BODYFIX SYSTEM

K121530 · Medical Intelligence Medizintechnik GmbH · IYE · Jun 20, 2012 · Radiology

Device Facts

• Record ID: K121530
• Device Name: BODYFIX SYSTEM
• Applicant: Medical Intelligence Medizintechnik GmbH
• Product Code: IYE · Radiology
• Decision Date: Jun 20, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5050
• Device Class: Class 2

Intended Use

This product is intended to be used by radiologists and surgeons for the following: Patient positioning and immobilization Stereotactic diagnostic localization Patient positioning and immobilization device for stereotactic radiotherapy of extracranial targets

Device Story

BodyFIX System provides non-invasive patient positioning and immobilization for radiotherapy and surgical procedures. System components include vacuum cushions, cover sheets, carbon fiber baseplate, and BodyFIX Vacuum Pump P3. Vacuum pump inflates, forms, and deflates vacuum cushions to stabilize patient anatomy. Used in clinical settings (radiotherapy/surgery) by radiologists and surgeons. Device facilitates precise patient alignment for imaging (CT/MRI) and treatment delivery (photon linear accelerator). Immobilization reduces diaphragmatic movement and patient motion, improving targeting accuracy for extracranial therapeutic targets. Benefits include enhanced reproducibility of patient setup and reduced localization errors.

Clinical Evidence

No clinical data provided. Bench testing only. Performance metrics reported include transversal plane CT localization error (mean 0.5 ±0.7 mm), longitudinal plane localization error (range 0.3 - 2.0 mm), and Linac set-up error (approx 1.0 mm).

Technological Characteristics

Carbon fiber sandwich construction with hard foam core. Vacuum-based immobilization principle. Includes vacuum pump (P3) with dual-pump configuration. Dimensions approx 600 x 988 x 510 mm. Power 1000 VA max. Operates on 100-240 V AC. Integrated stereotactic fiducials. Non-invasive fixation using vacuum cushions and plastic fixation sheets.

Indications for Use

Indicated for patient positioning and immobilization for stereotactic radiotherapy, radiosurgery, sonography, surgery/CAS, imaging, neurosurgery, and brachytherapy of extracranial targets. Applicable to thoracic, abdominal, pelvic, arm, and leg therapeutic 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

• BodyFIX (K013391)

Submission Summary (Full Text)

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## Traditional 510(k) 510(k) Summary

### JUN 2 0 2012

### BodyFIX System

- Applicant
- 2. Address
- 3. Contact Person
- 4. Preparation Date
- 5. Device Submitted
- 6. Proprietary Name
- 7. Common Name
- 8. Classification Name
- 9. Substantial Equivalence
- 10. Device Description

- BodyFIX 510(k) Summary
Medical Intelligence Medizintechnik GmbH Robert-Bosch-Straße 8 Schwabmuenchen 86830 Germany Michael Wolff, [phone] April 19th, 2012 / June 13th, 2012

BodyFIX System

BodyFIX

BodyFIX

Accelerator, Linear, Medical

The BodyFIX System is substantially equivalent in terms of intended use to the following currently marketed device: BodyFIX (K013391).

The BodyFIX System is a patient positioning and immobilization device for use with radiotherapy, radiosurgery, sonography, surgery/CAS, imaging neurosurgery and brachytherapy treatments of extracranial targets. The principal parts of the system include the vacuum cushion, cover sheet, vacuum supply (vacuum pump), target positioner and localizer, and carbon fiber baseplate.

The BodyFIX Vacuum Pump P3 is a high-performance vacuum pump that contains two separate pumps; the BlueBAG pump and the BodyFIX pump.

- 1- BlueBAG pump provides the vacuum for inflating, forming and deflating the BlueBAG vacuum cushions.

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# Traditional 510(k) 510(k) Summary

## BodyFIX System .

:

| Dimensions | 600 x 988 x 510 (approx) | 580 x 410 x 355 (approx) |
|--------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------|
| Construction Material | Carbon fibre sandwich with<br>hard foam core | |
| Stereotactic fiducial built into frame | Yes | |
| Weight | 77 kg (approx) | 39 kg (approx) |
| Noise | 60dB (A) | |
| Operation Mode | Continuous (unattended<br>running) | |
| Power | 1000 VA (max) | 1100 VA |
| Voltage | 100; 110; 120; 230; 240; V AC | |
| Current | 8 A (max) | |
| Fuses | T8 A/250 V AC | |
| Metohod of suppressing<br>diaphragmatic movement | Plastic fixation sheet and<br>stabilising cushion | Plastic fixation sheet and<br>stabilising cushion |
| Fixation | Vacuum cushion and plastic<br>fixation sheet | Vacuum cushion and plastic<br>fixation sheet |
| Imaging studies | CT and/or MRI for treatment<br>planning | |
| Clinical Applications | Patient positioning and<br>immobilisation, thoracic,<br>abdominal, pelvic, arm and leg<br>therapeutic targets | |
| Transversal plane CT localisation<br>error x,y | Mean 0.5 ±0.7 mm | |
| Longitudinal plane localisation<br>error z | Range 0.3 - 2.0 mm | |
| Linac set-up error | 1.0 mm approx | |
| Anterior Body Form<br>(immobilisation) | Yes | Yes |
| Posterior Body Form<br>(immobilisation) | Yes | Yes |
| Treatment Modality | Photon linear accelerator | Photon linear accelerator |
| Immobilisation | Non-invasive | Non-invasive |
| HF Emissions (CISPR 11) | Class B | Class B |
| Electromagnetic Environment<br>Guidelines | The unit or system solely uses<br>HF-energy for its internal<br>function. Therefore its HF<br>emissions are very low, and | The unit or system solely uses<br>HF-energy for its internal<br>function. Therefore its HF<br>emissions are very low, and |

510(k) Summary

.

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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-Strabe 8 SCHWABMUNCHEN 86830 GERMANY

JUN 2 0 2012

Re: K121530

Trade/Device Name: BodyFIX® System Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: May 4, 2012 Received: May 24, 2012

#### 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 (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 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,

Janine M. Morris

Acting 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):

Device Name: BodyFIX® System

Indications for Use: .

This product is intended to be used by radiologists and surgeons for the following:

. Patient positioning and immobilization

- Stereotactic diagnostic localization .
- Patient positioning and immobilization device for . stereotactic radiotherapy of extracranial targets

Prescription Use YES (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use NO (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mull D. Oth

Division of Rediological Devices stic Device Evaluation and Office of In Vitro Diagno

K1A21530

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