(111 days)
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No
The document describes a standard radiation therapy treatment planning system with no mention of AI or ML capabilities. The functionality described aligns with traditional treatment planning workflows.
No
This device is a software system for treatment planning and analysis, not the therapeutic device itself which would administer radiation.
No
Explanation: The device is described as a "treatment planning system" for radiation therapy. While it uses patient data (CT images) to generate "estimates of dose distributions expected during the proposed treatment," its primary function is to plan treatments, not to diagnose a medical condition. Diagnosis involves identifying the nature of a disease, and RayStation's output (treatment parameters and dose estimates) is for therapeutic purposes, not for diagnosing an illness.
Yes
The device description explicitly states that RayStation 4.0.2 is a "software program for planning and analysis of radiation therapy plans." The entire description focuses on the software's functions and processes, with no mention of accompanying hardware components that are part of the medical device itself. While it uses input from hardware (CT scanner), the device being cleared is the software system.
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." It helps in creating treatment plans, setting up treatment units, and estimating dose distributions. This is a therapeutic planning tool, not a diagnostic tool.
- Device Description: The description reinforces its role as a "treatment planning system" for radiation therapy.
- Lack of Diagnostic Function: There is no mention of the device being used to diagnose a disease, condition, or state of health. It doesn't analyze biological samples (blood, tissue, etc.) or provide information for diagnostic purposes.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. RayStation's function is focused on planning and delivering a therapeutic intervention (radiation therapy).
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 4.0.2 is a treatment planning system, i.e. a software program for planning and analysis of radiation therapy plans. Typically, a treatment plan is created by importing patient images obtained from a CT scanner, defining regions of interest either manually or semi-automatically, deciding on a treatment setup and objectives, optimizing the treatment parameters, comparing rival plans to find the best compromise, computing the clinical dose distribution, approving the plan and exporting it.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
CT images
Anatomical Site
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Indicated Patient Age Range
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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
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Description of the test set, sample size, data source, and annotation protocol
The test specification of RayStation 4.0.2 is a further developed version of the test specification of RayStation 3.5. This is supported by the requirements specification, for which the same is true. The successful verification and validation of RayStation 4.0.2 therefore support the substantial equivalence of the above RayStation versions.
The verification performed for proton planning verifies the functionality for
- Proton planning treatment plan calculation .
- Proton energy range estimation .
- Proton dose calculation .
- Pencil Beam Scanning (PBS) .
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 4.0.2 is as safe and effective, and performs as well as the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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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| Title: | Document ID: | Version: |
|---|---|---|
| 510(k) Submission RayStation 4.0.2 | RSL-D-61-04 | 1.0 |
510(k) Summary 5.
510(k) owner 5.1
RaySearch Laboratories AB Sveavägen 25, plan 9 111 34 Stockholm Sweden
+46 (8) 54506130 Tel: +46 (8) 54506139 Fax:
5.2 Contact person
Ladan Amiri, Sr. Quality and Regulatory Affairs Engineer
5.3 Preparation date January 14, 2014
5.4 Trade name
RayStation
Trade name and version number are written together, i.e. "RayStation 4.0.2" to easily distinguish the submitted device from the predicate device RayStation 3.5.
5.5 Common name
Radiation treatment planning system
5.6 Classification name
Medical charged-particle radiation therapy system (21 CFR 892.5050, Product Code MUJ)
5.7 Predicate devices
| RayStation 3.5 | K130617 |
|---|---|
| XiO RTP System | K102216 |
5.8 Device description
RayStation 4.0.2 is a treatment planning system, i.e. a software program for planning and analysis of radiation therapy plans. Typically, a treatment plan is created by importing patient images obtained from a CT scanner, defining regions of interest either manually or semi-automatically, deciding on a treatment setup and objectives, optimizing the treatment parameters, comparing rival plans to find the best compromise, computing the clinical dose distribution, approving the plan and exporting it.
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 4.0.2 | ||
| 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 creates a plan and a treatment setup with specified machine, treatment energy and delivery type (SMLC) |
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|
Title:
| · A - A - A - A - A - A - A - A - A - A - A - A - A - A - A - A - A - A - A - A - A - A - A - A - A - A - A - A - A - A - A - A - A - A - A - A - A - A - A - A - A - A - A - | Document ID: | Version: |
|---|---|---|
| and of the super for seems of the bearing the first for the first for the first and the first of the first of the first of the first for the first for the first for the first | ||
| 510(k) Submission RayStation 4.0.2 | RSL-D-61-04 | 14.40 |
| 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 creates an optimization problem | ||
| 10. | The user defines the algorithm and segmentation settings and starts the optimization | 11. | The system generates a deliverable step-and-shoot plan |
| 12. | The system displays the plan as |
- 2D and 3D dose and patient displays
- DVH curves
- Plan data (beams, segments etc.) |
| 13. | The user reviews the plan | | |
| 14. | The user enters the Plan Evaluation module and evaluates the plan | | |
| 15. | The user approves and exports the plan together with dose, structure sets and images | 16. | 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 4.0.2 is the same as for the predicate device RayStation 3.5.
Technological characteristics summary 5.10
5.10.1 General technology
The technological characteristics are the same for RayStation 4.0.2 as for the predicate device RayStation 3.5.
Comparing RayStation 4.0.2 with RayStation 3.5, the newer version includes usability, performance and connectivity improvements. Both versions are built on the same software platform and share basic design. Both versions have been developed under the same quality system meeting the same requirements for safety and effectiveness.
5.10.2 Proton planning with Pencil Beam Scanning (PBS)
The proton planning functionality in RayStation 3.5 is extended in RayStation 4.0.2 by adding Pencil Beam Scanning (PBS) functionality.
The RayStation 4.0.2 proton planning with Pencil Bam Scanning (PBS) technology is substantially equivalent to the predicate device XiO RTP System - Proton Spot Scanning.
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| ` Title: | Document ID: | Version | |
|---|---|---|---|
| 510(k) Submission RayStation 4.0.2 | |||
| But a sua change a comments a comments of the | L-D-61-04 | ||
| 12 C 1 | COLL LE CLAIN CHARGE CHANNELL |
Comparing RayStation 4.0.2 and XiO RTP Systems give the user the ability to crate proton treatment plans that involve a series of small proton beams for which dose and monitor units are calculated and displayed individually. This allows users to create intensity modulated ration therapy (IMRT) plans with protons.
5.11 Assessment of non-clinical performance data
5.11.1 General technology
The test specification of RayStation 4.0.2 is a further developed version of the test specification of RayStation 3.5. This is supported by the requirements specification, for which the same is true. The successful verification and validation of RayStation 4.0.2 therefore support the substantial equivalence of the above RayStation versions.
5.11.2 Proton planning
The verification performed for proton planning verifies the functionality for
- Proton planning treatment plan calculation .
- Proton energy range estimation .
- Proton dose calculation .
- Pencil Beam Scanning (PBS) .
This is the same functionality as included in the predicate device XiO RTP System. The test results thereby support a determination of substantial equivalence.
5.12 Test conclusion
The summary of the performed non-clinical tests shows that RayStation 4.0.2 is as safe and effective, and performs as well as the predicate devices.
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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles an abstract caduceus, with three wavy lines representing the serpent and a stylized staff.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 15, 2014
RaySearch Laboratories AB % Ms. Ladan Amiri Sr. Quality and Regulatory Affairs Engineer Sveavagen 25, plan 9 111 34 Stockholm SWEDEN
Re: K140187 Trade/Device Name: RayStation 4.0.2 Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: MUJ Dated: April 13, 2014 Received: April 16, 2014
Dear Ms. Amiri:
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 (2 l 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.
4
Page 2—Ms. Amiri
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" (21CFR 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/Industrv/default.htm.
Sincerely yours,
Smh.7)
for
Janine M. Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
5
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K140187
Device Name RayStation 4.0.2
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.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Smh.7)
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