(78 days)
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No
The description focuses on hardware components (detector array, electrometer) and standard software functions (data acquisition, display, analysis) without mentioning any AI/ML terms or capabilities.
No
Explanation: The device is used for dose distribution measurements and analyses on radiation therapy beams, primarily for quality assurance and testing purposes, not for direct therapeutic intervention on a patient.
No
The device is used to measure and analyze radiation therapy beams for quality assurance and performance, not to diagnose medical conditions in patients.
No
The device description explicitly states that the device "consists of a linear detector array... a multi-channel electrometer... and Windows based software". This indicates the device includes significant hardware components in addition to the software.
Based on the provided information, the Victoreen Thebes II, Model 7020, is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to perform dose distribution measurements and analyses on radiation therapy beams. This is a measurement and quality assurance tool for a medical device (radiation therapy equipment), not a test performed on biological samples (in vitro) to diagnose or monitor a patient's condition.
- Device Description: The device consists of a detector array, electrometer, and software for analyzing radiation beams. It does not involve the analysis of biological specimens.
IVD devices are specifically designed to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or treatment decisions. The Victoreen Thebes II operates on the radiation beam itself, not on a patient's biological sample.
N/A
Intended Use / 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.
Product codes
90 IYE
Device Description
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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc)
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§ 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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle with three wing-like shapes, symbolizing health, services, and people. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the emblem.
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.
1
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