ELEKTA SYNERGY SYSTEM

K032996 · Elekta Oncology Systems, Ltd. · IYE · Oct 23, 2003 · Radiology

Device Facts

• Record ID: K032996
• Device Name: ELEKTA SYNERGY SYSTEM
• Applicant: Elekta Oncology Systems, Ltd.
• Product Code: IYE · Radiology
• Decision Date: Oct 23, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.5050
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Elekta Synergy™ System is intended to be used for radiation therapy treatment of malignant neoplastic diseases, as determined by a licensed medical practitioner.

Device Story

Elekta Synergy™ System is an enhancement to the Precise Treatment Systems Digital Accelerator (SL/SLi Series, K963624). Device functions as a medical charged-particle radiation therapy system. Primary purpose is to improve information available for patient positioning during the treatment process. Used in clinical settings by trained medical professionals. System components undergo safety testing per IEC 60601-1 and IEC 60601-2-1. Device design and manufacturing adhere to ISO 9001, ISO 13485, and 21 CFR 820 quality standards. Hazard analysis indicates no new safety or effectiveness concerns compared to predicate. Software level of concern is classified as Major.

Clinical Evidence

No clinical data provided. Safety and effectiveness are supported by hazard analysis, compliance with international safety standards (IEC 60601-1, IEC 60601-2-1), and the established track record of the predicate device.

Technological Characteristics

Medical charged-particle radiation therapy system. Enhances patient positioning capabilities of the predicate SL/SLi Series accelerator. Components comply with IEC 60601-1 and IEC 60601-2-1 safety standards. Software level of concern is Major.

Indications for Use

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

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

• Precise Treatment Systems Digital Accelerator (SL/SLi Series) (K963624)

Submission Summary (Full Text)

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## SUMMARY OF SAFETY & EFFECTIVENESS

K032996

## OCT 2 3 2003

Elekta Limited hereby provide the following material summarising safety and effectiveness information for the Elekta Synergy™ System. This information is summarised as follows: -

- 1. The Elekta Synergy™ System is an enhancement to the previously reported Precise Treatment Systems Digital Accelerator (formally designated the SL/SLi Series, D.C. K963624) and its commercially available options.
These devices have an established and proven track record for safety. The primary reason for the introduction of this product is to improve information available to allow the set up of the patient position as part of the treatment process. The Elekta Synergy " System does not raise additional types of safety or effectiveness considerations.

- 2. It is our opinion that the Elekta Synergy™ System does not have technological characteristics that raise additional types of safety or effectiveness questions, and that we consider it an enhancement to the previously cleared devices within the Elekta product range.
- 3. The accompanying documents provided for the user contain comprehensive information to ensure safe and effective use. Past experience with substantially equivalent predicate devices has shown our device to be safe and effective when used as directed by the accompanying documents provided for the user.
- 4. The components of the Elekta Synergy™ System are subject to compliance testing as defined in the internationally recognised safety standards IEC 60601-1 and IEC 60601-2-1.
- 5. The components of the Elekta Synergy™ System are designed to bear the CE mark affirming compliance with all relevant European Directives in force, in particular the European Medical Device Directive. As a result of this, products may be sold freely without restriction throughout the entire European Union.
- 6. The Elekta Limited Quality Management System has been established to satisfy the requirements of ISO 9001, ISO 13485, the Medical Device Directive 93/42/EEC Annex II and US 21 CFR 820. Elekta Limited has developed the Elekta Synergy™ System using an established and documented Quality Management System.

| REF.: PH2RA006 | |
|------------------------------------------------------------------------------|------------|
| Summary of Safety & Effectiveness Information for the Elekta Synergy™ System | |
| N.C. 4513 341 3467 | |
| Attachment No: 6 | |
| Page 1 of 2 | 2003/09/01 |

© 2003 Elekta Limited. All rights reserved

ELEKTA LIMITED, CRAWLEY. UK.

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## SUMMARY OF SAFETY & EFFECTIVENESS

K032996

- 7. Elekta Limited is a registered medical device manufacturer of assessed capability against the requirements of ISO 9001, ISO 13485 and the Medical Device Directive 93/42/EEC Annex II.
- 8. In accordance with the above requirements all parts of the Quality System are subject to periodic and systematic internal Quality Audits. These audits are performed by trained personnel not having direct responsibilities in the functions being audited.
- 9. The quality system is subject to regular, planned and documented GMP audits conducted by external auditors from SGS Yarsley (UK Notified Body) and the FDA.
- 10. Elekta Limited has conducted hazard analysis on the elements of the Elekta Synergy "" System and has concluded that it does not introduce hazards that raise new types of safety or effectiveness considerations. After considering the Guidance for the Content of Pre-Market Notification Submissions of Medical Devices Containing Software Elekta Limited has concluded the level of concern appropriate to the device is "Major".

Signature

D.H. Hart

Signature

Vice President Research & Development

Signature

Atauds

Director Product Management

. **Date** .

. Date

..................... Date

12 SEP 2003
.................

.12. Sept. 2003

A. Ataide

Director Product Management

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Signature

Regulatory Affairs Manager

| REF.: PH2RA006 | Summary of Safety & Effectiveness Information<br>for the Elekta Synergy™ System | N.C. 4513 341 3467<br>Attachment No: 6 |
|--------------------------------------------|---------------------------------------------------------------------------------|----------------------------------------|
| | | Page 2 of 2 2003/09/01 |
| © 2003 Elekta Limited. All rights reserved | | |
| ELEKTA LIMITED, CRAWLEY, UK. | | |

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and wings. The eagle's head is facing left. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## OCT 2 3 2003

Elekta Oncology Systems, Ltd. % Mr. Peter Stegagno Elekta, Inc. 4775 Peachtree Industrial Boulevard Building 300, Suite 300 NORCROSS GA 30092

Re: K032996

Trade/Device Name: Elekta Synergy™ System Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II

Product Code: 90 IYE Dated: September 12, 2003 Received: September 25, 2003

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 adultcration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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) 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 Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of the letter:

| 8xx. 1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [phone] |

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html.

Sincerely vours.

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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510(k) Number (if known):

K032996

Device Name ..................................................... Elektem

Indication for Use:

The Elekta Synergy™ System is intended to be used for radiation therapy treatment of malignant neoplastic diseases, as determined by a licensed medical practitioner.

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use | ______________________________________________________________________________________________________________________________________________________________________________ |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| (Per 21 CFR 801.109) | |

OR

Over-The-Counter Use

David C. Egnor

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

(Optional Format 1-2-96)