(105 days)
No
The summary does not mention AI, ML, or related terms, and the description focuses on the physical components and standard radiation therapy principles.
Yes.
The device delivers radiation treatment for lesions, tumors, and conditions where radiation treatment is indicated, which is a therapeutic function.
No
The device is described as providing "protons for precision radiotherapy of lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated" and delivering "radiation treatment." This indicates it is a therapeutic device, not a diagnostic one.
No
The device description explicitly lists multiple hardware components (Cyclotron, Beam Transport System, Treatment Rooms, Treatment Control Room) and the performance studies mention hardware design verification and validation testing. This indicates it is a system with significant hardware components, not a software-only device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the ProBeam 360° Proton Therapy System provides protons for precision radiotherapy of lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated. This describes a therapeutic device that delivers radiation directly to the patient's body for treatment.
- Device Description: The description details a system with components like a Cyclotron, Beam Transport System, Treatment Rooms, and a Treatment Control Room. These are all components of a system designed to generate and deliver radiation for therapy.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not interact with or analyze such specimens.
The ProBeam 360° Proton Therapy System is a therapeutic medical device used for delivering radiation treatment, not an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
LHN
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
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
2D and image acquisition CBCT, nozzle mounted
Anatomical Site
anywhere in the body
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
October 6, 2023
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font size below it.
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).
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
2
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Image /page/3/Picture/1 description: The image shows the logo for Varian, a Siemens Healthineers Company. The word "varian" is written in a bold, sans-serif font. Below the logo is the text "A Siemens Healthineers Company" in a smaller font size.
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: 650-424-5369 E-mail: submissions.support@varian.com 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
4
Image /page/4/Picture/0 description: The image shows the logo for Varian, a Siemens Healthineers Company. The word "varian" is written in a bold, sans-serif font. Below the word "varian" is the text "A Siemens Healthineers Company" in a smaller font. The logo is in black and white.
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
5
Image /page/5/Picture/0 description: The image shows the word "varian" in a bold, sans-serif font. The letters are all lowercase and black. The word is centered in the image and takes up most of the space. The background is white.
A Siemens Healthineers Company
| Table 1. Comparison of Subject Device to ProBeam 360° System version 1.0 Predicate Device | ||||
|---|---|---|---|---|
| Device Characteristic | Predicate Device: | |||
| ProBeam 360° Proton Therapy | ||||
| System v1.0 | ||||
| K221791 | Subject Device: | |||
| ProBeam 360° Proton Therapy | ||||
| System v2.0 | Comparison | |||
| Intended Use/ 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. | ProBeam 360° Proton Therapy | |||
| System provides protons for | ||||
| precision radiotherapy of lesions, | ||||
| tumors, and conditions anywhere | ||||
| in the body where radiation | ||||
| 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 | ||||
| Beam Line | Beam line with steerer, | |||
| quadrupole, dipole and scanning | ||||
| magnets. | Beam line with steerer, | |||
| quadrupole, dipole and scanning | ||||
| magnets. | Same | |||
| Beam Transport | ||||
| System | Beam Ports | None | Beam Ports (assembly magnets, | |
| beam stop, and beam diagnostic) | Beam ports allow for | |||
| beam assignment to | ||||
| selected treatment | ||||
| room(s) in a multi-room | ||||
| configuration. Refer to | ||||
| Table 3 for comparison | ||||
| to reference device. | ||||
| Beam Angle Adjustment | Adjustable: Rotational type | |||
| isocentric 360° Gantry | Adjustable: Rotational type | |||
| isocentric 360° Gantry | Same | |||
| Beam Delivery | Beam Spot Scanning | Beam Spot Scanning | Same | |
| Beam Spot Shape | Spot size expressed as 1σ (sigma) | |||
| value of the gaussian profile of the | ||||
| beam in air at 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 | Spot size expressed as 1σ (sigma) | |||
| value of the gaussian profile of the | ||||
| beam in air at 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 | 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 | |||
| configuration | Two (2) to five (5) gantry rooms | Modular, configurable | ||
| system allows for | ||||
| multiple treatment | ||||
| rooms in one | ||||
| installation. Refer to | ||||
| Table 3 for comparison | ||||
| to reference device. | ||||
| Patient Positioning | Leoni Orion 6-AxisRobotic | |||
| Treatment Table (K160518) | Leoni Orion 6-AxisRobotic | |||
| Treatment Table (K160518) | Same | |||
| Maximum Load | 226 kg (500 lbs) | 226 kg (500 lbs) | Same |
6
Image /page/6/Picture/0 description: The image shows the word "Varian" in a bold, sans-serif font. The letters are black and closely spaced together. The image appears to be a logo or brand name.
A Siemens Healthineers Company
| Device Characteristic | Predicate Device:
ProBeam 360° Proton Therapy
System v1.0
K221791 | Subject Device:
ProBeam 360° Proton Therapy
System v2.0 | Comparison |
|-----------------------------------------|-----------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Patient Position Verification
System | 2D and image acquisition CBCT,
nozzle mounted | 2D and image acquisition CBCT,
nozzle mounted | Same |
| Image Acquisition | Functionality included in PVA /
Imaging Supervisor. 2D and CBCT
(3D) image acquisition. | Functionality included in PVA /
Imaging Supervisor. 2D and CBCT
(3D) image acquisition. | Same |
| Software | | | |
| Version | ProBeam 360° version 1.0 | ProBeam 360° version 2.0 | Support multi-room
configuration of the
system including the
Beam Scheduler. Refer
to Table 3 for
comparison to reference
device. |
| Beam Priority | Beam priority can be assigned to
the single treatment room | Beam priority is able to be
assigned and prioritized in each
treatment room prior to beam
delivery. | Substantially equivalent
to ProBeam 360° v1.0
(K221791) |
| Beam Scheduler | Beam request applies only to
single room | Beam request must be scheduled
among multi-room configuration
(2 to 5 treatment rooms) | Allows for beam
assignment to selected
treatment room(s) in
multi-room
configuration. Refer to
Table 3 for comparison
to reference device. |
| Network Connectivity | Remote Monitoring and Limited
Remote control | Remote Monitoring and Limited
Remote control | Same |
| 2D/3D Match | Integration of 2D/3D algorithm
into P2VA | Integration of 2D/3D algorithm
into P2VA | Same |
| CBCT Imaging | 3D CBCT reconstruction algorithm | 3D CBCT reconstruction
algorithm | Same |
| 3D/3D Match | 3D/3D registration algorithm for
patient setup | 3D/3D registration algorithm for
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
ProBeam Proton Therapy System v2.0
K133191 | Subject Device
ProBeam 360° Proton Therapy System
v2.0 | Comparison |
|---------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use /
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. | ProBeam 360° Proton Therapy System
v2.0 provides protons for precision
radiotherapy of lesions, tumors, and
conditions anywhere in the body where
radiation treatment is indicated. | Same as ProBeam PTS v2.0
(K133191) |
| Beam Delivery | | | |
| Beam Ports | 60-degree Beam Ports (assembly
magnets, beam stop, and beam
diagnostic) | 90-degree Beam Ports (assembly
magnets, beam stop, and beam
diagnostic) | Substantially the same as
ProBeam PTS v2.0
(K133191). The 90-degree
bend facilitates the smaller
footprint of the ProBeam
360° v2.0. |
| Physical Characteristics | | | |
7
Image /page/7/Picture/0 description: The image shows the logo for Varian, a Siemens Healthineers Company. The word "Varian" is written in a bold, sans-serif font. Below the word "Varian" is the text "A Siemens Healthineers Company" in a smaller font.
| Table 2. Comparison of Subject Device to Reference Device Multi-Room Configuration | |||
|---|---|---|---|
| ------------------------------------------------------------------------------------ | -- | -- | -- |
| Device Characteristic | Reference Device
ProBeam Proton Therapy System v2.0
K133191 | Subject Device
ProBeam 360° Proton Therapy System
v2.0 | Comparison |
|---------------------------------|----------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Treatment Room
Configuration | Two (2) to five (5) rotational type
isocentric gantry rooms; or fixed beam
rooms | Two (2) to five (5) rotational type
isocentric gantry rooms | Substantially the same as
ProBeam PTS v2.0
(K133191) for the gantry
room. Gantry rooms in the
ProBeam 360° System
have a smaller footprint. |
| Software | | | |
| Beam Scheduler | Beam request must be scheduled
among multi-room configuration (2 to 5
treatment rooms) | Beam request must be scheduled
among multi-room configuration (2 to 5
treatment rooms) | Same as ProBeam PTS v2.0
(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).