SonoSync

{0}------------------------------------------------ August 23, 2024 Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there 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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. Samsung Medison Co., Ltd. Jee Young Ju Regulatory Affairs Specialist 3366, Hanseo-ro, Nam-myeon Hongcheon-gun, Gangwon-do 25108 REPUBLIC OF KOREA Re: K241302 SonoSync Trade/Device Name: Regulation Number: 21 CFR 892.2050 Regulation Name: Medical Image Management And Processing System Regulatory Class: Class II Product Code: LLZ, IYN, IYO Dated: July 12, 2024 Received: July 12, 2024 Dear Jee Young Ju: 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" (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). {1}------------------------------------------------ Your device is also subject to, among other requirements, the Quality System (OS) 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 (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/combinationproducts/guidance-regulatory-information/postmarketing-safety-reporting-combination-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. 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-reporting-mdr-how-reportmedical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device (https://www.fda.gov/medical-devices/deviceadvice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuingeducation/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/medicaldevices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumereducation-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely. ### Marjan Bakhtiari-nejad -S For Yanna Kang, Ph.D. Assistant Director 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 {2}------------------------------------------------ # Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below. Submission Number (if known) K241302 Device Name SonoSync Indications for Use (Describe) SonoSync is a software solution for live streaming images acquired through ultrasound systems to healthcare professionals for diagnostic image viewing, remote access, review, consultation, quidance, support and education in real time. It is required to follow the technical and operator requirements in the User Manual. As users of this remote solution, the healthcare professionals take responsibility for ensuring that image quality, display contrast and ambient light conditions meet the generally accepted practices of the ultrasound imaging. 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. 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." {3}------------------------------------------------ # SAMSUNG #### Traditional 510(k) # K241302 # 510(K) Summary: In accordance with 21 CFR 807.92, the following summary of information is provided: - Date Prepared May 9, 2024 1. - 2. Manufacturer SAMSUNG MEDISON CO., LTD. 3366, Hanseo-ro, Nam-myeon, Hongcheon-gun, Gangwon-do, Republic of Korea - 3. Primary Contact Person Ju, Jee-Young Regulatory Affairs Specialist Phone: +82.2.2194.0861 Fax: +82. 2.2194.0273 Email: jee.ju(@samsungmedison.com - Secondary Contact Person 4. Ninad Gujar Vice President Phone: +1.978.564.8632 Fax: +1.978.564.8677 Email: ngujar@neurologica.com #### న్. Proposed Device - Common/Usual Name : System, Image Processing, Radiological. - - -Proprietary Name : SonoSync - : Medical image management and processing system. Regulation Name - - Regulatory Class : Class II - - Product Code : LLZ(Primary), IYN, IYO - - Regulation Number : 21 CFR 892.2050(Primary), 892.1550, 892.1560 - - Predicate Devices 6. - Collaboration Live (K212777) Primary - - 7. Device Description SonoSync is a software solution that allows medical professionals to stream ultrasound images live, providing real-time access to diagnostic imaging, remote viewing, reviewing, consulting, guiding, supporting, and educating. SonoSync supports four main features: remote diagnostic viewing and guiding, remote clinical training and education, collaboration, and remote service support. With permission from the person operating the ultrasound equipment, a remote user can control the ultrasound equipment using a virtual remote touch panel and remote control panel. Furthermore, under the technical, operational, and environmental conditions described in {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the word "SAMSUNG" in large, bold, blue letters. The font is sans-serif and the letters are evenly spaced. The background is plain white, which makes the blue letters stand out. the manual, healthcare professionals can provide clinical diagnostics at a remote location as if directly using the ultrasound equipment. - 8. Indication for Use SonoSync is a software solution for live streaming images acquired through ultrasound systems to healthcare professionals for diagnostic image viewing, remote access, review, consultation, guidance, support and education in real time. It is required to follow the technical and operator requirements in the User Manual. As users of this remote solution, the healthcare professionals take responsibility for ensuring that image quality, display contrast and ambient light conditions meet the generally accepted practices of the ultrasound imaging. | Attribute | SonoSync<br>(Subject Device) | Collaboration Live<br>K212777<br>(Predicate Device) | Compa<br>rison | |------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------| | Regulation Name | Medical image management<br>and processing system | Medical image management and<br>processing system | Identical | | Product<br>Code(s) | Primary: LLZ<br>Secondary: IYN, IYO | Primary: LLZ<br>Secondary: IYN, IYO | Identical | | Indications<br>for Use | SonoSync is a software solution for<br>live streaming images acquired<br>through ultrasound systems to<br>healthcare professionals for<br>diagnostic image viewing, remote<br>access, review, consultation,<br>guidance, support and education in<br>real time.<br>It is required to follow the technical<br>and operator requirements in the<br>User Manual.<br>As users of this remote solution, the<br>healthcare professionals take<br>responsibility for ensuring that<br>image quality, display contrast and<br>ambient light conditions meet the<br>generally accepted practices of the<br>ultrasound imaging. | Collaboration Live is indicated for<br>remote console access of the<br>Philips ultrasound system for<br>diagnostic image viewing and<br>review, consultation, guidance,<br>support, and education in real<br>time. Access must be granted by<br>the healthcare professionals<br>operating the ultrasound system.<br>Compliance with the technical<br>and operator requirements<br>specified in the User Manual is<br>required.<br>It is the responsibility of the<br>healthcare professionals at the<br>remote client to ensure image<br>quality , display contrast, and<br>ambient light conditions are<br>consistent with the generally<br>accepted standards of the clinical<br>application. | Identical | - Comparison of Technological Characteristics with the Predicate Device 9. {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the word "SAMSUNG" in large, bold, blue letters. The font is sans-serif and the letters are evenly spaced. The word is centered and takes up most of the frame. The background is white. | Features | - Streaming<br>- Text Chat<br>- Voice Chat<br>- Video Chat<br>- Image Sharing<br>- Remote Control<br>- Marking<br>- Remote Image Quality<br>- Invitation | - Image viewing and review<br>- Text Chat<br>- Voice Calling<br>- Video Calling<br>- Remote Asset Sharing<br>- Remote Control<br>- Network Indicator<br>- Remote Image Quality<br>- Remote User Measurement | Identical | |-------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------| | Remote<br>System<br>Hardware | Commercially available off-the-<br>shelf computer hardware | Commercially available off-the-<br>shelf computer hardware | Identical | | Supported<br>Imaging<br>Modalities | Ultrasound | Ultrasound | Identical | | Intended<br>Users | Qualified healthcare professionals | Qualified healthcare professionals | Identical | | Remote-client<br>Use<br>Environment | Clinical environment with ambient<br>light condition consistent with the<br>generally accepted standards of the<br>clinical application. | Clinical environment with ambient<br>light condition consistent with the<br>generally accepted standards of the<br>clinical application. | Identical | | Remote<br>Diagnostic Use | Image visualized for<br>diagnostic review and viewing<br>on Chrome compliant Browser | Image visualized for diagnostic<br>review and viewing on remote-<br>client<br>Reacts | Identical | ## 10. Summary of Non-Clinical Testing Pre-set criteria were utilized in validation tests to assess whether remote viewing and reviewing with SonoSync matched the performance of local ultrasound systems. Specifications for remote displays and required network bandwidth to ensure diagnostic image quality were identified. Labeling materials have been prepared to inform users about the necessary specifications for safely and effectively conducting remote diagnostic reviews and viewing. ## 11. Conclusion Since the predicate device and the subject device have a similar intended use and key technological features, the non-clinical data support the safety of the device and demonstrate that the SonoSync should perform as intended in the specified use conditions. Therefore, SAMSUNG MEDISON CO., LTD. considers the subject device to be as safe, as effective, and performance is substantially equivalent to the primary predicate device that is currently marketed for the same indication for use. #### END of 510(k) Summary ।