MOSFET AUTOSENSE WIRELESS

K032725 · Thomson & Nielsen Electronics, Ltd. · IYE · Oct 3, 2003 · Radiology

Device Facts

• Record ID: K032725
• Device Name: MOSFET AUTOSENSE WIRELESS
• Applicant: Thomson & Nielsen Electronics, Ltd.
• Product Code: IYE · Radiology
• Decision Date: Oct 3, 2003
• 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

MOSFET AutoSense Wireless system; provides dosimetry and detects radiation dose delivered to patients during therapeutic radiation procedures. System verifies output of radiation-producing devices. Used in clinical settings by healthcare professionals. Device inputs include radiation exposure signals detected by MOSFET sensors; transforms signals into dose measurements. Output provides real-time or post-procedure dose verification data to clinicians; assists in ensuring accurate radiation delivery and patient safety.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

MOSFET-based radiation dosimetry system; wireless connectivity; intended for verification of radiation therapy output. Class II device under 21 CFR 892.5050.

Indications for Use

Indicated for patients undergoing therapeutic radiation procedures requiring dosimetry or dose verification. Intended for prescription use.

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

OCT - 3 2003

Ms. Mary Herbert Document Control Coordinator Thomson & Nielsen Electronics, Ltd. 25B Northside Road Ottawa ON K2H 8S1 CANADA

## Re: K032725

Trade/Device Name: MOSFET AutoSense Wireless Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charges-particle radiation therapy system Regulatory Class: II Product Code: 90 IYE Dated: August 29, 2003 Received: September 3, 2003

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); 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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SPECIAL 510(K) PATIENT DOSE Thomson Nielsen VERIFICATION SYSTEM MODIFICATION

## ATTACHMENT 2

## INDICATIONS FOR USE STATEMENT

510(K) NUMBER:

K∅3 27 25

DEVICE NAME:

INDICATIONS FOR USE:

MOSFET AutoSense Wireless

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.

*Prescription Use*

Nancychordon

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K032725