Halcyon

K170817 · Varian Medical Systems, Inc. · IYE · Jun 27, 2017 · Radiology

Device Facts

• Record ID: K170817
• Device Name: Halcyon
• Applicant: Varian Medical Systems, Inc.
• Product Code: IYE · Radiology
• Decision Date: Jun 27, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5050
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

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.

Device Story

Halcyon is a medical linear accelerator (linac) for Image Guided Radiation Therapy (IGRT), Intensity Modulated Radiation Therapy (IMRT), and Volumetric Modulated Arc Therapy (VMAT). It delivers radiation via a single 6MV flattening filter-free energy beam. The system comprises an accelerator and patient support couch within a shielded treatment room, operated from an external control console. Key design features include a ring-gantry with enclosed moving parts and a stacked dual-bank multi-leaf collimator (MLC) that replaces traditional beam-limiting jaws. The device provides 3 degrees of freedom for couch movement. It is used by clinicians to treat tumors and lesions, with output used to guide and deliver precise radiation doses, potentially improving treatment accuracy and patient outcomes.

Clinical Evidence

Bench testing only. Verification and validation testing conducted per FDA Quality System Regulation (21 CFR 820), ISO 13485, and ISO 14971. Electrical safety and EMC testing performed per IEC 60601-1 and IEC 60601-1-2. No clinical data presented.

Technological Characteristics

Medical linear accelerator; single 6MV flattening filter-free energy; ring-gantry design; stacked dual-bank MLC; 3-degree-of-freedom couch. Conforms to AAMI/ANSI ES60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-2-1, IEC 60825-1, IEC 60976, IEC 61217, IEC 62274, IEC 62304, IEC 62366, ISO 10993-1, IEC 60601-2-68, and ISO 15223-1.

Indications for Use

Indicated for delivery of stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body in adult and pediatric patients.

Regulatory Classification

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.

Predicate Devices

• TrueBeam 2.7 (K162472)

Submission Summary (Full Text)

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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 [phone] or [phone] 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 [phone] or [phone] 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: [phone] |
| | Fax: [phone] |
| | E-mail: [e-mail] |
| | 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.