INTEGRITY(TM)

K112613 · Elekta Limited · IYE · Dec 16, 2011 · Radiology

Device Facts

• Record ID: K112613
• Device Name: INTEGRITY(TM)
• Applicant: Elekta Limited
• Product Code: IYE · Radiology
• Decision Date: Dec 16, 2011
• 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.q. 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 R1.1 is an integrated digital control system for Elekta medical linear accelerators; functions as interface and machine control software. Operates on a dedicated control cabinet; used by clinicians/service engineers in clinical settings. Transforms treatment plans into machine control commands for beam delivery; manages static/dynamic radiation beams, gantry movement, and collimator rotation. Provides diagnostic tools for service engineers; improves VMAT beam delivery consistency. Output assists practitioners in delivering radiation to target volumes while sparing healthy tissue. Enhances compatibility with Elekta product range.

Clinical Evidence

No clinical data. Evidence consists of non-clinical module, integration, and system-level verification and validation testing. Regression testing verified the integrity of software changes. System performance was validated under actual use conditions by qualified personnel on production-equivalent systems. Compliance with voluntary consensus safety standards (IEC 60601-1, IEC 60601-2-1, IEC 62304, IEC 62366, ISO 14971) was demonstrated.

Technological Characteristics

Integrated digital control system comprising a dedicated control cabinet running interface and machine control software. Connectivity: Networked within Elekta accelerator ecosystem. Standards: IEC 60601-1, IEC 60601-2-1, IEC 60601-1-4, IEC 62304, IEC 60601-1-6, IEC 62366, ISO 14971. Software-based control of MLC, gantry, and collimator movement.

Indications for Use

Indicated for patients requiring radiation therapy for lesions, arterio-venous malformations, and malignant or benign tumors in any body area. Used by licensed practitioners for single or multiple fraction static or dynamic radiation delivery.

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

• Integrity™ R1.0 (K102200)

Submission Summary (Full Text)

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K112613

## 510(k) SUMMARY

Date of preparation of summary: 1st September 2011

#### Submitted by:

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

#### Contact name: Mr. Andrew Hedges

| Trade Name: | Integrity™ R1.1 |
|----------------------|-------------------------------------------------------------------|
| Common Name: | Control System, Medical Linear Accelerator |
| Classification Name: | Medical charged-particle radiation therapy system, 21CFR 892.5050 |
| Product Code: | IYE |
| Predicate Device: | Integrity™ R1.0 (K102200) |

#### Product Description:

This Traditional 510(k) describes enhancements to the integral software performing the interface and machine control functions for the Elekta Limited range of medical digital linear accelerators. These modifications provide improvements to beam delivery, compatibility with a wider range of Elekta products and the provision of diagnostic tools to assist service engineers

#### 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.q. 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.

#### Summary of Technological Characteristics:

Integrity™ is an integrated digital control system, providing interface and machine control functions for the Elekta Limited 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 substantially equivalent to its predicate device, Integrity™ R1.0 (K102200) in safety and effectiveness. The intended use, principles of operation, technological characteristics and labelling are the same or equivalent to the predicate device.

The primary difference between the predicate device and the modified device is the improved consistency of VMAT beam delivery and added flexibility for fault diagnosis. It does not introduce additional clinical functionality or performance.

Elekta Ltd., Linac House, Fleming Way, Crawley, West Sussex RH10 9RR UK Tel:[phone] Fax:[phone] www.elekta.com Registered in England No. 324454 DEC 1 6 2011

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| Functionality | NEW DEVICE<br>Integrity R1.1 | | PREDICATE DEVICE<br>IntegrityR1.0 | |
|----------------------------------------------|------------------------------|-----------|-----------------------------------------|---------|
| | MLCi2 | BM | MLCi2 | BM |
| MLC move during<br>irradiation | No change | No change | YES | YES |
| Max. speed of MLC<br>movement | No change | No change | 2cm/s | 2.5cm/s |
| Variable leaf speed | No change | No change | YES | YES |
| Interdigitation | No change | No change | YES | YES |
| Back up diaphragms | No change | No change | YES | NO |
| Back up diaphragms<br>move during | No change | No change | Track last<br>leaf for<br>lower leakage | N/A |
| Gantry move during<br>irradiation | No change | No change | YES | YES |
| Variable gantry speed | No change | No change | YES | YES |
| Collimator rotates<br>during irradiation | No change | No change | YES | YES |
| Variable Doserates<br>(available dose rates) | No change | No change | ( 255 ) | ( 255 ) |
| Treatment Delivery<br>Time ≈ | No change | No change | 1.4 min | 1.4 min |

### 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 actual use conditions have been performed by competent and professionally qualified personnel. Results from verification and validation testing demonstrate that conformance to applicable technical design specification and assured safety & effectiveness have been met.

Testing has been undertaken on both production equivalent systems at Elekta and at · customer 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 60601-1-4, IEC 62304, IEC 60601-1-6, IEC 62366 and ISO 14971.

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/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the logo is a stylized image of an eagle.

## 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 Crawley, West Sussex RH10 9RR UNITED KINGDOM

DEC 1 6 2011

Re: K112613

Trade/Device Name: Integrity R1.1 Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: November 7, 2011 Received: November 9, 2011

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,

Mary Patel

Mary S. Pastel, Sc.D. 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): (< l ( 26 13

Device Name: Integrity R1.1

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)

..

(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 Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety |
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510K. K112613
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| 2011/07/12 | Elekta Integrity ^TM | Document 04 - 01 |
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| © 2011 Elekta Limited, Crawley, UK. All rights reserved. | | Page 1 of 1 |