The TrueBeam and Edge Systems are intended to provide stereotactic radiotherapy for lesions, 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 carvinoma), 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 TrueBeam™ and Edge™ Radiotherapy Delivery Systems are medical linear accelerators that integrate 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 is a 510(k) Premarket Notification for the TrueBeam/Edge Radiotherapy Delivery Systems from Varian Medical Systems, Inc. The purpose of this submission is to demonstrate substantial equivalence to previously cleared predicate devices.

The document states that no changes have been made to the device and no new testing has been performed. This implies that the current submission relies on the performance data and acceptance criteria established for the predicate devices. Therefore, the specific details regarding acceptance criteria and a study proving the device meets them are not explicitly provided for this specific submission. Instead, the submission asserts that the device is substantially equivalent to previously cleared devices which would have undergone such scrutiny.

Based on the provided text, here is what can be inferred and what information is not available:

1. A table of acceptance criteria and the reported device performance:

Not explicitly provided in this document for the current submission. The document states, "No changes have been made to the device and no new testing has been performed." This implies reliance on previous testing and acceptance criteria for predicate devices like K123291 (TrueBeam Radiotherapy System and Accessories).

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

Not available in this document. Since no new testing was performed for this submission, these details would be found in the documentation for the predicate devices.

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):

Not available in this document. As no new testing was performed, this information is not included here. This would have been established during the testing of the predicate devices.

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

Not available in this document. Similar to the above, this information pertains to the testing of predicate devices, not this specific submission which states no new testing.

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 and not available.
- This device is a radiation therapy delivery system, not an AI or imaging interpretation device that would involve human readers interpreting AI outputs.
- The document explicitly states, "No changes have been made to the device and no new testing has been performed."

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

Not applicable and not available. This is a hardware system for radiation delivery, not an algorithm that would be tested in a standalone manner for performance metrics like sensitivity or specificity.

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

Not available in this document. This information would be relevant to the performance testing of the predicate devices, which is not detailed here.

8. The sample size for the training set:

Not applicable and not available. This is a radiation therapy delivery system, not an AI/machine learning algorithm requiring a "training set" in the typical sense.

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

Not applicable and not available. As above, this is not an AI/machine learning algorithm with a training set.

Summary of what is provided by the document regarding performance and equivalence:

The core of this 510(k) submission is that the TrueBeam and Edge Radiotherapy Delivery Systems are substantially equivalent to their previously cleared predicate devices.

Predicate Devices: TrueBeam Radiotherapy System and Accessories (K123291), CyberKnife Robotic Radiosurgery System and CyberKnife VSI Systems (K102650), Agility™ (K123808).
Reason for Substantial Equivalence Claim:
- "The device itself is unchanged from the previous submission K123291."
- "The principles of operation, technological characteristics and labeling are substantially equivalent."
- The only change highlighted for this submission is the addition of specific examples of lesions, tumors, and conditions to the Indications for Use statement, which "does not change the therapeutic effect of the device" and "fall within the previously cleared general indication."
- "No changes have been made to the device and no new testing has been performed."

Therefore, for the current submission (K140528), the "proof" that the device meets acceptance criteria is the argument of substantial equivalence to predicate devices that have already met their respective acceptance criteria through prior studies and FDA clearance. The document explicitly states that no new testing was performed for this specific submission because the device itself is unchanged.

Summary

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

September 5, 2014

Varian Medical Systems, Inc. % Mr. Peter J. Coronado Director, Global Regulatory Affairs 3100 Hansen Way PALO ALTO CA 84304

Re: K140528

Trade/Device Name: TrueBeam, TrueBeam STx, Edge Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: July 31, 2014 Received: August 4, 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,

Michael D'Hara

For

Janine M. Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K140528

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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Varian Medical Systems, Inc. 3100 Hansen Way Palo Alto, CA 94304-1038 USA Tel +1 650 493 4000 www.varian.com

Premarket Notification [510(k)] Summary

TrueBeam/Edge Radiotherapy Delivery Systems

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

Submitter's Name:	Varian Medical Systems, Inc.3100 Hansen Way E-110Palo Alto, CA 94304Contact Name: Peter J. CoronadoPhone: 650.424.6320Fax: 650.646.9200Date: 31 July 2014
Proprietary Name:	TrueBeam™/ TrueBeam STx™ Radiotherapy Delivery SystemEdge™ Radiotherapy Delivery System
Classification Name:	Medical charged-particle radiation therapy system21 CFR 892.5050, Class IIProduct Code: IYE
Common/Usual Name:	Medical linear accelerator
Predicate Devices:	TrueBeam Radiotherapy System and Accessories: K123291CyberKnife Robotic Radiosurgery System and CyberKnife VSI Systems:K102650Agility™ K123808
Device Description:	The TrueBeam™ and Edge™ Radiotherapy Delivery Systems are medical linearaccelerators that integrate the previously cleared Trilogy Radiotherapy systemand 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 in aradiation-shielded vault and a control console area located outside thetreatment room.
Intended 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.
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,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, 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),breast tumors, sarcomas, lymphoid tumors (such as Hodgkin's and non-Hodgkin's lymphoma), skin cancers (such as squamous cell, basal cell, andmelanoma), benign diseases (such as schwannoma, arteriovenousmalformation, cavernous malformation, trigeminal neuralgia, chordoma,glomus tumors, and hemangiomas), metastasis (including all parts of the bodysuch as brain, bone, liver, lung, kidney, and skin) and pediatric tumors (such asglioma, ependymoma, pituitary tumors, hemangioblastoma,craniopharyngioma, meningioma, metastasis, medulloblastoma,nasopharyngeal tumors, arteriovenous malformation, cavernousmalformation and skull base tumors).
TechnologicalCharacteristics	This device has the same technological characteristics as the previouslycleared TrueBeam device K123291. This submission does not introduce anydevice modifications.
SubstantialEquivalence	The indication for use statement for the TrueBeam and Edge radiotherapydelivery systems is similar but not identical to its primary predicate deviceK123291. The changes made with this submission include specific indicationsfor some typical lesions, tumors and conditions that may be treated withradiation. The addition of this text to the indication statement does notchange the therapeutic effect of the device. These treatment sites fall withinthe previously cleared general indication “to provide stereotactic radiosurgeryand precision radiotherapy for lesions, tumors, and conditions anywhere inthe body where radiation therapy is indicated”. The device itself is unchangedfrom the previous submission K123291. The principles of operation,technological characteristics and labeling are substantially equivalent.The functionality and intended use of the TrueBeam and Edge systems issubstantially equivalent to that of its predicate devices, CyberKnife andCyberKnife VSI Systems (K102650) and Agility™ K123808, in safety andeffectiveness.
Summary ofperformance testing	No changes have been made to the device and no new testing has beenperformed.

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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.