Who is the manufacturer of ClearRT Helical kVCT for the Radixact Treatment Delivery System?

Accuray Incorporated filed the 510(k) submission for ClearRT Helical kVCT for the Radixact Treatment Delivery System (K202412).

What is the FDA product code for ClearRT Helical kVCT for the Radixact Treatment Delivery System?

IYE. It is classified under 21 CFR 892.5050 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for ClearRT Helical kVCT for the Radixact Treatment Delivery System?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like ClearRT Helical kVCT for the Radixact Treatment Delivery System?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

ClearRT Helical kVCT for the Radixact Treatment Delivery System

Q: What are the predicate devices for ClearRT Helical kVCT for the Radixact Treatment Delivery System?

Radixact Treatment Delivery System (K161146).

K202412 · Accuray Incorporated · IYE · Dec 18, 2020 · Radiology

Device Facts

Record ID	K202412
Device Name	ClearRT Helical kVCT for the Radixact Treatment Delivery System
Applicant	Accuray Incorporated
Product Code	IYE · Radiology
Decision Date	Dec 18, 2020
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.5050
Device Class	Class 2
Attributes	Therapeutic

Intended Use

The kVCT Imaging Feature is an option within the intended use of the Radixact Treatment Delivery System. 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, non-rotational, 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

The kVCT Imaging Feature is an add-on for the Radixact Treatment Delivery System, a radiation therapy device. It enables the acquisition of kV x-ray images to provide Image Guided Radiation Therapy (IGRT). The system uses a kV x-ray source and a flat panel detector to acquire 2D images, which are then reconstructed into 3D CT images. The device is operated by clinical staff in a treatment room (vault). The output consists of 3D CT images used for patient positioning and treatment verification. It does not diagnose disease, recommend treatment, or quantify effectiveness. The feature improves tissue contrast and image quality compared to the predicate's megavoltage CT (MVCT) imaging. The system uses dynamic collimation and filtering to manage the imaging beam. The output assists clinicians in verifying target alignment before radiation delivery, potentially increasing the precision of therapy.

Clinical Evidence

No clinical or animal studies were conducted. Substantial equivalence is supported by bench testing, including verification and validation of design specifications, performance testing of imaging characteristics (spatial resolution, contrast, uniformity, noise), and compliance with applicable FDA-recognized consensus safety standards for radiation therapy equipment.

Technological Characteristics

The system includes a kV x-ray source (40-150 kV) and a CsI:Tl flat panel detector. It features dynamic IEC-Xb/Yb collimating blades and a dynamically selectable copper filter (0.2, 0.3, 0.5 mm). The gantry is a CT-style design with an 85 cm bore. The system is a stand-alone radiation delivery unit. Software controls include an Embedded Controls Subsystem (ECS) modified to manage kV triggering, collimation, and panel actuation. The system is designed for helical acquisition.

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

Radixact Treatment Delivery System (K161146)

Reference Devices

Motion Tracking And Compensation Feature For The Radixact Treatment Delivery System (K182687)

Related Devices

K101038 — RAD II SIMULATOR, RAD II KV IMAGER, DUAL RAD II KV IMAGER · Acceletronics Digital Imaging, LLC · Aug 17, 2010
K191267 — ImagingRing System on Rails · Medphoton GmbH · Aug 1, 2019
K100115 — XVI R4.5 · Elekta , Ltd. · Mar 10, 2010
K981056 — VARIAN XIMATRON SCAN VISION CT · Varian Medical Systems, Inc. · Jun 12, 1998
K161146 — Radixact Treatment Delivery System · Accuray Incorporated · Jun 24, 2016

Submission Summary (Full Text)

{0}------------------------------------------------ December 18, 2020 Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left 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 is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. Accuray Incorporated % Keith Picker Senior Regulatory Affairs Specialist 1240 Deming Way MADISON WI 53717 ## Re: K202412 Trade/Device Name: kVCT Imaging Feature for the Radixact Treatment Delivery System Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: Class II Product Code: IYE Dated: November 24, 2020 Received: November 25, 2020 Dear Keith 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. 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) K202412 #### Device Name kVCT Imaging Feature for the Radixact Treatment Delivery System Indications for Use (Describe) The kVCT Imaging Feature is an option within the indications for use of the Radixact Treatment Delivery System. 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) | <div> <svg class="bi bi-check-square-fill" fill="currentColor" height="1em" viewbox="0 0 16 16" width="1em" xmlns="http://www.w3.org/2000/svg"> <path d="M2 0a2 2 0 0 0-2 2v12a2 2 0 0 0 2 2h12a2 2 0 0 0 2-2V2a2 2 0 0 0-2-2H2zm10.03 4.97a.75.75 0 0 0-1.08.022L7.477 9.417 5.384 7.323a.75.75 0 0 0-1.06 1.06L6.97 11.03a.75.75 0 0 0 1.079-.02l3.992-4.99a.75.75 0 0 0-.01-1.05z" fill-rule="evenodd"></path> </svg> Prescription Use (Part 21 CFR 801 Subpart D) </div> | |------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | <div> <svg class="bi bi-square" fill="currentColor" height="1em" viewbox="0 0 16 16" width="1em" xmlns="http://www.w3.org/2000/svg"> <path d="M0 2a2 2 0 0 1 2-2h12a2 2 0 0 1 2 2v12a2 2 0 0 1-2 2H2a2 2 0 0 1-2-2V2zm1.5 0a.5.5 0 0 0-.5.5v11a.5.5 0 0 0 .5.5h11a.5.5 0 0 0 .5-.5v-11a.5.5 0 0 0-.5-.5h-11z" fill-rule="evenodd"></path> </svg> Over-The-Counter Use (21 CFR 801 Subpart C) </div> | #### 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}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the Accuray logo. The logo consists of a stylized atom symbol in teal, green, and purple, followed by the word "ACCURAY" in teal, with a registered trademark symbol next to it. The logo is clean and modern. #### Section 8 510(k) Summary K202412 #### Submitter Accuray Incorporated 1240 Deming Way Madison, WI 53717 Phone: 608-824-3069 Fax: 608-824-2996 | Contact: | Keith Picker | |----------------|-------------------| | Date Prepared: | November 24, 2020 | ### Device Identification Device Name: kVCT Imaging Feature for the Radixact Treatment Deliverv System Trade & Brand Names: ClearRT Helical kVCT for the Radixact Treatment Delivery System Common Name: Radiation Therapy System Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: Class II Product Code: IYE ### Predicate Device Radixact Treatment Delivery System (K161146) #### Reference Device: Motion Tracking And Compensation Feature For The Radixact Treatment Delivery System (K182687) #### Device Description The kVCT Imaging Feature is designed for use with the predicate Radixact Treatment Delivery System last cleared on K161146. The primary functions of the kVCT Imaging Feature are: 1) acquisition of kV x-ray images according to input protocols in concert with other subsystems, 2) correcting 2D images and 3) returning reconstructed 3D images. The Radixact Treatment Delivery System is a radiation therapy delivery system that provides Image Guided Radiation Therapy (IGRT) using integral megavoltage CT {4}------------------------------------------------ imaging capabilities and delivers helical (rotational) and fixed-angle (non-rotational) radiation therapy to tumors and other targeted tissues. Neither the Radixact Treatment Delivery System nor the kVCT Imaging Feature diagnose disease, recommend treatment regimens or quantify treatment effectiveness. Accordingly, they are not intended for diagnostic use. ### Intended Use The kVCT Imaging Feature is an option within the intended use of the Radixact Treatment Delivery System. 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, non-rotational, 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 kVCT Imaging Feature is an option within the indications for use of the Radixact Treatment Delivery System. 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. The intended use and indications for use statements for the kVCT Imaging Feature (shown above) are the same as for the Radixact Treatment Delivery System (last cleared on K161146), except for the addition of the introductory sentence as kVCT Imaging is a type of Image Guided Radiotherapy (IGRT). ## Technological Characteristics The Radixact Treatment Delivery System with the use of the kVCT Imaging Feature has imaging and treatment capabilities equivalent to those of the predicate Radixact Treatment Delivery System. It also has a similar functionally-equivalent CT style gantry and patient couch. The intended use and indications for use of the kVCT Imaging Feature fit within those of the predicate Radixact Treatment Delivery System. Additionally, the predicate and subject devices have substantially equivalent performance specifications and technological characteristics. Further, the Radixact Treatment Delivery System with the use of the kVCT Imaging Feature and the predicate device employ the same fundamental scientific principles and have substantially equivalent principles of operation. The main difference between the predicate and the subject device is the use of the kVCT Imaging Feature. Where there are technological differences between the subject and predicate devices, those differences do not raise different questions of safety or effectiveness. {5}------------------------------------------------ A substantial equivalence table comparing the similarities and differences between the Radixact Treatment Delivery System with the use of the kVCT Imaging Feature and the predicate device is presented below in Table 5.5.1. The minor differences between the subject and predicate devices do not raise different questions of safety or effectiveness. A table comparing the similarities and differences between the Radixact Treatment Delivery System with the use of the kVCT Imaging Feature and the reference device (K182687) is provided in Table 5.5.2 below. The minor differences between the subject and predicate devices do not raise different questions of safety or effectiveness. The kV Imaging subsystem provides three-dimensional CT images with equivalent or better performance than the predicate device (MVCT). The kVCT energy range offer improved intrinsic tissue contrast and image quality characteristics compared to that of MVCT imaging. {6}------------------------------------------------ # Table 5.5.1 Device Comparison Table: Radixact Treatment Delivery System with kVCT Imaging Feature | Device Characteristic | Predicate Device Radixact Treatment Delivery System (K161146) | Subject Device Radixact Treatment Delivery System with kVCT Imaging Feature | Analysis | |----------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | System Description | | | | | 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, non- rotational, 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. | The kVCT Imaging Feature is an option within the intended use of the Radixact Treatment Delivery System. 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, non- rotational, 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. | Identical | | Device Characteristic | Predicate Device Radixact Treatment Delivery System (K161146) | Subject Device Radixact Treatment Delivery System with kVCT Imaging Feature | Analysis | | 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. | The kVCT Imaging Feature is an option within the indications for use of the Radixact Treatment Delivery System. 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. | Identical | | Classification | §892.5050 Medical charged-particle radiation therapy system, class II | Same as predicate | Identical | | System Configuration | Stand-alone radiation delivery system (does not include data management system or planning system) | Stand-alone radiation delivery system with kV imaging added (does not include data management system or planning system) | Substantially equivalent. The introduction of the kVCT imaging feature does not raise different issues of safety or effectiveness. The risk acceptability determination was not impacted by the modified design. | | Device Characteristic | Predicate Device Radixact Treatment Delivery System (K161146) | Subject Device Radixact Treatment Delivery System with kVCT Imaging Feature | Analysis | | Vault (Treatment Room) | | | | | Minimum Room Dimensions (H*W*L) | 274 x 462 x 602 cm | 274.3 x 463 x 602 cm | Substantially equivalent. Minor differences are negligible. | | Device Dimensions (gantry + couch) (H*W*L) | 255 x 280 x 473 cm | 255 x 280 x 470.5 cm | Substantially equivalent. Minor differences are negligible. | | Device Mass (kg) | 6580 kg | 7000 kg (approximate) | Substantially equivalent. The added mass due to the kVCT imaging subsystem does not result in different questions of safety or effectiveness. | | Line Voltage | 380 - 480 Vac 3- Phase | 380 - 480 Vac 3-Phase | Identical | | Ambient Room Temperature | 20 - 24 °C | 20 - 24 °C | Identical | | Relative Humidity (non- condensing) | 30 - 60 % | 30 - 60 % | Identical | | Device Characteristic | Predicate Device Radixact Treatment Delivery System (K161146) | Subject Device Radixact Treatment Delivery System with kVCT Imaging Feature | Analysis | | Gantry Mechanical Features | | | | | Bore Diameter | 85 cm | 85 cm | Identical | | Degrees of Rotation | Continuous rotation around Y- axis (axes per IEC 61217) | Continuous rotation around Y- axis (axes per IEC 61217) | Identical | | Direction of Rotation | Clockwise | Clockwise | Identical | | Rotational Speed (Treatment) | 1 - 5 RPM | 1 - 5.08 RPM | Substantially equivalent. Minor differences are negligible and do not result in different questions of safety or effectiveness. | | Rotational Speed (Imaging) | 10 RPM | Up to 10 RPM | Substantially equivalent. Rotational speed is unchanged for MVCT imaging. Slower speeds are used for some kVCT imaging applications. | | Couch Support in Bore | Provided | Provided | Identical | | Radiation Delivery Modes | | | | | Description | Helical, Direct | Helical, Direct | Identical | | Device Characteristic | Predicate Device Radixact Treatment Delivery System (K161146) | Subject Device Radixact Treatment Delivery System with kVCT Imaging Feature | Analysis | | Photon Beam | | | | | Accelerator Type | Standing wave | Standing wave | Identical | | RF Source | Magnetron | Magnetron | Identical | | Nominal Energy | 6 MV | 6 MV | Identical | | Fixed Field Size | 1.0 cm x 40 cm 2.5 cm x 40 cm 5.0 cm x 40 cm | 1.0 cm x 40 cm 2.5 cm x 40 cm 5.0 cm x 40 cm | Identical | | Dynamic Field Size | 1.0 – 2.5 cm x 40 cm 1.0 – 5.0 cm x 40 cm | 1.0 – 2.5 cm x 40 cm 1.0 – 5.0 cm x 40 cm | Identical | | Dose Rate | 850 cGy/min standard 1000 cGy/min optional | 850 cGy/min standard 1000 cGy/min optional | Identical | | MV Beam Collimation | | | | | Description | Primary collimation, jaws and multi-leaf collimator (MLC) | Primary collimation, jaws and multi-leaf collimator (MLC) | Substantially equivalent. kVCT does not change the behavior of the jaws. | | Device Characteristic | Predicate Device Radixact Treatment Delivery System (K161146) | Subject Device Radixact Treatment Delivery System with kVCT Imaging Feature | Analysis | | MVCT Imaging | | | | | Source | Megavoltage Computed Tomography | Megavoltage Computed Tomography | Identical | | Field of View (FOV) | 39 cm diameter | 39 cm diameter | Identical | | Scan Length [Specification not detailed in K161146] | 135 cm | 135 cm | Identical | | Imaging Dose | 0.5 - 3.0 cGy (imaging dose near center of Tomo- Phantom) | 1.1 - 3.4 cGy (CTDIvol, Head) 0.8 - 2.5 cGy (CTDIvol, Body) | Identical. Differences shown are due to additional detail provided and dose characterized in CTDIvol | | Slice Spacing | 1, 2, 3, 4 and 6 mm reconstruction Intervals…