Halcyon and Ethos radiotherapy system are indicated for the delivery of stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body where radiation is indicated for adults and pediatric patients.
The Halcyon and Ethos Radiotherapy System produce CBCT images that can be used in Image Guided Radiation Therapy, and the simulation and planning for radiation therapy.

Device Description

Halcyon and Ethos radiotherapy system are single energy medical linear accelerators (linacs) designed to deliver Image Guided Radiation Therapy and radiosurgery, using Intensity Modulated and Volumetric Modulated Arc Therapy techniques. They consist of the accelerator and patient support within a radiation shielded treatment room and a control console outside the treatment room.
An electron gun generates electrons which are accelerated by radio frequency (RF) power from a magnetron. The electrons strike a tungsten target producing photons (X-rays) for treatment and MV Imaging. The photons produced by the target are monitored and controlled by a pressurized ion chamber.
A beam collimation subsystem consisting of a primary and secondary collimator and two stacked multileaf collimators (MLCs) shapes the photon beam to define the treatment area.
X-Ray images of the patient are used by the treater to verify the correct treatment location. MV Imaging uses the treatment beam and a flat panel imager whereas kV imaging uses a high-capacity kV X-ray tube, a kV collimation system with full fan bowtie filter with movable y-blades to define the imaging beam size and to capture the image, a kV imager.
Halcyon and Ethos radiotherapy system deliver a treatment generated by a Treatment Planning System from a physician's prescription. kV CBCT images from HyperSight can additionally be used for planning treatments. Ethos radiotherapy system is capable of delivering adaptive treatments which can take into account changes in tumour geometry between treatment sessions.

AI/ML Overview

The provided text describes a 510(k) submission for the Halcyon and Ethos Radiotherapy System, focusing on expanding the indications for use of its HyperSight CBCT images for primary treatment planning, effectively proving it is clinically equivalent to plans generated from conventional and simulator CT images.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

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

Acceptance Criteria	Reported Device Performance/Outcome
Patient-Specific QA	The test results demonstrate that the Halcyon 4.0 with HyperSight imaging system produces primary treatment plans that are clinically equivalent to plans generated from conventional and simulator CT images. The dose calculation specifications demonstrate equivalence to standard CT scanners.
Ionization chamber measured dose ±3% as predicted by treatment planning system	No specific performance metrics for this criterion are provided in the text beyond the overall conclusion of clinical equivalence.
2D gamma analysis of predicted planar dose distribution as compared to measured signal from the portal imaging panel - at least 95% of analyzed points passed 3%/2mm gamma criteria	No specific performance metrics for this criterion are provided in the text.
Image Acquisition and Contouring
Successful creation of contours for each dataset	Implied to be successful, as cases provided "contours, and clinical planning objectives" and plans were created.
All relevant organs-at-risk and targets are discernable	The clinical cases "comprise a wide range of tissues to challenge the treatment planning tasks of organ segmentation and dose calculation, including metal artifacts (as in dentition, fiducials, or hip prosthesis)," suggesting discernibility was achieved.
Treatment Plan Comparison
From established, published Clinical Goals for each anatomical site	"Each type of plan (CT- and HyperSight-based) was evaluated against clinical objectives, consisting of target coverage goals and normal tissue constraints." The overall conclusion states clinical equivalence.

2. Sample size used for the test set and the data provenance:

Sample Size: 26 human subject cases.
Data Provenance: Obtained from three institutions in the US and Europe. The data was from institutionally approved prospective single-site clinical studies. All cases were adult patients planned to receive radiation therapy for head/neck, thorax (including breast), abdomen, or pelvis conditions.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

The text states that for each case, a "summary list identifying the dosimetrist and physician involved with each case" was provided. It does not specify the exact number of experts involved in establishing ground truth (e.g., contours, clinical planning objectives) for the test set, nor their specific qualifications (e.g., years of experience).

4. Adjudication method for the test set:

The text does not explicitly describe an adjudication method for the test set data. It mentions that "planning CT and HyperSight CBCT image sets, contours, and clinical planning objectives were provided to Varian," implying these were already established by the contributing institutions.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done in the context of human readers improving with AI assistance. This study focused on the equivalence of treatment plans generated from different image sources (conventional CT vs. HyperSight CBCT) by the system (RapidPlan), rather than evaluating human reader performance with or without AI assistance. The "AI" aspect is more embedded in or implied by the "RapidPlan" system's ability to generate plans.

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

Yes, a standalone study was effectively performed. Varian "created radiation treatment plans for each type of image separately, using a standardized planning approach (RapidPlan) available in the Varian Eclipse treatment planning system." This indicates an algorithm-driven comparison of plans generated from different image inputs, rather than focusing on human interaction with the device for performance improvement.

7. The type of ground truth used:

The ground truth primarily consisted of:
- Clinical Planning Objectives: These were established by the contributing institutions, including target coverage goals and normal tissue constraints.
- Contours: Provided for each case, likely drawn by clinicians at the institutions, representing the anatomical structures for planning.
- Conventional CT Images: These served as a "gold standard" or reference against which the HyperSight CBCT image-based plans were compared for clinical equivalence.
- Measurements: Ionization chamber measured dose and 2D gamma analysis were used for patient-specific QA, which are objective physical measurements.

8. The sample size for the training set:

The document does not specify the sample size for the training set. The study described is a clinical validation (test set) for the expanded indication of the already existing device. It focuses on the performance comparison for the intended use, not on the details of the model's training.

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

Not applicable/Not provided in the document. The document describes a study to support a change in the Indications for Use for an existing device, specifically validating the use of HyperSight CBCT images for primary treatment planning. It does not detail how the ground truth for the original training of the Halcyon/Ethos system or its RapidPlan component was established.

Summary

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November 3, 2023

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Varian Medical Systems Inc. % Lynn Allman Senior Director Regulatory Affairs 911 Hansen Way m/s E110 PALO ALTO, CA 94304

Re: K232113

Trade/Device Name: Halcyon, Ethos Radiotherapy System Regulation Number: 21 CFR 892.5050 Regulation Name: Medical Charged-Particle Radiation Therapy System Regulatory Class: Class II Product Code: IYE Dated: October 5, 2023 Received: October 6, 2023

Dear Lynn Allman:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (OS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming

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product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,

Locon Weidner

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

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Indications for Use

510(k) Number (if known) K232113

Device Name Halcyon and Ethos Radiotherapy System

Indications for Use (Describe)

Indications for Use:

The Halcyon and Ethos Radiotherapy System produce CBCT images that can be used in Image Guided Radiation Therapy, and the simulation and planning for radiation therapy.

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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K232113

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PREMARKET NOTIFICATION

510(k) Summary

Halcyon and Ethos Radiotherapy System

As required by 21 CFR 807.92

Submitter's Name:	Varian Medical Systems3100 Hansen Way, m/s E110Palo Alto CA94304
Contact Name:	Lynn Allman-Senior Director Regulatory AffairsPhone: (650) 424-5369Fax: 650/646.9200E-mail: submissions.support@varian.comDate: 01 Nov 2023
Proprietary Name:	Halcyon, Ethos Radiotherapy System
Classification Name:	Medical charged-particle radiation therapy system21CFR892.5050, IYE, Class II
Common/Usual Name:	Medical Linear Accelerator
Predicate Devices:	Halcyon, Ethos Radiotherapy System (K222941)
Device Description:	Halcyon and Ethos radiotherapy system are single energy medical linear accelerators(linacs) designed to deliver Image Guided Radiation Therapy and radiosurgery, usingIntensity Modulated and Volumetric Modulated Arc Therapy techniques. They consist ofthe accelerator and patient support within a radiation shielded treatment room and acontrol console outside the treatment room.An electron gun generates electrons which are accelerated by radio frequency (RF)power from a magnetron. The electrons strike a tungsten target producing photons (X-rays) for treatment and MV Imaging. The photons produced by the target are monitoredand controlled by a pressurized ion chamber.A beam collimation subsystem consisting of a primary and secondary collimator and twostacked multileaf collimators (MLCs) shapes the photon beam to define the treatmentarea.X-Ray images of the patient are used by the treater to verify the correct treatmentlocation. MV Imaging uses the treatment beam and a flat panel imager whereas kVimaging uses a high-capacity kV X-ray tube, a kV collimation system with full fan bowtiefilter with movable y-blades to define the imaging beam size and to capture the image, akV imager.
	Halcyon and Ethos radiotherapy system deliver a treatment generated by a TreatmentPlanning System from a physician's prescription. kV CBCT images from HyperSight canadditionally be used for planning treatments. Ethos radiotherapy system is capable ofdelivering adaptive treatments which can take into account changes in tumour geometrybetween treatment sessions.
Intended Use	Halcyon and Ethos Radiotherapy System are intended to provide stereotacticradiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere inthe body where radiation treatment is indicated.
	The intended use is the same as the predicate.
Indications for Use:	Halcyon and Ethos Radiotherapy System are indicated for the delivery of stereotacticradiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere inthe body where radiation is indicated for adults and pediatric patients.The Halcyon and Ethos Radiotherapy System produce CBCT images that can be used inImage Guided Radiation Therapy, and the simulation and planning for radiation therapy.
Significant Differences:	The significant difference compared to the predicate is to remove the limitation tosimulation and planning for only adaptive radiation therapy for the CBCT images and toreflect this in the Indications for Use.
	There are no technological differences in this device compared with the predicate. Use ofCBCT images for planning of adaptive treatments was covered in K222941. This 510(k)includes further data to demonstrate feasibility to produce primary treatment plans usingthe HyperSight imaging system that are clinically equivalent to plans generated fromconventional and simulator CT images.
Non-clinical Testing:	There was no non-clinical testing performed related to the significant change in thedevice. Further cybersecurity information was provided to FDA including test reports, planand summary report and labelling in the form of a Security White Paper to address therequirements of section 524B of the FD&C Act
Clinical Tests:	Overview:The following information was acquired as evidence for the safe use of HyperSight imagesfor primary treatment planning:•Images comparing sim CT vs Halcyon CBCTp in 26 patients including 16 men and 10women for different anatomical sites• Comparison of treatment plans (CT Sim-image based vs CBCTp image-based) for
	different anatomical sites created on those patients' images• Specifications of dose calculation such as DVH and other measurements that can beused to compare and validate these treatment plans
	Summary of the testing:A data set consisting of 26 human subject cases was obtained from three institutions inUS and Europe utilizing HyperSight imaging in institutionally approved prospective single-site clinical studies. The clinical studies included adult patients who were planned toreceive radiation therapy for conditions in the head/neck, thorax (including breast),abdomen, or pelvis. Both men and women and members of all races and ethnic groupswere eligible for these trials. Prospective study participants were excluded due topregnancy or plans for pregnancy during the clinical study, or due to an unwillingness or

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inability to provide informed consent to participate in the study. For two institutions, CBCT images were obtained using the CBCTp workflow, while the third captured images with the IGRT workflow. HyperSight images covered the same area of the body that was being treated with radiotherapy. The 26 cases are the first 26 patients submitted to Varian across the three studies; no selection of cases was made for this analysis.

For each case, planning CT and HyperSight CBCT image sets, contours, and clinical planning objectives were provided to Varian along with a summary list identifying the dosimetrist and physician involved with each case. Varian created radiation treatment plans for each type of image separately, using a standardized planning approach (RapidPlan) available in the Varian Eclipse treatment planning system. Each type of plan (CT- and HyperSight-based) was evaluated against clinical objectives, consisting of

target coverage goals and
normal tissue constraints.

The clinical cases provide a range of commonly encountered anatomies from head to pelvis in actual clinical treatment conditions. In addition, these anatomies comprise a wide range of tissues to challenge the treatment planning tasks of organ segmentation and dose calculation, including metal artifacts (as in dentition, fiducials, or hip prosthesis). In regions where respiratory motion could occur (thorax and abdomen), breath-hold or a 5.9-second free-breathing CBCT acquisition was utilized to limit motion artifacts.

The acceptance criteria applied to the evaluation included the following:

Patient-Specific QA
- lonization chamber measured dose ±3% as predicted by treatment O planning system
- O 2D gamma analysis of predicted planar dose distribution as compared to measured signal from the portal imaging panel - at least 95% of analyzed points passed 3%/2mm gamma criteria
Image Acquisition and Contouring
- Successful creation of contours for each dataset O
- O All relevant organs-at-risk and targets are discernable
Treatment Plan Comparison
- From established, published Clinical Goals for each anatomical site O

No adverse events were reported or observed.

Overall Conclusion:

The test results demonstrate the feasibility of the Halcyon 4.0 with HyperSight imaging system to produce primary treatment plans that are clinically equivalent to plans generated from conventional and simulator CT images.

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Standards Conformance: Halcyon and Ethos radiotherapy system conform to the same FDA recognised standards as the predicate device. See table below.

EN ISO 13485:2016.	Quality management systems. Requirements for regulatory purposes.
EN ISO 14971:2019.	Medical devices - Application of risk management to medical devices.
ISO 15223-1:2016.	Medical devices - Symbols to be used with medical devicelabels, labelling and information to be supplied - Part 1: General requirements.
AAMI/ANSI/ISO 10993-1	Biological evaluation of medical devices - Part 1: Evaluation and testing within arisk management process. (Biocompatibility)
IEC 62304: 2006+A1:2015	Medical device software - Software Life Cycle processes. (Software/Informatics)
IEC 62366-1:2015	Medical devices -Application of usability engineering to medical devices.(General I (QS/RM)).
ANSI / AAMI ES60601-1:2005 (IEC60601-1:2005, MOD) + A1 2012	Medical electrical equipment -- Part 1: General requirementsfor basic safety and essential performance. (General)
IEC 60601-2-1:2020 (Edition 4.0)	Medical electrical equipment - Part 2-1: Particular requirements for the basicsafety and essential performance of electron accelerators in the range 1 MeV to50 MeV. (Radiology).
IEC 60601-1-2:2014 (4th Edition)	General requirements for basic safety and essential performance - Collateralstandard: Electromagneticcompatibility - Requirements and tests. (General II (ES/EMC))
IEC 60601-1-6 Edition 3.1 2013-10	Medical electrical equipment - Part 1-6: General requirements for basic safetyand essential performance - Collateral standard: Usability (General I (QS/RM))
IEC 60601-1-3 Edition 2.1 2013-042	Medical electrical equipment - Part 1-3 General requirements for basic safetyand essential performance - Collateral Standard: Radiation protection indiagnostic X-ray equipment
IEC 60601-2-68:2014.	Medical electrical equipment –Part 2-68: Particular requirements for the basicsafety and essential performance of X-ray-based image guided radiotherapyequipment for use with electron accelerators, light ion beam therapyequipment and radionuclide beam therapy equipment
IEC 60601-2-44:2009+AMD1:2012+AMD2:2016).	Medical electrical equipment – Part 2-44: Particularrequirements for the basic safety and essential performance of X-ray equipmentfor computed tomography
IEC 60976 Ed. 2.0 2007.	Medical electrical equipment - Medical electron accelerators - Functionalperformance characteristics. (Radiology)
IEC 61217: 2011.	Radiotherapy equipment - Coordinates, movements, and scales. (Radiology)
IEC 62274: 2005	(FDA Consensus Standard), Medical electrical equipment - Safety ofradiotherapy record and verify systems. (Radiology)
IEC 60825-1 Ed. 2.0 2007.	Safety of laser products - Part 1: Equipment classification, and requirements[Including: technical corrigendum 1 (2008),Interpretation sheet 1 (2007), Interpretation sheet 2 (2007)].(Radiology)
AAMI RT2:2017	Radiation therapy readiness check

Argument for Substantial Equivalence to the Predicate Device:

Halcyon and Ethos Radiotherapy System in this submission are the same devices with the same intended use, techological characteristic specifications and non-clinical testing as cleared in the predicate device, K22941. Further clinical data have been supplied to FDA

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to demonstrate the suitability of the device for acquiring CBCT images with HyperSight for use in primary radiotherapy treatment planning. This includes

. Images comparing sim CT vs Halcyon CBCTp in 26 patients including 16 men and 10 women for different anatomical sites
. Comparison of treatment plans (CT Sim-image based vs CBCTp image-based) for different anatomical sites created on those patients' images
. Specifications of dose calculation used to compare and validate these treatment plans.

The conclusion of the clinical testing is that, based on the results, Halcyon 4.0 with HyperSight imaging configuration, specifically for 125 and 140 kVp imaging energies, allows for creation of treatment plans that are equivalent in quality and accuracy of delivery to standard CT scanners.

Varian therefore believes that the expanded indications for use to include using HyperSight CBCT images for primary treatment planning does not affect the safety or effectiveness of the subject device compared to the predicate and therefore does not represent a new intended use or raise different questions of safety or effectiveness.

Referring to the 510(k) Decision-Making Flowchart in "The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]" Guidance Notes:

1. The predicate (Halcyon and Ethos Radiotherapy System 4.0) is a legally marketed device. (K222941).
1. The device and its predicate have the same intended use.
1. The device and its predicate have the same technological characteristics.

Varian therefore believes that Halcyon and Ethos Radiotherapy System are substantially equivalent to the predicate.

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.