HEADFIX

K030439 · Medical Intelligence Medizintechnik GmbH · IYE · May 8, 2003 · Radiology

Device Facts

• Record ID: K030439
• Device Name: HEADFIX
• Applicant: Medical Intelligence Medizintechnik GmbH
• Product Code: IYE · Radiology
• Decision Date: May 8, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5050
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The VBH HeadFIX™is intended for positioning and immobilization of the head and neck, stereotactic diagnostic localization and stereotactic radiotherapy of cranial targets.

Device Story

VBH HeadFIX is a cranial fixation system for stereotactic radiotherapy and radiosurgery. System components include vacuum pump, vacuum cushion, target positioner screens, baseplate, post set, and cranial localizer. Used in clinical settings by radiologists and surgeons to immobilize and position patient head and neck for diagnostic localization and radiotherapy. Device provides stable platform for cranial targeting; ensures patient stability during treatment procedures.

Clinical Evidence

No clinical data. Bench testing not required for this Class II device per FDA.

Technological Characteristics

Cranial fixation system comprising vacuum pump, vacuum cushion, target positioner screens, baseplate, post set, and cranial localizer. Mechanical immobilization device.

Indications for Use

Indicated for radiologists and surgeons to perform positioning and repositioning of the patient's head, stereotactic diagnostic localization, and stereotactic radiotherapy of cranial targets.

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

• Radionics Gill-Thomas-Cosman (GTC) Relocatable Head Holder
• Orfit Industries' Raycast Immobilization Systems Hardware and Thermoplastic Materials
• BrainLAB's Brain Mask System

Submission Summary (Full Text)

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## 510(k) SUMMARY

K030439

| 1. Applicant: | Medical Intelligence Medizintechnik GmbH |
|--------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 2. Address: | Feyerabendstrasse 13 - 15<br>86830 Schwabmünchen<br>Germany |
| 3. Contact Persons: | Cornelia Damsky Tel: [phone]<br>Christian Müller Tel: [phone] |
| 4. Preparation Date: | February 7, 2003 |
| 5. Device Submitted: | VBH HeadFIX™ and accessories |
| 6. Proprietary Name: | VBH HeadFIX™ |
| 7. Common Name: | HeadFIX™ |
| 8. Classification Name: | Accelerator, Linear, Medical for positioning and<br>repositioning of the patient's head for stereotactic<br>diagnostic localization and stereotactic<br>radiotherapy. Product Code IYE |
| 9. Substantial Equivalence: | The VBH HeadFIX™ is substantially equivalent in<br>terms of intended use to the following currently<br>marketed devices: Radionics Gill-Thomas-<br>Cosman (GTC) Relocatable Head Holder, Orfit<br>Industries' Raycast Immobilization Systems<br>Hardware and Thermoplastic Materials, and<br>BrainLAB's Brain Mask System. |
| 10. Device Description: | The VBH HeadFIX™ is a fixation device for cranial<br>stereotactic radiotherapy and radiosurgery. The<br>major parts of the system include the Vacuum<br>Pump, Vacuum Cushion, Target Positioner<br>Screens and Baseplate, Post Set, and Cranial<br>Localizer. |
| 11. Intended Use: | The VBH HeadFIX™is intended for positioning and<br>immobilization of the head and neck, stereotactic<br>diagnostic localization and stereotactic<br>radiotherapy of cranial targets. |
| 12. Legally-Marketed Predicated<br>Device: | Radionics Gill-Thomas-Cosman (GTC)<br>Relocatable Head Holder, Orfit Industries' Raycast<br>Immobilization Systems Hardware and<br>Thermoplastic Materials, and BrainLAB's Brain<br>Mask System. |

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## 13. Performance Data:

No performance data is required for this Class II device nor requested by the Food and Drug Administration (Office of Device Evaluation). A database search has been performed to evaluate any adverse effects of the device that is currently marketed.

No data submitted for section 807.92 6[(b)(1)(2)(3c)].

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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure with three stylized lines representing its body and wings.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Cornelia Damsky Regulatory Consultant Cornelia Damsky, Inc. 56 Westcott Road STAMFORD CT 06902 MAY - 8 2003

Re: K030439 Trade/Device Name: HeadFIX Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: 90 IYE Dated: February 7, 2003 Received: February 11, 2003

Dear Ms. Damsky:

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 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:

| 8xxx. 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. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K030439

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Page_ of _____________________________________________________________________________________________________________________________________________________________________

510(k) Number (If known): K030439

Device Name: VBH HeadFIX

Indications For Use:

This product is intended for use by radiologists and surgeons for: Positioning and repositioning of the patient's head; Stereotactic diagnostic localization; and Stereotactic radiotherapy of cranial targets

(PLEASE DO NOT WRITE BEELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

イ Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use_

David A. Ingram

(Division Sign-Off)
Division of Reproductive, Abdominal,
Radiological Devices K030439
510(k) Number