MOSAIQ® OIS (Oncology Information System)

{0}------------------------------------------------ February 23, 2023 Image /page/0/Picture/1 description: The image shows the logo for the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. Elekta Solutions AB % Melinda Smith Director, Regulatory Affairs & Quality - Americas Elekta, Inc. 400 Perimeter Center Terrace NE Suite 50 ATLANTA GA 30346 ## Re: K223229 Trade/Device Name: MOSAIO® Oncology Information System Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: Class II Product Code: IYE Dated: January 26, 2023 Received: January 27, 2023 ### Dear Melinda Smith: 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. 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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 {1}------------------------------------------------ 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 medical devices and radiation-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, Image /page/1/Picture/5 description: The image shows a digital signature. The signature is for Lora D. Weidner. The signature was created on February 23, 2023 at 14:33:58 -05'00'. Lora D. Weidner, Ph.D. Assistant Director Radiation Therapy Team DHT8C: Division of Radiological Imaging and Radiation Therapy Devices OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use # 510(k) Number (if known) K223229 Device Name MOSAIQ® Oncology Information System ### Indications for Use (Describe) MOSAIQ® is an oncology information system used to manage workflows for treatment planning and delivery. It supports information flow among healthcare facility personnel and can be used wherever radiotherapy are prescribed. Users can configure MOSAIQ® for Medical Oncology use, Radiation Oncology use, or the two together. Medical oncology dose calculations are designed to support both adult and pediatric patients. It lets users: - · Assemble electronic patient charts and treatment plans, order diagnostic tests, and prescribe medications. - · Generate and keep medication formulary lists and calculate applicable medication dosages for medical oncology. - · Import, view, annotate, adjust, enhance, manage and archive images. - · Compare radiation treatment plans and evaluate dose coverage. - · Design leaf plans for operation with radiotherapy treatment machines that have multi-leaf collimators. - · Make sure radiation treatment plans imported from treatment planning systems agree with treatment machine constraints. MOSAIQ® reads actual settings from the treatment machine communication interface. It compares these settings with predefined values. If a mismatch occurs between the planned values and the actual machine settings, the system warns the user. · View reference images to setup treatment. MOSAIQ® refers to predefined settings to help treatment machine setup and communicates patient and machine setup instructions. - · Record actual delivered radiation values in an electronic chart to track treatment. - · Use stereotactic localization to calculate set-up coordinates for treatments. - · Monitor Intrafractional motion with real time image overlay. MOSAIQ® is not intended for use in diagnosis. Type of Use (Select one or both, as applicable) | <label><input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</label> | |-------------------------------------------------------------------------------------------------| |-------------------------------------------------------------------------------------------------| | <label><input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</label> | |-------------------------------------------------------------------------------------| |-------------------------------------------------------------------------------------| ### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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The graphic is a circle with three smaller circles inside of it. ## TRADITIONAL 510(K) SUMMARY (21 CFR § 807.92) #### -SUBMITTER Contact: Elekta Solutions AB Kungstensgatan 18 Box 7593 Stockholm, SE SE10393 Melinda Smith, MS, RAC, CBA Melinda.Smith@elekta.com Establishment Registration #: 510(k) Number: Date Prepared: 3015232217 K223229 7 December 2022 #### DEVICE II. | Trade Name: | MOSAIQ Oncology Information System | |-------------------------|---------------------------------------------------| | Product Classification: | Class II | | Common Name: | Radiation charged-particle radiation system | | Regulation Number: | 21 CFR § 892.5050 | | Regulation Description: | Medical charged-particle radiation therapy system | | Product Code: | IYE | #### lll. PREDICATE DEVICE Predicate Device: MOSAIQ OIS (K203172) #### IV. DEVICE DESCRIPTION The MOSAIQ® Oncology Information System (OIS) is an image-enabled electronic medical record system. It manages clinical and administrative workflows within oncology departments and facilitates efficient patient care. It can be configured for Medical Oncology, Radiation Oncology, or both. The Medical Oncology (MO) configuration is a medical oncology charting solution that includes customizable regimens (Care Plans) that automate chemotherapy orders for labs, procedures, and appointments. Configurable flowsheet views are used for reviewing treatment administration, documents, assessment and lab data. Users can enter medications and screen for drug/drug and drug/allergy interactions. MOSAIQ also performs standard calculations such as Body Surface Area (BSA) and Area Under the Curve (AUC). The Medical Administration Record (MAR) supports all information related to chemotherapy and blood product administration, clinical trial study drugs, dose amounts, infusion time, multiple administration, etc. The Radiation Oncology configuration is also a charting solution with Computerized Physician Order Entry (CPOE) capability, along with added features for image management, patient setup and positioning, verify and record, plan import, review, and approval, stereotactic localization, and pretreatment checks. MOSAIQ's Radiation Oncology functionality can be used to support a wide variety of treatment modalities including Intensity Modulated Radio Therapy (IMRT), Image Guided Radio Therapy (IGRT), particle therapy, and stereotactic radiotherapy. It can import and store treatment plans from Therapy Planning Systems (TPS) via DICOM import/DICOM RT import. {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logo for Elekta, a company that specializes in precision radiation medicine. The logo features a stylized teal-colored circle with three smaller circles inside, followed by the company name "Elekta" in a sans-serif font, also in teal. The overall design is clean and modern, reflecting the company's focus on innovation and technology in the healthcare industry. In addition to these, the current version of MOSAIQ introduces the following modifications for radiation oncology: - · Anatomic Position Monitoring (APM) with Manual interrupt (also referred to as True Tracking as it 'tracks' in 3D and enables the system to gate using the 3D position of the anatomy's motion) - · APM with Anatomic Tolerance Check (ATC) - · Adaptive Therapy with optional Baseline Shift (BLS) Recoverv - · Care Rules for motion management. These modifications are not contained solely within MOSAIQ, as the full clinical benefit is achieved with interoperability of Unity, Monaco RTP, and MOSAIQ OIS. #### V. INTENDED USE / INDICATIONS FOR USE MOSAIQ® is an oncology information system used to manage workflows for treatment planning and delivery. It supports information flow among healthcare facility personnel and can be used wherever radiotherapy and/or chemotherapy are prescribed. Users can configure MOSAIQ® for Medical Oncology use, Radiation Oncology use, or the two together. Medical oncology dose calculations are designed to support both adult and pediatric patients. It lets users: - · Assemble electronic patient charts and treatment plans, order diagnostic tests, and prescribe medications. - · Generate and keep medication formulary lists and calculate applicable medication dosages for medical oncology. - · Import, view, annotate, adjust, enhance, manage and archive images. - · Compare radiation treatment plans and evaluate dose coverage. - · Design leaf plans for operation with radiotherapy treatment machines that have multileat collimators. - · Make sure radiation treatment plans imported from treatment planning systems agree with treatment machine constraints. MOSAIQ® reads actual settings from the treatment machine through the machine communication interface. It compares these settings with predefined values. If a mismatch occurs between the planned values and the actual machine settings, the system warns the user. - · View reference images to setup treatment. MOSAIQ® refers to predefined settings to help treatment machine setup, and communicates patient and machine setup instructions. - · Record actual delivered radiation values in an electronic chart to track treatment. - · Use stereotacticlocalization to calculate set-up coordinates for treatments. - · Monitor intrafractional motion with real time image overlay. MOSAIQ is not intended for use in diagnosis. #### VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH PREDICATE MOSAIQ® Oncology Information System version 3.2 is an updated version of the predicate device and has identical intended use and technological characteristics (identical designs, principles of operation, and use environments) as well as the same indications for use as the predicate device cleared per K203172. The similarities and differences in key device characteristics and performance specifications of the current and predicate MOSAIQ configuration are noted in the table below. Through adequate verification, validation and usability evaluations. Elekta has concluded that the differences do not impact the substantial equivalence with the predicate device. {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the logo for Elekta. The logo consists of a circular graphic to the left of the word "Elekta". The graphic is a circle with three smaller circles inside of it. The word "Elekta" is written in a sans-serif font. | Technological Characteristics Comparison | | MOSAIQ<br>(Subject Device) | MOSAIQ<br>(K203172) | |-------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------|---------------------| | Administrative Features<br>– MDDS (non-medical)<br>Features | Practice management features – billing,<br>scheduling, scheduling, billing, management<br>reporting and data analysis | ✓ | ✓ | | Medical oncology<br>management | Includes plan of care management, calculation of<br>medication dosage, and dose delivery tracking | ✓ | ✓ | | Radiation Oncology<br>Management | Ability to add a radiation prescription, import<br>radiation therapy treatment plans, machine setup<br>including<br>patient positioning, treatment calendar<br>management, cumulative dose tracking and<br>eChart Check feature for weekly chart check.<br>Review of treatment plans through Evaluate<br>feature. | ✓ | ✓ | | Imaging Functionality | Ability to import, view, annotate, manipulate,<br>enhance, manage and archive images | ✓ | ✓ | | Record and Verify-<br>Sequencer | Verifies radiation treatment plans against<br>treatment machine constraints, provides the<br>capability to notify clinicians of actions that need<br>to take place prior to treatment, displays<br>reference images for setup purposes, and<br>facilitates treatment machine setup according to<br>predefined settings. Recording of actual treatment<br>values and interfaces with treatment machines. | ✓ | ✓ | | MLC Fit | Design leaf plans for operation with radiotherapy<br>treatment machines that have multi-leaf<br>collimators. | ✓ | ✓ | | Modality support | Supports IMRT, IGRT, particle therapy,<br>stereotactic radiotherapy and MR-Linac<br>treatments | ✓ | ✓ | | Motion<br>Management in<br>Treatment<br>Session<br>Manager | Motion monitoring with manual interrupt | ✓ | ✓ | | | Anatomical Position Monitoring (APM) with<br>manual interrupt | ✓ | X | | | APM with ATC (Anatomical Tolerance Check) | ✓ | X | | | Adaptive Therapy with optional BLS (Baseline<br>Shift) Recovery | ✓ | X | | Stereotactic<br>Localization | Stereotactic localization through MOSAIQ<br>LOCATE feature allows clinicians to visualize the<br>target on patient images, perform image<br>calibration, and calculate stereotactic coordinates. | ✓ | ✓ | | DICOM Connectivity | DICOM connectivity with compatible systems | ✓ | ✓ | | Operating System | Windows operating system<br>Support for Windows 10 | ✓ | ✓ | #### SUMMARY OF PERFORMACE TESTING (NON-CLINICAL) VII. Design verification and performance testing were carried out in accordance with design controls of FDA's Quality System Regulation (21 CFR §820.30), applicable ISO 13485 Quality Management System requirements, ISO 14971 risk management requirements, IEC 62304 requirements for software life-cycle processes. Non-clinical testing was performed to evaluate device performance and functionality against design and risk management requirements at sub-system, integration and system levels. Software verification testing was conducted and documented in accordance with {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the logo for Elekta. The logo consists of a circular graphic to the left of the word "Elekta". The circular graphic is made up of a larger circle with three smaller circles inside of it. The word "Elekta" is written in a sans-serif font. FDA guidance 1 for devices that pose a major level of concern (Class C per IEC 62304). Basic safety and essential performance have been satisfied through conformance with device-specific recognized consensus standards, as well as the general and collateral safety and essential performance standards for medical devices listed below. | Standard No. | Standard Title | |---------------|-------------------------------------------------------------------------------------------------------------------------------------| | ISO 14971 | Medical Devices – Application of risk management to medical devices | | IEC 62304 | Medical device software - Software life-cycle processes | | ISO 62083 | Medical electrical equipment - Requirements for the safety of radiotherapy<br>treatment planning systems | | IEC 61217 | Radiotherapy equipment - Coordinates, movements and scales | | IEC 62274 | Medical electrical equipment - Safety of radiotherapy record and verify systems | | AAMI RT2:2017 | Radiation therapy readiness check | | IEC 62366-1 | Medical devices - Application of usability engineering to medical devices | | ISO 15223 | Medical devices -Symbols to be used with medical devices, labeling and information<br>to be supplied - Part 1: General requirements | ### VIII. SUMMARY OF PERFORMACE TESTING (CLINICAL) No animal or clinical tests were performed to establish substantial equivalence with the predicate device. The performance data demonstrate that MOSAIQ is as safe and effective and performs as well as the predicate device. #### IX. SUBSTANTIAL EQUIVALENCE CONCLUSION MOSAIQ is substantially equivalent (SE) to the predicate device, MOSAIQ (K203172). The intended use and indications for use are identical to the predicate device and the principles of operation remain unchanged. The technological characteristics are substantially equivalent to the predicate device; the additional motion management strategies do not affect the fundamental scientific technology or raise different questions of safety or effectiveness of the device. The device safety and performance have been addressed by non-clinical testing in conformance with pre-determined performance criteria, FDA guidance, and recognized consensus standards. The results of verification and validation as well as conformance to relevant safety standards demonstrate that MOSAIQ meets the established safety and performance criteria and is substantially equivalent to the predicate device. ¹ Content of Premarket Submissions for Software Contained in Medical Devices – Guidance for Industry and Food and Drug Administration Staff, May 2005