(165 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, 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).
The TrueBeam and VitalBeam Radiotherapy System is a medical linear accelerator that delivered therapeutic radiation to patient in accordance with the physician's prescription.
Here's a summary of the acceptance criteria and the study information based on the provided text, formatted to your requests. However, please note that the document is a 510(k) summary for a radiotherapy system, which focuses on demonstrating substantial equivalence to a predicate device for regulatory approval. It is not a clinical study of an AI/ML device, and therefore many of the requested fields related to AI performance, ground truth establishment, and expert involvement are not applicable or not provided in this type of document.
Acceptance Criteria and Device Performance
This document describes a medical device (TrueBeam, TrueBeam STx, Edge, and VitalBeam radiotherapy systems) that has undergone updates. The "acceptance criteria" here refer to conformance to regulatory standards and a demonstration of substantial equivalence to a predicate device, rather than performance metrics for an AI algorithm. The performance is assessed through verification, validation, and safety standards testing.
1. Table of Acceptance Criteria and Reported Device Performance
Since this is not an AI/ML device with specific performance metrics like sensitivity, specificity, or AUC, the "performance" here refers to compliance with safety and functional standards.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Conformance to FDA Quality System Regulation (21 CFR §820) | Hardware and software verification and validation testing conducted, and confirmed conformance. |
| Conformance to ISO 13485 Quality Management System standard | Design and development, including verification and validation testing, conducted within an established Quality System compliant to EN ISO 13485:2016. |
| Conformance to ISO 14971 Risk Management Standard | Design and development, including verification and validation testing, conducted within an established Quality System compliant to EN ISO 14971:2012. Outcome: No Discrepancy Reports (DRs) remaining with a priority of Safety Intolerable. |
| Software documentation as per FDA Guidance | Provided documentation as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." |
| Software Safety Level | Software considered a "major" level of concern. |
| Biocompatibility (patient-contact materials) | No change to patient-contact materials biocompatibility in this medical device. Conformance to ANSI/AAMI/ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1" confirmed. |
| Human factors validation (IEC 62366) | Validation study conducted according to IEC 62366 to verify that the device "performs well as intended for the intended users, uses, and use environments." |
| Electrical safety (IEC 60601-1) | Testing conducted. System complies with IEC 60601-1 standards for safety. |
| Electromagnetic compatibility (EMC) (IEC 60601-1-2) | Testing conducted. System complies with IEC 60601-1-2 standard for EMC. |
| Conformance to other recognized standards (e.g., IEC 60601-2-1) | Conforms to various listed standards (e.g., IEC 60601-1-6, IEC 62304, IEC 60825-1, IEC 60601-1-3, IEC 61217, IEC 62274, ISO 10993-1, IEC 60601-2-68, ISO 15223-1). Full details refer to Summary of Use of Voluntary Consensus Standards document in Section 09. |
| Intended Use and Indications for Use | Unchanged from predicate device. |
| Principle of Operation | No changes from predicate device. |
| Safety Profile | Results of verification, validation, and safety standards testing demonstrate no changes to the safety profile of the device. Outcome: The product conformed to the defined user needs and intended uses, and there were no discrepancy reports (DRs) remaining which had a priority of Safety Intolerable. Therefore, the device is substantially equivalent to the predicate device. |
2. Sample Size Used for the Test Set and Data Provenance
This document describes a regulatory submission for a radiotherapy system, not an AI/ML diagnostic or prognostic device that typically uses "test sets" of patient data for performance evaluation in the typical sense. The testing described is primarily hardware and software verification and validation, along with compliance to international standards. Therefore, information about a "sample size for a test set" or "data provenance" (country, retrospective/prospective) related to patient data for AI evaluation is not applicable and not provided in this document.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Given that this is not an AI/ML device being evaluated for diagnostic or prognostic accuracy on patient data, the concept of "ground truth" and "experts establishing ground truth" in the context of a "test set" is not applicable here. The "experts" involved would be engineers, physicists, and regulatory specialists confirming compliance with technical and safety standards.
4. Adjudication Method for the Test Set
As this is not an AI/ML study involving human interpretation of data where adjudication is needed, an "adjudication method" is not applicable and not described in the document.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study comparing human readers with and without AI assistance was not done and is not relevant for this type of medical device submission. This document pertains to a radiotherapy treatment delivery system, not an AI-assisted diagnostic or interpretation tool.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was done
This is not applicable as the TrueBeam is a medical linear accelerator for radiation therapy delivery, not an AI algorithm intended for standalone performance evaluation in the way this question implies. Any "algorithms" (e.g., iCBCT reconstruction) are components of the system, and their performance is evaluated as part of the overall system's functional and safety requirements, not as standalone AI products.
7. The Type of Ground Truth Used
The "ground truth" in this context is the adherence to established engineering, safety, and regulatory standards, along with the device's functional specifications. It's established through:
- Engineering specifications and design documents: Dictating how the device should perform.
- International Consensus Standards: Like IEC 60601 series, IEC 62304, ISO 13485, ISO 14971, which define safety and performance requirements.
- Verification and Validation Testing: Empirical testing to confirm the device meets these specifications and standards.
- Clinical use (implied/previous predicate data): The safety and efficacy of radiation therapy itself, and the predicate device, form the basis. The current submission demonstrates that the updated device maintains that safety and efficacy.
It is not expert consensus on patient pathology, or outcomes data in the sense of a clinical trial for a novel AI diagnostic.
8. The Sample Size for the Training Set
This is not applicable as the device is not an AI/ML system that undergoes "training" on a dataset in the typical machine learning sense. The development of the device follows traditional engineering design, verification, and validation processes. While some components like the iCBCT algorithm might involve data for development, the concept of a "training set" for the whole system, as understood for AI, isn't present in this document.
9. How the Ground Truth for the Training Set was Established
Since there is no "training set" in the AI/ML context for the device as a whole, this question is not applicable. In the case of component algorithms (like iCBCT), any "ground truth" for their development would be based on known physics, simulation data, and expert validation of imaging quality, but this detail is not provided in a 510(k) summary focused on substantial equivalence.
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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 Systems3100 Hansen Way, m/s E110Palo Alto CA94304 |
|---|---|
| Primary Contact Person: | Peter J. CoronadoSr. Director Regulatory AffairsPhone: (650) 424.6320Fax: (650) 646.9200E-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 linearaccelerator that delivered therapeutic radiation to patient in accordancewith the physician's prescription. |
| Intended Use | The intended use is the same as the predicate. |
| TrueBeam-TrueBeam STx-Edge:The TrueBeam™ radiotherapy delivery system is intended to providestereotactic radiosurgery and precision radiotherapy for lesions, tumors,and conditions anywhere in the body where radiation treatment isindicated. | |
| VitalBeam:The VitalBeam system is intended to provide stereotactic radiosurgery andprecision radiotherapy for lesions, tumors, and conditions anywhere in thebody 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 DeviceTrueBeam andVitalBeam v2.7(K171733 andK172013) | Subject DeviceTrueBeam-TrueBeamSTx-Edge andVitalBeam v3.0 |
|---|---|---|
| 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 stereotactic radiosurgeryand precision radiotherapy for lesions, tumors, and conditionsanywhere in the body where radiation treatment is indicated. | Yes | Yes |
| Software Operating System | Windows 7 | Windows 10 |
| Treatment Techniques | ||
| Feature | Predicate DeviceTrueBeam andVitalBeam v2.7(K171733 andK172013) | Subject DeviceTrueBeam-TrueBeamSTx-Edge andVitalBeam 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 -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; segments allowedwith 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 DeviceTrueBeam andVitalBeam v2.7(K171733 andK172013) | Subject DeviceTrueBeam-TrueBeamSTx-Edge andVitalBeam v3.0 |
| MLC, collimator rotation), couch translation and rotation forpatient set up and treatment delivery.Local (in treatment room) couch motion control for manualpositioning and automated positioning to plan values. Tx Plans pre-treatment QA (incl. exceeding pre-defined doselimits) | Yes | Yes |
| Delta Couch automated patient alignment shifts (Delta CouchShift). (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 (6degrees of freedom) | Yes | Yes |
| Treatment application recognizes common isocenter within and acrossplans 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/SRTdelivery | 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,Poured Blocks, Compensators, Physical wedges | Yes | Yes |
| Patient ID (bar code label) verification & Custom accessory verification(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)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 permitcurrent session delivery only | Yes | Yes |
| Feature | Predicate DeviceTrueBeam andVitalBeam v2.7(K171733 andK172013) | Subject DeviceTrueBeam-TrueBeamSTx-Edge andVitalBeam v3.0 |
| HET console electronically sends Plan setup data to the HET systemsupervisor | 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. | 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 FieldEdges Plot, Matched Structures and Field Edges, Related Images,Double Exposure, ROI, couch shift values, respiratory-gated image | Yes | Yes |
| Feature | Predicate DeviceTrueBeam andVitalBeam v2.7(K171733 andK172013) | Subject DeviceTrueBeam-TrueBeamSTx-Edge andVitalBeam 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:43 x 43 imager | Yes | Yes |
| Proximity detection: | ||
| Touch guards on kV source, kV detector, positioning units with additionof supplemental capacitive collision detection system (kV CCDS) on kVsource | Yes | Yes |
| Type of digital image produced: | ||
| • Digital radiographs, fluoroscopic image frames, cone-beam CTimage projections, respiratory-gated radiographs, respiration-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• Online 4D CBCT and Extended CBCT• Short Arc CBCT | Yes | Yes |
| • Iterative CBCT (iCBCT)• Automatic Exposure Control (AEC) | Yes | Yes |
| • Iterative CBCT (iCBCT - includes pelvis large and image gently) | Yes | Yes |
| • iCBCT improvements (Improvement to the iCBCT algorithm,for when the patient's outer contour is changing during a CTscan.) | 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 representation oftreatment aperture | Yes | Yes |
| Feature | Predicate DeviceTrueBeam andVitalBeam v2.7(K171733 andK172013) | Subject DeviceTrueBeam-TrueBeamSTx-Edge andVitalBeam v3.0 |
| Image comparison techniques: 2D-2D and 3D-3D image matchingunder fully automatic conditions using mutual information, or semi-automatic matching conditions with use of both automated image andmanual matching, or fully manual matching conditionsImage comparison with: Soft tissue, bony anatomy, fiducial markers,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) andunplanned 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 standards listed below.
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| Test results showed conformance to applicable requirements specificationsand assured hazard safeguards functioned properly. | |||
|---|---|---|---|
| Software verification and validation testing were conducted, andIndustry and FDA Staff, "Guidance for the Content of PremarketSubmissions for Software Contained in Medical Devices." | documentation was provided as recommended by FDA's Guidance for | ||
| The software for this device was considered as a "major" level of concernsince a failure or latent flaw in the software could directly result in seriousinjury or death to the patient or operator. | |||
| There was no change to patient-contact materials biocompatibility in thismedical device. Therefore, no change occurred in conformance toANSI/AAMI/ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1".Human factors validation study was conducted according to the standardIEC 62366 to verify that TrueBeam, TrueBeam STx, Edge and VitalBeam v3.0performs well as intended for the intended users, uses, and useenvironments. | |||
| Electrical safety and electromagnetic compatibility (EMC) testing wereconducted on this medical device. The system complies with the IEC 60601-1 standards for safety and the IEC 60601-1-2 standard for EMC. | |||
| Standards Conformance: | Varian TrueBeam conforms to the following FDA recognised standards. Forfull details refer to Summary of Use of Voluntary Consensus Standardsdocument in Section 09 of this 510k submission. | ||
| IEC 60601-1:2005IEC EN 60601-1-6: 2010+ A1: 2013IEC 62304:2006 +A1:2015IEC 60825-1 Ed. 2.0 2007 | IEC 6060-1-2: 2014IEC 60601-2-1: 2009/A1: 2014IEC 62366-1: 2015IEC 60976 Ed. 2.0 2007 | IEC 60601-1-3:2008/A1:2013IEC 61217: 2011IEC 62274: 2005ISO 10993-1:2009 | |
| IEC 60601-2-68:2014 | ISO 15223-1:2016 | EN ISO 13485:2016 | |
| IEC 60601-2-68:2014 |
TrueBeam, TrueBeam STx, Edge and VitalBeam was designed and developed, including verification and validation testing, within an established Quality System compliant to:
EN ISO 13485:2016 EN ISO 14971:2012 21 CFR §820 – Quality System Regulation
Conclusion of Non-Clinical testing
The outcome was that the product conformed to the defined user needs and intended uses and that there were no DRs (discrepancy reports) remaining which had a priority of Safety Intolerable. Therefore, the subject device is substantially equivalent to the predicate device.
Argument for Substantial Equivalence to the Predicate Device
TrueBeam, TrueBeam STx, Edge and VitalBeam v3.0 (subject device) are substantially equivalent to the TrueBeam and VitalBeam v2.7 (predicate device). A subset of technological characteristics and features of the current device is different to the predicate. These differences are all considered by Varian to be 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 results of the verification, validation and safety standards testing demonstrates that there are no changes to the safety profile of the device. Therefore, the TrueBeam, TrueBeam STx, Edge and VitalBeam v3.0 (subject device) is substantially equivalent to the TrueBeam and VitalBeam v2.7 (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.