IPLAN RT FIBERTRACKING

K052220 · Brainlab AG · IYE · Sep 30, 2005 · Radiology

Device Facts

• Record ID: K052220
• Device Name: IPLAN RT FIBERTRACKING
• Applicant: Brainlab AG
• Product Code: IYE · Radiology
• Decision Date: Sep 30, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

iPlan RT FiberTracking's indications for use is to prepare and present patient and image data based on CT, MR, Angiographic and other imaging sources including - image preparation - - image localization - - image fusion - - image segmentation - - isocenter handling - - plan review and approval - - fiber tracking - where the result is used for stereotactic radiation treatment planning that is intended for use in stereotactic, conformal, computer planned, LINAC based radiation treatment of cranial, head and neck and extracranial lesions. iPlan RT 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 TT FiberTracking can be used million in a scienced region of interest. The StainLAB medical devices such as BrainSCAN, iPlan RT Image, and iPlan RT Dose where this medical device is used for radiotherapy treatment planning.

Device Story

iPlan RT FiberTracking is a software module enhancing Intuition Image functionality. It imports and processes diffusion-weighted MRI data (DTI) to calculate and display fiber bundles within a selected region of interest. The device performs image preparation, localization, fusion, and segmentation. It is used by clinicians for stereotactic radiation treatment planning for cranial, head and neck, and extracranial lesions. The output consists of visualized fiber tracks and treatment plans, which are integrated with other BrainLAB systems like BrainSCAN, iPlan RT Image, and iPlan RT Dose. This assists physicians in radiotherapy planning, potentially improving treatment precision for lesions.

Clinical Evidence

No clinical data provided; substantial equivalence is based on bench testing and validation of software functionality.

Technological Characteristics

Software-based medical device for image processing and radiation treatment planning. Operates on DTI (diffusion-weighted MRI) data. Integrates with existing BrainLAB software platforms (Intuition Image, BrainSCAN, iPlan RT Image, iPlan RT Dose).

Indications for Use

Indicated for patients requiring stereotactic radiation treatment planning for cranial, head and neck, and extracranial lesions. Utilizes CT, MR, Angiographic, and diffusion-weighted MRI data for image preparation, fusion, segmentation, and fiber tracking.

Regulatory Classification

Identification

A medical charged-particle radiation therapy system is a device that produces by acceleration high energy charged particles (e.g., electrons and protons) intended for use in radiation therapy. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.

Predicate Devices

• iPlan! FiberTracking (K041703)
• Intuition Image (K032511)

Submission Summary (Full Text)

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SEP 3 0 2005

K05 22

# 5 Po 11 Summary of etv and Effectiveness for iPlan RT FiberTracking

#### Manufacturer:

| Address: | BrainLAB AG<br>Ammerthalstrasse 8<br>85551 Heimstetten<br>Germany<br>Phone: [phone]<br>Fax: [phone] |
|-----------------|--------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Mr. Per Persson |
| Summary Date: | August 11, 2005 |
| Device Name: | |
| Trade name: | iPlan RT FiberTracking |

Common/Classification Name:

Planning System / Medical charged-particle radiation therapy system

## Predicate Device: iPlan! FiberTracking (K041703). Intuition Image (K032511).

Device Classification Name: Medical charged-particle radiation therapy system Regulatory Class: Class II

## Indications For Use:

iPlan RT FiberTracking's indications for use is to prepare and present patient and image data based on CT, MR, Angiographic and other imaging sources including

- image preparation -
- image localization -
- image fusion -
- image segmentation -
- isocenter handling -
- plan review and approval
- fiber tracking -

where the result is used for stereotactic radiation treatment planning that is intended for use in stereotactic, conformal, computer planned, LINAC based radiation treatment of cranial, head and neck and extracranial lesions.

## Fiber Tracking:

iPlan RT 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

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fiber bundles in a selected region of interest. The created treatment plans of iPlan TT FiberTracking can be used million in a scienced region of interest. The StainLAB medical devices such as BrainSCAN, iPlan RT Image, and iPlan RT Dose where this medical device is used for radiotherapy treatment planning.

## Device Description:

iPlan RT FiberTracking is developed to enhance the functionality of Intuition Image software with the import and il lan in 11 Tiber Husking to do volupes (DTI). Additional to the basic functions of Intuition Image (viewing, drawing, planning of annuolen concernment of this application provides functions for the import and inflage fusion and attrootable racessing of the DTI data and the display of calculated fiber tracks.

#### Substantial equivalence:

Substantial equivalioner.
iPlan RT FiberTracking has been verified and validated according to BrainLAB's procedures for product design in in 11 i be rrucking nad boon vermes the safety and effectiveness of the system. The information provided by and developmont. The railer was found to be substantially equivalent with the predicate device iPlan! FiberTracking (K041703) and Intuition Image (K032511).

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Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo is circular in shape, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. Inside the circle is an abstract image of an eagle.

Public Health Service

Food and Drug Administratio 9200 Corporate Boulevard Rockville MD 20850

Mr. Rainer Birkenbach Executive Vice President BrainLAB AG Ammerthalstrasse 8 85551 Heimstetten Germany

SEP 3 0 2005

Re: K052220

Trade/Device Name: iPlan RT FiberTracking Regulation Number: 21 CFR 892.5050 Regulation Name: Medical chargedparticle radiation therapy system Regulatory Class: II Product Code: IYE, MUJ Dated: August 11, 2005 Received: August 15, 2005

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, Drug, and Cosmetic Act (Act) that do not requirc 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 (Premarket Approval), 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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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 one of the following numbers, based on the regulation number at the top of this letter:

| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|-----------------|----------------------------------|--------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 yours,

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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| 510(k) Number (if known): | Kp52222 |
|---------------------------|---------|
|---------------------------|---------|

Device Name:

iPlan RT FiberTracking

Indications For Use:

iPlan RT FiberTracking's indications for use is to prepare and present patient and image data based on CT, MR, Angiographic and other imaging sources including

- image preparation -
- image localization ﮯ
- image fusion -
- image seqmentation -
- isocenter handling -
- plan review and approval -
- fiber tracking

where the result is used for stereotactic radiation treatment planning that is intended for use in wholo the roban formal, computer planned, LINAC based radiation treatment of cranial, head and neck and extracranial lesions.

Fiber Tracking:

iPlan RT 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 mnt ooallify of fiber bundles in a selected region of interest. The created treatment plans of iPlan RT and display of can be used with other iPlan treatment plans and other BrainLAB medical devices such as BrainSCAN, iPlan RT Image, and iPlan RT Dose where this medical device is used for radiotherapy treatment planning.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)
OR

Over-The-Counter Use

(Optional Format I-2-96)

Division of Reproductive, Abdom