(26 days)
No
The summary describes a mechanical device (multileaf collimator) for shaping radiation fields. There is no mention of AI, ML, image processing, or any data-driven decision-making processes typically associated with AI/ML in medical devices. The control is described as a function of accelerator dose fraction or gantry angle, which are standard parameters in radiation therapy, not indicative of AI/ML.
No.
The device is an accessory to linear accelerators, which are therapeutic devices. Its function is to shape the X-ray field during radiation delivery, assisting the clinician in delivering radiation and sparing surrounding tissue, but it does not directly administer therapy itself.
No
The device is described as an accessory X-ray collimator intended to shape the X-ray field perimeter for the delivery of radiation therapy, not for diagnosing conditions. It assists in treatment, not diagnosis.
No
The device description clearly states it is an "accessory X-ray collimator" and a "Multileaf Collimator (HD120 MLC)" designed to be "mounted on Varian Trilogy Tx and Trilogy linear accelerators." This indicates a physical hardware component, not a software-only device.
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 an accessory X-ray collimator used to shape the X-ray field for radiation therapy and radiosurgery. It assists clinicians in delivering radiation to defined target volumes while sparing surrounding normal tissue. This is a therapeutic application, not a diagnostic one.
- Device Description: The description focuses on the physical characteristics of the collimator and its function in shaping the radiation beam. There is no mention of analyzing biological samples or providing diagnostic information.
- Lack of IVD characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
The device is a component of a radiation therapy system used for treatment, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The Varian High-Definition 120 Multileaf Collimator (HD120 MLC) is an accessory X-ray collimator designed to be mounted on Varian Trilogy Tx and Trilogy linear accelerators 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 a function of the accelerator dose fraction or gantry angle. The intended use is to assist the clinician in the delivery of radiation to defined target volumes while sparing surrounding normal tissue and critical organs from excess radiation.
The Varian High-Definition120 Multileaf Collimator (HD120 MLC) is provided to assist the clinician in the delivery of external beam radiation to defined target volumes during radiosurgery and radiotherapy while sparing surrounding normal tissue and critical organs from excess radiation.
Product codes
90 TYE, IYE
Device Description
The High-Definition 120 Multileaf Collimator (HD120 MLC) provides higher resolution via finer width leaves in the center section of the treatment field. The total number of leaves remains the same at 120. As a result of the finer leaves, the treatment field has been modified from 40 cm in width. The length of the treatment field remains unchanged.
The objective of the area occupied by the finer leaves is to provide for higher definition shaping of treatment fields. These fields are primarily directed at small targets during single fraction Stereotactic Radiosurgery (SRS) and multi-fraction Stereotactic Radiotherapy (SRT).
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
Clinician
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
510(k) Summary
AUG 1 5 2007
The information below is provided for the High-Definition 120 Multileaf Collimator (HD120 MLC), following the format of 21 CFR 807.92.
- Varian Medical Systems 1. Submitter: 3100 Hansen Way, M/S e110 Palo Alto, CA 94304 Contact Name: Vy Tran Phone: 650/424.5731 Fax: 650/842.5040 E-mail: vy.tran@yarian.com
-
- Name of the Device: High-Definition 120 Multileaf Collimator (HD120 MLC) High-Definition 120 Multileaf Collimator (HD120 MLC) Trade / Proprietary Name: 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 TYE
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- Predicate Devices to claim substantial equivalence: Varian Medical Systems Millennium Multileaf Collimator - K050442
-
- Description of the Device:
The High-Definition 120 Multileaf Collimator (HD120 MLC) provides higher resolution via finer width leaves in the center section of the treatment field. The total number of leaves remains the same at 120. As a result of the finer leaves, the treatment field has been modified from 40 cm in width. The length of the treatment field remains unchanged.
The objective of the area occupied by the finer leaves is to provide for higher definition shaping of treatment fields. These fields are primarily directed at small targets during single fraction Stereotactic Radiosurgery (SRS) and multi-fraction Stereotactic Radiotherapy (SRT).
-
- Intended Use Statement
The Varian High-Definition 120 Multileaf Collimator (HD120 MLC) is an accessory X-ray collimator designed to be mounted on Varian Trilogy Tx and Trilogy linear accelerators 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 a function of the accelerator dose fraction or gantry angle. The intended use is to assist the clinician in the delivery of radiation to defined target volumes while sparing surrounding normal tissue and critical organs from excess radiation.
- Intended Use Statement
1
Indications for Use Statement 6.
The Varian High-Definition120 Multileaf Collimator (HD120 MLC) is provided to assist the clinician in the delivery of external beam radiation to defined target volumes during radiosurgery and radiotherapy while sparing surrounding normal tissue and critical organs from excess radiation.
7. Substantial Equivalence
The High-Definition 120 Multileaf Collimator (HD120 MLC) submission illustrates substantial equivalence to the predicate device.
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized symbol that resembles three curved lines or waves emanating from a single point.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
AUG 1 5 2007
Ms. Vy Tran Corporate Director, Regulatory Affairs Varian Medical Systems, Inc. 3100 Hansen Way PALO ALTO CA 94304-1038
Re: K071992
Trade/Device Name: High-Definition 120 Multileaf Collimator (HD120 MLC) Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: July 19, 2007 Received: July 20, 2007
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.
Image /page/2/Picture/10 description: The image shows a circular logo with the text "1906-2006" at the top. The letters "FDA" are prominently displayed in the center of the logo. Below the letters, the word "Centennial" is written in a smaller font. Three stars are arranged in a horizontal line at the bottom of the logo.
tocting and Promoting Publio Hoalth
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Page 2 -
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.
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology). | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 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 (240) 276-3150
or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.
Sincerely yours,
Nancy C. Hogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Image /page/4/Picture/0 description: The image shows the logo for Varian Medical Systems. The logo consists of the word "VARIAN" in a serif font, with the "I" stylized to resemble a person. Below the word "VARIAN" are the words "medical systems" in a smaller, sans-serif font. The logo is black and white.
Varian Medical Systems, Inc. 3100 Hansen Way Palo Alto, CA 94304-1038 USA Tel +1 650 493 4000 www.varian.com
Indications for Use Statement
510(k) Number (if
known):
Device Name:
High-Definition 120 Multileaf Collimator (HD120 MLC)
Indications for Use:
The Varian High-Definition 120 Multileaf Collimator (HD120 MLC) is provided to assist the clinician in the delivery of external beam radiation to defined target volumes during radiosurgery and radiotherapy while sparing surrounding normal tissue and critical organs from excess radiation.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use X OR Over-the-counter
(Per 21 CFR § 801.109)
JWhang
(Division Sign-Off)
Division of Reproductive, Abdominal and
Radiological Devices
510(k) Number K071992