IGTFusion

{0}------------------------------------------------ August 16, 2018 Image /page/0/Picture/1 description: The image contains the logo of 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 text logo on the right. The FDA text logo is in blue and includes the words "FDA U.S. FOOD & DRUG ADMINISTRATION". IGI Technologies % E.J. Smith Consultant Smith Associates 1468 Harwell Avenue CROFTON MD 21114 Re: K180522 Trade/Device Name: IGTFusion Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: July 16, 2018 Received: July 16, 2018 Dear E.J. 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/cdrl/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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Michael D. O'Hara For Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Section 4 {3}------------------------------------------------ #### Indications for Use 510(k) Number (if known) K180522 Device Name IGTFusion Indications for Use (Describe) IGTFusion is a stand-alone software product that provides the physician 3 means for comparison of medical imaging data from multiple DICOM conformant imaging modality sources. It allows the display, registration and fusing of medical images as an aid during use by diagnostic radiology, oncology, radiation therapy planning, interventional radiology and other medical Specialties. IGTFusion is not intended for mammography diagnosis. Type of Use (Select one or both, as applicable) [X] Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) #### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED. #### FOR FDA USE ONLY Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page. {4}------------------------------------------------ # Section 5 {5}------------------------------------------------ ### 510(k) Summary | Submitter: | IGI Technologies<br>387 Technology Drive<br>College Park, MD 20742 | |---------------------------|--------------------------------------------------------------------| | Contact Person: | Will Plishker, PhD<br>CEO | | Telephone Number: | 202-713-9571 | | Email: | will@igitechnologies.com | | | | | Summary Preparation Date: | February 22, 2018 | | Device Description: | | | Trade Name: | IGTFusion | | Common Name: | Picture Archive and Communication Systems | | Classification Name: | Picture Archive and Communication Systems | | Regulatory Class: | Class II | | Product Code: | LLZ | | C.R.F. Section: | 21 CFR 892.2050 | #### Predicate Devices: | | Manufacturer | Brand Name | 510(k) Number | |-----------|---------------------------------|-------------|---------------| | Primary | Velocity Medical Solutions, LLC | VelocityAIS | K081076 | | Reference | Mirada Medical Ltd LLC | RTx | K130393 | #### Device Description: The purpose of IGTFusion is to assist the user with the visual evaluation, comparison, and merging of information between anatomical and functional images from a single patient. The user needs to take into consideration the product's limitations and accuracy when integration from the registration results for final interpretation. IGTFusion does not replace the usual procedures for visual comparison of datasets by a user. Fusion images are intended to provide additional information to a user's existing workflow for patient evaluation. The potential hazards associated with this software product are no different from those of other PACS components and may be variously obviated by decisions made by the user of the product. None of these failures are expected to contribute to patient death or injury. In consequence, IGTFusion is considered to have no adverse effect on health since the results represent only a part of the information that a user will utilize for final interpretation. In this regard, IGT Fusion represents a moderate level of concern with respect to patient safety. {6}------------------------------------------------ #### Indications for Use: IGTFusion is a stand-alone software product that provides the physician 3 means for comparison of medical imaging data from multiple DICOM conformant imaging modality sources. It allows the display, registration and fusing of medical images as an aid during use by diagnostic radiology, oncology, radiation therapy planning, interventional radiology and other medical Specialties. IGTFusion is not intended for mammography diagnosis. #### Intended Use: The purpose of IGTFusion is to assist the user with the visual evaluation and comparison of information between anatomical and functional images from a single patient. The supported modalities are CT, PET, and MR. #### Substantial Equivalence Discussion: Discussion of Technological Similarities: IGTFusion, Mirada RTx and VelocityAlS have the same visualization capabilities, registration, DICOM Compliance and each has a Graphical User Interface. IGTFusion and VelocityAlS both have same reporting capabilities. Discussion of Technological Differences: While the core features of IGTFusion match with existing predicate devices, the packaging of how those features are delivered are different. Instead of providing a complex workstation with many extra features for interaction and visualization, IGTFusion provides only the essential representations to streamline the process of utilizing fusion visualization. Instead of requiring a clinician to sit at a workstation or log on remotely to a software GUI, IGTFusion is more like a fusion appliance, providing quick fusion visualization with a minimum of interaction required. After a floating image is selected, clinicians may push a series of interest from PACS or even directly from imaging equipment for quick visualization. Such minimal activity also lends itself more easily into larger workflow processing pipelines which are generating and consuming images for more complex applications. This approach is founded on our image registration engine which has been extensively tested to show that is as accurate existing solutions without the need of extra tools. This general approach also lends itself to avoiding advanced visualization features such volume rendering and annotations, which strictly enhance (i.e. are not required for) image fusion. These differences raise no new issues of safety and effectiveness. Non-Clinical Performance Standards: - . AAMI / ANSI / ISO 14971:2007/(R)2010 (Corrected 4 October 2007), Medical devices - Applications of risk management to medical devices - . AAMI / ANSI / IEC 62304:2006, Medical device software life cycle processes - Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, dated May 11, 2005 Clinical Studies: {7}------------------------------------------------ No clinical studies were conducted. Conclusion: The proposed device (IGTFusion) does not result in any new potential safety risk and performs in accordance with its intended use as well as comparatively with the intended use of the chosen predicates. We conclude that IGTFusion is as safe and effective as the predicate device and poses no unanswered questions regarding safety and efficacy.