(102 days)
Not Found
No
The description focuses on the mechanical and electronic control of the leaves for beam shaping, with no mention of AI or ML for decision-making, image analysis, or treatment planning. The changes described are related to hardware, electronics, usability, and serviceability.
Yes
Explanation: The device is intended to assist in the delivery of radiation therapy, which is a therapeutic intervention for diseases like cancer.
No
The device is an accessory X-ray collimator designed to shape the radiation beam during radiotherapy and radiosurgery. Its purpose is to assist in the delivery of treatment, not to diagnose a condition.
No
The device description clearly details physical hardware components (MLC head, leaf banks, leaves, motors, carriages) that are integral to the device's function of shaping the radiation beam. While it mentions computer-controlled aspects and updates to electronics and IT hardware, it is not solely software.
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 the clinician in the delivery of external beam radiation to defined target volumes during radiosurgery and radiotherapy." This describes a device used in vivo (on a living patient) for therapeutic purposes (delivering radiation treatment).
- Device Description: The description details a mechanical accessory for a linear accelerator that shapes a radiation beam. This is consistent with a device used for external beam radiation therapy, not for testing biological samples in vitro.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment.
IVD devices are specifically designed to perform tests on biological samples outside of the body. This device is designed to directly interact with the patient's body by shaping a radiation beam.
N/A
Intended Use / Indications for Use
The Varian Multileaf Collimator is intended 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 (comma separated list FDA assigned to the subject device)
90 IYE
Device Description
The Varian Multileaf Collimator (MLC) is an accessory X-ray collimator designed to be mounted on a Varian radiotherapy linear accelerator.
The Multileaf Collimator (MLC) head is mounted on a Varian Linear Accelerator, where it shapes the radiation beam before it is delivered to the patient. The MLC head is permanently bolted onto the casting that holds the X-Jaws and Y-Jaws of the Varian Linear Accelerator gantry.
The MLC head assembly contains two leaf banks, plus associated electromechanical components. The MLC head is located behind covers during operation, which prevent unintended contact with any person.
The MLC leaves reside in two carriages. Each leaf is driven by an independent motor. When shaping the radiation field perimeter to conform to the tumor outline, adjacent MLC leaves from opposing banks can move past one another. This feature, known as leaf inter-digitation, allows for the creation of complex shapes.
The two carriage drives are independently controlled. Smooth motion of the leaves and carriages is achieved using a trapezoidal velocity profile that ramps up speed of the leaves or carriages to a fixed speed, and then ramps speed down until the leaf (or carriage) stops precisely at the final position.
The various MLC models provide varying numbers and widths of leaves. The leaf banks extend over different widths within the Multileaf Collimator, for the 52-leaf. 80-leaf, and the 120-leaf Millennium MLC, and the HD120 Ml.C models. The Varian Multileaf Collimator (MLC) head contains many computer-controlled mechanical "leaves" or "slats" that continually shape the treatment beam as the radiation is delivered from different angles around the patient.
The changes to the Varian Multileaf Collimator provide updates for electronics and information technology hardware, improvements in usability and serviceability, and additional discrepancy fixes. The operation and intended use of the device remain unchanged. Overall safety of the device is unchanged.
All other features and technological characteristics of the Varian Multileaf Collimator are unchanged compared to the Varian predicate device cleared in K071992.
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
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Verification testing was performed to demonstrate that the performance and functionality of the new and existing features met the design input requirements. Regression testing was performed to verify the integrity of any changes. Validation testing was performed on a production equivalent device, under clinically representative conditions by qualified personnel.
Results from Verification and Validation testing demonstrate that the product met defined user needs and defined design input requirements.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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.
0
K133240 JAN 3 1 2014
Varian Medical Systems, Inc. 3100 Hansen Way Palo Alto, CA 94304-1038 Tel +1 650 493 4000 www.varian.com
January 7, 2014
510(k) Summary
The information below is provided for the Varian Multileaf Collimator. following the format of 21 CFR 807.92.
-
- 510(k) Owner: Varian Medical Systems 3100 Hansen Way. M/S C 260 Palo Alto. CA 94304 Contact Name: Peter J. Coronado - Director, Regulatory Affairs Phone: 650/424.6320 Fax: 650/842.5040 E-mail: submissions.support@varian.com
| 2. Name of the Device:
Trade/Proprietary Names: | Varian Multileaf Collimator (MLC)
Millennium 52-leaf Multileaf Collimator
Millennium 80-leaf Multileaf Collimator
Millennium 120-leaf Multileaf Collimator
High-Definition 120 Multileaf Collimator (HD120 MLC) |
|----------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Accessory to Medical Linear Accelerator |
| Classification Name: | Medical Charged Particle Radiation Therapy System
21 CFR §892.5050
Class II
Product Code 90 IYE |
- Predicate Device: High-Definition 120 Multileaf Collimator K071992 3.
-
- Description of the Device:
The Varian Multileaf Collimator (MLC) is an accessory X-ray collimator designed to be mounted on a Varian radiotherapy linear accelerator.
The Multileaf Collimator (MLC) head is mounted on a Varian Linear Accelerator, where it shapes the radiation beam before it is delivered to the patient. The MLC head is permanently bolted onto the casting that holds the X-Jaws and Y-Jaws of the Varian Linear Accelerator gantry.
1
The MLC head assembly contains two leaf banks, plus associated electromechanical components. The MLC head is located behind covers during operation, which prevent unintended contact with any person.
The MLC leaves reside in two carriages. Each leaf is driven by an independent motor. When shaping the radiation field perimeter to conform to the tumor outline, adjacent MLC leaves from opposing banks can move past one another. This feature, known as leaf inter-digitation, allows for the creation of complex shapes.
The two carriage drives are independently controlled. Smooth motion of the leaves and carriages is achieved using a trapezoidal velocity profile that ramps up speed of the leaves or carriages to a fixed speed, and then ramps speed down until the leaf (or carriage) stops precisely at the final position.
The various MLC models provide varying numbers and widths of leaves. The leaf banks extend over different widths within the Multileaf Collimator, for the 52-leaf. 80-leaf, and the 120-leaf Millennium MLC, and the HD120 Ml.C models. The Varian Multileaf Collimator (MLC) head contains many computer-controlled mechanical "leaves" or "slats" that continually shape the treatment beam as the radiation is delivered from different angles around the patient.
The changes to the Varian Multileaf Collimator provide updates for electronics and information technology hardware, improvements in usability and serviceability, and additional discrepancy fixes. The operation and intended use of the device remain unchanged. Overall safety of the device is unchanged.
All other features and technological characteristics of the Varian Multileaf Collimator are unchanged compared to the Varian predicate device cleared in K071992.
-
- Intended Use Statement
The Varian Multileaf Collimator is intended 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.
- Intended Use Statement
- Indications for Use Statement
The Varian Multileaf Collimator is intended 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.
2
7. Substantial Equivalence
The modified device, the Varian Multileaf Collimator (MLC), is substantially equivalent to the predicate device of K071992.
Compared with the predicate device, the basic operation and technological characteristics are the same. Operational differences are described in the Instructions for Use and accompanying user documentation. The indications for use and the intended use of the device are changed.
A comparison table illustrating the substantial equivalence of the modified device to the predicate device appears below.
| DESCRIPTION | MULTILEAF
COLLIMATOR
K071992 | VARIAN
MULTILEAF
COLLIMATOR |
|----------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------|-----------------------------------|
| Release version of control software | MLC 7.0 | MLC 8.0 |
| Support for Millennium 52-leaf, 80-leaf, 120-leaf, and
HD120 MLC models | yes | yes |
| Support for Saturne MLC, Mark Series controllers and
BrainLab m3 MLC | yes | no |
| Support for digitizer panel hardware | yes | no |
| Support for 3rd party interface (3PI) | yes | no |
| Screen color scheme is that of 4DITC as default | no | yes |
| System offset diagnostics facilitate the transfer of
patients between 6.x and 7.x machines | no | yes |
| Supports local languages (non-English) on screen
display, including Unicode compliance for display of
extended language character sets | no | yes |
| Zoom capability for MLC leaf position display | no | yes |
| Improved ZIP file creation for system information
capture | no | yes |
| Updated electronics: Low Profile Controller Unit | no | yes |
| Instructions for Use document adds recommendations
on jaw positions to minimize out-of-field dose from
scattered radiation | no | yes |
| Visual display of Complete Irradiated Area Outline is
calculated using a common system-wide component | no | yes |
| Capability to use either 4:3 or 16:9 display ratio
monitor | no (4:3 ratio only) | yes |
Changes in Technological characteristics:
510(k) Summary - Varian Multileaf Collimator - 07 January 2014
Page 3 of 4
3
| DESCRIPTION | MULTILEAF
COLLIMATOR
K071992 | VARIAN
MULTILEAF
COLLIMATOR |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------|-------------------------------------------------------|
| Shaper software application is used for manual
creation of treatment plans | yes | No (used for Physics
and Service analysis
only) |
| Warning message when the MLC is in use but the
Varian 4D Integrated Treatment Console (4DITC)
software (K091132) is not also in use: "This mode is
not to be used for clinical treatments." | no | yes |
Summary of Non-Clinical Testing 8.
Verification testing was performed to demonstrate that the performance and functionality of the new and existing features met the design input requirements.
Regression testing was performed to verify the integrity of any changes. Validation testing was performed on a production equivalent device, under clinically representative conditions by qualified personnel.
9. Conclusions from Non-Clinical testing
Results from Verification and Validation testing demonstrate that the product met defined user needs and defined design input requirements. Varian therefore considers the Multileaf Collimator to be safe and effective, and to perform at least as well as the predicate device.
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 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 a human figure embracing a bird or eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 31, 2014
Varian Medical Systems. Inc. % Mr. Peter Coronado Director, Global Regulatory Affairs 3100 Hansen Way PALO ALTO CA 94304
Re: K133240
Trade/Device Name: Varian Multileaf Collimator Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: Oct. 17, 2013 Received: Oct. 21. 2013
Dear Mr. Coronado:
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. Drue, 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA). it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
5
Page 2 - Mr. Peter J. Coronado
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.lda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803). please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Michael D. O'Hara.
for
Janine M. Morris Director. Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
6
Indications for Use
510(k) Number (if known): K133240
Device Name: Varian Multileaf Collimator
Indications For Use:
The Varian Multileaf Collimator 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.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Michael D. O'Hara
(Division Sign-Off) Page 1 of Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health 510(k) _______________________________________________________________________________________________________________________________________________________________________