Elucis

{0}------------------------------------------------ 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 text on the right. The symbol on the left is a stylized representation of a human figure. The text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters. The words "U.S. FOOD & DRUG" are on the top line, and the word "ADMINISTRATION" is on the bottom line. Realize Medical Inc. % Dan La Russa Co-founder & Chief Product Officer (CPO) 405-2197 Riverside Drive Ottawa, Ontario K1H 7X3 CANADA Re: K220649 January 17, 2023 Trade/Device Name: Elucis Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: LLZ Dated: December 20, 2022 Received: December 20, 2022 Dear Dan La Russa: 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 {1}------------------------------------------------ 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. Jessica Lamb Jessica S. Lamb, Ph.D. Assistant Director Imaging Software Team DHT8B: Division of Radiological Imaging and Electronic Products 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) K220649 Device Name Elucis #### Indications for Use (Describe) Elucis is intended for use as a software interface and image segmentation system for the transfer of medical imaging information to an output file. It is also intended for measuring and treatment planning. Elucis should be used in conjunction with expert clinical judgement. Type of Use (Select one or both, as applicable) | <span style="font-size:10pt"><b> </b></span> Prescription Use (Part 21 CFR 801 Subpart D) | |-------------------------------------------------------------------------------------------| | <span style="font-size:10pt"><b> </b></span> Over-The-Counter Use (21 CFR 801 Subpart C) | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. 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The text "Realize MEDICAL" is written in a simple, sans-serif font, with "Realize" in a larger font size than "MEDICAL". K220649 Summary Preparation date: 4/18/2022 405-2197 Riverside Drive Ottawa, Ontario, Canada K1H 7X3 | Device Information | | |----------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------| | Item | Information | | Type of 510(k) submission | Traditional | | Sponsor / Submitter: | Name: Dan La Russa<br>Company: Realize Medical Inc.<br>Address: 405-2197 Riverside Drive,<br>Ottawa, ON, Canada, K1H 7X3 | | Correspondent Contact Information: | Name: Dan La Russa<br>Title: Co-founder and Chief Product Officer (CPO)<br>Phone: 613-883-3461<br>Email: dan@realizemed.com | | Device Common Name: | Image processing system | | Device Proprietary Name: | Elucis | | Proposed Device Classification<br>Regulation | 21 CFR 892.2050 | | Device Classification Name | System, Image Processing, Radiological | | Device Classification | Class II | | Classification Product Code | LLZ | | Device Review Panel | Radiology | | Prior FDA Document Numbers | None | | Basis of submission | New Device | | Convenience Kit Description | None | | Number of Devices in Summary | One | {4}------------------------------------------------ Realize MEDICAL | Predicate Device Information | | |----------------------------------------------------------|-------------------------| | Predicate Device | Mimics Medical | | Predicate Device Manufacturer | Materialise N.V. | | Predicate Device Common Name | Image processing system | | Predicate Device Premarket Notification<br>510(k) number | K183105 | | Predicate Device Classification | Class II | | Predicate Device Classification Product Code | LLZ | ## Device Description Elucis is a software system for creating, visualizing, and interacting with three-dimensional (3D) models in a desktop 2D environment and an extended (virtual) reality (XR) environment. Medical images (e.g., CT and MRI) and, optionally, 3D structure files in a variety of file formats are used as input. Users can create 3D anatomical models directly from one or more medical images using a variety of manual and semi-automatic image segmentation tools available in the XR environment. These models, and the images from which they were created, can be used to conduct measurements and plan treatments. The core functionality in Elucis includes the ability to: - View medical images in a variety of planar and volumetric reformations - Import medical images in DICOM and other formats and import 3D model files - Create 3D models from medical images using a variety of common modeling tools - Review and edit existing 3D models - Perform measurements on images and models - Plan treatments using 3D models and associated medical images - Save and export images, measurements, 3D models, and other treatment planning information ## Device Intended Use Elucis is intended for use as a software interface and image segmentation system for the transfer of medical imaging information to an output file. It is also intended for measuring and treatment planning. Elucis should be used in conjunction with expert clinical judgement. ## Comparison to Predicate Device Elucis shares the following technological characteristics with the predicate device. This includes the ability to: - Import 3D model files and medical images in DICOM and other formats, - View medical images and models in a variety of planar and volumetric reformations, {5}------------------------------------------------ - Create 3D models from medical images using a variety of common modeling tools - Perform measurements on images and models - . Plan treatments using 3D models and associated medical images - Save and export information, including 3D models, images, measurements, and other treatment planning information The following technological differences exist between the subject and predicate devices: - Modeling, measurement, and treatment planning activities are performed in a virtual XR environment in the subject device - Advanced modeling algorithms enable 3D modeling operations, as well as dynamic segmentation of multi-phase (4D) images in real time in the subject device - . Support for collaboration between multiple remote users, both on the desktop and in the accompanying extended (virtual) reality (XR) environment in the subject device - In support of treatment planning activities, the subject device enables: - O Models to be moved and/or resized independently - Annotations, including mark-ups, voice memos, and other staging elements O - The subject device does not support automated workflows with scripting, nor can it be interfaced with third-party applications for finite element analysis Despite these technological differences, the additional modeling and annotation capabilities available in the subject device are a matter of convenience for users, and do not affect the format of the final output produced by the system, nor the safety and efficacy of the device. ## Performance Data The overall safety, efficacy, and performance of Elucis was established using software verification and validation tests conducted in accordance with FDA's Guidance for Industry and FDA Staff, entitled "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices". Software verification tests were defined and conducted for all specified software requirements. Additional validation tests were conducted to verify geometric accuracy of 3D models and accuracy of measurements. End-user was conducted with a group of intended users, representing a diverse mix of clinical roles, educational backgrounds, and experience, to confirm overall usability. The geometric accuracy of virtual models created in the subject device was assessed via comparisons against the same models made with the predicate device. Results were obtained for a range of anatomical structures and medical image scan types. All observed deviations were within acceptance criteria, demonstrating that Elucis is substantially equivalent to the predicate device for model creation and measurement. All performance testing results serve to demonstrate the substantially equivalent to the predicate device. ## Summary Based on a comparison of intended use, technological characteristics, and the outcome of verification and validation tests, Elucis may be deemed substantially equivalent to the Mimics Medical predicate device from Realize Medical Inc. Section 5 {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the logo for Realize Medical. The logo features a stylized electrocardiogram (EKG) waveform to the left of the text. The text "Realize MEDICAL" is written in a simple, sans-serif font, with "Realize" in a slightly larger font size than "MEDICAL". Materialise (K183105). While differences in intended use and technological characteristics exist, they do not alter the intended use of the subject device, its performance characteristics, or safety and risk profile relative to that of the predicate.