RAYSTATION

K130617 · Raysearch Laboratories AB · MUJ · May 10, 2013 · Radiology

Device Facts

• Record ID: K130617
• Device Name: RAYSTATION
• Applicant: Raysearch Laboratories AB
• Product Code: MUJ · Radiology
• Decision Date: May 10, 2013
• 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 3.5 is a radiation treatment planning software system. Input: patient CT images via DICOM. Workflow: user defines regions of interest (ROIs) manually or semi-automatically; specifies beam configuration, isocenter, dose grid, and fluence grid resolution; defines optimization problem; system computes clinical dose distribution and generates deliverable treatment plan. Output: treatment unit set-up parameters and dose distribution estimates. Used in clinical settings by qualified radiation therapy staff. Healthcare providers review and approve plans to guide radiation therapy administration. Benefits: enables precise treatment planning and analysis for radiation therapy delivery.

Clinical Evidence

Bench testing only. Verification and validation testing confirmed functionality for treatment planning, including electron energies (4-25 MeV), 3D radiotherapy dose calculation, asymmetric/non-coplanar fields, proton energy range estimation, and proton dose calculation. Results support substantial equivalence to predicate devices.

Technological Characteristics

Software-based treatment planning system. Utilizes Voxel Monte Carlo (VMC++) algorithm for electron dose calculation. Connectivity via DICOM. Operates on a shared software platform with previous versions. No specific hardware materials or sterilization methods applicable as it is a software-only 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 2.5 (K120387)
• DCM 2.0 (K020971)
• Proton Vision 7.0 (K000922)

Submission Summary (Full Text)

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K130617

MAY 1 0 2013

| Title: | Document ID: | Version: |
|----------------------------------|--------------|----------|
| 510(k) Submission RayStation 3.5 | RSL-D-61-04 | 1.0 |

### 5. 510(k) Summary

### 5.1 510(k) owner

RaySearch Laboratories AB Sveavägen 25. plan 9 111 34 Stockholm Sweden

liel: [phone] [phone] Fax:

### 5.2 Contact person

David Hedfors, Quality and Regulatory Affairs Manager

#### 5.3 Preparation date

February 22, 2013

### 5.4 Trade name

RayStation

Trade name and version number are written together. i.e. "RavStation 3.5" to easily distinguish the submitted device from the predicate device RayStation 2.5.

#### 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 2.5 | K120387 |
|-------------------|---------|
| DCM 2.0 | K020971 |
| Proton Vision 7.0 | K000922 |

### 5.8 Device description

RayStation 3.5 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 from a CT scanner, defining regions of interest either manually or semi-automatically, deciding on a realment 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 3.5 | |
| 2. The user imports a patient with CT images through DICOM | 3. The system imports the data and checks data consistency |
| 4. The user enters the Structure Definition module and creates ROIs using the contouring tools | 5. The system adds the ROIs to the patient structure set |
| 6. The user enters the Treatment Specification module and creates a plan and a treatment setup with specified | |

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| Title: | Document ID: | Version | |
|----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|---------|------------------------------------------------------------------------|
| 510(k) Submission RayStation 3.5 | RSL-D-61-04 | 1.0 | |
| 7. | machine, treatment energy and delivery type<br>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 |
| 9. | The user enters the Plan Optimization module and creates an optimization problem | | |
| 10. | The user defines the algorithm and delivery settings and starts the optimization | | |
| | | 11. | The system generates a deliverable treatment plan |
| | | 12. | The system displays the plan in a number of user configurable displays |
| 13. | The user reviews the plan | | |
| 14. | The user enters the Plan Approval 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 in DICOM format |

#### 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 3.5 is the same as for the predicate device RayStation 2.5.

#### 5.10 Technological characteristics summary

### 5.10.1 General technology

The technological characteristics are the same for RayStation 3.5 as for the predicate device RayStation 2.5.

Comparing RayStation 3.5 with RayStation 2.5, 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 Electron planning

The RayStation 3.5 electron planning technology is substantially equivalent to the predicate device DCM 2.0 electron planning.

Comparing RayStation 3.5 with DCM 2.0. both systems perform calculations using the Voxel Monte Carlo (VMC++) algorithm, supported by an electron beam model.

### 5.10.3 Proton planning

The RayStation 3.5 proton planning technology is substantially equivalent to the predicate device Proton Vision 7.0 proton planning.

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| Title: | Document ID: | Version: |
|----------------------------------|--------------|----------|
| 510(k) Submission RayStation 3.5 | RSL-D-61-04 | 1.0 |

Comparing RayStation 3.5 and Proton Vision 7.0, both systems calculate and display prospective or verification treatment plans for patients undergoing a course of proton therapy. Both systems provide tools for proton energy range estimation, proton dose calculation and dosimetric plan review.

#### 5.11 Assessment of non-clinical performance data

### 5.11.1 General technology

The test specification of RayStation 3.5 is a further developed version of the test specification of RayStation 2.5. This is supported by the requirements specification, for which the same is true. The successful verification and validation of RayStation 3.5 therefore support the substantial equivalence of the two RayStation versions.

### 5.11.2 Electron planning

The verification performed for electron planning verifies the functionality for

- Treatment planning with electron energies from 4 to 25 MeV. . This is a small extension of the energy range of the predicate device. which ranges from 6 to 25 McV. The extension does not require a new or modified algorithm or technology.
- Dose calculation for 3D radiotherapy treatment with combined modality plans. .
- Calculation of asymmetric and non-coplanar fields.

This is the same functionality as included in the predicate device DCM 2.0. The test results thereby support a determination of substantial equivalence.

## 5.11.3 Proton planning

The verification performed for proton planning verifies the functionality for

- Proton planning treatment plan calculation .
- Proton energy range estimation .
- Proton dose calculation .

This is the same functionality as included in the predicate device Proton Vision 7.0. 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 3.5 is as safe and effective, and performs as well as the predicate devices.

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & 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 an abstract symbol that resembles a stylized eagle or bird in flight, composed of three curved lines.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

May 10, 2013

RaySearch Laboratories AB % Mr. David Hedfors Quality and Regulatory Affairs Manager Sveavägen 25, Plan 9 111 34 STOCKHOLM SWEDEN

· Re: K130617

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: March 4, 2013 Received: April 4, 2013

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 (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. Hedfors

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industrv/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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm1.

Sincerely yours,

Michael D. O'Hara

Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

for

Enclosure

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# Indications for Use

510(k) Number (if known): K130617

Device Name: RayStation

Indications for Use:

RayStation is a software system designed for treatment planning and analysis of radiation therapy. The treatment plaus 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)

Machiel D. O'Hara

(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health

510(k) K130617

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