RayStation 7

K180379 · RaySearch Laboratories AB (PUBL) · MUJ · Apr 25, 2018 · Radiology

Device Facts

• Record ID: K180379
• Device Name: RayStation 7
• Applicant: RaySearch Laboratories AB (PUBL)
• Product Code: MUJ · Radiology
• Decision Date: Apr 25, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5050
• Device Class: Class 2
• Attributes: Software as a Medical Device

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.

Device Story

RayStation 7.0 is a radiation therapy treatment planning system (TPS) software. Inputs include patient image data (CT, PET, MRI) via DICOM. System performs image fusion, contouring, and dose computation using collapsed cone convolution. Features include multi-criteria optimization, dose tracking, treatment adaptation, and deformable registration. Used in clinical settings by radiation therapy staff to generate deliverable treatment plans. Output includes 2D/3D dose distributions, DVH curves, and treatment parameters (beams, segments). Clinicians review and approve plans for administration. Benefits include optimized treatment planning, improved computational speed, and enhanced connectivity for radiation therapy workflows.

Clinical Evidence

Bench testing only. Verification and validation were performed based on updated requirements and test specifications derived from the predicate device to confirm safety and effectiveness.

Technological Characteristics

Software-based radiation therapy treatment planning system. Features collapsed cone convolution dose computation, multi-criteria optimization, and deformable registration. Supports DICOM connectivity for image import/export. Operates on a shared software platform with the predicate device.

Indications for Use

Indicated for radiation therapy treatment planning and analysis in patients requiring radiation therapy. Intended for use by clinically qualified radiation therapy staff.

Regulatory Classification

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.

Predicate Devices

• RayStation 6.1 (K171536)

Submission Summary (Full Text)

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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.

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# 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 ([e-mail]) or phone [phone] 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)

| <span> ☑ Prescription Use (Part 21 CFR 801 Subpart D) </span> | <span> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </span> |
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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: [phone]

#### 5.2 Contact person

David Hedfors Quality and Regulatory Affairs Director RaySearch Laboratories AB (publ) Email: [e-mail] [phone] 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 | |

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| 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<br>including isocenter, dose grid and fluence<br>grid resolution | 8. The system adds the plan and treatment<br>setup to the patient case |
| 9. The user enters the Plan Optimization<br>module and optimizes the plan parameters | 10. The system generates a deliverable plan<br>11. The system displays the plan as<br>- 2D and 3D dose and patient displays<br>- DVH curves<br>- Plan data (beams, segments etc.) |
| 12. The user reviews the plan<br>13. The user enters the Plan Evaluation<br>module and evaluates the plan<br>14. The user approves and exports the plan<br>together with dose, structure sets and<br>images | 15. The system exports the plan and patient<br>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.