(105 days)
Not Found
No
The summary describes a radiation therapy treatment planning system with advanced features like multi-criteria optimization and deformable registration, but it does not mention or imply the use of AI or ML technologies. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No
RayStation is a software system for planning and analysis of radiation therapy, not a device that directly administers therapy or has a therapeutic effect itself.
No
The device is a treatment planning and analysis system for radiation therapy, which does not involve diagnosing medical conditions.
Yes
The device description explicitly states "RayStation 4.5 is a radiation therapy treatment planning system, i.e. a software program for planning and analysis of radiation therapy treatment plans." This indicates it is a software-only device. While it processes imaging data (CT, PET, MRI), it does not describe any hardware components included as 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 involves planning how to deliver radiation to a patient, not analyzing samples taken from a patient (which is the core of IVD).
- Device Description: The description reinforces this by calling it a "radiation therapy treatment planning system."
- No mention of analyzing biological samples: There is no indication that the software interacts with or analyzes any biological samples (blood, tissue, urine, etc.) from a patient.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. RayStation's function is entirely focused on planning the delivery of a medical treatment (radiation therapy) based on imaging data.
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 4.5 is a radiation therapy treatment planning system, i.e. a software program for planning and analysis of radiation therapy treatment plans. Functionality includes fusion capabilities (CT, PET and MRI), contouring, collapsed cone convolution dose computation and 4D data compatibility, as well as unique features such as multi-criteria optimization, dose tracking, treatment adaptation and deformable registration, all available on one platform.
The main workflow, creating a treatment plan from imported patient image data, is described below:
User
- The user launches RayStation 4.5
- 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 delivery type
- 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.)
- The system exports the plan and patient data to a DICOM server
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT, PET, 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 4.5 is a further developed version of the test specification of RayStation 4.0.2. This is supported by the requirements specification, for which the same is true. The successful verification and validation of RayStation 4.5 therefore support the substantial equivalence of the above RayStation versions.
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.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of three human profiles facing to the right, arranged in a stacked formation. The profiles are rendered in a dark color, creating a sense of depth and unity. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 23, 2014
RaySearch Laboratories AB % Mr. David Hedfors Quality And Regulatory Affairs Manager Sveav 25. Plan 9 Stockholm, 111 34 SWEDEN
Re: K141860 Trade/Device Name: RayStation Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: MUJ Dated: August 21, 2014 Received: August 25, 2014
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Michael D. O'Hara
for
Janine M. Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known): K141860
Device Name: RayStation 4.5
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.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health 510(k)
Page 1 of 1
3
| Title: | Document ID: | Version: |
|---|---|---|
| RayStation 4.5 | RSL-D-61-227 | 1.0 |
7. 510(k) Summary
7.1 510(k) owner
RaySearch Laboratories AB Sveavägen 25, floor 9 111 34 Stockholm Sweden
Tel: +46 (8) 54506130 +46 (8) 54506139 Fax:
7.2 Contact person
David Hedfors Quality and Regulatory Affairs Manager david.hedfors@raysearchlabs.com
7.3 Preparation date
June 27, 2014
7.4 Trade name
RayStation
Trade name and version number are often combined, i.e. "RayStation 4.5", to easily distinguish the submitted device from the predicate device RayStation 4.0.2.
7.5 Common name
Radiation Therapy Treatment Planning System
7.6 Classification name
Medical charged-particle radiation therapy system (21 CFR 892.5050, Product Code MUI)
7.7 Predicate device
RayStation 4.0.2 K140187
7.8 Device description
RayStation 4.5 is a radiation therapy treatment planning system, i.e. a software program for planning and analysis of radiation therapy treatment plans. Functionality includes fusion capabilities (CT, PET and MRI), contouring, collapsed cone convolution dose computation and 4D data compatibility, as well as unique features such as multi-criteria optimization, dose tracking, treatment adaptation and deformable registration, all available on 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 4.5 | |
| 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 delivery type |
4
| Title:
RayStation 4.5 | Document ID:
RSL-D-61-227 | Version:
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
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
- 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 | |
7.9 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 4.5 is the same as for the predicate device RayStation 4.0.2.
7.10 Technological characteristics summary
The technological characteristics are the same for RayStation 4.5 as for the predicate device RayStation 4.0.2.
Comparing RayStation 4.5 with RayStation 4.0.2, 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.
The test specification of RayStation 4.5 is a further developed version of the test specification of RayStation 4.0.2. This is supported by the requirements specification, for which the same is true. The successful verification and validation of RayStation 4.5 therefore support the substantial equivalence of the above RayStation versions.