PROFILER 2

K063021 · Sun Nuclear Corp. · IYE · Nov 22, 2006 · Radiology

Device Facts

• Record ID: K063021
• Device Name: PROFILER 2
• Applicant: Sun Nuclear Corp.
• Product Code: IYE · Radiology
• Decision Date: Nov 22, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5050
• Device Class: Class 2

Intended Use

The Profiler 2 is a device that is designed for use as a radiation scanning system that is used to measure beam data in radiotherapy departments for dose modeling in the treatment planning computer.

Device Story

Profiler 2 (Model 1174) functions as radiation scanning system for radiotherapy quality assurance; collects dosimetry modeling data for treatment planning. Device operated by radiation therapy professionals in clinical settings; not used on patients. System utilizes external power converter (100-240 VAC to 18 VDC) connected via power/data interface (PDI) and 8-pin DIN connector; data transmitted to computer via 9-pin serial connection. Safety features include shielded housing to prevent electromagnetic interference and line markings to protect electronics from direct radiation beams. Output used by clinicians to verify radiation beam characteristics; ensures accuracy of treatment planning models; benefits patient by supporting precise radiation delivery.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Radiation scanning system; Model 1174. Powered by external 18 VDC converter (100-240 VAC input). Connectivity via 8-pin DIN and 9-pin serial interface. Features shielded housing and radiation-protected electronics. Standalone system for professional use.

Indications for Use

Indicated for use by radiation therapy professionals in radiotherapy departments to measure radiation beam data for dose modeling in treatment planning computers. Not for use on patients.

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.

Submission Summary (Full Text)

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KD63021

## Safety and Effectiveness Summary for Profiler 2

Profiler 2 is only used by the radiation therapy professionals, and is not used with the patient. A standard commercial power converter converts the power from the wall outlet voltage (100 to 240 VAC) to 18 VDC. The converter is then connected to a power/data interface (PDI) and then supplies the 18 VDC power to the Profiler 2 through a single 8 pin DIN connector. A standard 9 pin serial connectors connects the PDI to a computer. The commercial power converter and PDI device are fully tested for safety. Therefore, Profiler 2 should not generate a shock hazard to the operator.

Sun Nuclear has deemed the devices safe and effective for their intended uses as long as they are used in accordance with all of the accompanying labeling and instructions. When used properly, Profiler2 can collect the useful dosimetry modeling data for radiation therapy treatment planning. Sun Nuclear believes that responsible design and quality assurance practices were followed during the development and manufacture of Profiler 2 (Model 1174).

## Safety features of Profiler 2

| Feature | Effect |
|-----------------------------|----------------------------------------------------------|
| 1. Standard power converter | Eliminate electrical shock |
| 2. Shielded housing | Prevent E&M interference |
| 3. Line mark on device | Protect electronics being under direct radiation<br>beam |

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Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

Mr. Noel M. Downey Official Correspondent Sun Nuclear Corporation 425-A Pineda Court MELBOURNE FL 32940

NOV 2 2 2006

Re: K063021

Trade/Device Name: Profiler 2 Model 1174 Regulation Number: 21 CFR 892.5050 Regulation Name: Medical Charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: September 29, 2006 Received: October 2, 2006

Dear Mr. Downey:

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.

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Protecting and Promoting Public Health

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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 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/cdrl/industry/support/index.html.

Sincerely yours,

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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510(k) Number (if known):

Device Name: _________________________________________________________________________________________________________________________________________________________________

## Indications for Use:

The Profiler 2 is a device that is designed for use as a radiation scanning system that is used to measure beam data in radiotherapy departments for dose modeling in the treatment planning computer.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Percsription Use ✓

OR

Over-The-Counter Use

David A. Szymanski

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