(332 days)
Not Found
No
The provided text describes a radiotherapy system with imaging capabilities and treatment planning features. It details the hardware components, imaging modalities, and performance metrics. There is no mention of AI, ML, deep learning, or any related terms in the description, intended use, or performance studies summary. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
Yes
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, which directly treats medical conditions.
No
This device is a radiotherapy system designed for treatment and therapy delivery, not for diagnosing medical conditions. While it uses imaging for patient localization, its primary function is therapeutic.
No
The device description clearly outlines multiple hardware components including a LINAC, collimators, MLC, and a kVCT system, indicating it is a physical radiotherapy system with integrated software, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is 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". This describes a therapeutic device that delivers radiation to treat a condition, not a device used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or treatment.
- Device Description: The description details a "hybrid imaging-therapy system" that delivers radiation therapy (IMRT, SBRT, SRT, SRS) and uses imaging (kVCT) for patient localization prior to treatment. It does not mention any components or processes related to analyzing biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analysis of biological specimens (blood, urine, tissue, etc.)
- Reagents or assays
- Providing diagnostic information
- Measuring biomarkers or analytes
The device is clearly a radiotherapy system used for delivering treatment, which falls under a different regulatory classification than IVDs.
N/A
Intended Use / 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.
Product codes
IYE, MUJ
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Kilovoltage (KV) X-ray CT imaging
Anatomical Site
anywhere in the body
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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.
Key Metrics
Coincidence of mechanical and radiation isocenter: 90% of points passing 3%/3mm (for points greater than 10% maximum dose)
Dose rate output constancy: =5MU, +/- 5% (2-4 MU)
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.5050 Medical charged-particle radiation therapy system.
(a)
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.(b)
Classification. Class II. When intended for use as a quality control system, the film dosimetry system (film scanning system) included as an accessory to the device described in paragraph (a) of this section, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
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). 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
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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) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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Premarket Notification [510(k)] Summary
| Premarket Notification [510(k)] Summary | |
|---|---|
| Reflexion Medical Radiotherapy System RXM1000 | |
| SUBMITTER | Reflexion Medical, Inc. |
| 25841 Industrial Blvd, Suite 275 | |
| Hayward, CA 94545 | |
| Contact Name: Kathy O'Shaughnessy, PhD | |
| Phone: (650) 239-9070 x1035 | |
| Fax: (650) 521-5916 | |
| Date of preparation: March 11, 2020 | |
| DEVICE | Name of Device: Reflexion Medical Radiotherapy System |
| Trade or Brand Name: Reflexion System One, Reflexion System RXM1000 | |
| Common/usual Name: Medical Linear Accelerator | |
| Regulation Number: 21 CFR 892.5050 | |
| Classification Name: Medical charged-particle radiation therapy system | |
| Regulatory Class: Class II | |
| 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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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
Characteristic | Predicate Device:
TomoTherapy Treatment
System | Subject Device:
Reflexion Medical
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
2.5 cm x 40 cm
5.0 cm x 40 cm | 1.0 cm x 40 cm
2.0 cm x 40 cm
3.0 cm x 40 cm (QA mode) | The field sizes for clinical use
are substantially equivalent.
Differences do not inhibit it's
intended use. |
| Isocenter distance | 85 cm | 85 cm | Same |
| Nominal Dose Rate | 850 cGy/min | 850 cGy/min | Same |
| Collimation | | | |
| Primary
Collimation | Tungsten block with
rectangular, fixed aperture | Tungsten block with
rectangular, fixed aperture | Same |
| Jaw placement | Jaws are placed after the MLC | Split jaw design – the lower
jaws are placed after the MLC | Substantially equivalent.
Subject device uses a split jaw
design. |
| Device
Characteristic | Predicate Device:
TomoTherapy Treatment
System | Subject Device:
Reflexion Medical
Radiotherapy System | Analysis |
| Jaw - movement | Static Mode
Dynamic Mode | Static mode | Substantially equivalent.
Subject device is static only. |
| Multileaf
Collimator | 0 to 400 mm wide by 5 to 20
mm long
Binary (fully in or fully out);
pneumatic
64 tungsten leaves (tongue and
groove), 10cm thick | 0 to 400 mm wide by 10 to 30
mm long
Binary (fully in or fully out);
spring-loaded pneumatic
64 tungsten leaves (tongue and
groove), 11cm thick | Substantially equivalent. Minor
differences are negligible. |
| Leaf Resolution at
isocenter | 0.625 cm in IEC-x direction at
isocenter | 0.625 cm in IEC-x direction at
isocenter (leaf width is 0.614
cm) | Same |
| MLC Leaf transition
time | 90% of points passing 3%/3mm (for points
greater than 10% maximum dose) |
| Dose rate output constancy | ≤ 2% |
| Dose output linearity | ± 2% ≥5MU
± 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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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.