PT2 VARIAN PROTON THERAPY SYSTEM

K101294 · Varian Medical Systems, Oncology Systems · LHN · Dec 27, 2010 · Radiology

Device Facts

• Record ID: K101294
• Device Name: PT2 VARIAN PROTON THERAPY SYSTEM
• Applicant: Varian Medical Systems, Oncology Systems
• Product Code: LHN · Radiology
• Decision Date: Dec 27, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5050
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

PT2 Varian Proton Therapy System provides protons for precision radiotherapy of lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.

Device Story

PT2 Varian Proton Therapy System is a proton radiation therapy system used for precision treatment of lesions and tumors. The system comprises a superconducting cyclotron (250 MeV), a beam transport system, up to four isocentric gantry treatment rooms, and a treatment control room. The device operates by generating a proton beam, transporting it to the treatment room, and delivering it via beam spot scanning. During spot scanning, the beam stops at specific points until a predefined proton fluence is reached, then moves to the next spot; depth is adjusted by changing beam energy. The system utilizes a 6-axis treatment table for patient positioning and includes a laser positioning system. It is operated by clinical staff in a radiation therapy environment to deliver treatment according to a physician's prescription. The output is a controlled proton beam that enables precise dose delivery to the target volume, potentially improving therapeutic outcomes for patients with localized tumors.

Clinical Evidence

No clinical data provided. Substantial equivalence is supported by bench testing, including verification and validation testing of the system's performance characteristics.

Technological Characteristics

Superconducting isochronous cyclotron (helium cryogen cooled); 250 MeV energy; beam transport via quadrupoles and dipole magnets; beam delivery via spot scanning; 6-axis treatment table; laser positioning system; 1-4 isocentric gantries. No patient position verification system included.

Indications for Use

Indicated for patients requiring 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

• Proteus 235 Proton Therapy System (K082416)

Submission Summary (Full Text)

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# Premarket Notification [510(k)] Summary PT2 Varian Proton Therapy System

DEC 27 2010

The following information is provided following the format of 21 CFR 807.92.

| Submitter's Name: | Varian Medical Systems, Inc.<br>3100 Hansen Way e-110<br>Palo Alto, CA 94304 | |
|-----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Contact Name: Vy Tran<br>Phone: [phone]<br>Fax: [phone]<br>Date: 5 May 2010 | |
| Proprietary Name: | PT2 Varian Proton Therapy System | |
| Classification Name: | Medical charged-particle radiation therapy system<br>21 CFR 892.5050, Class II<br>Product Code: LHN | |
| Common/Usual Name: | Proton Therapy System | |
| Predicate Devices: | Proteus 235 Proton Therapy System from Ion Beam Applications S.A.<br>(K082416). | |
| Device Description: | PT2 Varian Proton Therapy System is a proton radiation therapy system<br>which delivers therapeutic radiation in accordance with a physician's<br>prescription. | |
| | The system consists of four major components, | |
| | 1) Cyclotron required to generate the photon beam<br>2) Beam line - transports beam from the cyclotron to the required<br>treatment room<br>3) Up to 4 radiation treatment rooms<br>4) Treatment Control room | |
| Statement of Intended Use | PT2 Varian Proton Therapy System provides protons for precision<br>radiotherapy of lesions, tumors, and conditions anywhere in the<br>body where radiation treatment is indicated. | |
| Statement of Indications for Use: | PT2 Varian Proton Therapy System provides protons for precision<br>radiotherapy of lesions, tumors, and conditions anywhere in the<br>body where radiation treatment is indicated. | |
| Technological Characteristics: | See device comparison table below. | |
| Description | IBA Proton Therapy System - Proteus 235 | PT2 Varian Proton Therapy System |
| 510(k) Number | K082416 | K101294 |
| Intended Use | The PTS is a medical device designed to<br>produce and deliver a proton beam for the<br>treatment of patients with localized tumors<br>and other conditions susceptible to<br>treatment by radiation. | PT2 Varian Proton Therapy System provides<br>protons for precision radiotherapy of<br>lesions, tumors, and conditions anywhere in<br>the body where radiation treatment is<br>indicated. |
| Indications For Use | The PTS is a medical device designed to<br>produce and deliver a proton beam for the<br>treatment of patients with localized tumors<br>and other conditions susceptible to<br>treatment by radiation. | PT2 Varian Proton Therapy System, provides<br>protons for precision radiotherapy of<br>lesions, tumors, and conditions anywhere in<br>the body where radiation treatment is<br>indicated. |
| Proton Accelerator | Isochronous Cyclotron (not<br>superconducting) | Isochronous Cyclotron (superconducting<br>type using helium cryogen cooling) |
| Treatment Particle | Proton | Proton |
| Cyclotron energy | 230 MeV | 250 MeV |
| Proton Energy Selection | 70-230 MeV | 90-230 MeV (usable energy range) |
| Energy Selection | Via mechanical degrader system and Energy<br>Selection System based on magnetic<br>deflection | Via mechanical degrader system and Energy<br>Selection System based on magnetic<br>deflection |
| Beam Transport | Standard beam optical system with<br>quadrupoles and dipole magnets | Standard beam optical system with<br>quadrupoles and dipole magnets |
| Number of Treatment<br>Rooms | 3 to 7 treatment rooms with fixed beam<br>treatment stations or isocentric gantries. | 1 to 4 treatment rooms with isocentric<br>gantries.<br>No fixed beam treatment stations. |
| Beam angle adjustment | Fixed in Fixed Beam treatment stations<br>or adjustable via Rotating Isocentric Gantry | Adjustable via Rotating Isocentric Gantry |
| Beam delivery | Beam Scattering or<br>Pencil Beam Scanning<br>The pencil beam scanning is defined as the<br>act of moving a charged particle beam of<br>particular properties and/or changing one or<br>more of the properties of that beam (e.g.<br>Intensity (e.g. # protons/second), size (e.g. 1<br>sigma), position etc.) | Beam Spot Scanning in all treatment<br>stations<br>The beam spot scanning is defined as the<br>act of moving a charged particle beam of<br>particular properties from one spot to the<br>next over the whole treatment volume<br>and/or changing one or more of the<br>properties of that beam (e.g. Intensity (e.g. #<br>protons/second), position etc.). The<br>charged particle beam stops on each spot<br>until the predefined the proton fluence<br>according to a prescription is reached and<br>moves to the next spot. After one layer of<br>spots is done the depth will be changed by<br>the change of the energy and the next layer<br>of spots will be executed. |
| Patient Positioning | 6-Axis Treatment Table | 6-Axis Treatment Table |
| Patient Position<br>Verification System | Included | Not included |
| Laser positioning system | Included | Included |

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### Summary of Performance Testing

Results of verification and validation testing demonstrate that the
PT2 Varian Proton Therapy System satisfies the intended use as described above.

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Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with three stripes forming its body and wing. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular fashion around the eagle.

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

L. 2.7 ..

Re: K101294

Trade/Device Name: PT2 Varian Proton Therapy System Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: LHN Dated: September 17, 2010 Received: September 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 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,

Signature

David G. Brown, Ph.D. 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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Image /page/4/Picture/0 description: The image shows the logo for Varian Medical Systems. The word "VARIAN" is in large, bold letters, with a stylized "i" that has a dot above it. Below the word "VARIAN" are the words "medical systems" in smaller letters.

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

## Indications for Use Statement

DEC 27 2010

510(k) Number: KIO1294 Device Name:

PT2 Varian Proton Therapy System

PT2 Varian Proton Therapy System, provides protons for precision radiotherapy of lesions, tumors, and conditions anywhere in the body where radiation treatmont 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 Beatler Exchilder (OBE) OFF OD

*(Division Sign-Off)*

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

510K K161294

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