VARIAN UNIQUE SINGLE ENERGY LINEAR ACCELERATOR

K101751 · Varian Medical Systems, Oncology Systems · IYE · Aug 10, 2010 · Radiology

Device Facts

• Record ID: K101751
• Device Name: VARIAN UNIQUE SINGLE ENERGY LINEAR ACCELERATOR
• Applicant: Varian Medical Systems, Oncology Systems
• Product Code: IYE · Radiology
• Decision Date: Aug 10, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5050
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The UNIQUE 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

The UNIQUE is a single-energy linear accelerator for stereotactic radiosurgery and precision radiotherapy. It delivers radiation to lesions, tumors, and conditions throughout the body. The device utilizes a magnetron for beam generation and a clutch drive mechanism. It supports standard and RapidArc treatments, where gantry rotation speed and dose rate are modulated. The system is operated by clinical staff in a radiation therapy environment. It integrates with accessories including the RPM Respiratory Gating system, PortalVision, 4D Integrated Treatment Console, and Millennium Multi-Leaf Collimator. The device provides precision treatment delivery, enabling healthcare providers to target tumors while sparing surrounding healthy tissue, potentially improving patient outcomes in oncological care.

Clinical Evidence

Bench testing only. Verification and validation activities were conducted to demonstrate that the device meets acceptance criteria for safety and effectiveness. No clinical study data was required or provided.

Technological Characteristics

Single-energy linear accelerator (6 MV). Magnetron-based beam generation; clutch drive mechanism. Supports RapidArc (gantry rotation/dose rate modulation). Includes Exact Couch with IGRT couch top. Software: C-Series 8.0. Connectivity: Supports External System Gating Interface (EXGI).

Indications for Use

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

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 (K072916)

Reference Devices

• RPM Respiratory Gating (063270)
• PortalVision (K091209)
• 4D Integrated Treatment Console (K091132)
• Millennium Multi-Leaf Collimator (K050442)

Submission Summary (Full Text)

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K101757

## 510(k) Summary

The information below is provided for the UNIQUE, following the format of 21 CFR 807.92.

AUG 1 0 2010

- Varian Medical Systems 1. Submitter: 3100 Hansen Way, M/S E110 Palo Alto, CA 94304 Contact Name: Vy Tran Phone: [phone] Fax: [phone] E-mail: [e-mail]

| 2. Name of the Device: | UNIQUE |
|----------------------------|---------------------------------------------------|
| Trade / Proprietary Names: | UNIQUE |
| Common or Usual Names: | Single Energy Linear Accelerator |
| Classification Name: | Medical Charged Particle Radiation Therapy System |
| | 21 CFR §892.5050 |
| | Class II |
| Product Code: | 90 IYE |

- 3. Predicate Device: Varian Trilogy K072916
- 4. Description of the Device:

,

The UNIQUE is a Single Energy Linear Accelerator and includes modifications to the previously cleared Varian Trilogy. The UNIQUE provides additional features, safety improvements, and usability improvements. UNIQUE is supported by the following Varian accessories: RPM Respiratory Gating (063270), PortalVision (K091209), 4D Integrated Treatment Console (K091132), Millennium Multi-Leaf Collimator (K050442).

- 5. Intended Use Statement
The UNIQUE 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 UNIQUE is indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.

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## 7. Substantial Equivalence

The UNIQUE is substantially equivalent to the predicate device, the Varian Trilogy.

The functionality of the UNIQUE is equivalent to the functionality of the Varian Trilogy in safety and effectiveness. Varian design control procedures applied to the development of the UNIQUE include requirements reviews, risk analysis, and verification and validation testing. The results of verification and validation activities demonstrate that the acceptance criteria have been met.

Compared with the predicate device, the Varian Trilogy, the basic operation is the same. Operational differences are described in the Instructions for Use for the UNIQUE.

## Substantial Equivalence Table

The table below illustrates the substantial equivalence between the UNIQUE and the predicate device, the Varian Trilogy (K072916).

The intended use for both devices is to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.

| Item | Trilogy - K072916 | UNIQUE |
|----------------------------------------------------------------------------------------------------------------------|-------------------------------|--------------------------------|
| C-Series Software: improvements for<br>usability and safety, as well as support for<br>additional features | C-Series 7.7 | C-Series 8.0 |
| Photon Energy (MV) available | 4-25 MV | 6 MV |
| Selectable Number of Photon Beams | Two | One |
| Dose Rates | 50-600 MU/min (1000 SRS rate) | 100 - 600 MU/min (No SRS rate) |
| Maximum standard treatment field size | 40cm x 40cm | 40cm x 40cm |
| Electron Treatment | Yes | No |
| Arc Treatments: Standard and RapidArc<br>where gantry rotation speed and dose rate<br>are varied. | Yes | Yes |
| Non-arc photon treatment mode<br>programmable MU maximum dose | 999 MU | 1999 MU |
| Patient Support surface: Exact Couch | Yes | Yes |
| Patient support surface: Exact couch<br>pedestal with IGRT couch top for improved<br>MV imaging | No | Yes |
| Drive mechanism | Direct Drive | Clutch |
| Treatment Beam generation | Klystron | Magnetron |
| Support for External System Gating<br>Interface "EXGI" (K072916) - export of<br>beam information to external devices | No | Yes |

510(k) Summary UNIQUE - Varian Medical Systems

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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird with three stylized lines forming its body and wings.

## 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

AUG 1 0 2010

Ms. Vy Tran Official Correspondent Varian Medical Systems, Inc. 3100 Hansen Way PALO ALTO CA 94304-1038

Re: K101751

Trade/Device Name: UNIQUE Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: June 18, 2010 Received: June 22, 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 (21 CLT Allis 101 and 5450. 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 tolli the [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Donald J. Trump

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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K101751

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Varian Medical Systems, Inc. 3100 Hansen Way Palo Alto, CA 94304-1038 USA Tel [phone] www.varian.com

# Indications for Use

AUG 1 0 2010

510(k) Number (if known):

Device Name: UNIQUE

Indications for Use:

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The UNIQUE 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)

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(Division Sign-Off)

(Division Sign-Off) Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety

510K K101751

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