Accuray Precision Treatment Planning System

K171086 · Accuray Incorporated · IYE · Jun 8, 2017 · Radiology

Device Facts

• Record ID: K171086
• Device Name: Accuray Precision Treatment Planning System
• Applicant: Accuray Incorporated
• Product Code: IYE · Radiology
• Decision Date: Jun 8, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

The Accuray 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 Accuray 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 Accuray 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 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.

Device Story

Accuray Precision™ Treatment Planning System is a software-based tool for radiation oncology. Inputs include diagnostic CT, MR, and PET images. Users (physicians, physicists, dosimetrists) register/fuse images, contour target volumes and critical structures, and specify treatment delivery machine (CyberKnife® or TomoTherapy®), delivery mode (IMRT, 3DCRT), and dose criteria. The system calculates/optimizes dose distributions. Output is a treatment plan for review, approval, and delivery. Used in clinical settings to facilitate precise radiation delivery, minimizing dose to healthy tissue while targeting diseased tissue.

Clinical Evidence

Bench testing only. Performance testing included absolute dose, End-to-End (E2E) testing for CyberKnife, and Gamma index analysis for CyberKnife and TomoTherapy systems to verify dose calculation accuracy and plan quality.

Technological Characteristics

PC-class workstation software. Dose calculation algorithms include Superposition/Convolution, Ray Tracing, FSPB, and Monte Carlo. Supports IMRT and 3DCRT techniques. Connectivity via central database server (iDMS™).

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.

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

• Accuray Precision™ Treatment Planning System (K161136)

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 8, 2017

Accuray Incorporated % Shweta Kaushik, Ph.D., RAC Senior Regulatory Affairs Specialist 1310 Chesapeake Terrace SUNNYVALE CA 94089

Re: K171086

Trade/Device Name: Accuray Precision™ Treatment Planning System Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE, MUJ Dated: April 10, 2017 Received: April 12, 2017

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 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) K171086

Device Name

Accuray Precision™ Treatment Planning System

#### Indications for Use (Describe)

The Accuray 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)

| <span> <b>☑</b> Prescription Use (Part 21 CFR 801 Subpart D) </span> |
|----------------------------------------------------------------------------|
| <span> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </span> |

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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

Accurav Incorporated 1310 Chesapeake Terrace Sunnyvale, California 94089 Phone: [phone] Fax: [phone]

Contact Person Shweta Kaushik

# Date Prepared

April 10, 2017

## Device Name

Device Name: Accuray Precision™ Treatment Planning System Marketed Trade or Model Name: Accuray Precision™ Treatment Planning System Common Name: Radiation therapy treatment planning system Regulation Number: 21 CFR 892.5050 Regulatory Classification Name: Medical charged-particle radiation therapy system Requlatory Class: II Regulatory Product Code: IYE, MUJ Classification Panel: Radiology

## Device Description

The Accuray 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.

The radiation treatment plan is developed by using diagnostic CT (primary image series) and/or secondary images (MR and PET) of the patient previously acquired prior to treatment and saved into the central database server (iDMS™) Data Management

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System). The images are imported from the database server into the Accuray Precision™ System and registered/ fused for dose calculation and to accurately define/contour regions of interest (target) and the surrounding critical anatomical structures to avoid.

The user (dosimetrist/ medical physician) then specifies the treatment delivery machine (CyberKnife® or TomoTherapy® systems), treatment delivery mode (e.g. 3DCRT, IMRT) and the patient alignment at the treatment machine. This is followed by specifying the radiation dose criteria for the identified regions of interest, as well as the number of fractions over which this dose is to be administered. After the relevant data has been entered, the user initiates the treatment plan calculation or optimization process. When the treatment plan has been calculated, the user may refine the plan with adjustments to the regions of interest, avoidance structures, and dose criteria and re-optimize the plan.

Once an optimized treatment plan is produced that meets the requirements of the intended therapy, the prescribing physician approves the plan for delivery and the plan is saved on the database server as a treatment delivery plan. The plan reports are also printed for the patient record.

#### Indications for Use

The Accuray 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 Accuray 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

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system. Plans must be reviewed and approved by qualified medical practitioners prior to delivery.

The Accuray 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 Accuray 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 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 device (Accuray Precision™ Treatment Planning System with modifications) and the predicate device (Accuray Precision™ Treatment Planning System, last cleared on K161136) in terms of fundamental scientific technology or principles of operation. A brief summary of the technological characteristics of the subject device in comparison to those of the predicate device is provided below:

| Device<br>Characteristic | Accuray Precision™ Treatment<br>Planning System (K161136)<br>(Predicate Device) | Accuray Precision™ Treatment<br>Planning System with modifications<br>(Subject Device) |
|-----------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The Accuray Precision™ treatment<br>planning system is indicated for creation<br>and assessment of external photon beam<br>irradiation treatment plans for radiation<br>therapy, stereotactic radiotherapy or<br>stereotactic radiosurgery for lesions, | Same as predicate |
| Device<br>Characteristic | Accuray Precision™ Treatment<br>Planning System (K161136)<br>(Predicate Device) | Accuray Precision™ Treatment<br>Planning System with modifications<br>(Subject Device) |
| | tumors and conditions anywhere in the<br>body when radiation treatment is<br>indicated. A treatment plan provides an<br>estimate of the dose distribution and the<br>parameters utilized by the radiation<br>delivery system. Plans must be reviewed<br>and approved by qualified medical<br>practitioners prior to delivery. | |
| | The Accuray Precision™ Treatment<br>Planning System is intended to be used<br>by physicians, medical physicists, and<br>dosimetrist to generate radiation therapy,<br>stereotactic radiotherapy or stereotactic<br>radiosurgery treatment plans. Plans may<br>be created with the Precision treatment<br>planning system for delivery using<br>Intensity Modulated Radiation Therapy<br>(IMRT) or 3-D Conformal Radiation<br>Therapy (3DCRT) techniques. | |
| | The users will be able to create a plan that<br>satisfies established clinical objectives.<br>For stereotactic radiosurgery, the plan will<br>generally involve delivering a tumoricidal<br>dose to target tissue, while minimizing<br>dose to other tissues. For radiation<br>therapy and stereotactic radiotherapy, the<br>plan will generally involve delivering a<br>damaging dose to diseased tissue at a<br>level that allows healthy tissue in the<br>target volume to recover, while also<br>minimizing dose to tissue outside the<br>target volume. | |
| | The treatment plan with dose distributions<br>and complete delivered dose value along<br>with the input data will be available<br>through a user display or printed report for<br>user review and evaluation against the<br>treatment prescription and established<br>physics models. The treatment plan will<br>then be saved by the user, approved by<br>the qualified medical practitioner, and<br>subsequently delivered by the treatment<br>delivery system. | |
| Hardware | PC class workstation | Same as predicate |
| Associated<br>Treatment<br>Delivery<br>System | Determines treatment planning and dose<br>distribution for the CyberKnife and<br>TomoTherapy Systems | Same as predicate with added<br>support for continued patient<br>treatment on TomoTherapy system<br>upgraded to a future configuration |
| Device<br>Characteristic | Accuray Precision™ Treatment<br>Planning System (K161136)<br>(Predicate Device) | Accuray Precision™ Treatment<br>Planning System with modifications<br>(Subject Device) |
| Dose<br>Calculation<br>Algorithms | Superposition/ Convolution, Ray Tracing,<br>FSPB and Monte Carlo (only for circular<br>collimators) | Same as predicate with<br>modifications to Monte Carlo dose<br>calculation algorithm to support<br>InCise™ Multileaf Collimator (MLC) |
| Dosimetry<br>Tests | Absolute Dose and End-to-End (E2E)<br>(CyberKnife Systems)<br>Gamma index (Both CyberKnife and<br>TomoTherapy Systems) | Same as predicate |

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# Performance

The performance test data for subject device, Accuray Precision™ Treatment Planning System with modifications, confirms that the user will be able to create, save, review and modify treatment plans with the same or higher level of quality as compared to the treatment plans created using the predicate device, Accuray Precision™ Treatment Planning System. The results from testing included in the premarket notification demonstrate that the performance characteristics of the subject device are equivalent to the predicate device.

# Substantial Equivalence

The subject device, Accuray Precision™ Treatment Planning System with modifications, is substantially equivalent to the predicate device, Accuray Precision™ Treatment Planning System, in intended use, technological characteristics and performance. The modifications performed to the predicate device do not raise new questions of safety or efficacy and the subject device is as safe and as effective as the predicate device.