SuperSonic HepaVu

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September 20, 2024 SuperSonic Imagine % Charlotte Turc Official Correspondent Zac de l'Enfant 135 Rue Émilien Gautier Aix-En-Provence, 13290 FRANCE Re: K242223 Trade/Device Name: SuperSonic® HepaVu™ Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic Pulsed Doppler Imaging System Regulatory Class: Class II Product Code: IYN, IYO, ITX Dated: July 29, 2024 Received: September 4, 2024 Dear Charlotte Turc: 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, ## 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 510(k) Number (if known) K242223 Device Name SuperSonic® HepaVu™ #### Indications for Use (Describe) The SuperSonic Imagine® SuperSonic® Hepa Vi™ ultrasound diagnostic system and transducers are intended for general purpose pulse echo ultrasound imaging, soft tissue viscoelasticity imaging, doppler fluid flow analysis of the human body. The SuperSonic Imagine® SuperSonic® HepaVu™ ultrasound system is indicated for use in the following applications, for imaging and measurement of anatomical structures: Abdominal for Adult and Pediatric. Modes of operation include: B-mode ID : Panoramic Imaging; Spatial Compounding], M-mode. Doppler [Pulsed Wave (PW); Color and Power Doppler (Color Flow Imaging), Color Doppler (Angio PL.U.S)], Tissue Harmonic Imaging, Contrast Enhanced Ultrasound Imaging (CEUS); Shear Wave Elastography (SWE); Shear Wave dispersion Viscosity (Vi PLUS); Combination Modes [(B/Color Flow); (B/SWE), (B/PW), (B/PW/Color Flow); (B/Color flow/ SWE); (B/M-mode/Color flow)]. In addition, the SuperSonic® HepaVu™ ultrasound diagnostic systems and associated transducers are intended for: - · Measurements of abdominal anatomical structures, - · Measurements of broad band shear wave speed, and tissue stiffness in internal structures of the liver and the spleen, - · Measurements of brightness ratio between liver and kidney, - · Visualization of abdominal vascularization, microvascularization and perfusion, - Quantification of abdominal vascularization and perfusion The shear wave speed, ultrasound attenuation coefficient, backscattering coefficient, viscosity and stiffness measurements, the brightness ratio, the visualization, microvascularization and perfusion, the quantification of vascularization and perfusion may be used as an aid to clinical management of adult and pediatric patients with liver disease. This device is intended for use by, or by the order of, and under the supervision of a licensed physician qualified to use or direct the use of the device is intended for use in hospital environment or physician's office This system should only be used by trained Health Care Professionals (HCP) who are knowledgeable about the risk of excessive acoustic energy in the body, particularly in the case where a great amount of fluid is present in the scanning area. 1 Information delivered by the device must be used by a licensed physician qualified to establish a 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) ## CONTINUE ON A SEPARATE PAGE IF NEEDED. {4}------------------------------------------------ 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." {5}------------------------------------------------ Image /page/5/Picture/0 description: The image contains the logo for "SuperSonic Imagine". The word "SuperSonic" is in a light blue color, while the word "imagine" is in a dark gray color. There is a trademark symbol to the bottom right of the word "imagine". ## 510(K) Summary ## K242223 This summary of safety and effectiveness information is submitted in accordance with 21 CFR §807.92. - 1. Submitter's name, address, telephone number, contact person SuperSonic Imagine, S.A. Zac de l'Enfant 135 Rue Émilien Gautier 13290 Aix-En-Provence FRANCE Telephone: +33(4) 42 99 24 24 E-mail : contactsFR@supersonicimagine.com Primary Contact: Shalyna BANSROPUN, Quality and Regulatory Affairs Manager Telephone: +33(4) 42 99 24 24 Date: September-19-2024 - 2. Name of the device, including the trade or proprietary name if applicable, the common or usual name, and the classification name, if known: Common/Usual Name: Ultrasound Diagnostic System with Accessories Proprietary Name: SuperSonic® HepaVu™ Classification: Class II | Classification Name: | 21 CFR Section | Product Code | |------------------------------------------|----------------|--------------| | Ultrasonic Pulsed Doppler Imaging System | 892.1550 | 90-IYN | | Ultrasonic Pulsed Echo Imaging System | 892.1560 | 90-IYO | | Diagnostic Ultrasound Transducer | 892.1570 | 90-ITX | - 3. Substantially Equivalent/Predicate Device AIXPLORER® / SUPERSONIC® MACH range Ultrasound Imaging System (K222191), cleared on 10/28/2022 {6}------------------------------------------------ ## 4. Description of Device The SuperSonic Imagine® SuperSonic® HepaVu™ systems are cart based ultrasound imaging systems used to perform non-invasive diagnostic hepatology purpose ultrasound imaging studies. The system contains a scan converter and can be coupled to a variety of linear and curved trransducers to produce images, which are displayed on a LCD monitor. An adjustable control panel with integrated touch screen allows the user to perform an ultrasound exam quickly and efficiently in accordance with ALARA principles. The system also allows the user to perform measurements, capture images to digital memory or to an external device (such as a printer), and review diagnostic studies in the form of a report. The system functions in a manner identical to the predicate devices and transducers for the imaging modes: B-Mode (harmonic or fundamental), M-mode, Color Flow (and sub-modes as CFI-ColorFlow Imaging, CPI-ColorPower Imaging- also called Amplitude Doppler, dCPI-directional Color Power Imaging and Angio PLU.S), Pulsed Wave Doppler, 3D imaging, CEUS-Contrast Enhanced Ultrasound Imaging and for ShearWaveTM elastography and Strain Elastography. The principle software change with respect to the MACH software version is related to the following feature: - -Backscattering coefficient (BSc): The backscattering coefficient characterizes the ability of a tissue to reflect incoming ultrasound wave back to the direction from which they came. Local measurement of the backscattering is expressed in db/cm.str over a range of values (from -38 db/cm.str to -24 db/cm.str). Bsc PLUS mode is available for all Abdominal presets on C6-1X and C9-2X transducers. ### 5. Indications for Use The SuperSonic Imagine® SuperSonic® HepaVu™ ultrasound diagnostic system and transducers are intended for general purpose pulse echo ultrasound imaging, soft tissue viscoelasticity imaging, doppler fluid flow analysis of the human body. The SuperSonic Imagine® SuperSonic® HepaVu™ ultrasound system is in the following applications, for imaging and measurement of anatomical structures: Abdominal for Adult and Pediatric. Modes of operation include: B-mode [2D ; Panoramic Imaging; Spatial Compounding], M-mode, Doppler [Pulsed Wave (PW); Color and Power Doppler (Color Flow Imaging), Color Doppler (Angio PL.U.S)], Tissue Harmonic Imaging, Contrast Enhanced Ultrasound Imaging (CEUS); ShearWave Elastography (SWE); ShearWave dispersion Viscosity (Vi PLUS); Combination Modes [[8/Color Flow]; (B/SWE), (B/PW), (B/PW/Color Flow); (B/Color flow/SWE); (B/Mmode/Color flow)]. In addition, the SuperSonic® SuperSonic® HepaVu™ range ultrasound diagnostic systems and associated transducers are intended for: - Measurements of abdominal anatomical structures, - Measurements of broad band shear wave speed, and tissue stiffness in internal structures of the liver and the spleen, - . Measurements of brightness ratio between liver and kidney, - Visualization of abdominal vascularization, microvascularization and perfusion, - Quantification of abdominal vascularization and perfusion The shear wave speed, ultrasound attenuation coefficient, backscattering coefficient, viscosity and stiffness measurements, the brightness ratio, the visualization, microvascularization and perfusion, the quantification of vascularization and perfusion may be used as an aid to clinical management of adult and pediatric patients with liver disease. {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the logo for Supersonic Imagine. The word "SUPERSONIC" is written in light blue, with the word "imagine" written in dark gray below it. A trademark symbol is located to the bottom right of the word "imagine". This device is intended for use by, or by the order of, and under the supervision of a licensed physician qualified to use or direct the use of the device is intended for use in hospital environment or physician's office This system should only be used by trained Health Care Professionals (HCP) who are knowledgeable about the risk of excessive acoustic energy in the body, particularly in the case where a great amount of fluid is present in the scanning area. 1 Information delivered by the device must be used by a licensed physician qualified to establish a diagnosis. ## 6. Summary of Technological Characteristics – New Device compared to Predicates | | NEW DEVICE<br>SuperSonic® HepaVu™ | PREDICATE DEVICE<br>AIXPLORER® MACH / SUPERSONIC® MACH range | Discussion | |-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------| | 510(k) Number | Unknown | K222191 | - | | Classification<br>Name | Ultrasonic Pulsed Doppler Imaging System<br>(892.1550)<br>Ultrasonic Pulsed Echo Imaging System<br>(892.1560)<br>Diagnostic Ultrasound Transducer<br>(892.1570) | Ultrasonic Pulsed Doppler Imaging System<br>(892.1550)<br>Ultrasonic Pulsed Echo Imaging System (892.1560)<br>Diagnostic Ultrasound Transducer (892.1570) | Identical | | Class | Class II | Class II | Identical | | Product Code | IYN, IYO, ITX | IYN, IYO, ITX | Identical | | Indications for use | The SuperSonic Imagine® SuperSonic® HepaVu™ ultrasound diagnostic system and<br>transducers are intended for general purpose pulse echo ultrasound imaging, soft<br>tissue viscoelasticity imaging, doppler fluid<br>flow analysis of the human body.<br><br>The SuperSonic Imagine® SuperSonic® HepaVu™ ultrasound system is indicated for<br>use in the following applications, for imaging<br>and measurement of anatomical structures:<br>Abdominal for Adult and Pediatric.<br><br>Modes of operation include: B-mode [2D ;<br>Panoramic Imaging; Spatial Compounding],<br>M-mode, Doppler [Pulsed Wave (PW); Color<br>and Power Doppler (Color Flow Imaging),<br>Color Doppler (Angio PL.U.S)], Tissue<br>Harmonic Imaging, Contrast Enhanced<br>Ultrasound Imaging (CEUS); ShearWave<br>Elastography (SWE); ShearWave dispersion<br>Viscosity (Vi PLUS); Combination Modes<br>[(B/Color Flow); (B/SWE), (B/PW),<br>(B/PW/Color Flow); (B/ M-mode); (B/Color<br>flow/SWE); (B/M-mode/Color flow)].<br><br>In addition, the SuperSonic Imagine®<br>SuperSonic® HepaVu™ range ultrasound<br>diagnostic systems and associated<br>transducers are intended for:<br>Measurements of abdominal anatomical<br>structures,<br>Measurements of broad band shear wave<br>speed, and tissue stiffness in internal<br>structures of the liver and the spleen | The SuperSonic Imagine® SuperSonic® MACH<br>range ultrasound diagnostic systems and<br>transducers are intended for general purpose<br>pulse echo ultrasound imaging, soft tissue<br>viscoelasticity imaging, doppler fluid flow analysis<br>of the human body.<br><br>The SuperSonic Imagine® SuperSonic® MACH<br>Range ultrasound systems are indicated for use in<br>the following applications, for imaging and<br>measurement of anatomical structures:<br>Abdominal, Small Organs, Musculoskeletal,<br>Superficial Musculoskeletal, Vascular, Peripheral<br>Vascular, OB-GYN, Pelvic, Pediatric, Urology,<br>Trans-rectal, Transvaginal and Neonatal/Adult<br>Cephalic, Non-invasive Cardiac.<br><br>Modes of operation include: B-mode [2D ; 3D ;<br>Panoramic Imaging; Spatial Compounding], M-<br>mode, Doppler [Continuous Wave (CW); Pulsed<br>Wave (PW); Color and Power Doppler (Color Flow<br>Imaging), Color Doppler (Angio PL.U.S)], Strain<br>Elastography, Tissue Harmonic Imaging, Contrast<br>Enhanced Ultrasound Imaging (CEUS); ShearWave<br>Elastography (SWE); ShearWave dispersion<br>Viscosity (Vi PLUS); Combination Modes [ (B/Color<br>Flow); (B/SWE), (B/PW), (B/PW/Color Flow); (B/<br>M-mode); (B/Color flow/SWE); (B/CW) ; (B/M-<br>mode/Color flow); (B/Strain Elastography/SWE)].<br><br>In addition, the SuperSonic Imagine® SuperSonic®<br>MACH Range ultrasound diagnostic systems and<br>associated transducers are intended for:<br>Measurements of abdominal anatomical<br>structures | Identical: adapted to<br>liver applications | | NEW DEVICE | PREDICATE DEVICE | Discussion | | | SuperSonic® HepaVu™ | AIXPLORER® MACH / SUPERSONIC® MACH range | | | | Measurements of brightness ratio between<br>liver and kidney,<br>Visualization of abdominal vascularization,<br>microvascularization and perfusion,<br>Quantification of abdominal vascularization<br>and perfusion<br>The shear wave speed, ultrasound<br>attenuation coefficient, backscattering<br>coefficient, viscosity and stiffness<br>measurements, the brightness ratio, the<br>visualization of vascularization,<br>microvascularization and perfusion, the | Measurements of broad band shear wave speed,<br>and tissue stiffness in internal structures of the<br>liver and the spleen,<br>Measurements of brightness ratio between liver<br>and kidney,<br>Visualization of abdominal vascularization,<br>microvascularization and perfusion,<br>Quantification of abdominal vascularization and<br>perfusion<br>The shear wave speed, beam attenuation, viscosity<br>and stiffness measurements, the brightness ratio,<br>the visualization of vascularization,<br>microvascularization and perfusion, the<br>quantification of vascularization and perfusion<br>may be used as an aid to clinical management of<br>adult and pediatric patients with liver disease. | | | | quantification of vascularization and<br>perfusion may be used as an aid to clinical<br>management of adult and pediatric patients<br>with liver disease. | Furthermore, the SuperSonic® MACH ultrasound<br>diagnostic systems and associated transducers are<br>intended for:<br>Measurement of breast anatomical structures<br>Measurements of broad band shear waves speed<br>and tissue stiffness in internal structures of the<br>breast<br>Visualization of breast structures and micro-<br>vascularization<br>Visualization of breast masses morphology using<br>shearwave elastography and mmicro-<br>vascularization 2D mapping.<br>The shear waves speed and stiffness<br>measurements may be used as an aid to<br>management of women patients with breast<br>masses, as shearwave elastography in conjunction<br>with 2D gray scale imaging and vascularization<br>provides added information to better characterize<br>breast masses and improved the diagnostic<br>accuracy of ultrasound.<br>This device is intended for use by, or by the order<br>of, and under the supervision of a licensed<br>physician qualified to use or direct the use of the<br>device. This device is intended for use in hospital<br>environment or physician's office This system<br>should only be used by trained Health Care<br>Professionals (HCP) who are knowledgeable about<br>the risk of excessive acoustic energy in the body,<br>particularly in the case where a great amount of<br>fluid is present in the scanning area.<br>1 Information delivered by the device must be used by a licensed<br>physician qualified to establish a diagnosis. | | | | General<br>Description | General purpose, mobile, software<br>controlled diagnostic ultrasound system. To<br>acquire ultrasound data and to display the<br>data in various modes of operation. | General purpose, mobile, software controlled<br>diagnostic ultrasound system. To acquire<br>ultrasound data and to display the data in various<br>modes of operation. | Identical | | | NEW DEVICE | PREDICATE DEVICE | Discussion | | | SuperSonic® HepaVu™ | AIXPLORER® MACH / SUPERSONIC® MACH range | | | | Consists of two parts: the system console and the transducer. The system console contains the user interface, a display, system electronics and optional peripherals (printers, etc...). | Consists of two parts: the system console and the transducer. The system console contains the user interface, a display, system electronics and optional peripherals (printers, etc...). | Identical | | | Abdominal (liver, kidney, spleen) | Abdominal (liver, kidney, spleen) | Identical | | | - | Small organs (Breast, Thyroid, Testicle, etc) | N/A | | | - | Musculoskeletal | N/A | | | -…