Radixact Treatment Delivery System

K161146 · Accuray Incorporated · IYE · Jun 24, 2016 · Radiology

Device Facts

• Record ID: K161146
• Device Name: Radixact Treatment Delivery System
• Applicant: Accuray Incorporated
• Product Code: IYE · Radiology
• Decision Date: Jun 24, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5050
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Radixact Treatment Delivery System is intended to be used for the delivery of radiation therapy, stereotactic radiotherapy or stereotactic radiosurgery to tumors or other targeted tissues. The megavoltage x-ray radiation is delivered using rotational, nonrotational, intensity modulated (IMRT), or non-modulated (non-IMRT/three dimensional conformal) treatment techniques and using image-guided (IGRT) or non-image-guided workflows in accordance with the physician approved plan.

Device Story

Radixact Treatment Delivery System is a radiation therapy device providing Image Guided Radiation Therapy (IGRT) via integral megavoltage CT (MVCT) imaging. It delivers helical (rotational) and fixed-angle (non-rotational) radiation therapy to tumors. The system operates as a standalone delivery unit, executing treatment plans generated by external planning systems (e.g., Accuray Precision) and managed by external data systems (e.g., iDMS). It is operated by clinical staff in a radiation oncology environment. The device uses a standing wave accelerator and magnetron to produce a 6 MV photon beam, with collimation via primary jaws and a multi-leaf collimator (MLC). The physician uses the system to deliver radiation according to an approved plan; the device does not diagnose, recommend regimens, or quantify effectiveness. Benefits include precise, image-guided delivery of radiation therapy to targeted tissues.

Clinical Evidence

No clinical tests were required to establish substantial equivalence. Evidence consists of bench-only verification and validation testing demonstrating conformance to design specifications and recognized consensus safety standards.

Technological Characteristics

Radiation therapy delivery system; standing wave accelerator; magnetron RF source; 6 MV nominal energy; multi-leaf collimator (MLC); integral MVCT imaging (39 cm FOV); 85 cm bore; continuous gantry rotation; patient couch; standalone configuration; 380-480V 3-phase power; IEC 61217 compliant axes.

Indications for Use

Indicated for the delivery of radiation therapy, stereotactic radiotherapy or stereotactic radiosurgery to tumors or other targeted tissues anywhere in the body under the direction of a licensed medical practitioner.

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

• TomoTherapy Treatment System (K121934)

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 24, 2016

Accuray Incorporated % Mr. Keith Picker Regulatory Affairs Specialist 1209 Deming Way MADISON WI 53717

Re: K161146

Trade/Device Name: Radixact Treatment Delivery System Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: April 22, 2016 Received: April 22, 2016

Dear Mr. Picker:

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

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 yours.

Michael D'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) K161146

Device Name

Radixact Treatment Delivery System

#### Indications for Use (Describe)

The Radixact Treatment Delivery System is indicated for the delivery of radiation therapy, stereotactic radiotherapy or stereotactic radiosurgery to tumors or other targeted tissues anywhere in the direction of a licensed medical practitioner.

| Type of Use (Select one or both, as applicable) |
|---------------------------------------------------------------------------------------|
| <span style="font-size: large;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) |
| <span style="font-size: large;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) |

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Image /page/3/Picture/0 description: The image shows the Accuray logo. The logo consists of a stylized graphic to the left of the word "ACCURAY". The graphic is made up of three curved lines in green, purple, and blue. The word "ACCURAY" is in a sans-serif font and is blue. There is a registered trademark symbol to the right of the word "ACCURAY".

#### Section 8 510(k) Summary

#### Submitter

Accuray Incorporated 1209 Deming Way Madison, WI 53717-1954 Phone: [phone] Fax: [phone]

| Contact: | Keith Picker |
|----------------|----------------|
| Date Prepared: | April 25, 2016 |

#### Device Identification

Device Name: Trade & Brand Names: Common Name: Regulation Number: Regulation Name: Regulatory Class: Product Code:

Radixact Treatment Delivery System Radixact Treatment Delivery System Radiation Therapy System 21 CFR 892.5050 Medical charged-particle radiation therapy system Class II IYE

#### Predicate Device

TomoTherapy Treatment System (K121934)

#### Device Description

The Radixact Treatment Delivery System is a radiation therapy delivery system that provides Image Guided Radiation Therapy (IGRT) using integral megavoltage CT imaging capabilities and delivers helical (rotational) and fixed-angle (non-rotational) radiation therapy to tumors and other targeted tissues.

The Radixact Treatment Delivery System is an updated design of the radiation delivery elements of the predicate TomoTherapy Treatment System (last cleared on K121934). The Radixact Treatment Delivery System delivers radiation therapy treatment plans generated on planning systems such as Accuray's Precision™ Treatment Planning System and stored on Accuray's iDMS™ Integrated Data Management System devices. The planning and data management devices are not addressed in this 510(k).

The Radixact Treatment Delivery System is a prescription device that delivers radiation in accordance with a physician approved plan. As with the TomoTherapy Treatment System, the Radixact Treatment Delivery System does not diagnose disease, recommend

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treatment regimens or quantify treatment effectiveness. Accordingly, it is not intended for diagnostic use.

## Intended Use

The Radixact Treatment Delivery System is intended to be used for the delivery of radiation therapy, stereotactic radiotherapy or stereotactic radiosurgery to tumors or other targeted tissues. The megavoltage x-ray radiation is delivered using rotational, nonrotational, intensity modulated (IMRT), or non-modulated (non-IMRT/three dimensional conformal) treatment techniques and using image-guided (IGRT) or non-image-guided workflows in accordance with the physician approved plan.

## Indications for Use

The Radixact Treatment Delivery System is indicated for the delivery of radiation therapy, stereotactic radiotherapy or stereotactic radiosurgery to tumors or other targeted tissues anywhere in the body under the direction of a licensed medical practitioner.

While the indications for use of the Radixact Treatment Delivery System are stated slightly differently from those of the predicate, the differences are not critical to the intended use of the devices nor do they affect the safety and/or effectiveness of the new device as compared to the predicate device. Both devices provide the same types of radiation therapy.

## Technological Characteristics

The Radixact Treatment Delivery System has imaging and treatment capabilities equivalent to those of the predicate TomoTherapy Treatment System. It also has a similar functionally-equivalent CT style gantry and patient couch. Further, the clinical workflow is the same as that of the predicate TomoTherapy Treatment System.

The Radixact Treatment Delivery System and the predicate device employ the same fundamental scientific principles, and have substantially equivalent technological characteristics and principles of operation. The main difference between the predicate TomoTherapy Treatment System and the Radixact Treatment Delivery System is that the predicate includes integral treatment planning and data management subsystems, whereas the Radixact Treatment Delivery System is strictly a radiation treatment delivery device.

Where there are technological differences between the Radixact Treatment Delivery System and the predicate device, those differences do not raise different questions of safety or effectiveness.

A table comparing the predicate cleared on K121934 and the Radixact Treatment Delivery System is presented below:

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| General Characteristics | Predicate Device<br>TomoTherapy<br>Treatment System<br>(K121934) | Subject Device<br>Radixact<br>Treatment Delivery System |
|--------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------|
| System Configuration | Radiation delivery system<br>integrated with data management<br>system and planning system | Stand alone radiation delivery<br>system (does not include data<br>management system or<br>planning system) |
| Vault | | |
| Min. Room Dimensions | | |
| Height* | 270 cm | 274 cm** |
| Width* | 462 cm | 462 cm** |
| Length* | 596 cm | 602 cm** |
| Device Dimensions<br>(gantry and couch) | | |
| Height* | 252 cm | 255 cm** |
| Width* | 280 cm | 280 cm** |
| Length* | 466 cm | 473 cm** |
| Weight | 4,943 kg | 6580 kg** |
| Environment | | |
| Line Voltage | 380-480V, 3-Phase | Identical to predicate |
| Ambient Room<br>Temperature | 68-75 °F (20-24 °C) | Identical to predicate |
| Relative Humidity | 30%-60%, non-condensing | Identical to predicate |
| | | |
| <b>Gantry Mechanical<br/>Features</b> | | |
| Degrees of Rotation | Continuous rotation around Y-<br>axis (axes per IEC 61217) | Identical to predicate |
| Direction of Rotation | Clockwise | Identical to predicate |
| Bore Size | 85 cm diameter | Identical to predicate |
| Speed of Rotation<br>Treatment<br>Imaging | 1 to 5 RPM<br>6 RPM | Identical to predicate<br>10 RPM |
| Couch Support in Bore | Not provided | Provided |
| <b>Radiation Delivery<br/>Modes</b> | Helical<br>Direct | Identical to predicate<br>Identical to predicate |
| <b>Photon Beam</b> | | |
| Accelerator Type | Standing wave | Identical to predicate |
| RF Source | Magnetron | Identical to predicate |
| Nominal Energy | 6 MV | Identical to predicate |
| Fixed Field Size | 1.0 cm x 40 cm<br>2.5 cm x 40 cm<br>5.0 cm x 40 cm | Identical to predicate<br>Identical to predicate<br>Identical to predicate |
| Dynamic Field Size | 1.0 - 2.5 cm x 40 cm<br>1.0 - 5.0 cm x 40 cm | Identical to predicate<br>Identical to predicate |
| Dose Rate | 850 cGy/min | 850 cGy/min or 1000 cGy/min<br>options |
| Collimation | Primary collimation, jaws and<br>multi-leaf collimator (MLC) | Identical to predicate |
| General Characteristics | Predicate Device<br>TomoTherapy<br>Treatment System<br>(K121934) | Subject Device<br>Radixact<br>Treatment Delivery System |
| Imaging | | |
| Field of View | 39 cm diameter | Identical to predicate |
| Dose per MVCT image<br>(typical) | 0.5 - 3.0 cGy | Identical to predicate |
| Slice spacing | 1, 2, 3, 4 and 6 mm<br>reconstruction intervals | Identical to predicate |
| Spatial Resolution | 1.6 mm spatial resolution | Identical to predicate |
| Laser System | | |
| Stationary | Green lasers, identify virtual and<br>actual isocenter | Identical to predicate |
| Moveable<br>(for patient<br>positioning and<br>registration) | Red lasers, offset from virtual<br>isocenter | Identical to predicate |
| Patient Couch | | |
| Biocompatibility | Carbon-fiber top | Equivalent to predicate |
| Motion<br>X-axis<br>Y-axis<br>Z-axis | Independent of other axes<br>Coupled with Z-axis<br>(via couch Cobra motion)<br>Coupled with Y-axis<br>(via couch Cobra motion) | Identical to predicate<br>Independent of other axes<br>Independent of other axes |
| Power Distribution | | |
| Isolation | Transformer | Equivalent to predicate |
| UPS for Data Back-up | Provided | Equivalent to predicate |
| General Characteristics | Predicate Device<br>TomoTherapy<br>Treatment System<br>(K121934) | Subject Device<br>Radixact<br>Treatment Delivery System |
| Operator Station | User interface to system<br>functions (i.e., patient and<br>procedure selection, and<br>procedure delivery) | Functionally equivalent to<br>predicate |
| Machine Control<br>Software | Controls radiation delivery and<br>positioning systems (referred to<br>as the RDS - Radiation Delivery<br>System) | Functionally equivalent to<br>predicate (referred to as the<br>ECS – Embedded Controls<br>Subsystem) |
| Data Interfaces<br>Operator Station | Provides measurements and<br>status during operation | Functionally equivalent to<br>predicate |
| Database | Integrated database used for<br>gathering operational data and<br>storage of procedure data | Works with functionally-<br>equivalent external database |
| Safety Features | Interlock Subsystems<br>Data integrity checking | Functionally equivalent to<br>predicate<br>Functionally equivalent to<br>predicate |

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* Dimensions are rounded to the nearest centimeter.

** Information Source: Radixact Site Planning Guide T-SPG-01000, Rev A.

## Performance Data

The Radixact Treatment Delivery System was tested and shown to be in compliance with the requirements of applicable recognized consensus safety standards for medical devices. Results of verification and validation testing confirm that the Radixact Treatment Delivery System conforms to design specifications and meets the needs of the intended users. No clinical tests were required to establish substantial equivalence. The performance data demonstrate that the Radixact Treatment Delivery System is as safe and effective, and performs as well as the predicate device.

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#### Conclusion

The Radixact Treatment Delivery System is substantially equivalent to the predicate The intended use, major technological characteristics and the principles of device. operation of the Radixact Treatment Delivery System are substantially equivalent to those of the predicate device. Minor differences do not raise different questions of safety and effectiveness of the Radixact Treatment Delivery System in comparison to the predicate device. Further, performance data demonstrate that the Radixact Treatment Delivery System is as safe and effective, and performs as well as the predicate device. Accordingly, the Radixact Treatment Delivery System is substantially equivalent to the predicate device.