TRUE BEAM, TRUE BEAM STX, EDGE

K140528 · Varian Medical Systems, Inc. · IYE · Sep 5, 2014 · Radiology

Device Facts

• Record ID: K140528
• Device Name: TRUE BEAM, TRUE BEAM STX, EDGE
• Applicant: Varian Medical Systems, Inc.
• Product Code: IYE · Radiology
• Decision Date: Sep 5, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5050
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Indications for Use

The TrueBeam and Edge Systems are intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body where radiation therapy is indicated for adults and pediatric patients.

Device Story

Medical linear accelerator system; delivers photon, electron, and diagnostic kV X-ray radiation; installed in radiation-shielded vault with external control console. Used by clinicians for stereotactic radiosurgery and precision radiotherapy. Integrates functionality of previously cleared Trilogy system. Device operates by generating radiation beams to treat tumors and lesions; clinical staff use system to plan and deliver targeted radiation therapy. Benefits include precise treatment of various malignancies and benign conditions throughout the body.

Clinical Evidence

No clinical data; no new testing performed as the device is unchanged from the previously cleared predicate.

Technological Characteristics

Medical linear accelerator; photon, electron, and diagnostic kV X-ray radiation sources. System consists of radiation-producing component for shielded vault and external control console. Same technological characteristics as K123291.

Indications for Use

Indicated for adults and pediatric patients requiring stereotactic radiosurgery or precision radiotherapy for lesions, tumors, and conditions anywhere in the body, including brain, spine, head and neck, thoracic, gynecologic, gastrointestinal, genitourinary, breast, skin, and pediatric tumors, as well as benign diseases and metastases.

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 Radiotherapy System and Accessories (K123291)
• CyberKnife Robotic Radiosurgery System and CyberKnife VSI Systems (K102650)
• Agility (K123808)

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

September 5, 2014

Varian Medical Systems, Inc. % Mr. Peter J. Coronado Director, Global Regulatory Affairs 3100 Hansen Way PALO ALTO CA 84304

Re: K140528

Trade/Device Name: TrueBeam, TrueBeam STx, Edge Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: July 31, 2014 Received: August 4, 2014

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-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.

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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/Resourcesfor You/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

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Sincerely yours,

Michael D'Hara

For

Janine M. Morris 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) K140528

#### Device Name

TrueBeam and Edge Radiotherapy Delivery System

#### Indications for Use (Describe)

The TrueBeam and Edge Systems are intended to provide stereotactic radiotherapy for lesions, and conditions anywhere in the body where radiation therapy is indicated for adults and pediatric patients.

The TrueBeam and Edge Systems may be used in the delivery of radiation for treatment that includes: bram and spine tumors (such as glioma, meningioma, craniopharyngioma, pituitary tumors, spinal cord tumors, hemangioblastoma, orbital tumors, optic nerve tumors, and skull based tumors (such as unknown primary of the head and neck, oral cavity, hypopharynx, larynx, oropharynx, sinonasal, salivary gland, and thyroid cancer), thoracic tumors (such as ung cancer, esophageal cancer, thymic tumors, and mesothelioma), gynecologic tumors (such as ovarian, endometrial, vulvar, and vaginal), gastrointestinal tumors (such as gastric, hepatobiliary, colon, rectal, and anal carvinoma), genitourinary tumors (such as prostate, bladder, testicular, and kidney), breast tumors, sarcomas, lymphoid tumors (such as Hodgkin's lymphoma), skin cancers (such as squamous cell, and melanoma), benign diseases (such as schwannoma, arteriovenous malformation, cavemous malformation, trigeninal neuralgia, chordoma, glomus tumors, and hemangiomas), metastasis (including all parts of the body such as brain, bone, liver, lung, kidney, and skin) and pediatric tumors (such as glioma, pitutary tumors, hemangioblastoma, craniopharyngioma, metastasis, medulloblastoma, nasopharyngeal tumors, arteriovenous malformation, cavernous malformation and skull base tumors).

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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#### FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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Varian Medical Systems, Inc. 3100 Hansen Way Palo Alto, CA 94304-1038 USA Tel [phone] www.varian.com

# Premarket Notification [510(k)] Summary

# TrueBeam/Edge Radiotherapy Delivery Systems

The following information is provided following the format of 21 CFR 807.92(c).

| Submitter's Name: | Varian Medical Systems, Inc.<br>3100 Hansen Way E-110<br>Palo Alto, CA 94304<br><br>Contact Name: Peter J. Coronado<br>Phone: [phone]<br>Fax: [phone]<br><br>Date: 31 July 2014 |
|-----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Proprietary Name: | TrueBeam™/ TrueBeam STx™ Radiotherapy Delivery System<br>Edge™ Radiotherapy Delivery System |
| Classification Name: | Medical charged-particle radiation therapy system<br>21 CFR 892.5050, Class II<br>Product Code: IYE |
| Common/Usual Name: | Medical linear accelerator |
| Predicate Devices: | TrueBeam Radiotherapy System and Accessories: K123291<br>CyberKnife Robotic Radiosurgery System and CyberKnife VSI Systems:<br>K102650<br>Agility™ K123808 |
| Device Description: | The TrueBeam™ and Edge™ Radiotherapy Delivery Systems are medical linear<br>accelerators that integrate the previously cleared Trilogy Radiotherapy system<br>and associated accessories into a single device.<br><br>The system consists of two major components, a photon, electron, and<br>diagnostic kV X-ray radiation beam-producing component that is installed in a<br>radiation-shielded vault and a control console area located outside the<br>treatment room. |
| Intended Use<br>Statement | The TrueBeam and Edge Systems are intended to provide stereotactic<br>radiosurgery and precision radiotherapy for lesions, tumors, and conditions<br>anywhere in the body where radiation therapy is indicated for adults and<br>pediatric patients. |
| Indications for Use<br>Statement | The TrueBeam and Edge Systems are intended to provide stereotactic<br>radiosurgery and precision radiotherapy for lesions, tumors, and conditions<br>anywhere in the body where radiation therapy is indicated for adults and<br>pediatric patients.<br><br>The TrueBeam and Edge Systems may be used in the delivery of radiation for<br>treatment that includes: brain and spine tumors (such as glioma, meningioma,<br>craniopharyngioma, pituitary tumors, spinal cord tumors, hemangioblastoma,<br>orbital tumors, ocular tumors, optic nerve tumors, and skull based tumors),<br>head and neck tumors (such as unknown primary of the head and neck, oral<br>cavity, hypopharynx, larynx, oropharynx, nasopharynx, sinonasal, salivary<br>gland, and thyroid cancer), thoracic tumors (such as lung cancer, esophageal<br>cancer, thymic tumors, and mesothelioma), gynecologic tumors (such as<br>ovarian, cervical, endometrial, vulvar, and vaginal), gastrointestinal tumors<br>(such as gastric, pancreatic, hepatobiliary, colon, rectal, and anal carcinoma),<br>genitourinary tumors (such as prostate, bladder, testicular, and kidney),<br>breast tumors, sarcomas, lymphoid tumors (such as Hodgkin's and non-<br>Hodgkin's lymphoma), skin cancers (such as squamous cell, basal cell, and<br>melanoma), benign diseases (such as schwannoma, arteriovenous<br>malformation, cavernous malformation, trigeminal neuralgia, chordoma,<br>glomus tumors, and hemangiomas), metastasis (including all parts of the body<br>such as brain, bone, liver, lung, kidney, and skin) and pediatric tumors (such as<br>glioma, ependymoma, pituitary tumors, hemangioblastoma,<br>craniopharyngioma, meningioma, metastasis, medulloblastoma,<br>nasopharyngeal tumors, arteriovenous malformation, cavernous<br>malformation and skull base tumors). |
| Technological<br>Characteristics | This device has the same technological characteristics as the previously<br>cleared TrueBeam device K123291. This submission does not introduce any<br>device modifications. |
| Substantial<br>Equivalence | The indication for use statement for the TrueBeam and Edge radiotherapy<br>delivery systems is similar but not identical to its primary predicate device<br>K123291. The changes made with this submission include specific indications<br>for some typical lesions, tumors and conditions that may be treated with<br>radiation. The addition of this text to the indication statement does not<br>change the therapeutic effect of the device. These treatment sites fall within<br>the previously cleared general indication “to provide stereotactic radiosurgery<br>and precision radiotherapy for lesions, tumors, and conditions anywhere in<br>the body where radiation therapy is indicated”. The device itself is unchanged<br>from the previous submission K123291. The principles of operation,<br>technological characteristics and labeling are substantially equivalent.<br><br>The functionality and intended use of the TrueBeam and Edge systems is<br>substantially equivalent to that of its predicate devices, CyberKnife and<br>CyberKnife VSI Systems (K102650) and Agility™ K123808, in safety and<br>effectiveness. |
| Summary of<br>performance testing | No changes have been made to the device and no new testing has been<br>performed. |

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