The Agility multileaf collimator is indicated for use when additional flexibility is required in conforming the radiation beam to the anatomy to be exposed.

The associated Integrity R3.1 software is the interface and control software for the Elekta medical digital linear accelerator and is intended to assist a licensed practitioner in the delivery of radiation to defined target volumes (e.g. lesions, arterio-venous malformations, malignant and benign tumors), whilst sparing surrounding normal tissue and critical organs from excess radiation.

Both High Dose Rate mode and flattened beams are intended to be used for single or multiple fractions, delivered as static and/or dynamic, in gated or un-gated deliveries, in all areas of the body where such treatment is indicated.

The use of the Agility multileaf collimator in conjunction with an Elekta digital linear accelerator may be helpful in the delivery of radiation for treatment that includes but is not limited to malignant and benign brain tumors, brain metastases, spine lesions treated using SRS, squamous cell carcinoma of the head and neck, lung, breast, pancreatic, hepatic malignancies treated using SBRT, prostate, and bone metastases.

Device Description

This Traditional 510(k) describes changes to the Elekta range of medical linear accelerators when fitted with the Agility multileaf collimator and associated Integrity linac control system. Items added are; High Dose Rate mode x-rays, specific clinical indications for use, and the Response™ gating interface that enables the linac treatment beam to be automatically turned on and off by signals from an external gating device.

High Dose Rate mode x-rays are provided by changes to the filtering arrangement to reduce wasteful attenuation of the beam.

AI/ML Overview

The Elekta Agility Multileaf Collimator system, including the Agility MLC, Integrity R3.1 software, High Dose Rate mode, and Response™ gating interface, underwent non-clinical performance testing to demonstrate substantial equivalence to predicate devices and conformance to applicable technical design specifications, assuring safety and effectiveness.

Here's a breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance:

Attribute	Acceptance Criteria (New Device)	Reported Device Performance (New Device)	Predicate Device (Varian TrueBeam K111106)	Predicate Device (Varian RPM K983629)
Average transmission through leaf bank (High Dose Rate Mode)	<0.375%	<0.375%	Interleaf <2%	N/A
Peak transmission through leaf bank (High Dose Rate Mode)	<0.5%	<0.5%	Interleaf <3%	N/A
X-radiation leakage in patient plane outside collimator cone (High Dose Rate Mode)	<0.2% max, <0.1% avg.	<0.2% max, <0.1% avg.	Information not available	N/A
X-radiation leakage outside patient plane (High Dose Rate Mode)	<0.5% (at 1 m)	<0.5% (at 1 m)	Information not available	N/A
Dynamic Delivery Capability, sliding window	Yes	Yes	Yes	Unknown
Dynamic Delivery Capability, Dynamic arc	Yes	Yes	Yes	Unknown
Dynamic Delivery capability, VMAT	Yes	Yes	Yes (Rapid Arc)	Unknown
Multiple island shielding	Yes	Yes	Yes	N/A
Offset field shaping	Yes	Yes	Yes	N/A
6MV - Minimum dose rate (unflattened beams)	200 MU/min	200 MU/min	Not known	N/A
6MV - Maximum dose rate (unflattened beams)	1400 MU/min	1400 MU/min	1400 MU/min	N/A
10MV -Minimum dose rate (unflattened beams)	400 MU/min	400 MU/min	Not known	N/A
10MV - Maximum dose rate (unflattened beams)	2200 MU/min	2200 MU/min	2400 MU/min	N/A
Control module in the control room for enabling or disabling automated gating and for status review (Gating Interface)	Yes	Yes	Yes	N/A
Relay module on the linac (Gating Interface)	Yes	Yes	Equivalent	N/A
Electrically isolated connection between the Relay module on the linear accelerator and the Control module in the Control room (Gating Interface)	Yes	Yes	Unknown	N/A
Protection for the linear accelerator against rapid gating cycles that may result in delivery of a radiation beam that does not meet IEC specification (Gating Interface)	Yes	Yes	Unknown	N/A
The latency of the signal transmission from the external gating device to operation of the Relay Module (Gating Interface)	<40 ms	<40 ms	Unknown	N/A
Support external gating device for Respiratory Breath-Hold gating (Gating Interface)	Yes	Yes	Yes	N/A
Support external gating device for Exception gating (Gating Interface)	Yes *	Yes *	No**	N/A
Support external gating device for Free-Breathing gating (Gating Interface)	Yes *	Yes *	No **	N/A
3D Conformal (Gating Interface)	Yes	Yes	Yes	N/A
Intensity Modulated Radiation Therapy (IMRT) (Gating Interface)	Yes	Yes	Yes	N/A
Image Guided Radiation Therapy (IGRT) (Gating Interface)	Yes	Yes	Yes	N/A
High Dose Rate (unflattened beams) (Gating Interface)	Yes	Yes	Unknown	N/A

*with validated external gating device which has 510(k) clearance
**other methods are not supported with the RPM interface

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

The document does not explicitly state a specific numerical sample size for a "test set" in the context of patient data or clinical images. The testing described is "non-clinical performance testing" which involved:

"module, integration and system level verification"
"regression testing"
"Validation of the system under clinically representative conditions"
"Testing has been undertaken on production equivalent systems both at Elekta and at hospital sites."

This suggests testing was performed on a sufficient number of hardware and software configurations to ensure functionality and safety, but not on a specific number of patient cases or images for diagnostic performance.

The data provenance is from non-clinical performance testing performed at Elekta and hospital sites. It is not based on retrospective or prospective patient data for an AI-specific algorithm performance evaluation. It's focused on the physical and software performance of the medical device components.

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

This information is not provided in the document. Given that the testing is non-clinical performance testing of a medical linear accelerator accessory, the concept of "ground truth" as established by medical experts (e.g., radiologists) for image interpretation or diagnosis would not typically apply. Instead, the acceptance criteria relate to physics performance metrics and software functionality, which would be verified against engineering specifications by qualified engineers and physicists. The document mentions "competent and professionally qualified personnel" for validation, but does not specify their number or exact qualifications.

4. Adjudication method for the test set:

This information is not provided and is not applicable in the context of this type of non-clinical device performance testing. Adjudication methods are typically used when multiple experts are interpreting data to establish a consensus ground truth for classification or detection tasks, which is not the nature of the testing described.

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, a multi-reader, multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of AI on human reader performance in diagnostic tasks (e.g., radiologists interpreting images with or without AI assistance). The device
(a multileaf collimator and control system for radiation therapy) is not an AI-powered diagnostic tool, but rather a treatment delivery system for which the performance is measured by physical and software parameters, not human reader interpretation.

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

While the device itself is an "algorithm" in the sense of software control, the term "standalone" in this context usually refers to an AI algorithm processing data (e.g., images) independently of human intervention for diagnostic or analytical purposes. This device is a component of a larger system (radiation therapy) where human practitioners make clinical decisions.

The document describes comprehensive testing of the device's components and integrated system to ensure they meet performance specifications. This is "standalone" in the sense that the device performs its functions as designed, but it's not an AI performing an independent diagnostic task. The validation focused on the technical performance of radiation delivery and control.

7. The type of ground truth used:

The "ground truth" for the non-clinical performance testing described would be the engineering design specifications and recognized international standards (e.g., IEC 60601-1, IEC 60601-2-1, IEC 62366, ISO 14971). The device's measured physics performance (e.g., transmission, leakage, dose rates) and software functionality were compared against these predetermined, quantitative criteria.

8. The sample size for the training set:

Not applicable. The device is not an AI algorithm that learns from a training set of data. It's a hardware and software system designed and programmed to perform specific functions.

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

Not applicable. As stated above, there is no "training set" in the context of AI model development for this traditional medical device submission. The device's functionality is based on engineering design and rigorous testing against established specifications and standards.

Summary

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K 123808

510(k) SUMMARY

APR 0 4 2013

Date of preparation of summary: 14th February 2013

Submitted by:

Elekta Limited Linac House, Fleming Way, Crawley, West Sussex RH10 9RR, United Kingdom Telephone: +44 (0)1293 654165 Fax: +44 (0)1293 658445

Contact name: Patrick Hull

Trade Name:	AgilityTM
Common Name:	Multileaf Collimator
Classification Name:	Medical Linear Accelerator Accessory, 21CFR 892.5050
Product Code:	IYE
Predicate Devices:	Agility™ (K121328), Varian RPM (983629), Varian TrueBeam Linear Accelerator (K111106)

Product Description:

High Dose Rate mode x-rays are provided by changes to the filtering arrangement to reduce wasteful attenuation of the beam.

Indications for Use and Intended Use Statement:

The Agility multileaf collimator is indicated for use when additional flexibility is required in conforming the radiation beam to the anatomy to be exposed.

Both High Dose Rate Mode and flattened beams are intended to be used for single or multiple fractions, delivered as static and/or dynamic, in gated or un-gated deliveries, in all areas of the body where such treatment is indicated.

The use of the Aglity multileaf collimator in conjunction with an Elekta digital linear accelerator may be helpful in the delivery of radiation for treatment that includes but is not limited to malignant and benign brain tumors, brain metastases, spine lesions treated using SRS, squamous cell carcinoma of the head and neck, lung, breast, pancreatic, hepatic malignancies treated using SBRT, prostate, and bone metastases.

Summary of Technological Characteristics:

The Elekta range of medical linear accelerators when fitted with the Agility multileaf collimator beam limiting device and its associated linear accelerator control software, Integrity R3.1, and the addition of High Dose Rate mode x-rays and a gating interface do not introduce any novel forms of technology.

Substantial Equivalence

The functionality of the Elekta medical linear accelerator with Agility™ and High Dose Rate mode is substantially equivalent to that of its predicate device, Agility (K1211328), in safety and effectiveness. The intended use, principles of operation, technological characteristics and labeling are substantially equivalent except for the addition of a number of specific indications for use.

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Substantial Equivalence Table for High Dose Rate Mode

The primary functional differences between the predicate device and the new device are the changes made to the linac control software and beam filtration to allow the user the option to select unflattened x-ray beams in High Dose Rate mode and the option to fit a gating interface upgrade kit to permit external gating devices to temporarily suspend beam delivery.

Attributes	Elekta linac with Agility, FFF &Integrity R3.1 (this submission)	Varian TrueBeam LinearAccelerator (K111106)
Physics Performance
Average transmission through leafbank	<0.375%	Interleaf <2%
Peak transmission through leafbank	<0.5%	Interleaf <3%
X-radiation leakage in patientplane outside collimator cone	<0.2% max, <0.1% avg.	Information not available
X-radiation leakage outside patientplane	<0.5% (at 1 m)	Information not available
Delivery Techniques
Dynamic Delivery Capability,sliding window	yes	yes
Dynamic Delivery Capability,Dynamic arc	yes	yes
Dynamic Delivery capability, VMAT	yes	Yes (Rapid Arc)
Multiple island shielding	yes	yes
Offset field shaping	yes	yes
Beam Data - unflattened beams
6MV - Minimum dose rate	200 MU/min	Not known
6MV - Maximum dose rate	1400 MU/min	1400 MU/min
10MV -Minimum dose rate	400 MU/min	Not known
10MV - Maximum dose rate	2200 MU/min	2400 MU/min

Substantial Equivalence Table for Response Gating Interface

The functionality of the Elekta medical linear accelerator with Agility™ and the Response gating interface is substantially equivalent to that of its predicate device, RPM Respiratory Gating System (K983629), in safety and effectiveness. The intended use, principles of operation, technological characteristics and labeling are substantially equivalent except for the addition of a number of specific indications for use.

Attributes	Elekta linac withResponse™ (thissubmission)	Varian RPM withgating of a Clinac(K983629)
Components
Control module in the control room for enabling ordisabling automated gating and for status review	yes	yes
Relay module on the linac	yes	equivalent
Electrically isolated connection between the Relay moduleon the linear accelerator and the Control module in theControl room	yes	unknown

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Additional features
Protection for the linear accelerator against rapid gatingcycles that may result in delivery of a radiation beam thatdoes not meet IEC specification	yes	unknown
The latency of the signal transmission from the externalgating device to operation of the Relay Module	<40 ms	unknown
Automated gating methods supported
Support external gating device for Respiratory Breath-Hold gating	yes	yes
Support external gating device for Exception gating	Yes *	No**
Support external gating device for Free-Breathing gating	Yes *	No **
Delivery Techniques
3D Conformal	Yes	Yes
Intensity Modulated Radiation Therapy (IMRT)	Yes	Yes
Image Guided Radiation Therapy (IGRT)	Yes	Yes
Dynamic Delivery Capability, sliding window	Yes	Unknown
Dynamic Delivery Capability, dynamic arc	Yes	Unknown
Dynamic Delivery Capability, VMAT	Yes	Unknown
High Dose Rate (unflattened beams)	yes	Unknown

with validated external aating device which has 510(k) clearance

** other methods are not supported with the RPM interface

Summary of non clinical performance testing

Testing in the form of module, integration and system level verification was performed to evaluate the performance and functionality of the new and existing features against the requirement specification.

Regression testing has been performed successfully to verify the integrity of any changes.

Validation of the system under clinically representative conditions has been performed by competent and professionally qualified personnel. Results from verification and validation testing demonstrate that conformance to applicable technical design specifications have been met and assured safety & effectiveness as been achieved.

Testing has been undertaken on production equivalent systems both at Elekta and at hospital sites.

The system is subject to compliance testing to voluntary consensus safety standards. Details of the standards employed in the design are specified in the Standard Data Report in section 9 which includes but is not limited to, IEC 60601-1, IEC 60601-2-1, IEC 62366 and ISO 14971.

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Image /page/3/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol resembling an abstract human figure or bird in flight, composed of three curved lines.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

April 4, 2013

Patrick Hull Regulatory Affairs Specialist Elekta Limited Linac House Fleming Way CRAWLEY, WEST SUSSEX RH10 9RR UNITED KINGDOM

Re: K123808

Trade/Device Name: AgilityTM Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: March 6, 2013 Received: March 7, 2013

Dear Mr. Hull:

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. 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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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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,

Michito FDA Hara

Janine M. Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

for

Enclosure

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Indications for Use

510(k) Number (if known): K123808

Agility TM Device Name:

Indications for Use:

The Agility multileaf collimator is indicated for use when additional flexibility is required in conforming the radiation beam to the anatomy to be exposed.

Both High Dose Rate mode and flattened beams are intended to be used for single or multiple fractions, delivered as static and/or dynamic, in gated or un-gated deliveries. in all areas of the body where such treatment is indicated.

The use of the Agility multileaf collimator in conjunction with an Elekta digital linear accelerator may be helpful in the delivery of radiation for treatment that includes but is not limited to malignant and benign brain tumors, brain metastases, spine lesions treated using SRS, squamous cell, carcinoma of the head and neck, lung, breast, pancreatic, hepatic malignancies treated using SBRT, prostate, and bone metastases.

Prescription Use YES (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use NO (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)

the HARA

(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health

K123808 510(k)

Page 1 of 1

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.