MOSFET AUTOSENSE, MODEL TN-RD-60

K013279 · Thomson & Nielsen Electronics, Ltd. · IYE · Oct 18, 2001 · Radiology

Device Facts

• Record ID: K013279
• Device Name: MOSFET AUTOSENSE, MODEL TN-RD-60
• Applicant: Thomson & Nielsen Electronics, Ltd.
• Product Code: IYE · Radiology
• Decision Date: Oct 18, 2001
• 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

The TN-RD-60 Patient Dose Verification System (also referred to as MOSFET AutoSense) is a dosimetry system used to measure and verify radiation doses delivered to patients during therapeutic radiation procedures. The system monitors the output of radiation-producing devices to ensure accurate delivery. It is intended for use by clinical professionals in a radiation therapy setting. The device provides real-time or post-procedure dose verification, allowing clinicians to confirm that the prescribed radiation dose matches the actual delivered dose, thereby supporting quality assurance and patient safety in radiotherapy.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and intended use.

Technological Characteristics

The system utilizes MOSFET (Metal-Oxide-Semiconductor Field-Effect Transistor) technology for radiation sensing. It is designed for dosimetry and verification of radiation-producing equipment output. Specific materials, dimensions, and software architecture details are not provided in the source text.

Indications for Use

Indicated for patients undergoing therapeutic radiation procedures requiring dosimetry or dose verification. Used for verifying the output of 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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Image /page/0/Picture/1 description: The image shows a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three wing-like shapes. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES" is arranged in a circular fashion around the bird-like figure.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## OCT 1 8 2001

Ms. Norma Thomson Vice President Thomson & Nielsen Electronics Ltd. 25B Northside Road OTTAWA ON CANADA K2H 8S1

Re: K013279

Trade/Device Name: TN-RD-60 Patient Dose Verification System Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II

Product Code: 90 IYE Dated: September 28, 2001 Received: October 2, 2001

Dear Ms. Thomson:

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 ror as blance of 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 (Act ) that do not require approval of a premarket approval application (PMA). You way, 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 (scctions 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 510(k) premarket I 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 11 you t the Office of Compliance at one of the following numbers, based on the regulation number at the top of this 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" (21 CFR Part 807.97). 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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## Special 510(k) - Patient Dose Verification System Modification

## ATTACHMENT 2 -

## INDICATIONS FOR USE STATEMENT

510(k) Number:

K013279

MOSFET AutoSense Patient Dose Verification System Device Name:

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.

David L. Seaymore

Prescription Use