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K Number
K180572
Device Name
AIXPLORER MACH Ultrasound Diagnostic Systems Aixplorer Mach 30, Aixplorer Mach 20, Aixplorer Mach 10
Manufacturer
Supersonic Imagine
Date Cleared
2018-05-29

(85 days)

Product Code
IYNITXIYO
Regulation Number
892.1550
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The SuperSonic Imagine AIXPLORER® MACH ultrasound diagnostic systems and transducers are intended for general purpose pulse echo ultrasound imaging, soft tissue elasticity imaging, doppler fluid flow analysis of the human body. The SuperSonic Imagine AIXPLORER® 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, Transrectal, Trans-vaginal and Neonatal/Adult Cephalic, Non-invasive Cardiac. In addition, the SuperSonic Imagine AIXPLORER® MACH 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 and stiffness measurements, the brightness ratio, the visualization of vascularization, microvascularization and perfusion, the quantification of vascularization may be used as an aid to clinical management of adult and pediatric patients with liver disease.
Device Description
The SuperSonic Imagine AIXPLORER® 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 ShearWave™ elastography.
More Information

K173021, K160524, K163120

Not Found

No
The document does not mention AI, ML, or related terms, and the device description focuses on standard ultrasound imaging modes and functionalities.

No
The device is described as an "ultrasound diagnostic system" intended for imaging and measurement, and for aiding in clinical management. Its primary function is diagnostic, not therapeutic.

Yes

The Intended Use / Indications for Use section explicitly states that the device is an "ultrasound diagnostic systems." The Device Description also refers to it as performing "non-invasive diagnostic general 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.

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 taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
  • Device Function: The SuperSonic Imagine AIXPLORER® MACH is an ultrasound imaging system. It uses sound waves to create images of internal structures of the body. It performs non-invasive diagnostic studies directly on the patient.
  • Intended Use: The intended use clearly describes imaging and measurement of anatomical structures within the human body, not the analysis of specimens taken from the body.

Therefore, the device falls under the category of medical imaging devices, not In Vitro Diagnostic devices.

N/A

Intended Use / Indications for Use

The SuperSonic Imagine AIXPLORER® MACH ultrasound diagnostic systems and transducers are intended for general purpose pulse echo ultrasound imaging, soft tissue elasticity imaging, doppler fluid flow analysis of the human body. The SuperSonic Imagine AIXPLORER® 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, Transrectal, Trans-vaginal and Neonatal/Adult Cephalic, Non-invasive Cardiac.

In addition, the SuperSonic Imagine AIXPLORER® MACH 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 and stiffness measurements, the brightness ratio, the visualization of vascularization, microvascularization and perfusion, the quantification of vascularization 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 AIXPLORER® 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 ShearWave™ elastography.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasound

Anatomical Site

Abdominal, Small Organs, Musculoskeletal, Superficial Musculoskeletal, Vascular, Peripheral Vascular, Intraoperative, OB-GYN, Pelvic, Pediatric, Urology, Transrectal, Trans-vaginal, Neonatal/Adult Cephalic, Liver, Spleen, Kidney, Breast, Thyroid, Testicle, Prostate, Penis

Indicated Patient Age Range

Adult and Pediatric patients

Intended User / Care Setting

Not Found

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 listed standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, NEMA UD 2, NEMA UD 3, ISO 10993-1) to support a determination of substantial equivalence. The testing confirmed that the Aixplorer® MACH Systems perform according to the stated intended use and 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 clinical evaluation by literature route was required to support substantial equivalence and to widen the indications for use of Aixplorer® MACH range Ultrasound Diagnostic Systems.

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.

K173021, K160524, K163120

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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

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 contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

May 29, 2018

SuperSonic Imagine % Laurence Hermitte Quality & Regulatory Affairs Director Les jardins de la Duranne - Bat E&F - 510 rue Rene Descartes Aix-en-Provence, 13857 FRANCE

Re: K180572

Trade/Device Name: AIXPLORER® MACH Ultrasound Diagnostic Systems AIXPLORER® MACH 30, AIXPLORER® MACH 20, AIXPLORER® MACH 10 Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: March 8, 2018 Received: March 12, 2018

Dear Laurence Hermitte:

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. 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 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);

1

Page 2 - Laurence Hermitte

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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Michael D. O'HaraFor

Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

2

Indications for Use

510(k) Number (if known) K180572

Device Name

AIXPLORER MACH Ultrasound Diagnostic Systems AIXPLORER MACH 30, AIXPLORER MACH 20, AIXPLORER MACH 10

Indications for Use (Describe)

The SuperSonic Imagine AIXPLORER® MACH ultrasound diagnostic systems and transducers are intended for general purpose pulse echo ultrasound imaging, soft tissue elasticity imaging, doppler fluid flow analysis of the human body. The SuperSonic Imagine AIXPLORER® 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, Transrectal, Trans-vaginal and Neonatal/Adult Cephalic, Non-invasive Cardiac.

In addition, the SuperSonic Imagine AIXPLORER® MACH 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 and stiffness measurements, the brightness ratio, the visualization of vascularization,

microvascularization and perfusion, the quantification of vascularization may be used as an aid to clinical management of adult and pediatric patients with liver disease.

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

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3

510(k) number (if known):

Device Name: AIXPLORER® MACH 30 (SSIP95030), AIXPLORER® MACH 20 (SSIP95020) and AIXPLORER® MACH 10 (SSIP95010) Ultrasound Diagnostic Systems

Intended Use: Diagnostic ultrasound imaging, soft tissue elasticity imaging, fluid flow analysis of the human body as follows:

Clinical Application
General
(Track 1 Only)Specific
(Tracks 1 & 3)BMPWDCWDColor
DopplerCombined (Specify)Other* (Specify)
OphthalmicOphthalmic
Fetal Imaging &
OtherFetalNNNNNN 1, 3, 4, 11N 5, 6, 10
Abdominal (including urolology): Liver,
Kidney, Spleen...NNNNNN 1, 2, 3, 4N 5, 6, 7, 8, 9, 10, 11,13,
14, 16
Intra-operative (Specify) vascular,
abdominal, small organsNNNN 1, 3, 4N 5, 6, 8, 9
Intra-operative (Neuro)
Laparoscopic
PediatricNNNNNN 1, 2, 3, 4N 5, 6, 7, 8, 9, 10, 11, 13,
16
Small Organ (Breast, Thyroid,
Testicle, Prostate, penis, etc...)NNNN 1, 2, 3, 4,12N 5, 6, 7, 8, 9, 10, 14
Neonatal CephalicNNNN 1, 2, 3, 4N 5, 6, 7, 9
Adult CephalicNNNN 1, 3, 4N 5, 6
Trans-rectalNNNN 1, 2, 3, 4N 5, 6, 7, 8
Trans-vaginalNNNNNN 1, 2, 3, 4N 5, 6, 7, 8, 11
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal (Conventional)NNNN 1, 2, 3, 4N 5, 6, 7, 8, 9, 10, 14
Musculo-skeletal (Superficial)NNNN 1, 2, 3, 4N 5, 6, 7, 8, 9, 10, 14
Intravascular
GYNNNNNNN 1, 2, 3, 4N 5, 6, 7, 8 11, 14
PelvicNNNNNN 1, 2, 3, 4N 5, 6, 7, 8,11, 14
Other (Specify)
CardiacCardiac AdultNNNNNN 1, 3, 4, 11, 17,
18N, 5
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral
VesselPeripheral vesselNNNN, 1, 3, 4N, 5, 6, 8, 9, 10
Other (Specify)NNNN, 1, 3, 4N, 5, 6, 8, 9, 10

N = new indication;

Additional Comments:

1: Combined modes include: B+ Color Flow

2: Combined modes include: B+ ShearWave™ Elastography

3: Combined modes include: B+ Pulsed Wave

  • 4: Combined modes include: B+ Pulsed Wave + Color Flow
  • 5: Harmonic Imaging
  • 6: Spatial Compounding
  • 7: ShearWave™ Elastography
  • 8: Imaging Guidance for Biopsies
  • 9: Panoramic Imaging
  • 10: 3D Imaging

Prescription Use X (Part 21 CFR 801 Subpart D) 11: Combined modes include: B+ M mode

12: Combined modes include: B Mode + Color flow +

Shearwave™ Elastography

  • 13: CEUS (Contrast Enhancement UltraSound)
    14: Angio PL.U.S (Color Doppler improvement)

  • 15: Needle PL.U.S

  • 16: Brightness ratio

  • 17: Combined mode include: B+ Continuous Wave

  • 18: Combined mode include: B+ M mode + Color flow

Over-The-Counter Use

(21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

AND/OR

4

510(k) Number (if known):

Device Name: L10-2 transducer (SSIP95103)

Intended Use: Diagnostic ultrasound imaging, soft tissue elasticity imaging, fluid flow analysis of the human body as follows:

Clinical ApplicationMode of Operation
General
(Track 1 Only)Specific
(Tracks 1 & 3)BMPWDCWDColor
DopplerCombined
(Specify)Other* (Specify)
OphthalmicOphthalmic
Fetal Imaging
& OtherFetal
Abdominal (including urolology): Liver,
Kidney, Spleen...NNNNNN, 1, 2, 3, 4N, 5, 6, 7, 8, 9, 13,14, 15,
16
Intra-operative (Specify)
Intra-operative (Neuro)
Laparoscopic
PediatricNNNNNN, 1, 2, 3, 4N, 5, 6, 7, 8, 9, 15, 16
Small Organ (for example Breast, Thyroid,
Testicle, Prostate, penis, etc...)NNNNNN, 1, 2, 3, 4,
12N, 5, 6, 7, 8, 9, 1415
Neonatal CephalicNNNNNN, 1, 2, 3, 4N, 5, 6, 7, 9
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal (Conventional)NNNNNN, 1, 2, 3, 4N, 5, 6, 7, 8, 9, 1415
Musculo-skeletal (Superficial)NNNNNN, 1, 2, 3, 4N, 5, 6, 7, 8, 9, 1415
Intravascular
GYN
Pelvic
Other (Specify)
CardiacCardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral
VesselPeripheral vesselNNNNNN, 1, 3, 4N, 5, 6, 8, 915
Other (Specify)NNNNNN, 1, 3, 4N, 5, 6, 8, 915

N = new indication;

5: Harmonic Imaging

6: Spatial Compounding

7: ShearWave™ Elastography

8: Imaging Guidance for Biopsies

Additional Comments:

1: Combined modes include: B+ Color Flow 2: Combined modes include: B+ ShearWave™ Elastography

3: Combined modes include: B+ Pulsed Wave

9: Panoramic Imaging

10: 3D Imaging

11: Combined modes include: B+ M mode

4: Combined modes include: B+ Pulsed Wave + Color Flow 12: Combined modes include: B Mode + Color flow + Shearwave™

Elastography

13: CEUS (Contrast Enhancement UltraSound)

14: Angio PL.U.S (Color Doppler improvement)

  • 15: Needle PL.U.S
  • 16: Brightness ratio

17: Combined mode include: B+ Continuous Wave

18: Combined mode incluseds: B+ M mode + Color flow Over-The-Counter Use

AND/OR

Prescription Use X (Part 21 CFR 801 Subpart D)

(21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH; Office of In Vitro Diagnostics and Radiological Health (OIR)

5

510(k) Number (if known):

Device Name: C6-1X transducer (SSIP95101)

Intended Use: Diagnostic ultrasound imaging, soft tissue elasticity imaging, fluid flow analysis of the human body as follows:

Clinical ApplicationMode of Operation
General
(Track 1 Only)Specific
(Tracks 1 & 3)BMPWDCWDColor
DopplerCombined
(Specify)Other* (Specify)
OphthalmicOphthalmic
Fetal Imaging &
OtherFetalNNNNNN 1, 3, 4, 11N 5, 6
Abdominal (including urolology), Liver,
Kidney, Spleen.NNNNNN 1, 2, 3, 4, 11N 5, 6, 7, 8, 9, 13,14, 16,
Intra-operative (Specify)
Intra-operative (Neuro)
Laparoscopic
PediatricNNNNNN 1, 2, 3, 4N 5, 6, 7, 8, 13,16
Small Organ (Breast, Thyroid, Testicle,
Prostate, penis, etc...)NNNNNN 1, 2, 3, 4N 5, 6, 7, 8
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal (Conventional)
Musculo-skeletal (Superficial)
Intravascular
GYNNNNNNN 1, 2, 3, 4N 5, 6, 7, 8, 14
PelvicNNNNNN 1, 2, 3, 4N 5, 6, 7, 8, 14
Other (Specify)
CardiacCardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral
VesselPeripheral vesselNNNNNN 1, 3, 4N 5, 6, 8
Other (Specify)NNNNNN 1, 3, 4N 5, 6, 8

N = new indication;

Additional Comments:

5: Harmonic Imaging

6: Spatial Compounding 7: ShearWave™ Elastography

  • 1: Combined modes include: B+ Color Flow
    3: Combined modes include: B+ Pulsed Wave

4: Combined modes include: B+ Pulsed Wave + Color Flow

9: Panoramic Imaging 2: Combined modes include: B+ ShearWave™ Elastography 10: 3D Imaging

  1. 3D Imaging
  2. Combining data

11: Combined modes include: B+ M modes

  • 12: Combined modes include: B Mode + Color flow + Shearwave™
    Elastography

13: CEUS (Contrast Enhancement UltraSound)

14: Angio PL.U.S (Color Doppler improvement)

  • 15: Needle PL.U.S.
  • 16: Brightness ratio

17: Combined mode include: B+ Continuous Wave

18: Combined mode incluseds: B+ M mode + Color flow

Prescription Use X (Part 21 CFR 801 Subpart D)

8: Imaging Guidance for Biopsies

  • AND/OR
  • Over-The-Counter Use

(21 CFR 807 Subpart C)

6

510(k) Number (if known):

Device Name: E12-3 transducer (SSIP95102)

Intended Use: Diagnostic ultrasound imaging, soft tissue elasticity imaging, fluid flow analysis of the human body as follows:

Clinical ApplicationMode of Operation
General
(Track 1 Only)Specific
(Tracks 1 & 3)BMPWDCWDColor
DopplerCombined
(Specify)Other* (Specify)
OphthalmicOphthalmic
Fetal Imaging &
OtherFetalNNNNN 1, 3, 4, 11N 5, 6
Abdominal (including urolology): Liver, Kidney,
Spleen...
Intra-operative (Specify)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (for example Breast, Thyroid,
Testicle, Prostate, penis, etc...)NNNNN1, 2, 3, 4N 5, 6, 7, 8
Neonatal Cephalic
Adult Cephalic
Trans-rectalNNNNN 1, 2, 3, 4N 5, 6, 7, 8
Trans-vaginalNNNNN1, 2, 3, 4,
11N5, 6, 7, 8
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal (Conventional)
Musculo-skeletal (Superficial)
Intravascular
GYNNNNNN 1, 2, 3, 4,
11N 5, 6, 7, 8
PelvicNNNNN1, 2, 3, 4,
11N 5, 6, 7, 8
Other (Specify)
CardiacCardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral
VesselPeripheral vessel
Other (Specify)NNNN 1, 3, 4N 5, 6, 8

N = new indication; N

Additional Comments:

1: Combined modes include: B+ Color Flow

2: Combined modes include: B+ ShearWave™ Elastography

3: Combined modes include: B+ Pulsed Wave

4: Combined modes include: B+ Pulsed Wave + Color Flow

5: Harmonic Imaging

6: Spatial Compounding

7: ShearWave™ Elastography

8: Imaging Guidance for Biopsies

  1. Needle / L.O.

  2. Brightness ra

  3. Brightness ratio

  4. Combined mode include

  5. Combined mode include: B+ Continuous Wave

  6. Combined mode include: B+ M mode + Color

Prescription Use X (Part 21 CFR 801 Subpart D)

(21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

9: Panoramic Imaging

10: 3D Imaging

11: Combined modes include: B+ M modes

12: Combined modes include: B Mode + Color flow + Shearwave™ Elastography

Liistography
13. CEUS (Con

13: CEUS (Contrast Enhancement UltraSound) 14: Angio PL.U.S (Color Doppler improvement)

15: Needle PL.U.S.

16: Brightness ratio

17: Combined mode include: B+ Continuous Wave

18: Combined mode incluseds: B+ M mode + Color flow

AND/OR Over-The-Counter Use

(21 CFR 807 Subpart C)

7

510(k) Number (if known):

Device Name: LV16-5 transducer (SSIP95108)

Intended Use: Diagnostic ultrasound imaging, soft tissue elasticity imaging, fluid flow analysis of the human body as follows:

Clinical ApplicationMode of Operation
General
(Track 1 Only)Specific
(Tracks 1 & 3)BMPWDCWDColor
DopplerCombined
(Specify)Other* (Specify)
OphthalmicOphthalmic
Fetal Imaging &
OtherFetal
Abdominal (including urolology):
Liver, Kidney, Spleen...NNNNN 1, 2, 3, 4N 5, 6, 7, 8, 9, 10
Intra-operative (Specify)
Intra-operative (Neuro)
Laparoscopic
PediatricNNNNN 1, 2, 3, 4N 5, 6, 7, 8, 9, 10
Small Organ (for example Breast, N
Thyroid, Testicle, Prostate, penis,
etc...)NNNNN 1, 2, 3, 4N 5, 6, 7, 8, 9, 10
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal (Conventional)NNNNN 1, 2, 3, 4N 5, 6, 7, 8, 9, 10
Musculo-skeletal (Superficial)NNNNN 1, 2, 3, 4N 5, 6, 7, 8, 9, 10
Intravascular
GYN
Pelvic
Other (Specify)
CardiacCardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral
VesselPeripheral vesselNNNNN 1, 3, 4N 5, 6, 8, 9, 10
Other (Specify)

N = new indication;

Additional Comments:

5: Harmonic Imaging

  • 1: Combined modes include: B+ Color Flow 2: Combined modes include: B+ ShearWave™ Elastography
    3: Combined modes include: B+ Pulsed Wave

9: Panoramic Imaging

10: 3D Imaging

11: Combined modes include: B+ M modes

12: Combined modes include: B Mode + Color flow + Shearwave™

4: Combined modes include: B+ Pulsed Wave + Color Flow

6: Spatial Compounding

7: ShearWave™ Elastography

  • 8: Imaging Guidance for Biopsies
  • Elastography

13: CEUS (Contrast Enhancement UltraSound)

14: Angio PL.U.S (Color Doppler improvement)

  • 15: Needle PL.U.S.
  • 16: Brightness ratio

17: Combined mode include: B+ Continuous Wave

18: Combined mode incluseds: B+ M mode + Color flow

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

8

510(k) Number (if known):

Device Name: MC12-3 transducer (SSIP95106)

Intended Use: Diagnostic ultrasound imaging, soft tissue elasticity imaging, fluid flow analysis of the human body as follows:

Clinical ApplicationMode of Operation
General
(Track 1 Only)Specific
(Tracks 1 & 3)BMPWDCWDColor
DopplerCombined
(Specify)Other* (Specify)
OphthalmicOphthalmic
Fetal Imaging
& OtherFetal
Abdominal (including urolology): Liver,
Kidney, Spleen...NNNNNN, 1, 2, 3, 4N, 5, 6, 7, 8, 9, 13
Intra-operative (Specify)
Intra-operative (Neuro)
Laparoscopic
PediatricNNNNNN, 1, 2, 3, 4N, 5, 6, 7, 8, 9, 13
Small Organ (for example Breast, Thyroid,
Testicle, Prostate, penis, etc...)NNNNNN, 1, 2, 3, 4N, 5, 6, 7, 8, 9
Neonatal CephalicNNNNNN, 1, 2, 3, 4N, 5, 6, 7, 9
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal (Conventional)NNNNNN, 1, 2, 3, 4N, 5, 6, 7, 8, 9
Musculo-skeletal (Superficial)NNNNNN, 1, 2, 3, 4N, 5, 6, 7, 8, 9
Intravascular
GYN
Pelvic
Other (Specify)
CardiacCardiac Adult
Cardiac PediatricNNNNNN 1,3,4,11N, 5, 6
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral
VesselPeripheral vesselNNNNNN, 1, 3, 4N, 5, 6, 8, 9
Other (Specify)NNNNNN, 1, 3, 4N, 5, 6, 8, 9

N = new indication; P = previously cleared by FDA (K171105)

4: Combined modes include: B+ Pulsed Wave + Color Flow

Additional Comments:

5: Harmonic Imaging

6: Spatial Compounding

7: ShearWave™ Elastography

8: Imaging Guidance for Biopsies

1: Combined modes include: B+ Color Flow

3: Combined modes include: B+ Pulsed Wave

9: Panoramic Imaging

2: Combined modes include: B+ ShearWave™ Elastography 10: 3D Imaging

11: Combined modes include: B+ M modes

12: Combined modes include: B Mode + Color flow + Shearwave™

Elastography

13: CEUS (Contrast Enhancement UltraSound)

14: Angio PL.U.S (Color Doppler improvement)

  • 15: Needle PL.U.S.
  • 16: Brightness ratio
  • 17: Combined mode include: B+ Continuous Wave
  • 18: Combined mode incluseds: B+ M mode + Color flow

X Prescription Use

  • Over-The-Counter Use (21 CFR 807 Subpart C)
    (Part 21 CFR 801 Subpart D)

  • (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
    AND/OR

Concurrence of CDRH; Office of In Vitro Diagnostics and Radiological Health (OIR)

9

510(k) Number (if known):

Device Name: P5-1X transducer (SSIP95107)

Intended Use: Diagnostic ultrasound imaging, soft tissue elasticity imaging, fluid flow analysis of the human body as follows:

Clinical ApplicationMode of Operation
General
(Track 1 Only)Specific
(Tracks 1 & 3)BMPWDCWDColor
DopplerCombined
(Specify)Other* (Specify)
OphthalmicOphthalmic
Fetal Imaging
& OtherFetal
Abdominal (including urolology): Liver,
Kidney, Spleen...NNNNNN 1, 3, 4, 11,
17N 5, 6, 16
Intra-operative (Specify)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (for example Breast, Thyroid,
Testicle, Prostate, penis, etc...)NNNNN 1, 3, 4N 5, 6
Neonatal Cephalic
Adult CephalicNNNNN 1, 3, 4N 5, 6
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal (Conventional)
Musculo-skeletal (Superficial)
Intravascular
GYN
Pelvic
Other (Specify)
CardiacCardiac AdultNNNNNN 1, 3, 4, 11,
17, 18N, 5, 6
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral
VesselPeripheral vesselNNNNNN 1, 3, 4, 17N 5, 6
Other (Specify)NNNNNN 1, 3, 4, 17N 5, 6

N = new indication; N Additional Comments:

5: Harmonic Imaging

6: Spatial Compounding

7: ShearWave™ Elastography

8: Imaging Guidance for Biopsies

1: Combined modes include: B+ Color Flow

3: Combined modes include: B+ Pulsed Wave

4: Combined modes include: B+ Pulsed Wave + Color Flow

9: Panoramic Imaging

2: Combined modes include: B+ ShearWave™ Elastography 10: 3D Imaging

11: Combined modes include: B+ M modes

12: Combined modes include: B Mode + Color flow + Shearwave™ Elastography

13: CEUS (Contrast Enhancement UltraSound)

14: Angio PL.U.S (Color Doppler improvement)

15: Needle PL.U.S.

  • 16: Brightness ratio
    17: Combined mode include: B+ Continuous Wave

18: Combined mode incluseds: B+ M mode + Color flow

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use

(21 CFR 807 Subpart C)

10

510(k) Number (if known):

Device Name: LH20-6 transducer (SSIP95104)

Intended Use: Diagnostic ultrasound imaging, soft tissue elasticity imaging, fluid flow analysis of the human body as follows:

Clinical ApplicationMode of Operation
General
(Track 1
Only)Specific
(Tracks 1 & 3)BMPWDCWDColor
DopplerCombined
(Specify)Other* (Specify)
OphthalmicOphthalmic
Fetal
Imaging &
OtherFetal
Abdominal (including urolology): Liver,
Kidney, Spleen...
Intra-operative (Specify) Vascular,
abdominal, small organsNNNNNN 1, 3, 4N 5, 6, 915
Intra-operative (Neuro)
Laparoscopic
PediatricNNNNNN 1, 2, 3, 4N 5, 6, 7, 915
Small Organ (for example Breast, Thyroid,
Testicle, Prostate, penis, etc...)NNNNNN 1, 2, 3, 4N 5, 6, 7, 915
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal (Conventional)NNNNNN 1, 2, 3, 4N 5, 6, 7, 915
Musculo-skeletal (Superficial)NNNNNN 1, 2, 3, 4N 5, 6, 7, 915
Intravascular
GYN
Pelvic
Other (Specify)
CardiacCardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral
VesselPeripheral vesselNNNNNN 1, 3, 4N 5, 6, 915
Other (Specify)NNNNNN 1, 3, 4N 5, 6, 915

N = new indication;

Additional Comments:

1: Combined modes include: B+ Color Flow

2: Combined modes include: B+ ShearWave™ Elastography

3: Combined modes include: B+ Pulsed Wave

4: Combined modes include: B+ Pulsed Wave + Color Flow

5: Harmonic Imaging

6: Spatial Compounding

7: ShearWave™ Elastography

8: Imaging Guidance for Biopsies

  • 9: Panoramic Imaqing
    10: 3D Imaging

11: Combined modes include: B+ M modes

12: Combined modes include: B Mode + Color flow + Shearwave™

Elastography

13: CEUS (Contrast Enhancement UltraSound)

14: Angio PL.U.S (Color Doppler improvement)

  • 15: Needle PL.U.S.
  • 16: Brightness ratio

17: Combined mode include: B+ Continuous Wave

  • 18: Combined mode incluseds: B+ M mode + Color flow
    Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

11

510(k) Number (if known):

Device Name: L18-5 transducer (SSIP95100)

Intended Use: Diagnostic ultrasound imaging, soft tissue elasticity imaging, fluid flow analysis of the human body as follows:

Clinical ApplicationMode of Operation
General
(Track 1 Only)Specific
(Tracks 1 & 3)BMPWDCWDColor
DopplerCombined
(Specify)Other* (Specify)
OphthalmicOphthalmic
Fetal Imaging & Fetal
OtherAbdominal (including urolology):
Liver, Kidney, Spleen...NNNN 1, 2, 3, 4N 5, 6, 7, 8, 9, 1415
Intra-operative (Specify)
Intra-operative (Neuro)
Laparoscopic
PediatricNNNN 1, 2, 3, 4N 5, 6, 7, 8, 91515
Small Organ (for example Breast,
Thyroid, Testicle, Prostate, Penis)NNNN 1, 2, 3, 4, 12N 5, 6, 7, 8, 9, 14
Neonatal CephalicNNNN1, 2, 3, 4N 5, 6, 7, 9
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal (Conventional)NNNN 1, 2, 3, 4N 5, 6, 7, 8, 9,1415
Musculo-skeletal (Superficial)NNNN 1, 2, 3, 4N 5, 6, 7, 8, 9,1415
Intravascular
GYN
Pelvic
Other (Specify)
CardiacCardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral
VesselPeripheral vesselNNNN 1, 3, 4N 5, 6, 8, 915
Other (Specify)NNNN 1, 3, 4N 5, 6, 8, 915

N = new indication;

Additional Comments:

5: Harmonic Imaging

6: Spatial Compounding

7: ShearWave™ Elastography

8: Imaging Guidance for Biopsies

  • 1: Combined modes include: B+ Color Flow
    3: Combined modes include: B+ Pulsed Wave

9: Panoramic Imaging 2: Combined modes include: B+ ShearWave™ Elastography

10: 3D Imaging

11: Combined modes include: B+ M modes 4: Combined modes include: B+ Pulsed Wave + Color Flow

12: Combined modes include: B Mode + Color flow + Shearwave™ Elastography

13: CEUS (Contrast Enhancement UltraSound)

14: Angio PL.U.S (Color Doppler improvement)

  • 15: Needle PL.U.S.
  • 16: Brightness ratio
  • 17: Combined mode include: B+ Continuous Wave
  • 18: Combined mode incluseds: B+ M mode + Color flow

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use

(21 CFR 807 Subpart C)

12

510(k) Number (if known):

Device Name: C9-2X (SSIP95105)

Intended Use: Diagnostic ultrasound imaging, soft tissue elasticity imaging, fluid flow analysis of the human body as follows:

Clinical ApplicationMode of Operation
General
(Track 1 Only)Specific
(Tracks 1 & 3)BMPWDCWDColor
DopplerCombined
(Specify)Other* (Specify)
OphthalmicOphthalmic
Fetal Imaging & OtherFetalNNNNNN 1, 3, 4, 11N 5, 6
OtherAbdominal (including urolology):
Liver, Kidney, Spleen...NNNNNN 1, 2, 3, 4, 11N 5, 6, 7, 8, 9, 13, 14, 16
Intra-operative (Specify)
Intra-operative (Neuro)
Laparoscopic
PediatricNNNNN 1, 2, 3, 4N 5, 6, 7, 8, 13, 16
Small Organ (for example Breast,
Thyroid, Testicle, Prostate, Penis)NNNNN 1, 2, 3, 4N 5, 6, 7, 8
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal (Conventional)
Musculo-skeletal (Superficial)
Intravascular
GYNNNNNNN, 1, 2, 3, 4N, 5, 6, 7, 8, 14
PelvicNNNNNN, 1, 2, 3, 4N, 5, 6, 7, 8, 14
Other (Specify)
CardiacCardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral
VesselPeripheral vesselNNNNNN, 1, 3, 4N, 5, 6, 8
Other (Specify)NNNNNN, 1, 3, 4N, 5, 6, 8

N = new indication;

5: Harmonic Imaging

6: Spatial Compounding

7: ShearWave™ Elastography

8: Imaging Guidance for Biopsies

Additional Comments:

  • 1: Combined modes include: B+ Color Flow 3: Combined modes include: B+ Pulsed Wave
    4: Combined modes include: B+ Pulsed Wave + Color Flow

9: Panoramic Imaging

2: Combined modes include: B+ ShearWave™ Elastography 10: 3D Imaging

11: Combined modes include: B+ M modes

12: Combined modes include: B Mode + Color flow + Shearwave™

  • Elastography
    13: CEUS (Contrast Enhancement UltraSound)

14: Angio PL.U.S (Color Doppler improvement)

  • 15: Needle PL.U.S.
  • 16: Brightness ratio

17: Combined mode include: B+ Continuous Wave

18: Combined mode incluseds: B+ M mode + Color flow

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use

(21 CFR 807 Subpart C)

13

510(k) Summary of Safety and Effectiveness

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

Submitted by: SuperSonic Imagine, S.A. Les Jardins de la Duranne - Bât. E & F 510, rue René Descartes 13857 Aix-en-Provence Cedex France Telephone: +33 442 99 24 24

Distributed by: SuperSonic Imagine, Inc. Weston North America Telephone: +1(954) 660 3528

Corresponding Official: Jacques Souquet Chief Innovation Officer Telephone: +33 442 99 24 35

Date: 2018.02.09

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: AIXPLORER® MACH Ultrasound Diagnostic Systems AIXPLORER® MACH 30, AIXPLORER® MACH 20 AIXPLORER®MACH 10

Classification: Class II

Classification Name:21 CFR SectionProduct Code
Ultrasonic Pulsed Doppler Imaging System892.155090-IYN
Ultrasonic Pulsed Echo Imaging System892.156090-IYO
Diagnostic Ultrasound Transducer892.157090-ITX

3) Substantially Equivalent/Predicate Devices

AIXPLORER® Ultrasound Imaging System (K173021), cleared on 01/09/2018 FibroScan (K160524), cleared on 03/18/2016 Epiq 7 (K163120) cleared on 01/10/2017

14

4) Description of Device

The SuperSonic Imagine AIXPLORER® 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 ShearWave™ elastography.

5) Indication for Use

The SuperSonic Imagine AIXPLORER® MACH ultrasound diagnostic systems and transducers are intended for general purpose pulse echo ultrasound imaging, soft tissue elasticity imaging, doppler fluid flow analysis of the human body.

The SuperSonic Imagine AIXPLORER® 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, Intraoperative, OB-GYN, Pelvic, Pediatric, Urology, Trans-rectal, Trans-vaginal and Neonatal/Adult Cephalic, Non-invasive Cardiac.

In addition, the SuperSonic Imagine AIXPLORER® MACH range ultrasound diagnostic systems and associated transducers are intended for:

  • i Measurements of abdominal anatomical structures,
  • -Measurements of broad band shear wave speed, and tissue stiffness in internal structures of the liver, the spleen and other biological tissue in the abdomen,
  • -Measurements of brightness ratio between liver, kidney, and other biological structures of the abdomen,
  • -Visualization of abdominal vascularization, microvascularization and perfusion,
  • -Quantification of abdominal vascularization and perfusion.

The shear wave speed and stiffness measurements, the brightness ratio, the visualization of vascularization, microvascularization and perfusion, the quantification and perfusion may be used as an aid to clinical management of pediatric and adult patients with liver disease.

15

6) Summary of Technological Characterisitics – New Device compared to Predicates

| | AIXPLORER®&
AIXPLORER® Ultimate
(predicates) | EPIQ 7
(predicate) | FibroScan® 530
Compact
(predicate) | AIXPLORER®
MACH range |
|---------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------|--------------------------|
| 510(k) Number | K173021 | K163120 | K160524 | Unassigned |
| Classification Name | Ultrasonic Pulsed Doppler
Imaging System (892.1550)
Ultrasonic Pulsed Echo
Imaging System (892.1560)
Diagnostic Ultrasound
Transducer (892.1570) | Identical to
K173021 | Ultrasonic Pulsed
Echo Imaging
System (892.1560)
Diagnostic
Ultrasound
Transducer
(892.1570) | Identical to
K173021 |
| Class | Class II | Identical | Identical | Identical |
| Intended Use | 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 K173021 |
| General Description | 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 |
| | 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) | Identical | Identical | Identical |
| | Small organs (*) | Identical | -- | Identical |
| | AIXPLORER®&
AIXPLORER® Ultimate
(predicates) | EPIQ 7
(predicate) | FibroScan® 530
Compact
(predicate) | AIXPLORER®
MACH range |
| | | | | |
| | Musculoskeletal | Identical | -- | Identical |
| | Fetal | Identical | -- | Identical |
| | GYN | Identical | -- | Identical |
| | Cardiac (non invasive) | Cardiac | -- | Identical to
K173021 |
| | Adult and neonatal
cephalic | Identical | -- | Identical |
| | Pediatric | Identical | Identical | Identical |
| | Urology | Identical | -- | Identical |
| | Vascular | Identical | -- | Identical |
| | Peripheral vascular | Identical | -- | Identical |
| | Trans-rectal | Identical | -- | Identical |
| | Trans-vaginal | Identical | -- | Identical |
| Imaging modes | | | | |
| | B-Mode (Harmonic,
Fundamental) | Identical | -- | Identical |
| | M-Mode | Identical | Identical | Identical |
| | PW | Identical | -- | Identical |
| Conventional | CW | -- | -- | Identical to
K163120 |
| | Color Doppler | Identical | -- | Identical |
| | Amplitude Doppler | Identical | -- | Identical |
| | Microvascular (Angio
PL.U.S) | ---(**) | -- | Identical to
K173021 |
| Other | Spatial compounding,
Panoramic | Identical | -- | Identical |
| | Contrast | Identical | -- | Identical |
| | AIXPLORER®&
AIXPLORER® Ultimate
(predicates) | EPIQ 7
(predicate) | FibroScan® 530
Compact
(predicate) | AIXPLORER®
MACH range |
| | | | --- (has specific | |
| | Combination of modes | Identical | modes: A-mode,
CAP). | Identical |
| | ShearWave Elastography | Identical | VCTE | Identical |
| Design | | | | |
| Cart | Mobile cart based product
with control panel and
monitor | Identical | Identical | Identical |
| Controls | Typical ultrasound
imaging controls (gain,
depth mode select...) | Identical | Identical | Identical |
| Biopsy guide | Available | Identical | -- | Identical |
| Track | Track 3 (Acoustic Output
Display) | Identical | Identical | Identical |
| Patient Contact
Materials | Yes, per ISO 10993-1 | Identical | Identical | Identical |
| Acoustic Output
within FDA
guidelines | Yes, as per NEMA UD-3 | Identical | Identical | Identical |
| Image Review | Yes | Identical | Identical | Identical |
| Measurement
Package | Yes | Identical | Identical | Identical |
| Calculation
Package | Yes | Identical | Identical | Identical |
| Report | Yes | Identical | Identical | Identical |
| General Safety | Conforms to IEC60601-1,
60601-1-2, 60601-2-37 | Identical | Identical | Identical |
| Labeling | Conforms to 21 CFR Part
801 | Identical | Identical | Identical |

16

17

Note:

*: Breast, Thyroid, Testicle, etc
**:--- means not applicable

:: --- means not applicable

18

    1. 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.
Reference StandardTests Performed
IEC 60601-1 Ed.3.1All applicable electrical, basic safety and essential performance tests.
IEC 60601-1-2 Ed.4All applicable testing pertaining to electromagnetic compatibility.
IEC 60601-2-37 Ed.2.1All 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 10993-1Applicable biocompatibility tests per FDA 510(k) Memorandum - #G95-1 - per the appropriate device category.

The above testing confirmed that the Aixplorer® 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).

8) A brief discussion of the clinical tests submitted, referenced, or relied on in the premarket notification submission for a determination of substantial equivalence

The subject of this premarket submission required a clinical evaluation by literature route to support substantial equivalence and to widen the indications for use of Aixplorer® MACH range Ultrasound Diagnostic Systems.

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.