XVI R4.5

K100115 · Elekta , Ltd. · IYE · Mar 10, 2010 · Radiology

Device Facts

• Record ID: K100115
• Device Name: XVI R4.5
• Applicant: Elekta , Ltd.
• Product Code: IYE · Radiology
• Decision Date: Mar 10, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5050
• Device Class: Class 2

Intended Use

The Elekta X-Ray Volume Imaging system, XVI, is an electronic imaging device (EID), designed to be used with the Elekta range of medical linear accelerators and intended to be used as part of radiation therapy treatment process, as determined by a licensed medical practitioner. XVI, is intended to confirm patient positioning and support decision making in response to target displacement resulting from organ deformation and anatomical movement. Symmetry™ is a software option within XVI that can be used to acquire and display volumetric images of sequential phases of the breathing cycle for the evaluation of respiration induced motion, to assist in identification of appropriate target locations within anatomical structures in motion.

Device Story

XVI is a kV X-ray imaging accessory for Elekta medical linear accelerators; acquires volumetric images at point of treatment. Inputs: kV X-ray projections; outputs: 3D volumetric images. Features: Symmetry™ (4D VolumeView™) for respiration-induced motion evaluation; 3D shaped region of interest registration; dual registration for critical structures and target position; 3D seed registration for implanted markers. Operated by clinicians in radiation therapy departments. System facilitates patient positioning correction by providing spatial relationship between anatomy and forthcoming MV treatment. Benefits: improved target localization accuracy in presence of organ deformation or movement.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on technological characteristics and bench testing of the imaging system and software enhancements.

Technological Characteristics

kV radiation source and image detector mounted on linac gantry. Connectivity via DICOM. Software-based imaging processing for 3D/4D reconstruction. No changes to underlying hardware from predicate.

Indications for Use

Indicated for patients undergoing radiation therapy requiring target localization and positioning confirmation. Used to evaluate respiration-induced motion and anatomical displacement/deformation to assist clinicians in identifying target locations.

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

• Elekta Synergy® (K051932)

Submission Summary (Full Text)

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KLOO11S

# 510(k) SUMMARY

## Date of preparation of summary: January 11th 2010

Submitted by:

MAR I 0 2010

| Submitted by: | Elekta Limited<br>Linac House, Fleming Way, Crawley, West Sussex<br>RH10 9RR, United Kingdom |
|----------------------|----------------------------------------------------------------------------------------------|
| Telephone: | [phone] |
| Fax: | [phone] |
| Contact name: | Mr Andrew Hedges |
| Trade Name: | XVI R4.5 |
| Common Name: | Elekta X-Ray Volume Imaging system, XVI |
| Classification Name: | Medical Linear Accelerator Accessory, 21 CFR 892.5050, IYE |

Predicate Device: Elekta Synergy® (K051932)

#### Product Description:

This Traditional 510(k) describes modifications made to the XVI kilo-voltage imaging accessory of the Elekta range of digital linear accelerators. The primary reason for these enhancements is to improve the acquisition and utilization of kV images in facilitating the correction of patient position for anatomical changes or movement. The additional features are; Symmetry™ (4D VolumeView™) to evaluate respiration induced motion, 3D shaped region of interest for registration, dual registration for quantitative information regarding both the critical structures and target position, and 3D seed registration of implanted markers. Improvements have also been made to the operator interface, connectivity with other systems through DICOM and in the provision of licensable options to tailor individual features.

#### Intended Use Statement:

The intended use for the device has been amended to incorporate an extended imaging functionality for the confirmation of target localization;

The Elekta X-Ray Volume Imaging system, XVI, is an electronic imaging device (EID), designed to be used with the Elekta range of medical linear accelerators and intended to be used as part of radiation therapy treatment process, as determined by a licensed medical practitioner

XVI, is intended to confirm patient positioning and support decision making in response to target displacement resulting from organ deformation and anatomical movement. Symmetry™ is a software option within XVI that can be used to acquire and display volumetric images of sequential phases of the breathing cycle for the evaluation of respiration induced motion, to assist in identification of appropriate target locations within anatomical structures in motion.

### Summary of Technological Characteristics:

The XVI system consists of a kV radiation source mounted onto the linac gantry drum and a kV radiation image detector. Incorporation of the kV imaging system onto the same structure as the treatment system allows high quality images of the patient anatomy to be acquired at the point of treatment and their content to be spatially related to the forthcoming MV treatment, as previously cleared under Control Number K051932.

There has been no change made to the underlying technological characteristics of the product.

#### Substantial Equivalence

The functionality for the XVI R4.5 is equivalent to its predicate device XVI R3.5 as part of the Elekta Synergy (K051932) in safety and effectiveness. The fundamental technica! characteristics are the same as those of the predicate device and differences in operation are described in the comparison chart and discussion provided elsewhere in this 510(k) submission.

Elekta Ltd., 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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Image /page/1/Picture/0 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of a caduceus, a symbol often associated with medicine and healthcare.

## 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. Andrew Hedges Regulatory Affairs Engineer Elekta Limited Linac House, Fleming Way Crawley, West Sussex, RH10 9RR UNITED KINGDOM

MAR 1 0 2010

Re: K100115

Trade/Device Name: XVI Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE · Dated: January 11, 2010

Received: January 15, 2010

### Dear Mr. Hedges:

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 intreated commerce prior to May 28, 1976, the enactment date of the Medical Device Amendmants or to devices that have been reclassified in accordance with the provisions of the Fedral Forl, Or to 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 provisiopp 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 misburanting 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 aft 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

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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,

Amelia J. P.

Donald J. St.Pierre 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): K100115

Device Name: XVI

Indications for Use:

The Elekta X-Ray Volume Imaging system, XVI, is an electronic imaging device (EID), designed to be used with the Elekta range of medical linear accelerators and intended to be used as part of radiation therapy treatment process, as determined by a licensed medical practitioner.

XVI, is intended to confirm patient positioning and support decision making in response to target displacement resulting from organ deformation and anatomical movement. Symmetry™ is a software option within XVI that can be used to acquire and display volumetric images of sequential phases of the breathing cycle for the evaluation of respiration induced motion, to assist in identification of appropriate target locations within anatomical structures in motion.

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 Diagnostic Devices (OIVD)

Joff

(Division Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety

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