(90 days)
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None
No
The description focuses on the mechanical and control aspects of a multileaf collimator for radiotherapy, with no mention of AI or ML for tasks like treatment planning, image analysis, or adaptive therapy.
No.
The device (MLC) shapes the radiation field from a linear accelerator, which is the therapeutic device, to conform to tumor shapes. The MLC itself is an accessory that assists in the delivery of radiotherapy, but it is not directly administering therapeutic action to the patient.
No
This device is a multileaf collimator system used with linear accelerators in external beam radiotherapy to shape the radiation field to conform to tumor shapes. It is a therapy device, not a diagnostic device.
No
The device description explicitly details hardware components such as the collimator, Local Control Equipment (LCE), Multi Leaf Controller Unit (MLCU), jaws, leaves, and stepping motors. This indicates it is a hardware device with potentially integrated software, not a software-only medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Function: The 120 Leaf MLC is a component of a linear accelerator used for external beam radiotherapy. Its purpose is to shape the radiation field that is directed at a tumor within the patient's body.
- Lack of Specimen Analysis: The description clearly states the device is used with a linear accelerator to adjust the field shape for treating tumors. There is no mention of analyzing any biological specimens.
Therefore, the function and intended use of the 120 Leaf MLC fall outside the scope of In Vitro Diagnostics. It is a device used in the delivery of radiation therapy, which is an in-vivo (within the living body) treatment.
N/A
Intended Use / Indications for Use
The 120 Leaf MLC is indicated for use with the Mitsubishi EXL series linear accelerators to provide the ability to adjust the field shape to conform to tumor shapes. It can be a substitute for conventional customer blocks.
Product codes
90 IYE
Device Description
This submission is intended to be applicable to the 120 Leaf multileaf collimator system (MLC) which can be used on Mitsubishi linear accelerators for external beam radiotherapy. The MLC system is design to provide the ability to adjust the field shape to conform to tumor shapes. It can be a substitute for conventional customer provided blocks. The MLC system consists of the collimator, the Local Control Equipment (LCE) located in the treatment room, and Multi Leaf Controller Unit (MLCU).
The collimator consists of three sets of jaws which determines the field size and shape. The top (Y-direction) jaws consist of a pair of monoblocks just like conventional accelerator therapy collimators. The middle (X-direction) jaws also consist of a pair of monoblocks. These jaws move in tandem and determine the field length.
The lower set of jaws consist of 60 pairs of leaves (120 leaves). Each pair of leaves is independently driven by a stepping motor. Each pair of leaves can be independently set to provide irregular-shaped field settings.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
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Intended User / Care Setting
Not Found
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
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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)
Not Found
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
510 (k) SUMMARY
JAN | 4 1998
MITSUBISHI LINEAR ACCELERATORS EXL SERIES
1. Submitter:
The 510 (k) is submitted by Hideyuki Kawakami, Product Manager, Medical Systems Division, Mitsubishi Electronics America, Inc., 800 Cottontail Lane, Somerset, NJ 08873. This 510 (k) summary was prepared on October 9, 1997.
2. Device Name:
The 510 (k) submission is for Mitsubishi 120 Leaf MLC, an accessory for Mitsubishi EXL series of linear accelerators with computerized control consoles.
3. Predicate device:
The devices described in this submission are considered to be substantially equivalent to the Mitsubishi multileaf collimator.
The device is also equivalent to a multileaf collimator manufactured and distributed by Varian Associates Inc.
The predicate device are legally marketed, having been found to be substantially equivalent through the 510 (k) premarket notification process.
4. Device description:
This submission is intended to be applicable to the 120 Leaf multileaf collimator system (MLC) which can be used on Mitsubishi linear accelerators for external beam radiotherapy. The MLC system is design to provide the ability to adjust the field shape to conform to tumor shapes. It can be a substitute for conventional customer provided blocks. The MLC system consists of the collimator, the Local Control Equipment (LCE) located in the treatment room, and Multi Leaf Controller Unit (MLCU).
The collimator consists of three sets of jaws which determines the field size and shape. The top (Y-direction) jaws consist of a pair of monoblocks just like conventional accelerator therapy collimators. The middle (X-direction) jaws also consist of a pair of monoblocks. These jaws move in tandem and determine the field length.
The lower set of jaws consist of 60 pairs of leaves (120 leaves). Each pair of leaves is independently driven by a stepping motor. Each pair of leaves can be independently set to provide irregular-shaped field settings.
5. Intended use:
The 120 Leaf MLC is indicated for use with the Mitsubishi EXL series linear accelerators to provide the ability to adjust the field shape to conform to tumor shapes. It can be a
1
substitute for conventional customer blocks.
6. Comparison of technological characteristics:
This submission describes the modification of existing MLC by increasing the number of leaves. Positions of leaves in both types of MLC are adjusted by motor drive mechanisms using computerized controllers.
2
Public Health Service
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the caduceus symbol. The logo is black and white.
Food and Drug Administration 9200 Cornorate Boulevard Rockville MD 20850
Mitsubishi Electronics America, Inc. c/o C. L. McIntosh & Associates 12300 Twinbrook Parkway. Suite 625 Rockville, MD 20852
T. Whit Athey
Re:
K973963 Mitsubishi 120 Leaf Multileaf Collimator (MLC) for EXL Accelerator Series Dated: October 14, 1997 Received: October 16, 1997 Regulatory class: II 21 CFR 892.5050/Procode: 90 IYE
JAN 1 4 1998
Dear Mr. Athey:
Attn:
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, 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 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 (QS) 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 marked 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 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/cdrb/dsmamain.html"..............................................................................................
Sincerely yours.
W.Liau Yu
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
X973963 510(K) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name:
120 Leaf Multileaf Collimator for EXL Linear Accelerator Series
Indications For Use:
The 120 Leaf MLC is indicated for use with the Mitsubishi EXL series linear accelerators to provide the ability to adjust the field shape to conform to tumor shapes. It can be a substitute for conventional customer blocks.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ONANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Elvid A. bejerm
n of Reproductive. Abdominal. 510(k) Number
Prescription Use
OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________