RefleXion Medical Radiotherapy System

{0}------------------------------------------------ March 12, 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 square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. RefleXion Medical, Inc % Kathy O'Shaughnessy, PhD V.P. Regulatory, Quality Assurance, Clinical 25841 Industrial Blvd, Suite 275 HAYWARD CA 94545 #### Re: K190978 Trade/Device Name: RefleXion Medical Radiotherapy System Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: Class II Product Code: IYE, MUJ Dated: February 13, 2020 Received: February 14, 2020 Dear Dr. O'Shaughnessy: 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). 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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) K190978 Device Name RefleXion Medical Radiotherapy System #### Indications for Use (Describe) The RefleXion Medical Radiotherapy System is indicated for treatment planning and precise delivery of image-guided radiation therapy, stereotactic radiotherapy, or stereotactic radiosurgery for tumors or other targeted tissues anywhere in the body when radiation treatment is indicated, while minimizing the delivery of radiation to vital healthy tissue. The megavoltage X-ray radiation is delivered in a rotational, modulated, image-guided format in accordance with the physician approved plan. | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------| | <div> <span> <span style="text-decoration: overline;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> <span style="text-decoration: overline;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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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}------------------------------------------------ ## Premarket Notification [510(k)] Summary | Premarket Notification [510(k)] Summary | | |-----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Reflexion Medical Radiotherapy System RXM1000 | | SUBMITTER | Reflexion Medical, Inc.<br>25841 Industrial Blvd, Suite 275<br>Hayward, CA 94545 | | | Contact Name: Kathy O'Shaughnessy, PhD<br>Phone: (650) 239-9070 x1035<br>Fax: (650) 521-5916<br>Date of preparation: March 11, 2020 | | DEVICE | Name of Device: Reflexion Medical Radiotherapy System<br>Trade or Brand Name: Reflexion System One, Reflexion System RXM1000<br>Common/usual Name: Medical Linear Accelerator<br>Regulation Number: 21 CFR 892.5050<br>Classification Name: Medical charged-particle radiation therapy system<br>Regulatory Class: Class II<br>Product Code IYE (radiation therapy), MUJ (planning) | | PREDICATE DEVICE | TomoTherapy Treatment System (K121934) | #### DEVICE DESCRIPTION The RefleXion Medical Radiotherapy System (RMRS), a hybrid imaging-therapy system, is capable of delivering intensity-modulated radiation therapy (IMRT), stereotactic body radiation therapy (SBRT), stereotactic radiotherapy (SRT) and stereotactic radiosurgery (SRS) utilizing an on-board kilovoltage CT (kVCT) system for patient localization and field sizes based on jaws which are 40 cm wide, with slice width choices of 1.0 cm and 2.0 cm to optimize patient treatment. It is also equipped with a binary multileaf collimator (MLC) used to create intensity modulated radiation fields at a source-axis distance of 85 cm. It can achieve a nominal dose rate of 850 cGy/min. The RMRS consists of the following clinical subsystems: 6 MV photon radiotherapy delivery, Kilovoltage (KV) X-ray CT imaging, MV X-ray detection, and treatment planning. The LINAC along with the fixed primary collimator, adjustable collimators, and multileaf collimator (MLC) mount in the therapy plane. The kVCT imaging plane is separate from the therapy plane and provides images used to localize the patient prior to treatment. Additionally, the system is designed architecturally to include PET imaging components for future product enhancements. Although the PET subsystem hardware is present in the system, its functionality is currently disabled. {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the word "reflexion" in a sans-serif font. The letters are dark gray, except for the "x", which is orange. The word is written in lowercase letters. #### INDICATIONS FOR USE/INTENDED USE STATEMENT The RefleXion Medical Radiotherapy System is indicated for treatment planning and precise delivery of image-guided radiation therapy, stereotactic radiotherapy, or stereotactic radiosurgery for tumors or other targeted tissues anywhere in the body when radiation treatment is indicated, while minimizing the delivery of radiation to vital healthy tissue. The megavoltage X-ray radiation is delivered in a rotational, modulated, image-guided format in accordance with the physician approved plan. #### COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE The RefleXion Medical Radiotherapy System and the predicate device employ the same fundamental scientific principles and have substantially equivalent principles of operation and technological characteristics. The treatment delivery components of the RefleXion and TomoTherapy devices are the same or equivalent with regards to energy, beam properties, materials and other physical properties. Key differences between the subject device and the predicate device include the following: - . Faster rotation of the system at 60 RPM. - Use of a new faster-speed binary MLC design. - Addition of a kVCT subsystem for patient positioning. - . Addition of a method to correct for pitch and yaw set-up errors. | Device<br>Characteristic | Predicate Device:<br>TomoTherapy Treatment<br>System | Subject Device:<br>Reflexion Medical<br>Radiotherapy System | Analysis | |--------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------| | 510(k) number | K121934 | K190978 | | | Ring Gantry | | | | | Bore Diameter | 85 cm | 85 cm | Same | | Speed of Rotation | | | Substantially equivalent. | | Treatment | 1 to 5 RPM | 60 RPM | | | Imaging | 6 RPM | 60 RPM | | | Photon Beam | | | | | Beam energy | 6 MV (single energy) | 6 MV (single energy) | Same | | Fixed Field Size | 1.0 cm x 40 cm<br>2.5 cm x 40 cm<br>5.0 cm x 40 cm | 1.0 cm x 40 cm<br>2.0 cm x 40 cm<br>3.0 cm x 40 cm (QA mode) | The field sizes for clinical use<br>are substantially equivalent.<br>Differences do not inhibit it's<br>intended use. | | Isocenter distance | 85 cm | 85 cm | Same | | Nominal Dose Rate | 850 cGy/min | 850 cGy/min | Same | | Collimation | | | | | Primary<br>Collimation | Tungsten block with<br>rectangular, fixed aperture | Tungsten block with<br>rectangular, fixed aperture | Same | | Jaw placement | Jaws are placed after the MLC | Split jaw design – the lower<br>jaws are placed after the MLC | Substantially equivalent.<br>Subject device uses a split jaw<br>design. | | Device<br>Characteristic | Predicate Device:<br>TomoTherapy Treatment<br>System | Subject Device:<br>Reflexion Medical<br>Radiotherapy System | Analysis | | Jaw - movement | Static Mode<br>Dynamic Mode | Static mode | Substantially equivalent.<br>Subject device is static only. | | Multileaf<br>Collimator | 0 to 400 mm wide by 5 to 20<br>mm long<br>Binary (fully in or fully out);<br>pneumatic<br>64 tungsten leaves (tongue and<br>groove), 10cm thick | 0 to 400 mm wide by 10 to 30<br>mm long<br>Binary (fully in or fully out);<br>spring-loaded pneumatic<br>64 tungsten leaves (tongue and<br>groove), 11cm thick | Substantially equivalent. Minor<br>differences are negligible. | | Leaf Resolution at<br>isocenter | 0.625 cm in IEC-x direction at<br>isocenter | 0.625 cm in IEC-x direction at<br>isocenter (leaf width is 0.614<br>cm) | Same | | MLC Leaf transition<br>time | <20 msec | <7 msec | Substantially equivalent. The<br>subject device's MLC leaves<br>move faster to accommodate<br>faster gantry rotation. | | Imaging - for patient positioning | | | | | Energy | MVCT – 3.5 MV (nominal for<br>positioning)<br>Provided by the therapy beam<br>(at lower energy) | kVCT - 120 kV<br>Separate system located in a<br>plane approx. 40 cm from<br>therapy plane | Substantially equivalent. | | Dose per image<br>(typical) | 0.5 – 3.0 cGy depending on<br>resolution and body thickness | 2.45 cGy (body), 5.13 cGy<br>(head) (CTDIvol, nominal<br>settings) | Similar; physician chooses at<br>time of treatment planning | | High contrast<br>spatial resolution | 3 lp/cm (typical) | 4 lp/cm | Similar | | Low contrast<br>resolution | 2% density for 2 cm object<br>(typical) | Visibility of 5 mm object for 1%<br>contrast | Subject device increases<br>visibility of lower<br>contrast/smaller objects | | Treatment Planning | | | | | Associated<br>Treatment Delivery<br>System | Determines treatment planning<br>and dose distribution for the<br>Tomotherapy System. | Determines treatment planning<br>and dose distribution for the<br>Reflexion System. | Same function for each system | | Planning | 6 MV External beam x-ray and<br>inverse planning | 6 MV External beam x-ray and<br>inverse planning | Same | | Image Series Used | Image series (CT) | Image series (CT) | Same | | Treatment Delivery Software | | | | | Delivery Modes<br>Supported | IMRT, SRS, SRT, SBRT | IMRT, SRS, SRT, SBRT | Same | | Patient Setup and<br>Localization | Yes | Yes | Same | | Patient Couch | | | | | Biocompatible | Yes | Yes - Couch top is<br>biocompatible | Same | | Degrees of<br>Freedom | Y, Z (software control)<br>X (manual)<br>Roll (adjust initial gantry angle)<br>Pitch, yaw (rotate patient) | X, Y, Z, pitch, yaw (software<br>control)<br>Roll (adjust initial gantry angle) | The subject device adds<br>software correction in the x,<br>pitch and yaw axes. | {5}------------------------------------------------ # refle»«on {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the word "reflexion" in a sans-serif font. The letters are mostly dark gray, except for the "X" in the middle, which is orange. The word is presented in a clean and modern style. #### PERFORMANCE DATA Verification and validation testing have been conducted to demonstrate that the device performs as intended. Bench testing included system and subsystem tests including: - . Performance tests to applicable standards (including electrical safety and electromagnetic compatibility). - Safety/Interlock tests to ensure risk mitigations performed as specified. - Dosimetric performance evaluation of the RefleXion system. - Treatment Planning System Dose accuracy tests to evaluate the accuracy of the RefleXion treatment planning system. - . Geometric localization accuracy tests for the RefleXion system. - Imaging performance testing. - . Validation testing including end-to-end tests, usability testing, and tests to ensure the system performance checks function as intended. Results of bench testing showed conformance to applicable requirements and specifications. Specifications of key performance tests are provided below: | Performance Test | Specification | |----------------------------------------------------------|-----------------------------------------------------------------------------| | Coincidence of mechanical and radiation isocenter | ≤ 1mm | | kVCT imaging to MV treatment plane localization accuracy | ≤ 1mm | | kVCT geometric accuracy | ≤ 1mm | | Dosimetric accuracy | >90% of points passing 3%/3mm (for points<br>greater than 10% maximum dose) | | Dose rate output constancy | ≤ 2% | | Dose output linearity | ± 2% ≥5MU<br>± 5% (2-4 MU) | Software verification and validation documentation was 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 software for this device was considered as a "major" level of concern. The subject device conforms in whole or in part with the following standards: IEC60601-1, IEC60601-1-2, IE60601-1-3, IEC60601-1-6, IEC60601-2-1, IEC60601-2-44, IEC60601-2-68, IEC62366-1, IEC60976, IEC61217, IEC62083, IEC6274. For those recognized standards in which there are clauses that are not applicable, summary reports with justifications have been included in the submission. No animal studies or clinical tests have been included with this pre-market submission. {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the word "reflexion" in a sans-serif font. The letters are dark gray, except for the "x", which is orange. The word is horizontally oriented and centered in the image. #### CONCLUSION The non-clinical data support the safety of the device and the verification and validation testing performed demonstrates that the RefleXion Medical Radiotherapy System performs as intended in the specified use conditions. RefleXion therefore considers the RefleXion Medical Radiotherapy System to be substantially equivalent to the predicate device.