Aixplorer MACH30/ SUPERSONIC MACH30, Aixplorer MACH20/ SUPERSONIC MACH20, SUPERSONIC MACH40 by SuperSonic Imagine

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 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 submodes 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 and Strain Elastography.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study proving device performance:

Device: SuperSonic Imagine AIXPLORER® MACH30/SUPERSONIC MACH30, AIXPLORER® MACH20/SUPERSONIC MACH20, SUPERSONIC MACH40 Ultrasound Diagnostic Systems.

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state specific numerical acceptance criteria for performance metrics. Instead, the submission focuses on demonstrating "substantial equivalence" to a predicate device (AIXPLORER® MACH range sw V2, K191007) and adherence to recognized standards.

However, based on the intended use for liver disease and breast masses, and the discussion of ShearWave™ Elastography (SWE), we can infer the acceptance criteria and reported performance qualitatively:

Acceptance Criteria (Inferred from Intended Use & Discussion)	Reported Device Performance (Qualitative, from Summary)
For Liver Disease:
- Aid in clinical management of adult and pediatric patients with liver disease through measurements of broad band shear wave speed, tissue stiffness, brightness ratio, visualization and quantification of vascularization, microvascularization, and perfusion.	Shearwave speed, beam attenuation, viscosity, and stiffness measurements, brightness ratio, visualization, microvascularization, and quantification of vascularization and perfusion may be used as an aid to clinical management of adult and pediatric patients with liver disease.
For Breast Masses:
- Aid in management of women patients with breast masses, by providing added information through shearwave elastography in conjunction with 2D gray scale imaging and vascularization to better characterize breast masses and improve diagnostic accuracy.	Addition of Shear Wave elastography to conventional B-mode Ultrasound increased the specificity of breast mass assessment. It can significantly improve the positive predictive value of biopsy recommendation for probably benign and low suspicion breast lesions... while preserving sensitivity.
- High intra-operator repeatability and inter-observer reproducibility for SWE evaluation of breast lesions to increase inter-observer agreement on global cancer risk assessment.	SWE evaluation of breast lesions increases the inter-observer agreement on their global cancer risk assessment with ultrasound, thanks to its "almost perfect" intra-operator repeatability and high inter-observer reproducibility.
- Contribution to defining more appropriate management strategies (e.g., accurate cancer size measurements, correlation with aggressiveness and response to neo-adjuvant chemotherapy) for breast cancers with SWE.	Evaluation of breast cancers with SWE seem to contribute to defining more appropriate management strategies through more accurate cancer size measurements, correlation with cancer aggressiveness and response to neo-adjuvant chemotherapy treatment.
General Performance:
- Performance according to stated intended use and within pre-determined product specifications and external standard requirements.	"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."
- Substantial equivalence to predicate devices for safety and effectiveness.	"Results of non-clinical testing confirmed the substantial equivalence of the AIXPLORER® MACH / SUPERSONIC MACH Systems to the predicate device(s)." "Performance testing demonstrated that the submission device is at least as safe and effective as the predicate devices..."

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Not specified. The submission refers to a "clinical evaluation by literature route" and provides a "Summary of literature review." This implies that the performance claims are based on published studies, not a new clinical trial conducted specifically for this 510(k) submission.
Data Provenance: Retrospective, as it relies on a "literature review." The specific countries of origin for the studies included in the literature review are not mentioned in this document.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable in the context of this submission. Since the clinical evidence is based on a literature review, the experts establishing ground truth would be those involved in the original studies cited, but these details are not provided in this 510(k) summary.

4. Adjudication Method for the Test Set

Not applicable, as a new test set requiring adjudication was not explicitly created for this submission. The clinical evidence relies on previously published research.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Improvement with AI vs. without AI Assistance

MRMC Study: The document explicitly mentions that "Addition of Shear Wave elastography to conventional B-mode Ultrasound increased the specificity of breast mass assessment" and "increases the inter-observer agreement." This strongly suggests that a form of comparative effectiveness study was done in the literature reviewed, comparing human interpretation with and without SWE. However, it is not explicitly stated as a new MRMC study conducted for this specific 510(k) submission.
Effect Size: The document uses qualitative terms like "increased specificity" and "significantly improve the positive predictive value," and "almost perfect" intra-operator repeatability and "high inter-observer reproducibility" for SWE. However, no specific numerical effect sizes (e.g., AUC improvement, percentage increase in sensitivity/specificity, or agreement metrics) are provided in this summary.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

The device is an ultrasound diagnostic system that includes ShearWave™ Elastography functionality. The "clinical evaluation by literature route" focuses on the utility of SWE as an aid to human interpretation. Phrases like "Addition of Shear Wave elastography to conventional B-mode Ultrasound" and "shearwave elastography in conjunction with 2D gray scale imaging and vascularization provides added information to better characterize breast masses" indicate that the performance described is a human-in-the-loop scenario, where SWE provides information to aid the clinician. Therefore, a standalone (algorithm only) performance study as typically understood for an AI diagnostic device is not described here. The SWE technology itself generates quantitative data (shear wave speed, stiffness) that is interpreted by the user.

7. The Type of Ground Truth Used

Based on the literature review summary for breast masses, the ground truth likely involved:

Pathology: "Improve the diagnostic accuracy of ultrasound" and "assess the risk of lesion malignancy" strongly imply pathological diagnosis (biopsy results) as the ground truth for breast mass characterization.
Outcomes Data: "More appropriate management strategies," "accurate cancer size measurements," "correlation with cancer aggressiveness and response to neo-adjuvant chemotherapy treatment" suggest that long-term patient outcomes or confirmed clinical diagnoses were used as ground truth in the cited literature.

For liver disease, although not explicitly stated, ground truth would similarly rely on established diagnostic methods for liver pathology and progression.

8. The Sample Size for the Training Set

Not applicable. This submission is for an ultrasound system with enhanced features (including ShearWave™ Elastography), not a standalone AI model that undergoes a distinct training phase in the typical sense of deep learning or machine learning. The underlying SWE algorithms would have been developed and validated through extensive research, but a "training set" as understood for a new AI algorithm is not detailed here.

9. How the Ground Truth for the Training Set Was Established

Not applicable for the same reasons as #8. The document does not describe a new AI model with a dedicated training set. The clinical evaluation relies on previously established literature for the performance of SWE technology.

Summary

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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)

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.

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

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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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(Track 1 Only)	Specific(Tracks 1 & 3)	B	M	PWD	CWD	ColorDoppler	Combined (Specify)	Other* (Specify)
Ophthalmic	Ophthalmic
Fetal Imaging &Other	Fetal	P	P	P		P	P : 1, 3, 4, 11	P : 5, 6, 10
	Abdominal (including urolology): Liver,Kidney, Spleen...	P	P	P		P	P : 1, 2, 3, 4	P : 5, 6, 7, 8, 9, 10,11, 13, 14, 15, 16, 21, 22
	Intra-operative (Specify) vascular,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, 11,13, 15, 16, 14, 18, 19,
	Small Organ (Breast, Thyroid,Testicle, Prostate, penis, etc...)	P		P		P	P : 1, 2, 3, 4, 12	P : 6, 7, 8, 9, 10, 14, 15,18, 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, 15,19, 20
	Musculo-skeletal (Superficial)	P		P		P	P : 1, 2, 3, 4	P : 5, 6, 7, 8, 9, 10, 14, 15,19, 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, 17,18	P : 5
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other (Specify)
PeripheralVessel	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(Track 1 Only)	Specific(Tracks 1 & 3)	B	M	PWD	CWD	ColorDoppler	Combined(Specify)	Other* (Specify)
Ophthalmic	Ophthalmic
Fetal Imaging& Other	Fetal
	Abdominal (including urolology): Liver,Kidney, Spleen...	P	P	P	P	P	P: 1, 2, 3, 4	P: 5, 6, 7, 8, 9, 13,14, 15,16, 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, 16,14, 21, 22
	Small Organ (for example Breast, Thyroid,Testicle, Prostate, penis, etc...)	P	P	P	P	P	P: 1, 2, 3, 4,12	P: 5, 6, 7, 8, 9, 14, 15, 19,20, 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, 19,20
	Musculo-skeletal (Superficial)	P	P	P	P	P	P: 1, 2, 3, 4	P: 5, 6, 7, 8, 9, 14, 15, 19,20
	Intravascular
	GYN
	Pelvic
	Other (Specify)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other (Specify)
PeripheralVessel	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 Flow2: Combined modes include: B+ ShearWave™ Elastography3: Combined modes include: B+ Pulsed Wave4: Combined modes include: B+ Pulsed Wave + Color Flow5: Harmonic Imaging6: Spatial Compounding7: ShearWave™ Elastography	12: Combined modes include: B Mode + Color flow + Shearwave™ Elastography13: CEUS (Contrast Enhancement UltraSound)14: Angio PL.U.S (Color Doppler improvement)15: Needle PL.U.S16: Brightness ratio17: Combined mode include: B+ Continuous Wave18: Combined mode include: B+ M mode + Color flow
Clinical Application				Mode of Operation
General(Track 1 Only)	Specific(Tracks 1 & 3)	B	M	PWD	CWD	ColorDoppler	Combined(Specify)	Other* (Specify)
Ophthalmic	Ophthalmic
Fetal Imaging &Other	Fetal	P	P	P		P	P: 1, 3, 4, 11	P: 5, 6
	Abdominal (including urolology), Liver,Kidney, Spleen.	P	P	P		P	P: 1, 2, 3, 4, 11	P: 5, 6, 7, 8, 9, 13,14, 16,21, 22
	Intra-operative (Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	P		P		P	P: 1, 2, 3, 4	P: 5, 6, 7, 8, 13,16,9, 14, 21, 22
	Small Organ (Breast, Thyroid, Testicle,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)
PeripheralVessel	Peripheral vessel	P		P		P	P: 1, 3, 4	P: 5, 6, 8
	Other (Specify)	P		P		P	P: 1, 3, 4	P: 5, 6, 8

N = new indication; P = Previously cleared by FDA (K191007)

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

11: Combined modes include: B+ M mode

Prescription Use _ X

(Part 21 CFR 801 Subpart D)

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

19: Strain Elastography

20: Combined mode: B Mode + Strain + SWE

21: Vi PLUS

22: Att PLUS & SSp PLUS

AND/OR

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

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

Diagnostic Ultrasound Indications for Use

510(k) Number (if known): K203645

Device Name: L10-2 transducer (linear transducer, SSIP95103)

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

9: Panoramic Imaging

10: 3D Imaging

11: Combined modes include: B+ M mode

Prescription Use _ X

(Part 21 CFR 801 Subpart D)

19: Strain Elastography;

20: Combined mode: B Mode + Strain + SWE

21: Vi PLUS

22: Att PLUS & SSp PLUS AND/OR

Over-The-Counter Use

(21 CFR 807 Subpart C)

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

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510(k) Number (if known): K203645

Device Name: C6-1X transducer (curved array transducer, SSIP95101)

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

N = new indication; P = Previously cleared by FDA (K191007)

2: Combined modes include: B+ ShearWave™ Elastography

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

Additional Comments:

5: Harmonic Imaging

9: Panoramic Imaging

10: 3D 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

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

19: Strain Elastography

20: Combined mode: B Mode + Strain + SWE

21: Vi PLUS

22: Att PLUS & SSp PLUS
AND/OR

Prescription Use _ X (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 807 Subpart C)

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

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510(k) Number (if known): K203645

Device Name: E12-3 transducer (endocavitary transducer, SSIP95102)

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

General(Track 1 Only)	Clinical ApplicationSpecific(Tracks 1 & 3)	B	M	PWD	CWD	ColorDoppler	Mode of OperationCombined(Specify)	Other* (Specify)
Ophthalmic	Ophthalmic
Fetal Imaging &Other	Fetal	P	P	P		P	P : 1, 3, 4, 11	P : 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...)	P		P		P	P: 1, 2, 3, 4	P: 5, 6, 7, 8
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal	P	P	P		P	P: 1, 2, 3, 4	P: 5, 6, 7, 8
	Trans-vaginal	P	P	P		P	P: 1, 2, 3, 4,11	P: 5, 6, 7, 8
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal (Conventional)
	Musculo-skeletal (Superficial)
	Intravascular
	GYN	P	P	P		P	P: 1, 2, 3, 4,11	P: 5, 6, 7, 8
	Pelvic	P	P	P		P	P: 1, 2, 3, 4,11	P: 5, 6, 7, 8
	Other (Specify)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other (Specify)
PeripheralVessel	Peripheral vessel
	Other (Specify)	P		P		P	P: 1, 3, 4	P: 5, 6, 8
	Clinical Application	Mode of Operation
General(Track 1 Only)	Specific(Tracks 1 & 3)	B	M	PWD	CWD	ColorDoppler	Combined(Specify)	Other* (Specify)
Ophthalmic	Ophthalmic
Fetal Imaging &Other	Fetal
	Abdominal (including urolology):Liver, Kidney, Spleen...	P		P		P	P: 1, 2, 3, 4	P: 5, 6, 7, 8, 9, 10
	Intra-operative (Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	P		P		P	P: 1, 2, 3, 4	P: 5, 6, 7, 8, 9, 10
	Small Organ (for example Breast,Thyroid, Testicle, Prostate, penis,etc...)	P		P		P	P: 1, 2, 3, 4	P: 5, 6, 7, 8, 9, 10
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal (Conventional)	P		P		P	P: 1, 2, 3, 4	P: 5, 6, 7, 8, 9, 10
	Musculo-skeletal (Superficial)	P		P		P	P: 1, 2, 3, 4	P: 5, 6, 7, 8, 9, 10
	Intravascular
	GYN
	Pelvic
	Other (Specify)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other (Specify)
PeripheralVessel	Peripheral vessel	P		P		P	P: 1, 3, 4	P: 5, 6, 8, 9, 10
	Other (Specify)
N = new indication; P = Previously cleared by FDA (K191007)
1: Combined modes include: B+ Color Flow5: Harmonic Imaging6: Spatial Compounding7: ShearWave™ Elastography8: Imaging Guidance for Biopsies9: Panoramic Imaging10: 3D Imaging11: Combined modes include: B+ M mode	12: Combined modes include: B Mode + Color flow + Shearwave™ Elastography2: Combined modes include: B+ ShearWave™ Elastography13: CEUS (Contrast Enhancement UltraSound)3: Combined modes include: B+ Pulsed Wave14: Angio PL.U.S (Color Doppler improvement)4: Combined modes include: B+ Pulsed Wave + Color Flow15: Needle PL.U.S16: Brightness ratio17: Combined mode include: B+ Continuous Wave18: Combined mode include: B+ M mode + Color flow19: Strain Elastography20: Combined mode: B Mode + Strain + SWE21: Vi PLUS22: Att PLUS & SSp PLUS
Prescription Use X AND/OR Over-The-Counter Use __(Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C)
Clinical Application		Mode of Operation
General(Track 1 Only)	Specific(Tracks 1 & 3)	B	M	PWD	CWD	ColorDoppler	Combined(Specify)	Other* (Specify)
Ophthalmic	Ophthalmic
Fetal Imaging& Other	Fetal
	Abdominal (including urology): Liver,Kidney, Spleen...	P		P	P	P	P: 1, 2, 3, 4	P: 5, 6, 7, 8, 9, 13
	Intra-operative (Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	P		P	P	P	P: 1, 2, 3, 4	P: 5, 6, 7, 8, 9, 13
	Small Organ (for example Breast, Thyroid,Testicle, Prostate, penis, etc...)	P					P: 1, 2, 3, 4	P: 5, 6, 7, 8, 9
	Neonatal Cephalic	P		P	P	P	P: 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: 1, 2, 3, 4	P: 5, 6, 7, 8, 9
	Musculo-skeletal (Superficial)	P		P	P	P	P: 1, 2, 3, 4	P: 5, 6, 7, 8, 9
	Intravascular
	GYN
	Pelvic
	Other (Specify)
Cardiac	Cardiac Adult
	Cardiac Pediatric	P	P	P	P	P	P: 1,3,4,11	P: 5, 6
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other (Specify)
PeripheralVessel	Peripheral vessel	P		P	P	P	P: 1, 3, 4	P: 5, 6, 8, 9
	Other (Specify)	P		P	P	P	P: 1, 3, 4	P: 5, 6, 8, 9

N = new indication; P = Previously cleared by FDA (K191007)

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

Prescription Use

(Part 21 CFR 801 Subpart D)

5: Harmonic Imaging

6: Spatial Compounding

7: ShearWave™ Elastography

8: Imaging Guidance for Biopsies

9: Panoramic Imaging

10: 3D Imaging

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

19: Strain Elastography

20: Combined mode: B Mode + Strain + SWE

21: Vi PLUS

22: Att PLUS & SSp PLUS

AND/OR

(21 CFR 807 Subpart C)

Over-The-Counter Use

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

{8}------------------------------------------------

510(k) Number (if known): K203645

Device Name: LV16-5 transducer (motorized linear transducer, SSIP95108)

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

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

{9}------------------------------------------------

510(k) Number (if known): K203645

Device Name: MC12-3 transducer (micro-curved transducer, SSIP95106)

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

N = new indication; P = Previously cleared by FDA (K191007)

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

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

19: Strain Elastography

20: Combined mode: B Mode + Strain + SWE

21: Vi PLUS
22: Att PLUS & SSp PLUS

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

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

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

{10}------------------------------------------------

510(k) Number (if known): K203645

Device Name: P5-1X transducer (Phased Array transducer, SSIP95107)

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

Clinical Application			Mode of Operation
General(Track 1 Only)	Specific(Tracks 1 & 3)	B	M	PWD	CWD	ColorDoppler	Combined(Specify)	Other* (Specify)
Ophthalmic	Ophthalmic
Fetal Imaging& Other	Fetal
	Abdominal (including urolology): Liver,Kidney, Spleen...	P	P	P	P	P	P: 1, 3, 4, 11,17	P: 5, 6, 16
	Intra-operative (Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
	Small Organ (for example Breast, Thyroid,Testicle, Prostate, penis, etc...)	P	P	P		P	P: 1, 3, 4	P: 5, 6
	Neonatal Cephalic
	Adult Cephalic	P	P			P	P: 1, 3, 4	P: 5, 6
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal (Conventional)
	Musculo-skeletal (Superficial)
	Intravascular
	GYN
	Pelvic
	Other (Specify)
Cardiac	Cardiac Adult	P	P	P	P	P	P : 1, 3, 4, 11,17, 18	P: 5, 6
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other (Specify)
PeripheralVessel	Peripheral vessel	P		P	P	P	P: 1, 3, 4, 17	P: 5, 6
	Other (Specify)	P		P	P	P	P: 1, 3, 4, 17	P: 5, 6

3: Combined modes include: B+ Pulsed Wave

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

graphy

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

17: Combined mode include: B+ Continuous Wave

20: Combined mode: B Mode + Strain + SWE

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

15: Needle PL.U.S

16: Brightness ratio

21: Vi PLUS

19: Strain Elastography

22: Att PLUS & SSp PLUS

5: Harmonic Imaging 6: Spatial Compounding

Spatial Compounding
ShearWave™ Elastography

7: ShearWave™ Elastography
8: Imaging Guidance for Biopsies

9: Panoramic Imaging

10: 3D Imaqinq

11: Combined modes include: B+ M mode

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

Over-The-Counter Use

(21 CFR 807 Subpart C)

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

{11}------------------------------------------------

510(k) Number (if known): K203645

Device Name: LH20-6 transducer (linear transducer, SSIP95104)

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

Clinical Application			Mode of Operation
General(Track 1Only)	Specific(Tracks 1 & 3)	B	M	PWD	CWD	ColorDoppler	Combined(Specify)	Other* (Specify)
Ophthalmic	Ophthalmic
FetalImaging &Other	Fetal
	Abdominal (including urolology): Liver,Kidney, Spleen...
	Intra-operative (Specify) Vascular,abdominal, small organs	P	P	P	P		P: 1, 3, 4	P: 5, 6, 915
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	P	P	P	P		P: 1, 2, 3, 4	P: 5, 6, 7, 915
	Small Organ (for example Breast, Thyroid,Testicle, Prostate, penis, etc...)	P	P	P	P		P: 1, 2, 3, 4	P: 5, 6, 7, 915
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal (Conventional)	P	P	P	P		P: 1, 2, 3, 4	P: 5, 6, 7, 9, 15
	Musculo-skeletal (Superficial)	P	P	P	P		P: 1, 2, 3, 4	P: 5, 6, 7, 9, 15
	Intravascular
	GYN
	Pelvic
	Other (Specify)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other (Specify)
PeripheralVessel	Peripheral vessel	P	P	P	P		P: 1, 3, 4	P: 5, 6, 9, 15
	Other (Specify)	P	P	P	P		P: 1, 3, 4	P: 5, 6, 9, 15

1: Combined modes include: B+ Color Flow

3: Combined modes include: B+ Pulsed Wave

2: Combined modes include: B+ ShearWave™ Elastography

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 include: B+ M mode + Color flow

19: Strain Elastography

20: Combined mode: B Mode + Strain + SWE

21: Vi PLUS 22: Att PLUS & SSp PLUS

11: Combined modes include: B+ M mode

Prescription Use (Part 21 CFR 801 Subpart D)

5: Harmonic Imaging

6: Spatial Compounding

9: Panoramic Imaging 10: 3D Imaging

7: ShearWave™ Elastography

8: Imaging Guidance for Biopsies

Over-The-Counter Use

(21 CFR 807 Subpart C)

(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) Diagnostic Ultrasound Indications for Use

{12}------------------------------------------------

510(k) Number (if known): K203645

Device Name: L18-5 transducer Linear Array Transducer, SSIP95100)

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

Clinical Application				Mode of Operation
General(Track 1 Only)	Specific(Tracks 1 & 3)	B	M	PWD	CWD	ColorDoppler	Combined(Specify)	Other* (Specify)
Ophthalmic	Ophthalmic
Fetal Imaging &Other	Fetal
	Abdominal (including urolology):Liver, Kidney, Spleen...	P		P		P	P: 1, 2, 3, 4	P: 5, 6, 7, 8, 9, 14, 15
	Intra-operative (Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	P		P		P	P: 1, 2, 3, 4	P: 5, 6, 7, 8, 9, 14, 15
	Small Organ (for example Breast,Thyroid, Testicle, Prostate, Penis)	P		P		P	P: 1, 2, 3, 4, 12	P: 5, 6, 7, 8, 9, 14, 19, 20
	Neonatal Cephalic	P		P		P	P: 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: 1, 2, 3, 4	P: 5, 6, 7, 8, 9,14, 15, 19,20
	Musculo-skeletal (Superficial)	P		P		P	P: 1, 2, 3, 4	P: 5, 6, 7, 8, 9,14, 15, 19,20
	Intravascular
	GYN
	Pelvic
	Other (Specify)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other (Specify)
PeripheralVessel	Peripheral vessel	P		P		P	P: 1, 3, 4	P: 5, 6, 8, 9, 15
	Other (Specify)	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

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

11: Combined modes include: B+ M mode

Prescription Use _ X (Part 21 CFR 801 Subpart D) 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

19: Strain Elastography

20: Combined mode: B Mode + Strain + SWE

21: Vi PLUS

22: Att PLUS & SSp PLUS

AND/OR

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)

Concurrence of CDRH; Office of In Vitro Diagnostics and Radiological Health (OIR) Diagnostic Ultrasound Indications for Use

{13}------------------------------------------------

510(k) Number (if known): K203645

Device Name: C9-2X transducer, curved array transducer (SSIP95105)

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

Clinical Application			Mode of Operation
General(Track 1 Only)	Specific(Tracks 1 & 3)	B	M	PWD	CWD	ColorDoppler	Combined(Specify)	Other* (Specify)
	Ophthalmic
Fetal Imaging &Other	Fetal	P	P	P		P	P: 1, 3, 4, 11	P: 5, 6
Other	Abdominal (including urolology):Liver, Kidney, Spleen...	P	P	P		P	P: 1, 2, 3, 4, 11	P: 5, 6, 7, 8, 9, 13, 14, 16,21, 22
	Intra-operative (Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	P		P		P	P: 1, 2, 3, 4	P: 5, 6, 7, 8, 13, 16 – N: 21,22
	Small Organ (for example Breast,Thyroid, Testicle, Prostate, Penis)	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
	Pelvic	P	P	P		P	P: 1, 2, 3, 4	P: 5, 6, 7, 8, 14
	Other (Specify)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other (Specify)
PeripheralVessel	Peripheral vessel	P		P		P	P: 1, 3, 4	P: 5, 6, 8
Vessel	Other (Specify)	P		P		P	P: 1, 3, 4	P: 5, 6, 8

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

11: Combined modes include: B+ M mode

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

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

13: CEUS (Contrast Enhancement UltraSound)

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

20: Combined mode: B Mode + Strain + SWE

17: Combined mode include: B+ Continuous Wave

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

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

(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)

15: Needle PL.U.S

16: Brightness ratio

21: Vi PLUS

19: Strain Elastography

22: Att PLUS & SSp PLUS

{14}------------------------------------------------

K203645 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: Hologic Inc. 250 Campus Dr. Malborough, MA 01752 North America Telephone: 508-263-2900

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

Date: 2020.11.30

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 30 / SUPERSONIC MACH30, AIXPLORER® MACH 20 / SUPERSONICMACH20, SUPERSONIC MACH40

Classification: Class II

Classification Name:	21 CFR Section	Product Code
Ultrasonic Pulsed Doppler Imaging System	892.1550	90-IYN
Ultrasonic Pulsed Echo Imaging System	892.1560	90-IYO
Diagnostic Ultrasound Transducer	892.1570	90-ITX

3) Substantially Equivalent/Predicate Devices

Primary Predicate Device	AIXPLORER® MACH range Ultrasound Imaging System (K191007), cleared on10/25/2019
Reference devices	Aplio i900, i800, i700 V2 (K173090), cleared on 01/11/2018
	Resona 7 (K171233) cleared on 09/12/2017

{15}------------------------------------------------

4) Description of Device

5) Indication for Use

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, OBGYN, 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 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 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

{16}------------------------------------------------

	SuperSonic Imagine	Canon MedicalSystem	Mindray medicalInternational	SuperSonic Imagine
	Aixplorer MACH rangesw V2(Primary PredicateDevice)	Aplio i900, i800and i700 V2.0(ReferenceDevice)	Resona 7(ReferenceDevice)	AIXPLORER® MACH /SUPERSONIC MACHrange sw V3
510(k)Number	K191007	K173090	K171233	K203645
ClassificationName	Ultrasonic PulsedDoppler ImagingSystem (892.1550)Ultrasonic Pulsed EchoImaging System(892.1560)Diagnostic UltrasoundTransducer (892.1570)	Identical	Identical	Identical
Class	Class II	Identical	Identical	Identical
Intended Use	Diagnostic ultrasoundimaging, soft tissueelasticity imaging, fluidflow analysis of thehuman body	Diagnosticultrasoundimaging or fluidflow analysis ofthe human body	DiagnosticUltrasound imagingor fluid flow analysisof the human body	Identical to K191007
Indication foruse	The SuperSonic ImagineAIXPLORER®MACH rangeultrasounddiagnosticsystems andtransducers areintended forgeneral purposepulse echoultrasoundimaging, softtissueviscoelasticityimaging, dopplerfluid flow analysis	The diagnosticultrasoundsystems Aplioi900 Model TUS-Al900, Aplio i800Model TUS-Al800, Aplio i700Model TUS-Al700, Aplio i600Model TUS-Al600, areindicated for thevisualisation ofstructures, anddynamicprocesses withthe human bodyusing ultrasoundand to provideimage	The Resona7/Resona7CV/Resona7EXP/Resona7S/Resona 7OBdiagnosticultrasound system isapplicable foradults, pregnantwomen, pediatricpatients andneonates. It isintended for use infetal, abdominal,intra-operative(abdominal,thoracic, andvascular), pediatric,small organ (breast,thyroid, testes),	Identical toprimaryPredicate DeviceK191007The SuperSonicImagineAIXPLORER®MACH /SUPERSONICMACH rangeultrasounddiagnosticsystems andtransducers areintended forgeneral purposepulse echoultrasoundimaging, soft
of the humanbody.The SuperSonicImagineAIXPLORER®MACH ultrasounddiagnosticsystems areindicated for usein the followingapplications, forimaging andmeasurement ofanatomicalstructures:Abdominal, SmallOrgans,Musculoskeletal,SuperficialMusculoskeletal,Vascular,PeripheralVascular,Intraoperative,OB-GYN, Pelvic,Pediatric, Urology,Trans-rectal,Trans-vaginal andNeonatal/AdultCephalic, NoninvasiveCardiac.In addition, theSuperSonicImagineAIXPLORER®MACH ultrasounddiagnosticsystems andassociatedtransducers areintended for:- Measurements ofabdominal anatomicalstructures,- Measurements ofbroad band shearwave speed, andtissue stiffness inof the human body	information fordiagnosis in thefollowingapplications :fetal, abdominal,intraoperative(abdominal),pediatric, smallorgans,transvaginal,transrectal,neonatalcephalic, adultcephalic, cardica(both adult andpediatric),peripheralvascular,transoesophageal,musculoskeletal(bothconventionaland superficial)andlaparoscopic.	neonatal cephalic,adult cephalic,trans-rectal,transvaginal,musculo-skeletal(conventional,superficial), cardiacadult, cardiacpediatric,transesoph.(cardiac), peripheralvessel and urologyexams.	tissueviscoelasticityimaging, dopplerfluid flowanalysis of thehuman body.The SuperSonicImagineAIXPLORER®MACH /SUPERSONICMACH ultrasounddiagnosticsystems andassociatedtransducers are

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

{17}------------------------------------------------

{18}------------------------------------------------

- Measurements ofbrightness ratiobetween liver andkidney,- Visualization ofabdominalvascularization,microvascularizati onand perfusion,- Quantification ofabdominalvascularization andperfusion. Theshearwave speed,beam attenuation,viscosity and stiffnessmeasurements, thebrightness ratio, thevisualization ofvascularization,microvascularization andperfusion, thequantification ofvascularization andperfusion may be used asan aid to clinicalmanagement of adult andpediatric patients withliver disease.		- Measurements ofbroad band shearwave speed, andtissue stiffness ininternal structuresof the liver and thespleen,- Measurements ofbrightness ratiobetween liver andkidney,- Visualization ofabdominalvascularization,microvascularization and perfusion,- Quantification ofabdominalvascularizationand perfusion.The shearwavespeed, beamattenuation,viscosity andstiffnessmeasurements,the brightnessratio, thevisualization ofvascularization,microvascularization and perfusion,the quantificationof vascularizationand perfusion maybe used as an aidto clinicalmanagement ofadult and pediatricpatients with liverdisease.Expansion forK203645Furthermore, theSuperSonicImagineAIXPLORER® MACH/ SUPERSONICMACH ultrasounddiagnostic systemsand associated
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------	--	----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

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				transducers areintended for:- Measurements ofbreast anatomicalstructures- Measurements ofbroad band shearwaves speed andtissue stiffness ininternal structuresof the breast- Visualization of breaststructures andmicrovascularization-Visualization of breastmasses morphologyusing shearwaveelastography andmicrovascularization 2Dmapping
	General purpose,mobile, softwarecontrolleddiagnosticultrasound system.To acquireultrasound dataand to display thedata in variousmodes ofoperation.	Identical	Identical	Identical
GeneralDescription	Consists of twoparts: the systemconsole and thetransducer. Thesystem consolecontains the userinterface, adisplay, systemelectronics andoptionalperipherals(printers, etc...).	Identical	Identical	Identical
ClinicalApplications	Abdominal (liver,kidney, spleen)	Identical	Identical	Identical
	Small organs (*)	Identical	Identical	Identical
	Musculoskeletal	Identical	Identical	Identical
	Fetal	Identical	Identical	Identical
	GYN	Identical	Identical	Identical
	Cardiac (noninvasive)	Cardiac	Identical	Identical toK191007
	Adult andneonatal cephalic	Identical	Identical	Identical
	Pediatric	Identical	Identical	Identical
	Urology	Identical	Identical	Identical
	Vascular	Identical	Identical	Identical
	Peripheralvascular	Identical	Identical	Identical
	Trans-rectal	Identical	Identical	Identical
	Trans-vaginal	Identical	Identical	Identical
Imagingmodes
Conventional	B-Mode(Harmonic,Fundamental)	Identical	Identical	Identical
	M-Mode	Identical	Identical	Identical
	PW	Identical	Identical	Identical
	CW	CW	Identical	Identical toK191007

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Color Doppler	Identical	Identical	Identical
Amplitude Doppler	Identical	Identical	Identical
Microvascular(Angio PL.U.S)	--(**)	--	Identical toK191007

Other	Spatial compounding, Panoramic	Identical	Identical	Identical
	Contrast	Identical	Identical	Identical
	Combination of modes	Identical	Identical	Identical
	ShearWaveElastography	Identical	Identical	Identical
	Strain Elastography	Identical	Identical	Identical toK191007
Design
Cart	Mobile cart basedproduct with controlpanel and monitor	Identical	Identical	Identical
Controls	Typical ultrasoundimaging controls (gain,depth mode select...)	Identical	Identical	Identical
Biopsyguide	Available	Identical	Available	Identical
Track	Track 3 (Acoustic OutputDisplay)	Identical	Identical	Identical
PatientContactMaterials	Yes, per ISO 10993-1	Identical	Identical	Identical
AcousticOutputwithin FDAguidelines	Yes, as per NEMA UD-3	Identical	Identical	Identical

ImageReview	Yes	Identical	Identical	Identical
Measurement Package	Yes	Identical	Identical	Identical
CalculationPackage	Yes	Identical	Identical	Identical
Report	Yes	Identical	Identical	Identical
GeneralSafety	Conforms toIEC60601-1,60601-12, 60601-37	Identical	Identical	Identical
Labeling	Conforms to 21 CFR Part801			Conforms to 21 CFR Part801The user interfaceincludes a dedicatedmenu for Bi-Rads. Thismenu provides Bi-Radslexicon classificationwhich allows the user toclassify the lesionaccording to Bi-Radscriteria.Bi-RADS (ACR***)lexicon classification UserInterface is composed offollowing information :- Tissue Composition- Masses :• Shape• Orientation• Margin• Echo PatternThese information arecriteria for lesioncharacterizationaccording to Bi-RADSscoring to assess the riskof lesion malignancy.

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Vol_002-22

*: Breast, Thyroid, Testicle, etc
**:--- means not applicable
*** American College of Radiology

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7) 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 Standard	Tests Performed
IEC 60601-1 Ed.3.1	All applicable electrical, basic safety and essentialperformance tests.
IEC 60601-1-2 Ed.4	All applicable testing pertaining to electromagneticcompatibility.
IEC 60601-2-37 Ed.2.1	All applicable testing pertaining to the particularrequirements for the safety of ultrasonic medicaldiagnostic and monitoring equipment.
NEMA UD 2 (Rev. 3)	All tests applicable in order to demonstratecompliance with the "Accoustic OutputMeasurement Standard for Diagnostic UltrasoundEquipment".
NEMA UD 3 (Rev. 2)	All tests applicable in order to demonstratecompliance with the "Standard For Real TimeDisplay Of Thermal And Mechanical AcousticOutput Indices On Diagnostic UltrasoundEquipment".
ISO 10993-1	Applicable biocompatibility tests per FDA 510(k)Memorandum - #G95-1 - per the appropriatedevice category.

The above testing confirmed that the AilXPLORER® 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 / SUPERSONIC 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 / SUPERSONIC MACH range Ultrasound Diagnostic Systems. Summary of literature review : Owing to its correlation with cancer risk, real-time mapping of breast lesions stiffness has proven to produce important information to breast physicians that can improve the global management patients with breast lesions. Addition of Shear Wave elastography to conventional B-mode Ultrasound increased the specificity of breast mass assessment. It can significantly improve the positive predictive value of biopsy recommendation for probably benign and low suspicion breast lesions on ultrasound, while preserving the sensitivity of breast ultrasound. This been demonstrated in diagnostic settings. The addition of SWE evaluation of breast lesions also increases the inter-observer agreement on their global cancer risk assessment with ultrasound, thanks to its "almost perfect" intra-operator repeatability and high inter-observer reproducibility. The evaluation of breast cancers with SWE seem to contribute to defining more appropriate management strateqies thanks to more accurate cancer size measurements, to correlation with cancer aggressiveness and response to neo-adjuvant chemotherapy treatment.

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

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testing demonstrated that the submission device is at least as safe and effective as the predicate devices listed in item 3.

Regulation Number and Section

§ 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.