Vivid T9/Vivid T8

{0}------------------------------------------------ February 11, 2025 Image /page/0/Picture/1 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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font below that. GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC Lee Bush Regulatory Affairs Director 3200 N Grandview Blvd WAUKESHA, WI 53188 Re: K243628 Trade/Device Name: Vivid T9/Vivid T8 Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic Pulsed Doppler Imaging System Regulatory Class: Class II Product Code: IYN, IYO, ITX Dated: November 25, 2024 Received: November 25, 2024 Dear Lee Bush: 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 (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 Rue"). 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}------------------------------------------------ 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-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, # Marjan Nabili -S for Yanna Kang, Ph.D. Assistant Director Mammography and Ultrasound Team 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 Enclosure {3}------------------------------------------------ ## Indications for Use Submission Number (if known) #### K243628 Device Name Vivid T9/Vivid T8 #### Indications for Use (Describe) The Vivid T9/Vivid T8 is a general-purpose ultrasound system, specialized for use in cardiac imaging. It is intended for use by qualified and trained Healthcare professionals for ultrasound imaging, measurement, display and analysis of the human body and fluid. The device is intended for use in a hospital environment including echo lab, other hospital settings, operating room, Cath lab, and in private medical offices. The systems support the following clinical applications: Fetal/Obstetrics, Abdominal (includes GYN), Pediatric, Small Organ (includes breast, testes, thyroid), Neonatal Cephalic, Cardiac (includes Adult and Pediatric), Peripheral Vascular, Musculoskeletal Conventional, Musculoskeletal Superficial, Urology (Including prostate), Transesophageal, Transrectal, Transvaginal, Interventional guidance (including Biopsy, Fluid Drainage, Vascular Access), Thoracic/Pleural, Intraoperative(Vascular). Modes of operation include: B, M, PW Doppler, CW Doppler, Color Doppler, Color M, Power Doppler, Harmonic Imaging, Coded Pulse and Combined modes: B/M, B/ PWD, B/Color/PWD, B/Power/PWD. 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) #### 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}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logo for GE HealthCare. The logo consists of a circular emblem on the left and the text "GE HealthCare" on the right. The emblem is a stylized version of the letters "GE" inside of a circle. The text is in a simple, sans-serif font. GE HealthCare 510(k) Premarket Notification Submission | K243628 | 510(k) Summary | |---------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | In accordance with 21 CFR 807.92 the following summary of information is provided:<br>Date: Nov 25, 2024 | | Submitter: | GE Medical Systems Ultrasound and Primary care Diagnostics, LLC<br>3200 N Grandview Blvd<br>Waukesha, WI 53188, USA | | Manufacturer: | GE Medical Systems (China) Co., Ltd.<br>No.19, ChangJiang Road, WuXi National Hi-Tech Dev. Zone,<br>214028 Jiangsu China | | Primary Contact Person: | Lee Bush<br>Regulatory Affairs Director<br>GE HealthCare<br>T:(262) 309-9429 | | Alternate Contact Person: | Yuan Wang<br>Senior Lead Specialist, Regulatory<br>Affairs<br>GE HealthCare<br>T: +86 13816996425 | | Device Trade Name: | Vivid T9/Vivid T8 | | Common/Usual Name:<br>Classification Names: | Diagnostic Ultrasound System<br>Class II | | Product Code: | IYN (primary), IYO, ITX (secondary)<br>Ultrasonic Pulsed Doppler Imaging System. 21CFR 892.1550, 90-IYN;<br>Ultrasonic Pulsed Echo Imaging System, 21CFR 892.1560, 90-IYO;<br>Diagnostic Ultrasound Transducer, 21 CFR 892.1570, 90-ITX | | Primary Predicate Device:<br>Reference Device(s): | K221147 Vivid T9/Vivid T8<br>K220619 Vivid S70N/S60N<br>K211524 LOGIQ Fortis | | Classification Names:<br>Product Code: | Class II<br>IYN (primary), IYO, ITX (secondary)<br>Ultrasonic Pulsed Doppler Imaging System. 21CFR 892.1550, 90-IYN;<br>Ultrasonic Pulsed Echo Imaging System, 21CFR 892.1560, 90-IYO;<br>Diagnostic Ultrasound Transducer, 21 CFR 892.1570, 90-ITX | {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the GE HealthCare logo. The logo consists of a circular emblem with a stylized "GE" monogram on the left, followed by the text "GE HealthCare" on the right. The color of the logo is a shade of purple. GE HealthCare 510(k) Premarket Notification Submission Device Description: Vivid T9/Vivid T8 is a Track 3, diagnostic ultrasound system, which is primarily intended for cardiac imaging and analysis but also includes vascular and general radiology applications. It is a full featured diagnostic ultrasound system that provides digital acquisition, processing, analysis and display capability. > The Vivid T9/Vivid T8 consists of a mobile console with control panel color LCD touch panel, LCD display monitor and optional image storage and printing devices. It includes a variety of electronic array transducers operating in linear, curved, sector/phased array, matrix array, and dual array including dedicated CW transducers. The user-interface includes an operator control panel, a 21.5-inch-wide screen LCD monitor (mounted on an arm for rotation and/or adjustment of height), a 10.1-inch touch panel with multi-touch capabilities and alphanumeric keyboard. The smart standby battery is an option to allow the system to not have to be powered down when moving from room to room. Imaging is not allowed when it is not plugged in. The system includes electronics for transmit and receive of ultrasound data, ultrasound signal processing, software computing, hardware for image storage, hard copy printing, and network access to the facility through both LAN and wireless (supported by use of a wireless LAN USB-adapter) connection. Vivid T8 and Vivid T9 are based on the same SW platform and similar HW design. Each system may have different configurations available. The configurations may differ by available SW-options and transducers provided commercially. Vivid T9 has height-adjustable control panel, while Vivid T8's control panel can't be adjustable. Vivid T9 has monitor flexible arm, while Vivid T8 has a monitor fixed arm and monitor flexible arm as an option. The product named Vivid T9 represents the system that has the full functionality and is offered with full support for transducers. {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the GE HealthCare logo. The logo consists of the GE monogram in a circle on the left, followed by the words "GE HealthCare" in a sans-serif font. The color of the logo is purple. The logo is simple and modern, and it is easily recognizable. GE HealthCare 510(k) Premarket Notification Submission Intended Use: The Vivid T9/Vivid T8 is a general-purpose ultrasound system, specialized for use in cardiac imaging. It is intended for use by qualified and trained Healthcare professionals for ultrasound imaging, measurement, display and analysis of the human body and fluid. > The device is intended for use in a hospital environment including echo lab, other hospital settings, operating room, Cath lab, and in private medical offices. > The systems support the following clinical applications: Fetal/Obstetrics, Abdominal (includes GYN), Pediatric, Small Organ (includes breast, testes, thyroid), Neonatal Cephalic, Adult Cephalic, Cardiac (includes Adult and Pediatric), Peripheral Vascular, Musculoskeletal Conventional, Musculoskeletal Superficial, Urology (Including prostate), Transcranial, Transesophageal, Transrectal, Transvaginal, Interventional guidance (including Biopsy, Fluid Drainage, Vascular Access), Thoracic/Pleural, Intraoperative(Vascular). Modes of operation include: B, M, PW Doppler, CW Doppler, Color Doppler, Color M, Power Doppler, Harmonic Imaging, Coded Pulse and Combined modes: B/M, B/PWD, B/Color/PWD, B/Power/PWD. - The Vivid T9/Vivid T8 employs the same fundamental scientific Technology: technology as its predicate device(s). Determination of Substantial Equivalence: Comparison to Predicates The proposed Vivid T9/Vivid T8 is substantially equivalent to the predicate devices. The following is an overview of the differences between the Vivid T9/Vivid T8 and the predicate Vivid T9/Vivid T8 (K221147). Indications for Use: The proposed Vivid T9/Vivid T8 and predicate Vivid T9/Vivid T8 (K221147) have similar clinical indications for use, however the proposed device Vivid T9/Vivid T8 is adding Vascular Access which has been cleared on reference devices Vivid S70N/S60N (K220619). Transducers: - The proposed Vivid T9/Vivid T8 and predicate Vivid T9/Vivid T8 (K221147) transducers are the same. - The clinical indications and modes on the proposed Vivid T9/Vivid ● T8 are the same as on the predicate device Vivid T9/Vivid T8 (K221147) {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the logo for GE HealthCare. The logo consists of a purple circular emblem on the left, followed by the text "GE HealthCare" in purple. The emblem appears to be a stylized version of the letters "GE" within a circular border. ## Software Features/Functionality: - Clarity +: similar to Advanced SRI-HD on cleared LOGIQ Fortis (K211524). It is a real-time image processing/filtering technique that suppresses noise and graininess (reduces speckles) while sharpening boundaries and small structures. - DICOM Encapsulated PDF reports: allows PDF reports generated on . the system to be transferred through DICOM data flows and stored in DICOM storage, in accordance with the DICOM standard. - Remote Viewing: same as on cleared Vivid S70N/S60N(K220619), ● enables streaming of the main monitor over the local network. This feature is not for diagnostic use. - . One-click QuickApps shortcuts: allows users to maintain high-quality tissue and blood flow visualization during transition between high flow / low flow and superficial / deep scanning with only one-click on the main screen. ### Accessories: - Additional wireless adapter Netgear A8000 ● - Additional Transend DVD writer ● ## Summary of Non-Clinical Tests: The device has been evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness as well as thermal, electrical, electromagnetic and mechanical safety, and has been found to conform with applicable medical device safety standards. The proposed Vivid T9/Vivid T8 complies with voluntary standards: - AAMI/ANSI ES60601-1. Medical Electrical Equipment Part 1: ● General Requirements for Safety, 2005/A2:2021 - AAMI TIR69:2017/(R2020) Technical Information Report Risk ● management of radio-frequency wireless coexistence for medical devices and systems - IEC 60601-1-2 Medical Electrical Equipment Part 1-2: General ● Requirements for Basic Safety and Essential Performance -Collateral Standard: Electromagnetic Disturbance - Requirements and Tests, Edition 4.1, 2020 - . IEC 60601-2-37, Medical Electrical Equipment - Part 2-37: Particular Requirements for the Safety of Ultrasonic Medical Diagnostic and Monitoring Equipment, Edition 2.1, 2015 - ISO 10993-1, Biological Evaluation of Medical Devices-Part 1: ● Evaluation and Testing Within Risk Management Process, Fifth edition, 2018 - ISO 14971, Application of risk management to medical devices, ● 2019 {8}------------------------------------------------ Image /page/8/Picture/0 description: The image shows the GE HealthCare logo. The logo consists of a circular emblem on the left and the text "GE HealthCare" on the right. The emblem features a stylized "GE" in a circular design, and the text is in a simple, sans-serif font. - . NEMA PS 3.1 - 3.20. Digital Imaging and Communications in Medicine (DICOM) Set. (Radiology), 2022d - . IEC 62359. Ultrasonics - Field characterization - Test methods for the determination of thermal and mechanical indices related to medical diagnostic ultrasonic fields, Edition 2.1, 2017 The following quality assurance measures are applied to the development of the system: - Risk Analysis ● - Requirements Reviews - Design Reviews ● - Testing on unit level (Module verification) ● - Integration testing (System verification) ● - . Performance testing (Verification & Validation) - Safety testing (Verification) ● Transducer materials and other patient contact materials are biocompatible. #### Summary of Clinical Tests: The subject of this premarket submission, Vivid T9/Vivid T8, did not require clinical studies to support substantial equivalence. Conclusion: Based on the equipment design similarities, conformance to recognized performance standards, and performance testing, GE HealthCare considers the proposed Vivid T9/Vivid T8 to be as safe, effective, and performs in a substantially equivalent manner as the predicate Vivid T9/Vivid T8 (K221147).