(16 days)
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.
Not Found
The provided document is a 510(k) clearance letter from the FDA for a device called "TN-RD-60 Patient Dose Verification System" (later referred to as "MOSFET AutoSense Patient Dose Verification System"). This letter indicates that the device has been found substantially equivalent to a legally marketed predicate device.
The document does not contain specific acceptance criteria or details of a study proving the device meets those criteria. Such information would typically be found in the 510(k) submission itself, which is not provided here. The clearance letter only confirms that the FDA has reviewed the submission and made a substantial equivalence determination based on the provided information.
Therefore, I cannot provide the requested information from the 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 | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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:
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
§ 892.5050 Medical charged-particle radiation therapy system.
(a)
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.(b)
Classification. Class II. When intended for use as a quality control system, the film dosimetry system (film scanning system) included as an accessory to the device described in paragraph (a) of this section, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.