Lightning Viewer

{0}------------------------------------------------ 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 square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. Nexsys Electronics Inc. dba Medweb % Dr. Yujan Shrestha CEO Innolitics 1101 West 34th St #550 Austin, Texas 78705 December 20, 2024 Re: K242362 Trade/Device Name: Lightning Viewer Regulation Number: 21 CFR 892.2050 Regulation Name: Medical Image Management And Processing System Regulatory Class: Class II Product Code: LLZ Dated: November 21, 2024 Received: November 21, 2024 Dear Dr. Yujan Shrestha: 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. {1}------------------------------------------------ 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" (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 (QS) 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-udi-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. {2}------------------------------------------------ 3 For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device (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 Lamb Assistant Director Imaging Software Team DHT8B: Division of Radiologic 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) K242362 Device Name Lightning Viewer #### Indications for Use (Describe) Lightning Viewer is software for diagnostic and clinical review intended for use in General Radiology (images from modalities including CR/DR/XT, CT, FL, MR, MG, NM, US/US Echo, PET, VL) and other healthcare imaging applications. Lightning Viewer is intended to be used with off the shelf computing devices. Display monitors used for reading medical images for diagnostic purposes must comply with applicable clinical requirements, requlatory approvals, and with quality control requirements for their use and maintenance. With appropriate display monitors, lighting, image quality, and level of lossy image compression, Lightning Viewer is intended for diagnostic purposes to be used by trained healthcare professionals. Display calibration and lighting conditions should be verified by viewing a test pattern prior to use for diagnostic purposes. Lightning Viewer supports major desktop browsers such as Microsoft Edge, Chrome, Safari, and Windows. Lightning Viewer displays both lossless and lossy compressed images. Each healthcare professional must ensure that they have the necessary environment to ensure the appropriate image quality for their clinical purpose and determine the level of lossy image compression acceptable for their purpose. Lossy image compression should not be used for primary reading in mammography. Lightning Viewer can be utilized for image manipulation by radiology technologists or other healthcare professionals. Lightning Viewer can be used to verify that images captured in a medical imaging system have a diagnostic quality: to correct viewing characteristics of the image such as orientation, rotation, and contrast; as well as to add annotations to mark significant findings or provide guidance for radiologists. Lightning Viewer can store annotations and measurements as DICOM presentation states without changing the original image data. Lightning Viewer can display annotations and measurements as an overlay on images from DICOM objects, and from Computer-Aided Diagnosis (CAD) and AI software. The viewer can perform 3D Multi-Planar Reformatting (MPR), 3D Maximum Intensity Projection (MIP) and 3D Volume Rendering (VR). Lightning Viewer is purposed to aid in reviewing findings through its ability to display clinical documents and reports side by side with the images. This can be used side by side with a reporting tool to create diagnostic reports. 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) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. {4}------------------------------------------------ Image /page/4/Picture/0 description: The image contains the logo for Innolitics. The logo consists of a blue hexagon-like shape on the left and the word "Innolitics" in blue on the right. The hexagon shape is made up of six triangular shapes that are arranged to form a hexagon. # 1. CONTACT INFORMATION | Company Name | Nexsys Electronics Inc. dba Medweb | |-----------------------------|-------------------------------------------------------| | Address | 800 Airport Blvd Suite 318, Burlingame, CA 94010 | | Phone Number | 415-541-9980 | | Company Representative | Brian Bandy, Director of Software Development, Medweb | | Email | bbandy@medweb.com | | Primary Correspondent | Yujan Shrestha, CEO, Innolitics | | Primary Correspondent Email | fda@innolitics.com | | Date Summary Prepared | August 8th, 2024 | # 2. DEVICE INFORMATION | Item | Description | |-------------------|----------------------------------------| | Device Name | Lightning Viewer | | Manufacturer | Nexsys Electronics Inc. dba Medweb | | Product Code | LLZ | | Regulation Number | 892.2050 | | Regulation Name | System, Image Processing, Radiological | | Regulatory Class | Class II | | Review Panel | Radiology | # 3. PREDICATE DEVICE INFORMATION | Item | Description | |--------------|----------------------| | Device Name | OmegaAI Image Viewer | | Manufacturer | RamSoft Inc. | {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the logo for Innolitics. The logo consists of a blue hexagon-like shape on the left and the word "Innolitics" in blue on the right. The hexagon shape is made up of six triangular pieces that are arranged to form a hexagon with a white space in the center. Effective Date: 2024-12-20 Page 2 of 7 | Item | Description | |-------------------|----------------------------------------| | 510(k) Number | K222476 | | Product Code | LLZ | | Regulation Number | 892.2050 | | Regulation Name | System, Image Processing, Radiological | | Regulatory Class | Class II | | Review Panel | Radiology | # 4. DEVICE DESCRIPTION Lightning Viewer is a web-based DICOM medical image viewer that allows for diagnostic viewing, measuring, manipulating, and annotation of radiological series and images. The Lightning Viewer is part of a server, providing healthcare professionals with a comprehensive tool for accessing and interacting with medical images. Key features and functions of the Medweb Lightning Viewer include: - A web browser-based interface for easy access without client software installation ● - Support for multiple imaging modalities including CR/DR/XR, CT, MR, US/US Echo, MG (Mammo), FL (Fluoro), VL (visual light), NM (Nuclear medicine), PET - . Advanced image manipulation tools such as window/level adjustment, zooming, panning, and image rotation - . Measurement and annotation capabilities including length, angle, area, and freehand ROI tools - Specialized tools for specific imaging modalities, such as for mammography tools and spine labeling - . MPR (Multiplanar Reconstruction) mode with crosshairs tool for 3D visualization and MIP (Maximum Intensity Projection) - . Synchronized scrolling across series and studies for efficient comparison - Customizable layouts and hanging protocols for various study types - DICOM-compliant image viewing and data management . The Medweb Lightning Viewer consists of a user-friendly workspace with a customizable toolbar, providing quick access to commonly used tools. The viewer supports various layout options, including side-by-side comparison of series and prior studies. Users can easily navigate {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the logo for Innolitics. The logo consists of a blue hexagon-like shape on the left and the word "Innolitics" in blue on the right. The hexagon shape is made up of several triangular pieces that are arranged to form the hexagon. through image stacks, adjust window/level settings, and apply advanced visualization techniques like MPR. Effective Date: 2024-12-20 Medweb Lightning Viewer is designed to integrate seamlessly with existing PACS installations. It allows authorized users to access patient studies from multiple sources, facilitating efficient workflow for radiologists, physicians, and other healthcare professionals. Lightning Viewer provides a comprehensive set of tools for image review and analysis. It supports various image formats and modalities, making it a versatile solution for healthcare facilities of all sizes. The system employs user authentication and access controls to ensure that only authorized personnel can access sensitive patient information. This makes it suitable for use both within healthcare facilities and for remote access by referring physicians or specialists, promoting efficient telemedicine and teleradiology practices. # 4.1. Key Marketing Claims Lightning Viewer is a zero-footprint web viewer for medical images, offering fast and efficient access to patient studies. It provides a comprehensive toolset for image manipulation and analysis in a user-friendly interface. Medweb's Lightning Viewer supports DICOM-compliant images and integrates seamlessly with existing PACS. ## 5. INTENDED USE The intended use of Medweb Lightning Viewer is to review and navigate diagnostic images. The viewer includes tools to aid in visualizing a region of interest. # 6. INDICATIONS FOR USE Lightning Viewer is software for diagnostic and clinical review intended for use in General Radiology (images from modalities including CR/DR/XT, CT, FL, MR, MG, NM, US/US Echo, PET, VL) and other healthcare imaging applications. Lightning Viewer is intended to be used with off the shelf computing devices. Display monitors used for reading medical images for diagnostic purposes must comply with applicable clinical requirements, regulatory approvals, and with quality control requirements for their use and maintenance. With appropriate display monitors, lighting, image quality, and level of lossv image compression, Lightning Viewer is intended for diagnostic purposes to be used by trained healthcare professionals. Display calibration and lighting conditions should be verified by viewing a test pattern prior to use for diagnostic purposes. {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the logo for Innolitics. The logo consists of a blue hexagon-like shape on the left and the word "Innolitics" in blue on the right. The hexagon shape is made up of six overlapping, curved shapes that create a sense of depth and movement. The word "Innolitics" is written in a bold, sans-serif font. Effective Date: 2024-12-20 Lightning Viewer supports major desktop browsers such as Microsoft Edge, Chrome, Safari, and Windows. Lightning Viewer displays both lossless and lossy compressed images. Each healthcare professional must ensure that they have the necessary environment to ensure the appropriate image quality for their clinical purpose and determine the level of lossy image compression acceptable for their purpose. Lossy image compression should not be used for primary reading in mammography. Lightning Viewer can be utilized for image manipulation by radiology technologists or other healthcare professionals. Lightning Viewer can be used to verify that images captured in a medical imaging system have a diagnostic quality; to correct viewing characteristics of the image such as orientation, rotation, and contrast; as well as to add annotations to mark significant findings or provide guidance for radiologists. Lightning Viewer can store annotations and measurements as DICOM presentation states without changing the original image data. Lightning Viewer can display annotations and measurements as an overlay on images from DICOM objects, and from Computer-Aided Diagnosis (CAD) and AI software. The viewer can perform 3D Multi-Planar Reformatting (MPR), 3D Maximum Intensity Projection (MIP) and 3D Volume Rendering (VR). Lightning Viewer is purposed to aid in reviewing findings through its ability to display clinical documents and reports side by side with the images. This can be used side by side with a reporting tool to create diagnostic reports. # 7. CONTRAINDICATIONS FOR USE Lightning Viewer is contraindicated for the following: - For use on monitors that do not meet technical specifications required for radiographic 1. image review, including 5 mega-pixel resolution. - Lossy image compression must not be used for primary reading in mammography. 2. # 8. SUBSTANTIAL EQUIVALENCE SUMMARY Lightning Viewer is similar to the predicate device in the following ways: - . Intended use: Both devices are intended for diagnostic purposes and to be used as a review tool. - Indications for use: Both devices have similar indications for use as SaMD for . diagnostic review in radiology and healthcare imaging. - . Technology characteristics: Both devices have similar core capabilities in image manipulation, 3D imaging, and AI/CAD annotation display across major desktop browsers and various imaging modalities. {8}------------------------------------------------ Image /page/8/Picture/0 description: The image contains the logo for Innolitics. The logo consists of a geometric shape on the left and the word "Innolitics" on the right. The geometric shape is a hexagon made up of six overlapping triangles. The word "Innolitics" is written in a sans-serif font and is in blue. - . Safety: Both devices SaMD/viewer systems, and don't pose any direct safety hazard to the patient. Effective Date: 2024-12-20 - Performance Testing: As both devices are SaMD/viewer systems, both were subjected ● to similar verification and validation testing. See Device Comparison Table below for details. #### 8.1. Indications for Use Comparison Lightning Viewer and the predicate device have similar indications for use. Both devices are software solutions for diagnostic and clinical review in general radiology and other healthcare imaging applications. They support major desktop browsers and various imaging modalities. allowing for image manipulation, 3D imaging, and AI/CAD annotation display. While the predicate offers broader functionality across more specialties and mobile platforms, these differences do not raise new questions of safety or effectiveness. The core diagnostic capabilities, image quality considerations, and emphasis on appropriate display conditions remain consistent between both viewers. The absence of mobile functionality or extended specialties in Lightning Viewer's indications does not impact its safety or effectiveness within its intended use scope. | Feature | Lightning Viewer | OmegaAI Image Viewer | Comments | |-----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended Use | Lightning Viewer is<br>intended for diagnostic<br>purposes and to be used<br>as a review tool. | The OmegaAI Image Viewer<br>is intended for diagnostic<br>purposes and to be used as a<br>review tool. | Same | | Mammographic<br>Use | Lossy image<br>compression should not<br>be used for primary<br>reading in<br>mammography. | Lossy image<br>compression should not be<br>used for primary reading in<br>mammography. | Same | | Image<br>Manipulation<br>Features | Adjustment Tools:<br>Window level, rotate,<br>flip, pan, stack scroll, and<br>zoom.<br>Markup Tools:<br>Annotate, angle, cobb<br>angle, probe, Mark ROI,<br>and measurement. | Adjustment Tools:<br>Window level, rotate, flip,<br>pan, stack scroll, and zoom.<br>Markup Tools:<br>Annotate, angle, cobb angle,<br>probe, Mark ROI, and<br>measurement. | Same | | Feature | Lightning Viewer | OmegaAI Image Viewer | Comments | | Specialized<br>Tools | Spine labeling:<br>Mammography tools | Unknown. | The subject device has specialized tools for<br>specific use cases, such as spine labeling<br>and mammography tools. These tools fall<br>under the same general intended use to<br>review and navigate diagnostic images and<br>aiding users in visualizing a region of<br>interest. Thus, the inclusion of these<br>specialized tools do not raise any new<br>questions of safety and effectiveness. | | Support<br>Modalities | Supports the following<br>image modalities<br>CR/DR/XR, CT, FL, MR,<br>MG, NM, US/US Echo,<br>PET and VL. | View all image modalities,<br>including CR, CT, DX, MR,<br>MG, NM, US, PET, RG, SC,<br>VL, XA, PET, and Film<br>Digitizer. | Both devices support a wide range of image<br>modalities, including CR, CT, MR, MG,<br>NM, US, PET, and VL. The predicate<br>device supports additional modalities like<br>DX, RG, SC, XA, and Film Digitizer. This<br>difference does not raise any new questions<br>of safety or effectiveness. The additional<br>modalities supported by the predicate device<br>do not impact the safety or effectiveness of<br>Lightning Viewer for its intended use cases. | | Architecture | A web-based software<br>solution that displays<br>images and reports from a<br>PACS through a zero-<br>footprint application<br>accessible via a web<br>browser, requiring no<br>installation. | Server-based software<br>solution that displays images<br>and reports from a PACS<br>using a zero-footprint<br>application (browser).<br>No installation is needed. | Both devices are zero-footprint and require<br>no installation. The subject device is web-<br>based, while the predicate device is server-<br>based. The architectural difference does not<br>impact the core functionality, safety, or<br>effectiveness of either device. Both<br>architectures are commonly used in medical<br>imaging and have established safety and<br>performance profiles. | | Technology | Use of various<br>technology standards like<br>DICOM, DICOMweb,<br>WADO, Rest, HL7. | Use of various technology<br>standards (LDAP, SSO,<br>HTTPS, HTML, HL-7<br>Integration web services,<br>etc.) | Both devices utilize industry-standard<br>technologies for communication and data<br>exchange (DICOM, HL7). Each device uses<br>a different set of additional technologies to<br>support its architecture and features (e.g.,<br>web-based vs. server-based). These<br>differences do not impact the safety or<br>effectiveness of the devices. The different<br>technologies used by the devices are all<br>industry-standard and well-established for<br>their respective purposes (security,<br>communication, data exchange). | | Support<br>Platforms,<br>Devices | Supports major browsers<br>like Chrome and Safari. | Supports major desktop (for<br>diagnostic purposes) and<br>mobile platforms (for non-<br>diagnostic purposes; can be<br>used as a review tool) such as<br>Microsoft Edge, Chrome, | The predicate device supports a wider range<br>of platforms, including desktop and mobile<br>operating systems. Lightning Viewer is<br>designed as a web-based application and<br>relies on the browser's capabilities for<br>compatibility and rendering. This difference | | Feature | Lightning Viewer | OmegaAI Image Viewer | Comments | | | | Safari, Apple iOS, Android,<br>Windows and Mac devices. | does not raise new questions of safety or<br>effectiveness. | ## 8.2. Device Comparison Table {9}------------------------------------------------ Image /page/9/Picture/0 description: The image contains the logo for Innolitics. The logo consists of a blue hexagon-like shape on the left and the word "Innolitics" in blue on the right. The hexagon shape is made up of three overlapping shapes that create a sense of depth. #### 510(k) Summary DOC-0031 Rev C Effective Date: 2024-12-20 Page 6 of 7 {10}------------------------------------------------ Image /page/10/Picture/0 description: The image contains the logo for Innolitics. The logo consists of a geometric shape on the left and the company name "Innolitics" on the right. The geometric shape is a hexagon made up of six triangular shapes that are shaded in different hues of blue. The company name is written in a bold, sans-serif font, also in blue. # 9. PERFORMANCE DATA #### 9.1. Software Verification and Validation Testing Software verification and validation testing were conducted, and documentation was provided as recommended by 2023 FDA Guidance "Content of Premarket Submissions for Device Software Functions". The software verification and validation testing verified that the design requirements were successfully met. The intended use and user needs were successfully validated. As the intended use, functionality and performance of the subject device and the predicate device are equivalent, the result of the performance testing is evidence that the Lightning Viewer performs in an equivalent manner to the OmegaAI Image Viewer. #### 9.2. Non-Clinical Performance Testing A phantom study using a dataset with known voxel dimensions to evaluate the accuracy of the device's measurement calculations was performed and demonstrated that the device accurately calculates distance and angle measurements based on user-defined inputs. #### 9.3. Clinical Performance Testing No clinical performance data was necessary to claim substantial equivalence. #### 10. CONCLUSION The Lightning Viewer shares similar technological characteristics, intended use, and functionality with the predicate device. There are no differences between the devices that raise new questions of safety and effectiveness. Furthermore, non-clinical performance test data and software verification and validation demonstrate that Lightning Viewer performs comparably to the predicate device in terms of safety and effectiveness. Based on the device comparisons and the acceptable testing results, it is determined that Lightning Viewer is substantially equivalent to the predicate device.