POSITIONER

K063839 · C-Rad Positioning AB · IYE · Feb 8, 2007 · Radiology

Device Facts

• Record ID: K063839
• Device Name: POSITIONER
• Applicant: C-Rad Positioning AB
• Product Code: IYE · Radiology
• Decision Date: Feb 8, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5050
• Device Class: Class 2

Intended Use

The Positioner system is intended for use in radiation therapy clinics to accurately position patients for radiation therapy in a teproducible way. The system provides information about a patient's position and the adjustments required in order to position the patient as a close as possible to a reference setup. The system shall only be used by hospital personnel, qualified to work in radiation therapy or diagnostics departments.

Device Story

Positioner system facilitates patient alignment for radiation therapy. System components: ceiling-mounted laser-camera unit (LS-100) and Windows-based PC application (cPosition). Operation: visible laser light (635nm) projects lines onto patient; camera records laser lines; triangulation technique calculates 3D surface contour; multiple contours combined to form full 3D surface image. Software compares scanned 3D image against reference image; calculates required adjustments for alignment. Used in radiation therapy clinics by qualified hospital personnel. Output: positional information and adjustment requirements displayed to clinician to guide patient positioning. Benefits: improved accuracy and reproducibility of patient setup for radiation treatment.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Ceiling-mounted laser-camera unit (LS-100); visible laser light (635nm); triangulation-based 3D surface imaging; Windows-based PC software (cPosition); standalone system.

Indications for Use

Indicated for patients undergoing radiation therapy requiring accurate, reproducible positioning prior to treatment. For use by qualified hospital personnel in radiation therapy or diagnostics departments.

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

• AlignRT (K052682)

Submission Summary (Full Text)

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## 510(k) SUMMARY

Owner

C-RAD Positioning AB Kungsängsvägen 29 753 23 Uppsala Phone no: [phone] Fax no: [phone]

Contact person Bengt-Eric Rösth Chief Executive Officer Phone no: [phone]

Date of preparation December 12, 2006

Trade name of device Positioner

Common name Radiotherapy positioning system

#### Classification name

Medical charged-particle radiation therapy system Regulation: 21 CFR 892.5050

Predicate marketed devices AlignRT (K052682) - Vision RT Ltd. FEB 8 2007

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#### Device description

The system consists of a laser-camera unit (LS-100) mounted in the ceiling, and a Windows based application (cPosition) running on a standard PC.

The system is non-invasive and uses visible laser light (635nm) to project lines on the patient. The laser-camera scans a 3D surface by projecting a series of laser lines which are recorded by the camera. From each camera recording a 3D contour of the measured object is calculated using triangulation technique and by adding the contours a full 3D surface image is achieved.

The PC software compares the scanned image with a reference image and calculates the adjustments required in order to match the two images.

#### Intended use

The Positioner system is intended for use in radiation therapy clinics to accurately position patients for radiation therapy in a teproducible way. The system provides information about a patient's position and the adjustments required in order to position the patient as a close as possible to a reference setup.

The system shall only be used by hospital personnel, qualified to work in radiation therapy or diagnostics departments.

#### Technological comparison

The Positioner system is substantial equivalent to the predicate devices in terms of their intended use and technological characteristics. There are differences between the Positioner system and predicate devices in terms of their principles of operation, materials, performance, human factors and energy delivered by the system. However, performance data has been submitted to show that Positioner achieves its intended use and that these technological differences raise no new efficacy or safety concerns.

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Image /page/2/Picture/0 description: The image is a black and white circular logo. The text around the circle reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". Inside the circle is a symbol that appears to be three stylized human profiles facing to the right, with lines suggesting movement or connection between them. The overall impression is of a government agency focused on health and human services.

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

Mr. Bengt-Eric Rösth CEO C-RAD Positioning AB Kungsängsvägen 29 Uppsala 75323 SWEDEN

### 8 2007

Re: K063839

Trade/Device Name: Positioner Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: December 20, 2006 Received: December 26, 2006

Dear Mr. Rösth:

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 coomnerce 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 Noss enair 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 levices, 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 FFA may publish further announcements concerning your device in the Federal Register.

Image /page/2/Picture/10 description: The image shows a circular seal with the text "1876-1976" at the top. The letters "PA" are in the center of the seal in a bold, block-like font. Below the letters, the word "Centennial" is written in a cursive font. There are four stars at the bottom of the seal.

Protecting and Promoting Public Health

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Page 2 --

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 Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|----------------|----------------------------------|--------------|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

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 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. Hogdon

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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NC-RAD

# INDICATIONS FOR USE

063839

510(k) Number:

Device Name: Positioner

#### Indications for use:

The Positioner system is intended for use in radiation therapy clinics to accurately position patients in a reproducible way, prior to treatment. The system provides information about a patient's position and the adjustments required in order to position the patient as close as possible to a reference setup.

The system shall only be used by hospital personnel, qualified to work in radiation therapy or diagnostics departments.

Prescription Use***_***_

Jorind Co. Segmen

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