(46 days)
Not Found
No
The summary describes a standard oncology information system focused on workflow, scheduling, and data management, with no mention of AI or ML capabilities.
No.
The device is an oncology information system for managing workflows, scheduling, and clinical information, not for providing therapy directly.
No
The "Intended Use / Indications for Use" section explicitly states "RayCare is not intended for use in diagnostic activities."
Yes
The device description explicitly states "RayCare is a software-only system". The listed functionalities are all software-based processes for managing information and workflows.
Based on the provided information, RayCare is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section explicitly states: "RayCare is not intended for use in diagnostic activities."
- Device Description: The description focuses on managing workflows, scheduling, and clinical information for oncology care and follow-up. It does not describe any functionality related to analyzing biological samples or providing diagnostic information based on such analysis.
- Lack of IVD Characteristics: The document does not mention any activities typically associated with IVD devices, such as:
- Analyzing blood, tissue, or other biological samples.
- Providing results that are used to diagnose a disease or condition.
- Mentioning any specific assays or tests.
RayCare is described as an oncology information system that supports the management of cancer care, which falls under the category of medical software used for clinical workflow and data management, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
RayCare is an oncology information system used to support workflows, scheduling and clinical information management for oncology care and follow-up. Ray be used in the transfer, storage, conversion and display of patient data in all areas of cancer care including radiation therapy, medical oncology and surgical oncology. RayCare is not intended for use in diagnostic activities.
Product codes
MUJ
Device Description
RayCare is an oncology information system that supports healthcare professionals in managing cancer care. The system is structured in functionality modules that are listed below. RayCare is a software-only system with a client part that allows the user to interact with the system and a server part that performs the necessary processing and storage functions. Selected aspects of RayCare are configurable, such as adapting workflow templates to the specific needs of the clinic.
- Patient clinical data
- Care administration
- Clinical notes and documents
- Workflow and task management
- Charge capture
- Scheduling and calendar functions
- PACS
- Image viewer
- Simulation and imaging
- System administration
- Authentication, authorization and audit logging
- Hospital system integrations
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Intended users are cancer care clinic personnel including clinical and administrative personnel.
RayCare servers are located within the hospital IT environment. RayCare clients are used within the internal hospital network or within a secure wireless network in the hospital.
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 verification and validation of RayCare 2.3 is based on the intended use and functionalities included in a standard oncology information system, and on the standards ISO 14971, IEC 61217, IEC 62304 and IEC 62366. The successful verification and validation of RayCare 2.3 therefore support the substantial equivalence to the MOSAIQ Oncology Information System predicate device. The summary of the performed non-clinical tests shows RayCare 2.3 is as safe and effective and performs as well as the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the agency's name on the right. The symbol on the left is a stylized depiction of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters. The words "FOOD & DRUG" are larger than the other words.
RaySearch Laboratories AB (publ) % Mr. David Hedfors Quality and Regulatory Affairs Director Sveavägen 44 111 34 Stockholm SWEDEN
July 8, 2019
Re: K191384
Trade/Device Name: RayCare 2.3 Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: Class II Product Code: MUJ Dated: May 20, 2019 Received: May 23, 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
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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
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Indications for Use
510(k) Number (if known) K191384
Device Name RayCare 2.3
Indications for Use (Describe)
RayCare is an oncology information system used to support workflows, scheduling and clinical information management for oncology care and follow-up. Ray be used in the transfer, storage, conversion and display of patient data in all areas of cancer care including radiation therapy, medical oncology and surgical oncology. RayCare is not intended for use in diagnostic activities.
| 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-RC-2D Traditional 510(k) Submission RayCare 2.3 | 2.0 |
5. 510(k) Summary
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
May 20th, 2019
5.4 Trade name
The trade name is RayCare.
The trade name and version number are written together, i.e. "RayCare 2.3".
The marketing name is RayCare 2D.
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
K183034, MOSAIQ Oncology Information System
5.8 Device description
RayCare is an oncology information system that supports healthcare professionals in managing cancer care. The system is structured in functionality modules that are listed below.
RayCare is a software-only system with a client part that allows the user to interact with the system and a server part that performs the necessary processing and storage functions. Selected aspects of RayCare are configurable, such as adapting workflow templates to the specific needs of the clinic.
- . Patient clinical data
- . Care administration
- Clinical notes and documents
- Workflow and task management ●
- . Charge capture
- Scheduling and calendar functions ●
- PACS
- Image viewer ●
- Simulation and imaging ●
- System administration ●
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- . Authentication, authorization and audit logging
- . Hospital system integrations
5.9 Intended use
RayCare is an oncology information system used to support workflows, scheduling and clinical information management for oncology care and follow-up. RayCare may be used in the transfer, storage, conversion and display of patient data in all areas of cancer care including radiation therapy, medical oncology and surgical oncology.
RayCare is not intended for use in diagnostic activities.
5.9.1 Intended users
Intended users are cancer care clinic personnel including clinical and administrative personnel.
User group access is controlled according their defined usage needs, training and education requirements are defined per group. For safety related activities, the user of the system must also have appropriate training in using the system.
5.9.2 Intended environment
RayCare servers are located within the hospital IT environment. RayCare clients are used within the internal hospital network or within a secure wireless network in the hospital.
5.10 Technological characteristics summary
The technological characteristics are the same for RayCare 2.3 as for the predicate device.
Comparing RayCare with the MOSAIQ Oncology Information System, both devices are oncology information systems and are used to manage clinical and administrative workflows for treatment planning and delivery. They both support information flow among healthcare facility personnel and can be used whenever radiotherapy is prescribed.
Both devices include management of electronic patient charts, image reviewing and archiving, comparisons of treatment plans and dose coverage and treatment setup review and recording. Note, however, that RayCare does not include functionality for recording of treatment delivery sessions.
5.11 Assessment of non-clinical performance data
The verification and validation of RayCare 2.3 is based on the intended use and functionalities included in a standard oncology information system, and on the standards ISO 14971, IEC 61217, IEC 62304 and IEC 62366. The successful verification and validation of RayCare 2.3 therefore support the substantial equivalence to the MOSAIQ Oncology Information System predicate device.
5.12 Test conclusion
The summary of the performed non-clinical tests shows RayCare 2.3 is as safe and effective and performs as well as the predicate device.