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 adaptive 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.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the "Halcyon and Ethos Radiotherapy System." However, it does not contain the specific details regarding acceptance criteria for device performance or a detailed study proving the device meets these criteria in the format requested. The document primarily focuses on regulatory compliance, device description, intended use, significant differences from the predicate device, and non-clinical testing.

Here's a breakdown of what is and is not available in the provided text:

What's NOT available in the text:

A table of acceptance criteria and reported device performance: The document mentions "Test results showed conformance to applicable requirements specifications" but does not provide the specific performance criteria or the quantitative results.
Sample size for the test set and data provenance: No information on the number of images/patients used for testing or where the data came from (e.g., country, retrospective/prospective).
Number of experts and their qualifications for establishing ground truth: No details about experts for ground truth.
Adjudication method for the test set: Not mentioned.
Multi-reader multi-case (MRMC) comparative effectiveness study: There is no mention of a human reader study or comparison with humans, with or without AI assistance.
Standalone algorithm performance: While the document describes the software, it doesn't present performance metrics for the algorithm in isolation.
Type of ground truth used: Not specified.
Sample size for the training set: Not mentioned.
How the ground truth for the training set was established: Not mentioned.

What IS available from the text (related to the request):

Device Name: Halcyon, Ethos Radiotherapy System
Predicate Device: Halcyon, Ethos Radiotherapy System (K192377) - This implies that the current submission is for updates/modifications to an existing cleared device.
Indications for Use (Modified from Predicate): "The Halcyon and Ethos Radiotherapy System produce CBCT images that can be used in Image Guided Radiation Therapy, and the simulation and planning for adaptive radiation therapy."
Significant Differences (which necessitated the new submission):
- Cone Beam CT for Planning (CBCTp) with customizable protocols, guided workflow, interactive isocenter placement, patient marking, treatment position verification, and highly accurate HU specifications for dose calculation.
- High Performance Imaging (new hardware and software for 6-second kV CBCT acquisition, 6RPM gantry rotation, XL imager, new kV collimator, larger capacity x-ray tube, iCBCT-based metal artifact reduction, extended FOV up to 70 cm).
- Beam-Hold Interface for external motion compensation systems.
- Automatic mAs Detection.
Non-Clinical Testing:
- "Verification of the capability of the modified software and hardware to produce CBCT image Guided Radiotherapy and simulation and planning for adaptive radiation therapy was completed."
- "Validation of the use of the modified CBCTp work flow was also performed."
- "image quality and dose calculation accuracy was assessed and compared with planning CT images for its suitability to support adaptive planning."
- Testing conducted according to FDA Quality System Regulation (21 CFR §820), ISO 13485, ISO 14971, and "FDA's Guidance for Industry and FDA Staff, 'Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.'"
- Software Level of Concern: "major" (failure could result in serious injury or death).
- Electrical safety and EMC testing compliant with IEC 60601-1 and IEC 60601-1-2.
- Conclusion: "The outcome was that the product conformed to the defined user needs and intended uses and that there were no DRs (discrepancy reports) remaining which had a priority of Safety Intolerable or Customer Intolerable." This is a general statement of meeting requirements, but not specific performance metrics.
Ground Truth (implied): For the "image quality and dose calculation accuracy was assessed and compared with planning CT images for its suitability to support adaptive planning," the "planning CT images" would serve as a form of ground truth or reference standard for comparison. However, the details of this comparison are not provided.

In summary, the provided document does not contain the detailed study results and acceptance criteria in the requested format. It primarily confirms that non-clinical testing was performed and the device met its defined user needs and intended uses under regulatory guidelines for safety and performance, as compared to a predicate device.

Summary

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Image /page/0/Picture/0 description: The image contains 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, with the letters "FDA" in a blue box, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font below.

January 17, 2023

Varian Medical Systems, Inc % Peter Coronado Senior Director, Varian Oncology Systems Regulatory Affairs 3100 Hansen Way PALO ALTO CA 94304

Re: K222941

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: December 16, 2022 Received: December 16, 2022

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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for

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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.

Image /page/1/Picture/5 description: The image shows the name "Lora D. Weidner" in a simple, sans-serif font. The text is arranged vertically, with "Lora D." on the top line and "Weidner" on the second line. The background is plain and light.

Digitally signed by Lora D. Weidner -S Date: 2023.01.17 14:10:55 -05'00'

Lora Weidner, Ph.D. Assistant Director 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) K222941

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 adaptive radiation therapy.

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/0 description: The image shows three blue circles arranged horizontally. The circles are evenly spaced and appear to be the same size. The background is white, which makes the blue circles stand out. The image is simple and clean, with no other elements present.

K222941

Image /page/3/Picture/2 description: The image shows the logo for Varian, a Siemens Healthineers Company. The word "Varian" is in a bold, sans-serif font. Below the word "Varian" is the text "A Siemens Healthineers Company" in a smaller, sans-serif font. The logo is in black and white.

Varian Medical Systems

3100 Hansen Way Palo Alto, CA 94304 650.493.4000
800.544.4636

510(k) Summary		800.544.4636varian.com
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: Peter J. Coronado-Senior Director Regulatory AffairsPhone: 650/424.6320Fax: 650/646.9200E-mail: submissions.support@varian.comDate: 20 September 2022
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 (K192377)
Device Description:	Halcyon and Ethos Radiotherapy System are single energy medical linearaccelerators (linacs) designed to deliver Image Guided RadiationTherapy and radiosurgery, using Intensity Modulated and VolumetricModulated Arc Therapy techniques. They consist of the accelerator andpatient support within a radiation shielded treatment room and acontrol console outside the treatment room.
Intended Use	Halcyon and Ethos Radiotherapy System are intended to providestereotactic radiosurgery and precision radiotherapy for lesions, tumors,and conditions anywhere in the body where radiation treatment isindicated.

PREMARKET NOTIFICATION

The intended use is the same as the predicate.

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Image /page/4/Picture/0 description: The image shows the logo for Varian, a Siemens Healthineers Company. The word "varian" is written in a bold, sans-serif font. Below the word "varian" is the text "A Siemens Healthineers Company" in a smaller, sans-serif font. The logo is simple and modern.

Indications for Use:

Significant differences:

The significant differences compared to the predicate are:

Cone Beam CT for Planning (CBCTp): the Image Taker or Treater can acquire a kV CBCT that is used for the purpose of simulation and planning for adation therapy. This software feature includes customizable CBCTp protocols, guided workflow, interactive isocenter placement, Patient marking and treatment position verification. Additionally, highly accurate HU specifications for dose calculation are included due to new spectrum-dependent HU calibration and accurate modeling of the imaging chain. This feature requires Advanced Imaging.
. High Performance Imaging: is a combination of new hardware and software that enables 6 second kV CBCT acquisition for improved image quality. Improved imaging quality is achieved by 6RPM gantry rotation during image acquisition, an all-new XL imager, new kV collimator with filter, and larger capacity x-ray tube. Also included is new iCBCT-based metal artifact reduction and extended field of view (FOV) reconstruction out to 70 cm.
. Beam-Hold Interface: enables a validated external motion compensation system to send beam hold and release signals to HAL depending on the position or respiratory state of the patient.
. Automatic mAs Detection: This enables the system to automatically determine the optimal mAs (tubecurrent and time) to improve consistency of image quality

Non-clinical Testing

Verification of the capability of the modified software and hardware to produce CBCT image Guided Radiotherapy and simulation and planning for adaptive radiation therapy was completed. Validation of the use of the modified CBCTp work flow was also performed. In addition, the image quality and dose calculation accuracy was assessed and compared with planning CT images for its suitability to support adaptive planning. Hardware and software verification and validation testing was conducted according to the FDA Quality System Regulation (21 CFR §820), ISO 13485 quality Management System standard, ISO 14971 Risk Management Standard and the other FDA recognized consensus standards listed below. Test results showed conformance to applicable requirements specifications and assured hazard safeguards functioned properly. Software verification and validation testing were conducted and documentation was provided by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "major" level of concern, since a failure or latent flaw in the software could directly result in serious injury or death to the patient or operator. Electrical safety and electromagnetic compatibility (EMC) testing was conducted on this medical device. The system complies with the IEC 60601-1 standards for safety and the IEC 60601-1-2 standard for EMC.

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Image /page/5/Picture/0 description: The image shows the logo for Varian, a Siemens Healthineers Company. The word "varian" is written in a bold, sans-serif font. Below the word "varian" is the text "A Siemens Healthineers Company" in a smaller, sans-serif font. The logo is black and white.

Standards Conformance

Halcyon and Ethos Radiotherapy System conform to the following FDA recognised standards.

IEC 60601-1-3 Edition 2.1 2013-04 ANSI / AAMI ES60601-1:2005 (IEC 60601-1:2005, MOD) + A1 2012 IEC 60601-1-2:2014 (4th Edition) IEC 60601-1-6 Edition 3.1 2013-10 IEC 60601-2-1:2020 (Edition 4.0) IEC 60825-1 Ed. 2.0 2007 IEC 60976 Ed. 2.0 2007

IEC 61217: 2011 IEC 62274: 2005 IEC 62304: 2006 IEC 62366-1:2015 ISO 10993-1:2018 IEC 60601-2-68:2014 IEC 60601-2-44:2009+AMD1:2012+AMD2: AAMI RT2:2017 ISO 15223-1:2016 EN ISO 14971:2019 EN ISO 13485:2016

Conclusion of Non-Clinical testing

The outcome was that the product conformed to the defined user needs and intended uses and that there were no DRs (discrepancy reports) remaining which had a priority of Safety Intolerable or Customer Intolerable. Varian therefore considers Halcyon and Ethos Radiotherapy System to be safe and to perform at least as well as the predicate device.

Argument for Substantial Equivalence to the Predicate Device

A subset of technological characteristics and features of the current device is different to the predicate. These differences are all considered by Varian to be enhancements of the Intended Use is unchanged. The indications for use have been modified by the addition of the sentence "The Halcyon and Ethos Radiotherapy System produce CBCT images that can be used in Image Guided Radiation Therapy, and the simulation and planning for adaptive radiation therapy." There are no changes in the principle of operation of the device. The Verification and Validation demonstrates that the device is as safe and effective as the predicate. 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.