TrueBeam, TrueBeam STx, Edge, VitalBeam
Device Facts
| Record ID | K213977 |
|---|---|
| Device Name | TrueBeam, TrueBeam STx, Edge, VitalBeam |
| Applicant | Varian Medical Systems, Inc. |
| Product Code | IYE · Radiology |
| Decision Date | Jun 3, 2022 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.5050 |
| Device Class | Class 2 |
| Attributes | Therapeutic, Pediatric |
Indications for Use
The TrueBeam, TrueBeam STx, and Edge Systems are intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body where radiation therapy is indicated for adults and pediatric patients. The VitalBeam system is intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body where radiation therapy is indicated for adults and pediatric patients.
Device Story
Medical linear accelerator delivering therapeutic radiation for stereotactic radiosurgery and precision radiotherapy. Inputs include physician-prescribed treatment plans; system uses X-ray/electron beams for treatment and kV/MV imaging for patient positioning/verification. Operates via integrated console; features include respiratory gating, automated couch positioning, and MLC beam shaping. Used in clinical radiation therapy departments by physicians, therapists, and technicians. Enhancements in v3.0 include Windows 10 OS, isocentric parameterization, unplanned treatment mode, imaging-only sessions, and improved iCBCT reconstruction (modified McKinnon-Bates algorithm). Output is controlled radiation dose to target tissue; enables precise tumor treatment while sparing healthy tissue.
Clinical Evidence
Bench testing only. Verification and validation testing conducted per 21 CFR 820, ISO 13485, and ISO 14971. Electrical safety and EMC testing per IEC 60601-1 and 60601-1-2. Human factors validation per IEC 62366. No clinical data presented.
Technological Characteristics
Medical linear accelerator; photon/electron beam energy source. Features 120-leaf or HD120 MLC. Connectivity via DICOM RT/3.0, ADI v2.0/3.0. Software runs on Windows 10. Standards: IEC 60601-1, IEC 60601-2-1, IEC 60601-2-68, IEC 62304, IEC 62366, ISO 10993-1.
Indications for Use
Indicated for adults and pediatric patients requiring stereotactic radiosurgery or precision radiotherapy for lesions, tumors, and conditions including brain/spine tumors, head/neck cancers, thoracic, gynecologic, gastrointestinal, genitourinary, breast, sarcomas, lymphoid tumors, skin cancers, benign diseases (e.g., AVM, trigeminal neuralgia), and metastases.
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
Submission Summary (Full Text)
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Image /page/0/Picture/0 description: The image shows 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 in blue, with the words "U.S. FOOD & DRUG ADMINISTRATION" in blue as well. The FDA is a federal agency responsible for regulating and supervising the safety of food, drugs, and other products.
Varian Medical Systems, Inc. % Mr. Peter Coronado Sr. Director, Regulatory Affairs 3100 Hansen Way PALO ALTO CA 94304
Re: K213977
Trade/Device Name: TrueBeam™, TrueBeam STxTM, Edge™, VitalBeam Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: Class II Product Code: IYE Dated: May 5, 2022 Received: May 6, 2022
Dear Mr. 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,
Julie Sullivan, Ph.D. Assistant Director DHT 8C: 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) K213977
Device Name TrueBeam, TrueBeam STx, Edge, VitalBeam
Indications for Use (Describe) TrueBeam-TrueBeam STx-Edge:
The TrueBeam, TrueBeam STx, and Edge Systems are intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere radiation therapy is indicated for adults and pediatric patients.
The TrueBeam, TrueBeam STx, and Edge Systems may be used in the delivery of radiation for treatment that includes: brain and spine tumors (such as glioma, meningioma, craniopharyngioma, pituitary tumors, spinal cord tumors, hemangioblastoma, orbital tumors, ocular tumors, optic nerve tumors, and skull based tumors), head and neck tumors (such as unknown primary of the head and neck, oral cavity, hypopharynx, nasopharynx, sinonasal, salivary gland, and thyroid cancer), thoracic turnors (such as lung cancer, esophageal cancer, thymic tumors, and mesothelioma), gynecologic tumors (such as ovarian, cervical, endometrial, vulvar, and vaginal), gastrointestinal tumors (such as gastric, pancreatic, hepatobiliary, colon, rectal, and anal carcinoma), genitourinary tumors (such as prostate, bladder, testicular, and kidney), breast turnors, sarcomas, lymphoid tumors (such as Hodgkin's and non-Hodgkin's lymphoma), skin cancers (such as squamous cell, basal cell, and melanoma), benign diseases (such as schwannoma, arteriovenous malformation, cavernous malformation, trigeminal neuralgia, chordoma, glomus tumors, and hemangiomas), metastasis (including all parts of the body such as brain, bone, liver, lung, kidney, and skin) and pediatric tumors (such as glioma, ependymoma, pituitary tumors, hemangioblastoma, meningioma, metastasis, medulloblastoma, nasopharyngeal tumors, arteriovenous malformation, and skull base tumors).
# VitalBeam:
VitalBeam® is intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body where radiation therapy is indicated for adults and pediatric patients.
VitalBeam may be used in the delivery of radiation for treatment that includes: brain and spine tumors (such as glioma. meningioma, craniopharyngioma, pituitary tumors, spinal cord tumors, hemangioblastoma, orbital tumors, optic nerve tumors, and skull based tumors), head and neck tumors primary of the head and neck, oral cavity, hypopharynx, larynx, oropharynx, sinonasal, salivary gland, and thyroid cancer), thoracic tumors (such as lung cancer, esophageal cancer, thymic tumors, and mesothelioma), gynecologic tumors (such as ovarian, cervical, endometrial, vulvar, and vaginal), gastrointestinal tumors (such as gastric, pancreatic, hepatobiliary, colon, rectal, and anal carcinoma), genitourinary tumors (such as prostate, bladder, testicular, and kidney), breast tumors, sarcomas, lymphoid tumors (such as Hodgkin's and non-Hodgkin's lymphoma), skin cancers (such as squamous cell, basal cell, and melanoma), benign diseases (such as schwannoma, arteriovenous malformation, trigeminal neuralgia, chordoma, glomus tumors, and hemangiomas), metastasis (including all parts of the body such as brain, bone, liver, lung, kidney, and skin) and pediatric tumors (such as elioma, evendymoma, pituitary tumors. hemangioblastoma, craniopharyngioma, metastasis, medulloblastoma, nasopharyageal tumors, arteriovenous malformation, cavernous malformation, and skull base tumors).
Type of Use (Select one or both, as applicable)
X 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 TrueBeam and VitalBeam Radiotherapy Treatment System
# The following information follows the format of 21 CFR 807.92
| Submitter's Name: | Varian Medical Systems<br>3100 Hansen Way, m/s E110<br>Palo Alto CA94304 |
|-------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Primary Contact Person: | Peter J. Coronado<br>Sr. Director Regulatory Affairs<br>Phone: (650) 424.6320<br>Fax: (650) 646.9200<br>E-mail: submissions.support@varian.com |
| Date Prepared: | 17 December 2021 |
| Proprietary Name: | TrueBeam™ /TrueBeam STx™/Edge™/VitalBeam |
| Classification Name: | Medical charged-particle radiation therapy system |
| Regulation: | 21CFR892.5050 |
| Regulatory Class | Class II |
| Product Code: | IYE |
| Common/Usual Name: | Linear accelerator radiation therapy system |
| Predicate Devices: | TrueBeam Radiotherapy System and Accessories |
| Device Description: | The TrueBeam and VitalBeam Radiotherapy System is a medical linear<br>accelerator that delivered therapeutic radiation to patient in accordance<br>with the physician's prescription. |
| Intended Use | The intended use is the same as the predicate. |
| | TrueBeam-TrueBeam STx-Edge:<br>The TrueBeam™ radiotherapy delivery system is intended to provide<br>stereotactic radiosurgery and precision radiotherapy for lesions, tumors,<br>and conditions anywhere in the body where radiation treatment is<br>indicated. |
| | VitalBeam:<br>The VitalBeam system is intended to provide stereotactic radiosurgery and<br>precision radiotherapy for lesions, tumors, and conditions anywhere in the<br>body where radiation treatment is indicated. |
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#### TrueBeam-TrueBeam STx-Edge:
The TrueBeam™, TrueBeam STx and Edge™ Systems are intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body where radiation therapy is indicated for adults and pediatric patients.
The TrueBeam, TrueBeam STx and Edge Systems may be used in the delivery of radiation for treatment that includes: brain and spine tumors (such as glioma, meningioma, craniopharyngioma, pituitary tumors, spinal cord tumors, hemangioblastoma, orbital tumors, ocular tumors, optic nerve tumors, and skull based tumors), head and neck tumors (such as unknown primary of the head and neck, oral cavity, hypopharynx, larynx, oropharynx, nasopharynx, sinonasal, salivary gland, and thyroid cancer), thoracic tumors (such as lung cancer, esophageal cancer, thymic tumors, and mesothelioma), gynecologic tumors (such as ovarian, cervical, endometrial, vulvar, and vaginal), gastrointestinal tumors (such as gastric, pancreatic, hepatobiliary, colon, rectal, and anal carcinoma), genitourinary tumors (such as prostate, bladder, testicular, and kidney), breast tumors, sarcomas, lymphoid tumors (such as Hodgkin's and non-Hodgkin's lymphoma), skin cancers (such as squamous cell, basal cell, and melanoma), benign diseases (such as schwannoma, arteriovenous malformation, cavernous malformation, trigeminal neuralgia, chordoma, glomus tumors, and hemangiomas), metastasis (including all parts of the body such as brain, bone, liver, lung, kidney, and skin) and pediatric tumors (such as glioma, ependymoma, pituitary tumors, hemangioblastoma, craniopharyngioma, meningioma, metastasis, medulloblastoma, nasopharyngeal tumors, arteriovenous malformation, cavernous malformation, and skull base tumors).
#### VitalBeam:
VitalBeam® is intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body where radiation therapy is indicated for adults and pediatric patients.
VitalBeam may be used in the delivery of radiation for treatment that includes: brain and spine tumors (such as glioma, meningioma, craniopharyngioma, pituitary tumors, hemangioblastoma, orbital tumors, ocular tumors, optic nerve tumors, and skull based tumors), head and neck tumors (such as unknown primary of the head and neck, oral cavity, hypopharynx, larynx, oropharynx, nasopharynx, sinonasal, salivary gland, and thyroid cancer), thoracic tumors (such as lung cancer, esophageal cancer, thymic tumors, and mesothelioma), gynecologic tumors (such as ovarian, cervical, endometrial, vulvar, and vaginal), gastrointestinal tumors (such as gastric, pancreatic, hepatobiliary, colon, rectal, and anal carcinoma), genitourinary tumors (such as prostate, bladder, testicular, and kidney), breast tumors, sarcomas, lymphoid tumors (such as Hodgkin's and non-Hodgkin's lymphoma), skin cancers (such as squamous cell, basal cell, and melanoma), benign diseases as schwannoma, arteriovenous malformation, (such cavernous malformation, trigeminal neuralgia, chordoma, glomus tumors, and hemangiomas), metastasis (including all parts of the body such as brain, bone, liver, lung, kidney, and skin) and pediatric tumors (such as glioma, ependymoma, pituitary tumors, hemangioblastoma, craniopharyngioma, meningioma, metastasis, medulloblastoma, nasopharyngeal tumors, arteriovenous malformation, cavernous malformation, and skull base tumors).
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## Significant Changes:
Summary of Technological
Characteristics:
The significant changes in the subject device compared with the predicate device are:
- A Operating System update from Windows 7 to Windows 10
- A Isocentric Parameterization
- A Unplanned treatment mode
- A Imaging only session
- A iCBCT Improvements (Improvements were made to both reconstruction algorithm and hardware accelerator. Notably a modified version of the McKinnon-Bates algorithm for improved 4D CBCT)
Both subject device and the predicate device contain the same technological characteristics and functional scientific technology to deliver radiation therapy and stereotactic radiosurgery by authorized medical practitioners. A subset of technological characteristics and features of the current device is different to the predicate. These differences are all enhancements of the predicate. The Intended Use and indications for use are unchanged. There are no changes in the principle of operation of the device. The biocompatibility of patient-contacting components remains the same as the predicate device. The results of the verification, validation and safety standards testing demonstrates that there are no changes to the safety profile of the device.
The feature comparison chart below shows the difference between predicate and subject device. The features in Blue text in table below are new to the subject device.
| Feature | Predicate Device<br>TrueBeam and<br>VitalBeam v2.7<br>(K171733 and<br>K172013) | Subject Device<br>TrueBeam-<br>TrueBeamSTx-Edge and<br>VitalBeam v3.0 |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------|-----------------------------------------------------------------------|
| Intended Use:<br>The TrueBeam® system is intended to provide stereotactic<br>radiosurgery and precision radiotherapy for lesions, tumors, and<br>conditions anywhere in the body where radiation treatment is<br>indicated.<br>The VitalBeam system is intended to provide stereotactic radiosurgery<br>and precision radiotherapy for lesions, tumors, and conditions<br>anywhere in the body where radiation treatment is indicated. | Yes | Yes |
| Software Operating System | Windows 7 | Windows 10 |
| Treatment Techniques | | |
| Feature | Predicate Device<br>TrueBeam and<br>VitalBeam v2.7<br>(K171733 and<br>K172013) | Subject Device<br>TrueBeam-<br>TrueBeamSTx-Edge and<br>VitalBeam v3.0 |
| Basic integral treatment techniques include static photon, static aperture photon arc, and dynamic conformal arc. Additional treatment techniques include static electron and electron arc, IMRT/IMRS, RapidArc and VMAT, Total Body treatments (photon and electron). All photon treatment delivery techniques can be delivered under respiratory gating conditions. Fully automated treatment delivery | Yes | Yes |
| Unicode | Yes | Yes |
| Jaw tracking, Trajectory logs, RDSR & Smart connect | Yes | Yes |
| Automated Dynamic Beam (aka ADB /4Pi / Hyperarc) | Yes | Yes |
| Enlarged Bounding Box (w/in HyperArcTM) | Yes | Yes |
| Treatment Energy used 6-16 MV (BJR-17), 6-22 MeV | Yes | Yes |
| Treatment Energy used 4-25MV (BJR 17), 6-22 MeV | Yes | Yes |
| 6x FFF (High Intensity Mode) | Yes | Yes |
| 10x FFF (High Intensity Mode) | Yes | Yes |
| Varied Dose rate throughout arc travel -<br>Dose rate RT: Up to 600 MU/min<br>High dose rate: Up to 2400 MU/min | Yes | Yes |
| Varied gantry rotation speed throughout arc travel | Yes | Yes |
| Arc treatment Control points between two and 500; segments allowed<br>with zero dose; allowed respiratory gating | Yes | Yes |
| Isocenter ≤1.5 mm for all three rotational axes | Yes | Yes |
| Single Isocenter Multiplan | Yes | Yes |
| LaserGuard II Gantry Collision Detection System | Yes | Yes |
| Couch | | |
| Treatment Couch Motions | | |
| Small, corrective motions and large planned or targeted motions for couch longitudinal, lateral, vertical & rotational axes (4DoF). | Yes | Yes |
| Feature | Predicate Device<br>TrueBeam and<br>VitalBeam v2.7<br>(K171733 and<br>K172013) | Subject Device<br>TrueBeam-<br>TrueBeamSTx-Edge and<br>VitalBeam v3.0 |
| MLC, collimator rotation), couch translation and rotation for<br>patient set up and treatment delivery.<br>Local (in treatment room) couch motion control for manual<br>positioning and automated positioning to plan values. Tx Plans pre-treatment QA (incl. exceeding pre-defined dose<br>limits) | Yes | Yes |
| Delta Couch automated patient alignment shifts (Delta Couch<br>Shift). (Varian Treatment Couch) – Linear Encoder | Yes | Yes |
| Qfix kVue One Couch Top: s/w support only + MPC support | Yes | Yes |
| Perfect Pitch – automated corrective motion for pitch and roll axes (6<br>degrees of freedom) | Yes | Yes |
| Treatment application recognizes common isocenter within and across<br>plans then applies couch corrections to the common isocenter. | Yes | Yes |
| Integrated Treatment and Imaging Console | | |
| External beam: X-ray & ELECTRON plus PHOTON beam for SRS/SRT<br>delivery | Yes | Yes |
| Electron Energies: 7MeV & 11MeV | Yes | Yes |
| Coplanar, Non-coplanar, Arc fields | Yes | Yes |
| Beam shaping f(x): Dynamic wedges, Asymmetric collimators | Yes | Yes |
| Conical Collimator Verification (Varian ICVI) | Yes | Yes |
| Recognized patient-specific accessories: Electron Beam Collimators,<br>Poured Blocks, Compensators, Physical wedges | Yes | Yes |
| Patient ID (bar code label) verification & Custom accessory verification<br>(VVS compatibility) Patient selection from queue provided by the schedule Selected patient plan retrieval from info system Electronically send Plan setup data to linac | Yes | Yes |
| VVS - CV (Varian Verification System, conical Cone Verification)<br>compatibility | Yes | Yes |
| Set up verification & beam prevention if setup does not match Tx plan | Yes | Yes |
| Manual bolus verification | Yes | Yes |
| Override treatment parameters based on user rights and permit<br>current session delivery only | Yes | Yes |
| Feature | Predicate Device<br>TrueBeam and<br>VitalBeam v2.7<br>(K171733 and<br>K172013) | Subject Device<br>TrueBeam-<br>TrueBeamSTx-Edge and<br>VitalBeam v3.0 |
| HET console electronically sends Plan setup data to the HET system<br>supervisor | Yes | Yes |
| Access to MLC shape editing | Yes | Yes |
| Graphical display/editing of field parameters | Yes | Yes |
| Auto sequencing of fields for the selected patient | Yes | Yes |
| • Record treatment delivery results<br>• Send History to InfoSys archive in patient record | Yes | Yes |
| Interfaces:<br>• DICOM RT/3.0 data and image import/export capability;<br>• ADI v2.0 and v3.0 | Yes | Yes |
| ADI 3.0 (6DOF wit Brainlab Interoperability) | Yes | Yes |
| Motion Management Interface | Yes | Yes |
| Multi-leaf Collimator | | |
| 120-Leaf MLC | | |
| Maximum field sizes for 120 MLC: | | |
| Static field size: 40cm x 40cm. | Yes | Yes |
| Static aperture field size: 30cm x 40cm | | |
| IMRT field size: 34 cm x 40 cm | | |
| HD120 MLC | | |
| Maximum field sizes for HD120 MLC: | | |
| Static field size (MLC retracted): 40cm x 40 cm | Yes | Yes |
| Static aperture field size: 30cm x 22cm | | |
| IMRT field size: 34 cm x 22 cm | | |
| Imaging Techniques | | |
| MV Photon Imager Component | Yes | Yes |
| Reference Image Feature (Structure, Field Edges, Digital graticule) | Yes | Yes |
| Portal Image Matching: (Matching Common Features, Match Field<br>Edges Plot, Matched Structures and Field Edges, Related Images,<br>Double Exposure, ROI, couch shift values, respiratory-gated image | Yes | Yes |
| Feature | Predicate Device<br>TrueBeam and<br>VitalBeam v2.7<br>(K171733 and<br>K172013) | Subject Device<br>TrueBeam-<br>TrueBeamSTx-Edge and<br>VitalBeam v3.0 |
| acquisition, marker matching and portal dosimetry image acquisition.) | | |
| Low X imaging energy for high contrast portal imaging | Yes | Yes |
| kV Photon Imager Component | Yes | Yes |
| Integrated Component: MV Imager w/photon imaging:<br>43 x 43 imager | Yes | Yes |
| Proximity detection: | | |
| Touch guards on kV source, kV detector, positioning units with addition<br>of supplemental capacitive collision detection system (kV CCDS) on kV<br>source | Yes | Yes |
| Type of digital image produced: | | |
| • Digital radiographs, fluoroscopic image frames, cone-beam CT<br>image projections, respiratory-gated radiographs, respiration-<br>synchronized fluoroscopic image frames | Yes | Yes |
| • Offline 4D CBCT image projections | Yes | Yes |
| • Offline Multi-scan CBCT images | Yes | Yes |
| • 2D-3D Match | Yes | Yes |
| • Gated CBCT<br>• Online 4D CBCT and Extended CBCT<br>• Short Arc CBCT | Yes | Yes |
| • Iterative CBCT (iCBCT)<br>• Automatic Exposure Control (AEC) | Yes | Yes |
| • Iterative CBCT (iCBCT - includes pelvis large and image gently) | Yes | Yes |
| • iCBCT improvements (Improvement to the iCBCT algorithm,<br>for when the patient's outer contour is changing during a CT<br>scan.) | No | Yes |
| • Marker-less 4D CBCT binning | Yes | Yes |
| Movie Encoding Service | Yes | Yes |
| Basis of image comparison:<br>Soft tissue, bony anatomy, fiducial markers, digital representation of<br>treatment aperture | Yes | Yes |
| Feature | Predicate Device<br>TrueBeam and<br>VitalBeam v2.7<br>(K171733 and<br>K172013) | Subject Device<br>TrueBeam-<br>TrueBeamSTx-Edge and<br>VitalBeam v3.0 |
| Image comparison techniques: 2D-2D and 3D-3D image matching<br>under fully automatic conditions using mutual information, or semi-<br>automatic matching conditions with use of both automated image and<br>manual matching, or fully manual matching conditions<br>Image comparison with: Soft tissue, bony anatomy, fiducial markers,<br>digital representation of treatment aperture | Yes | Yes |
| Auto Beam hold Improvements | Yes | Yes |
| Marking Pixel Detection | Yes | Yes |
| Imaging only session (plan is only available for imaging) and<br>unplanned treatment mode (emergency treatment upto 5 fractions) | No | Yes |
| Respiratory Gating | | |
| Respiratory Gating Component | Yes | Yes |
| Single gating camera & visual coaching device (VCD) | Yes | Yes |
| MPC | | |
| MPC Collimator Device Check | Yes | Yes |
| Machine Performance Check of ICVI (MPC) | Yes | Yes |
| Developer Mode | | |
| Dual Energy kV Imaging (XI) (Developer mode research use) | Yes | Yes |
| Systems | | |
| Isocentric Parameterization | No | Yes |
| Other | | |
| 4 Rack Unit Workstation inheriting 4 computers | Yes | Yes |
| Encoder Diagnostics | Yes | Yes |
| kV source arm drive train (gearbox) (s/w support only) | Yes | Yes |
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Summary of Performance Testing:
Hardware and software verification and validation testing was conducted according to the FDA Quality System Regulation (21 CFR §820), ISO 13485 quality Management System standard, ISO 14971 Risk Management Standard and the other FDA recognized consensus…
