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.

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 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.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a Varian Multileaf Collimator (MLC). This document is primarily focused on demonstrating substantial equivalence to a predicate device rather than presenting a clinical study with detailed acceptance criteria and performance metrics typically seen for novel AI algorithms.

Therefore, many of the requested points, especially those related to AI-specific study details (such as sample sizes for test/training sets, ground truth establishment methods with expert consensus/pathology, MRMC studies, or standalone algorithm performance), are not applicable or not provided in this type of regulatory submission for a hardware device with software updates.

Here's an analysis based on the information provided:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not specify numerical acceptance criteria for a clinical study in terms of metrics like sensitivity, specificity, accuracy, or effect sizes for human reader improvement. Instead, the acceptance criteria are implicitly met by demonstrating that the device performs at least as well as the predicate device and met design input requirements.

Acceptance Criteria (Implicit)	Reported Device Performance (Summary)
Performance and functionality of new and existing features meet design input requirements.	Verification testing confirmed performance and functionality met design input requirements.
Integrity of any changes is maintained (no adverse effects from modifications).	Regression testing verified the integrity of changes.
Device operates safely and effectively under clinically representative conditions.	Validation testing on a production-equivalent device under clinically representative conditions by qualified personnel.
Overall safety of the device is unchanged compared to the predicate device.	Operation and intended use remain unchanged; overall safety of the device is unchanged.
Device is substantially equivalent to the predicate device (K071992).	Conclusion: The Multileaf Collimator is safe and effective, and performs at least as well as the predicate device.
No adverse impact on the intended use (assist clinician in external beam radiation delivery, sparing normal tissue).	Intended Use Statement and Indications for Use remain consistent.

2. Sample size used for the test set and the data provenance

Sample Size: Not specified. The testing described is "Verification testing," "Regression testing," and "Validation testing" on a "production equivalent device." These typically involve engineering and functional tests rather than studies with "test sets" in the clinical AI sense.
Data Provenance: Not applicable in the context of hardware/software functional testing. The testing would have been conducted internally by Varian Medical Systems.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This concept is not directly applicable here. The "ground truth" for this type of device (a medical linear accelerator accessory) would be its physical and functional specifications meeting engineering standards and its performance aligning with its intended use (accurate beam shaping). "Qualified personnel" are mentioned for validation testing, implying engineers and possibly clinical physicists who understand the device's operation. No mention of radiologists or other clinical experts establishing "ground truth" in terms of diagnoses or outcomes is made.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. Adjudication methods are typically used in clinical studies comparing human interpretations or AI outputs against a consensus. For a hardware device, performance is evaluated against engineering specifications.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No. This is not an AI diagnostic or assistive device in the direct sense of providing interpretations to human readers. It is a radiation therapy accessory. Therefore, an MRMC study is not relevant here.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. The device is a physical accessory controlled by software, working in conjunction with a linear accelerator and under clinician control for treatment planning and delivery. It's not a standalone algorithm in the sense of a medical diagnostic AI.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for this device's performance would be the engineering specifications, functional requirements (e.g., leaf positioning accuracy, speed, inter-digitation capability), safety standards, and demonstrated equivalence to the predicate device's performance. It is based on engineering and functional test results demonstrating adherence to design inputs, rather than clinical ground truth like pathology or outcomes data.

8. The sample size for the training set

Not applicable. This document describes a medical device accessory and its software updates, not an AI model that undergoes "training."

9. How the ground truth for the training set was established

Not applicable, as there is no mention of a "training set" for an AI model.

Summary

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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.

1. 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 CollimatorMillennium 80-leaf Multileaf CollimatorMillennium 120-leaf Multileaf CollimatorHigh-Definition 120 Multileaf Collimator (HD120 MLC)
Common Name:	Accessory to Medical Linear Accelerator
Classification Name:	Medical Charged Particle Radiation Therapy System21 CFR §892.5050Class IIProduct Code 90 IYE

Predicate Device: High-Definition 120 Multileaf Collimator K071992 3.
1. 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.

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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.

1. 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.

Indications for Use Statement

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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	MULTILEAFCOLLIMATORK071992	VARIANMULTILEAFCOLLIMATOR
Release version of control software	MLC 7.0	MLC 8.0
Support for Millennium 52-leaf, 80-leaf, 120-leaf, andHD120 MLC models	yes	yes
Support for Saturne MLC, Mark Series controllers andBrainLab 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 ofpatients between 6.x and 7.x machines	no	yes
Supports local languages (non-English) on screendisplay, including Unicode compliance for display ofextended language character sets	no	yes
Zoom capability for MLC leaf position display	no	yes
Improved ZIP file creation for system informationcapture	no	yes
Updated electronics: Low Profile Controller Unit	no	yes
Instructions for Use document adds recommendationson jaw positions to minimize out-of-field dose fromscattered radiation	no	yes
Visual display of Complete Irradiated Area Outline iscalculated using a common system-wide component	no	yes
Capability to use either 4:3 or 16:9 display ratiomonitor	no (4:3 ratio only)	yes

Changes in Technological characteristics:

510(k) Summary - Varian Multileaf Collimator - 07 January 2014

Page 3 of 4

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DESCRIPTION	MULTILEAFCOLLIMATORK071992	VARIANMULTILEAFCOLLIMATOR
Shaper software application is used for manualcreation of treatment plans	yes	No (used for Physicsand Service analysisonly)
Warning message when the MLC is in use but theVarian 4D Integrated Treatment Console (4DITC)software (K091132) is not also in use: "This mode isnot 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.

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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.

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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

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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) _______________________________________________________________________________________________________________________________________________________________________

Regulation Number and Section

§ 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.