(87 days)
K211867 RayStation 11.0
Not Found
No
The document explicitly states "Related to machine learning, there is no change compared to the predicate device."
No
This device is a software system used for planning, analysis, and administration of radiation therapy and medical oncology treatment plans. While it supports therapeutic efforts by providing tools for treatment planning and administration, it is not a therapeutic device itself as it does not directly administer therapy to the patient. It is a tool for healthcare professionals to prepare and manage treatments.
No
Explanation: RayStation is a treatment planning system for radiation therapy, which proposes treatment plans and is used to administer treatments. It does not diagnose diseases or medical conditions.
Yes
The device description explicitly states that RayStation is a "software system" and a "treatment planning system." While it interacts with hardware (treatment delivery devices, imaging systems), the device being submitted for 510(k) is the software itself, which performs the planning, analysis, and administration functions. The modifications described are also software-based (new algorithms, computation methods).
Based on the provided information, RayStation is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- RayStation's Intended Use: RayStation is a software system for radiation therapy and medical oncology. Its primary function is to propose and administer treatment plans based on user input and medical imaging data (CT, CBCT). It does not analyze specimens taken from the human body.
- Device Description: The description focuses on treatment planning, dose calculation, and treatment delivery, all of which are related to the administration of therapy, not the analysis of biological samples.
- Lack of IVD-related information: The document does not mention any analysis of biological specimens, laboratory procedures, or diagnostic markers, which are typical characteristics of IVD devices.
Therefore, RayStation falls under the category of a medical device used for treatment planning and delivery in radiation therapy and medical oncology, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
RayStation is a software system for radiation therapy and medical oncology. Based on user input, RayStation proposes treatment plans. After a proposed treatment plan is reviewed and approved by authorized intended users, RayStation may also be used to administer treatments.
The system functionality can be configured based on user needs.
Product codes
MUJ
Device Description
RayStation is a treatment planning system for planning, analysis and administration of radiation therapy and medical oncology treatment plans. It has a modern user interface and is equipped with fast and accurate dose and optimization engines.
RayStation consists of multiple applications:
. The main RayStation application is used for treatment planning.
. The RayPhysics application is used for commissioning of treatment machines to make them available for treatment planning and used for commissioning of imaging systems.
The RayTreat application is used for sending plans to treatment delivery devices for treatment and receiving records of performed treatments.
The device to be marketed, RayStation 11B, contains modified features compared to RayStation 11.0 as indicated below:
A simplified license configuration of RayStation is marketed as RayPlan. RayPlan has a limited set of purchasable licenses and some modules will not be accessible. RayPlan is marketed as RayPlan 11B.
EQD2 dose computation (new) - From photon and/or braction doses, it is possible to compute, deform and accumulate the two Gray equivalent (EQD2) dose. The computation of the EQD2 dose uses the biological linear quadratic model, which is also the basis for the already released biological optimization and evaluation functionality.
Generation of synthetic CT from CBCT (new) - Two new methods (algorithms) for synthetic CT generation will be included. The synthetic CT images are created by combining information in the CBCT image and a CT image for the specific patient to allow for dose computation using the HU values in the image, as for regular CT images. In RayStation 11.0 it is possible to compute dose on CBCT images for photons using bulk density assignments. The added functionality will improve the photon dose calculation accuracy on CBCT images. Handling of LET and other RBE components (new) - This functionality enables possibility to compute and evaluate the dose weighted LET (Linear Energy Transfer) for proton and light ion plans. LET is an additional dosimetric measure that can be used to assess the radiobiological effect of the proton and light ion radiation. Radiobiological equivalent (RBE) dose is a derived quantity with dependence on both the physical dose and the LET. In RayStation 11.0, it is possible to compute and evaluate RBE doses.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Related to machine learning, there is no change compared to the predicate device.
Input Imaging Modality
CBCT, CT
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
authorized intended users
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 11B is a further developed version of the test specification of RayStation 11.0. This is supported by the requirements specification, for which the same is true. The successful verification and validation of RayStation 11B therefore support the substantial equivalence of the above RayStation versions.
EOD2 dose computation (new) – Validation for photon and/or braction doses were validated as part of the Clinical Evaluation for Brachy and User Site Validation demonstrates that the dose computation adequate for clinical use.
Generation of synthetic CT from CBCT (new) – Validation of improved photon dose calculation accuracy on CBCT images was performed in CBCT Conversion validation demonstrates that the dose computation adequate for clinical use.
Handling of LET and other RBE components (new) - Validation of dose weighted LET (Linear Energy Transfer) for proton and light ion plans were performed as part of the Proton PBS Monte Carlo validation. The validation demonstrates that the dose computation adequate for clinical use.
The determination of substantial equivalence is not based on an assessment of non-clinical performance data. However, the entire system verification and validation specifications and reports are included in the submission as required by a software device of major concern.
A number of different types of verification activities have been performed:
. System Tests of RayStation
Risk analysis-based tests for use error mitigation verification
. Unit and subsystem testing for low-level testing
. Dose engine validation including internal testing
User validation in cooperation with cancer clinics
. Reviews of design, code and Master Labeling
The data obtained from the verification show that system tests, unit and subsystem tests have passed, and the validations been completed successfully. The reviews of design, code and labeling are also passed.
From the successful verification and validation activities, the conclusion can be drawn that RayStation 11B has met specifications and is as safe, as effective and performs as well as or better than the legally marketed predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K211867 RayStation 11.0
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
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RaySearch Laboratories AB (publ) % David Hedfors Quality and Regulatory Affairs Director Eugeniavägen 18 Stockholm. 113 68 Sweden
Re: K220141
Trade/Device Name: RayStation 11B Regulation Number: 21 CFR 892.5050 Regulation Name: Medical Charged-Particle Radiation Therapy System Regulatory Class: Class II Product Code: MUJ Dated: January 10, 2022 Received: January 18, 2022
Dear David 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. 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
1
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 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,
Julie Sullivan, Ph.D. Assistant Director Nuclear Medicine and Radiation Therapy 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) K220141
Device Name RayStation 11B
Indications for Use (Describe)
RayStation is a software system for radiation therapy and medical oncology. Based on user input, RayStation proposes treatment plans. After a proposed treatment plan is reviewed and approved by authorized intended users, RayStation may also be used to administer treatments.
The system functionality can be configured based on user needs.
| 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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510(k) Summary
RayStation 11B
4
| Document ID and Title | Version: |
|---|---|
| 510(k) Summary RayStation 11B | 1.0 |
Table of Contents
| 1. | 510(k) Summary | 3 |
|---|---|---|
| 1.1 510(k) owner | 3 | |
| 1.2 Contact person | 3 | |
| 1.3 Preparation date | 3 | |
| 1.4 Trade name | 3 | |
| 1.5 Common name | 3 | |
| 1.6 Classification name | 3 | |
| 1.7 Predicate devices | 3 | |
| 1.8 Device description | 3 | |
| 1.9 Intended use | 4 | |
| 1.10 Technological characteristics summary | 4 | |
| 1.11 Assessment of non-clinical performance data | 4 | |
| 1.12 Test conclusion | 4 |
5
Document ID and Title
510(k) Summary RayStation 11B
Version:
1.0
510(k) Summary
1.1 510(k) owner
RaySearch Laboratories AB (publ) Eugeniavägen 18 113 68 Stockholm Sweden
Tel: +46 8 510 530 00
1.2 Contact person
David Hedfors Quality and Regulatory Affairs Director RaySearch Laboratories AB (publ) quality@raysearchlabs.com Email: +46 722 366 110 Tel:
Preparation date 1.3
January 10th, 2022
1.4 Trade name
The trade name is RayStation.
The marketing name is RayStation 11B and RayPlan 11B.
1.5 Common name
Radiation therapy treatment planning system
1.6 Classification name
Medical charged-particle radiation therapy system (21 CFR 892.5050, Product Code MUJ)
1.7 Predicate devices
K211867 RayStation 11.0
1.8 Device description
RayStation is a treatment planning system for planning, analysis and administration of radiation therapy and medical oncology treatment plans. It has a modern user interface and is equipped with fast and accurate dose and optimization engines.
RayStation consists of multiple applications:
- . The main RayStation application is used for treatment planning.
- . The RayPhysics application is used for commissioning of treatment machines to make them available for treatment planning and used for commissioning of imaging systems.
- The RayTreat application is used for sending plans to treatment delivery devices for treatment and receiving records of performed treatments.
The device to be marketed, RayStation 11B, contains modified features compared to RayStation 11.0 as indicated below:
A simplified license configuration of RayStation is marketed as RayPlan. RayPlan has a limited set of purchasable licenses and some modules will not be accessible. RayPlan is marketed as RayPlan 11B.
EQD2 dose computation (new) - From photon and/or braction doses, it is possible to compute, deform and accumulate the two Gray equivalent (EQD2) dose. The computation of the EQD2 dose uses the biological linear quadratic model, which is also the basis for the already released biological optimization and evaluation functionality.
6
| Document ID and Title | Version: |
|---|---|
| 510(k) Summary RayStation 11B | 1.0 |
Generation of synthetic CT from CBCT (new) - Two new methods (algorithms) for synthetic CT generation will be included. The synthetic CT images are created by combining information in the CBCT image and a CT image for the specific patient to allow for dose computation using the HU values in the image, as for regular CT images. In RayStation 11.0 it is possible to compute dose on CBCT images for photons using bulk density assignments. The added functionality will improve the photon dose calculation accuracy on CBCT images. Handling of LET and other RBE components (new) - This functionality enables possibility to compute and evaluate the dose weighted LET (Linear Energy Transfer) for proton and light ion plans. LET is an additional dosimetric measure that can be used to assess the radiobiological effect of the proton and light ion radiation. Radiobiological equivalent (RBE) dose is a derived quantity with dependence on both the physical dose and the LET. In RayStation 11.0, it is possible to compute and evaluate RBE doses.
1.9 Intended use
RayStation is a software system for radiation therapy and medical oncology. Based on user input, RayStation proposes treatment plans. After a proposed treatment plan is reviewed and approved by authorized intended users, RayStation may also be used to administer treatments.
The system functionality can be configured based on user needs.
1.10 Technological characteristics summary
The technological characteristics are the same for RayStation 11B as for the predicate device RayStation 11.0. 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, by the same development teams, meeting the same requirements for safety and effectiveness.
The device to be marketed, RayStation 11B contains new features as indicated below:
- . EQD2 dose computation (new)
- . Generation of synthetic CT from CBCT (new)
- Handling of LET and other RBE components (new)
Related to machine learning, there is no change compared to the predicate device.
1.11 Assessment of non-clinical performance data
The test specification of RayStation 11B is a further developed version of the test specification of RayStation 11.0. This is supported by the requirements specification, for which the same is true. The successful verification and validation of RayStation 11B therefore support the substantial equivalence of the above RayStation versions.
EOD2 dose computation (new) – Validation for photon and/or braction doses were validated as part of the Clinical Evaluation for Brachy and User Site Validation demonstrates that the dose computation adequate for clinical use.
Generation of synthetic CT from CBCT (new) – Validation of improved photon dose calculation accuracy on CBCT images was performed in CBCT Conversion validation demonstrates that the dose computation adequate for clinical use.
Handling of LET and other RBE components (new) - Validation of dose weighted LET (Linear Energy Transfer) for proton and light ion plans were performed as part of the Proton PBS Monte Carlo validation. The validation demonstrates that the dose computation adequate for clinical use.
1.12 Test conclusion
The determination of substantial equivalence is not based on an assessment of non-clinical performance data. However, the entire system verification and validation specifications and reports are included in the submission as required by a software device of major concern.
A number of different types of verification activities have been performed:
- . System Tests of RayStation
7
- Risk analysis-based tests for use error mitigation verification ●
- . Unit and subsystem testing for low-level testing
- . Dose engine validation including internal testing
- User validation in cooperation with cancer clinics
- . Reviews of design, code and Master Labeling
The data obtained from the verification show that system tests, unit and subsystem tests have passed, and the validations been completed successfully. The reviews of design, code and labeling are also passed.
From the successful verification and validation activities, the conclusion can be drawn that RayStation 11B has met specifications and is as safe, as effective and performs as well as or better than the legally marketed predicate device.