K Number
K170817
Device Name
Halcyon
Date Cleared
2017-06-27

(99 days)

Product Code
Regulation Number
892.5050
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended 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.
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.
More Information

Not Found

No
The summary does not mention AI, ML, or related terms like deep learning or neural networks in the device description or performance studies. While it uses image guidance, this is a standard technique in radiation therapy and doesn't inherently imply AI/ML.

Yes.
The device is indicated for the delivery of stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body, which are therapeutic interventions.

No

Explanation: The device, Halcyon, is indicated for "delivery of stereotactic radiosurgery and precision radiotherapy," which are treatment modalities, not diagnostic. Its purpose is to deliver radiation for treatment, as further described by its function "to deliver Image Guided Radiation Therapy and Radiosurgery."

No

The device description explicitly states it consists of hardware components (accelerator, patient support, control console) in addition to software. The performance studies also include hardware verification and validation testing.

Based on the provided information, the Halcyon device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use clearly states that Halcyon is for the delivery of radiation therapy for lesions, tumors, and conditions anywhere in the body. This is a therapeutic application, not a diagnostic one performed in vitro (outside the body).
  • Device Description: The description details a medical linear accelerator (linac) used for delivering radiation, which is a treatment modality.
  • Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, etc.) or providing diagnostic information based on such analysis. The image processing mentioned is for guiding the radiation delivery, not for diagnosing a condition from a sample.

IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. Halcyon's function is to deliver treatment, not to perform such diagnostic tests.

N/A

Intended Use / 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.

Product codes (comma separated list FDA assigned to the subject device)

IYE

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

anywhere in the body

Indicated Patient Age Range

adults and pediatric patients.

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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.

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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

TrueBeam 2.7 (K162472).

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

§ 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.

0

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

1

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 UseThe 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.