IPLAN RT

K103246 · Brainlab AG · MUJ · Mar 16, 2011 · Radiology

Device Facts

• Record ID: K103246
• Device Name: IPLAN RT
• Applicant: Brainlab AG
• Product Code: MUJ · Radiology
• Decision Date: Mar 16, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

iPlan RT is a 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 is a software-based radiation treatment planning system used by clinicians to generate treatment plans and simulate dose delivery for external beam radiotherapy. It processes patient scan data to facilitate steps from outer contour detection to quality assurance. The system supports conformal beams, IMRT, circular arcs, and combined static/dynamic arc treatments. It utilizes convolution or Monte Carlo algorithms for dose calculation. An elastic deformation algorithm allows for the morphing of existing structures from prior scans onto new follow-up scans to adapt treatment plans during fractionated therapy. The system outputs DICOM RT files (Plan and Image) and parameter printouts. By enabling precise planning and plan adaptation, it assists healthcare providers in delivering targeted radiation, potentially improving treatment accuracy for cranial, head and neck, and extracranial lesions.

Clinical Evidence

No clinical data. Substantial equivalence and safety/effectiveness were demonstrated through non-clinical verification and validation testing, including hazard analysis.

Technological Characteristics

Software-based radiation treatment planning system. Features include convolution and Monte Carlo dose calculation algorithms, elastic deformation for image/structure registration, and support for DICOM RT standards. Operates on standard computing hardware. No specific materials or energy sources as it is a software-only device.

Indications for Use

Indicated for patients requiring stereotactic, conformal, Linac-based radiation treatment for cranial, head and neck, and extracranial lesions. Prescription use only.

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 RT Image (K080886)
• iPlan RT Dose (K080888)

Submission Summary (Full Text)

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K103246

MAR 1 6 2011

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

#### Manufacturer

| Address | Brainlab AG<br>Kapellenstr. 12<br>85622 Feldkirchen<br>Germany<br>Phone: [phone]<br>Fax: [phone] |
|----------------|-----------------------------------------------------------------------------------------------------------------------|
| Contact Person | Mr. Alexander Schwiersch |
| Summary Date | January 19, 2011 |

#### Device Name

| Device Name | |
|---------------------|--|
| Common Name | |
| Classification Name | |

Classification Number Regulatory Class FDA Establishment Registration Number

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

### Predicate Device

Predicate Device: iPlan RT Image K080886 510 (k):

Predicate Device: iPlan RT Dose K080888 510 (k):

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#### Intended Use

iPlan RT is a 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 Description

iPlan RT is a software program to generate treatment plans and to simulate the dose delivery for external beam radiotherapy. The system is the evolutionary successor of the predicate devices iPlan RT Image (K080886) and iPlan RT Dose (K080888). It is specialized for stereotactic procedures for cranial as well as extracranial lesions. It includes functions for all relevant steps from outer contour detection to quality assurance. It combines most of its predecessor's functionality iPlan RT Image and iPlan RT Dose together with additional improvements. Therefore, the new version shall be called "iPlan RT".

The device incorporates conformal beams, conformal IMRT beams, circular arcs, and both static and dynamic arc treatments. Moreover, a combination of optimized dynamic arc treatments together with IMRT beams was added to the treatment modalities.

The system calculates dose using a convolution algorithm as the previous version. Alternatively, a Monte Carlo method based calculation algorithm can be used as in iPlan RT Dose (K080888). The documentation & export function facilitates printouts of all parameters and results for the creation of DICOM RT (RT Plan and RT Image) files.

Adapting existing treatment plans during fractionated radiotherapy treatments is facilitated using an elastic deformation algorithm. Existing structures are morphed from an existing treatment plan onto a new follow-up scan. If necessary, these structures can be adapted by the physician and can be used to update the current treatment plan accordingly.

#### Summary of Non-Clinical Testing

The performed hazard analysis shows that all relevant hazards have been taken into consideration and the corresponding measures are effective. The Verification and Validation tests were completed according to Brainlab's procedures and show that iPlan RT

- has met its specifications,
- is substantially equivalent to the predicate devices and

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- is safe and effective for its intended use.

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#### Summary of Clinical Testing

Clinical testing is not required to demonstrate substantial equivalence or safety and effectiveness.

#### Conclusion `

The detailed comparison table (see "Experiences from previous product") shows substantial equivalence to the compared predicated devices.

iPlan RT 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 RT Image (K080886) and iPlan RT Dose (K080888).

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Image /page/3/Picture/0 description: The image shows the logo of the Department of Health & Human Services. The logo includes the department's emblem on the left and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" on the right. The emblem is a stylized representation of a human figure.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002

| Mr. Alexander Schwiersch | |
|----------------------------|-------------|
| Regulatory Affairs Manager | |
| Brainlab AG | |
| Kapellenstrasse 12 | |
| 85622 Feldkirchen | |
| GERMANY | MAR 16 2011 |

Re: K103246

Trade/Device Name: iPlan RT Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: MUJ Dated: February 11, 2011 Received: February 14, 2011

Dear Mr. Schwiersch:

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 includions for use stated in the enclosure) to legally marketed predicate devices marketed in intestate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendonsats, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Or to 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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21. Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of

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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation (1 - 1 (1 ) 701 and 5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its tiblin the [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely Yours.

Mary Patel

Mary S. Pastel, Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known): K103246

Device Name: iPlan RT

Indications For Use:

iPlan RT is a 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. .

Mary Satti
(Division Sign-Off)

Divisi Office of In Vitro Diagnostic I

510K K103241

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)

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