AGILITY

K121328 · Elekta , Ltd. · IYE · Jun 12, 2012 · Radiology

Device Facts

• Record ID: K121328
• Device Name: AGILITY
• Applicant: Elekta , Ltd.
• Product Code: IYE · Radiology
• Decision Date: Jun 12, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5050
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Aglify 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 R3.0 software is the interface and control software for the Elekta range of medical digital linear accelerators 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. It is intended to be used for single or multiple fractions, delivered as static and/or dynamic beams of radiation, in all areas of the body where such treatment is indicated.

Device Story

Agility is a multileaf collimator (MLC) accessory for Elekta medical linear accelerators; used by radiation oncologists/technicians in clinical settings to shape radiation beams. Device features 160 leaves (5mm width at isocenter) and dynamic leaf guides; utilizes 'Rubicon' fluorescing ruby markers for optical leaf tracking. System transforms treatment plan data into precise leaf movements; enables faster leaf speeds (up to 65 mm/s) and lower interleaf leakage (<0.5%) compared to predecessors. Controlled by Integrity R3.0 software; synchronizes leaf guides with leaf movement to eliminate split-field requirements. Output is a conformed radiation beam; allows clinicians to deliver precise doses to target volumes while sparing healthy tissue/organs. Benefits include improved beam conformity and treatment efficiency.

Clinical Evidence

Bench testing only. Module, integration, and system-level verification performed to evaluate performance against design requirements. Regression testing verified integrity of changes. Validation conducted under clinically representative conditions by qualified personnel. Compliance testing performed against voluntary consensus standards including IEC 60601-1, IEC 60601-2-1, IEC 60601-1-2, IEC 62304, IEC 62366, and ISO 14971.

Technological Characteristics

Multileaf collimator with 160 leaves (5mm width at isocenter). Features dynamic leaf guides, 'Rubicon' ruby leaf markers for optical tracking, and LED-based patient plane illumination. Control system includes a hardware firewall for network safety. Standards: IEC 60601-1, IEC 60601-2-1, IEC 60601-1-2, IEC 62304, IEC 62366, ISO 14971. Connectivity: Networked via Integrity R3.0 control software.

Indications for Use

Indicated for patients requiring radiation therapy for defined target volumes, including lesions, arterio-venous malformations, and malignant or benign tumors, in any body area where radiation treatment is indicated. Used for single or multiple fraction delivery via static or dynamic beams.

Regulatory Classification

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.

Predicate Devices

• MLCi2 (K082122)

Submission Summary (Full Text)

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K121328

JUN 1 2 2012

## 510(k) SUMMARY

Date of preparation of summary: 27th April 2012

#### Submitted by:

Elekta Limited Linac House, Fleming Way, Crawley, West Sussex RH10 9RR, United Kingdom Telephone: [phone] Fax: [phone]

ontact name: Patrick Hull

| Trade Name: | Agility ™ |
|----------------------|------------------------------------------------------|
| Common Name: | Multileaf Collimator |
| Classification Name: | Medical Linear Accelerator Accessory, 21CFR 892.5050 |
| Product Code: | IYE |
| Predicate Device: | MLCi2 (K082122) |

#### Product Description:

This Traditional 510(k) describes the addition of the new Agility multileaf collimator beam limiting device and its associated control software to the Elekta medical linear accelerator. The new device has 160 leaves of 5mm width at isocenter, a fast leaf speed of up to 65 mm/s, low leakage (<0.5%) and is capable of interdigitation within a maximum field size of 40 x 40 cm. Control is by extension to the existing Elekta linear accelerator control system software. Synchronization of the movement of the dynamic leaf guides with individual leaf movements achieves enhanced leaf speed and removes the need for a split field.

#### Indications For Use and Intended Use Statement:

The Aglify 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 R3.0 software is the interface and control software for the Elekta range of medical digital linear accelerators 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. It is intended to be used for single or multiple fractions, delivered as static and/or dynamic beams of radiation, in all areas of the body where such treatment is indicated.

#### Summary of Technological Characteristics:

Agility TM is a new multileaf collimator with a dedicated linac control system.

The Agility includes dynamic leaf guides, fluorescing ruby leaf markers ('Rubicon') for improved leaf tracking by the optics system, the elimination of backup diaphragms by providing low interleaf leakage, sculpted field defining diaphragms, separate lighting systems for patient plane illumination and movement control using LEDs, and a new control cabinet on which the Integrity user interface and machine control software is executed including a hardware firewall to provide safe network connection.

There are no novel forms of technology introduced by this device.

#### Substantial Equivalence

The functionality of the Elekta medical linear accelerator with Agility™ is substantially equivalent to that of its predicate device, MLCi2 (K082122), in safety and effectiveness. The intended use, principles of operation, technological characteristics and labelling are substantially equivalent.

The primary differences between the predicate device and the new device are the improved resolution across the 40cm x 40cm field size provided by the 5mm leaf width at isocenter, faster leaf and diaphragm speeds, and longer diaphragm over-travel. It does not directly infroduce additional clinical functionality.

Elekta Limited, Linac House, Fleming Way, Crawley, West Sussex RH10 9RR UK . Tel: [phone] Fax: [phone] www.elekta.com Registered.in England No. 3244454

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| Attributes | Elekta linac with Agility &<br>Integrity R3.0 (this submission) | Elekta linac with MLCi2 &<br>Integrity R1.1 (K802122) |
|-----------------------------------------------------------------|-----------------------------------------------------------------|-------------------------------------------------------|
| Mechanical | | |
| Interdigitation capable | yes | yes |
| Number of leaves | 160 | 80 |
| Nominal leaf width projection at<br>isocenter | 5 mm | 10 mm |
| Maximum field size | 40 x 40 cm | 40 x 40 cm |
| Maximum distance between leaves on<br>the same leaf guide | 20 cm | 32.5 cm |
| Leaf travel over central axis | 15 cm | 12.5 cm |
| Leaf nominal height | 90 mm | 82 mm |
| Leaf positioning resolution | 0.1 mm | 0.1 mm |
| Leaf positioning verification method | Optical and machine vision<br>system (Rubicon) | Optical and machine vision<br>system |
| Diaphragm over-travel | 12 cm | 0 |
| Dimensions / Weight / Speeds | | |
| Head rotation | 365 degrees | 365 degrees |
| Head weight | 420 kg | 380 kg |
| Radiation head diameter | 815 mm at the widest,<br>694 mm at the narrowest | 620 mm |
| Head to isocenter clearance | 45 cm | 45 cm |
| Head rotation speed for set-up | 12°/s | 12°/s |
| Head rotation speed for dynamic<br>delivery techniques | 6°/s | 6°/s |
| Leaf speed combined with the dynamic<br>leaf guide | up to 6.5 cm/s | 2.0 cm/sec |
| Leaf speed | up to 3.5 cm/s | 2.0 cm/sec |
| Diaphragm speed | up to 9 cm/s | 1.5 cm/s |
| Wedge | | |
| Integrated wedge size | Automatic 0-60° | Automatic 0-60° |
| Wedge field size | 30 x 40 cm | 30 x 40 cm |
| Physics Performance | | |
| Leaf position accuracy | 1 mm at isocenter<br>0.5 mm RMS* | ± 1 mm |
| Leaf position repeatability | 0.5 mm | 0.5 mm |
| Average transmission through leaf bank | <0.375% | 1.5% |
| Peak transmission through leaf bank | <0.5% | 2.1% |
| X-radiation leakage in patient plane<br>outside collimator cone | <0.2% max, <0.1% avg. | <0.2% max; <0.1% avg. |
| X-radiation leakage outside patient<br>plane | <0.5% (at 1 m) | <0.5% |
| Delivery techniques | | |
| Dynamic Delivery Capability, sliding<br>window | yes | yes |
| Dynamic Delivery Capability, dynamic<br>arc | yes | yes |
| Dynamic Delivery Capability, VMAT | yes | yes |
| Multiple island shielding | yes | yes |
| Offset field shaping | yes | yes |

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measured using stripe test

information from official product data - the test method may not be equivalent

Information from official product data - the test standard not specified

#### 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 not limited to IEC 60601-1, IEC 60601-2-1, IEC 60601-1-2, IEC 62304, IEC 62366 and ISO 14971.

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Image /page/3/Picture/0 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized caduceus-like symbol with three overlapping, curved shapes resembling bird wings or stylized waves. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the symbol. The text is in all capital letters and is evenly spaced around the perimeter of the circle.

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

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

Re: K121328

Trade/Device Name: Agility Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: April 30, 2012 Received: May 3, 2012

Trade/Device

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.

If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of

JUN 1 2 2012

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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely Yours,

Janine M. Morris

Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known):

Device Name:

### Agility

# Indications for Use

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.

> The associated Integrity R3.0 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. It is intended to be used for single or multiple fractions. delivered as static and/or dynamic beams of radiation, in all areas of the body where such treatment is indicated.

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 Diagnostic Devices (OIVD)

(Division Sign-Off)

Division of Radiologic Office of In Vitro Diagnostic Device Evaluati 510K

| 2012/04/14 | Agility ™ | Document 04 - 01 |
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| © 2012 Elekta Limited, Crawley, UK. All rights reserved. | | Page 1 of 1 |