(38 days)
No
The description focuses on the mechanical function of the MLC and its ability to dynamically shape radiation beams based on a "pre-existing schedule" or "as a function of the Clinac gantry position." There is no mention of AI/ML being used for decision-making, planning, or adapting the treatment based on real-time data or learned patterns. The "Mentions AI, DNN, or ML" section is also explicitly marked as "Not Found".
No
The device assists in the delivery of radiation therapy, but the radiation itself is the therapeutic agent, not the collimator. The collimator is a part of the radiation delivery system.
No
The device is described as an x-ray collimator used to shape radiation beams for treatment delivery, not for diagnosis. Its purpose is to assist in the delivery of radiation to defined target volumes while sparing normal tissue.
No
The device description clearly states it is an x-ray collimator with physical leaves, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device's function in assisting radiation oncologists in delivering radiation therapy to patients. This is a therapeutic application, not a diagnostic one.
- Device Description: The description details a physical component (a collimator) used to shape radiation beams. This is consistent with a medical device used in treatment delivery, not for analyzing biological samples or providing diagnostic information.
- 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 for diagnosis, monitoring, or prognosis of a disease or condition
- Using reagents or assays
The Varian MultiLeaf Collimator is a component of a radiation therapy system used for treating patients, not for diagnosing them.
N/A
Intended Use / Indications for Use
The Varian 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 this the MLC performs the same function as customized shadow blocks. Employing the MLC Arc Therapy feature enables movement of individual leaves of the MLC according to a pre-existing schedule while the host Clinac® linear accelerator is performing arc therapy. In this modality the beam shape created by the MLC can correspond to a beam's eye view of the treatment volume at all times while the gantry is rotating in arc therapy.
Product codes
90 IYE
Device Description
The Varian MultiLeaf Collimator (MLC) is an x-ray collimator designed to be mounted on a Varian Clinac® radiation therapy linear accelerator beneath the standard field defining collimator jaws to provide complex beam shaping supplementary to the Clinac's rectangular fields. It contains either 52 or 80 collimator leaves (26 or 40 opposed pairs of leaves), each of which can be positioned individually in order to provide an irregularly shaped treatment field that corresponds closely with the volume intended to be irradiated. With the dynamic arc therapy feature, the leaves may be continuously repositioned as a function of the Clinac gantry position during rotational irradiation (arc therapy) in order to provide dynamic conformal therapy.
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
973889
varian®
Summary of Safety and Effectiveness Information
NOV 2 | 1997
- Varian Oncology Systems 1. Submitter: 3045 Hanover Street Palo Alto, CA 94304
Charles H. Will, Manager Contact: Regulatory Compliance & Safety Phone (650) 424-5036 (650) 424-4830 FAX cwill@os.varian.com
October 13, 1997 Prepared:
- Varian MultiLeaf Collimator with dynamic arc therapy feature 2. Device Name:
- Varian MultilLeaf Collimator (K926449, K943224) 3. Predicate BrainLAB micro-MultiLeaf Collimator (K970586) Devices:
- The Varian MultiLeaf Collimator (MLC) is an x-ray collimator 4. Description: designed to be mounted on a Varian Clinac® radiation therapy linear accelerator beneath the standard field defining collimator jaws to provide complex beam shaping supplementary to the Clinac's rectangular fields. It contains either 52 or 80 collimator leaves (26 or 40 opposed pairs of leaves), each of which can be positioned individually in order to provide an irregularly shaped treatment field that corresponds closely with the volume intended to be irradiated. With the dynamic arc therapy feature, the leaves may be continuously repositioned as a function of the Clinac gantry position during rotational irradiation (arc therapy) in order to provide dynamic conformal therapy.
-
- Intended Use: The Varian 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 this the MLC performs the same
1
function as customized shadow blocks. Employing the MLC Arc Therapy feature enables movement of individual leaves of the MLC according to a pre-existing schedule while the host Clinac linear accelerator is performing arc therapy. In this modality the beam shape created by the MLC can correspond to a beam's eye view of the treatment volume at all times while the gantry is rotating in arc therapy.
-
- Technological The MLC version being reported in this 510(k) Notification is, Considerations: from a hardware standpoint, identical to the MLC reported in prior 510(k)'s (K926449 and K943224). The software to be provided with the MLC version notified herein contains the capability to provide dynamic arc therapy as described above.
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three tail feathers. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA".
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 2 1 1997
Charles Will Manager Regulatory Compliance & Safety Varian Associates, Inc. 3045 Hanover Street Palo Alto, California 94304
Re: K973889
Varian Multileaf Collimator with Dynamic arc Therapy Dated: October 13, 1997 Received: October 14, 1997 Regulatory class: II 21 CFR 892.5050/Procode: 90 IYE
Dear Mr. Will:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent for the indications for use stated in the enclosure) to 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). You may, therefore, 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 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS inspections, the Food and Drug Administration (FDA) will verify 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 Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under 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 predication 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 question 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/dsmamain.html".
Sincerely yours,
William Yui
Lillian Yin, Ph.D. 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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Statement of Indications for Use*
I state in my capacity as Manager, Regulatory Compliance and Safety, of Varian Oncology Systems that the Product which is the subject of this premarket notification is intended to be used for the following:
The Varian 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 this the MLC performs the same function as customized shadow blocks. Employing the MLC Arc Therapy feature enables movement of individual leaves of the MLC according to a pre-existing schedule while the host Clinac® linear accelerator is performing arc therapy. In this modality the beam shape created by the MLC can correspond to a beam's eye view of the treatment volume at all times while the gantry is rotating in arc therapy.
Charles Heuiel
Charles H. Will, Mayor
Charles H. Will, Manager Regulatory Compliance & Safety
October 13, 1997
Date
"Suggested language and format to meet the requirements of section 513(i) of the Federal Food, Drug, and Cosmetic Act, as amended, and 21 CFR sections 801.4 and 809.92(a)(5).
Kg 73889
510(k) Number
David G. Segblom
Division Sign-off
Division Sign-off Office of Device Evaluation
Prescription Use
(Per 21 CFR 801.109)
Over-the-Counter Use