(98 days)
No
The document does not mention AI, ML, or related terms in the device description, intended use, or performance studies.
No
This device is described as an "ultrasound diagnostic system" intended for "general purpose pulse echo ultrasound imaging" and "doppler fluid flow analysis," indicating its use for diagnosis rather than therapy.
Yes
The device explicitly states in its "Intended Use / Indications for Use" and "Device Description" sections that it is an "ultrasound diagnostic system" and used to "perform non-invasive diagnostic general purpose ultrasound imaging studies."
No
The device description explicitly states it is a "cart based ultrasound imaging system" and includes physical components like transducers, a scan converter, a monitor, and a control panel. This indicates it is a hardware device with integrated software, not a software-only medical device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Definition of IVD: In vitro diagnostics are tests performed on samples such as blood, urine, or tissue that have been taken from the human body to detect diseases or other conditions.
- Device Function: The description clearly states that this is an ultrasound diagnostic system. Ultrasound is a non-invasive imaging technique that uses sound waves to create images of internal body structures. It does not involve testing samples taken from the body.
- Intended Use: The intended use describes imaging and measurement of anatomical structures and fluid flow within the human body.
- Device Description: The device description details a cart-based ultrasound system with transducers, a scan converter, and a monitor. This aligns with the components of an ultrasound machine, not an IVD.
Therefore, the Hologic SuperSonic Imagine SUPERSONIC MACH range ultrasound diagnostic system is a medical imaging device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Hologic 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 Hologic SuperSonic SUPERSONIC MACH range ultrasound diagnosic systems are indicated for use in the following applications, for imaging and measurement of anatomical Small Organs, Musculoskeletal, Superficial Musculoskeletal, Vascular, Intraoperative, OB-GYN, Pelvic, Pediatric, Urology, Trans-rectal, Trans-vaginal 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); Shear Wave 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); (B/Strain Elastography/SWE)].
In addition, the Hologic SuperSonic SUPERSONIC MACH 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 shearwave speed, beam attenuation, viscosity and stiffness measurements, the visualization of vascularization, microvascularization and perfusion 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:
- Measurements 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 morphology using shearwave elastography and micro-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 improve the diagnostic accuracy of ultrasound.
Product codes
IYN, IYO, ITX
Device Description
The SuperSonic Imagine AIXPLORER® MACH / SUPERSONIC MACH systems are cart based ultrasound imaging systems used to perform non-invasive diagnostic general purpose ultrasound imaging studies.
The system contains a scan converter and can be coupled to a variety of linear, curved, micro-convex, and motorized linear and phased array transducers 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 PL.U.S), Pulsed Wave Doppler, Continuous Wave Doppler, 3D imaging, CEUS-Contrast Enhanced Ultrasound Imaging and for ShearWaveTM elastography and Strain Elastography.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Pulse echo ultrasound imaging
Anatomical Site
Abdominal, Small Organs, Musculoskeletal, Superficial Musculoskeletal, Vascular, Intraoperative, OB-GYN, Pelvic, Pediatric, Urology, Trans-rectal, Trans-vaginal and Neonatal/Adult Cephalic, Non-invasive Cardiac, liver, spleen, breast.
Indicated Patient Age Range
Adult and pediatric patients (specifically for liver disease), women patients (specifically for breast masses), Neonatal/Adult Cephalic.
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. 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.
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 was conducted per the following standards to support a determination of substantial equivalence to the predicate devices.
- 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 Aixplorer® MACH / SUPERSONIC MACH Systems perform according to 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).
Clinical tests: Not applicable.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
October 28, 2022
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.
SuperSonic Imagine % Shalyna Bansropun Regulatory Affairs Manager Zac de l`enfant 135 rue Emilien Gautier Aix en Provence, 13290 FRANCE
Re: K222191
Trade/Device Name: Aixplorer MACH30 / SUPERSONIC MACH30, Aixplorer MACH20 / SUPERSONIC MACH20, SUPERSONIC MACH40 Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: Class II Product Code: IYN, IYO, ITX Dated: September 23, 2022 Received: September 28, 2022
Dear Shalyna Bansropun:
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 (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 located 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.
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
1
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 803) for devices or postmarketing safety reporting (21 CFR 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 (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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.
For comprehensive regulatory information about mediation-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,
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
2
510{k) Number (if known) K222191
Device Name
AIXPLORER® MACH 30 / SUPERSONIC MACH30, AIXPLORER® MACH 20 / SUPERSONIC MACH20 and SUPERSONIC MACH 40
Indications for Use (Describe)
The Hologic 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 Hologic SuperSonic SUPERSONIC MACH range ultrasound diagnosic systems are indicated for use in the following applications, for imaging and measurement of anatomical Small Organs, Musculoskeletal, Superficial Musculoskeletal, Vascular, Intraoperative, OB-GYN, Pelvic, Pediatric, Urology, Trans-rectal, Trans-vaginal 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); Shear Wave 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); (B/Strain Elastography/SWE)].
In addition, the Hologic SuperSonic SUPERSONIC MACH 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 shearwave speed, beam attenuation, viscosity and stiffness measurements, the visualization of vascularization, microvascularization and perfusion 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:
- Measurements 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 morphology using shearwave elastography and micro-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 improve 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.
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)
FORM FDA 3881 (6/20)
Page 1 of 6
PSL' Publishing Services (301) - 443.6740
Lt
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Image /page/3/Picture/0 description: The image shows the logo for Hologic SuperSonic Imagine. The word "HOLOGIC" is in dark blue, while "SUPERSONIC" is in gray. The word "Imagine" is in light blue. The TM symbol is next to the word "SUPERSONIC".
K222191
510(k) Summary
This summary of safety and effectiveness information is submitted in accordance with 21 CFR §807.92.
-
- Submitter's name, address, telephone number, contact person
| Submitted by: | Distributed by: |
|---|---|
| SuperSonic Imagine, S.A. | Hologic Headquarters. |
| Zac de l'Enfant 135 Rue Émilien Gautier | 250 Campus Drive |
| 13290 Aix-En-Provence | Marlborough, MA 01752 |
| FRANCE | USA |
| Telephone: +33(4) 42 99 24 24 | Tel: +1.508.263.2900 |
| E-mail: contactsFR@supersonicimagine.com | Fax: +1.781.280.0668 |
| E-mail: info@hologic.com |
Corresponding Official: Shalyna BANSROPUN, Quality and Regulatory Affairs Manager Telephone: +33(6) 77 23 08 42
Date: Sept-22-2022
-
- 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
- Name of the device, including the trade or proprietary name if applicable, the common or usual name, and the classification name, if known:
Proprietary Name:
- AIXPLORER® MACH / SUPERSONIC MACH Ultrasound Diagnostic Systems o
- O AIXPLORER® MACH 30 / SUPERSONIC MACH30,
- AIXPLORER® MACH 20 / SUPERSONIC MACH 20, O
- SUPERSONIC MACH 40 o
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 |
4
Image /page/4/Picture/0 description: The image shows the logo for Hologic Supersonic Imagine. The word "HOLOGIC" is in blue, and the word "SUPERSONIC" is in gray and blue. The word "Imagine" is in gray.
3. Substantially Equivalent/Predicate Devices
| Primary Predicate Device | AIXPLORER® MACH range Ultrasound Imaging System (K203645), cleared
on 06/29/2021 |
|--------------------------|-------------------------------------------------------------------------------------|
| Reference devices | AIXPLORER® MACH range Ultrasound Imaging System (K202455),
cleared on 12/29/2020 |
| | Aplio i900, i800, i700 V2 (K173090), cleared on 01/11/2018 |
| | Resona 7 (K171233) cleared on 09/12/2017 |
4. Description of Device
The SuperSonic Imagine AIXPLORER® MACH / SUPERSONIC MACH systems are cart based ultrasound imaging systems used to perform non-invasive diagnostic general purpose ultrasound imaging studies.
The system contains a scan converter and can be coupled to a variety of linear, curved, micro-convex, and motorized linear and phased array transducers 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 PL.U.S), Pulsed Wave Doppler, Continuous Wave Doppler, 3D imaging, CEUS-Contrast Enhanced Ultrasound Imaging and for ShearWaveTM elastography and Strain Elastography.
5. Indication for Use
The Hologic 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 Hologic SuperSonic SUPERSONIC MACH range ultrasound diagnostic systems are indicated for use in the following applications, for imaging and measurement of anatomical structures: Abdominal, Small Organs, Musculoskeletal, Superficial Musculoskeletal, Vascular, Intraoperative, OB-GYN, Pelvic, Pediatric, Urology, Trans-rectal, Trans-vaginal 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/Color flow/SWE); (B/CW) ; (B/Mmode/Color flow); (B/Strain Elastography/SWE)]."
In addition, the Hologic SuperSonic Imagine SUPERSONIC MACH range ultrasound diagnostic systems and associated transducers are intended for:
- -Measurements of abdominal anatomical structures,
5
Image /page/5/Picture/0 description: The image shows the logo for Hologic Supersonic Imagine. The word "HOLOGIC" is in blue, and the words "SUPERSONIC" are in gray. The word "Imagine" is in light blue and is located below the word "SUPERSONIC".
- -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 shearwave speed, beam attenuation, viscosity and stiffness measurements, the brightness ratio, the visualization of vascularization 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.
Furthermore, the SUPERSONIC MACH ultrasound diagnostic systems and associated transducers are intended for:
- -Measurements 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 micro-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 improve 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 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.
6
Image /page/6/Picture/0 description: The image shows the logo for Hologic Supersonic Imagine. The word "HOLOGIC" is in blue, and the words "SUPERSONIC imagine" are in gray and blue. The word "SUPERSONIC" is in gray, and the word "imagine" is in blue.
6. Summary of Technological Characteristics – New Device compared to Predicates
| | SuperSonic Imagine | SuperSonic Imagine | Canon Medical
System | Mindray medical
International | SuperSonic Imagine |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Aixplorer MACH range sw
V3
(predicate) | Aixplorer MACH range sw
V2.1
(Reference) | Aplio i900, i800 and
i700 V2.0
(Reference) | Resona 7
(Reference) | AIXPLORER® MACH /
SUPERONIC MACH
range sw V4 |
| 510(k) Number | K203645 | K202455 | K173090 | K171233 | 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 | Identical | Identical |
| Class | Class II | Class II | Identical | Identical | Identical |
| Intended Use | Diagnostic ultrasound imaging,
soft tissue elasticity imaging,
fluid flow analysis of the
human body | Diagnostic ultrasound imaging,
soft tissue elasticity imaging,
fluid flow analysis of the
human body | Diagnostic
ultrasound
imaging or fluid flow
analysis of the
human
body | Diagnostic Ultrasound
imaging or fluid flow
analysis of the human
body | Identical to K203645 |
| | SuperSonic Imagine | SuperSonic Imagine | Canon Medical
System | Mindray medical
International | SuperSonic Imagine |
| Indication for Use | The SuperSonic Imagine
AIXPLORER® MACH/
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
AIXPLORER® MACH/
SUPERSONIC MACH
ultrasound diagnostic
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, Intraoperative, OB-
GYN, Pelvic, Pediatric,
Urology, Trans-rectal, Trans-
vaginal and Neonatal/Adult
Cephalic, Non-invasive
Cardiac.
In addition, the SuperSonic
Imagine AIXPLORER®
MACH/ SUPERSONIC
MACH ultrasound diagnostic
systems and associated
transducers are intended for: | The SuperSonic Imagine
AIXPLORER® MACH/
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
AIXPLORER® MACH/
SUPERSONIC MACH
ultrasound diagnostic
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, Intraoperative, OB-
GYN, Pelvic, Pediatric,
Urology, Trans-rectal, Trans-
vaginal and Neonatal/Adult
Cephalic, Non-invasive
Cardiac.
In addition, the SuperSonic
Imagine AIXPLORER®
MACH/ SUPERSONIC
MACH ultrasound diagnostic
systems and associated
transducers are intended for: | The diagnostic
ultrasound
systems Aplio i900
Model TUS-
AI900, Aplio i800
Model TUS-
AI800, Aplio i700
Model TUS-
AI700, Aplio i600
Model TUS-
AI600, are indicated
for the visualisation of
structures, and
dynamic processes
with the human body
using ultrasound and
to provide image
information for
diagnosis in the
following applications
: fetal, abdominal,
intraoperative
(abdominal),
pediatric, small
organs, transvaginal,
transrectal, neonatal
cephalic, adult
cephalic, cardica
(both adult and
pediatric), peripheral | The Resona
7/Resona
7CV/Resona
7EXP/Resona
7S/Resona 7OB
diagnostic ultrasound
system is applicable for
adults, pregnant
women, pediatric
patients and neonates.
It is intended for use in
fetal, abdominal, intra-
operative (abdominal,
thoracic, and vascular),
pediatric, small organ
(breast, thyroid, testes),
neonatal cephalic, adult
cephalic,
trans-rectal,
transvaginal,muscul
o-skeletal (conventional,
superficial), cardiac
adult, cardiac pediatric,
transesoph. (cardiac),
peripheral vessel and
urology exams. | Identical to K203645
Additional information
for clarification on "
Operator qualification
and device use
settings" and "mode of
operation". |
| SuperSonic Imagine | SuperSonic Imagine | Canon Medical
System | Mindray medical
International | SuperSonic Imagine | |
| -Measurements of abdominal
anatomical structures, | -Measurements of abdominal
anatomical structures, | vascular,
transoesophageal,
musculoskeletal (both
conventional and
superficial) and
laparoscopic. | | | |
| - Measurements of broad
band shear wave speed, and
tissue stiffness in internal
structures of the liver and the
spleen, | - 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, | - Measurements of
brightness ratio between liver
and kidney, | | | | |
| - Visualization of abdominal
vascularization,
microvascularization and
perfusion, | - Visualization of abdominal
vascularization,
microvascularization and
perfusion, | | | | |
| - Quantification of abdominal
vascularization and
perfusion. | - Quantification of abdominal
vascularization and
perfusion. | | | | |
| The shearwave 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. | The shearwave 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. | | | | |
| SuperSonic Imagine | SuperSonic Imagine | Canon Medical
System | Mindray medical
International | SuperSonic Imagine | |
| Furthermore, the SuperSonic
Imagine MACH ultrasound
diagnostic systems and
associated transducers are
intended for: | | | | | |
| - Measurements 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
micro-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 improve the diagnostic
accuracy of ultrasound. | | | | | |
| | SuperSonic Imagine | SuperSonic Imagine | Canon Medical
System | Mindray medical
International | SuperSonic Imagine |
| | 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 | Identical | Identical |
| General
Description | 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 | Identical | Identical |
| Clinical
Applications | Abdominal (liver, kidney,
spleen) | Abdominal (liver, kidney,
spleen) | Identical | Identical | Identical |
| | Small organs () | Small organs () | Identical | Identical | Identical |
| | Musculoskeletal | Musculoskeletal | Identical | Identical | Identical |
| | Fetal | Fetal | Identical | Identical | Identical |
| | GYN | GYN | Identical | Identical | Identical |
| | Cardiac (non invasive) | Cardiac (non invasive) | Identical | Identical | Identical to K203645 |
| | Adult and neonatal cephalic | Adult and neonatal cephalic | Identical | Identical | Identical |
| | Pediatric | Pediatric | Identical | Identical | Identical |
| | Urology | Urology | Identical | Identical | Identical |
| | SuperSonic Imagine | SuperSonic Imagine | Canon Medical
System | Mindray medical
International | SuperSonic Imagine |
| | Vascular | Vascular | Identical | Identical | Identical |
| | Peripheral vascular | Peripheral vascular | Identical | Identical | Identical |
| | Trans-rectal | Trans-rectal | Identical | Identical | Identical |
| | Trans-vaginal | Trans-vaginal | Identical | Identical | Identical |
| Imaging modes | | | | | |
| Conventional | B-Mode (Harmonic,
Fundamental) | B-Mode (Harmonic,
Fundamental) | Identical | Identical | Identical |
| | M-Mode | M-Mode | Identical | Identical | Identical |
| | PW | PW | Identical | Identical | Identical |
| | CW | CW | Identical | Identical | Identical |
| | Color Doppler | Color Doppler | Identical | Identical | Identical |
| | Amplitude Doppler | Amplitude Doppler | Identical | Identical | Identical |
| | Microvascular (Angio
PL.U.S) | Microvascular (Angio
PL.U.S) | --- (**) | --- | Identical to K203645 |
| Other | Spatial compounding,
Panoramic | Spatial compounding,
Panoramic | Identical | Identical | Identical |
| | Contrast | Contrast | Identical | Identical | Identical to K202455 |
| | Combination of modes | Combination of modes | Identical | Identical | Identical |
| | ShearWave Elastography | ShearWave Elastography | Identical | Identical | Identical |
| | Strain Elastography | Strain Elastography | Identical | Identical | Identical |
| | SuperSonic Imagine | SuperSonic Imagine | Canon Medical
System | Mindray medical
International | SuperSonic Imagine |
| Design | | | | | |
| Cart | Mobile cart based product
with control panel and
monitor | Mobile cart based product
with control panel and
monitor | Identical | Identical | Identical |
| Controls | Typical ultrasound imaging
controls (gain, depth mode
select...) | Typical ultrasound imaging
controls (gain, depth mode
select...) | Identical | Identical | Identical |
| Biopsy guide | Available | Available | Identical | Identical | Identical |
| Track | Track 3 (Acoustic Output
Display) | Track 3 (Acoustic Output
Display) | Identical | Identical | Identical |
| Patient Contact
Materials | Yes, per ISO 10993-1 | Yes, per ISO 10993-1 | Identical | Identical | Identical |
| Acoustic Output
within FDA
guidelines | Yes, as per NEMA UD-3 | Yes, as per NEMA UD-3 | Identical | Identical | Identical |
| Software Operation
System | Linux (Debian 9) | Linux (Debian 9) | Windows | Windows | Linux (Debian 11) |
| Image Review | Yes | Yes | Identical | Identical | Improvement of image
quality presets (Angio,
Abdo & Thyroid, MSK,
Ultrafast Doppler
Vascular). |
| Measurement
Package | Yes | Yes | Identical | Identical | Identical |
| Calculation
Package | Yes | Yes | Identical | Identical | Identical |
| | SuperSonic Imagine | SuperSonic Imagine | Canon Medical
System | Mindray medical
International | SuperSonic Imagine |
| Automated
Protocols | No | No | Yes | Yes | Inclusion of Optional
Automated Protocols
feature |
| Report | Yes | Yes | Identical | Identical | Identical |
| General Safety | Conforms to IEC60601-1,
60601-1-2, 60601-2-37 | Conforms to IEC60601-1,
60601-1-2, 60601-2-37 | Identical | Identical | Identical |
| Labeling | Conforms to 21 CFR Part
801 | Conforms to 21 CFR Part
801 | Identical | Identical | Identical |
7
SUPERSONIC"
"Woodle" "magine
8
SUPER imaqıne
9
SUPERSONIC"
SUPERSONIC"
Magine
10
SUPERSONIC"
"magine" magine
11
SUPERSONIC™
12
Image /page/12/Picture/0 description: The image contains the logo for Hologic Supersonic Imagine. The word "Hologic" is in blue, and the word "SUPERSONIC" is in gray. The word "Imagine" is in gray and is located below the other words.
13
HOLOGIC® SUPER imaqine
Note:
*: Breast, Thyroid, Testicle, etc
**:--- means not applicable
14
Image /page/14/Picture/0 description: The image shows the logo for Hologic Supersonic Imagine. The word "HOLOGIC" is in dark blue, and the word "SUPERSONIC" is in gray. The word "Imagine" is in light blue and is located below the word "SUPERSONIC".
-
- 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 was conducted per the following standards to support a determination of substantial equivalence to the predicate devices.
- 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 Aixplorer® MACH / SUPERSONIC MACH Systems perform according to 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.
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 devices listed in item 3.