PROBEAM PROTON THERAPY SYSTEM

K133191 · Varian Medical Systems · LHN · Jan 10, 2014 · Radiology

Device Facts

• Record ID: K133191
• Device Name: PROBEAM PROTON THERAPY SYSTEM
• Applicant: Varian Medical Systems
• Product Code: LHN · Radiology
• Decision Date: Jan 10, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5050
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

ProBeam Proton Therapy System delivers precision radiation therapy using proton beams. System components include a superconducting isochronous cyclotron (250 MeV output), beam transport system, treatment rooms (isocentric gantries or fixed beam), and a control room. The system utilizes the Bragg peak effect to target lesions while sparing surrounding normal tissue. Beam delivery employs spot scanning, where the proton beam moves across the treatment volume, stopping at predefined spots until the prescribed fluence is reached, then adjusting energy for subsequent layers. The system includes a 6-axis robotic treatment table and a dual kV X-ray imaging system for patient positioning and target localization. Operated by clinicians in a clinical setting, the system uses automated image comparison (mutual information, semi-automatic, or manual) to align patient anatomy with the treatment plan. Output is a controlled proton beam for therapeutic irradiation. Benefits include high-precision dose delivery to tumors with reduced radiation to healthy tissue.

Clinical Evidence

Bench testing only. System and sub-system level performance testing demonstrated substantial equivalence to the predicate device.

Technological Characteristics

Superconducting isochronous cyclotron; proton beam delivery; energy range 70-240 MeV; beam spot scanning; 6-axis robotic treatment table; dual kV X-ray imaging system with amorphous silicon (a-Si:H) flat panel detector; beam transport via quadrupoles and dipole magnets; software-controlled beam delivery and image matching.

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

• ProBeam Proton Therapy System (K101294)
• Varian On-board Imager Device (K042720)

Reference Devices

• Forte 6-Axis Robotic Treatment Table (K122413)

Submission Summary (Full Text)

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K133191
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# Premarket Notification [510(k)] Summary ProBeam Proton Therapy System

JAN 1 0 2014

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

Submitter's Name: Varian Medical Systems, Inc. 3100 Hansen Way e-110 Palo Alto. CA 94304 Contact Name: Vy Tran Phone: [phone] Fax: [phone] Date: 9 October 2013 Proprietary Name: ProBeam Classification Name: Medical charged-particle radiation therapy system 21 CFR 892.5050, Class II Product Code: LHN Common/Usual Name: Proton Therapy System 1) ProBeam Proton Therapy System (K101294) Predicate Devices: 2) Varian On-board Imager Device (K042720) ProBeam Proton therapy system, has been designed by Varian Medical Device Description: Systems to deliver radiation treatment in accordance with a prescribed treatment plan. The system takes advantage of the characteristics of proton charged particle beam delivery. The major characteristic of proton radiation therapy utilizes the Bragg peak to prevent radiation of normal tissue outside the target volume. The system consists of 4 major components: 1) Cyclotron required to generate the proton beam (output 250MeV) 2) Beam line to transport beam from the cyclotron to the required treatment room 3) Treatment room where the patient is irradiated as per the prescribed treatment plan 4) Control room to select patient and activate treatment delivery ProBeam Proton Therapy System provides protons for precision Statement of Intended Use radiotherapy of lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated. Statement of Indications for Use: ProBeam Proton Therapy System provides protons for precision radiotherapy of lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.

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### Technological Characteristics:

・

Refer to the Substantial Equivalence discussion in the table below:

| Feature | Predicate Device: | Modified Device: |
|-------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | ProBeam (K101294)<br>(Note: Also known as PT2 Varian Proton<br>Therapy System) | ProBeam |
| Intended Use | PT2 Varian Proton Therapy System provides protons<br>for precision radiotherapy of lesions, tumors, and<br>conditions anywhere in the body where radiation<br>treatment is indicated. | ProBeam Proton Therapy System provides protons<br>for precision radiotherapy of lesions, tumors, and<br>conditions anywhere in the body where radiation<br>treatment is indicated. |
| Indications For Use | PT2 Varian Proton Therapy System, provides protons<br>for precision radiotherapy of lesions, tumors, and<br>conditions anywhere in the body where radiation<br>treatment is indicated. | ProBeam Proton Therapy System provides protons<br>for precision radiotherapy of lesions. tumors, and<br>conditions anywhere in the body where radiation<br>treatment is indicated. |
| Proton Accelerator | Isochronous Cyclotron (superconducting type using<br>helium cryogen cooling) | No change |
| Treatment Particle | Proton | Proton |
| Cyclotron energy | 250 MeV | No change |
| Proton Energy<br>Selection | 90-230 MeV (usable energy range) | 70 - 240 MeV (usable energy range) |
| Energy Selection | Via mechanical degrader system and Energy<br>Selection System based on magnetic deflection | No Change |
| Beam Transport | Standard beam optical system with quadrupoles and<br>dipole magnets | No Change |
| Number of beam<br>delivery rooms | 1 to 4 treatment rooms with isocentric gantries.<br>No fixed beam treatment stations. | Customer can choose up to 6 beam delivery room<br>modules. The facility would be comprised of a<br>combination of modules including Treatment rooms<br>(either Isocentric gantries or fixed beam) and/or<br>research rooms |
| Beam angle<br>adjustment | Adjustable via Rotating Isocentric Gantry | Adjustable only in Rotating Isocentric Gantry rooms<br>For fixed beam rooms the beam is provided at a<br>fixed angle |
| | Beam Spot Scanning in all treatment stations | No change |
| Beam delivery | Note: The beam spot scanning is defined as the act<br>of moving a charged particle beam of particular<br>properties from one spot to the next over the whole<br>treatment volume and/or changing one or more of<br>the properties of that beam (e.g. Intensity (e.g. #<br>protons/second), position etc.). The charged<br>particle beam stops on each spot until the<br>predefined the proton fluence according to a<br>prescription is reached and moves to the next spot.<br>After one layer of spots is done the depth will be<br>changed by the change of the energy and the next<br>layer of spots will be executed. | Note: The beam spot scanning is defined as the act<br>of moving a charged particle beam of particular<br>properties from one spot to the next over the whole<br>treatment volume and/or changing one or more of<br>the properties of that beam (e.g. Intensity (e.g. #<br>protons/second), position etc.). The charged<br>particle beam stops on each spot until the<br>predefined the proton fluence according to a<br>prescription is reached and moves to the next spot.<br>After one layer of spots is done the depth will be<br>changed by the change of the energy and the next<br>layer of spots will be executed. |
| Laser positioning<br>system | Included | Included |
| Beam characteristics:<br>spot shape | 4 mm (Sigma) in the specified range(tolerance<br>range: for energies ≤100 MeV, beam spot size +<br>30% / -20%, for energies> 100 MeV beam spot<br>sizes ± 20%) | 4.0 mm +/- 15% (Sigma) for beam energies equal<br>or greater than 140 MeV to 240 MeV.<br>$(-0.02 * E / MeV + 6.8) +/- 15 % mm for beamenergies E from 70 MeV to less than 140 MeV.$ |
| Beam characteristics:<br>field size | Maximum field size is 25cm (x) x 25cm(y) | Maximum field size is 30cm (x) x 40cm(y) |
| Feature | Predicate Device: | Modified Device: |
| Maximum deviation of undeflected beam from isocenter | 3.0 mm | 1.0 mm |
| Value of energy dose rate at the Nominal Treatment Distance | >1 Gy/l /min | 2 Gy/l/min |
| Patient Positioning | Varian 6-Axis Treatment Table | Forte 6-Axis Robotic Treatment Table (K122413) |
| Maximum Load | 150Kg (330lbs) | 273 Kg (550lbs) |
| Pitch | $\pm$ 3° | No Change |
| Roll | $\pm$ 3° | No Change |
| Absolute positioning precision, radius sphere | ≤ 0.5 mm | No Change |
| Patient Position Verification System | Not included | Included |
| | Varian On-board Imager Device (K042720) | ProBeam Device Component: kV Imaging |
| Target localization technology | Single kV X-ray System | Dual kV X-ray System |
| 2D/3D Match | Not included | Included |
| X-ray source | Varian G-242 | Varian GS-20712 |
| Voltage | 40-150kV | 40-140kV |
| Exposure | 0.5-630 mAs | 0.1-370.1 mAs |
| Flat panel digital x-ray detector | Varian PaxScan 4030CB | No Change |
| Detector pixel elements | Amorphous Silicon (a-Si:H) photodiode plus thin film transistor | No Change |
| Type of digital image produced | digital radiographs or fluoroscopy | digital radiographs |
| Basis of image comparison | soft tissues, bony anatomy or fiducial markers | No change |
| Image comparison techniques | Fully automatic using mutual information. semi-automatic, or manual | No change |

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K133191
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### Summary of Performance Testing:

Testing has been performed at the system and sub-system level and demonstrated ProBeam is substantially equivalent to the predicate device.

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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 features a stylized eagle-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 symbol.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

January 10, 2014

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

Re: K133191

Trade/Device Name: ProBeam Proton Therapy System Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: LHN Dated: October 18, 2013 Received: October 21, 2013

#### 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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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Page 2-Ms. Tran

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/Medicall.ocvices/Resources/or You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/dcfault.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/MedicalDevices/ResourcesforYou/Industrv/default.htm.

Sincerely yours,

Michael D. O'Hara

for Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health

Center for Devices and Radiological Health

Enclosure

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## Indications for Use Form

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: ProBeam Proton Therapy System

Indications for Use:

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

AND/OR Over-The-Counter Use Prescription Use _____________________________________________________________________________________________________________________________________________________________ (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

..............................................................................................................................................................................

Concurrence of CDRH, Office of In Vitro Devices and Radiologic Health (OIR)

Michael D. O'Hara

Division Sign-Off Office of In Vitro Devices and Radiologic Health

K133191 510(k)__

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