STEREOTACTIC TARGET POSITIONER, TARGET POSITIONER FOR LEKSELL HEADRING, STEREOTACTIC COUNTERWEIGHT

K073018 · Brainlab AG · IYE · Jan 23, 2008 · Radiology

Device Facts

• Record ID: K073018
• Device Name: STEREOTACTIC TARGET POSITIONER, TARGET POSITIONER FOR LEKSELL HEADRING, STEREOTACTIC COUNTERWEIGHT
• Applicant: Brainlab AG
• Product Code: IYE · Radiology
• Decision Date: Jan 23, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5050
• Device Class: Class 2

Indications for Use

The Target Positioner is used to position the patient for the stereotactic radiotherapy/ radiosurgery. The optional usage of the Stereotactic Counterweight improves the accuracy of patient positioning during the treatment by compensating the Target Positioner after its removal.

Device Story

Target Positioner is a non-invasive mechanical device used in stereotactic radiotherapy/radiosurgery. It consists of an aluminum frame and transparent plastic carrier plates. Device aligns planned patient treatment isocenter with LINAC isocenter. It attaches to headrings or mask systems. Device must be removed prior to treatment. Optional stereotactic counterweight compensates for weight of positioner after removal to maintain positioning accuracy. Operated by clinical staff in a radiotherapy setting.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Mechanical device; aluminum frame; transparent plastic carrier plates. Non-invasive. Interfaces with headrings or mask systems. No energy source. No software.

Indications for Use

Indicated for patients undergoing stereotactic radiotherapy or radiosurgery requiring precise positioning of the treatment isocenter.

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 LINAC Hardware (K934657)

Submission Summary (Full Text)

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JAN 23 2008

# 510 (k) Summary of Safety and Effectiveness for Target Positioner

#### Manufacturer:

| Address: | BrainLAB AG<br>Kapellenstrasse 12<br>85622 Feldkirchen<br>Germany |
|-----------------|-------------------------------------------------------------------|
| | Phone: [phone]<br>Fax: [phone] |
| Contact Person: | Mr. Rainer Birkenbach |
| Summary Date: | October 23, 2007 |

#### Device Name:

Trade name:

Common Name:

Stereotactic Target Positioner, Target Positioner for Leksell Headring, Stereotactic Counterweight

Target Positioner, Counterweight

### Predicate Device: BrainLAB LINAC Hardware (K934657)

Device Classification Name: Medical charged-particle radiation therapy system (892/6050) Requlatory Class; Class II

#### Intended Use:

The Target Positioner is used to position the patient for the stereotactic radiotherapy/ radiosurgery.

The optional usage of the Stereotactic Counterweight improves the accuracy of patient positioning during the treatment by compensating the Target Positioner after its removal.

#### Device Description:

The Target Positioner is a non-invasive mechanical device that consists of an aluminum frame and four Target Positioner Carrier Plates made of transparent plastics.

In order to ensure a rigid fixation to different types of Headring respectively to the BrainLAB Mask System, various Target Positioners with adapted interface specifications are provided. The Target Positioner enables alignment of the planned patient's treatment isocenter with the LINAC Isocenter.

Prior to the treatment the Target Positioner has to be removed.

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K073018
pg. 2 of 2

The usage of the Stereotactic Counterweight improves the accuracy of patient positioning during the treatment by compensating the weight of the Target Positioner after its removal.

#### Substantial equivalence:

The Target Positioner has 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 LINAC Hardware (K934657).

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

A

3 2018

Mr.Rainer Birkenbach Executive Vice President BrainLAB AG Kapellenstraße 12 85622 Feldkirchen GERMANY

Re: K073018

Trade/Device Name: Target Positioner Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: October 23, 2007 Received: October 25, 2007

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 (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.

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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,

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 Center for Devices and Radiological Health's (CDRH's) 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 Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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,

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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## Indications for Use

510(k) Number (if known):

K073018

Device Name: Target Positioner

Indications For Use:

The Target Positioner (TaPo) is used to position the patient for the stereotactic radiotherapy/radiosurgery.

The optional usage of the Stereotactic Counterweight improves the accuracy of patient positioning during the treatment by compensating the weight of the Target Positioner after its removal.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ X (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)

| (Division Sign-Off) | <div style="text-align:left"></div> <img alt="signature" src="signature.png"/> |
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Division of Reproductive, Abdominal, and
Radiological Devices Concurrence of CDRH, Office of Device Evaluation (ODE)

| 510(k) Number | K073018 |
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