VARIAN HIGH ENERGY LINEAR ACCELERATOR

K100890 · Varian Medical Systems · IYE · Jul 13, 2010 · Radiology

Device Facts

• Record ID: K100890
• Device Name: VARIAN HIGH ENERGY LINEAR ACCELERATOR
• Applicant: Varian Medical Systems
• Product Code: IYE · Radiology
• Decision Date: Jul 13, 2010
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.5050
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Varian High Energy Linear Accelerator is intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.

Device Story

Varian High Energy Linear Accelerator provides stereotactic radiosurgery and precision radiotherapy. Device delivers high-energy radiation to treat lesions, tumors, and conditions throughout the body. Operated by clinical staff in a radiotherapy setting. System utilizes C-Series control software (release 8.0) to manage radiation delivery, incorporating safety and usability improvements. Output consists of controlled radiation beams for therapeutic intervention. Clinical decision-making relies on provider assessment of patient condition and treatment planning. Benefits include precise targeting of radiation to minimize damage to surrounding healthy tissue.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on technological characteristics and design similarities to the predicate devices.

Technological Characteristics

Medical charged-particle radiation therapy system (21 CFR 892.5050). Features C-Series control software (release 8.0). System architecture maintains consistency with previously cleared Trilogy Radiotherapy System models. Operates as a high-energy linear accelerator for radiation delivery.

Indications for Use

Indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body requiring radiation treatment.

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

• Varian Trilogy Radiotherapy System (K081188)
• Varian Trilogy Radiotherapy System (K072916)

Submission Summary (Full Text)

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#### 510(k) Summary

The information below is provided for the Varian High Energy Linear Accelerator, following the format of 21 CFR 807.92.

1. Submitter: Varian Medical Systems 3100 Hansen Way, M/S e110 Palo Alto, CA 94304 Contact Name: Vy Tran Phone: [phone] Fax: [phone] E-mail: [e-mail]

JUL 13 2010

| Name of the Device: | Varian High Energy Linear Accelerator |
|----------------------------|---------------------------------------|
| Trade / Proprietary Names: | Novalis Tx, Trilogy, Trilogy Tx |
| | Clinac iX, Clinac Cx |
| | Clinac 2100C, 2100 C/D, 2300 C/D |
| | Clinac 21 EX, 23 EX |
| | Clinac DHX, DMX |
| Common or Usual Names: | Novalis Tx, Trilogy, Trilogy Tx |
| | Clinac iX, Clinac Cx |
| | Clinac 2100C, 2100 C/D, 2300 C/D |

Clinac 21 EX, 23 EX Clinac DHX, DMX

Classification Name:

Medical Charged Particle Radiation Therapy System 21 CFR §892.5050 Class II

Product Code:

2.

90 ГҮЕ

- Predicate Device: 3.
Varian Trilogy Radiotherapy System: K081188. K072916

### 4. Description of the Device:

The Varian High Energy Linear Accelerator models provide various selections among the features, specifications, and accessories that have been most recently cleared as Trilogy Radiotherapy Delivery System (K081188, K072916).

The 8.0 release of the C-Series control software provides additional features, safety improvements, and usability improvements.

All other features of the Varian High Energy Linear Accelerator models remain as cleared by K081188, K072916.

510(k) Summary - Varian High Energy Linear Accelerator

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- 5. Intended Use Statement
The Varian High Energy Linear Accelerator is intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.

- 6. Indications for Use Statement
The Varian High Energy Linear Accelerator is indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.

- 7. Substantial Equivalence
The Varian High Energy Linear Accelerator submission illustrates substantial equivalence to the predicate device.

## 510(k) Summary - Varian High Energy Linear Accelerator

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The logo is black and white and appears to be a simple, clean design.

## 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

Ms. Vy Tran Vice President Corporate Regulatory Affairs Varian Medical Systems, Inc. 3100 Hansen Way PALO ALTO CA 94304-1038

/JUL 1 3 2010

Re: K100890

Trade/Device Name: Varian High Linear Accelerator Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: May 28, 2010 Received: June 1, 2010

Dear Ms. Tran:

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 vours.

Amold H.B.

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): K100890

Device Name: Varian High Energy Linear Accelerator

Indications for Use:

The Varian High Energy Linear Accelerator is indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.

Prescription Use X (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)

Muhel D'Shm

Office of In Vitro Diagnostic

510K KUNG 90

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