AIXPLORER by SUPERSONIC IMAGINE | FDA 510(k) Summary

The SuperSonic Imagine AIXPLORER® Ultrasound System is indicated for use in the following applications: Abdominal, Small organs, Musculoskelatal, Superficial Musculoskeletal, Vascular, Intraoperative, OB-GYN, Pelvic, Pediatric, Urology, Trans-rectal, Trans-vaginal and Neonatal/adult Cephalic.

The system also provides the ability to measure anatomical structures (Abdominal, Small Organs, Musculoskeletal, Superficial Musculosketal, Peripheral Vascular, Intraoperative, GYN, Pelvic, Pediatric, Urology, Trans-rectal, Neonatal/ Adult Cephalic, Fetal/Obstetrics).

Device Description

The SuperSonic Imagine AIXPLORER® system is a cart based ultrasound imaging system 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, M-mode, Color Flow, Pulsed Wave Doppler, Harmonic Imaging, Amplitude Doppler, 3D imaging and for ShearWave™ elastography.

AI/ML Overview

The provided text is a 510(k) Pre-market Notification for the SuperSonic Imagine Aixplorer® Ultrasound System. It primarily focuses on demonstrating substantial equivalence to predicate devices for its intended uses and various transducers. Crucially, this document does not contain information about acceptance criteria or a study proving the device directly meets acceptance criteria in the context of diagnostic performance (e.g., accuracy, sensitivity, specificity).

Instead, the document asserts substantial equivalence based on technological characteristics and compliance with general safety and performance standards. It explicitly states that clinical data is not required because the device uses the same technology and principles as predicate devices.

Therefore, many of the requested sections about acceptance criteria and performance studies cannot be filled from this document. However, I can extract information regarding non-clinical tests and the general nature of the device's validation.

Here's a breakdown based on the available information:

A table of acceptance criteria and the reported device performance
- Acceptance Criteria: The document implies that the acceptance criteria are adherence to various electrical safety, electromagnetic compatibility, acoustic output, and biocompatibility standards. For instance, acoustic output must be "within FDA guidelines" as per NEMA UD-3.
- Reported Device Performance: The document states that "All data fell within pre-determined product specifications and external standard requirements." However, specific numerical performance metrics (e.g., sensitivity, specificity, accuracy) are not provided as diagnostic performance studies were not conducted or submitted for this specific 510(k). The performance is described in terms of its ability to operate in various imaging modes (B-Mode, M-mode, Color Flow, Pulsed Wave Doppler, etc.) and for various clinical applications, which are identical or similar to predicate devices.

Acceptance Criterion (Implied)	Reported Device Performance
IEC 60601-1 3rd Edition (Electrical, basic safety)	All applicable tests confirmed compliance.
UL 60601-1 1st Edition (Electrical, basic safety for USA)	All applicable tests confirmed compliance.
IEC 60601-1-2 3rd Edition (Electromagnetic compatibility)	All applicable tests confirmed compliance.
IEC 60601-2-37 2nd Edition (Safety for ultrasonic medical devices)	All applicable tests confirmed compliance.
NEMA UD 2 (Rev. 3) (Acoustic Output Measurement)	Demonstrated compliance with the standard.
NEMA UD 3 (Rev. 2) (Real Time Display of Thermal and Mechanical Acoustic Output Indices)	Demonstrated compliance with the standard.
ISO 10993-1 (Biocompatibility)	Applicable tests performed per FDA 510(k) Memorandum - #G95-1.
Stated Intended Use (Imaging modes and clinical applications)	Performs according to the stated intended use.
New Transducers (XP5-1 and SLH20-6) Performance	Performance tests conducted and confirmed adherence to specifications.

Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- No information provided regarding a sample size for a test set related to diagnostic performance, as clinical studies were not submitted.
- Non-clinical testing of the device and new transducers was performed, but no specific "test set" in terms of patient data is mentioned. The testing was likely conducted in a lab environment in France (where SuperSonic Imagine is based).
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable, as no clinical studies with a test set requiring ground truth establishment by experts were submitted.
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable, as no clinical studies with a test set requiring adjudication were submitted.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. This is not an AI/CADe device. No MRMC study was mentioned.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an AI/CADe device. No standalone algorithm performance was discussed.
The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not applicable for diagnostic performance. For non-clinical tests, "ground truth" would be the specific requirements of the mentioned standards (IEC, UL, NEMA, ISO).
The sample size for the training set
- Not applicable. This is not an AI/CADe device, and no training set is mentioned.
How the ground truth for the training set was established
- Not applicable. This is not an AI/CADe device, and no training set is mentioned.

Summary

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Image /page/0/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three overlapping human profiles facing to the right, resembling a bird in flight.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

November 20, 2014

SuperSonic Imagine % Ms. Aurelie Gruener Senior Regulatory Affairs Manager Les Jardins de la Duranne 510, rue Rene Descartes - Bat. E & F 13 857 Aix-en-Provence FRANCE

Re: K142100 Trade/Device Name: Aixplorer Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: October 28, 2014 Received: November 5, 2014

Dear Ms. Gruener:

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 (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); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Robert A. Ochs

for

Janine M. Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K142100

Device Name AIXPLORER® Ultrasound System

The SuperSonic Imagine AIXPLORER® Ultrasound System is indicated for use in the following applications:

Abdominal, Small organs, Musculoskelatal, Superficial Musculoskeletal, Vascular, Intraoperative, OB-GYN, Pelvic, Pediatric, Urology, Trans-rectal, Trans-vaginal and Neonatal/adult Cephalic.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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510(k) number (if known): K142100

Device Name: AIXPLORER® Ultrasound System

Intended Use: Diagnostic ultrasound imaging or 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
	Abdominal (including urolology)	P	P	P		P	P, 1, 2, 3, 4	P, 5, 6, 7, 8, 10, 9
	Intra-operative (Specify)vascular, abdominal, smallorgans	N	N	N		N	N 1, 3, 4	N 5, 6, 9
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	P	P	P		P	P, 1, 2, 3, 4	P, 5, 6, 7, 8, 10, 9
	Small Organ (Breast, Thyroid,Testicle, Prostate, penis, etc...)	P	P	P		P	P, 1, 2, 3, 4	P, 5, 6, 7, 8, 10, 9
	Neonatal Cephalic	P	P	P		P	P, 1, 2, 3, 4	P, 5, 6, 7, 9
	Adult Cephalic	N	N	N		N	N 1, 3, 4	N 5, 6
	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	P, 5, 6, 7, 8
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal (Conventional)	P	P	P		P	P, 1, 2, 3, 4	P, 5, 6, 7, 8, 10, 9
	Musculo-skeletal (Superficial)	P	P	P		P	P, 1, 2, 3, 4	P, 5, 6, 7, 8, 10, 9
	Intravascular
	GYN	P	P	P		P	P, 1, 2, 3, 4	P, 5, 6, 7, 8, 10
	Pelvic	P	P	P		P	P, 1, 2, 3, 4	P, 5, 6, 7, 8, 10
	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, 8, 10, 9
	Other (Specify)	P	P	P		P	P. 1. 3. 4	P. 5. 6. 8. 9

N = new indication; P = previously cleared by FDA (K121329)

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

11: Combined modes include: B+ M modes

ing

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)

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

AND/OR

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510(k) Number (if known): K142100

Device Name: SL15-4 transducer (1D Linear Array Transducer)

Intended Use: Diagnostic ultrasound imaging or 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	P	P	P	P		P 1, 2, 3, 4	P 5, 6, 7, 8, 9
	Intra-operative (Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	P	P	P	P		P 1, 2, 3, 4	P 5, 6, 7, 8, 9
	Small Organ (for example Breast,Thyroid, Testicle, Prostate, Penis)	P	P	P	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
	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)

N = new indication; P = previously cleared by FDA (K121329)

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

4: Combined modes include
5: Harmonic Imaging

5: Harmonic Imaging 6: Spatial Compounding

. Spatial Compounding

Prescription Use X (Part 21 CFR 801 Subpart D) 7: ShearWave™ Elastography

8: Imaging Guidance for Biopsies

9: Panoramic Imaging

10: 3D Imaging

11: Combined modes include: B+ M modes

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

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

AND/OR

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510(k) Number (if known): K142100

Device Name: SC6-1 transducer (curved array transducer)

Intended Use: Diagnostic ultrasound imaging or 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	N	N	N		N	N, 1, 3, 4, 11	N, 5, 6
	Abdominal (including urolology)	P	P			P	P 1, 2, 3, 4	P 5, 6, 7, 8, 9
	Intra-operative (Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	P	P			P	P 1, 2, 3, 4	P 5, 6, 7, 8, 9
	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)	P	P			P	P 1, 2, 3, 4	P 5, 6, 7, 8, 9
	Musculo-skeletal (Superficial)	P	P			P	P 1, 2, 3, 4	P 5, 6, 7, 8, 9
	Intravascular
	GYN	P	P			P	P 1, 2, 3, 4	P 5, 6, 7, 8
	Pelvic	P	P			P	P 1, 2, 3, 4	P 5, 6, 7, 8
	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
	Other (Specify)	P	P			P	P 1, 3, 4	P 5, 6, 8, 9

N = new indication; P = previously cleared by FDA (K121329)

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

AND/OR

Prescription Use X (Part 21 CFR 801 Subpart D) 7: ShearWave™ Elastography

8: Imaging Guidance for Biopsies

9: Panoramic Imaging 10: 3D Imaging

3D Imaging
Combined modes include: D

11: Combined modes include: B+ M modes

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): K142100

Device Name: SE12-3 transducer (endocavitary transducer)

Intended Use: Diagnostic ultrasound imaging or 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 &	Fetal	N	N	N	N	N	N, 1, 3, 4, 11	N, 5, 6
Other	Abdominal
	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 1, 2, 3, 4	P 5, 6, 7, 8
	Trans-vaginal	P		P		P	P 1, 2, 3, 4	P 5, 6, 7, 8
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal (Conventional)
	Musculo-skeletal (Superficial)
	Intravascular
	GYN	P		P		P	P 1, 2, 3, 4	P 5, 6, 7, 8
	Pelvic	P		P		P	P 1, 2, 3, 4	P 5, 6, 7, 8
	Other (Specify)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other (Specify)
Peripheral	Peripheral vessel
Vessel	Other (Specify)	P		P		P	P 1, 3, 4	P 5, 6, 8

N = new indication; P = previously cleared by FDA (K121329)

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

AND/OR

Prescription Use X (Part 21 CFR 801 Subpart D) 7: ShearWave™ Elastography

8: Imaging Guidance for Biopsies 9: Panoramic Imaging

10: 3D Imaging

11: Combined modes include: B+ M modes

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): K142100

Device Name: SLV16-5 transducer (motorized linear transducer)

Intended Use: Diagnostic ultrasound imaging or 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	P	P	P	P	P	P 1, 2, 3, 4	P 5, 6, 7, 8, 10, 9
	Intra-operative (Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	P	P	P	P	P	P 1, 2, 3, 4	P 5, 6, 7, 8, 10, 9
	Small Organ (for example Breast,Thyroid, Testicle, Prostate, penis,etc...)	P	P	P	P	P	P 1, 2, 3, 4	P 5, 6, 7, 8, 10, 9
	Neonatal Cephalic
	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, 10, 9
	Musculo-skeletal (Superficial)	P	P	P	P	P	P 1, 2, 3, 4	P 5, 6, 7, 8, 10, 9
	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, 10, 9
	Other (Specify)

N = new indication; P = previously cleared by FDA (K121329)

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

Prescription Use X (Part 21 CFR 801 Subpart D) 7: ShearWave™ Elastography

8: Imaging Guidance for Biopsies

9: Panoramic Imaging

10: 3D Imaging

11: Combined modes include: B+ M modes

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

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

AND/OR

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510(k) Number (if known): K142100

Device Name: SL10-2 transducer (linear transducer)

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

	Clinical Application	Mode of Operation
General(Track 1 Only)	Specific(Tracks 1 & 3)	в	M PWD CWD	ColorDoppler	Combined(Specify)	Other* (Specify)
Ophthalmic	Ophthalmic
Fetal Imaging Fetal
& Other	Abdominal	P	P	P	P, 1, 2, 3, 4	P, 5, 6, 7, 8, 9
	Intra-operative (Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	P	P	P	P, 1, 2, 3, 4	P, 5, 6, 7, 8, 9
	Small Organ (for example Breast, Thyroid,Testicle, Prostate, penis, etc )	P	D	P	P, 1, 2, 3, 4	P, 5, 6, 7, 8, 9
	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
	Musculo-skeletal (Superficial)	P	P	P	P, 1, 2, 3, 4	P, 5, 6, 7, 8, 9
	Intravascular
	GYN
	Pelvic
	Other (Specify)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other (Specify)
Peripheral	Peripheral vessel	P	P	P	P, 1, 3, 4	P, 5, 6, 8, 9
Vessel	Other (Specify)	P	P	P	P, 1, 3, 4	P, 5, 6, 8, 9

N = new indication; P = previously cleared by FDA (K121329)

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

(Part 21 CFR 801 Subpart D)

Prescription Use

AND/OR

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

11: Combined modes include: B+ M modes

7: ShearWave™ Elastography

9: Panoramic Imaging

10: 3D Imaging

8: Imaging Guidance for Biopsies

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

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510(k) Number (if known): K142100

Device Name: SMC12-3 transducer (micro-curved transducer)

Intended Use: Diagnostic ultrasound imaging or 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	FetalAbdominal	P		P		P	P, 1, 2, 3, 4	P, 5, 6, 7, 8, 9
	Intra-operative (Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	P		P		P	P, 1, 2, 3, 4	P, 5, 6, 7, 8, 9
	Small Organ (for example Breast, Thyroid,Testicle, Prostate, penis, etc...)	P		P		P	P, 1, 2, 3, 4	P, 5, 6, 7, 8, 9
	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
	Musculo-skeletal (Superficial)	P		P		P	P, 1, 2, 3, 4	P, 5, 6, 7, 8, 9
	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
	Other (Specify)	P		P		P	P, 1, 3, 4	P, 5, 6, 8, 9

N = new indication; P = previously cleared by FDA (K121329)

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

(Part 21 CFR 801 Subpart D)

Prescription Use

AND/OR

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

11: Combined modes include: B+ M modes

7: ShearWave™ Elastography

9: Panoramic Imaging

10: 3D Imaging

8: Imaging Guidance for Biopsies

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

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510(k) Number (if known): K142100

Device Name: XP5-1 transducer (Phased Array transducer)

Intended Use: Diagnostic ultrasound imaging or 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	N	N	N	N	N	N 1, 3, 4	N 5, 6
	Intra-operative (Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
	Small Organ (for example Breast, Thyroid,Testicle, Prostate, penis, etc...)	N	N	N	N	N	N 1, 3, 4	N 5, 6
	Neonatal Cephalic
	Adult Cephalic	N	N	N	N	N	N 1, 3, 4	N 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
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other (Specify)
PeripheralVessel	Peripheral vessel	N	N	N	N	N	N 1, 3, 4	N 5, 6
	Other (Specify)	N	N	N	N	N	N 1, 3, 4	N 5, 6

N = new indication; P = previously cleared by FDA (K121329)

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

AND/OR

Prescription Use X (Part 21 CFR 801 Subpart D) 7: ShearWave™ Elastography

8: Imaging Guidance for Biopsies

9: Panoramic Imaging 10: 3D Imaging

11: Combined modes include: B+ M modes

Combined modes include: B+ M modes

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): K142100

Device Name: SLH20-6 transducer (linear transducer)

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

General(Track 1Only)	Clinical ApplicationSpecific(Tracks 1 & 3)	B	M	PWD	CWD	ColorDoppler	Combined(Specify)	Other* (Specify)
Ophthalmic	Ophthalmic
FetalImaging &Other	Fetal
	Abdominal
	Intra-operative (Specify) Vascular,abdominal, small organs	N	N	N	N	N	N 1, 3, 4	N 5, 6, 9
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	N	N	N	N	N	N 1, 3, 4	N 5, 6, 9
	Small Organ (for example Breast, Thyroid,Testicle, Prostate, penis, etc...)	N	N	N	N	N	N 1, 3, 4	N 5, 6, 9
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal (Conventional)	N	N	N	N	N	N 1, 3, 4	N 5, 6, 9
	Musculo-skeletal (Superficial)	N	N	N	N	N	N 1, 3, 4	N 5, 6, 9
	Intravascular
	GYN
	Pelvic
	Other (Specify)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other (Specify)
PeripheralVessel	Peripheral vessel	N	N	N	N	N	N 1, 3, 4	N 5, 6, 9
	Other (Specify)	N	N	N	N	N	N 1, 3, 4	N 5, 6, 9

N = new indication; P = previously cleared by FDA (K121329)

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

10: 3D Imaging

11: Combined modes include: B+ M modes

7: ShearWave™ Elastography

9: Panoramic Imaging

8: Imaging Guidance for Biopsies

X Prescription Use (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)

AND/OR

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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. 11714 North Creek Parkway N Suite 150 Bothell, WA 98011 North America Telephone: +1(425) 686 6380

Corresponding Official:

Jacques Souquet Chief Executive Officer Telephone: +33 442 99 24 35

Date: 2014/07/25

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: Diagnostic Ultrasound System with Accessories Proprietary Name: Aixplorer®

Classification:

Regulatory 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

AIXPLORER® Ultrasound Imaging System (K132171), cleared on 09/24/2013 AIXPLORER® Ultrasound Imaging System (K132274), cleared on 09/24/2013 Siemens Acuson S2000TM Diagnostic Ultrasound System (K072786), cleared on 11/13/2007 Philips iU22 Ultrasound System (K093563), cleared on 02/01/2010

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4) Description of Device

5) Intended Use

The SuperSonic Imagine AIXPLORER® ultrasound system and transducer are intended for general purpose pulse echo ultrasound imaging and Doppler fluid flow analysis of the human body.

The SuperSonic Imagine AIXPLORER® ultrasound system is indicated for use in the following applications: Abdominal, Small Organs, Musculoskeletal, Superficial Musculoskeletal, Vascular, Peripheral Vascular, Intraoperative, OB-GYN, Pelvic, Pediatric, Urology, Trans-rectal, Trans-vaginal and Neonatal/Adult Cephalic.

The system also provides the ability to measure anatomical structures (Abdominal, Small Organs, Musculoskeletal, Superficial Musculoskeletal, Peripheral Vascular, Intraoperative, GYN, Pelvic, Pediatric, Urology, Trans-rectal, Trans-vaginal, Neonata/Adult Cephalic, Fetal/Obstetrics).

	Philipsiu22 (predicate)	Siemens AcusonS2000TM(predicate)	SuperSonicImagineAIXPLORER®(predicateK132171)	SuperSonicImagineAIXPLORER®(predicateK132274)	SuperSonicImagineAIXPLORER®(new device)
	--**	General Radiology	--**	--**	--**
	Abdominal,Small Organs*	Identical	Identical	Identical	Identical
	Musculoskeletal	Identical	Identical	Identical	Identical
		SuperficialMusculoskeletal	Identical	Identical	Identical
ClinicalApplications	Fetal	Identical	Identical	---	Identical
	---	Transcranial	---	---	---
	---	OB	Identical	---	Identical
		GYN	Identical	Identical	Identical
	Cardiac	Identical	---	---	---
	---	Pelvic	Identical	Identical	Identical
	Adult and neonatalcephalic	Identical	Identical (forneonatal cephalic)	Identical (forneonatal cephalic)	Identical
	Pediatric	Identical	Identical	Identical	Identical
	Urology	Identical	Identical	Identical	Identical
	---	Vascular	Identical	Identical	Identical
	PeripheralVascular	Identical	Identical	Identical	Identical
	Ophthalmic	---	---	---	---
	Intra-operative	Identical	---	---	Identical
	Laparoscopic	---	---	---	---
	Trans-rectal	---	Identical	Identical	Identical
	Trans-vaginal	---	Identical	Identical	Identical
	Fetal echo	---	---	---	Identical
ImagingModes
	B-mode,	Identical	Identical	Identical	Identical
	M-mode,	Identical	Identical	---	Identical
Conventional	PW,	Identical	Identical	Identical	Identical
	CW (continuousWave),	Identical	---	---	---
	Color Doppler,	Identical	Identical	Identical	Identical
	Amplitude Doppler	Identical	Identical	Identical	Identical
	Harmonic imaging,	Identical	Identical	Identical	Identical
Other	SpatialCompounding,Panoramic,Contrast	Identical	Identical	Identical	Identical
	---	Identical	---	---	---
	---	Identical	Identical	---	---
	---	Elastography	Identical	Identical	Identical
	B-mode+Color,	Identical,	Identical	Identical	Identical
	B-mode+Color+PW	Identical	Identical	Identical	Identical
Combination	B-mode +PW	Identical	Identical	Identical	Identical
	---	Identical	---	---	Identical
	---	B-mode+Elastography	Identical	Identical	Identical
Transducers
	Linear Array	Identical	Identical	Identical	Identical
Transducertypes	Curved Array	Identical	Identical	Identical	Identical
	Phased Array	Identical	---	---	Identical
	Laparoscopic	---	---	---	---
	probe
	Motorized LinearProbe	Identical	Identical	Identical	Identical
	Microconvexprobe	Identical	Identical	Identical	Identical
Track	Track 3 (AcousticOutput Display)	Identical	Identical	Identical	Identical
PatientContactMaterials	Yes, per ISO-10993- 1	Identical	Identical	Identical	Identical
AcousticOutput withinFDAguidelines	Yes, as per NEMAUD-3	Identical	Identical	Identical	Identical
GeneralSafety	Conforms to IEC60601-1, IEC60601-2	Identical	Identical	Identical	Identical

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

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

Note:

*: Breast, Thyroid, Testicle, etc

**: --- means not applicable

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 3rd Edition	All applicable electrical, basic safety and essentialperformance tests.
UL 60601-1 1st Edition	All applicable electrical, basic safety and essentialperformance tests specific to the U.S.A.
IEC 60601-1-2 3rd Edition	All applicable testing pertaining to electromagneticcompatibility.
IEC 60601-2-37 2nd Edition	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 "Acoustic 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.

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In addition to the referenced standards testing, performance tests were conducted with respect to new transducers (XP5-1 and SLH20-6).

The above testing confirmed that the Aixplorer System performs according to the stated intended use. All data fell within pre-determined product specifications and external standard requirements. Results of nonclinical testing confirmed the substantial equivalence of the Aixplorer System 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

Clinical data is not required as the Aixplorer System uses the same technology and principles as predicate devices.

9) Conclusion

The manufacturer and the design and development of the submission device comply with 21 CFR Part 820 and ISO 13485 (2003) Quality Standards. The submission device, designed to comply with applicable safety standards, is tested during manufacturing process to ensure compliance with these standards. Consequently, according tests performed, the opinion of SuperSonic Imagine is the submission device is as safe and effective as the predicate devices cited 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.