(78 days)
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.
The provided text is a 510(k) premarket notification letter from the FDA for a medical device called "Victoreen Thebes II Model 7020". This document focuses on the regulatory approval of the device and confirms its substantial equivalence to a predicate device.
It does NOT contain information regarding acceptance criteria, specific performance metrics, or study details such as sample size, data provenance, expert qualifications, ground truth establishment, or any comparative effectiveness studies (MRMC or standalone AI performance).
The document primarily states the device's 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."
Since the requested information (acceptance criteria, performance data, study design, etc.) is entirely absent from the provided text, I cannot generate a response that directly answers your specific questions.
Therefore, I must state that the provided input does not contain the information necessary to describe the acceptance criteria and the study that proves the device meets them.
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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 | (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" (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 (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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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
§ 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.