Precision Treatment Planning System

K161136 · Accuray Incorporated · MUJ · Jun 24, 2016 · Radiology

Device Facts

• Record ID: K161136
• Device Name: Precision Treatment Planning System
• Applicant: Accuray Incorporated
• Product Code: MUJ · Radiology
• Decision Date: Jun 24, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

The Precision™ treatment planning system is indicated for creation and assessment of external photon beam irradiation treatment plans for radiation therapy, stereotactic radiotherapy or stereotactic radiosurgery for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated. A treatment plan provides an estimate of the dose distribution and the parameters utilized by the radiation delivery system. Plans must be reviewed and approved by qualified medical practitioners prior to delivery.

Device Story

Precision Treatment Planning System (TPS) creates and assesses external photon beam radiation therapy plans. Inputs include DICOM image series (CT, MR, PET). System transforms inputs into dose distribution estimates and delivery parameters using optimization and dose calculation subsystems. Operates on PC-class workstations with integrated GPU processing. Used by physicians, medical physicists, and dosimetrists in clinical settings to generate IMRT or 3DCRT plans. Output provided via user display or printed report for review against prescriptions and physics models. Facilitates tumoricidal dose delivery to targets while sparing healthy tissue; supports clinical decision-making through plan evaluation and approval by qualified practitioners.

Clinical Evidence

Bench testing only. Performance data demonstrates the system enables creation, saving, review, and modification of treatment plans with quality levels equivalent to or higher than those produced by the predicate systems.

Technological Characteristics

PC-class workstation with integrated GPU for optimization and dose calculation. Supports DICOM image series (CT, MR, PET). Features include rigid and deformable image registration, autosegmentation (Brain, Male Pelvis, Head and Neck), and multiple plan modes (IMRT, 3DCRT, Forward Planning). Connectivity via standard DICOM protocols.

Indications for Use

Indicated for creation and assessment of external photon beam irradiation treatment plans for radiation therapy, stereotactic radiotherapy, or stereotactic radiosurgery for lesions, tumors, and conditions anywhere in the body requiring radiation treatment. Intended for use by physicians, medical physicists, and dosimetrists.

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

• CyberKnife MultiPlan Treatment Planning System (K150873)
• TomoTherapy Planning Station (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 % Shweta Kaushik, Ph.D., RAC Regulatory Affairs Specialist II 1310 Chesapeake Terrace SUNNYVALE CA 94089

Re: K161136

Trade/Device Name: Precision Treatment Planning System Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: MUJ, IYE Dated: June 7, 2016 Received: June 9, 2016

Dear Dr. Kaushik:

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 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)

K161136

Device Name Precision™ Treatment Planning System

#### Indications for Use (Describe)

The Precision™ treatment planning system is indicated for creation and assessment of external photon beam irradiation treatment plans for radiation therapy, stereotactic radiotherapy or stereotactic radiosurgery for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated. A treatment plan provides an estimate of the dose distribution and the parameters utilized by the radiation delivery system. Plans must be reviewed and approved by qualified medical practitioners prior to delivery.

Type of Use (Select one or both, as applicable)

| <label><input checked="checked" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</label> |
|--------------------------------------------------------------------------------------------------------|
| <label><input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</label> |

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# 510(k) SUMMARY

This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.

# Name, Address, Phone and Fax number of the Applicant

Accuray Incorporated 1310 Chesapeake Terrace Sunnyvale, California 94089 Ph: [phone] Fax: [phone]

Contact Person Shweta Kaushik

Date Prepared April 21, 2016

# Device Name

Device Name: Precision™ Treatment Planning System Common Name: Radiation therapy treatment planning system Marketed Trade or Model Name: Precision™ Treatment Planning System Regulatory Classification Name: Medical charged-particle radiation therapy system Regulatory Class: II Regulatory Product Code: MUJ Classification Panel: Radiology Regulation Number: CFR 892.5050

# Device Description

The Precision™ Treatment Planning System is a radiation therapy planning system used for creation and assessment of treatment plans for delivery by radiation therapy, stereotactic radiotherapy or stereotactic radiosurgery treatment systems. It includes the planning system features of both the currently marketed predicate devices: CyberKnife

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MultiPlan Treatment Planning System (K150873) and the TomoTherapy Planning Station (K121934). Hence, the Precision Treatment Planning System is intended for treatment planning for multiple platforms:

- · Accuray's robotic radiosurgery systems, including but not limited to the CyberKnife® Treatment Delivery System (last cleared K150873).
- · Accuray's ring gantry systems, including but not limited to the Radixact™ Treatment Delivery System which is a next generation TomoTherapy® Treatment System (last cleared K121934).

## Indications for Use

The Precision™ treatment planning system is indicated for creation and assessment of external photon beam irradiation treatment plans for radiation therapy, stereotactic radiotherapy or stereotactic radiosurgery for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated. A treatment plan provides an estimate of the dose distribution and the parameters utilized by the radiation delivery system. Plans must be reviewed and approved by qualified medical practitioners prior to delivery.

## Intended Use

The Precision™ treatment planning system is indicated for creation and assessment of external photon beam irradiation treatment plans for radiation therapy, stereotactic radiotherapy or stereotactic radiosurgery for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated. A treatment plan provides an estimate of the dose distribution and the parameters utilized by the radiation delivery system. Plans must be reviewed and approved by qualified medical practitioners prior to delivery.

The Precision™ Treatment Planning System is intended to be used by physicians, medical physicists, and dosimetrists to generate radiation therapy, stereotactic radiotherapy or stereotactic radiosurgery treatment plans. Plans may be created with the Precision treatment planning system for delivery using Intensity Modulated Radiation Therapy (IMRT) or 3-D Conformal Radiation Therapy (3DCRT) techniques.

The users will be able to create a plan that satisfies established clinical objectives. For stereotactic radiosurgery, the plan will generally involve delivering a tumoricidal dose to target tissue, while minimizing dose to other tissues. For radiation therapy and

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stereotactic radiotherapy, the plan will generally involve delivering a damaging dose to diseased tissue at a level that allows healthy tissue in the target volume to recover, while also minimizing dose to tissue outside the target volume.

The treatment plan with dose distributions and complete delivered dose value along with the input data will be available through a user display or printed report for user review and evaluation against the treatment prescription and established physics models. The treatment plan will then be saved by the user, approved by the qualified medical practitioner, and subsequently delivered by the treatment delivery system.

# Technological Characteristics

There is no significant difference between the subject and predicate devices in terms of fundamental scientific technology or principles of operation. During the design of subject device, some modifications or additions were made to the CyberKnife MultiPlan Treatment Planning System to either include the functionality of TomoTherapy Planning Station or to improve the existing functionality/ user interface. A brief summary of the technological characteristics of the subject device in comparison to those of the predicate devices is provided below:

| Device<br>Characteristic | CyberKnife<br>MultiPlan<br>Treatment<br>Planning System<br>(K150873)<br>(Primary<br>Predicate Device) | TomoTherapy<br>Planning Station<br>(K121934)<br>(Predicate Device) | Precision Treatment Planning<br>System<br>(Subject Device) |
|--------------------------------------------|-------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------|
| Associated<br>Treatment<br>Delivery System | Determines<br>treatment planning<br>and dose<br>distribution for the<br>CyberKnife System | Determines<br>treatment planning<br>and dose<br>distribution for the<br>TomoTherapy<br>System | Same as predicates as determines<br>treatment planning and dose<br>distribution for both CyberKnife and<br>TomoTherapy Systems |
| Hardware | PC class<br>workstation | PC class<br>workstation | Same as predicates (PC class<br>workstation) |
| Image series<br>used | DICOM image<br>series (CT, MR,<br>PET, etc.) | DICOM image<br>series (CT) | Same as predicates (CT, MR,<br>PET, etc.) |
| Image registration | Rigid image<br>registration | N/A | Same as predicate with added<br>Deformable Fusion |

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#### Precise, innovative tumor treatments™

| Device<br>Characteristic | Cyberknife<br>MultiPlan<br>Treatment<br>Planning System<br>(K150873)<br>(Primary<br>Predicate Device) | TomoTherapy<br>Planning Station<br>(K121934)<br>(Predicate Device) | Precision Treatment Planning<br>System<br>(Subject Device) |
|---------------------------------------------------|-------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|
| Autosegmentation<br>(VOI contour tool) | Brain, Male Pelvis | N/A | Same as predicate with added<br>Head and Neck<br>Autosegmentation tool |
| Treatment<br>Machine set-up | Default for<br>CyberKnife System | Default for<br>TomoTherapy<br>System | Same as predicates but with<br>added option to select treatment<br>delivery system if multiple<br>machines are available |
| Plan Modes | N/A | IMRT, 3DCRT | Same as predicate with added<br>Forward Planning mode |
| Optimization and<br>dose calculation<br>subsystem | N/A | Separate GPU<br>processing<br>hardware | Same as predicate with GPU<br>integrated into the PC workstation |

#### Performance

The performance test data for Precision Treatment Planning System demonstrates that the user will be able to create, save, review and modify treatment plans with the same or higher level of quality as currently produced by each of the individual predicate treatment planning systems. Thus, Precision Treatment Planning System demonstrates similar performance characteristics to the predicate devices.

## Substantial Equivalence

The subject device, Precision Treatment Planning System is substantially equivalent to both predicate devices: CyberKnife MultiPlan Treatment Planning System and TomoTherapy Planning Station in intended use, technological characteristics and performance. The minor differences in technological characteristics raise no new questions of safety or efficacy and the performance data confirms that the Precision Treatment Planning System is as safe and effective as the predicate devices.