RayCare is an oncology information system used to support workflows and scheduling, as well as clinical information, planning and treatment management for oncology care. 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.

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

AI/ML Overview

The provided text is a 510(k) summary for the RayCare 3.1 device, an oncology information system. However, it does not contain specific acceptance criteria, performance metrics, or detailed study information that would allow a comprehensive answer to your request.

The document primarily focuses on demonstrating substantial equivalence to a predicate device (RayCare 2.3) by highlighting similar technological characteristics and stating that verification and validation were performed according to relevant standards.

Therefore, I cannot provide a complete answer to your request based solely on the provided input.

However, I can extract the available information and indicate where details are missing:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance
Not specified in the document.	The document states, "The summary of the performed non-clinical tests shows RayCare 3.1 is as safe and effective and performs as well as the predicate device." However, no specific metrics or thresholds are provided for "safe," "effective," or "performs as well."

2. Sample size used for the test set and the data provenance

Sample size for the test set: Not specified in the document.
Data provenance: Not specified in the document.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Number of experts: Not specified in the document.
Qualifications of experts: Not specified in the document.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not specified in the document.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

MRMC study: Not specified in the document.
Effect size: Not applicable, as no MRMC study or AI assistance is described. The device is an oncology information system, not an AI-powered diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

The document implies that verification and validation were done on the device's functionalities, but it does not detail specific "standalone" performance studies in the context of an algorithm's diagnostic or analytical capability. RayCare 3.1 is an information system, not primarily an AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not specified in the document. The document refers to "intended use and functionalities included in a standard oncology information system" for its verification and validation, implying functional rather than diagnostic ground truth.

8. The sample size for the training set

Not applicable/Not specified. This device is an oncology information system, not an AI/ML model that typically requires a training set in the conventional sense.

9. How the ground truth for the training set was established

Not applicable/Not specified, as it's not an AI/ML model with a typical training set.

Summary of what is available in the document regarding testing:

Assessment of non-clinical performance data: "The verification and validation of RayCare 3.1 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."
Test conclusion: "The summary of the performed non-clinical tests shows RayCare 3.1 is as safe and effective and performs as well as the predicate device."

This document focuses on demonstrating substantial equivalence to an existing predicate device by showing that the new device has the same technological characteristics and has undergone standard verification and validation processes applicable to medical software. It does not contain the kind of detailed performance study data often found for AI/ML-driven diagnostic devices.

Summary

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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 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) % Ms. Viktoria Hammarstedt Quality and Regulatory Affairs Specialist Sveavägen 44 Stockholm, 11134 SWEDEN

June 10, 2020

Re: K200487

Trade/Device Name: RayCare 3.1 Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: Class II Product Code: MUJ Dated: May 11, 2020 Received: May 13, 2020

Dear Ms. Hammarstedt:

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) K200487

Device Name RayCare 3.1

Indications for Use (Describe)

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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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

Viktoria Hammarstedt Quality and Regulatory Affairs Specialist RaySearch Laboratories AB (publ) Email: quality@raysearchlabs.com +46 8 51053003 Tel:

5.3 Preparation date

February 19, 2020

5.4 Trade name

The trade name is RayCare. The trade name and version number are written together, i.e. "RayCare 3.1". The marketing name is RayCare 3B.

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

K191384, RayCare 2.3 Oncology Information System

Product code: MUJ, Regulation number: 892.5050

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.

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

K200487

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. Hospital system integrations

5.9 Technological characteristics summary

The technological characteristics are the same for RayCare 3.1 as for the predicate device.

Comparing RayCare 3.1 with RayCare 2.3, 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.

5.10 Assessment of non-clinical performance data

The verification and validation of RayCare 3.1 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 3.1 therefore support the substantial equivalence to the RayCare 2.3 Oncology Information System predicate device.

5.11 Test conclusion

The summary of the performed non-clinical tests shows RayCare 3.1 is as safe and effective and performs as well as the predicate device.

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.