FRAXION

K112210 · Medical Intelligence Medizintechnik GmbH · IYE · Nov 22, 2011 · Radiology

Device Facts

• Record ID: K112210
• Device Name: FRAXION
• Applicant: Medical Intelligence Medizintechnik GmbH
• Product Code: IYE · Radiology
• Decision Date: Nov 22, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5050
• Device Class: Class 2

Intended Use

Fraxion™ is intended to be used for immobilization, positioning and re-positioning during Stereotactic Radiotherapy (SRT) in all parts of the brain and head in a Linear Accelerator environment. Further Fraxion™ is used to immobilize and position the head during image acquisition to support treatment planning. Under certain circumstances (e.g. when the patient will not tolerate an invasive frame) Fraxion™ may also be used for Stereotactic Radiosurgery (SRS) in a Linear Accelerator environment.

Device Story

Fraxion™ is a non-invasive cranial immobilization and positioning system for stereotactic radiotherapy (SRT) and radiosurgery (SRS). System components include a frame, patient control unit, frontpiece with mouthpiece, vacuum cushion, and thermoplastic mask. Used in clinical settings (Linear Accelerator environment) by healthcare professionals to stabilize the patient's head during image acquisition for treatment planning and throughout the radiation delivery process. By providing precise, reproducible positioning, the device facilitates accurate targeting of radiation, potentially improving treatment outcomes while offering a non-invasive alternative for patients who cannot tolerate traditional invasive frames.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

System comprises a mechanical frame, frontpiece, mouthpiece, vacuum cushion, and thermoplastic mask. Designed for cranial immobilization in a linear accelerator environment. No electronic sensing, energy source, or software algorithms described.

Indications for Use

Indicated for patients requiring head/brain immobilization, positioning, and re-positioning for Stereotactic Radiotherapy (SRT) or Stereotactic Radiosurgery (SRS) in a Linear Accelerator environment, including patients unable to tolerate invasive frames.

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

• Elekta Esarte Frame System (K051746)
• Elekta Extend System (K092083)
• Medical Intelligence HeadFIX System (K030439)

Submission Summary (Full Text)

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NOV 22222011

## MEDICAL INTELLIGENCE MEDIZINTECHNIK GMBH

Image /page/0/Picture/2 description: The image contains the word "ELEKTA" in a large, bold font. Above the word "ELEKTA" is the text "KII2210 P. 1 of 1". To the left of the word "ELEKTA" is a circle with a dot on the edge and a dashed line leading from the center of the circle to the dot.

| 1. | Applicant: | Medical Intelligence Medizintechnik GmbH |
|-----|------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 2. | Address: | Robert-Bosch-Str. 8<br>86830 Schwabmünchen<br>Germany |
| 3. | Contact Person: | Mr. Michael Wolff<br>Tel.: [phone] |
| 4. | Preparation Date: | July 20, 2011 |
| 5. | Device Submitted: | Fraxion™ |
| 6. | Proprietary Name: | Fraxion™ |
| 7. | Common Name: | Fraxion™ |
| 8. | Classification Name: | Accelerator, Linear, Medical |
| 9. | Substantially Equivalence: | The Fraxion™ is substantially equivalent in terms of intended use<br>to the following marketed devices: Elekta Esarte Frame System<br>(K051746), Elekta Extend System (K092083), Medical Intelligence<br>HeadFIX System (K030439). |
| 10. | Device Description: | Fraxion™ is a device for cranial stereotactic radiotherapy and<br>radiosurgery. The major parts of the system include the Fraxion<br>frame, Patient Control Unit, Frontpiece incl. Mouthpiece, vacuum<br>cushion, thermoplastic mask and Stereotactic Frame. |
| 11. | Intended Use | Fraxion™ is intended to be used for immobilization, positioning<br>and re-positioning during Stereotactic Radiotherapy (SRT) in all<br>parts of the brain and head in a Linear Accelerator environment.<br>Further Fraxion™ is used to immobilize and position the head<br>during image acquisition to support treatment planning.<br>Under certain circumstances (e.g. when the patient will not tolerate<br>an invasive frame) Fraxion™ may also be used for Stereotactic<br>Radiosurgery (SRS) in a Linear Accelerator environment. |
| 12. | Legally-Marketed Predicated Device | Elekta Esarte Frame System, Elekta Extend System and Medical<br>Intelligence HeadFIX System |

## Fraxion™ - 510(k) Summary

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Image /page/1/Picture/0 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with three stripes representing the department's mission. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.

Public Health Service

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

Mr. Michael Wolff Regulatory Affairs Manager Medical Intelligence Medizintechnik GmbH Robert-Bosch-Strasse 8 86830 SCHWABMUENCHEN GERMANY

NOV 222 2011

Re: K112210

Trade/Device Name: Fraxion™ Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: May 20, 2011 Received: August 1, 2011

Dear Mr. Wolff:

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 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 (OS) 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 and Safety at [phone]. 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 toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely Yours.

Mary Pastel

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 Form

510(k) Number (if known): _ K 11 2乙10

Device Name: Fraxion™

Indications for Use:

Fraxion™ is intended to be used for immobilisation, positioning and re-positioning during Stereotactic Radiotherapy (SRT) in all parts of the brain and head in a Linear Accelerator environment.

Further Fraxion™ is used to immobilise and position the head during image acquisition to support treatment planning.

Under certain circumstances (e.g. when the patient will not tolerate an invasive frame) Fraxion™ may also be used for Stereotectic Radiosurgery (SRS) in a Linear Accelerator environment.

Prescription Use
(Part 21 CFR 801 Subpart D)

Over-The-Counter Use AND/OR (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Ruhard D. Dohn
Division Sign Off

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K112210

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