PORTABLE DOSIMETER DOSE VERIFICATION SYSTEM, MODEL TD-RD-90

K092285 · Best Medical Canada , Ltd. · IYE · Aug 28, 2009 · Radiology

Device Facts

• Record ID: K092285
• Device Name: PORTABLE DOSIMETER DOSE VERIFICATION SYSTEM, MODEL TD-RD-90
• Applicant: Best Medical Canada , Ltd.
• Product Code: IYE · Radiology
• Decision Date: Aug 28, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.5050
• Device Class: Class 2

Intended Use

To provide dosimetry or to detect the dose delivered to a patient during therapeutic radiation procedures. The system is intended for the verification of the output of radiation producing devices.

Device Story

Portable Dosimeter measures radiation dose delivered to patients during therapeutic procedures; verifies output of radiation-producing devices. Used in clinical settings by medical physicists or radiation therapists. Device captures radiation signals; processes data to quantify dose; provides output for verification of therapeutic delivery. Enables quality assurance of radiation therapy equipment; ensures accurate dose delivery to patients.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Portable dosimeter for radiation therapy verification. Operates as a medical charged-particle radiation therapy system accessory (21 CFR 892.5050).

Indications for Use

Indicated for dosimetry or dose detection during therapeutic radiation procedures; intended for verification of radiation output from radiation-producing devices.

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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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002

## AUG 2 8 2009

Ms. Mary Herbert Quality and Regulatory Manager Best Medical Canada Ltd. 413 March Road Ottawa, Ontario K2K 0E4 CANADA

Re: K092285

Trade/Device Name: Portable Dosimeter Regulation Number: 21 CFR 892.5050 Regulation Name: Medical Charged-particle radiation therapy system Regulatory Class: II Product Code: TYE Dated: July 28, 2009 Received: July 29, 2009

#### Dear Ms. Herbert:

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); medical device reporting of medical

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device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrl/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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,

Lamme M. Thonak

Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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25 medical canada verification system MODIFICATION

# ATTACHMENT 2

# INDICATIONS FOR USE STATEMENT

510(K) NUMBER: KO92285

## DEVICE NAME:

Portable Dosimeter

INDICATIONS FOR USE:

To provide dosimetry or to detect the dose delivered to a patient during therapeutic radiation procedures. The system is intended for the verification of the output of radiation producing devices.

Hulut Reime

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