VARIAN HIGH ENERGY LINEAR ACCELERATOR

K112839 · Varian Medical Systems · IYE · Nov 14, 2011 · Radiology

Device Facts

• Record ID: K112839
• Device Name: VARIAN HIGH ENERGY LINEAR ACCELERATOR
• Applicant: Varian Medical Systems
• Product Code: IYE · Radiology
• Decision Date: Nov 14, 2011
• Decision: SESE
• Submission Type: Traditional
• 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 delivers high-energy radiation for stereotactic radiosurgery and precision radiotherapy. Device utilizes photon treatment modes, including Flattening Filter Free (FFF) high-intensity mode. System includes modified couch motion rules for targeted anatomy below couch surface and enhanced safety interlocks. Operated by clinical staff in radiation oncology settings. System transforms programmed dose parameters into controlled radiation delivery. Healthcare providers use output to treat lesions and tumors; device enables precise dose delivery to target volumes. Benefits include expanded treatment capabilities for complex anatomy and increased dose delivery rates for specific photon energies.

Clinical Evidence

Bench testing only. Verification and validation testing performed to ensure compliance with functional requirements, use cases, and hazard mitigations. Testing confirmed adherence to international standards including IEC 60601-1 (general safety), IEC 60601-1-2 (EMC), and IEC 60601-2-1 (medical accelerator safety). No clinical data presented.

Technological Characteristics

Medical charged-particle radiation therapy system. Features FFF (Flattening Filter Free) high-intensity photon mode. Connectivity includes control software (C-Series 9.0). Safety features include hardware and secondary software interlocks for dose delivery and collision protection. Supports extended couch travel range. Operates via programmable dose delivery (up to 9999 MU) with maximum rates up to 2400 MU/min for 10x FFF mode.

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 High Energy Linear Accelerator (K100890)

Submission Summary (Full Text)

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K112839

#### 510(k) Summary

# NOV 1 4 2011

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<br>3100 Hansen Way, M/S e110<br>Palo Alto, CA 94304<br>Contact Name: Vy Tran<br>Phone: [phone]<br>Fax: [phone]<br>E-mail: [e-mail] |
|----|------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|----|------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

| 2. | Name of the Device:<br>Trade / Proprietary Names: | Varian High Energy Linear Accelerator<br>Novalis Tx, Trilogy, Trilogy Tx<br>Clinac iX, Clinac Cx<br>Clinac 2100C, 2100 C/D, 2300 C/D<br>Clinac 21 EX, 23 EX<br>Clinac DHX, DMX |
|----|---------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Common or Usual Names: | Novalis Tx, Trilogy, Trilogy Tx<br>Clinac iX, Clinac Cx<br>Clinac 2100C, 2100 C/D, 2300 C/D<br>Clinac 21 EX, 23 EX<br>Clinac DHX, DMX |
| | Classification Name: | Medical Charged Particle Radiation Therapy System<br>21 CFR §892.5050<br>Class II |
| | Product Code: | 90 IYE |

- 3. Predicate Device: Varian High Energy Linear Accelerator K100890
- 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 the Varian High Energy Linear Accelerator, K100890.

The changes to the Varian High Energy Linear Accelerator provide support for treatments using the high intensity photon treatment mode, also known as FFF (Flattening Filter Free). Additionally, couch motion rules are modified to enable the use of patient support systems where the targeted anatomy and the treatment isocenter area below the surface of the couch top. Modifications that augment existing safety controls are also included.

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All other features of the Varian High Energy Linear Accelerator models remain as cleared by K100890.

- 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.

- Indications for Use Statement 6.
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 modified device, the Varian High Energy Linear Accelerator, is substantially equivalent to the predicate device, the Varian High Energy Linear Accelerator (K100890).

The intended use and indications for use for the device are unchanged - see items 5 and 6 above.

The functionality of the Varian High Energy Linear Accelerator is equivalent to the functionality of the Varian predicate device in safety and effectiveness. Compared with the predicate device, the Varian High Energy Linear Accelerator (K100890), the basic operation is the same.

The comparison table below illustrates the substantial equivalence of the cleared device, Varian High Energy Linear Accelerator (K100890) and the modified device, Varian High Energy Linear Accelerator.

| Feature and/or Specification | Cleared Device (High<br>Energy Linear<br>Accelerator K100890) | Device with Change<br>(High Energy Linear<br>Accelerator) |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------|------------------------------------------------------------------------------------|
| Release version of control software | C-Series 8.0 | C-Series 9.0 |
| For gantry rotation from outside the treatment<br>room, collision protection between the gantry<br>& couch, when the couch is outside the<br>boundary conditions set by the user | motion rules are<br>enforced when the<br>imaging arms are<br>extended | motion rules are enforced<br>whether the imaging arms<br>are extended or retracted |
| Extended Travel Range Zone includes the 10<br>cm additional height needed to support the<br>Third-party Prone Breast Couch Insert | No | Yes |
| Interlock preventing additional dose from<br>being delivered after beam hold has been set | Hardware control | Hardware control plus<br>additional secondary<br>software check |
| Software and hardware support for FFF / HIM<br>(Flattening Filter Free/High Intensity Mode) | No | Yes |
| Maximum rate at which dose delivery occurs<br>for 10x photon energy | 600 MU per minute | 600 MU per minute |

510(k) Summary - Varian High Energy Linear Accelerator

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| Feature and/or Specification | Cleared Device (High Energy Linear Accelerator K100890) | Device with Change (High Energy Linear Accelerator) |
|---------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------|
| Maximum rate at which dose delivery occurs for 10x FFF photon energy | None | 2400 MU per minute |
| Maximum rate at which dose delivery occurs for 6x SRS photon energy | 1000 MU per minute | 1000 MU per minute |
| Maximum rate at which dose delivery occurs for 6x FFF photon energy | None | 1400 MU per minute |
| Maximum field size | 3D Conformal Radiation Therapy: 40cm x 40cm.<br>IMRT: 34cm x 40cm.<br>SRS: 15cm x 15cm | 3D Conformal Radiation Therapy: 40cm x 40cm.<br>IMRT: 34cm x 40cm.<br>SRS: 15cm x 15cm |
| Maximum allowable dose limit for fixed X treatment type (for non-SRS and non-FFF treatment types) | 1999 MU | 1999 MU |
| Maximum programmable dose | 9999 MU | 9999 MU |

#### 8. Summary of Performance Testing

The design control procedures applied to the development of the Varian High Energy Linear Accelerator include requirements reviews, risk analysis, and verification and validation testing,

The verification and validation testing results from bench testing support the substantial equivalence of the modified device with its predicate, the unmodified device. Testing included testing against functional requirements, validation of use cases, hazard mitigation and control testing for compliance with applicable international medical device standards including the general safety standard IEC 60601-1, the electromagnetic compatibility standard IEC 60601-1-2, and the medical accelerator safety standard IEC 60601-2-1.

The objectives of the testing were to ensure that the pre-defined acceptance criteria and pass/fail criteria were met, including all specifications, functional requirements, use cases, hazard mitigations, and compliance with applicable international standards.

The conclusion from the results of the performance testing summarized above is that the defined criteria have been met, and that the specifications have been substantiated by the testing. The table in item 7 presents the key specifications relevant to the modifications for the Varian High Energy Linear Accelerator.

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.

### 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 of Regulatory Affairs and Ouality Systems Varian Medical Systems 3100 Hansen Way, M/S E-110 PALO ALTO CA 94304-1129

NOV 1 4 2011

Re: K112839

Trade/Device Name: Varian High Energy Linear Accelerator Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: September 26, 2011 Received: September 28, 2011

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 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 (OS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 5.10(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 Pastel

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

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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)

Office of In Vitro Die

K112839
510K

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