BODYFIX

K013391 · Medical Intelligence Medizintechnik GmbH · IYE · Jan 11, 2002 · Radiology

Device Facts

• Record ID: K013391
• Device Name: BODYFIX
• Applicant: Medical Intelligence Medizintechnik GmbH
• Product Code: IYE · Radiology
• Decision Date: Jan 11, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5050
• Device Class: Class 2

Intended Use

The BodyFIX is intended for patient positioning and immobilization, stereotactic diagnostic localization and stereotactic radiotherapy of extracranial targets

Device Story

BodyFIX is a patient positioning and immobilization system for extracranial targets. Components include vacuum cushion, fixation sheet, vacuum supply, target positioner, localizer, and carbon fiber baseplate. Used in radiotherapy, radiosurgery, sonography, surgery/CAS, imaging, neurosurgery, and brachytherapy. Operated by radiologists and surgeons to stabilize patients during diagnostic or therapeutic procedures. System provides rigid immobilization to facilitate precise stereotactic localization and treatment delivery.

Clinical Evidence

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

Technological Characteristics

System components include vacuum cushion, fixation sheet, vacuum supply, target positioner, localizer, and carbon fiber baseplate. Mechanical immobilization device; no energy source or software components described.

Indications for Use

Indicated for patient positioning and immobilization, stereotactic diagnostic localization, and stereotactic radiotherapy of extracranial targets in patients undergoing radiotherapy, radiosurgery, sonography, surgery/CAS, imaging, neurosurgery, or brachytherapy.

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

• Med-Tec Inc.'s BodyFIX System
• Elekta Instrument AB's Stereotactic Body Frame
• Midco's BodyLoc

Submission Summary (Full Text)

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# Kol3391

JAN 1 1 2002

# 510(k) SUMMARY

| 1. | Applicant: | Medical Intelligence Medizintechnik GmbH | |
|-----|--------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------|
| 2. | Address: | Feyerabendstrasse 13 - 15 | |
| | | 86830 Schwabmünchen | |
| | | Germany | |
| 3. | Contact Persons: | Cornelia Damsky Tel: | [phone] |
| | | Christian Müller Tel: | [phone] |
| 4. | Preparation Date: | October 10, 2001 | |
| 5. | Device Submitted: | BodyFIX and accessories | |
| 6. | Proprietary Name: | BodyFIX | |
| 7. | Common Name: | BodyFIX | |
| 8. | Classification Name: | Accelerator, Linear, Medical for use in fixation of a<br>patient's body part for stereotactic diagnostic localization<br>and stereotactic radiotherapy. Product Code IYE | |
| 9. | Substantial Equivalence: | The BodyFIX system is substantially equivalent in terms<br>of intended use to the following currently marketed<br>devices: Med-Tec Inc.'s BodyFIX System, Elekta<br>Instrument AB's Stereotactic Body Frame and<br>accessories and Midco's BodyLoc. The characteristics of<br>this device are similar to those of the predicate devices<br>identified on the comparison chart, which is provided with<br>this premarket notification submission. | |
| 10. | Device Description: | The BodyFIX system is a patient positioning and<br>immobilization device for use with radiotherapy,<br>radiosurgery, sonography, surgery/CAS, imaging<br>neurosurgery and brachytherapy treatments of<br>extracranial targets. The five principal parts of the<br>system include the vacuum cushion, fixation sheet,<br>vacuum supply, target positioner and localizer, and<br>carbon fiber baseplate. | |
| 11. | Intended Use: | The BodyFIX is intended for patient positioning and<br>immobilization, stereotactic diagnostic localization and<br>stereotactic radiotherapy of extracranial targets | |

:

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- 12. Legally-Marketed Predicate
Device:

Med-Tec Inc.'s BodyFIX System, Elekta Instrument AB's Stereotactic Body Frame and Midco's BodyLoc

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 data base 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/2 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. Inside the circle is a stylized image of a bird-like figure, possibly representing an eagle or a similar bird, with its wings spread.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## JAN 1 1 2002

Medical Intelligence Medizintechnik GmbH Christian Muller Feverabendstrasse 13 - 15 86830 Schwabmunchen Germany

Re: K013391

Trade Name: Bodyfix Regulation Number: 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: October 12, 2001 Received: October 15, 2001

Dear Mr. Muller:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the ications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have May 20, 1970, the chargence 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, eontols pro hereis or uctice, 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.

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 or uny 1 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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Page 2 - Mr. Christian Muller

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [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), 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.

Celia M. Witten, Ph.D., M.D.

Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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KC13391

### BodyFIX

### INDICATIONS FOR USE

This product is intended for use by radiologists and surgeons for:

- Patient positioning and immobilization 미
- Stereotactic diagnostic localization 미
- Stereotactic radiotherapy of extracranial targets l

Hyt. Plurde

(Division Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number_________________________________________________________________________________________________________________________________________________________________