IPLAN RT IMAGE

K080886 · Brainlab AG · LHN · Jun 24, 2008 · Radiology

Device Facts

• Record ID: K080886
• Device Name: IPLAN RT IMAGE
• Applicant: Brainlab AG
• Product Code: LHN · Radiology
• Decision Date: Jun 24, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

iPlan RT Image's indications for use are to prepare and present patient and image data based on CT, MR, angiographic and other imaging sources including - image preparation - - image localization - n 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

iPlan RT Image is a software-based radiation treatment planning system. It ingests multi-modal medical imaging data (CT, MR, Angiographic, PET including SUV) to facilitate clinical workflows. Core functions include image preparation, localization, fusion, segmentation, isocenter handling, and plan review/approval. Used by clinicians in clinical settings to support stereotactic radiation treatment planning for cranial, head and neck, and extracranial lesions. The system transforms raw imaging data into actionable plans for LINAC-based radiation therapy, enabling precise targeting of lesions. It assists healthcare providers in visualizing anatomy and defining treatment parameters, ultimately aiming to improve the accuracy and efficacy of radiation delivery to patients.

Clinical Evidence

No clinical data provided; substantial equivalence is based on bench testing and comparison of technological characteristics and intended use to predicate devices.

Technological Characteristics

Software-based medical imaging and radiation treatment planning system. Operates on standard computing hardware. Features include image fusion, segmentation, and isocenter calculation. Connectivity supports standard medical imaging formats (CT, MR, PET, Angiographic).

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

• Intuition Image (K032511)
• iPlan RT FiberTracking (K052220)
• iPlan BOLD MRI (K053127)

Submission Summary (Full Text)

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K080886

## JUN 2 4 2008

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

#### Manufacturer:

| Address: | BrainLAB AG<br>Kapellenstrasse 12<br>85622 Feldkirchen<br>Germany | | |
|-----------------|-------------------------------------------------------------------|--------------------|--|
| | Phone: | [phone] | |
| | Fax: | [phone] | |
| Contact Person: | Mr. Per Persson | | |
| Summary Date: | March 25, 2008 | | |

## Device Name:

Trade name:

iPlan RT Image

Common/Classification Name:

Planning System / Medical charged-particle radiation therapy system

## Predicate Device: Intuition Image (K032511) iPlan RT FiberTracking (K052220) iPlan BOLD MRI (K053127)

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

#### Intended Use:

iPlan RT Image's indications for use are to prepare and present patient and image data based on CT, MR, angiographic and other imaging sources including

- image preparation -
- image localization
- n 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.

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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an emblem featuring a stylized eagle with three wing-like shapes, representing the department's mission related to health and human services.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

### JUN 2 4 2008

Mr. Rainer Birkenbach Executive Vice President BrainLAB AG Kapellenstraße 12, 85622 Feldkiechen GERMANY

Re: K080886

Trade/Device Name: iPlan RT Image Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: LHN Dated: March 26, 2008 Received: March 31, 2008

#### 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 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.

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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. Your 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.

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 logally 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 Center for Devices and Radiological Health's (CDRH's) 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 Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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.

Nancy 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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## Indications for Use

510(k) Number (if known):

K080886

Device Name: iPlan RT Image

Indications For Use:

iPlan RT Image's indications for use is to prepare and present patient and image data based on CT, MR, Angiographic, PET to include standardized uptake values (SUV) 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.

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)

Tonk Tithery

Division of Reproductive, Abdomina Radiological D 510(k) Number

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