VICTOREEN THEBES II, MODEL 7020

K024284 · Syncor Radiation Management · IYE · Mar 11, 2003 · Radiology

Device Facts

• Record ID: K024284
• Device Name: VICTOREEN THEBES II, MODEL 7020
• Applicant: Syncor Radiation Management
• Product Code: IYE · Radiology
• Decision Date: Mar 11, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5050
• Device Class: Class 2

Intended Use

The Victoreen Thebes II, Model 7020, is used to perform dose distribution measurements and analyses on radiation therapy beams.These measurements and analyses may be used for acceptance testing, beam trimming, routine beam checks and quality assurance measurements. The Victoreen Thebes II, Model 7020, consists of a linear detector array consisting of 47 waterproof, vented air ionization chambers; a multi-channel electrometer with 48 independent electrometers; and Windows based software that acquires beam profile data from the detector array and multi-channel electrometer, displays the measured beams one dimensional dose distribution profile graphically and performs beam profile analysis.

Device Story

Victoreen Thebes II Model 7020 is a radiation therapy beam measurement system. Input: radiation therapy beam signals captured via 47 waterproof, vented air ionization chambers in a linear detector array. Processing: 48-channel electrometer converts signals; Windows-based software acquires and processes beam profile data. Output: graphical display of one-dimensional dose distribution profiles and beam profile analysis. Used in clinical radiation therapy environments by medical physicists or technicians for acceptance testing, beam trimming, and quality assurance. Output informs clinicians on beam characteristics to ensure accurate radiation delivery.

Clinical Evidence

No clinical data provided; device is a measurement tool for radiation therapy quality assurance.

Technological Characteristics

System comprises a linear detector array with 47 waterproof, vented air ionization chambers and a 48-channel electrometer. Operates via Windows-based software for data acquisition, graphical display, and profile analysis. Connectivity is PC-based.

Indications for Use

Indicated for use by medical physicists or qualified technicians to perform dose distribution measurements and analyses on radiation therapy beams for acceptance testing, beam trimming, routine beam checks, and quality assurance.

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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 11 2003

Ms. Christine G. Castleberry Regulatory Affairs & Quality Assurance Manager Syncor Radiation Management 6045 Cochran Road SOLON OH 44139-3303

Re: K024284

Trade/Device Name: Victoreen Thebes II Model 7020 Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy device Regulatory Class: II Product Code: 90 IYE Dated: October 11, 2002 Received: December 23, 2002

Dear Ms. Castleberry:

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 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 electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.

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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 the letter:

| 8xx.1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [phone] |

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 may be obtained 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/dsma/dsmamain.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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Page I

510(k) Number (if known): K024284

Device Name: Victoreen Thebes II, Model 7020

Indications For Use:

The Victoreen Thebes II, Model 7020, is used to perform dose distribution measurements and analyses on radiation therapy beams.These measurements and analyses may be used for acceptance testing, beam trimming, routine beam checks and quality assurance measurements.

The Victoreen Thebes II, Model 7020, consists of a linear detector array consisting of 47 waterproof, vented air ionization chambers; a multi-channel electrometer with 48 independent electrometers; and Windows based software that acquires beam profile data from the detector array and multi-channel electrometer, displays the measured beams one dimensional dose distribution profile graphically and performs beam profile analysis.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Optional Format 3-10-98)

V Prescription Use

Marcy C bradon