INTEGRITY MODEL 1014284

K102200 · Elekta , Ltd. · IYE · Nov 4, 2010 · Radiology

Device Facts

• Record ID: K102200
• Device Name: INTEGRITY MODEL 1014284
• Applicant: Elekta , Ltd.
• Product Code: IYE · Radiology
• Decision Date: Nov 4, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5050
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Integrity™ is the interface for the Elekta range of digital medical 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 tumours), 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

Integrity R1.0 is an integrated digital control system and graphical user interface for Elekta medical linear accelerators. It operates on a dedicated control cabinet using the LynxOS operating system. The system manages machine control functions, including Continuously Variable Dose Rate (CVDR) for dynamic delivery techniques like VMAT, and supports MLCi2 leaf interdigitation for island field creation. Operated by clinical staff in a radiation therapy environment, the system translates treatment prescriptions into machine-controlled radiation delivery. By enabling more efficient dose rates and complex beam shaping, it assists practitioners in targeting tumors while sparing healthy tissue. The device serves as the primary interface for radiation delivery, directly affecting the precision and efficiency of patient treatment.

Clinical Evidence

No clinical data. The submission relies on bench testing and technical verification of the software enhancements and operating system transition.

Technological Characteristics

Integrated digital control system for medical linear accelerators. Comprises a dedicated control cabinet running LynxOS. Features include Continuously Variable Dose Rate (CVDR) and MLCi2 leaf interdigitation support. No changes to underlying hardware technological characteristics from predicate.

Indications for Use

Indicated for patients requiring radiation therapy for lesions, arterio-venous malformations, or malignant/benign tumors in any body area where radiation is clinically indicated. Used by licensed practitioners 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

• Desktop Pro™ (K080585)

Submission Summary (Full Text)

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# 510(k) SUMMARY

NOV - 4 2010

Date of preparation of summary: 28th July 2010

#### Submitted by:

Elekta Limited Linac House, Fleming Way, Crawley, West Sussex RH20 9RR, United Kingdom Telephone: [phone] Fax: [phone]

Contact name: Mr. Andrew Hedges

| Trade Name: | Integrity™ R1.0 |
|----------------------|--------------------------------------------|
| Common Name: | Control System, Medical Linear Accelerator |
| Classification Name: | Medical Linear Accelerator Accessory, IYE |
| Predicate Device: | Desktop Pro™ (K080585) |

#### Product Description:

This Traditional 510(k) describes enhancements to the integral software performing the graphical interface and machine control functions for the Elekta range of medical digital linear accelerators. Integrity R1.0 employs a new LynxOS operating system that has a proven track record in safety and security to replace RMX. The software introduces Continuously Variable Dose Rate (CVDR), which is an enhancement to standard dose rate for dynamic delivery techniques. This function increases the number of available dose rates which can make treatment delivery more efficient and provide smoother delivery of VMAT prescriptions. The software supports the ability for the MLCi2 leaves to interdigitate, supporting the creation of island fields for X-Ray treatment delivery techniques.

#### Intended Use Statement:

Integrity™ is the interface for the Elekta range of digital medical 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 turnours), 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:

Integrity™ is an integrated digital control system, providing interface and machine control functions for the Elekta range of digital accelerators. It comprises a dedicated control cabinet on which the interface and machine control software is executed. There has been no change made to the underlying technological characteristics of the product from the predicate device.

#### Substantial Equivalence

The functionality for Integrity™ is equivalent to its predicate device the Elekta Desktop Pro™ (K080585) in safety and effectiveness. The fundamental technical 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.

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## 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

NOV - 4 2010

Re: K102200

Trade Name: Integrity Regulation Number: 21 CFR §892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: August 2, 2010 Received: August 4, 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 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

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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.

Signature

David G. Brown, Ph.D. 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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# 1102200

## Indications for Use

NOV - 4 2010

510(k) Number (if known):

K102200

Device Name:

# Indications for Use

Indications for Use: Integrity™ 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 tumours), 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)

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| | Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) |
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| | Division of Radiological Devices |
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| 2010/05/12 | Elekta Integrity™ | Document 04 - 01 |
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© 2010 Elekta Limited, Crawley, UK. All rights reserved.