Accuray Precision Treatment Planning System

{0}------------------------------------------------ September 30, 2021 Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left side of the logo is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square are the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" in a smaller font below. Accuray Incorporated % Lizhi Yu Sr. Manager Regulatory Affairs APAC & AMS 1209 Deming Way MADISON WI 53717 ## Re: K212794 Trade/Device Name: Accuray Precision® Treatment Planning System Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: Class II Product Code: IYE, MUJ Dated: September 1, 2021 Received: September 2, 2021 Dear Lizhi Yu: 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmp/pmn.cfm identifies combination product submissions. 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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see {1}------------------------------------------------ https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, For Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K212794 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 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 style="text-decoration: underline;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="text-decoration: underline;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # 510(k) Summary # K212794 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 1209 Deming Way Madison, Wisconsin, 53717 #### Contact Person Lizhi Yu Sr. Manager Regulatory Affairs APAC & AMS Phone: 608-824-2885; Fax: 608-824-9552 yulizhi@accuray.com #### Date Prepared September 1. 2021 #### Device Name Subject Device Name: Accuray Precision® Treatment Planning System Marketed Trade or Model Name: Accurav 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 Regulatory Class: II Regulatory Product Code: IYE, MUJ Classification Panel: Radiology Predicate Device Name: Accuray Precision® Treatment Planning System (K171086) #### Device Description The Accuray Precision® Treatment Planning System is a radiation therapy planning system used for the 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 {4}------------------------------------------------ treatment and saved into the central database server (iDMS Data Management System). The images are imported from the database server into the Accuray Precision® Treatment Planning System to register/ fuse 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, Radixact 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 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 {5}------------------------------------------------ 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. #### Comparison of Technological Characteristics with the predicate Device 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 K171086) 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 Planning System (K171086)<br>Predicate Device | Accuray Precision®<br>Treatment Planning System<br>With modifications<br>Subject Device | |--------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------| | Intended Use | The Accuray Precision® Treatment Planning System is indicated<br>for creation and assessment of external photon beam irradiation<br>treatment plans for radiation therapy, stereotactic radiotherapy or<br>stereotactic radiosurgery for lesions, tumors and conditions<br>anywhere in the body when radiation treatment is indicated. A<br>treatment plan provides an estimate of the dose distribution and<br>the parameters utilized by the radiation delivery system. Plans<br>must be reviewed and approved by qualified medical practitioners<br>prior to delivery.<br><br>The Accuray Precision® Treatment Planning System is intended<br>to be used by physicians, medical physicists, and dosimetrists to<br>generate radiation therapy, stereotactic radiotherapy or<br>stereotactic radiosurgery treatment plans. Plans may be created<br>with the Accuray Precision® Treatment Planning System for<br>delivery using Intensity Modulated Radiation Therapy (IMRT) or<br>3-D Conformal Radiation Therapy (3DCRT) techniques.<br><br>The users will be able to create a plan that satisfies established<br>clinical objectives. For stereotactic radiosurgery, the plan will<br>generally involve delivering a tumoricidal dose to target tissue,<br>while minimizing dose to other tissues. For radiation therapy and<br>stereotactic radiotherapy, the plan will | Identical as predicate | {6}------------------------------------------------ | Device<br>Characteristic | Accuray Precision® Treatment Planning System (K171086)<br>Predicate Device | Accuray Precision®<br>Treatment Planning System<br>With modifications<br>Subject Device | |--------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------| | | generally, involve delivering a damaging dose to diseased tissue<br>at a level that allows healthy tissue in the target volume to<br>recover, while also minimizing dose to tissue outside the target<br>volume. | | | | The treatment plan with dose distributions and complete<br>delivered dose value along with the input data will be available<br>through a user display or printed report for user review and<br>evaluation against the treatment prescription and established<br>physics models. The treatment plan will then<br>be saved by the user, approved by the qualified medical<br>practitioner, and subsequently delivered by the treatment delivery<br>system. | | | Indications for<br>Use | The Accuray Precision® Treatment Planning System is indicated<br>for creation and assessment of external photon beam irradiation<br>treatment plans for radiation therapy, stereotactic radiotherapy or<br>stereotactic radiosurgery for lesions, tumors and conditions<br>anywhere in the body when radiation treatment is indicated. A<br>treatment plan provides an estimate of the dose distribution and<br>the parameters utilized by the radiation delivery system.<br>Plans must be reviewed and approved by qualified medical<br>practitioners prior to delivery. | Identical as predicate | | Associated<br>Treatment<br>Delivery System | Determines treatment planning and dose distribution for the<br>CyberKnife and TomoTherapy Systems | Same as predicate.<br>In this context, TomoTherapy<br>refers to the product line and<br>is inclusive of Radixact | | Hardware | PC class workstation | Same as predicate | | Dose Calculation<br>Algorithms | Superposition/ Convolution, Ray Tracing, FSPB and Monte Carlo<br>(InCise Multileaf Collimator (MLC) and circular collimators) | Substantially equivalent with<br>minor enhancements | | Dosimetry Tests | Absolute Dose specification (CyberKnife Systems)<br>Gamma test specification (CyberKnife)<br>Gamma index (TomoTherapy System) | Identical as predicate | | Data<br>Management<br>System | iDMS Data Management System (K161144) | iDMS Data Management<br>System is a component of<br>Accuray Precision®<br>Treatment Planning System | #### Performance Data 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. Software verification and validation was conducted, and documentation is 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 results from testing included in the premarket notification demonstrate that the performance characteristics of the subject device are substantial equivalent to the predicate device. {7}------------------------------------------------ ## Substantial Equivalence Summary 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 different questions of safety or efficacy. Therefore, the subject device is as safe and as effective as the predicate device.