MODEIFICATION TO IPLAN RT DOSE

K080888 · Brainlab AG · MUJ · Jun 11, 2008 · Radiology

Device Facts

• Record ID: K080888
• Device Name: MODEIFICATION TO IPLAN RT DOSE
• Applicant: Brainlab AG
• Product Code: MUJ · Radiology
• Decision Date: Jun 11, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.5050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

iPlan RT Dose is a stereotactic radiation treatment planning system 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 Dose is a stereotactic radiation treatment planning system used by clinicians to plan Linac-based radiation therapy. The system processes patient anatomical data to calculate radiation dose distributions for cranial, head and neck, and extracranial lesions. It enables conformal treatment planning, allowing physicians to visualize and optimize dose delivery to target volumes while sparing surrounding healthy tissue. The output is a treatment plan used to guide radiation delivery equipment. It is intended for use in clinical settings by trained medical professionals.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on bench testing and comparison of technological characteristics to predicate devices.

Technological Characteristics

Software-based radiation treatment planning system. Operates as a standalone workstation or networked application for dose calculation and conformal planning. Utilizes computer-based algorithms for radiation dose distribution modeling. No specific hardware materials or sterilization requirements as it is a software-only system.

Indications for Use

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

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

• BrainSCAN (K994413)
• iPlan RT Dose (K053584)

Submission Summary (Full Text)

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JUN 11 2008

Kososss

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

### Manufacturer

| Address | BrainLAB AG<br>Kapellenstr. 12<br>85622 Feldkirchen<br>Germany |
|----------------|----------------------------------------------------------------|
| Phone: | [phone] |
| Fax: | [phone] |
| Contact Person | Mr. Per Persson |
| Summary Date | March 28, 2008 |

### Device Name

Device Name Common Name Classification Name

Classification Number Regulatory Class FDA Establishment Registration Number

iPlan RT Dose System, Planning, Radiation Therapy Treatment Medical charged-particle radiation therapy system 21 CFR 892.5050 Class II 8043933

## Predicate Device

BrainSCAN (K994413) iPlan RT Dose (K053584)

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Image /page/1/Picture/0 description: The image is a circular seal or logo. The seal contains an image of an eagle with outstretched wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged around the top half of the circle. The eagle is facing to the right.

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# JUN 1 1 2008

Mr. Carsten Raupach Senior Project Manager BrainLAB AG Kapellenstraße 12 85622 Feldkirchen GERMANY

Re: K080888

Trade/Device Name: iPlan RT Dose Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: MUJ Dated: May 14, 2008 Received: May 16, 2008

Dear Mr. Raupach:

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. 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.

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 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 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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# Indications for Use

510(k) Number (if known): K080888

Device Name: iPlan RT Dose

Indications For Use:

iPlan RT Dose is a stereotactic radiation treatment planning system 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)

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

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