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, 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, 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 carvinoma), gentourinary 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 pediatric tumors (such as glioma, ependymoma, pituitary tumors, hemangioblastoma, meningioma, metastasis, medulloblastoma, nasopharyngeal tumors, arteriovenous malformation, avernous 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, pitutary 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 turnors (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 glioma, pituitary tumors, hemangioblastoma, craniopharyngioma, metastasis, medulloblastoma, nasopharyngeal tumors, arteriovenous malformation, cavernous malformation, and skull base tumors).

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.

AI/ML Overview

The provided text is a 510(k) Premarket Notification summary for the Varian Medical Systems TrueBeam™, TrueBeam STx™, Edge™, and VitalBeam radiotherapy delivery systems. This submission primarily focuses on expanding the indications for use to include "medically refractory essential tremor" for the TrueBeam™, TrueBeam STx™, and Edge™ Systems.

The document states that the subject device has the same technological characteristics as its previously cleared predicate device (K213977). Therefore, the provided text does not describe a new study to prove the device meets acceptance criteria for a newly designed or significantly modified product. Instead, it relies on the previously established performance, safety, and effectiveness of the predicate device and a literature review to support the expanded indication.

Here's an analysis based on the information provided, recognizing that it's a 510(k) for an expanded indication rather than a de novo submission for a new device:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not provide a specific table of acceptance criteria with numerical performance targets (e.g., accuracy, precision) for the device itself and its reported performance as these were established during the clearance of the predicate device (K213977).

Instead, the "Summary of Performance Testing" for the current submission K223839 states:

Criterion	Reported Performance
Performance Specifications	Equivalent to predicate device (K213977)
Principle of Operation	Same as predicate device (K213977)
Safety Profile	No changes demonstrated by verification, validation, and safety standards testing (for predicate device K213977)
Expanded Indication (medically refractory essential tremor) for TrueBeam™, TrueBeam STx™, Edge™	Literature review shows similar outcomes and complication rates for SRS treatment of tremor conditions, comparable to traditional surgical options and Gamma Knife. Linear accelerator-based SRS is reported to be safe and efficacious for this indication when other options are unavailable/contraindicated.

The "acceptance criteria" here implicitly refer to the continued safety and effectiveness of the device for its core functions, as established by the predicate device, and the literature-supported safety and efficacy of Stereotactic Radiosurgery (SRS) for medically refractory essential tremor when delivered by a linear accelerator.

2. Sample Size Used for the Test Set and Data Provenance:

For the device's core performance: Not applicable to this specific submission, as it relies on previous testing of the predicate device (K213977).
For the expanded indication (medically refractory essential tremor): The "Summary of Clinical Data" mentions a literature review of over 1300 patients treated with SRS for tremor conditions.
- Data Provenance: The data comes from published literature, implying a retrospective compilation of studies that likely originated from various countries and institutions. The document does not specify particular countries or whether the studies were prospective or retrospective, but typical clinical literature reviews will encompass both.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

For the device's core performance: Not applicable to this specific submission as it relies on the predicate.
For the expanded indication: The "ground truth" for the efficacy and safety of SRS for tremor conditions is established through published clinical outcomes. The decision to include "medically refractory essential tremor" as an indication is based on a review of these published studies. The document does not explicitly state how many experts conducted this literature review for Varian, nor their specific qualifications. However, such reviews are typically conducted by regulatory affairs professionals, sometimes with input from clinical experts (e.g., radiation oncologists, neurosurgeons) who would understand the clinical context and outcomes.

4. Adjudication Method for the Test Set:

Not applicable. This submission relies on a literature review of outcomes for an existing therapy, not on a new test set requiring multi-reader adjudication of images or data.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, an MRMC comparative effectiveness study was not done as described in this document. The submission is not about human readers improving with AI assistance; it's about the safety and efficacy of a medical linear accelerator system for an expanded treatment indication.

6. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance):

Not applicable. This device is a radiotherapy delivery system, a hardware and software system that always involves human operators (radiation oncologists, medical physicists, radiation therapists) in its use for treatment planning and delivery. It is not an "algorithm-only" diagnostic AI device.

7. Type of Ground Truth Used:

For the device's core performance: Not explicitly stated in this document but would typically involve physical measurements, phantom studies, and possibly clinical outcome data from previous device versions/studies.
For the expanded indication (medically refractory essential tremor): Clinical outcomes data from a literature review. This includes reported tremor improvement and complication rates from published studies using both linear accelerators and Gamma Knife for SRS treatment of tremor.

8. Sample Size for the Training Set:

Not applicable. This is not an AI/ML device that requires a training set in the typical sense. The "training" for the device's functionality would have been part of its original development and testing (for the predicate device), but this submission does not describe an AI training process.

9. How the Ground Truth for the Training Set Was Established:

Not applicable, as there is no mention of a training set for an AI/ML model in this submission.

Summary

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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, which is a blue square with the letters "FDA" in white. To the right of the blue 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: K223839

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: April 20, 2023 Received: April 20, 2023

Dear Peter Coronado:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (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

May 22, 2023

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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 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,

Lora D.
Weidner -S

Digitally signed by
Lora D. Weidner -S
Date: 2023.05.22
17:25:26 -04'00'

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) K223839

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, 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, nasopharynx, 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 carvinoma), gentourinary 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 pediatric tumors (such as glioma, ependymoma, pituitary tumors, hemangioblastoma, meningioma, metastasis, medulloblastoma, nasopharyngeal tumors, arteriovenous malformation, avernous 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, pitutary 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 turnors (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 glioma, pituitary tumors, hemangioblastoma, craniopharyngioma, metastasis, medulloblastoma, nasopharyngeal tumors, arteriovenous malformation, cavernous malformation, and skull base tumors).

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Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

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K223839 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:	18 May 2023
Proprietary Name:	TrueBeamTM /TrueBeam STxTM/EdgeTM/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.The system consists of two major components – a photon, electron anddiagnostic kV X-ray radiation beam producing component that is installed ina radiation-shielded vault and a control console area located outside thetreatment room.
Intended Use	The intended use is the same as the predicate.TrueBeam-TrueBeam STx-Edge:The TrueBeam TM 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), and medically refractory essential tremor (indicated for adults only).

VitalBeam:

VitalBeam may be used in the delivery of radiation for treatment that includes: brain and spine tumors (such as glioma, meningioma, craniopharyngioma, pituitary tumors, tumors, spinal coocord 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,

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	arteriovenous malformation, cavernous malformation, and skull basetumors).
Technological Characteristics:	The device has the same technological characteristics as the previouslycleared TrueBeam device K213977. The indications for use have expandedto include "medically refractory essential tremor" in TrueBeam™,TrueBeam STx and Edge™ System. This submission does not include anyother device modification.
Summary of Performance Testing:	The predicate and subject device have equivalent performancespecifications and have the same principle of operation. The results of theverification, validation and safety standards testing (Predicate device -K213977) demonstrates that there are no changes to the safety profile ofthe device.
Summary of Clinical Data:	Stereotactic Radiosurgery (SRS) has been used for decades to treat tremorconditions. In a literature review, over 1300 patients were treated with SRSfor tremor conditions with similar outcomes and complication rates astraditional surgical options. The attributes of advanced target localization,beam collimation, and patient immobilization are common to both linearaccelerators and Gamma Knife, allowing for both devices to delivercomparable doses to precisely-defined targets. Linear accelerators are inroutine clinical use for SRS treatments and recent publications reporttremor improvement and complication rates for linear accelerator-basedSRS comparable to those achieved with the Gamma Knife. The majority ofstudies reporting on the use of SRS for the treatment of tremor conditionsinclude a discussion on the importance of advanced imaging and adedicated/experienced treatment team in order to properly localize,immobilize, and treat these patients. In conclusion, linear accelerator-basedSRS for medically refractory essential tremor is reported to be a safe andefficacious treatment option in situations where other treatment optionsare not available or are otherwise contraindicated.

Argument for Substantial Equivalence to the Predicate Device

The subject device and predicate device have the same intended use of 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 expansion of the indications for use to include "medically refractory essential tremor" does not affect the design/principle of operation and does not introduce changes in the risk profile.

The technological characteristics and features of the subject device remain unchanged from the previous submission (Predicate device - K213977). There are no other modifications to predicate and subject device have equivalent performance specifications and have the same principle of operation. The verification and safety testing standards that support HET v3.0 (TrueBeam STx-Edge and VitalBeam) have been performed for the predicate device.

Based on the methods of evaluation and the data from the clinical literature, Varian believes that the subject device is substantially equivalent to the predicate device.

Regulation Number and Section

§ 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.