(204 days)
Yes
The device description explicitly mentions "machine learning planning and segmentation" as a unique feature.
No.
The device is a treatment planning system for radiation therapy, which is a software that helps plan and analyze radiation therapy but does not directly administer treatment.
No
Explanation: The device is described as a "radiation therapy treatment planning system" that provides "treatment unit set-up parameters and estimates of dose distributions." It is not used to diagnose a medical condition.
Yes
The device description explicitly states that RayStation is a "software program for planning and analysis of radiation therapy" and lists various software functionalities. There is no mention of accompanying hardware components being part of the device itself.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that RayStation is for "treatment planning and analysis of radiation therapy." This is a therapeutic application, not a diagnostic one.
- Device Description: The description reinforces its role as a "radiation therapy treatment planning system."
- Lack of Diagnostic Functionality: There is no mention of the device being used to diagnose a disease, condition, or state of health. IVDs are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. RayStation's inputs are imaging modalities (CT, PET, MRI) used for planning treatment, not for analyzing biological specimens.
Therefore, RayStation falls under the category of a medical device used for treatment planning in radiation therapy, not an in vitro diagnostic device.
No
The provided text does not contain any explicit statement that the FDA has reviewed and approved or cleared a Predetermined Change Control Plan (PCCP) for this specific device.
Intended Use / Indications for Use
RayStation is a software system designed for treatment planning and analysis of radiation therapy. The treatment plans provide treatment unit set-up parameters and estimates of dose distributions expected during the proposed treatment, and may be used to administer treatments after review and approval by the intended user.
The system functionality can be configured based on user needs.
The intended users of RayStation shall be clinically qualified radiation therapy staff trained in using the system.
Product codes
MUJ
Device Description
RayStation 9.1/RayStation 9.2 are radiation therapy treatment planning systems, i.e. a software program for planning and analysis of radiation therapy. The functionality includes fusion capabilities (CT, PET and MRI), contouring, collapsed cone convolution dose computation, 4D data compatibility and treatment console interfacing, as well as unique features such as machine learning planning and segmentation, multi-criteria optimization, dose tracking, treatment adaptation and deformable registration, all available in one platform.
The main workflow, creating a treatment plan from imported patient image data, is described below:
Flow of Events
User
- The user launches RayStation 9.1/RayStation 9.2
- The user imports a patient and case with CT images through DICOM
- The user enters the Structure Definition module and creates ROIs using the contouring tools
- The user enters the Plan Setup module and creates a plan and a treatment setup with specified machine, treatment energy and deliverv tvpe
- The user specifies beam configuration including isocenter, dose grid and fluence grid resolution
- The user enters the Plan Optimization module and optimizes the plan parameters
- The user reviews the plan
- The user enters the Plan Evaluation module and evaluates the plan
- The user approves and exports the plan together with dose, structure sets and images
System
3. The system imports the data and checks consistency of in-data
5. The system adds the ROIs to the patient case
8. The system adds the plan and treatment setup to the patient case
10. The system generates a deliverable plan
11. The system displays the plan as - 2D and 3D dose and patient displays - DVH curves - Plan data (beams, segments etc.)
15. The system exports the plan and patient data to a DICOM server
Mentions image processing
Not Found
Mentions AI, DNN, or ML
machine learning planning and segmentation
Input Imaging Modality
CT, PET, MRI, dual-energy CT/SRS image data
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
clinically qualified radiation therapy staff trained in using the system.
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
The test specifications of RayStation 9.2 are further developed versions of the test specifications of RayStation 8.1. This is supported by the requirements specification, for which the same is true.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The summary of the performed non-clinical tests shows that RayStation 9.1/RayStation 9.2 are as safe and effective and performs as well as the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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September 24, 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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.
RaySearch Laboratories AB (publ) % Ms. Viktoria Hammarstedt Quality and Regulatory Affairs Specialist Sveavägen 44 Stockholm, 11134 SWEDEN
Re: K200569
Trade/Device Name: RayStation 9.1 / RayStation 9.2 Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: Class II Product Code: MUJ Dated: June 11, 2020 Received: August 26, 2020
Dear Ms. Hammarstedt:
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/cfpmn/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
1
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see 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 mediation-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) K200569
Device Name RayStation 9.1 / RayStation 9.2
Indications for Use (Describe)
RayStation is a software system designed for treatment planning and analysis of radiation therapy. The treatment plans provide treatment unit set-up parameters and estimates of dose distributions expected during the proposed treatment, and may be used to administer treatments after review and approval by the intended user.
The system functionality can be configured based on user needs.
The intended users of RayStation shall be clinically qualified radiation therapy staff trained in using the system.
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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5. 510(k) Summary
5.1 510(k) owner
RaySearch Laboratories AB (publ) Sveavägen 44 111 34 Stockholm Sweden
Tel: +46 8 510 530 00
5.2 Contact person
Viktoria Hammarstedt Quality and Regulatory Affairs Specialist RaySearch Laboratories AB (publ) Email: quality@raysearchlabs.com Tel: +46 8 510 530 03
Preparation date 5.3
February 19, 2020
5.4 Trade name
The trade name is RayStation.
The trade name and version number are written together, i.e. "RayStation 9.1/RayStation 9.2" to easily distinguish the submitted device from the predicate device RayStation 8.1.
The marketing name is RayStation 9B and 9B SP1.
5.5 Common name
Radiation therapy treatment planning system
5.6 Classification name
Medical charged-particle radiation therapy system (21 CFR 892.5050, Product Code MUJ)
5.7 Predicate device
RayStation 8.1 K190387
5.8 Device description
RayStation 9.1/RayStation 9.2 are radiation therapy treatment planning systems, i.e. a software program for planning and analysis of radiation therapy. The functionality includes fusion capabilities (CT, PET and MRI), contouring, collapsed cone convolution dose computation, 4D data compatibility and treatment console interfacing, as well as unique features such as machine learning planning and segmentation, multi-criteria optimization, dose tracking, treatment adaptation and deformable registration, all available in one platform.
The main workflow, creating a treatment plan from imported patient image data, is described below: Elow of Events
| Flow of Events | |
|---|---|
| User | System |
| 1. The user launches RayStation 9.1/RayStation 9.2 | |
| 2. The user imports a patient and case with CT images through DICOM | 3. The system imports the data and checks consistency of in-data |
| 4. The user enters the Structure Definition module and creates ROIs using the contouring tools | 5. The system adds the ROIs to the patient case |
| 6. The user enters the Plan Setup module and |
4
creates a plan and a treatment setup with specified machine, treatment energy and deliverv tvpe 7. The user specifies beam configuration including isocenter, dose grid and fluence grid resolution 8. The system adds the plan and treatment setup to the patient case 9. The user enters the Plan Optimization module and optimizes the plan parameters 10. The system generates a deliverable plan 11. The system displays the plan as - 2D and 3D dose and patient displays - DVH curves - Plan data (beams, segments etc.) 12. The user reviews the plan 13. The user enters the Plan Evaluation module and evaluates the plan 14. The user approves and exports the plan together with dose, structure sets and images 15. The system exports the plan and patient data to a DICOM server
5.9 Intended use
RayStation is a software system designed for treatment planning and analysis of radiation therapy. The treatment plans provide treatment unit set-up parameters and estimates of dose distributions expected during the proposed treatment, and may be used to administer treatments after review and approval by the intended user.
The system functionality can be configured based on user needs.
The intended users of RayStation shall be clinically qualified radiation therapy staff trained in using the system.
5.10 Technological characteristics summary
The technological characteristics are the same for RayStation 9.2 as for the predicate device RayStation 8.1.
Comparing RayStation 9.1/RayStation 9.2 with RayStation 8.1, the newer version includes usability improvements as well as dose calculation based on dual-energy CT/SRS image data, updates to accommodate updated Toshiba beam intensity calculations, and support for seated treatments. Both versions are built on the same software platform and share design to a high degree. Both versions have been developed under the same quality system meeting the same requirements for safety and effectiveness.
5.11 Assessment of non-clinical performance data
The test specifications of RayStation 9.2 are further developed versions of the test specifications of RayStation 8.1. This is supported by the requirements specification, for which the same is true. The successful verification and validation of RayStation 9.2 therefore support the substantial equivalence of the above RayStation versions.
5.12 Test conclusion
The summary of the performed non-clinical tests shows that RayStation 9.1/RayStation 9.2 are as safe and effective and performs as well as the predicate device.