(105 days)
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 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.
The provided FDA 510(k) summary for the ProBeam 360° Proton Therapy System v2.0 (Multiroom) does not include specific acceptance criteria and detailed study results in the manner requested.
Instead, the document focuses on demonstrating substantial equivalence to a predicate device (ProBeam 360° Proton Therapy System v1.0, K221791) and a reference device (ProBeam Proton Therapy System v2.0, K133191). The study described is a design verification and validation process, rather than a clinical trial or performance study with defined statistically-based acceptance criteria against a specific benchmark.
Here's a breakdown of what can and cannot be extracted from the provided text according to your request:
Acceptance Criteria and Device Performance Study for ProBeam 360° Proton Therapy System v2.0 (Multiroom)
The ProBeam 360° Proton Therapy System v2.0 (Multiroom) primarily underwent design verification and validation testing to demonstrate that it performs as intended and meets its essential performance, confirming its substantial equivalence to previously cleared devices. The document does not specify quantitative acceptance criteria for performance metrics (such as sensitivity, specificity, accuracy) typically associated with medical device studies, nor does it provide a table of measured device performance against such criteria. The "performance" described is in the context of functionality and safety.
1. Table of Acceptance Criteria and Reported Device Performance
| Criterion Category | Acceptance Criterion (Infered/General) | Reported Device Performance (General) |
|---|---|---|
| Functionality | Device operates as intended to deliver proton radiation. | Design verification and validation testing performed; device "performs as intended and meets its essential performance." |
| Safety | Conformance to safety standards; proper hazard safeguards. | Conforms to FDA recognized consensus standards for electrical safety and electromagnetic compatibility. Hazard safeguards function properly. |
| Software | Software functions correctly and supports new configurations (multi-room, beam scheduling). | Software design verification and design validation testing conducted; supports multi-room configuration and Beam Scheduler. |
| System Integration | Integration of new components and configurations (e.g., beam ports, treatment room configuration, beam scheduler) functions correctly. | The multi-room configuration with beam ports and updated software has been verified and validated to operate correctly. |
| Regulatory Compliance | Compliance with relevant QMS, risk management, and software lifecycle standards. | Adheres to 21 CFR §820, ISO 13485, ISO 14971, and IEC 62304 standards. |
| Equivalence | Substantially equivalent to predicate device and reference device. | Achieved substantial equivalence to ProBeam 360° Proton Therapy System v1.0 (K221791) and ProBeam Proton Therapy System v2.0 (K133191). |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a "sample size" in terms of patient data or clinical cases for a test set. The testing described is non-clinical design verification and validation testing of the system components and software. This typically involves engineering tests, simulations, and hardware/software testing rather than patient data. Therefore, details regarding country of origin or retrospective/prospective nature are not applicable to the described non-clinical testing.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not provided in the document. As the described testing is non-clinical design verification and validation, the concept of "ground truth" as established by experts (e.g., clinicians) in the context of diagnostic accuracy or treatment efficacy is not directly relevant. The "ground truth" for these engineering tests would be the design specifications and expected functional behavior, which are internally verified by the manufacturer's engineers.
4. Adjudication Method for the Test Set
This information is not provided in the document. The adjudication method (e.g., 2+1, 3+1) is typically used in studies where human readers independently assess cases, and their discrepancies are resolved. This is not applicable to the non-clinical design verification and validation testing described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed, or at least not described in this 510(k) summary. The submission explicitly states: "No animal studies or clinical tests have been included in this submission." This type of study would involve human readers (possibly with and without AI assistance) evaluating clinical cases, which is not what was conducted for this submission.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
A standalone performance study of an algorithm in a clinical context (e.g., diagnostic accuracy for a specific disease) was not performed, or at least not described in this 510(k) summary. The device described is a proton therapy system, not typically a diagnostic AI algorithm. While software is a component, its performance testing is framed within system functionality and safety, not as an isolated algorithm performance study against clinical ground truth.
7. Type of Ground Truth Used
The ground truth for the non-clinical design verification and validation testing would be the engineering specifications, design requirements, and recognized industry standards (e.g., electrical safety, electromagnetic compatibility). These are validated through a series of tests to ensure the device performs according to its design and regulatory requirements. Clinical ground truth (e.g., pathology, outcomes data) was not used, as no clinical studies were submitted.
8. Sample Size for the Training Set
This information is not applicable/not provided. The document describes a medical device (proton therapy system), not an AI model that requires a "training set" of data in the typical machine learning sense. The software development follows a lifecycle process (IEC 62304) and involves verification and validation, but not training on a dataset of clinical cases.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable/not provided, for the same reason as in point 8. No "training set" in the context of machine learning was used or described.
In summary: The provided document is an FDA 510(k) summary for a hardware-based medical device (a proton therapy system) with associated software. The "study" it describes is the design verification and validation process to demonstrate the device's safety and effectiveness compared to existing, cleared devices, rather than a clinical performance study with specific quantitative acceptance criteria and clinical outcome measures.
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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).
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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 (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
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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)
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."
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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
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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:ProBeam 360° Proton TherapySystem v1.0K221791 | Subject Device:ProBeam 360° Proton TherapySystem v2.0 | Comparison | |
| Intended Use/ Indications forUse | ProBeam 360° Proton TherapySystem provides protons forprecision radiotherapy of lesions,tumors, and conditions anywherein the body where radiationtreatment is indicated. | ProBeam 360° Proton TherapySystem provides protons forprecision radiotherapy of lesions,tumors, and conditions anywherein the body where radiationtreatment 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 | ||||
| GantryBeam Line | Beam line with steerer,quadrupole, dipole and scanningmagnets. | Beam line with steerer,quadrupole, dipole and scanningmagnets. | Same | |
| Beam TransportSystem | Beam Ports | None | Beam Ports (assembly magnets,beam stop, and beam diagnostic) | Beam ports allow forbeam assignment toselected treatmentroom(s) in a multi-roomconfiguration. Refer toTable 3 for comparisonto reference device. |
| Beam Angle Adjustment | Adjustable: Rotational typeisocentric 360° Gantry | Adjustable: Rotational typeisocentric 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 thebeam 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 thebeam 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 Compactconfiguration | Two (2) to five (5) gantry rooms | Modular, configurablesystem allows formultiple treatmentrooms in oneinstallation. Refer toTable 3 for comparisonto reference device. | |
| Patient Positioning | Leoni Orion 6-AxisRoboticTreatment Table (K160518) | Leoni Orion 6-AxisRoboticTreatment 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:ProBeam 360° Proton TherapySystem v1.0K221791 | Subject Device:ProBeam 360° Proton TherapySystem v2.0 | Comparison |
|---|---|---|---|
| Patient Position VerificationSystem | 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-roomconfiguration of thesystem including theBeam Scheduler. Referto Table 3 forcomparison to referencedevice. |
| Beam Priority | Beam priority can be assigned tothe single treatment room | Beam priority is able to beassigned and prioritized in eachtreatment room prior to beamdelivery. | Substantially equivalentto ProBeam 360° v1.0(K221791) |
| Beam Scheduler | Beam request applies only tosingle room | Beam request must be scheduledamong multi-room configuration(2 to 5 treatment rooms) | Allows for beamassignment to selectedtreatment room(s) inmulti-roomconfiguration. Refer toTable 3 for comparisonto reference device. |
| Network Connectivity | Remote Monitoring and LimitedRemote control | Remote Monitoring and LimitedRemote control | Same |
| 2D/3D Match | Integration of 2D/3D algorithminto P2VA | Integration of 2D/3D algorithminto P2VA | Same |
| CBCT Imaging | 3D CBCT reconstruction algorithm | 3D CBCT reconstructionalgorithm | Same |
| 3D/3D Match | 3D/3D registration algorithm forpatient setup | 3D/3D registration algorithm forpatient 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 DeviceProBeam Proton Therapy System v2.0K133191 | Subject DeviceProBeam 360° Proton Therapy Systemv2.0 | Comparison |
|---|---|---|---|
| Intended Use /Indications for Use | ProBeam Proton Therapy Systemprovides protons for precisionradiotherapy of lesions, tumors, andconditions anywhere in the body whereradiation treatment is indicated. | ProBeam 360° Proton Therapy Systemv2.0 provides protons for precisionradiotherapy of lesions, tumors, andconditions anywhere in the body whereradiation treatment is indicated. | Same as ProBeam PTS v2.0(K133191) |
| Beam Delivery | |||
| Beam Ports | 60-degree Beam Ports (assemblymagnets, beam stop, and beamdiagnostic) | 90-degree Beam Ports (assemblymagnets, beam stop, and beamdiagnostic) | Substantially the same asProBeam PTS v2.0(K133191). The 90-degreebend facilitates the smallerfootprint of the ProBeam360° v2.0. |
| Physical Characteristics |
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| Table 2. Comparison of Subject Device to Reference Device Multi-Room Configuration | |||
|---|---|---|---|
| ------------------------------------------------------------------------------------ | -- | -- | -- |
| Device Characteristic | Reference DeviceProBeam Proton Therapy System v2.0K133191 | Subject DeviceProBeam 360° Proton Therapy Systemv2.0 | Comparison |
|---|---|---|---|
| Treatment RoomConfiguration | Two (2) to five (5) rotational typeisocentric gantry rooms; or fixed beamrooms | Two (2) to five (5) rotational typeisocentric gantry rooms | Substantially the same asProBeam PTS v2.0(K133191) for the gantryroom. Gantry rooms in theProBeam 360° Systemhave a smaller footprint. |
| Software | |||
| Beam Scheduler | Beam request must be scheduledamong multi-room configuration (2 to 5treatment rooms) | Beam request must be scheduledamong multi-room configuration (2 to 5treatment 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).
§ 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.