The TrueBeam and Edge Systems are intended to provide stereotactic radiosurgery for lesions, tumors, and conditions anywhere in the body where radiation therapy is indicated for adults and pediatric patients.

The TrueBeam and Edge Systems may be used in the delivery of radiation for treatment that includes: bram and spine tumors (such as glioma, meningioma, craniopharyngioma, pituitary tumors, spinal cord tumors, hemangioblastoma, orbital tumors, optic nerve tumors, and skull based 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 ung cancer, esophageal cancer, thymic tumors, and mesothelioma), gynecologic tumors (such as ovarian, endometrial, vulvar, and vaginal), gastrointestinal tumors (such as gastric, hepatobiliary, colon, rectal, and anal carcinoma), genitourinary tumors (such as prostate, bladder, testicular, and kidney), breast tumors, sarcomas, lymphoid tumors (such as Hodgkin's lymphoma), skin cancers (such as squamous cell, and melanoma), benign diseases (such as schwannoma, arteriovenous malformation, cavemous malformation, trigeninal 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, pitutary tumors, hemangioblastoma, craniopharyngioma, metastasis, medulloblastoma, nasopharyngeal tumors, arteriovenous malformation, cavernous malformation and skull base tumors).

Device Description

The TrueBeamTM Radiotherapy Delivery System is a medical linear accelerator that integrates the previously cleared Trilogy Radiotherapy system and associated accessories into a single device.

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

This document describes the regulatory submission for the TrueBeam and Edge Radiotherapy Delivery System. The acceptance criteria and supporting studies are based on performance testing and adherence to recognized standards, rather than direct clinical performance data from a specific study with clearly defined performance goals like sensitivity/specificity.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Reported Device Performance/Verification Method
Safety and Effectiveness (General)	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 other FDA recognized consensus standards. Test results showed conformance to applicable requirements specifications and assured hazard safeguards functioned properly.
Software Level of Concern	Software for this device was classified as a "major" level of concern. 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."
Biocompatibility	Biocompatibility evaluation for patient-contact materials was conducted in accordance with FDA Blue Book Memorandum #G95-2 "Use of International Standard ISO-10993, 'Biological Evaluation of Medical Device Part 1: Evaluation and Testing,'" and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process."
Electrical Safety and Electromagnetic Compatibility (EMC)	Electrical safety and electromagnetic compatibility (EMC) testing were conducted. The system complies with IEC 60601-1 standards for safety and IEC 60601-1-2 standard for EMC.
Conformance to Recognized Standards	The TrueBeam™, TrueBeam STx™ and Edge™ medical linear accelerators conform in whole or in part with the following FDA recognized consensus standards: AAMI/ANSI/IEC 60601-1:2005, ANSI/AAMI/ISO 10993-1:2003, IEC 60601-1-2:2007, IEC 60601-1-3:2008, IEC 60601-1-6:2010, IEC 60601-2-1:2009, IEC 60601-2-32:1994, IEC 60601-2-44:2009, IEC 60825:2007, IEC 60976:2007, IEC 61217:2011, IEC 62304:2006, IEC 62274:2005, IEC 62366:2007.
Technological Equivalence (Improvements)	The device incorporates new features compared to its predicate: 80-leaf MLC (vs. not present in predicate) and Manual bolus verification (vs. not present in predicate). These changes are presented as advancements that maintain or improve safety and effectiveness.
Substantial Equivalence to Predicate Device (K140528: TrueBeam Radiotherapy System and Accessories)	The results of verification, validation, and safety standards testing demonstrate that the TrueBeam, TrueBeam STx, and Edge are substantially equivalent to their predicate device. This is the overarching "acceptance criterion" for 510(k) submissions, where the new device is shown to be as safe and effective as a legally marketed predicate device.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document extensively references hardware and software verification and validation testing, biocompatibility evaluation, and electrical safety and EMC testing. These types of tests typically involve controlled laboratory environments and specific test protocols rather than human patient data sets in the way clinical studies for diagnostic algorithms would.

Test Set Sample Size: The document does not specify a "sample size" in terms of patient data. Instead, the "sample" for testing would be the device itself and its components. For software testing, it would involve test cases and scenarios designed to cover various functionalities and potential failure modes. For hardware, it would be the physical units and their sub-assemblies. The scale of these tests is not quantified in the provided text.
Data Provenance: Not applicable in the context of patient data. The provenance relates to the testing environment and standards adherence rather than patient demographics or origin.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided. For this type of device (a radiotherapy delivery system), "ground truth" is established through engineering specifications, scientific principles, and adherence to recognized standards for performance, safety, and effectiveness, not through expert consensus on medical images or patient outcomes in the same way an AI diagnostic device would.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. As described above, the "test set" refers to engineering and software validation, not a clinical study involving expert adjudication of medical findings.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is a radiotherapy delivery system, not an AI-assisted diagnostic tool designed to be used by human readers for interpretation. Therefore, an MRMC study comparing human reader performance with and without AI assistance is irrelevant to this device.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

This is not an "algorithm only" device in the sense of a diagnostic AI. It is a medical device system that includes algorithms for its operation and control. The performance described here is the integrated system's conformance to safety and performance standards, which implicitly includes the performance of its internal algorithms as part of the overall system. The testing described (hardware and software verification/validation) assesses the device's standalone performance according to its specifications.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for this device's validation is established by:

Engineering specifications and design requirements: The device is designed to meet specific technical parameters and safely deliver radiation.
International and national standards: Compliance with standards like IEC 60601 series, ISO 13485, ISO 14971, ISO 10993-1, and FDA's quality system regulations. These standards define accepted benchmarks for safety, performance, and manufacturing quality.
Predicate device equivalence: The device is considered "substantially equivalent" to an already cleared device (K1405528), meaning its performance characteristics are comparable and it raises no new questions of safety or effectiveness.

8. The sample size for the training set

Not applicable. This document describes a medical device, not a machine learning model that requires a "training set" of data for learning.

9. How the ground truth for the training set was established

Not applicable, as there is no "training set" for this type of device.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus, with three human profiles facing to the right. The profiles are stacked on top of each other, creating a sense of depth and unity.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

December 19, 2014

Varian Medical Systems, Inc. % Mr. Peter J. Coronado Director, Varian Oncology Systems Regulatory Affairs 911 Hansen Way PALO ALTO CA 94304

Re: K143224

Trade/Device Name: TrueBeam and Edge Radiotherapy Delivery System Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: November 5, 2014 Received: November 10, 2014

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. 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Robert A. Ochs

Robert Ochs, Ph.D. Acting Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K143224

Device Name

TrueBeam and Edge Radiotherapy Delivery System

Indications for Use (Describe)

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)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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Premarket Notification [510(k)] Summary TrueBeam Radiotherapy Treatment System

The following information is provided following the format of 21 CFR 807.92.

I. Submitter's Name:	Varian Medical Systems, Inc.3120 Hansen Way C-260Palo Alto, CA 94304Contact Name: Peter J. CoronadoPhone: 650.424.5731Fax: 650.842.5040Date: November 2014
II. Trade Name:	TrueBeamTM/TrueBeam STxTM/EdgeTM
Common Name:	Linear accelerator radiation therapy system
Classification Name:	Medical charged-particle radiation therapy system21 CFR 892.5050, Class IIProduct Code: 90 IYE
III. Predicate Device:	TrueBeam Radiotherapy System and Accessories: K140528
IV. Device Description:	The TrueBeamTM Radiotherapy Delivery System is a medical linearaccelerator that integrates the previously cleared Trilogy Radiotherapysystem and associated accessories into a single device.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.
V. Intended UseStatement	The TrueBeam TM system is intended to provide stereotactic radiosurgery andprecision radiotherapy for lesions, tumors, and conditions anywhere in thebody where radiation treatment is indicated.
Indications for UseStatement	The TrueBeam and Edge Systems are intended to provide stereotacticradiosurgery and precision radiotherapy for lesions, tumors, and conditionsanywhere in the body where radiation therapy is indicated for adults andpediatric patients.The TrueBeam and Edge Systems may be used in the delivery of radiation fortreatment that includes: brain and spine tumors (such as glioma, meningioma,craniopharyngiaryngioma, 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, oralcavity, hypopharynx, larynx, oropharynx, nasopharynx, sinonasal, salivarygland, and thyroid cancer), thoracic tumors (such as lung cancer, esophagealcancer, thymic tumors, and mesothelioma), gynecologic tumors (such asovarian, 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), breasttumors, sarcomas, lymphoid tumors (such as Hodgkin's and non-Hodgkin's

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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).

VI. Technological Characteristics:

Significant changes to the predicate device are listed below.

Feature	Cleared device	Device with change
80-leaf MLC	No	Yes
Manual bolus verification	No	Yes

VII. Summary ofperformancetesting:	Hardware and software verification and validation testing was conductedaccording to the FDA Quality System Regulation (21 CFR §820), ISO 13485 qualityManagement System standard, ISO 14971 Risk Management Standard and theother FDA recognized consensus standards listed below. Test results showedconformance to applicable requirements specifications and assured hazardsafeguards functioned properly.Software verification and validation testing were conducted and documentationwas provided as recommended by FDA's Guidance for Industry and FDA Staff,"Guidance for the Content of Premarket Submissions for Software Contained inMedical Devices." The software for this device was considered as a "major" level ofconcern, since a failure or latent flaw in the software could directly result in seriousinjury or death to the patient or operator.The biocompatibility evaluation for the patient-contact materials in this medicaldevice was conducted in accordance with the FDA Blue Book Memorandum #G95-2"Use of International Standard ISO-10993, 'Biological Evaluation of Medical DevicePart 1: Evaluation and Testing,'" May 1, 1995, and International Standard ISO10993-1 "Biological Evaluation of Medical Devices – Part 1: Evaluation and TestingWithin a Risk Management Process," as recognized by FDA.Electrical safety and electromagnetic compatibility (EMC) testing were conductedon this medical device. The system complies with the IEC 60601-1 standards forsafety and the IEC 60601-1-2 standard for EMC.
Standardsconformance:	Varian TrueBeam™, TrueBeam STx™ and Edge™ medical linear acceleratorsconform in whole or in part with the following FDA recognized consensusstandards:
	AAMI/ANSI/IEC 60601-1:2005	IEC 60601-2-1: 2009	IEC 61217: 2011
	ANSI/AAMI/ISO 10993-1:2003	IEC 60601-2-32: 1994	IEC 62304: 2006
	IEC 60601-1-2:2007	IEC 60601-2-44: 2009	IEC 62274: 2005
	IEC 60601-1-3: 2008	IEC 60825: 2007	IEC 62366:2007
	IEC 60601-1-6:2010	IEC 60976: 2007
Conclusion:	The results of verification, validation and safety standards testingdemonstrate that the TrueBeam, TrueBeam STx, and Edge are substantiallyequivalent to their 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.