FRAMELESS RADIOSURGERY COMPONENTS

K053500 · Brainlab AG · IYE · Feb 3, 2006 · Radiology

Device Facts

• Record ID: K053500
• Device Name: FRAMELESS RADIOSURGERY COMPONENTS
• Applicant: Brainlab AG
• Product Code: IYE · Radiology
• Decision Date: Feb 3, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5050
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Frameless Radiosurgery Components are a device used for fixation, localization and repositioning of the patient's head and neck or head, neck, and shoulders in a linear accelerator environment for stereotactic radiosurgery/radiotherapy procedures.

Device Story

Mechanical fixation system for patient immobilization during stereotactic radiosurgery/radiotherapy; non-invasive components attach to patient to maintain head, neck, and shoulder positioning in linear accelerator environments; used for repeated diagnostic tomographic scanning; operated by clinical staff; provides stable platform for radiation delivery; ensures consistent patient alignment; facilitates accurate treatment planning and delivery; compatible with existing BrainLAB Robotics and Brainscan systems.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Mechanical, non-invasive fixation components. Materials and specific standards not disclosed. Standalone mechanical system; no energy source, connectivity, or software components.

Indications for Use

Indicated for patients requiring fixation, localization, and repositioning of the head, neck, and shoulders during stereotactic radiotherapy or radiosurgery procedures in a linear accelerator environment, or for repeated diagnostic tomographic scanning. Indicated for any medical condition where stereotactic radiotherapy is considered safe and effective.

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

• BrainLAB Mask System (K945903)
• BrainLAB CT/X-Ray Localizer (K954861)

Reference Devices

• BrainLAB Robotics
• BrainLAB Brainscan

Submission Summary (Full Text)

{0}------------------------------------------------

# 053500

FEB 3 2006

### 510(k) Summary of Safety and Effectiveness for Frameless Radiosurgery Components

| Manufacturer: | BrainLAB AG |
|-----------------------------|-----------------------------------------------------------------------------------------------------------|
| Address: | Ammerthalstrasse 8<br>85551 Heimstetten<br>Germany<br>Phone: [phone]<br>Fax: [phone] |
| Contact Person: | Mr. Rainer Birkenbach |
| Summary Date: | January 12, 2006 |
| Device Name:<br>Trade name: | Frameless Radiosurgery System |
| Common/Classification Name: | Frameless Radiosurgery Components |
| Predicate Device: | BrainLAB Mask System (K945903)<br>BrainLAB CT/X-Ray Localizer (K954861) |
| Device Classification Name: | Medical charged-particle radiation therapy system (892.5050) |
| Regulatory Class: | Class II |

#### Intended Use:

The Frameless Radiosurgery Components are a device used for fixation, localization and repositioning of the patient's

- head and neck ເ
- ﺳ head, neck, and shoulders

in a linear accelerator environment for stereotactic radiosurgery/radiotherapy procedures,

#### Device Description:

The Frameless Radiosurgery Components only include mechanical devices, which can be repeatedly attached to the patient to keep his/her head and neck (head, neck and shoulders) in the same position for radiotherapy/radiosurgery. All components are intended to be non-invasive. The Frameless Radiosurgery Components are indicated for any medical condition in which the use of stereotactic radiotherapy may be considered to be safe and effective. They may be used also for repeated diagnostic tomographic scanning, The Frameless Radiosurgery Components can be used with other devices, which have already been cleared by the FDA (e.g. BrainLAB Robotics, BrainLAB Brainscan).

#### Substantial equivalence:

The Frameless Radiosurgery Components have 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 device BrainLAB Mask System (K945903) and BrainLAB CT/X-Ray Localizer (K954861).

{1}------------------------------------------------

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 3 2006

Mr. Rainer Birkenbach Executive Vice President BrainLAB AG Ammerthalstraße 8 85551 Heimstetten GERMANY

Re: K053500 Trade/Device Name: Frameless Radiosurgery Components Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: December 7, 2005 Received: December 16, 2005

Dear Mr. Birkenbach:

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 (Premarket Approval), 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 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 clectronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.

{2}------------------------------------------------

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 this letter:

| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|-----------------|----------------------------------|--------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). 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 vours,

Nancy C. Bugdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{3}------------------------------------------------

## Indications for Use

510(k) Number (if known):

KOS3500

Device Name:

Frameless Radiosurgery Components

Indications For Use:

The Frameless Radiosurgery Components are a device used for fixation and reposition and repositioning of the patient´s

- head and neck
- head, neck, and shoulders -

in a linear accelerator environment for stereotactic radiosurgery/radiotherapy procedures.

Mansel C. Bringdon

(Division Sign-Off) Division of Reproductive. Abdominal and Radiological Devices 510(k) Number

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)