ELEKTA SYNERGY; ELEKTA SYNERGY S AND XVIR3.5

K051932 · Elekta, Inc. · IYE · Aug 12, 2005 · Radiology

Device Facts

• Record ID: K051932
• Device Name: ELEKTA SYNERGY; ELEKTA SYNERGY S AND XVIR3.5
• Applicant: Elekta, Inc.
• Product Code: IYE · Radiology
• Decision Date: Aug 12, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.5050
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Elekta Synergy®, Elekta Synergy® S, and XVI R3.5 are intended to be used for radiation therapy treatment of malignant neoplastic diseases, as determined by a licensed medical practitioner.

Device Story

Elekta Synergy and Synergy S are medical linear accelerators integrated with XVI R3.5 kV imaging accessory; provides radiation therapy for malignant neoplastic diseases. System utilizes common MV and kV isocenter with orthogonal beam paths for image-guided radiation therapy. Modifications include hardware and software updates to enhance patient throughput, improve image quality/management, provide clinical presets, and facilitate DICOM connectivity. Operated by clinical staff in radiation oncology settings. Output includes therapeutic radiation beams and diagnostic images used by physicians for treatment planning and delivery; enables precise patient positioning and verification.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and design modifications to a previously cleared predicate device.

Technological Characteristics

Medical linear accelerator with integrated kV imaging system (XVI R3.5). Features common MV and kV isocenter and orthogonal beam paths. Connectivity via DICOM. Software modifications for image processing and workflow efficiency.

Indications for Use

Indicated for radiation therapy treatment of malignant neoplastic diseases in patients as determined by a licensed physician.

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® System (K032996)

Submission Summary (Full Text)

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KOS/932

## 510(k) SUMMARY

#### Date of preparation of summary:

4th July 2005

#### Submitted by:

Elekta Limited Linac House, Fleming Way Crawley, West Sussex RH20 9RR United Kingdom

#### Contact name, (application correspondent):

Peter Stegagno, Director, Regulatory Affairs & Quality Assurance 4775 Peachtree Industrial Boulevard, Building 300, Suite 300 Norcross, Georgia, 30092 USA

| Email: | [e-mail] | |
|--------|---------------------------------|------------------------|
| | Telephone: [phone] x2548 | Fax: (770) 448 6338 |

| Trade Name: | Elekta Synergy®, Elekta Synergy® S, and XVI R3.5 |
|----------------------|---------------------------------------------------|
| Common Name: | Medical Linear Accelerator (with Patient Imaging) |
| Classification Name: | Medical Linear Accelerator Accessory 90 IYE |
| Predicate Device: | Elekta Synergy® System (K032996) |

#### Product Description:

This Premarket Notification Special 510(k) describes modifications to the Elekta Synergy® System; a combination of the specially prepared Elekta medical linear accelerator, Elekta Synergy® Platform, with the XVI on-board kV imaging accessory. The primary reasons for the modifications to this product are to provide:

- Hardware & software support for increased patient throughput �
- Easier selection of parameters & provision of clinical presets to improve efficiency �
- Improved image quality and image management �
- Improved tools for device set-up and image processing �
- Improved connectivity with other systems through DICOM �

#### Intended Use Statement:

This is unchanged from the predicate device and is defined as;

The Elekta Synergy®, Elekta Synergy® S, and XVI R3.5

are intended to be used for radiation therapy treatment of malignant neoplastic diseases, as determined by a licensed medical practitioner."

### Summary of Technological Characteristics:

The Elekta Synergy® and Elekta Synergy® S comprise a standard Elekta medical linear accelerator, modified to accept the fitting of a kV imaging system (XVI R3.5), with a common MV and kV isocentre and orthogonal beam paths, all as previously cleared under Control Number K032996.

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

:

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#### Public Health Service

AUG 1 2 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Elekta Limited % Mr. Peter Stegagno Director, Regulatory Affairs & Quality Assurance Elekta, Inc. 4775 Peachtree Industrial Boulevard Building 300, Suite 300 NORCROSS GA 30092

Re: K051932 Trade/Device Name: Elekta Synergy®, Elekta Synergy® S and XVI R3.5 Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: July 8, 2005 Received: July 13, 2005

Dear Mr. Stegagno:

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 either class II (Special Controls) or class III (Premarket Approval), it may be subject to such 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); 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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This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to ocgin manusing of substantial equivalence of your device to a legally premarket nothcation. The I DA Intentig or our 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 Part 801), please if you desire spective advice for your do the following numbers, based on the regulation number at the top of this letter:

| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|-----------------|----------------------------------|--------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Also, please note the regulation entired, for responsibilities under the Act from the 807.97). You may obtain other general 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,

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

| 510(k) Number (if known): | K051932 |
|----------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | Elekta Synergy ^® , Elekta Synergy ^® S, and XVI R3.5 |
| Indication for Use: | The Elekta Synergy ^® , Elekta Synergy ^® S, and XVI R3.5 are intended to be used for radiation therapy treatment of malignant neoplastic diseases, as determined by a licensed physician. |
| Prescription Use<br>(Per 21 CFR 801.109 Subpart D) | - YES <span style="text-align:center">AND/OR</span> Over-The-Counter Use - NO<br>(21 CFR 801 Subpart C) |

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

David R. Lignon

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number _