ProBeam 360° Proton Therapy System v2.0 (Multiroom)

K231863 · Varian Medical Systems, Inc. · LHN · Oct 6, 2023 · Radiology

Device Facts

• Record ID: K231863
• Device Name: ProBeam 360° Proton Therapy System v2.0 (Multiroom)
• Applicant: Varian Medical Systems, Inc.
• Product Code: LHN · Radiology
• Decision Date: Oct 6, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5050
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

ProBeam 360° 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 360° Proton Therapy System v2.0 is a multi-room, compact proton therapy system delivering radiation treatment per physician-prescribed plans. Input: patient treatment plan data. Operation: 226MeV isochronous cyclotron generates protons; beam transport system (steerer, quadrupole, dipole, scanning magnets) directs beam to 2-5 treatment rooms via 90-degree beam ports; beam spot scanning delivers radiation. Output: proton beam for therapy. Used in clinical radiation oncology departments; operated by trained clinicians/technicians. System includes beam scheduler for multi-room management and CBCT/2D imaging for patient positioning. Output affects clinical decision-making by enabling precise dose delivery to target volumes while sparing normal tissue via Bragg peak attenuation. Benefits: compact footprint allows multi-room capacity in smaller facilities.

Clinical Evidence

Bench testing only. No clinical or animal studies were performed. Design verification and validation testing conducted per 21 CFR 820, ISO 13485, ISO 14971, and IEC 62304. Electrical safety and EMC testing performed per FDA-recognized consensus standards.

Technological Characteristics

Isochronous cyclotron (226 MeV) with superconducting coils and helium cryogen cooling. Beam delivery via spot scanning and 360° isocentric gantry. Multi-room configuration (2-5 rooms) with 90-degree beam ports. Patient positioning via 6-axis robotic table. Software-controlled beam scheduling and imaging (2D/CBCT).

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 360° Proton Therapy System v1.0 (K221791)

Reference Devices

• ProBeam Proton Therapy System v2.0 (K133191)
• Leoni Orion 6-Axis Robotic Treatment Table (K160518)

Submission Summary (Full Text)

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October 6, 2023

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Varian Medical Systems, Inc. % Peter Coronado Sr. Director, Regulatory Affairs 3100 Hansen Way PALO ALTO CA 94304

# Re: K231863

Trade/Device Name: ProBeam 360 Proton Therapy System v2.0 (Multiroom) Regulation Number: 21 CFR 892.5050 Regulation Name: Medical Charged-Particle Radiation Therapy System Regulatory Class: Class II Product Code: LHN Dated: September 6, 2023 Received: September 6, 2023

# Dear Peter Coronado:

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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (OS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Locon Weidner

Lora D. Weidner, Ph.D. Assistant Director Radiation Therapy Team DHT8C: Division of Radiological Imaging and Radiation Therapy Devices OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

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# Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.

Submission Number (if known)

## K231863

Device Name

ProBeam 360° Proton Therapy System v2.0 (Multiroom)

Indications for Use (Describe)

ProBeam 360° Proton Therapy System provides protons for precision radiotherapy of lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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# Premarket Notification - 510(k) Summary

# ProBeam 360° Proton Therapy System version 2.0

#### l. Submitter's Name

Varian Medical Systems 3100 Hansen Way Palo Alto, CA 94304

Contact Name: Dr. Lynn Allman, Senior Director Regulatory Affairs Phone: [phone] E-mail: [e-mail] Date Prepared: June 23, 2023

#### II. Device Information

Proprietary Name: ProBeam 360° Proton Therapy System version 2.0 (Multiroom) Common/ Usual Name: Proton Therapy System Classification Name: System, Radiation Therapy, Charged-Particle, Medical Regulation Number: §892.5050 Product Code: LHN

#### III. Predicate Device

ProBeam 360° Proton Therapy System v1.0 (K221791)

#### IV. Reference Device

ProBeam Proton Therapy System v2.0 (K133191)

#### V. Device Description

The ProBeam 360° Proton Therapy System v2.0 (Multiroom) is designed to deliver radiation treatment in accordance with the physician's prescribed treatment plan.

Proton radiation therapy takes advantage of the Bragg peak characteristic of proton attenuation to minimize radiation of normal tissue outside the target volume. Varian markets two lines of proton therapy systems, the standard ProBeam Proton Therapy Systems and the smaller, newer ProBeam 360° Systems. The ProBeam 360° Proton Therapy System line of proton systems includes single-room (cleared in K221791) and multi-room configurations.

The ProBeam 360° System Multiroom (subject device) introduces the multi-room, compact configuration and includes the following primary components:

- Cyclotron (226MeV)
- Beam Transport System (energy selection system and beam transport system)
- Two (2) to five (5) Treatment Rooms: Rotating Isocentric Gantry room with attached scanning nozzle; and a treatment table
- One Treatment Control Room for each treatment room within the chosen configuration

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#### VI. Indications for Use

ProBeam 360° Proton Therapy System provides protons for precision radiotherapy of lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.

The indications for use and intended use of the subject device is the same as the predicate device.

#### VII. Comparison of Technological Characteristics with the Predicate Device

The ProBeam 360° System version 2.0 (Multiroom) introduces the multi-room configuration to the ProBeam 360° line of proton therapy systems. The ProBeam 360° System Multiroom is substantially the same as the predicate device, the ProBeam 360° Proton Therapy System v1.0 (ProBeam 360° System v1.0) as cleared in K221791. The systems share the same intended use, compact design, and equivalent technological characteristics. The significant difference between ProBeam 360° System v2.0 and ProBeam 360° System v1.0 is in the configuration of the device.

ProBeam 360° System version 2.0 (Multiroom) adds a multi-room, modular design wherein a customer site may choose to construct a system of two (2) to five (5) treatment rooms with a rotating gantry. The multi-room configuration allows users to deliver proton beam to a maximum of five (5) treatment rooms within one facility, as compared to a single-room system which would require multiple facilities to achieve the same treatment capacity. The multi-room technology has been derived from the reference device, the standard ProBeam Proton Therapy System v2.0 (ProBeam PTS v2.0) as cleared under K133191. The ProBeam 360° System Multiroom combines the compact design of the ProBeam 360° System v1.0 (K221791) with the modular, multi-room design of the ProBeam PTS v2.0 (K133191).

The multi-room configuration adds 14 new risks, modifies three (3) existing risks, triggers verification of two (2) existing risk control measures, and is implemented through three (3) primary design changes:

- Addition of Beam Ports
- . Software change to facilitate beam request scheduling across multi room configuration
- Compact Gantry Room offered as multi-room system (from 2 to 5 treatment rooms)

In addition, the multi-room configuration introduces the following non-significant changes:

- . New Scanning Nozzle System (SNS) High Voltage (HV) power supply due to obsolescence
- . Fixed Defects inherited from the prior ProBeam release

Those primary changes affect four (4) device characteristics as identified in Tables 1 and 2.

- Beam Ports
- Treatment Room Configuration
- Software Release
- Beam Scheduler

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A Siemens Healthineers Company

| | | | Table 1. Comparison of Subject Device to ProBeam 360° System version 1.0 Predicate Device | |
|--------------------------------------|-----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Device Characteristic | Predicate Device:<br>ProBeam 360° Proton Therapy<br>System v1.0<br>K221791 | Subject Device:<br>ProBeam 360° Proton Therapy<br>System v2.0 | Comparison |
| Intended Use/ Indications for<br>Use | | ProBeam 360° Proton Therapy<br>System provides protons for<br>precision radiotherapy of lesions,<br>tumors, and conditions anywhere<br>in the body where radiation<br>treatment is indicated. | ProBeam 360° Proton Therapy<br>System provides protons for<br>precision radiotherapy of lesions,<br>tumors, and conditions anywhere<br>in the body where radiation<br>treatment is indicated. | Same |
| Radiation Source | | | | |
| | Accelerator | Isochronous Cyclotron | Isochronous Cyclotron | Same |
| | Type of Coils | Superconducting Coils | Superconducting Coils | Same |
| | Cooling Method | Helium Cryogen Cooling | Helium Cryogen Cooling | Same |
| | Treatment Particle | Proton | Proton | Same |
| | Cyclotron Energy | 226 MeV | 226 MeV | Same |
| | Nominal Energy | 69 MeV – 218 MeV | 69 MeV – 218 MeV | Same |
| Beam Delivery | | | | |
| | Gantry<br>Beam Line | Beam line with steerer,<br>quadrupole, dipole and scanning<br>magnets. | Beam line with steerer,<br>quadrupole, dipole and scanning<br>magnets. | Same |
| Beam Transport<br>System | Beam Ports | None | Beam Ports (assembly magnets,<br>beam stop, and beam diagnostic) | Beam ports allow for<br>beam assignment to<br>selected treatment<br>room(s) in a multi-room<br>configuration. Refer to<br>Table 3 for comparison<br>to reference device. |
| Beam Angle Adjustment | | Adjustable: Rotational type<br>isocentric 360° Gantry | Adjustable: Rotational type<br>isocentric 360° Gantry | Same |
| | Beam Delivery | Beam Spot Scanning | Beam Spot Scanning | Same |
| Beam Spot Shape | | Spot size expressed as 1σ (sigma)<br>value of the gaussian profile of the<br>beam in air at isocenter:<br>$σ$ = 3.8 mm ± 15% at 218 MeV<br>$σ$ = 4.4 mm ± 15% at 140 MeV<br>$σ$ = 5.9 mm ± 15% at 69 MeV | Spot size expressed as 1σ (sigma)<br>value of the gaussian profile of the<br>beam in air at isocenter:<br>$σ$ = 3.8 mm ± 15% at 218 MeV<br>$σ$ = 4.4 mm ± 15% at 140 MeV<br>$σ$ = 5.9 mm ± 15% at 69 MeV | Same |
| Beam Field Size | | Max: 25cm (x) x 25cm (y) | Max: 25cm (x) x 25cm (y) | Same |
| | Dose Rate | 2 Gy/l/min | 2 Gy/l/min | Same |
| Physical Characteristics | | | | |
| Treatment Room Configuration | | Single Gantry Room Compact<br>configuration | Two (2) to five (5) gantry rooms | Modular, configurable<br>system allows for<br>multiple treatment<br>rooms in one<br>installation. Refer to<br>Table 3 for comparison<br>to reference device. |
| Patient Positioning | | Leoni Orion 6-AxisRobotic<br>Treatment Table (K160518) | Leoni Orion 6-AxisRobotic<br>Treatment Table (K160518) | Same |
| Maximum Load | | 226 kg (500 lbs) | 226 kg (500 lbs) | Same |

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**A Siemens Healthineers Company**

| Device Characteristic | Predicate Device:<br>ProBeam 360° Proton Therapy<br>System v1.0<br>K221791 | Subject Device:<br>ProBeam 360° Proton Therapy<br>System v2.0 | Comparison |
|-----------------------------------------|-----------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Patient Position Verification<br>System | 2D and image acquisition CBCT,<br>nozzle mounted | 2D and image acquisition CBCT,<br>nozzle mounted | Same |
| Image Acquisition | Functionality included in PVA /<br>Imaging Supervisor. 2D and CBCT<br>(3D) image acquisition. | Functionality included in PVA /<br>Imaging Supervisor. 2D and CBCT<br>(3D) image acquisition. | Same |
| Software | | | |
| Version | ProBeam 360° version 1.0 | ProBeam 360° version 2.0 | Support multi-room<br>configuration of the<br>system including the<br>Beam Scheduler. Refer<br>to Table 3 for<br>comparison to reference<br>device. |
| Beam Priority | Beam priority can be assigned to<br>the single treatment room | Beam priority is able to be<br>assigned and prioritized in each<br>treatment room prior to beam<br>delivery. | Substantially equivalent<br>to ProBeam 360° v1.0<br>(K221791) |
| Beam Scheduler | Beam request applies only to<br>single room | Beam request must be scheduled<br>among multi-room configuration<br>(2 to 5 treatment rooms) | Allows for beam<br>assignment to selected<br>treatment room(s) in<br>multi-room<br>configuration. Refer to<br>Table 3 for comparison<br>to reference device. |
| Network Connectivity | Remote Monitoring and Limited<br>Remote control | Remote Monitoring and Limited<br>Remote control | Same |
| 2D/3D Match | Integration of 2D/3D algorithm<br>into P2VA | Integration of 2D/3D algorithm<br>into P2VA | Same |
| CBCT Imaging | 3D CBCT reconstruction algorithm | 3D CBCT reconstruction<br>algorithm | Same |
| 3D/3D Match | 3D/3D registration algorithm for<br>patient setup | 3D/3D registration algorithm for<br>patient setup | Same |

### Table 1. Comparison of Subject Device to ProBeam 360° System version 1.0 Predicate Device

## Table 2. Comparison of Subject Device to Reference Device Multi-Room Configuration

| Device Characteristic | Reference Device<br>ProBeam Proton Therapy System v2.0<br>K133191 | Subject Device<br>ProBeam 360° Proton Therapy System<br>v2.0 | Comparison |
|---------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use /<br>Indications for Use | ProBeam Proton Therapy System<br>provides protons for precision<br>radiotherapy of lesions, tumors, and<br>conditions anywhere in the body where<br>radiation treatment is indicated. | ProBeam 360° Proton Therapy System<br>v2.0 provides protons for precision<br>radiotherapy of lesions, tumors, and<br>conditions anywhere in the body where<br>radiation treatment is indicated. | Same as ProBeam PTS v2.0<br>(K133191) |
| Beam Delivery | | | |
| Beam Ports | 60-degree Beam Ports (assembly<br>magnets, beam stop, and beam<br>diagnostic) | 90-degree Beam Ports (assembly<br>magnets, beam stop, and beam<br>diagnostic) | Substantially the same as<br>ProBeam PTS v2.0<br>(K133191). The 90-degree<br>bend facilitates the smaller<br>footprint of the ProBeam<br>360° v2.0. |
| Physical Characteristics | | | |

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| Table 2. Comparison of Subject Device to Reference Device Multi-Room Configuration | | | |
|------------------------------------------------------------------------------------|--|--|--|
|------------------------------------------------------------------------------------|--|--|--|

| Device Characteristic | Reference Device<br>ProBeam Proton Therapy System v2.0<br>K133191 | Subject Device<br>ProBeam 360° Proton Therapy System<br>v2.0 | Comparison |
|---------------------------------|----------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Treatment Room<br>Configuration | Two (2) to five (5) rotational type<br>isocentric gantry rooms; or fixed beam<br>rooms | Two (2) to five (5) rotational type<br>isocentric gantry rooms | Substantially the same as<br>ProBeam PTS v2.0<br>(K133191) for the gantry<br>room. Gantry rooms in the<br>ProBeam 360° System<br>have a smaller footprint. |
| Software | | | |
| Beam Scheduler | Beam request must be scheduled<br>among multi-room configuration (2 to 5<br>treatment rooms) | Beam request must be scheduled<br>among multi-room configuration (2 to 5<br>treatment rooms) | Same as ProBeam PTS v2.0<br>(K133191) |

#### VIII. Summary of Performance Testing (Non-Clinical Testing)

The ProBeam 360° System version 2.0 (Multiroom) and its corresponding software version have undergone formal design verification and design validation testing. Design verification and design validation testing demonstrates that the ProBeam 360° System Multiroom performs as intended and meets its essential performance. The software for the subject device is considered to have a "major" level of concern, since a failure or latent flaw in the software could directly result in serious injury or death to the patient or operator.

Hardware and software design verification and design validation testing was performed according to the FDA Quality System Regulation (21 CFR §820), ISO 13485 Quality Management System Standard, ISO 14971 Risk Management Standard, and IEC 62304 Software Life Cycle Process standard. Test results demonstrate conformance to applicable requirements specifications and assure hazard safeguards function properly.

Software design verification and design validation testing was conducted, and documentation is provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (May 2005). Electrical Safety and Electromagnetic Compatibility (EMC) testing was performed for the ProBeam 360° System Multiroom. The system conforms to FDA recognized consensus standards for electrical safety and electromagnetic compatibility.

No animal studies or clinical tests have been included in this submission.

#### IX. Determination of Substantial Equivalence to the Predicate Device

A subset of technological characteristics and features of the subject device differs from the predicate device. These differences are all considered to be enhancements of the predicate, which facilitate the compact, multi-room design of the subject device, ProBeam 360° System Multiroom.

The intended use and indications for use are the same as the predicate device. Further, there are no changes in the principle of operation of the devices. The Verification and Validation demonstrates that the device is as safe and effective as the predicate. Varian therefore believes the data demonstrates that the ProBeam 360° System v2.0 is substantially equivalent to the predicate device, ProBeam 360° System v1.0 (K221791).