RefleXion Medical Radiotherapy System

K190978 · Reflexion Medical, Inc. · IYE · Mar 12, 2020 · Radiology

Device Facts

• Record ID: K190978
• Device Name: RefleXion Medical Radiotherapy System
• Applicant: Reflexion Medical, Inc.
• Product Code: IYE · Radiology
• Decision Date: Mar 12, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5050
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

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.

Device Story

RefleXion Medical Radiotherapy System is a hybrid imaging-therapy device for IMRT, SBRT, SRT, and SRS. It utilizes a 6 MV photon radiotherapy delivery system and an on-board 120 kV kVCT system for patient localization. The system features a ring gantry rotating at 60 RPM, a binary multileaf collimator (MLC) with 64 tungsten leaves, and a patient couch with software-controlled X, Y, Z, pitch, and yaw adjustments. The device operates by using kVCT images to localize the patient, followed by rotational, modulated radiation delivery based on a physician-approved treatment plan. It is intended for use in clinical settings by trained professionals to treat tumors while sparing healthy tissue. The system architecture includes PET imaging components, though currently disabled. The device benefits patients by providing precise, image-guided radiation delivery with faster gantry rotation and improved localization capabilities compared to traditional systems.

Clinical Evidence

No clinical data or animal studies were provided. Evidence consists of bench testing, including electrical safety, electromagnetic compatibility, dosimetric performance, geometric localization accuracy, and imaging performance. Key metrics: isocenter coincidence ≤ 1mm; kVCT localization accuracy ≤ 1mm; dosimetric accuracy >90% of points passing 3%/3mm criteria; dose rate output constancy ≤ 2%.

Technological Characteristics

Hybrid system with 6 MV photon LINAC and 120 kV kVCT. Components: tungsten-based binary MLC (64 leaves, 11cm thick), split jaw collimation, 85 cm source-axis distance. Connectivity: networked treatment planning. Software: major level of concern. Standards: IEC 60601-1, 60601-1-2, 60601-1-3, 60601-1-6, 60601-2-1, 60601-2-44, 60601-2-68, 62366-1, 60976, 61217, 62083, 6274.

Indications for Use

Indicated for patients requiring image-guided radiation therapy, stereotactic radiotherapy, or stereotactic radiosurgery for tumors or targeted tissues anywhere in the body.

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

• TomoTherapy Treatment System (K121934)

Submission Summary (Full Text)

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March 12, 2020.

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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). 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

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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 ([e-mail]) or phone [phone] 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

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### 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> |

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## 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: [phone] x1035<br>Fax: [phone]<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.

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#### 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. |

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# refle»«on

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#### 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.

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#### 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.