(72 days)
RayStation 6.1 K171536
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No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on traditional treatment planning functionalities.
No
The device is a software system for planning and analysis of radiation therapy, providing treatment unit set-up parameters and dose estimates. It does not directly administer treatment or exert a therapeutic effect on the patient.
No
Explanation: RayStation is described as a "treatment planning system," which is used for planning and analysis of radiation therapy and calculating dose distributions. This aligns with therapeutic rather than diagnostic purposes.
Yes
The device description explicitly states that RayStation 7.0 is a "software program for planning, management and analysis of radiation therapy treatment." While it interacts with imaging modalities (CT, PET, MRI) and treatment units, the core device being described and submitted for 510(k) is the software itself.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- RayStation's Function: RayStation is a software system for radiation therapy treatment planning and analysis. It uses medical imaging data (CT, PET, MRI) to create treatment plans and estimate dose distributions for administering radiation therapy.
- Lack of Specimen Analysis: The description clearly states that RayStation works with imaging data and is used for planning and analyzing radiation treatment. There is no mention of analyzing biological specimens from the human body.
Therefore, RayStation falls under the category of medical devices used for treatment planning and delivery, not for in vitro diagnostic testing.
N/A
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 7.0 is a radiation therapy treatment planning system, i.e. a software program for planning, management and analysis of radiation therapy treatment. 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 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 System
-
The user launches RayStation 7.0
-
The user imports a patient and case with CT images through DICOM 3. The system imports the data and checks consistency of in-data
-
The user enters the Structure Definition module and creates ROIs using the contouring tools 5. The system adds the ROIs to the patient case
-
The user enters the Plan Setup module and creates a plan and a treatment setup with specified machine, treatment energy and
-
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
-
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.)
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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
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
CT, PET and MRI
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The test specification of RayStation 7.0 is a further developed version of the test specification of RayStation 6.1. This is supported by the requirements specification, for which the same is true. The successful verification and validation of RayStation 7.0 therefore support the substantial equivalence of the above RayStation versions.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
RayStation 6.1 K171536
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
Image /page/0/Picture/0 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, and then the word "ADMINISTRATION" in a smaller font size below that.
RaySearch Laboratories AB (publ) % Mr. David Hedfors Quality and Regulatory Affairs Director Sveavägen 44 111 34 Stockholm SWEDEN
April 25, 2018
Re: K180379
Trade/Device Name: RayStation 7.0 Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: MUJ Dated: April 16, 2018 Received: April 18, 2018
Dear Mr. Hedfors:
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. 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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
Page 2 - Mr. David Hedfors
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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Michael D. O'Hara For
Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K180379
Device Name RayStation 7
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.
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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| Document ID and Title | Version: |
|---|---|
| RSL-D-RS-7.0 Traditional 510(k) Submission RayStation 7.0 | 1.0 |
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
David Hedfors Quality and Regulatory Affairs Director RaySearch Laboratories AB (publ) Email: david.hedfors@raysearchlabs.com +46 722 366 110 Tel:
5.3 Preparation date
February 3rd, 2018
5:4 Trade name
The trade name is RayStation.
The trade name and version number are written together, i.e. "RayStation 7.0" to easily distinguish the submitted device from the predicate device RayStation 6.1.
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 6.1 K171536
5.8 Device description
RayStation 7.0 is a radiation therapy treatment planning system, i.e. a software program for planning, management and analysis of radiation therapy treatment. 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 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 | System |
| 1. The user launches RayStation 7.0 | |
| 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 creates a plan and a treatment setup with specified machine, treatment energy and |
4
| Document ID and Title | Version |
|---|---|
| RSL-D-RS-7.0 Traditional 510(k) Submission RayStation 7.0 | 1.0 |
| 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 |
- 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
- 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 | 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.
The intended use for RayStation 7.0 is the same as for the predicate device RayStation 6.1.
5.10 Technological characteristics summary
The technological characteristics are the same for RayStation 7.0 as for the predicate device RayStation 6.1.
Comparing RayStation 7.0 with RayStation 6.1, the newer version includes usability, computational speed and connectivity improvements. 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 specification of RayStation 7.0 is a further developed version of the test specification of RayStation 6.1. This is supported by the requirements specification, for which the same is true. The successful verification and validation of RayStation 7.0 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 7.0 is as safe and effective, and performs as well as the predicate device.