(28 days)
Not Found
No
The summary describes a mechanical device (multileaf collimator) for shaping radiation beams and does not mention any AI or ML components or functions.
No
The device is described as an x-ray collimator that assists in delivering radiation therapy, which is a treatment, but the device itself is a component of a larger therapeutic system, not a standalone therapeutic device. It assists in the delivery, but doesn't directly provide the therapy.
No
The device is described as an x-ray collimator used by a radiation oncologist to deliver radiation therapy, not to diagnose a condition.
No
The device description explicitly states it is an "x-ray collimator designed to be mounted on a C or EX Series Varian Clinac® radiation therapy linear accelerator," indicating it is a physical hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used to assist in the delivery of radiation therapy to patients. This is a therapeutic application, not a diagnostic one.
- Device Description: The description confirms it's an x-ray collimator mounted on a linear accelerator, which is a piece of equipment used for radiation treatment.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, tissue, etc.), detecting diseases, or providing diagnostic information about a patient's condition.
IVD devices are used to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device's function is entirely focused on the delivery of treatment.
N/A
Intended Use / Indications for Use
The Varian Millennium 120 Multileaf Collimator (MLC) is provided to assist the radiation oncologist in the delivery of radiation to defined target volumes while sparing surrounding normal tissue and critical organs from excess radiation. In a static mode, the MLC performs the same function as the customized shadow blocks. In a dynamic mode, a series of MLC leaf positions can be indexed to either Clinac® dose fraction or gantry angle to create a changing beam shape while the radiation beam is on to create a three dimensional dose distribution.
Product codes
90 IYE
Device Description
The Varian Millennium Multileaf Collimator (MLC) is an x-ray collimator designed to be mounted on a C or EX Series Varian Clinac® radiation therapy linear accelerator beneath the standard field defining the collimator jaw.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
radiation oncologist
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
FEB 8 1559 KG90085
varian@ oncology systems
Premarket Notification [510K] Summary as required by 21 CFR 807.92
Date Summary was prepared; January 8, 1999
Submitter's Name: Varian Oncology Systems 3045 Hanover Street Palo Alto, CA 94304
Contact Person:
Linda S. Nash Regulatory Compliance & Radiation Safety Manager Phone (650) 424-6990 (650) 424-4830 FAX E-Mail linda.nash@os.varian.com
Device Name: Millennium MLC - 120
Classification Name: Medical Linear Accelerator Accessory, 90 IYE (per 21 CFR section 892.5050)
Predicate Device: Varian Multileaf Collimator with Dynamic Arc Therapy, K973889
Product Description:
The Varian Millennium Multileaf Collimator (MLC) is an x-ray collimator designed to be mounted on a C or EX Series Varian Clinac® radiation therapy linear accelerator beneath the standard field defining the collimator jaw.
Image /page/0/Picture/13 description: The image shows a logo for "Partners for Life". The words "Partners" and "For" are stacked on top of each other in a bold, sans-serif font. The word "Life" is written in a cursive script and extends to the right of the other words. The logo is in black and white.
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Intended Use:
The Varian Millennium Multileaf 120 Collimator (MLC) is an x-ray collimator designed to be mounted on a C or EX Series Varian Clinac® radiation therapy linear accelerator and is intended to shape the x-ray field perimeter. Field shape can either be static (fixed) or dynamic. Dynamic field shapes are controlled as a function of either Clinac® dose fraction or gantry angle. The intended use to assist the radiation oncologist in the delivery of radiation to defined target volumes while sparing surrounding normal tissue and critical organs from excess radiation.
Technological Characteristics:
See the attached "Specification Comparison Chart" (Tab F).
2
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three heads, representing the department's mission to protect the health of all Americans and provide essential human services. The eagle is surrounded by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
FEB 8 1999
Linda Nash Regulatory Compliance And Radiation Safety Manager Varian Associates, Inc. 3045 Hanover Street Palo Alto, CA 94304-1129
Re:
K990085 Millenium MLC-120 (Multileaf Collimator) Dated: January 8, 1999 Received: January 11, 1999 Regulatory class: II 21 CFR 892.5050/Procode: 90 IYE
Dear Mr. Nash:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have We neve reviewed your oodlor of the indications for use stated in the enclosure) to legally decemined the devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the manced production as noo manova lices that have been reclassified in accordance with the provisions of the Mcaral Food, Drug, and Cosmetic Act (Act). 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 (Premarket Approval), it may ir your additional controls. Existing major regulations affecting your device can be found in the Code of De Subject to Julianal Controlly - Extentially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Mourden of the arreral voyalerily such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal rogatory dollor. In adallion, 1971 hay paur premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. 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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,
Capt. Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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# Indications For Use
510(k) Number (if known): _K990085
Device Name: Millennium MLC - 120
Indications for Use: The Varian Millennium 120 Multileaf Collimator (MLC) is provided to assist the radiation oncologist in the delivery of radiation to defined target volumes while sparing surrounding normal tissue and critical organs from excess radiation. In a static mode, the MLC performs the same function as the customized shadow blocks. In a dynamic mode, a series of MLC leaf positions can be indexed to either Clinac® dose fraction or gantry angle to create a changing beam shape while the radiation beam is on to create a three dimensional dose distribution.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH/Office of Device Evaluation (ODE) | |
|--------------------------------------------------------------------|--------------------------------|
| (Division Sign-Off) | |
| Division of Reproductive, Abdominal, ENT, and Radiological Devices | |
| 510(k) Number | [K990085](https://510k.innolitics.com/search/K990085) |
| Prescription Use (per 21 CFR 801.109) | OR Over-The-Counter Use ______ |
Varian Associates, Inc. 3045 Hanover Street Palo Alto, California 94304-1129 U.S.A. 650.493.4000 FAX: 650.424.4830
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