(99 days)
Halcyon is 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.
Halcyon is a single energy medical linac designed to deliver Image Guided Radiation Therapy and Radiosurgery, using Intensity Modulated and Volumetric Modulated Arc Therapy techniques. It consists of the accelerator and patient support within a radiation shielded treatment room and a control console outside the treatment room.
This document is a 510(k) Premarket Notification for the Halcyon medical linear accelerator. It describes the device, its intended use, and non-clinical testing performed to demonstrate substantial equivalence to a predicate device.
Here's an analysis of the provided text in relation to acceptance criteria and supporting studies:
1. Table of Acceptance Criteria and Reported Device Performance:
The document focuses on the regulatory submission process, demonstrating safety and effectiveness through non-clinical testing and conformance to standards, rather than reporting specific performance metrics against pre-defined acceptance criteria for a clinical study. The conclusion states that "the product conformed to the defined user needs and intended uses."
Therefore, a table of specific acceptance criteria and reported device performance (e.g., accuracy, precision) in the context of a clinical study cannot be extracted from this document. The document primarily discusses:
| Acceptance Criterion (Implicit) | Reported Device Performance (Summary) |
|---|---|
| Conformance to Safety Standards | Complies with IEC 60601-1 for safety. |
| Conformance to EMC Standards | Complies with IEC 60601-1-2 for EMC. |
| Conformance to Quality Systems | Conducted according to FDA Quality System Regulation (21 CFR §820), ISO 13485, ISO 14971, and other FDA recognized consensus standards. |
| Software Safety/Functionality | Software V&V conducted and documentation provided; considered "major" level of concern. No remaining Safety Intolerable or Customer Intolerable Discrepancy Reports (DRs). |
| Equivalence to Predicate | The device is considered as safe and effective and to perform at least as well as the predicate device (TrueBeam 2.7). |
2. Sample Size Used for the Test Set and the Data Provenance:
This document does not describe a clinical test set with human patient data or samples. The testing described is primarily non-clinical verification and validation (V&V) of hardware and software, and conformance to engineering and safety standards. Therefore, information about sample size for a test set and data provenance (e.g., country of origin, retrospective/prospective) is not applicable or available in this context.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:
As no clinical test set is described, information about experts for ground truth establishment is not applicable to this document. The "ground truth" for the non-clinical testing would be the specifications and requirements defined for the device's development.
4. Adjudication Method for the Test Set:
Given the absence of a clinical test set, an adjudication method is not applicable to this document.
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:
This document describes a medical linear accelerator, which is a device for radiation therapy delivery. It is not an AI-driven diagnostic or image interpretation device that would typically involve a multi-reader, multi-case study to assess human reader improvement with AI assistance. Therefore, no MRMC study or effect size is reported.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done:
The Halcyon is a medical device for treatment delivery, not a standalone algorithm. While it contains software, the "standalone performance" in this context refers to the device's ability to accurately deliver radiation according to a treatment plan, which is what the non-clinical V&V aimed to demonstrate. There is no mention of a separate standalone algorithm performance study in the way it's typically discussed for AI/ML diagnostic tools.
7. The Type of Ground Truth Used:
For the non-clinical testing described, the "ground truth" implicitly refers to:
- Engineering specifications and requirements: The device was tested against its design specifications and functional requirements.
- Standard compliance: The device's performance was compared against the requirements of various international standards (e.g., IEC 60601 series, ISO 13485, ISO 14971).
- Predicate device performance: The claim of "at least as well as the predicate device" suggests that the predicate's known performance serves as a benchmark.
8. The Sample Size for the Training Set:
This document does not describe an AI/ML model that would have a "training set" in the conventional sense of machine learning for diagnostic or predictive tasks. The software development follows traditional V&V processes, not a data-driven training paradigm with a specific training set size.
9. How the Ground Truth for the Training Set Was Established:
As there is no "training set" described for an AI/ML model, the establishment of ground truth for such a set is not applicable to this document. The "ground truth" for the device's software and hardware development is established through its design specifications, regulatory standards, and established engineering principles.
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Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, 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
June 27, 2017
Varian Medical Systems Inc. % Mr. Peter Coronado Director, Varian Oncology Systems Regulatory Affairs 911 Hansen Wav PALO ALTO CA 94304
Re: K170817
Trade/Device Name: Halcyon Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: May 26, 2017 Received: May 30, 2017
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
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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.
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/ResourcesforYou/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,
Michael D. O'Hara
For
Robert Ochs, Ph.D 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) K170817
Device Name Halcyon
Indications for Use (Describe)
Halcyon is 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.
| 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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PREMARKET NOTIFICATION
510(k) Summary
Halcyon
As required by 21 CFR 807.92
| Submitter's Name: | Varian Medical Systems |
|---|---|
| 3100 Hansen Way, m/s E110 | |
| Palo Alto CA94304 | |
| Contact Name: Peter J. Coronado-Director Regulatory Affairs | |
| Phone: 650/424.6230 | |
| Fax: 650/646.9200 | |
| E-mail: submissions.support@varian.com | |
| Date:26th May 2017 | |
| Proprietary Name: | Halcyon |
| Classification Name: | Medical charged-particle radiation therapy system |
| 21CFR892.5050, IYE, Class II | |
| Common/Usual Name: | Medical Linear Accelerator |
| Predicate Devices: | TrueBeam 2.7 (K162472). |
| Device Description: | Halcyon is a single energy medical linac designed to deliver Image Guided |
| Radiation Therapy and Radiosurgery, using Intensity Modulated and | |
| Volumetric Modulated Arc Therapy techniques. It consists of the | |
| accelerator and patient support within a radiation shielded treatment room | |
| and a control console outside the treatment room. | |
| Intended Use | The Halcyon radiotherapy delivery system is intended to provide |
| stereotactic radiosurgery and precision radiotherapy for lesions, tumors, | |
| and conditions anywhere in the body where radiation treatment is | |
| indicated. | |
| The intended use is the same as the predicate. |
Indications for Use:
Halcyon is 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.
Significant differences:
The significant differences compared to the predicate are:
- Multi-leaf collimator (MLC) consists of two sets of opposed leaf banks that are stacked. The upper leaf bank replaces beam-limiting movable jaws.
- . Ring design of gantry and stand; moving gantry parts are enclosed within panels
- . One Treatment Energy and MV Imaging Energy: 6MV, Flattening Filter Free
- 3 Degrees of Freedom of couch movement, compared with 4 or 6 in the predicate.
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Non-clinical Testing
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 as recommended 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.
Standards Conformance
Halcyon conforms to the following standards. For full details refer to document: "Introduction to Standards Conformance Forms and Summary Reports."
- AAMI/ ANSI ES60601-1: 2005 IEC 60601-1-2: 2007 & 2014 IEC 60601-1-6: 2013 IEC 60601-2-1: 2014 IEC 60825-1 Ed. 2.0 2007 IEC 60976 Ed. 2.0 2007 IEC 61217: 2011 IEC 62274: 2005 IEC 62304: 2006 AAMI / ANSI / IEC 62366:2007/(R)2013 ISO 10993-1:2009 IEC 60601-2-68:2014 ISO 15223-1:2012
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 to be safe and effective 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 remains unchanged. There are no new sites or tumor types listed in the Indications for Use compared with the predicate. There are no changes in the principle of operation of the device. The Verification demonstrates that the device is as safe and effective as the predicate. Varian therefore believes that Halcyon is substantially equivalent to the predicate.
§ 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.