(29 days)
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.
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.
- Faster patient plan downloads via ethernet
The provided 510(k) summary for the Millennium Multi-leaf Collimator (K050442) outlines a modification to an existing device, primarily focusing on engineering enhancements rather than a new AI-powered diagnostic or predictive tool. Therefore, many standard acceptance criteria and study design elements typically associated with AI/ML medical devices are not explicitly detailed in this document.
Based on the information provided, here's a breakdown:
1. Table of Acceptance Criteria and Reported Device Performance:
The 510(k) summary does not contain a quantitative table of acceptance criteria and reported device performance in the way one would expect for a diagnostic AI device (e.g., sensitivity, specificity, AUC). Instead, the improvements are described qualitatively:
| Acceptance Criteria (Implied) | Reported Device Performance (Implied) |
|---|---|
| Support Large Field IMRT | Device includes "Large Field IMRT treatments" capability. |
| Smooth Motion Control | Device includes "Smooth motion control." |
| Faster Plan Downloads | Device includes "Faster patient plan downloads via ethernet." |
| Field Shaping Ability | "Intended to shape the X-ray field perimeter. Field shape can be either static (fixed) or dynamic. Dynamic field shapes are controlled as a function of either Clinac® dose fraction or gantry angle." This function is maintained and enhanced from the predicate device. |
| Substantial Equivalence | Determined to be substantially equivalent to the predicate device (K990085). |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not describe a "test set" in the context of data for an AI/ML algorithm. This 510(k) is for a physical device modification, not a software algorithm evaluated against a dataset of patient images or outcomes. Therefore, there is no mention of sample size for a test set or data provenance (country of origin, retrospective/prospective). The evaluations would likely involve engineering testing, performance verification, and possibly clinical use data from the previous version of the device, but these details are not provided in this summary.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
Not applicable. This is not an AI/ML device requiring expert-established ground truth from medical images or patient data. The "ground truth" for this device would be its ability to perform its mechanical and electronic functions (e.g., accurately shaping radiation fields, smooth movement).
4. Adjudication Method:
Not applicable. There is no adjudication method described as this is not a study involving human-expert consensus on medical data.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
Not applicable. This device is a physical component of a radiation therapy system, not an AI software intended to assist human readers in interpretation. Therefore, an MRMC study is not relevant.
6. Standalone (Algorithm Only) Performance:
Not applicable. This is a physical device, not an algorithm. Its performance is intrinsically linked to its operation within the linear accelerator system.
7. Type of Ground Truth Used:
The "ground truth" for this medical device would be based on engineering specifications, physical measurements, and performance benchmarks for radiation field shaping, motion control, and data transfer speeds. It would also implicitly rely on the established safety and efficacy of the predicate device (K990085). The document does not specify the exact methods for defining or verifying this "ground truth."
8. Sample Size for the Training Set:
Not applicable. This device is a hardware modification, not an AI/ML algorithm that requires a "training set" of data.
9. How the Ground Truth for the Training Set Was Established:
Not applicable. As there is no AI/ML training set, there's no ground truth established for it.
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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 TherapySystem21 CFR §892.5050Class IIProduct 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.
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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
§ 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.