(53 days)
Not Found
No
The document describes standard ultrasound imaging modes and measurements, including new features like backscattering coefficient calculation. There is no mention of AI, ML, or any related technologies in the intended use, device description, or performance studies summary. The predicate device also does not indicate AI/ML capabilities.
No.
The device is described as an "ultrasound diagnostic system" intended for "pulse echo ultrasound imaging" and "measurement of anatomical structures" to aid in "clinical management of adult and pediatric patients with liver disease." It functions as an imaging and measurement tool for diagnosis, not for treatment.
Yes.
The "Intended Use / Indications for Use" section explicitly states that the device is an "ultrasound diagnostic system" and is "intended for general purpose pulse echo ultrasound imaging... of the human body." It further specifies its use for "imaging and measurement of anatomical structures" and notes that information delivered by the device "must be used by a licensed physician qualified to establish a diagnosis." The "Device Description" also clearly indicates that it is used to "perform non-invasive diagnostic hepatology purpose ultrasound imaging studies."
No
The device description explicitly states it is a "cart based ultrasound imaging system" and includes hardware components like transducers, a scan converter, LCD monitor, and control panel. While it has software, it is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Function: The SuperSonic Imagine® SuperSonic® HepaVu™ system is an ultrasound diagnostic system. It uses sound waves to create images and perform measurements within the human body. It does not analyze samples taken from the body.
- Intended Use: The intended use clearly states it's for "general purpose pulse echo ultrasound imaging, soft tissue viscoelasticity imaging, doppler fluid flow analysis of the human body." and for "imaging and measurement of anatomical structures." This is consistent with in-vivo imaging, not in-vitro analysis.
Therefore, while it is a diagnostic device, it falls under the category of medical imaging devices, not In Vitro Diagnostic devices.
N/A
Intended Use / 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 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 [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 [(B/Color Flow); (B/SWE), (B/PW), (B/PW/Color Flow); (B/Color flow/SWE); (B/M-mode/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.
Product codes (comma separated list FDA assigned to the subject device)
IYN, IYO, ITX
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
ultrasound diagnostic system
Anatomical Site
Abdominal (liver, kidney, spleen)
Indicated Patient Age Range
Adult and Pediatric
Intended User / Care Setting
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.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical testing has been conducted per the following standards, as per the below table :
| Reference Standard | Tests Performed |
|---|---|
| IEC 60601-1 Ed.3.1 | All applicable electrical, basic safety and essential performance tests. |
| IEC 60601-1-2 Ed.4 | All applicable testing pertaining to electromagnetic compatibility. |
| IEC 60601-2-37 Ed.2.1 | All applicable testing pertaining to the particular requirements for the safety of ultrasonic medical diagnostic and monitoring equipment. |
| NEMA UD 2 (Rev. 3) | All tests applicable in order to demonstrate compliance with the "Accoustic Output Measurement Standard for Diagnostic Ultrasound Equipment". |
| NEMA UD 3 (Rev. 2) | All tests applicable in order to demonstrate compliance with the "Standard For Real Time Display Of Thermal And Mechanical Acoustic Output Indices On Diagnostic Ultrasound Equipment". |
| ISO 10993-1 | Applicable biocompatibility tests per FDA 510(k) Memorandum - #G95-1 - per the appropriate device category. |
The above testing confirmed that the SuperSonic® HepaVu™ System performs in accordance with the stated intended use. All data fell within pre-determined product specifications and external standard requirements. Results of non-clinical testing confirmed the substantial equivalence of the Aixplorer® MACH Systems to the predicate device(s).
No clinical tests have been performed on SuperSonic® HepaVu™ System.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1550 Ultrasonic pulsed doppler imaging system.
(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image shows 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 FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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.
-
- 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
- Submitter's name, address, telephone number, contact person
Primary Contact: Shalyna BANSROPUN, Quality and Regulatory Affairs Manager Telephone: +33(4) 42 99 24 24
Date: September-19-2024
-
- 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
- Name of the device, including the trade or proprietary name if applicable, the common or usual name, and the classification name, if known:
| 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 |
-
- Substantially Equivalent/Predicate Device
AIXPLORER® / SUPERSONIC® MACH range Ultrasound Imaging System (K222191), cleared on 10/28/2022
- Substantially Equivalent/Predicate Device
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
SuperSonic® HepaVu™ | PREDICATE DEVICE
AIXPLORER® MACH / SUPERSONIC® MACH range | Discussion |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------|
| 510(k) Number | Unknown | K222191 | - |
| Classification
Name | Ultrasonic Pulsed Doppler Imaging System
(892.1550)
Ultrasonic Pulsed Echo Imaging System
(892.1560)
Diagnostic Ultrasound Transducer
(892.1570) | Ultrasonic Pulsed Doppler Imaging System
(892.1550)
Ultrasonic Pulsed Echo Imaging System (892.1560)
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
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 [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
[(B/Color Flow); (B/SWE), (B/PW),
(B/PW/Color Flow); (B/ M-mode); (B/Color
flow/SWE); (B/M-mode/Color flow)].
In addition, the SuperSonic Imagine®
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 | The SuperSonic Imagine® SuperSonic® MACH
range ultrasound diagnostic systems 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® MACH
Range ultrasound systems are indicated for use in
the following applications, for imaging and
measurement of anatomical structures:
Abdominal, Small Organs, Musculoskeletal,
Superficial Musculoskeletal, Vascular, Peripheral
Vascular, OB-GYN, Pelvic, Pediatric, Urology,
Trans-rectal, Transvaginal and Neonatal/Adult
Cephalic, Non-invasive Cardiac.
Modes of operation include: B-mode [2D ; 3D ;
Panoramic Imaging; Spatial Compounding], M-
mode, Doppler [Continuous Wave (CW); Pulsed
Wave (PW); Color and Power Doppler (Color Flow
Imaging), Color Doppler (Angio PL.U.S)], Strain
Elastography, Tissue Harmonic Imaging, Contrast
Enhanced Ultrasound Imaging (CEUS); ShearWave
Elastography (SWE); ShearWave dispersion
Viscosity (Vi PLUS); Combination Modes [ (B/Color
Flow); (B/SWE), (B/PW), (B/PW/Color Flow); (B/
M-mode); (B/Color flow/SWE); (B/CW) ; (B/M-
mode/Color flow); (B/Strain Elastography/SWE)].
In addition, the SuperSonic Imagine® SuperSonic®
MACH Range ultrasound diagnostic systems and
associated transducers are intended for:
Measurements of abdominal anatomical
structures | Identical: adapted to
liver applications |
| NEW DEVICE | PREDICATE DEVICE | Discussion | |
| SuperSonic® HepaVu™ | AIXPLORER® MACH / SUPERSONIC® MACH range | | |
| 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 of vascularization,
microvascularization and perfusion, the | 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, beam attenuation, viscosity
and stiffness measurements, the brightness ratio,
the visualization of vascularization,
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. | | |
| quantification of vascularization and
perfusion may be used as an aid to clinical
management of adult and pediatric patients
with liver disease. | Furthermore, the SuperSonic® MACH ultrasound
diagnostic systems and associated transducers are
intended for:
Measurement of breast anatomical structures
Measurements of broad band shear waves speed
and tissue stiffness in internal structures of the
breast
Visualization of breast structures and micro-
vascularization
Visualization of breast masses morphology using
shearwave elastography and mmicro-
vascularization 2D mapping.
The shear waves speed and stiffness
measurements may be used as an aid to
management of women patients with breast
masses, as shearwave elastography in conjunction
with 2D gray scale imaging and vascularization
provides added information to better characterize
breast masses and improved the diagnostic
accuracy of ultrasound.
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. This 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. | | |
| General
Description | General purpose, mobile, software
controlled diagnostic ultrasound system. To
acquire ultrasound data and to display the
data in various modes of operation. | General purpose, mobile, software controlled
diagnostic ultrasound system. To acquire
ultrasound data and to display the data in various
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 |
| | - | Fetal | N/A |
| | - | GYN | N/A |
| | - | Cardiac (non invasive) | N/A |
| | - | Adult and neonatal cephalic | N/A |
| Clinical
Applications | Pediatric | Pediatric | Identical use for pediatric
(Abdominal) |
| | - | Urology | N/A |
| | - | Vascular | N/A |
| | - | Peripheral vascular | N/A |
| | - | Trans-rectal | N/A |
| | - | Trans-vaginal | N/A |
| | Imaging modes | | |
| | B-Mode (Harmonic, Fundamental) | B-Mode (Harmonic, Fundamental) | Identical |
| | M-Mode | M-Mode | Identical |
| Conventional | PW | PW | Identical |
| | - | CW | N/A |
| | Color Doppler | Color Doppler | Identical |
| | Amplitude Doppler | Amplitude Doppler | Identical |
| | Microvascular (Angio PL.U.S) | Microvascular (Angio PL.U.S) | Identical |
| | Spatial compounding, Panoramic | Spatial compounding, Panoramic | Identical |
| | Contrast | Contrast | Identical |
| | Combination of modes | Combination of modes | Identical |
| Other | ShearWave Elastography | ShearWave Elastography | Identical |
| | - | Strain Elastography | N/A |
| | Attenuation (Att PLUS) | Attenuation (Att PLUS) | Identical |
| | Sound Speed Plane wave (SSp PLUS) | Sound Speed Plane wave (SSp PLUS) | Identical |
| | Backscattering (Bsc plus) | - | New |
| | Design | | |
| | NEW DEVICE | PREDICATE DEVICE | Discussion |
| | SuperSonic® HepaVu™ | AIXPLORER® MACH / SUPERSONIC® MACH range | |
| Cart | Mobile cart based product with control panel
and monitor | Mobile cart based product with control panel and
monitor | Identical |
| Controls | Typical ultrasound imaging controls (gain,
depth mode select...) | Typical ultrasound imaging controls (gain, depth
mode select...) | Identical |
| Biopsy guides | Available | Available | Identical |
| Track | Track 3 (Acoustic Output Display) | Track 3 (Acoustic Output Display) | Identical |
| Patient
Contact
Materials | Yes, per ISO 10993-1 :2018 | Yes, per ISO 10993-1 :2018 | Identical |
| Acoustic
Output
within
FDA
guidelines | Yes, as per NEMA UD-3 | Yes, as per NEMA UD-3 | Identical |
| General Safety | Conform to IEC60601-1:2020, 60601-1-
2:2020, 60601-2-37:2015 | Conform to IEC60601-1:2020, 60601-1-2:2020,
60601-2-37:2015 | Identical |
| Accessoires | | | |
| | L10-2
C6-1X | L18-5
L10-2
C6-1X | Identical
with
reduction of the
number of probes in
accordance with the |
| | C9-2X | C9-2X | HepaVu™ scope. |
| Probes | | LV16-5 | |
| | | LH20-6 | |
| | | P5-1X | |
| | | E12-3 | |
| | | MC12-3 | |
| Cleaning
&
Disinfectants | Yes | Yes | Identical |
| Probe sheaths | C6-1X & C9-2X probes
610-637
610-1000
610-542
610-362
L10-2 probe | C6-1X & C9-2X probes
610-637
610-1000
610-542
610-362
L10-2 probe | Identical with
reduction of the
number of probes in
accordance with the
HepaVu™ scope. |
| | 610-323
610-001 | 610-323
610-001 | |
| Gel | Yes | Yes | Identical |
| Biopsy Guides | C6-1X probe
672-002 by Clvco
610-901 by Clvco
C9-2X probe
653-005 by Clvco | L18-5 probe
672-001 by Clvco
C6-1X probe
672-002 by Clvco
610-901 by Clvco
E12-3 probe | Identical
with
reduction
of
the
number of probes in
accordance with the
HepaVu™ scope. |
| | | 657-014 by Clvco
610-666 by Clvco
610-1275 by Clvco | |
| | NEW DEVICE
SuperSonic® HepaVu™ | PREDICATE DEVICE
AIXPLORER® MACH / SUPERSONIC® MACH range | Discussion |
| Gel warmer | Yes | Yes | Identical |
| Footswitch | Yes | Yes | Identical |
| DICOM | Yes | Yes | Identical |
| Barcode Scanner | Yes | Yes | Identical |
| ECG | Yes | Yes | Identical |
8
Image /page/8/Picture/0 description: The image contains the logo for "Supersonic Imagine". The word "Supersonic" is in a light blue font, while the word "Imagine" is in a dark gray font. The "TM" symbol is located to the bottom right of the word "Imagine".
9
Image /page/9/Picture/0 description: The image shows the logo for "Supersonic Imagine". The word "SUPERSONIC" is in light blue, and the word "imagine" is in dark gray. There is a trademark symbol to the right of the word "imagine".
10
SUPERSONIC
11
Image /page/11/Picture/0 description: The image shows the logo for "SuperSonic Imagine". The word "SUPERSONIC" is in a light blue sans-serif font, stacked above the word "imagine" which is in a dark gray sans-serif font. The letters "TM" are in the bottom right corner of the logo.
-
- A brief discussion of the non clinical tests submitted, referenced, or relied on in the premarket notification submission for a determination of substantial equivalence
Non-clinical testing has been conducted per the following standards, as per the below table :
- A brief discussion of the non clinical tests submitted, referenced, or relied on in the premarket notification submission for a determination of substantial equivalence
| Reference Standard | Tests Performed |
|---|---|
| IEC 60601-1 Ed.3.1 | All applicable electrical, basic safety and essential |
| performance tests. | |
| IEC 60601-1-2 Ed.4 | All applicable testing pertaining to electromagnetic |
| compatibility. | |
| IEC 60601-2-37 Ed.2.1 | All applicable testing pertaining to the particular |
| requirements for the safety of ultrasonic medical | |
| diagnostic and monitoring equipment. | |
| NEMA UD 2 (Rev. 3) | All tests applicable in order to demonstrate compliance |
| with the "Accoustic Output Measurement Standard for | |
| Diagnostic Ultrasound Equipment". | |
| NEMA UD 3 (Rev. 2) | All tests applicable in order to demonstrate compliance |
| with the "Standard For Real Time Display Of Thermal | |
| And Mechanical Acoustic Output Indices On Diagnostic | |
| Ultrasound Equipment". | |
| ISO 10993-1 | Applicable biocompatibility tests per FDA 510(k) |
| Memorandum - #G95-1 - per the appropriate device | |
| category. |
The above testing confirmed that the SuperSonic® HepaVu™ System performs in accordance with the stated intended use. All data fell within pre-determined product specifications and external standard requirements. Results of non-clinical testing confirmed the substantial equivalence of the Aixplorer® MACH Systems to the predicate device(s).
-
- A brief discussion of the clinical tests submitted, referenced, or relied on in the premarket notification submission for a determination of substantial equivalence
Not applicable. No clinical tests have been performed on SuperSonic® HepaVu™ System.
- A brief discussion of the clinical tests submitted, referenced, or relied on in the premarket notification submission for a determination of substantial equivalence
12
Image /page/12/Picture/0 description: The image contains the logo for "Supersonic Imagine". The word "SUPERSONIC" is in a light blue sans-serif font, stacked above the word "imagine" which is in a dark gray sans-serif font. To the right of "imagine" is the trademark symbol.
9. Conclusion
The manufacturer and the design and development of the submission device comply with 21 CFR Part 820 and ISO 13485 (2016) Quality Standards. The submission device, designed to comply with applicable safety standards, is tested during the manufacturing process to ensure compliance with these standards. Performance testing demonstrated that the submission device is at least as safe and effective as the predicate device.
Fin du Document / End of Document