INTUITION IMAGE

K032511 · Brainlab AG · LHN · Jan 21, 2004 · Radiology

Device Facts

• Record ID: K032511
• Device Name: INTUITION IMAGE
• Applicant: Brainlab AG
• Product Code: LHN · Radiology
• Decision Date: Jan 21, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

Intuition Image'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 - 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.

Device Story

Intuition Image is a software-based planning tool for stereotactic radiation therapy. It ingests CT, MR, and angiographic imaging data. The system provides tools for image preparation, localization, fusion, and segmentation of anatomical structures. It allows correlation of patient data with Talairach/Tournoux or Schaltenbrand/Wahren brain atlases. Operated by clinicians (radiologists, neurosurgeons) on a standalone workstation or via intranet, the software facilitates isocenter handling and plan review. Outputs serve as pre-planning data for radiotherapy/radiosurgery systems, including BrainLAB's Intuition Dose or BrainSCAN, or third-party planning systems. By streamlining image processing and anatomical mapping, the device assists clinicians in defining treatment parameters, potentially improving the accuracy and efficiency of radiation treatment planning.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Software-based tool for standard computer workstations. Features include automatic and manual image segmentation, image fusion, and anatomical atlas correlation (Talairach/Tournoux, Schaltenbrand/Wahren). Connectivity via intranet. No specific hardware materials or energy sources defined as it is a software-only planning system.

Indications for Use

Indicated for patients requiring stereotactic, conformal, computer-planned, LINAC-based radiation treatment for cranial, head and neck, and extracranial lesions.

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! (K020631)
• BrainSCAN (K994413)

Submission Summary (Full Text)

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K\$\phi\$32511

# 510 (k) Summary of Safety and Effectiveness for Intuition Image

| Manufacturer: | BrainLAB AG |
|-----------------------------|----------------------------------------------------|
| Address: | Ammerthalstrasse 8<br>85551 Heimstetten<br>Germany |
| Phone: | [phone] |
| Fax: | [phone] |
| Contact Person: | Mr. Rainer Birkenbach |
| Summary Date: | August 1, 2003 |
| Device Name:<br>Trade name: | Intuition Image |

Common/Classification Name:

Planning System/X-ray radiation therapy system

## Predicate Device: iPlan! (K020631) BrainSCAN (K994413)

Device Classification Name: X-ray radiation therapy system Regulatory Class: Class II

## Intended Use:

Intuition Image'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 ﯩ

plan forlow and applied. where in roomputer planned, LINAC based radiation treatment of cranial, head and neck and extracranial lesions.

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K\$\emptyset\$32511

### Device Description:

Intuition Image is a software tool running on a standard, standalone computer workstation or being accessible via the intranet connection for pre-planning of treatments based on stereotactic systems.

The system provides e.g. tools for the automatic or manual segmentation of anatomical structures, which helps the user such as the radiologist or the neurosurgeon to quickly achieve the desired segmentation results through a variety of automatic and/or manual re-segmentations. Additionally anatomical and functional structures and segmentations of the human brain as defined and described by Talairach/Tournoux and/or Schaltenbrand/Wahren brain atlases can be correlated with the patient's brain data.

The created treatment plans of Intuition Image can be used on its own or in conjunction with other BrainLAB treatment planning systems such as Intuition Dose (to be developed) or BrainSCAN (K994413) for further planning of parameters, which are relevant for Radiotherapy/Radiosurgery. Intuition Image may also serve as a pre-planning station for various third party treatment planning systems.

### Substantial equivalence:

Intuition Image 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 devices iPlan! (K020631) and BrainSCAN (K994413).

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its wing and body. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 2 1 2004

Mr. Rainer Birkenbach Executive Vice President BrainLAB AG Ammerthalstraße 8 85551 Heimstetten GERMANY

Re: K032511

Trade/Device Name: Intuition Image Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: 90 LHN, and MUJ Dated: December 5, 2003 Received: December 10, 2003

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 10 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 either class II (Special Controls) or class 111 (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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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 the letter:

| 8xx.1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [phone] |

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html.

Sincerely yours,

Nancy C. Brogdon

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

Enclosure

Page 2

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510(k) Number (if known): K\$\phi\$32511

Device Name:

Intuition Image

Indications For Use:

Intuition Image'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 -

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.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use __

(Optional Formal I-2-96)

(Division Sign-Off) Division of Reproductive, Abdom and Radiological Devices 510(k) Number