(127 days)
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, pitutary tumors, spinal cord tumors, hemangioblastoma, orbital tumors, ocular 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 tumors (such as lung 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, and melanoma), benign diseases (such as schwannoma, arteriovenous malformation, cavernous malformation, trigeminal neuralgia, chordoma, gand 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, meduloblastoma, nasopharyngeal tumors, arteriovenous malformation, and skull base tumors), and medically refractory essential tremor (indicated for adults only).
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 pediative patients. VitalBeam may be used in the delivery of radiation for treatment that includes: brain and spine tumors (such as glioma, meningioma, craniopharyngiona, pituitary tumors, spinal cord tumors, hemangioblastoma, orbital 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, 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, 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, pituitary tumors, hemangioblastoma, craniopharyngioma, meningioma, metastasis, medulloblastoma, nasopharyngeal tumors, arteriovenous malformation, cavernous malformation, and skull base tumors).
The TrueBeam and VitalBeam Radiotherapy System is a medical linear accelerator that delivered therapeutic radiation to patient in accordance with the physician's prescription.
The system consists of two major components – a photon, electron and diagnostic kV X-ray radiation beam producing component that is installed in a radiation-shielded vault and a control console area located outside the treatment room.
The provided text does not contain information about acceptance criteria or a study that proves a device meets such criteria for an AI/ML component. The document is a 510(k) summary for Varian Medical Systems' TrueBeam, TrueBeam STx, Edge, and VitalBeam radiotherapy systems (K231317).
It focuses on demonstrating substantial equivalence to a predicate device (K213977) by outlining the device's intended use, indications for use, technological characteristics, and compliance with various safety and performance standards. It explicitly states: "No animal or clinical tests are being submitted to establish substantial equivalence with the predicate device."
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and reported device performance.
- Sample sizes or data provenance for a test set.
- Number and qualifications of experts for ground truth establishment.
- Adjudication method for a test set.
- MRMC comparative effectiveness study details.
- Standalone performance data.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
The document discusses hardware and software verification and validation, human factors validation, and electrical safety/EMC testing, all against established standards, but not a specific study evaluating an AI/ML component against performance acceptance criteria. The "Templated-based fiducial detection algorithm for Auto Beam Hold" is mentioned as a new feature, suggesting an algorithmic component, but no specific performance study for this algorithm is detailed in the provided summary.
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September 12, 2023
Image /page/0/Picture/1 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, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Varian Medical Systems, Inc. % Peter J. Coronado Sr. Director, Regulatory Affairs 3100 Hansen Way. PALO ALTO CA 94304
Re: K231317
Trade/Device Name: TrueBeam, TrueBeam STx, Edge, VitalBeam Regulation Number: 21 CFR 892.5050 Regulation Name: Medical Charged-Particle Radiation Therapy System Regulatory Class: Class II Product Code: IYE Dated: August 11, 2023 Received: August 14, 2023
Dear Peter J. 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
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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 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 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,
Xin He A for
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) K231317
Device Name
TrueBeam, TrueBeam STx and Edge Radiotherapy Delivery System; 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, pitutary tumors, spinal cord tumors, hemangioblastoma, orbital tumors, ocular 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 tumors (such as lung 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, and melanoma), benign diseases (such as schwannoma, arteriovenous malformation, cavernous malformation, trigeminal neuralgia, chordoma, gand 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, meduloblastoma, nasopharyngeal tumors, arteriovenous malformation, and skull base tumors), and medically refractory essential tremor (indicated for adults only).
VitalBeam:
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 pediative patients. VitalBeam may be used in the delivery of radiation for treatment that includes: brain and spine tumors (such as glioma, meningioma, craniopharyngiona, pituitary tumors, spinal cord tumors, hemangioblastoma, orbital 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, 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, 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, pituitary tumors, hemangioblastoma, craniopharyngioma, meningioma, metastasis, medulloblastoma, nasopharyngeal tumors, arteriovenous malformation, cavernous malformation, and skull base tumors).
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.
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Image /page/4/Picture/0 description: The image shows three blue circles in a horizontal line at the top. Below the circles, the text "510(K) Summary" is written in a large, bold font. The text is the main focus of the image, suggesting it is a title or heading. The circles above may be a design element or part of a logo.
varian
Varian Medical Systems 3100 Hansen Way Palo Alto, CA 94304
The following information is provided as required by 21 CFR 807.92.
| SUBMITTER | |
|---|---|
| Name and Address: | Varian Medical Systems |
| 3100 Hansen Way, m/s E110 | |
| Palo Alto, CA 94304 | |
| Contact Person: | Peter J. Coronado |
| Sr. Director, Regulatory Affairs | |
| Phone: 650-424-6320 Fax: 650-646-9200 | |
| submissions.support@varian.com | |
| Date Prepared: | 05 May 2023 |
| DEVICE | |
| Subject Device Name: | TrueBeam™ /TrueBeam STx™/Edge™/VitalBeam |
| Common/Usual Name: | Linear accelerator radiation therapy system |
| Product Code and Classification: | Medical charged-particle radiation therapy system |
| IYE 21 CFR 892.5050 Class II | |
| PREDICATE DEVICE | |
| Predicate Device Name: | TrueBeam™ /TrueBeam STx™/Edge™/VitalBeam (K213977) |
| Reference Device(s): | No reference devices were used in this submission. |
DEVICE DESCRIPTION
The TrueBeam and VitalBeam Radiotherapy System is a medical linear accelerator that delivered therapeutic radiation to patient in accordance with the physician's prescription.
The system consists of two major components – a photon, electron and diagnostic kV X-ray radiation beam producing component that is installed in a radiation-shielded vault and a control console area located outside the treatment room.
INTENDED USE
TrueBeam-TrueBeam STx-Edge: The TrueBeam ™ radiotherapy delivery system is intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.
VitalBeam: The VitalBeam system is intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.
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Image /page/5/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, sans-serif font. The logo is black and white.
INDICATIONS FOR USE
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 Hodqkin's and non-Hodqkin's lymphoma), skin cancers (such as squamous 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 qlioma, ependymoma, pituitary tumors, hemanqioblastoma, craniopharynqioma, metastasis, medulloblastoma, nasopharynqeal tumors, arteriovenous malformation, cavernous malformation, and skull base tumors), and medically refractory essential tremor (indicated for adults only).
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, 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 neuralqia, 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,
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Image /page/6/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 simple and modern.
hemanqioblastoma, craniopharyngioma, metastasis, medulloblastoma, nasopharyngeal tumors, arteriovenous malformation, cavernous malformation, and skull base tumors).
SIGNIFICANT DIFFERENCES
The significant changes in the subject device compared to the predicate device are as follows:
- . Extended field of view CBCT reconstruction
- . Templated-based fiducial detection algorithm for Auto Beam Hold
- . 1.5 RPM gantry speed for imaging
- Metal artifact reduction .
SUMMARY OF TECHNOLOGICAL CHARACTERISTICS
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 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 DeviceTrueBeam andVitalBeam v3.0(K213977) | Subject DeviceTrueBeam-TrueBeamSTx-Edge andVitalBeam v4.0 |
|---|---|---|
| Intended Use:The TrueBeam® system is intended to provide stereotacticradiosurgery and precision radiotherapy for lesions, tumors, andconditions anywhere in the body where radiation treatment isindicated.The VitalBeam system is intended to provide stereotacticradiosurgery and precision radiotherapy for lesions, tumors, andindicated. | Yes | Yes |
| Software Operating System | Windows 10 | Windows 10 |
| Treatment Techniques | ||
| Basic integral treatment techniques include static photon,static aperture photon arc, and dynamic conformal arc. Additional treatment techniques include static electronand electron arc, IMRT/IMRS, RapidArc and VMAT, TotalBody treatments (photon and electron). All photon treatment delivery techniques can be deliveredunder respiratory gating conditions. Fully automated treatment delivery | Yes | Yes |
| Dynamic collimator for IMRT and VMAT | No | Yes |
| Mixed static and dynamic gantry-modulated fields | No | 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 -Dose rate RT: Up to 600 MU/minHigh 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; segmentsallowed 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 targetedmotions for couch longitudinal, lateral, vertical &rotational axes (4DoF).• Dynamic motion axes now include gantry, collimator(jaws, MLC, collimator rotation), couch translation androtation for patient set up and treatment delivery.• Local (in treatment room) couch motion control formanual positioning and automated positioning to planvalues.• Tx Plans pre-treatment QA (incl. exceeding pre-defineddose limits)• Delta Couch automated patient alignment shifts (DeltaCouch Shift). | Yes | Yes |
| • (Varian Treatment Couch) - Linear Encoder | ||
| Qfix kVue One Couch Top: s/w support only + MPC support | Yes | Yes |
| Perfect Pitch – automated corrective motion for pitch and rollaxes (6 degrees of freedom) | Yes | Yes |
| Treatment application recognizes common isocenter within andacross plans then applies couch corrections to the commonisocenter. | Yes | Yes |
| Integrated Treatment and Imaging Console | ||
| External beam: X-ray & ELECTRON plus PHOTON beam forSRS/SRT 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 BeamCollimators, Poured Blocks, Compensators, Physical wedges | Yes | Yes |
| Patient ID (bar code label) verification & Custom accessoryverification (VVS compatibility)• Patient selection from queue provided by the schedule• Selected patient plan retrieval from info system | Yes | Yes |
| VVS - CV (Varian Verification System, conical Cone Verification) 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 current session delivery only | Yes | Yes |
| HET console electronically sends Plan setup data to the HET system 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• Send History to InfoSys archive in patient record | Yes | Yes |
| Interfaces:• DICOM RT/3.0 data and image import/export capability;• 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.Static aperture field size: 30cm x 40cmIMRT field size: 34 cm x 40 cm | Yes | Yes |
| HD120 MLC | ||
| Maximum field sizes for HD120 MLC:Static field size (MLC retracted): 40cm x 40 cmStatic aperture field size: 30cm x 22cmIMRT field size: 34 cm x 22 cm | Yes | Yes |
| Imaging Techniques | ||
| MV Photon Imager Component | Yes | Yes |
| Reference Image Feature (Structure, Field Edges, Digital graticule) | Yes | Yes |
| Portal Image Matching: (Matching Common Features, MatchField Edges Plot, Matched Structures and Field Edges, RelatedImages, Double Exposure, ROI, couch shift values, respiratory-gated image acquisition, marker matching and portal dosimetry image acquisition.) | Yes | Yes |
| Low X imaging energy for high contrast portal imaging | Yes | Yes |
| kV Photon Imager Component | Yes | Yes |
| Integrated Component: MV Imager w/photon imaging:43 x 43 imager | Yes | Yes |
| Larger kV imager 43x43 | No | Yes |
| Metal artifact reduction | No | Yes |
| Extended FoV CBCT reconstruction | No | Yes |
| Templated-based fiducial detection algorithm for Auto Beam Hold | No | Yes |
| Proximity detection:Touch guards on kV source, kV detector, positioning units with addition of supplemental capacitive collision detection system (kV CCDS) on kV source | Yes | Yes |
| Type of digital image produced: | ||
| • Digital radiographs, fluoroscopic image frames, cone-beam CT image projections, respiratory-gatedradiographs, respiration-synchronized fluoroscopic imageframes | Yes | Yes |
| • Offline 4D CBCT image projections | Yes | Yes |
| • Offline Multi-scan CBCT images | Yes | Yes |
| • 2D-3D Match | Yes | Yes |
| • Gated CBCT | ||
| • Online 4D CBCT and Extended CBCT• Short Arc СВСТ | Yes | Yes |
| • Iterative CBCT (iCBCT)• Automatic Exposure Control (AEC) | Yes | Yes |
| • Iterative CBCT (iCBCT - includes pelvis large and imagegently) | Yes | Yes |
| • iCBCT improvements (Improvement to the iCBCTalgorithm, for when the patient's outer contour ischanging during a CT scan.) | Yes | Yes |
| • CBCT Mode editor | No | Yes |
| • Marker-less 4D CBCT binning | Yes | Yes |
| Movie Encoding Service | Yes | Yes |
| Basis of image comparison:Soft tissue, bony anatomy, fiducial markers, digital representationof treatment aperture | Yes | Yes |
| Image comparison techniques: 2D-2D and 3D-3D imagematching under fully automatic conditions using mutualinformation, or semi-automatic matching conditions with use ofboth automated image and manual matching, or fully manualmatching conditions | Yes | Yes |
| Image comparison with: Soft tissue, bony anatomy, fiducialmarkers, digital representation of treatment aperture | ||
| Auto Beam hold Improvements | Yes | Yes |
| Marking Pixel Detection | Yes | Yes |
| Imaging only session (plan is only available for imaging) andunplanned treatment mode (emergency treatment up to 5fractions) | Yes | Yes |
| 1.5 RPM gantry for imaging | 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 | Yes | 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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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, sans-serif font. The logo is black and white.
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Image /page/8/Picture/0 description: The image shows the logo for Varian, a Siemens Healthineers Company. The word "Varian" is in bold, sans-serif font. Below the word "Varian" is the text "A Siemens Healthineers Company" in a smaller, sans-serif font. The logo is in black and white.
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PERFORMANCE DATA
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Image /page/10/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, sans-serif font. The logo is simple and modern.
Hardware and software verification and validation testing was conducted according to the FDA Quality System Requlation (21 CFR §820), ISO 13485 quality Management System standard, ISO 14971 Risk Manaqement Standard and the other FDA recognized consensus standards listed below.
Test results showed conformance to applicable requirements specifications and assured hazard safequards functioned properly.
Software verification and 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."
The software for this device was considered as 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.
There was no change to patient-contact materials biocompatibility in this medical device. Therefore, no change occurred in conformance to ANSI/AAMI/ISO 10993-1 "Biological Evaluation of Medical Devices – Part 1".
Human factors validation study was conducted according to the standard IEC 62366 to verify that TrueBeam, TrueBeam STx, Edge and VitalBeam v4.0 performs well as intended for the intended users, uses, and use environments.
Electrical safety and electromagnetic compatibility (EMC) testing were conducted on this medical device. The system complies with the IEC 606011 standards for safety and the IEC 60601-1-2 standard for EMC.
STANDARDS
Varian TrueBeam, TrueBeam STx, Edge and VitalBeam confirms to the following FDA recoqnized standards. For full details refer to Summary Use of Voluntary Consensus Standards document in section 9 of this 510(k) submission.
| IEC 60601-1:2005+A1:2012 | IEC 60601-2-68:2014 | ISO 10993-1:2018 |
|---|---|---|
| IEC 62366-1:2015+A1:2020 | IEC 62304:2006+A1:2015 | ISO 15223-1:2021 |
| IEC 60601-1-6:2010+A1:2013 | IEC 61217:2011 | EN ISO 14971:2019 |
| IEC 60601-1-2:2014 | IEC 60976:2007 | EN ISO 13485:2016 |
| IEC 60601-1-3:2008/A1:2013 | IEC 62274:2005 | EN ISO 20417:2021 |
| IEC 60601-2-1:2020 | AAMI RT2:2017 | ISO 15223-1:2021 |
CLINICAL TESTING
No animal or clinical tests are being submitted to establish substantial equivalence with the predicate device.
CONCLUSION
TrueBeam, TrueBeam STx, Edge and VitalBeam 4.0 is substantially equivalent to the TrueBeam STx, Edge and VitalBeam 3.0 predicate device. The intended use and indications for use are the same. The
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major technological characteristics are substantially equivalent to the predicate device, and the differences do not raise new questions of safety and effectiveness. The results of verification and validation as well as conformance to relevant safety standards demonstrate that TrueBeam STx, Edge and VitalBeam meets the safety and performance criteria and is substantially equivalent to the predicate device.
§ 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.