Change Healthcare Stratus Imaging PACS

{0}------------------------------------------------ November 12, 2024 Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left side of the logo is the Department of Health & Human Services logo. To the right of that 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. Change Healthcare Canada Company Alona Golik VP, Quality Assurance and Regulatory Affairs 10711 Cambie Road Richmond, BC V6X3G5 Canada Re: K241981 Trade/Device Name: Change Healthcare Stratus Imaging PACS Regulation Number: 21 CFR 892.2050 Regulation Name: Medical Image Management And Processing System Regulatory Class: Class II Product Code: LLZ Dated: October 17, 2024 Received: October 17, 2024 Dear Alona Golik: 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 (the 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 available 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. Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" {1}------------------------------------------------ (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). 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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-regulatory {2}------------------------------------------------ assistance/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 Lamb, Ph.D. Assistant Director Imaging Software Team DHT8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ #### Indications for Use Submission Number (if known) K241981 Device Name Change Healthcare Stratus Imaging PACS Indications for Use (Describe) Change Healthcare Stratus Imaging PACS is a software-based medical image management and processing system intended to process and display medical images for the purposes of diagnostic viewing and interpretation by qualified and trained healthcare professionals, including, but not restricted to, radiologists and non-radiology physicians. The Diagnostic Viewer of Change Healthcare Stratus Imaging PACS provides medical image postprocessing functions such as image manipulation and enhancement that are intended for use in the clinical image review and analysis of medical images acquired through DICOM-compliant imaging devices or IT interfaces. Change Healthcare Stratus Imaging PACS can be used as a full-featured medical image management and processing system or as an independent viewer in clinical settings. Only uncompressed or non-lossy compressed DICOM images can be used for primary image diagnosis and interpretation for mammography using monitors intended for mammography display and cleared by the requlatory authority in your region or jurisdiction. Change Healthcare Stratus Imaging PACS is not intended for diagnostic use on mobile devices. Type of Use (Select one or both, as applicable) Prescription Use (Part 21 CFR 801 Subpart D) he-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. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {4}------------------------------------------------ | 510(k) #: K241981 | 510(k) Summary | Prepared on: 2024-10-17 | |-------------------|----------------|-------------------------| |-------------------|----------------|-------------------------| | Contact Details | 21 CFR 807.92(a)(1) | |-----------------|---------------------| |-----------------|---------------------| | Applicant Name | Change Healthcare Canada Company | |-----------------------------|---------------------------------------------| | Applicant Address | 10711 Cambie Road Richmond BC V6X3G5 Canada | | Applicant Contact Telephone | 972-52-4084942 | | Applicant Contact | Mrs. Alona Golik | | Applicant Contact Email | ei.regulatory@optum.com | | Device Name | 21 CFR 807.92(a)(2) | |-------------|---------------------| |-------------|---------------------| | Device Trade Name | Change Healthcare Stratus Imaging PACS | |---------------------|------------------------------------------------| | Common Name | Medical image management and processing system | | Classification Name | System, Image Processing, Radiological | | Regulation Number | 892.2050 | | Product Code(s) | LLZ | | Legally Marketed Predicate Devices | | 21 CFR 807.92(a)(3) | |------------------------------------|--|---------------------| |------------------------------------|--|---------------------| | Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code | |-------------|----------------------------------------------------------|--------------| | K203249 | Change Healthcare Stratus Imaging PACS; Nucleus.io | LLZ | | Device Description Summary | | 21 CFR 807.92(a)(4) | |----------------------------|--|---------------------| |----------------------------|--|---------------------| Change Healthcare Stratus Imaging PACS is a software-based medical image management and processing system designed to perform the necessary functions required for diagnosis and interpretation of medical information. It is intended to be used by qualified and trained radiology physicians for the purpose of assisting in diagnosis and interpretation of medical images. Change Healthcare Stratus Imaging PACS provides users with a zero-footprint, browser-based diagnostic viewer capable of directly displaying diagnostic quality DICOM standard images, reports and discrete data information acquired by various data sources. The diagnostic viewer provides users with tools and features, including measurement, annotations, comparison, and digital processing of medical images, such as image manipulation, enhancement, and 3D/4D visualization. Change Healthcare Stratus Imaging PACS functionality, such as storage, import, sharing, retrieval, and display, that supports the day-to-day operations of qualified and trained healthcare professionals, such as technologists and PACS administrators. Change Healthcare Stratus Imaging PACS uses a cloud-based architecture offering zero-footprint deployment in hospitals, clinics imaging centers and other healthes. Authorized users from both clinical facilities and remote locations can directly access Change Healthcare Stratus Imaging PACS. Change Healthcare Stratus Imaging PACS operates on approved web browsers running on commercially available hardware that meets approved specifications. Change Healthcare Stratus Imaging PACS is designed to integrate with third party, off-the-shelf software through Application Programming Interfaces (APIs) and supported standards (for example, HL7, DICOM) to allow connectivity with systems used in the {5}------------------------------------------------ clinical environment such as reporting tools, EMRs, and advanced visualization tools. ## Intended Use/Indications for Use Change Healthcare Stratus Imaging PACS is a software-based medical image management and process and display medical images for the purpostic viewing and interpretation by qualified and trained healthcare professionals, including, but not restricted to, radiologists and non-radiology physicians. The Diagnostic Viewer of Change Healthcare Stratus Image post-processing functions such as image manipulation and enhancement that are in the clinical image review and analysis of medical images acquired through DICOM-compliant imaging devices or IT interfaces. Change Healthcare Stratus Imaging PACS can be used as a full-featured medical image management and processing system or as an independent viewer in clinical settings. Only uncompressed or non-lossy compressed DICOM images can be used for primary image diagnosis and interpretation for mammography using monitors intended for mammography display and cleared by the regulatory in your region or jurisdiction. Change Healthcare Stratus Imaging PACS is not intended for diagnostic use on mobile devices. # Indications for Use Comparison ### 21 CFR 807.92(a)(5) 21 CFR 807.92(a)(6) The subject device is an updated version of the predicate device, Change Healthcare Stratus Imaging PACS, also known as Nucleus.io (K203249). The Indications for use for the subject device are equivalent. There is no fundamental change to the device as an image processing and management solutions for use were updated to exclude functions such as "storage, distribution, sharing, networking" of medical images as they no longer fall within the FDA's definition of a medical device. Such changes do not affect the intended use of the software nor create a new intended use. Neither the subject nor the predicate device is indicated for any specific disease, condition, and both devices are not intended for diagnostic use on mobile devices. The indications for use of subject and predicate device are considered fundamentally the same, and only includes minor updates such as the removal of non-device functions and rewording for clarification purposes. # Technological Comparison The proposed device Change Healthcare Stratus Inaging PACS employs the same fundamental scientific technology as its predicate device Change Healthcare Stratus Imaging PACS/Nucleus.io [K203249]. Both devices are cloud based MIMPS and offer diagnostic viewing capabilities relying on DICOM and other industry standards for modes of operations. The feature set is fundamentally the same. Some minor functionality differences between Change Healthcare Stratus Imaging PACS and the predicate devices are that the subject device: · Integrates with PowerScribe (a 3rd party reporting tool), which enable users to create reports within the integrated tool for studies they are reviewing on the Diagnostic Viewer · Supports technologists' workflow in Diagnostic Viewer, such as linking, moving, deleting studies etc. · Enable user to create key images and saving the current presentation state (GSPS) so that the attributes can be later applied to the image These minor functionality differences do not raise new questions of safety or effectiveness compared to the predicate device. Thus, the subject device is considered substantially equivalent to the predicate device with respect to technological characteristics. #### Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b) Non-clinical tests, such as mechanical engineering performance testing, are not applicable to the subject device, as Change Healthcare Stratus Imaging PACS is software-only device (SaMD). During the product development of Change Healthcare Stratus Imaging PACS, software verification and validation tests were conducted in accordance with the Company's Quality Management System, which incorporates design control testing principals defined in the following FDA Guidance documents and FDA recognized consensus standards: - FDA Guidance for the Premarket Submissions for Device Software Functions, June 14, 2023 - General Principles of Software Validation; Final Guidance for Industry and FDA Staff, FDA, CDRH, January 11, 2002 - ISO 14971:2019 Third Edition 2019-12; Medical Devices Application Of Risk Management To Medical Devices - IEC 62366-1 Edition 1.1 2020-06 Consolidated Version; Medical devices - Part 1: Application of usability engineering to medical devices - IEC 62304 Edition 1.1 2015-06 Consolidated Version; Medical Device Software Software Life Cycle Processes Software verification and validation were completed to ensure that the features conformed to all new and previously defined ## 21 CFR 807.92(a)(5) {6}------------------------------------------------ specifications and any risks were properly mitigated, and that the modifications did not degrade the existing functionality. All the software specifications have met the acceptance criteria and the software ad all product release criteria. The testing results did not raise new or different questions of safety and effectiveness other than those already associated with the predicate device. The comparison of technological characteristics and software validation data demonstrates that the is substantially equivalent in the areas of technical characteristics, functionality, features, and indications for use. The new ce a fundamentally new scientific technology, and the device has been validated through system level test. Where there are differences between the subject and the predicate devices, those differences are minor and do not raise different questions of safety and effectiveness for the subject device. Therefore, subject device is as safe, as effective, and performs as well as or better than the predicate, Change Healthcare Stratus Imaging PACS/Nucleus.io [K203249].