(84 days)
Yes
The summary explicitly states "Related to machine learning, there is no change compared to the predicate device," indicating that the predicate device (and therefore likely the current device) incorporates machine learning.
No.
RayStation is a software system for radiation therapy planning and administration, not a device directly applying therapy.
No
Explanation: RayStation is described as a "treatment planning system for planning, analysis and administration of radiation therapy and medical oncology treatment plans," and is used to "propose treatment plans" and "administer treatments." While it involves analysis, its primary described function is treatment planning and administration, not the diagnosis of a condition.
Yes
The device description explicitly states "RayStation is a software system" and details its components as "multiple applications". While it interacts with hardware (treatment delivery devices), the device itself, as described for marketing, is the software system. The validation focuses on software performance and dose calculation, not hardware.
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 a software system for radiation therapy and medical oncology. It is used to propose, review, approve, and administer treatment plans. This is a therapeutic application, not a diagnostic one.
- Device Description: The description reinforces its role as a treatment planning system for radiation therapy and medical oncology. It focuses on dose calculation, optimization, and sending plans to treatment delivery devices.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or prognosis of diseases based on in vitro analysis.
The device's function is centered around planning and delivering radiation treatment, which is a therapeutic intervention, not an in vitro diagnostic process.
No
The letter does not explicitly state that the FDA has reviewed and approved or cleared a PCCP for this specific device; PCCP is not mentioned at all.
Intended Use / Indications for Use
RayStation is a software system for radiation therapy and medical oncology. Based on user input, RayStation proposes treatment plans. After a proposed treatment plan is reviewed and approved by authorized intended users, RayStation may also be used to administer treatments.
The system functionality can be configured based on user needs.
Product codes
MUJ
Device Description
RayStation is a treatment planning system for planning, analysis and administration of radiation therapy and medical oncology treatment plans. It has a modern user interface and is equipped with fast and accurate dose and optimization engines.
RayStation consists of multiple applications:
- . The main RayStation application is used for treatment planning.
- . The RayPhysics application is used for commissioning of treatment machines to make them available for treatment planning and used for commissioning of imaging systems.
- . The RayTreat application is used for sending plans to treatment delivery devices for treatment and receiving records of performed treatments.
The device to be marketed, RayStation 11.0, marketing name "RayStation 11A", contains modified features compared to version 10.1. The main change is planning for the CyberKnife linear accelerator treatment unit.
The device to be marketed supports planning and dose calculation for M6/S7 CyberKnife treatment machines. Older CyberKnife versions are not supported. The CyberKnife has one delivery technique, and different node sets. The node set defines the possible robot positions for different collimations (cones or MLC) and patient geometry (head or body). All node sets available for patient treatments are included in the validation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Related to machine learning, there is no change compared to the predicate device.
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Authorized intended users
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
The test specification of RayStation 11,0 is a further developed version of the test specification of RayStation 10.1. This is supported by the requirements specification, for which the same is true. The successful verification and validation of RayStation 11.0 therefore support the substantial equivalence of the above RayStation versions.
CyberKnife specific photon dose engine validation for RayStation 11.0 was performed for the collapsed cone and photon Monte Carlo dose engines. The validation shows that the dose computation is adequate for clinical use.
RayStation supports planning and dose calculation for M6/S7 CyberKnife treatment machines. Older CyberKnife versions are not supported, which is also stated in the Instructions for Use. The CyberKnife has one delivery technique and different node set defines the possible robot positions for different collimations (cones or MLC) and patient geometry (head or body). All node sets available for patient treatments are included in the validation.
The determination of substantial equivalence is not based on an assessment of non-clinical performance data. However, the entire system verification and validation specifications and reports are included in the submission as required by a software device of major concern.
A number of different types of verification activities have been performed:
- . System Tests of RayStation
- . Risk analysis-based tests for use error mitigation verification
- . Unit and subsystem testing for low-level testing
- . Dose engine validation including internal testing
- . User validation in cooperation with cancer clinics
- . Reviews of design, code and Master Labeling
The data obtained from the verification show that system tests, unit and subsystem tests have passed, and the validations been completed successfully. The reviews of design, code and labeling are also passed.
Key Metrics
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.
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September 8, 2021
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is the Department of Health & Human Services logo. To the right of that is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and "ADMINISTRATION" in a smaller font below.
RaySearch Laboratories AB (publ) % Mr. David Hedfors Quality and Regulatory Affairs Director Sveavägen 44 Stockholm, 111 34 SWEDEN
Re: K211867
Trade/Device Name: RayStation 11.0 Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: Class II Product Code: MUJ Dated: June 9, 2021 Received: June 16, 2021
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 mav, 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 avare 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-reporting
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combination-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,
Michael D. O'Hara
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
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Indications for Use
510(k) Number (if known) K211867
Device Name RayStation 11.0
Indications for Use (Describe)
RayStation is a software system for radiation therapy and medical oncology. Based on user input, RayStation proposes treatment plans. After a proposed treatment plan is reviewed and approved by authorized intended users, RayStation may also be used to administer treatments.
The system functionality can be configured based on user needs.
| 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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Image /page/3/Picture/0 description: The image shows the logo for RaySearch Laboratories. The word "RaySearch" is written in blue, with "Ray" being larger than "Search". Below "RaySearch" is the word "Laboratories" in gray. To the right of the text is a geometric design of gray lines converging at a blue hexagon.
K211867 RSL-D-RS-11.0 510(k) Summary
RayStation 11.0
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| Document ID and Title | Version: |
|---|---|
| RSL-D-RS-11.0 510(k) Summary RayStation 11.0 | 1.0 |
Table of Contents
| 1. | 510(k) Summary | 3 | |
|---|---|---|---|
| 1.1 | 510(k) owner | 3 | |
| 1.2 | Contact person | 3 | |
| 1.3 | Preparation date | 3 | |
| 1.4 | Trade name | 3 | |
| 1.5 | Common name | 3 | |
| 1.6 | Classification name | 3 | |
| 1.7 | Predicate devices | 3 | |
| 1.8 | Device description | 3 | |
| 1.9 | Intended use | 4 | |
| 1.10 | Technological characteristics summary | 4 | |
| 1.11 | Assessment of non-clinical performance data | 4 | |
| 1.12 | Test conclusion | 4 |
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| Document ID and Title | Version: |
|---|---|
| RSL-D-RS-11.0 510(k) Summary RayStation 11.0 | 1.0 |
510(k) Summary 1.
1.1 510(k) owner
RaySearch Laboratories AB (publ) Sveavägen 44 111 34 Stockholm Sweden
Tel: +46 8 510 530 00
1.2 Contact person
David Hedfors Quality and Regulatory Affairs Director RaySearch Laboratories AB (publ) Email: quality@raysearchlabs.com +46 722 366 110 Tel:
Preparation date 1.3
June 9th, 2021
1.4 Trade name
The trade name is RayStation.
The trade name and version number are written together, i.e. "RayStation 11.0" to easily distinguish the submitted device from the primary predicate device RayStation 10.1.
The marketing name is RayStation 11A.
1.5 Common name
Radiation therapy treatment planning system
1.6 Classification name
Medical charged-particle radiation therapy system (21 CFR 892.5050, Product Code MUJ)
1.7 Predicate devices
K210645 RayStation 10.1
1.8 Device description
RayStation is a treatment planning system for planning, analysis and administration of radiation therapy and medical oncology treatment plans. It has a modern user interface and is equipped with fast and accurate dose and optimization engines.
RayStation consists of multiple applications:
- . The main RayStation application is used for treatment planning.
- . The RayPhysics application is used for commissioning of treatment machines to make them available for treatment planning and used for commissioning of imaging systems.
- . The RayTreat application is used for sending plans to treatment delivery devices for treatment and receiving records of performed treatments.
The device to be marketed, RayStation 11.0, marketing name "RayStation 11A", contains modified features compared to version 10.1. The main change is planning for the CyberKnife linear accelerator treatment unit.
The device to be marketed supports planning and dose calculation for M6/S7 CyberKnife treatment machines. Older CyberKnife versions are not supported. The CyberKnife has one delivery technique, and different node sets. The node set defines the possible robot positions for different collimations (cones or MLC) and patient geometry (head or body). All node sets available for patient treatments are included in the validation.
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| Document ID and Title | Version: |
|---|---|
| RSL-D-RS-11.0 510(k) Summary RayStation 11.0 | 1.0 |
CyberKnife specific photon dose engine validation for RayStation 11.0 was performed for the collapsed cone and photon Monte Carlo dose engines. The validation shows that the dose computation is suited for clinical use.
1.9 Intended use
RayStation is a software system for radiation therapy and medical oncology. Based on user input, RayStation proposes treatment plans. After a proposed treatment plan is reviewed and approved by authorized intended users, RayStation may also be used to administer treatments.
The system functionality can be configured based on user needs.
1.10 Technological characteristics summary
The technological characteristics are the same for RayStation 11.0 as for the predicate device RayStation 10.1. 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, by the same development teams, meeting the same requirements for safety and effectiveness.
The device to be marketed, RayStation 11.0, marketing name "RayStation 11A", contains modified features compared to version 10.1. The one main change between the versions is the extension of the treatment planning, to include the CyberKnife linear accelerator treatment unit.
Related to machine learning, there is no change compared to the predicate device.
1.11 Assessment of non-clinical performance data
The test specification of RayStation 11,0 is a further developed version of the test specification of RayStation 10.1. This is supported by the requirements specification, for which the same is true. The successful verification and validation of RayStation 11.0 therefore support the substantial equivalence of the above RayStation versions.
1.11.1 CyberKnife treatment planning dose engine validation
CyberKnife specific photon dose engine validation for RayStation 11.0 was performed for the collapsed cone and photon Monte Carlo dose engines. The validation shows that the dose computation is adequate for clinical use.
RayStation supports planning and dose calculation for M6/S7 CyberKnife treatment machines. Older CyberKnife versions are not supported, which is also stated in the Instructions for Use. The CyberKnife has one delivery technique and different node set defines the possible robot positions for different collimations (cones or MLC) and patient geometry (head or body). All node sets available for patient treatments are included in the validation.
1.12 Test conclusion
The determination of substantial equivalence is not based on an assessment of non-clinical performance data. However, the entire system verification and validation specifications and reports are included in the submission as required by a software device of major concern.
A number of different types of verification activities have been performed:
- . System Tests of RayStation
- . Risk analysis-based tests for use error mitigation verification
- . Unit and subsystem testing for low-level testing
- . Dose engine validation including internal testing
- . User validation in cooperation with cancer clinics
- . Reviews of design, code and Master Labeling
The data obtained from the verification show that system tests, unit and subsystem tests have passed, and the validations been completed successfully. The reviews of design, code and labeling are also passed.
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| Document ID and Title | Version: |
|---|---|
| RSL-D-RS-11.0 510(k) Summary RayStation 11.0 | 1.0 |
From the successful verification and validation activities, the conclusion can be drawn that RayStation 11.0 have met specifications and is as safe, as effective and performs as well as or better than the legally marketed predicate device.