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

Device Description

The ProBeam 360° Proton Therapy System is a device that generates ionizing radiation (protons) in order to deliver radiation therapy in accordance with a predetermined treatment plan. The ProBeam 360° System version 1.0 is available in single-room, compact configuration and includes the following primary components: Cyclotron, Beam Transport System, Treatment Room with a rotating Gantry, Treatment Control Room.

AI/ML Overview

The provided text is a 510(k) Premarket Notification summary for the Varian ProBeam 360° Proton Therapy System. It details the device, its intended use, comparison to a predicate device, and a summary of performance testing.

However, it does not contain information about the acceptance criteria and the study that proves the device meets the acceptance criteria in the context of an AI/ML-driven medical device validation. The document explicitly states:

"No animal studies or clinical tests have been included in this pre-market submission."

This indicates that the submission relies on design verification and validation testing, conformance to standards, and comparison to a predicate device, rather than performance studies that would involve a test set, ground truth experts, MRMC studies, or standalone algorithm performance as typically found in AI/ML medical device submissions.

Therefore, I cannot extract the information required to answer your prompt points 1-9 from the provided text. The document describes a traditional medical device (a radiation therapy system), not an AI/ML device that requires validation of its diagnostic or predictive performance on a data set.

Summary

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December 1, 2022

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION".

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

Re: K221791

Trade/Device Name: ProBeam 360° Proton Therapy System Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: Class II Product Code: LHN Dated: October 28, 2022 Received: October 31, 2022

Dear Mr. 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 (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 located 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.

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 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see

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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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Lora D.Weidner -S	Digitally signed by LorD. Weidner -SDate: 2022.12.0119:38:07 -05'00'
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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

Enclosure

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Indications for Use

510(k) Number (if known) K221791

Device Name ProBeam 360° Proton Therapy System

Indications for Use (Describe)

The ProBeam 360° Proton Therapy System provides protons for precision radiotherapy of lesions, turnors, 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 1.0

K221791

l. Submitter's Name

Varian Medical Systems 3100 Hansen Way Palo Alto, CA 94304

Contact Name: Mr. Peter J. Coronado, Senior Director Regulatory Affairs Phone: 650-424-6320 | Fax: 650-646-9200 E-mail: submissions.support@varian.com Date Prepared: 18 June 2022

II. Device Information

Proprietary Name: ProBeam 360° Proton Therapy System version 1.0 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 Proton Therapy System v2.0 (K133191)

IV. Device Description

The ProBeam 360° Proton Therapy System is a device that generates ionizing radiation (protons) in order to deliver radiation therapy in accordance with a predetermined treatment plan.

The ProBeam 360° System version 1.0 is available in single-room, compact configuration and includes the following primary components:

Cyclotron
Beam Transport System ●
Treatment Room with a rotating Gantry
Treatment Control Room

V. 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.

VI. Comparison of Technological Characteristics with the Predicate Device

At a high-level, the subject device differs from the predicate device as a result of the following characteristics:

Smaller Gantry
. Compact single Gantry room configuration
Compact Beam Transport System ●

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Reduced-Energy Cyclotron ●
. Patient Positioning Robot
CBCT acquisition
Updated Software Release to support changes listed above ●

Table 1. Comparison of Subject Device to Predicate Device

Device	Predicate Device:	Subject Device:	Comparison
Characteristic	ProBeam Proton Therapy System(K133191)	ProBeam 360° Proton TherapySystem
Intended Use/Indications for Use	ProBeam Proton Therapy Systemprovides protons for precisionradiotherapy of lesions, tumors, andconditions anywhere in the bodywhere radiation treatment isindicated.	ProBeam 360° Proton Therapy Systemprovides protons for precisionradiotherapy of lesions, tumors, andconditions anywhere in the body whereradiation 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	250 MeV	226 MeV	Energy reduced cyclotron toallow compact Gantry design.Substantially equivalent toProBeam K133191
Nominal Energy	70 MeV – 240 MeV	69 MeV – 218 MeV	Reduced maximum beam energyto allow compact Gantry design.Substantially equivalent toProBeam K133191
Beam Delivery
Beam TransportSystem	Standard beam optical system withquadrupoles and dipole magnets	Standard beam optical system withquadrupoles and dipole magnets	Same
Switching System	Yes	None	Single Room system does notrequire room switching capabilityas compared to multi-roomsystem ProBeam K133191.
Beam TransportMagnets	Yes	Yes	Same
Beam AngleAdjustment	Adjustable: Rotating Isocentric GantryroomsFixed: Fixed Beam Room	Adjustable: Rotating Isocentric Gantryroom	Same as Adjustable in ProBeamK133191
Beam Delivery	Beam Spot Scanning	Beam Spot Scanning	Same
Beam Spot Shape	Spot size expressed as 1σ (sigma)value of the gaussian profile of thebeam in air at isocenter:$σ$ = 4.0 mm ± 15% at 240 MeV$σ$ = 4.0 mm ± 15% at 140 MeV$σ$ = 5.4 mm ± 15% at 70 MeV	Spot size expressed as 1σ (sigma) valueof the gaussian profile of the beam in airat isocenter:$σ$ = 3.8 mm ± 15% at 218 MeV$σ$ = 4.4 mm ± 15% at 140 MeV$σ$ = 5.9 mm ± 15% at 69 MeV	Substantially the same beamcharacteristics as ProBeamK133191.
Beam Field Size	Max: 30cm (x) x 40cm (y)	Max: 25cm (x) x 25cm (y)	Reduced field size as comparedto ProBeam K133191.
Dose Rate	2 Gy/l/min	2 Gy/l/min	Same
Physical Characteristics
Treatment RoomConfiguration	Multi-Room	Single Gantry Room Compactconfiguration	Allows installation in buildingwith small footprint. SingleGantry room is substantiallyequivalent to Rotating Isocentric
DeviceCharacteristic	Predicate Device:ProBeam Proton Therapy System(K133191)	Subject Device:ProBeam 360° Proton TherapySystem	Comparison
Patient Positioning	Forte 6-AxisRobotic Treatment Table(K122413)	Leoni Orion 6-AxisRobotic TreatmentTable (K160518)	Substantially equivalent
Maximum Load	273 Kg (550lbs)	226 kg (500 lbs)	New patient positioning systemas cleared in K160518 supportsup to 226 kg.
Patient PositionVerification System	2D image acquisition, wall-mountedor nozzle mounted	2D image acquisition and CBCT, nozzlemounted	Adapted from reference device toallows for 3D image CBCT. Nozzlemounted same as predicateProBeam K133191.
Image Acquisition	Functionality included in P2VA /Imaging Supervisor. Limited to 2Dimage acquisition.	Functionality included in PVA / ImagingSupervisor. 2D and CBCT (3D) imageacquisition.	Allows for 3D image CBCT. Seetable 2 for comparison toreference device.
Version	Version 2.0	ProBeam 360° version 1.0	Supports changes for compactGantry, patient positioning table,and operating system updates.
NetworkConnectivity	None	Remote Monitoring and Limited Remotecontrol	Remote network connectivityenables the Varian servicetechnicians to perform remoteservice activities.
2D/3D Match	Integration of 2D/3D algorithm intoP2VA	Integration of 2D/3D algorithm intoP2VA	Same
CBCT Imaging	None	3D CBCT reconstruction algorithm	Allows for 3D image CBCT. Seetable 2 for comparison toreference device.
3D/3D Match	Not included	3D/3D registration algorithm forpatient setup	Allows for 3D image CBCT. Seetable 2 for comparison toreference device

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varian

A Siemens Healthineers Company

Table 1. Comparison of Subject Device to Predicate Device

Table 2. Comparison of Subject Device to Reference Device

Device Characteristic	Reference Device:TrueBeam System(K123291)	Subject Device:ProBeam 360 Proton TherapySystem	Comparison
Imaging
Patient Position	3D CBCT	3D CBCT	Same
Verification System
Image Acquisition	Functionality included in PVA/Imaging Supervisor	Functionality included in PVA/ ImagingSupervisor	Same
CBCT Imaging	3D CBCT reconstructionalgorithm	3D CBCT reconstruction algorithm	Same
3D/3D Match	3D/3D registration algorithm forpatient setup	3D/3D registration algorithm forpatient setup	Same

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VII. Summary of Performance Testing (Non-Clinical Testing)

Design verification and design validation testing demonstrates that the ProBeam 360° System v1.0 performs as intended and meets its essential performance defined as: the functionality enabling its intended use to deliver the radiation dose as prescribed for treatment.

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 showed conformance to applicable requirements specifications and assured hazard safeguards functioned properly. Software design verification and design validation testing were conducted, and documentation was 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."

Electrical safety and electromagnetic compatibility (EMC) testing were performed for the ProBeam 360° System. 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 pre-market submission.

VIII. 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, single-room design of the subject device, ProBeam 360° System.

The Intended Use and indications for use are substantially 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 v1.0 is substantially equivalent to the predicate device, ProBeam Proton Therapy System v.2.0 (K133191).

Regulation Number and Section

§ 892.5050 Medical charged-particle radiation therapy system.

(a)
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.(b)
Classification. Class II. When intended for use as a quality control system, the film dosimetry system (film scanning system) included as an accessory to the device described in paragraph (a) of this section, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.