(29 days)
Not Found
No
The document describes a mechanical device for shaping radiation beams and mentions software updates for control and data transfer, but there is no mention of AI or ML in the intended use, device description, or specific sections for AI/ML information.
No
The device is described as an x-ray collimator designed to shape the x-ray field perimeter for radiation therapy, assisting in the delivery of radiation. It does not directly provide therapy but assists in the delivery of a therapeutic modality.
No
The device is described as an x-ray collimator designed to shape the x-ray field perimeter during radiation therapy, not to diagnose a condition.
No
The device description explicitly states it is a modification of a "present MLC device" and is "designed to be mounted on a 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 to defined target volumes in patients. This is a therapeutic application, not a diagnostic one.
- Device Description: The description details a physical device (a multi-leaf collimator) that shapes an x-ray beam. This is a component of a radiation therapy system, which is used for treatment, not diagnosis.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing information about a patient's health status, disease, or condition based on in vitro analysis.
- Using reagents or assays.
The device is a component of a radiation therapy system used for treating cancer, which falls under the category of therapeutic medical devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The Varian Millennium Multileaf Collimator (MLC) is an accessory X-ray collimator designed to be mounted on a Varian Clinac radiotherapy linear accelerator and is intended to shape the X-ray field perimeter. Field shape can be either static (fixed) or dynamic. Dynamic field shapes are controlled as function of Clinac dose fraction or gantry angle. The intended use is 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.
The Varian Millennium 120 Multi-leaf 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 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, IYE
Device Description
Millennium Multi-Leaf Collimator (MLC) Release v7.0 is a modification of the present MLC device (K990085) to include the following:
-
- Large Field IMRT treatments
- Smooth motion control 2.
-
- Faster patient plan downloads via ethernet
The Varian Millennium Multileaf Collimator (MLC) is an x-ray collimator designed to be mounted on a 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.
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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc)
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.
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Page 1 of 2
MAR 2 3 2005
510(k) Summary
The following information is provided following the format of 21 CFR 807.92 for the Millennium Multi-leaf Collimator
Varian Medical Systems Submitter: 3100 Hansen Way M/S E-110 Palo Alto, CA 94304-1129 Contact Name: Vy Tran Phone: (650) 424-5731 (650) 842-5040 Fax: Email: vy.tran@varian.com Date summary was prepared: February 17, 2005
1. Name of the Device:
| Trade/Proprietary Name: | Millennium Multi-Leaf Collimator |
|---|---|
| Common or Usual Name: | Accessory to Medical Linear Accelerator |
| Classification Name: | Medical Charged Particle Radiation Therapy |
| System | |
| 21 CFR §892.5050 | |
| Class II | |
| Product Code: 90 IYE |
2. Predicate Devices to claim substantial equivalence:
a. Varian Medical Systems' Millennium Multi-leaf Collimator (K990085)
3. Device Description:
Millennium Multi-Leaf Collimator (MLC) Release v7.0 is a modification of the present MLC device (K990085) to include the following:
-
- Large Field IMRT treatments
- Smooth motion control 2.
-
- Faster patient plan downloads via ethernet
The Varian Millennium Multileaf Collimator (MLC) is an x-ray collimator designed to be mounted on a 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.
-
- Intended Use Statement: The Varian Millennium Multileaf Collimator (MLC) is an accessory X-ray collimator designed to be mounted on a Varian Clinac radiotherapy linear accelerator and is intended to shape the X-ray field perimeter. Field shape can be either static (fixed) or dynamic. Dynamic field shapes are
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K050442
Page 2 of 2
controlled as function of Clinac dose fraction or gantry angle. The intended use is 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.
-
- Summary of the Technological Characteristics: The Substantial Equivalence Comparison Chart provides a comparison of the technological characteristics to those of the predicate devices. This chart is located in Tab 8 of the submission.
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Image /page/2/Picture/12 description: The image shows a seal for the Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES" around the perimeter. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 3 2005
Ms. Vy Tran Corporate Director, Regulatory Affairs Varian Medical Systems, Inc. 3100 Hansen Way PALO ALTO CA 94304-1038
Re: K050442
Trade/Device Name: Millenium 120 MLC Regulation Number: 21 CFR §892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: February 17, 2005 Received: February 22, 2005
Dear Ms. Tran:
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 (Premarket Approval), it may be subject to such 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.
3
This letter will allow you to begin marketing your device as described in your Section 510(k) r ms letter natification. The FDA finding of substantial equivalence of your device to a legally promated 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 does office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). You may obtain other general information on your responsibilities under the Act 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/dsmadsmam.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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510(k) Number (if known): K050442 Device Name: Millennium120 MLC
Indications For Use:
The Varian Millennium 120 Multi-leaf 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 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)
(Optional Format 3-10-98)
David in Lignon
1 Prescription Use