Predicate Devices

Reference Devices

None

AI/ML (Artificial Intelligence / Machine Learning)

Unknown
The device name "AIXPLORER" suggests potential AI integration, but the provided summary does not explicitly mention AI, ML, or related technologies in the device description or performance studies. The description focuses on standard ultrasound functionalities and comparisons to predicate devices without AI/ML features.

Therapeutic

No.
The device is described as an "ultrasound imaging system used to perform non-invasive diagnostic general purpose ultrasound imaging studies," indicating it is used for diagnosis, not therapy.

Diagnostic

Yes

The "Device Description" explicitly states, "The SuperSonic Imagine AIXPLORER® system is a cart based ultrasound imaging system used to perform non-invasive diagnostic general purpose ultrasound imaging studies."

SaMD (Software as a Medical Device)

No

The device description clearly states it is a "cart based ultrasound imaging system" and includes hardware components such as a scan converter, transducers, LCD monitor, and control panel.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use/Indications for Use: The intended use clearly states that the system is for "non-invasive diagnostic general purpose ultrasound imaging studies" and lists various anatomical sites for imaging. This describes a device used to visualize internal structures of the body, not to examine specimens derived from the human body (like blood, urine, tissue samples, etc.) outside of the body.
Device Description: The description details an ultrasound imaging system that produces images displayed on a monitor. This aligns with in vivo imaging, not in vitro testing.
Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any processes typically associated with in vitro diagnostics.

IVD devices are specifically designed to perform tests on specimens taken from the human body to provide information for diagnosis, monitoring, or screening. This ultrasound system performs imaging of the human body.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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).

Product codes

IYN, IYO, ITX

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasound

Anatomical Site

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

Indicated Patient Age Range

Neonatal/adult Cephalic, Pediatric, Fetal.

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Non-clinical testing was conducted per the following standards to support a determination of substantial equivalence to the predicate devices: IEC 60601-1 3rd Edition, UL 60601-1 1st Edition, IEC 60601-1-2 3rd Edition, IEC 60601-2-37 2nd Edition, NEMA UD 2 (Rev. 3), NEMA UD 3 (Rev. 2), ISO 10993-1. In addition, performance tests were conducted with respect to new transducers (XP5-1 and SLH20-6). The 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). Clinical data was not required.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

AIXPLORER® Ultrasound Imaging System (K132171), AIXPLORER® Ultrasound Imaging System (K132274), Siemens Acuson S2000TM Diagnostic Ultrasound System (K072786), Philips iU22 Ultrasound System (K093563)

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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.

Summary

0

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.

1

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

2

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.

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).

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

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"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

3

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	Color
Doppler	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, small
organs	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)
Peripheral
Vessel	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

4

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	Color
Doppler	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)
Peripheral
Vessel	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

5

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	Color
Doppler	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)
Peripheral
Vessel	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)

6

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	Color
Doppler	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)

7

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	Color
Doppler	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)
Peripheral
Vessel	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

8

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		Color
Doppler	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

X

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)

9

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	Color
Doppler	Combined
(Specify)	Other* (Specify)
Ophthalmic	Ophthalmic
Fetal Imaging
& Other	Fetal
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		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)
Peripheral
Vessel	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

X

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)

10

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	Color
Doppler	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)
Peripheral
Vessel	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)

11

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

b)

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

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

AND/OR

12

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

13

4) Description of Device

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.

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).

| | Philips
iu22 (predicate) | Siemens Acuson
S2000TM
(predicate) | SuperSonic
Imagine
AIXPLORER®
(predicate
K132171) | SuperSonic
Imagine
AIXPLORER®
(predicate
K132274) | SuperSonic
Imagine
AIXPLORER®
(new device) |
|------------------------------------------------|---------------------------------------------------|------------------------------------------|---------------------------------------------------------------|---------------------------------------------------------------|-----------------------------------------------------|
| | --** | General Radiology | --** | --** | --** |
| | Abdominal,
Small Organs* | Identical | Identical | Identical | Identical |
| | Musculoskeletal | Identical | Identical | Identical | Identical |
| | | Superficial
Musculoskeletal | Identical | Identical | Identical |
| Clinical
Applications | Fetal | Identical | Identical | --- | Identical |
| | --- | Transcranial | --- | --- | --- |
| | --- | OB | Identical | --- | Identical |
| | | GYN | Identical | Identical | Identical |
| | Cardiac | Identical | --- | --- | --- |
| | --- | Pelvic | Identical | Identical | Identical |
| | Adult and neonatal
cephalic | Identical | Identical (for
neonatal cephalic) | Identical (for
neonatal cephalic) | Identical |
| | Pediatric | Identical | Identical | Identical | Identical |
| | Urology | Identical | Identical | Identical | Identical |
| | --- | Vascular | Identical | Identical | Identical |
| | Peripheral
Vascular | Identical | Identical | Identical | Identical |
| | Ophthalmic | --- | --- | --- | --- |
| | Intra-operative | Identical | --- | --- | Identical |
| | Laparoscopic | --- | --- | --- | --- |
| | Trans-rectal | --- | Identical | Identical | Identical |
| | Trans-vaginal | --- | Identical | Identical | Identical |
| | Fetal echo | --- | --- | --- | Identical |
| Imaging
Modes | | | | | |
| | B-mode, | Identical | Identical | Identical | Identical |
| | M-mode, | Identical | Identical | --- | Identical |
| Conventional | PW, | Identical | Identical | Identical | Identical |
| | CW (continuous
Wave), | Identical | --- | --- | --- |
| | Color Doppler, | Identical | Identical | Identical | Identical |
| | Amplitude Doppler | Identical | Identical | Identical | Identical |
| | Harmonic imaging, | Identical | Identical | Identical | Identical |
| Other | Spatial
Compounding,
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 |
| Transducer
types | Curved Array | Identical | Identical | Identical | Identical |
| | Phased Array | Identical | --- | --- | Identical |
| | Laparoscopic | --- | --- | --- | --- |
| | probe | | | | |
| | Motorized Linear
Probe | Identical | Identical | Identical | Identical |
| | Microconvex
probe | Identical | Identical | Identical | Identical |
| Track | Track 3 (Acoustic
Output Display) | Identical | Identical | Identical | Identical |
| Patient
Contact
Materials | Yes, per ISO-
10993- 1 | Identical | Identical | Identical | Identical |
| Acoustic
Output within
FDA
guidelines | Yes, as per NEMA
UD-3 | Identical | Identical | Identical | Identical |
| General
Safety | Conforms to IEC
60601-1, IEC
60601-2 | Identical | Identical | Identical | Identical |

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

14

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 essential
performance tests.
UL 60601-1 1st Edition	All applicable electrical, basic safety and essential
performance tests specific to the U.S.A.
IEC 60601-1-2 3rd Edition	All applicable testing pertaining to electromagnetic
compatibility.
IEC 60601-2-37 2nd Edition	All applicable testing pertaining to the particular
requirements for the safety of ultrasonic medical
diagnostic and monitoring equipment.
NEMA UD 2 (Rev. 3)	All tests applicable in order to demonstrate
compliance with the "Acoustic Output
Measurement Standard for Diagnostic Ultrasound
Equipment".
NEMA UD 3 (Rev. 2)	All tests applicable in order to demonstrate
compliance with the "Standard For Real Time
Display Of Thermal And Mechanical Acoustic
Output Indices On Diagnostic Ultrasound
Equipment".
ISO 10993-1	Applicable biocompatibility tests per FDA 510(k)
Memorandum - #G95-1 – per the appropriate
device category.

16

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.