K Number

Device Name

RayStation

Manufacturer

RaySearch Laboratories AB (publ)

Date Cleared

2019-06-19

(120 days)

Product Code

MUJ

Regulation Number

892.5050

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 Description

RayStation 8.1 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 machine learning and segmentation, multi-criteria optimization, dose tracking, treatment adaptation and deformable registration, all available in one platform.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K180379

Reference Devices

K180379

AI/ML (Artificial Intelligence / Machine Learning)

Yes
The device description explicitly mentions "machine learning" as a unique feature.

Therapeutic

No
The device is a software system for planning and analysis of radiation therapy, not a device that directly administers therapy or has a therapeutic effect itself.

Diagnostic

Explanation: RayStation is a treatment planning system that estimates dose distributions and provides setup parameters for radiation therapy. While it uses medical imaging for planning, its primary function is to plan treatments rather than diagnose medical conditions.

SaMD (Software as a Medical Device)

Yes

The device is described as a "software system" and a "software program" for treatment planning and analysis, with no mention of accompanying hardware components being part of the submitted device.

IVD (In Vitro Diagnostic)

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 biological samples or providing diagnostic information from in vitro tests.
Device Description: The description reinforces this by detailing features related to radiation therapy planning, such as dose computation, treatment console interfacing, and optimization.
Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on in vitro tests.

IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. RayStation's function is focused on the delivery and planning of a medical treatment (radiation therapy) based on imaging data, not on analyzing biological samples for diagnostic purposes.

PCCP (Predetermined Change Control Plan) Authorized

No
The letter does not explicitly state that the FDA has reviewed and approved or cleared a PCCP for this specific device.

Overview

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

The user launches RayStation 8.1
The user imports a patient and case with CT images through DICOM
The system imports the data and checks consistency of in-data
The user enters the Structure Definition module and creates ROIs using the contouring tools
The system adds the ROIs to the patient case
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 system adds the plan and treatment setup to the patient case
The user enters the Plan Optimization module and optimizes the plan parameters
The system generates a deliverable plan
The system displays the plan as - 2D and 3D dose and patient displays - DVH curves - Plan data (beams, segments etc.)
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

Mentions image processing

Not Found

Mentions AI, DNN, or ML

machine learning

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 8.1 is a further developed version of the test specification of RayStation 7.0. This is supported by the requirements specification, for which the same is true. The successful verification and validation of RayStation 8.1 therefore support the substantial equivalence of the above RayStation versions.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K180379

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 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.

Summary

Image /page/0/Picture/0 description: The image shows 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 is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

RaySearch Laboratories AB (publ) % David Hedfors Quality and Regulatory Affairs Director Sveavagen 44 111 34 Stockholm SWEDEN

June 19, 2019

Re: K190387

Trade/Device Name: RayStation Regulation Number: 21 CFR 892.5050 Regulation Name: Medical Charged-Particle Radiation Therapy System Regulatory Class: Class II Product Code: MUJ Dated: June 14, 2019 Received: June 17, 2019

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. 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 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 mediation-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.

For

Thalia T. Mills, Ph.D. Director 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

Indications for Use

510(k) Number (if known) K190387

Device Name RayStation 8.1

Indications for Use (Describe)

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)
☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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Document ID and Title	Version:
RSL-D-RS-8.1 Traditional 510(k) Submission RayStation 8.1	1.0

510(k) Summary 5.

5.1 510(k) owner

RaySearch Laboratories AB (publ) Sveavägen 44 111 34 Stockholm Sweden

Tel: +46 8 510 530 00

5.2 Contact person

David Hedfors Quality and Regulatory Affairs Director RaySearch Laboratories AB (publ) Email: quality(@raysearchlabs.com Tel: +46 722 366 110

5.3 Preparation date

February 15th, 2019

5.4 Trade name

The trade name is RayStation.

The trade name and version number are written together, i.e. "RayStation 8.1" to easily distinguish the submitted device from the predicate device RayStation 7.0.

The marketing name is RayStation 8B.

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 7.0 K180379

5.8 Device description

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 8.1
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

K190387

Document ID and Title	Version
RSL-D-RS-8.1 Traditional 510(k) Submission RayStation 8.1	1.0
creates a plan and a treatment setup with
specified machine, treatment energy and
delivery type
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 | |
| 13. The user enters the Plan Evaluation
module and evaluates the plan | |
| 14. The user approves and exports the plan
together with dose, structure sets and
images | |

5.9 Intended use

data to a DICOM server

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 8.1 is the same as for the predicate device RayStation 7.0.

5.10 Technological characteristics summary

The technological characteristics are the same for RayStation 8.1 as for the predicate device RayStation 7.0.

Comparing RayStation 8.1 with RayStation 7.0, 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

5.12 Test conclusion

The summary of the performed non-clinical tests shows that RayStation 8.1 is as safe and effective and performs as well as the predicate device.