and where a reference to a rigid anatomical structure, such as the skull, a long bone, or vertebra, can be identified relative to a CT, Xray or MR based model of the anatomy. Example procedures include but are not limited to: - Cranial procedures - Spine procedures . - ENT procedures . - FiberTracking FiberTracking's indication for use is to prepare and present patient and image data based on MRI scanned with diffusion-weighted sequences. These diffusion images are used for the calculation and display of fiber bundles in a selected region of interest. The created treatment plans of iPlan! FiberTracking can be used with other iPlan! treatment plans and other BrainLAB medical devices such as VectorVision, where this medical device is used for image guided surgery. - BOLD MRI iPlan BOLD MRI indication for use is to prepare image data based on BOLD (blood oxygen level dependent) MRI scan studies and display the result as parametric images. When interpreted by a trained physician or surgeon this information may be used with other anatomical information for planning and image guided surgery.

Device Story

iPlan BOLD MRI is a software module for the iPlan planning system. It processes BOLD (blood oxygen level dependent) MRI sequences to visualize susceptibility changes as parametric images. Used by surgeons/physicians in clinical settings for pre-operative planning and image-guided surgery. Input: BOLD MRI scan data. Transformation: Processing of MRI sequences to generate parametric maps of susceptibility changes. Output: Parametric images displayed on screen. Clinical utility: Provides anatomical and functional information to assist in surgical planning and trajectory optimization; helps surgeons identify functional brain areas relative to anatomical structures. Benefits: Enables minimally invasive surgical approaches by providing enhanced visualization of brain function, potentially improving surgical precision and patient outcomes.

Clinical Evidence

No clinical data provided. Safety and effectiveness were established through internal verification and validation procedures.

Technological Characteristics

Software-based module for BOLD MRI sequence processing. Operates on the existing iPlan planning system platform. Visualizes MRI susceptibility changes as parametric images. No specific hardware or material requirements listed.

Indications for Use

Indicated for patients undergoing stereotactic surgery, including cranial, spine, and ENT procedures, requiring pre- and intraoperative planning, image-guided localization, or functional neurosurgical treatment (e.g., pallidotomy).

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

• BrainLAB iPlan (K041703)

Submission Summary (Full Text)

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/6.5-3127

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# FEB 9 510 (k) Summary of Safety and Effectiveness for iPlan BOLD MRI

2006

#### Manufacturer:

| Address: | BrainLAB AG |
|-----------------|--------------------------|
| | Ammerthalstrasse 8 |
| | 85551 Heimstetten |
| | Germany |
| | Phone: [phone] |
| | Fax: [phone] |
| Contact Person: | Mr. Rainer Birkenbach |
| Summary Date: | September 29, 2005 |

### Device Name: iPlan

The existent iPlan Planning System should be amended with the module BOLD MRI.

| Trade name: | iPlan (iPlan Cranial, iPlan Stereotaxy, iPlan ENT, iPlan RT, iPlan NET, iPlan FLOW) |
|-----------------------------|-------------------------------------------------------------------------------------|
| Common/Classification Name: | Planning System/Stereotaxic Instrument |

#### Predicate Device: BrainLAB iPlan (K041703)

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

### Intended Use:

iPlan's indications for use is to prepare and present patient and image data based on CT, MR, X-ray(Fluoro), including

- image preparation .
- image fusion .
- image segmentation .

where the result is used for the creation of treatment plans for Stereotactic Surgery:

### - Surgery Planning

The Surgery Planning is a tool for pre- and intraoperative stereotactic surgery planning based on stereotactic systems. Multiple graphical display functions and 3-dimensional views of anatomical structures offer effective and efficient means of presenting the anatomical data for diagnostic and surgical planning. Computer-graphic simulation in various views of a chosen probe path can help prevent probe intersections with unwanted, critical structures or vessels.

The surgeon can interactively change a probe path simulation through the image slices in the software with online calculation of the accompanying arc settings and graphical manipulation to aid in optimizing his approach. - BrainMAP

The BrainMAP module is a tool, which defines two and three-dimensional information about anatomical structures of the human brain for pre- and intraoperative planning of stereotactic procedures. These contours are defined and described by TalairactyTournoux and/or Schaltenbrand/Wahren based brain atlases.

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[K053127]

Page

The user is provided with information about the various functional and anatomical areas of the brain. These positions of the structures have to be correlated with every patients brain data. The correlation is defined by a procedure defined by Talairach/Tournoux. Using their grid system to divide the brain in particular areas, the program will be able to provide matching data for different patient data. BrainMAP may be used alone or in conjunction with neurosurgery.

#### - Functional Planning

The Functional Planning is based on Surgery Planning, which gives two- and three dimensional online information of a stereotactical surgical instrument (electrodes) for a neurosurgical functional treatment using a stereotactic arc. The user is provided with information by numerical results and by various displays and reconstruction planes based on patient images (CT, MRI, PET, SPECT) about the position and orientation relative to the patient of his surgical instrument to perform stimulation and treatment on to a preplanned trajectory .

The software is capable of displaying the trajectory and functional areas of the brain based on BrainMAP online on the screen and recording the stimulations by storing positions of the electrodes.

The Functional Planning is intended to be used with patients where measurement, stimulation and placement of electrodes in the brain (pallidotomy) are part of the treatment. The stereotactic arc system is useful for placing these electrodes or using the instruments during the treatment and in the planning phases of the functional treatment.

In addition iPlan's indications for use is to prepare and present patient and image data based on CT, MR, Xray(Fluoro) including

- image preparation .
- image fusion .
- image segmentation .

where the result is preplanned data to be used by other BrainLAB medical devices such as VectorVision (for performing the planned treatment) where these medical devices are used for:

#### - Image Guided Surgery

BrainLAB's Image Guided Surgery system is intended to be an intraoperative image quided localization system to enable minimally invasive surgery where the image guided surgery system is indicated for any medical condition in which the use of stereotactic surgery may be considered to be appropriate and where a reference to a rigid anatomical structure, such as the skull, a long bone, or vertebra, can be identified relative to a CT, Xray or MR based model of the anatomy.

Example procedures include but are not limited to:

- Cranial procedures �
- Spine procedures .
- ENT procedures .

#### - FiberTracking

FiberTracking's indication for use is to prepare and present patient and image data based on MRI scanned with diffusion-weighted sequences. These diffusion images are used for the calculation and display of fiber bundles in a selected region of interest. The created treatment plans of iPlan! FiberTracking can be used with other iPlan! treatment plans and other BrainLAB medical devices such as VectorVision, where this medical device is used for image guided surgery.

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K053127

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#### - BOLD MRI

iPlan BOLD MRI indication for use is to prepare image data based on BOLD (blood oxygen level dependent) MRI scan studies and display the result as parametric images. When interpreted by a trained physician or surgeon this information may be used with other anatomical information for planning and image guided surgery.

#### Device Description:

The BrainLAB iPlan BOLD MRI module is software used for processing BOLD (blood oxygen level dependent) MRI sequences and display of calculation results. The slight MRI susceptibility changes between the images are visualized as parametric images.

#### Substantial equivalence:

iPlan 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 iPlan (K041703).

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three horizontal bars above its head, all enclosed within a circle. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" is arranged around the perimeter of the circle.

Public Health Service

FEB 9 2006 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Rainer Birkenbach Executive Vice President Research and Development BrainLAB AG Ammerthalstrasse 8 85551 Heimstetten GERMANY

Re: K053127

Trade/Device Name: iPlan Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: II Product Code: HAW Dated: January 13, 2006 Received: January 17, 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. Drue. 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. 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 [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

barbara Buehn

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

Enclosure

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K05-3127

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## Indications for Use

510(k) Number (if known):

Device Name: iPlan

Indications For Use:

#### Intended Use:

iPlan's indications for use is to prepare and present patient and image data based on CT, MR, Xray(Fluoro), including

- . image preparation
- . image fusion
- image segmentation .

where the result is used for the creation of treatment plans for Stereotactic Surgery:

### - Surgery Planning

The Surgery Planning is a tool for pre- and intraoperative stereotactic surgery planning based on stereotactic systems. Multiple graphical display functions and 3-dimensional views of anatomical structures offer effective and efficient means of presenting the anatomical data for diagnastic and surgical planning. Computer-graphic simulation in various views of a chosen probe path, cach help prevent probe intersections with unwanted, critical structures or vessels.

The surgeon can interactively change a probe path simulation through the image slices in the software with on-line calculation of the accompanying arc settings and graphical manipulation to aid in optimizing his approach.

#### - BrainMAP

The BrainMAP module is a tool, which defines two and three-dimensional information about anatomical structures of the human brain for pre- and intraoperative planning of stereotactic procedures. These contours are defined and described by Talairach/Tournoux and/or Schaltenbrand/Wahren based brain atlases.

The user is provided with information about the position of the various functional and anatomical areas of the brain. These positions of the structures have to be correlated with every patients brain data. The correlation is defined by a procedure defined by Talairach/Tournoux. Using their nrd system to divide the brain in particular areas, the program will be able to provide matching data for different patient data. BrainMAP may be used alone or in conjunction with neurosurgery.

#### - Functional Planning

The Functional Planning is based on Surgery Planning, which gives two- and three dimensional online information of a stereotactical surgical instrument (electrodes) for a neurosurgical functional treatment using a stereotactic arc. The user is provided with information by numerical results and by various. displays and reconstruction planes based on patient images (CT, MRI, PET, SPECT) about than osition and orientation relative to the patient of his surgical instrument to perform stimulation and treatment on brain structures or to a preplanned trajectory .

The software is capable of displaying the trajectory and functional areas of the brain based on BrainMAP online on the screen and recording the stimulations by storing positions of the electrodes. The Functional Planning is inter tients where measurement, stimulation and placement of electrodes in the b in fight of the part of the treatment. The stereotactic arc system is useful for placing the system of Center the inst lyring the treatment and in the planning phases of the funct

Neurological Devices
Qabare brienm

Page 1 of 2

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In addition iPlan's indications for use is to prepare and present patient and image data based on CT, MR, X-ray(Fluoro) including

- . image preparation
- . image fusion
- image segmentation .

where the result is preplanned data to be used by other BrainLAB medical devices such as VectorVision (for performing the planned treatment) where these medical devices are used for:

### - Image Guided Surgery

BrainLAB's Image Guided Surgery system is intended to be an intraoperative image guided localization system to enable minimally invasive surgery where the image guided surgery system is indicated for any medical condition in which the use of stereotactic surgery may be considered to be appropriate and where a reference to a rigid anatomical structure, such as the skull, a long bone, or verfebra. can be identified relative to a CT, X-ray or MR based model of the anatomy.

Example procedures include but are not limited to:

- . Cranial procedures
- Spine procedures .
- ENT procedures .

#### - FiberTracking

FiberTracking's indication for use is to prepare and present patient and image data based on MRI scanned with diffusion-weighted sequences. These diffusion images are used for the calculation and display of fiber bundles in a selected region of interest. The created treatment plans of iPlan! FiberTracking can be used with other iPlan! treatment plans and other BrainLAB medical devices such as VectorVision, where this medical device is used for image guided surgery.

#### - BOLD MRI

iPlan BOLD MRI indication for use is to prepare image data based on BOLD (blood oxygen level dependent) MRI scan studies and display the result as parametric images. When interpreted by a trained physician or surgeon this information may be used with other anatomical information for planning and image guided surgery.

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)
M
Office of Device

neral, Restorative. and Neurological Devices

510(k) Number K053127

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