Aixplorer MACH30/ SUPERSONIC MACH30, Aixplorer MACH20/ SUPERSONIC MACH20, SUPERSONIC MACH40

K203645 · Supersonic Imagine · IYN · Jun 29, 2021 · Radiology

Device Facts

• Record ID: K203645
• Device Name: Aixplorer MACH30/ SUPERSONIC MACH30, Aixplorer MACH20/ SUPERSONIC MACH20, SUPERSONIC MACH40
• Applicant: Supersonic Imagine
• Product Code: IYN · Radiology
• Decision Date: Jun 29, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1550
• Device Class: Class 2
• Attributes: Pediatric

Intended 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, 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: -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 Imagine AIXPLORER® MACH / 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.

Device Story

Cart-based ultrasound system; utilizes console and various transducers (linear, curved, micro-convex, motorized linear, phased array) to acquire ultrasound data. Transforms acoustic inputs into B-mode, M-mode, Color Flow, Pulsed/Continuous Wave Doppler, 3D, CEUS, ShearWave elastography, and Strain elastography images. Operated by clinicians in clinical settings. Provides real-time visualization and quantitative measurements (e.g., shear wave speed, tissue stiffness, brightness ratio, vascularization/perfusion). Includes Bi-RADS lexicon classification interface for breast lesion characterization. Output aids clinical management of liver disease and breast mass assessment; improves diagnostic accuracy and characterization of lesions.

Clinical Evidence

Clinical evaluation via literature review. Evidence supports that Shear Wave elastography (SWE) combined with B-mode ultrasound improves specificity and positive predictive value for breast mass assessment, preserves sensitivity, and increases inter-observer agreement. SWE aids in defining management strategies for breast cancer by improving size measurement accuracy and correlating with cancer aggressiveness.

Technological Characteristics

Cart-based ultrasound system; LCD monitor; adjustable control panel with touchscreen. Transducers: linear, curved, micro-convex, motorized linear, phased array. Imaging modes: B-mode (harmonic/fundamental), M-mode, Color Flow (CFI, CPI, dCPI, Angio PL.U.S), PW/CW Doppler, 3D, CEUS, ShearWave/Strain elastography. Connectivity: digital memory, external printer. Safety: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, NEMA UD-2, NEMA UD-3, ISO 10993-1.

Indications for Use

Indicated for adult and pediatric patients for imaging and measurement of anatomical structures including abdominal, small organs, musculoskeletal, superficial musculoskeletal, vascular, intraoperative, OB-GYN, pelvic, pediatric, urology, trans-rectal, trans-vaginal, neonatal/adult cephalic, and non-invasive cardiac applications. Includes liver disease management and breast mass characterization in women.

Regulatory Classification

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.

Predicate Devices

• AIXPLORER® MACH range Ultrasound Imaging System (K191007)

Reference Devices

• Aplio i900, i800, i700 V2 (K173090)
• Resona 7 (K171233)

Submission Summary (Full Text)

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June 29, 2021

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: a symbol on the left and the FDA acronym with the agency's name on the right. The symbol on the left is a stylized representation of human services. To the right of the symbol is a blue square containing the acronym "FDA" in white letters. Next to the blue square, the words "U.S. FOOD & DRUG ADMINISTRATION" are written in blue.

SuperSonic Imagine % Jacques Souquet Chief Scientist and Innovation Officer Les Jardins de la Duranne- Bat E et F 510 rue René Descartes 13857Aix-en-Provence FRANCE

Re: K203645

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: April 12, 2021 Received: April 16, 2021

Dear Jacques Souquet:

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

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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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

For

Thalia, T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

#### Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below

510(k) Number (if known) K203645

#### Device Name

AIXPLORER® MACH 30 / SUPERSONIC MACH30, AIXPLORER® MACH 20 / SUPERSONIC MACH20 and SUPERSONIC MACH 40

Indications for Use (Describe)

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, 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:

-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 Imagine AIXPLORER® MACH / 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.

| Type of Use (Select one or both, as applicable) | | | | | |
|-------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------|------------------|---------------------------------------------|--|
| | <table><tr><td>Prescription Use (Part 21 CFR 801 Subpart D)</td><td><div> X </div></td></tr><tr><td>Over-The-Counter Use (21 CFR 801 Subpart C)</td><td></td></tr></table> | Prescription Use (Part 21 CFR 801 Subpart D) | <div> X </div> | Over-The-Counter Use (21 CFR 801 Subpart C) | |
| Prescription Use (Part 21 CFR 801 Subpart D) | <div> X </div> | | | | |
| Over-The-Counter Use (21 CFR 801 Subpart C) | | | | | |

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

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This section applies only to requirements of the Paperwork Reduction Act of 1995.

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

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510(k) number (if known): K203645

Device Name: AIXPLORER® MACH 30 / SUPERSONIC MACH30, AIXPLORER® MACH 20 / SUPERSONIC MACH20, SUPERSONIC MACH40

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

| | Clinical Application | | | | | | | |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---|-------------------|-----|------------------|----------------------------|-------------------------------------------------------|
| General<br>(Track 1 Only) | Specific<br>(Tracks 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Combined (Specify) | Other* (Specify) |
| Ophthalmic | Ophthalmic | | | | | | | |
| Fetal Imaging &<br>Other | Fetal | P | P | P | | P | P : 1, 3, 4, 11 | P : 5, 6, 10 |
| | Abdominal (including urolology): Liver,<br>Kidney, Spleen... | P | P | P | | P | P : 1, 2, 3, 4 | P : 5, 6, 7, 8, 9, 10,<br>11, 13, 14, 15, 16, 21, 22 |
| | Intra-operative (Specify) vascular,<br>abdominal, small organs | P | | P | | P | P : 1, 3, 4 | P: 5, 6, 8, 9 |
| | Intra-operative (Neuro) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | P | P | P | | P | P : 1, 2, 3, 4 | P : 5, 6, 7, 8, 9, 10, 11,<br>13, 15, 16, 14, 18, 19, |
| | Small Organ (Breast, Thyroid,<br>Testicle, Prostate, penis, etc...) | P | | P | | P | P : 1, 2, 3, 4, 12 | P : 6, 7, 8, 9, 10, 14, 15,<br>18, 19, 20, 21 |
| | Neonatal Cephalic | P | | P | | P | P : 1, 2, 3, 4 | P : 5, 6, 7, 9 |
| | Adult Cephalic | P | | P | | P | P : 1, 3, 4 | P : 5, 6 |
| | Trans-rectal | P | | P | | P | P : 1, 2, 3, 4 | P : 5, 6, 7, 8 |
| | Trans-vaginal | P | P | P | | P | P : 1, 2, 3, 4 | P : 5, 6, 7, 8, 11 |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | |
| | Musculo-skeletal (Conventional) | P | | P | | P | P : 1, 2, 3, 4 | P : 5, 6, 7, 8, 9, 10, 14, 15,<br>19, 20 |
| | Musculo-skeletal (Superficial) | P | | P | | P | P : 1, 2, 3, 4 | P : 5, 6, 7, 8, 9, 10, 14, 15,<br>19, 20 |
| | Intravascular | | | | | | | |
| | GYN | P | P | P | | P | P : 1, 2, 3, 4 | P : 5, 6, 7, 8, 11, 14 |
| | Pelvic | P | P | P | | P | P : 1, 2, 3, 4 | P: 5, 6, 7, 8, 11, 14 |
| | Other (Specify) | | | | | | | |
| Cardiac | Cardiac Adult | P | P | P | P | P | P : 1, 3, 4, 11, 17,<br>18 | P : 5 |
| | Cardiac Pediatric | | | | | | | |
| | Intravascular (Cardiac) | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | |
| | Intra-cardiac | | | | | | | |
| | Other (Specify) | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | P | | P | | P | P : 1, 3, 4 | P : 5, 6, 8, 9, 10, 15 |
| | Other (Specify) | P | | P | | P | P : 1, 3, 4 | P : 5, 6, 8, 9, 10, 15 |
| | Clinical Application | Mode of Operation | | | | | | |
| General<br>(Track 1 Only) | Specific<br>(Tracks 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify) | Other* (Specify) |
| Ophthalmic | Ophthalmic | | | | | | | |
| Fetal Imaging<br>& Other | Fetal | | | | | | | |
| | Abdominal (including urolology): Liver,<br>Kidney, Spleen... | P | P | P | P | P | P: 1, 2, 3, 4 | P: 5, 6, 7, 8, 9, 13,14, 15,<br>16, 21,22 |
| | Intra-operative (Specify) | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | P | P | P | P | P | P: 1, 2, 3, 4 | P: 5, 6, 7, 8, 9, 15, 16,<br>14, 21, 22 |
| | Small Organ (for example Breast, Thyroid,<br>Testicle, Prostate, penis, etc...) | P | P | P | P | P | P: 1, 2, 3, 4,<br>12 | P: 5, 6, 7, 8, 9, 14, 15, 19,<br>20, 21, 22 |
| | Neonatal Cephalic | P | P | P | P | P | N, 1, 2, 3, 4 | P: 5, 6, 7, 9 |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | |
| | Musculo-skeletal (Conventional) | P | P | P | P | P | P: 1, 2, 3, 4 | P: 5, 6, 7, 8, 9, 14,15, 19,<br>20 |
| | Musculo-skeletal (Superficial) | P | P | P | P | P | P: 1, 2, 3, 4 | P: 5, 6, 7, 8, 9, 14, 15, 19,<br>20 |
| | Intravascular | | | | | | | |
| | GYN | | | | | | | |
| | Pelvic | | | | | | | |
| | Other (Specify) | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | |
| | Cardiac Pediatric | | | | | | | |
| | Intravascular (Cardiac) | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | |
| | Intra-cardiac | | | | | | | |
| | Other (Specify) | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | P | P | P | P | P | P: 1, 3, 4 | P: 5, 6, 8, 9, 15 |
| | Other (Specify) | P | P | P | P | P | P: 1, 3, 4 | P: 5, 6, 8, 9, 15 |
| | N = new indication; P = Previously cleared by FDA (K191007) | | | | | | | |
| | 1: Combined modes include: B+ Color Flow<br>2: Combined modes include: B+ ShearWave™ Elastography<br>3: Combined modes include: B+ Pulsed Wave<br>4: Combined modes include: B+ Pulsed Wave + Color Flow<br>5: Harmonic Imaging<br>6: Spatial Compounding<br>7: ShearWave™ Elastography | 12: Combined modes include: B Mode + Color flow + Shearwave™ Elastography<br>13: CEUS (Contrast Enhancement UltraSound)<br>14: Angio PL.U.S (Color Doppler improvement)<br>15: Needle PL.U.S<br>16: Brightness ratio<br>17: Combined mode include: B+ Continuous Wave<br>18: Combined mode include: B+ M mode + Color flow | | | | | | |
| Clinical Application | | | | Mode of Operation | | | | |
| General<br>(Track 1 Only) | Specific<br>(Tracks 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify) | Other* (Specify) |
| Ophthalmic | Ophthalmic | | | | | | | |
| Fetal Imaging &<br>Other | Fetal | P | P | P | | P | P: 1, 3, 4, 11 | P: 5, 6 |
| | Abdominal (including urolology), Liver,<br>Kidney, Spleen. | P | P | P | | P | P: 1, 2, 3, 4, 11 | P: 5, 6, 7, 8, 9, 13,14, 16,<br>21, 22 |
| | Intra-operative (Specify) | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | P | | P | | P | P: 1, 2, 3, 4 | P: 5, 6, 7, 8, 13,16,<br>9, 14, 21, 22 |
| | Small Organ (Breast, Thyroid, Testicle,<br>Prostate, penis, etc...) | P | | P | | P | P: 1, 2, 3, 4 | P: 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 | | | | | | | |
| | GYN | P | P | P | | P | P: 1, 2, 3, 4 | P: 5, 6, 7, 8, 14, 11 |
| | Pelvic | P | P | P | | P | P: 1, 2, 3, 4 | P: 5, 6, 7, 8, 14, 11 |
| | Other (Specify) | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | |
| | Cardiac Pediatric | | | | | | | |
| | Intravascular (Cardiac) | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | |
| | Intra-cardiac | | | | | | | |
| | Other (Specify) |…