Who is the manufacturer of AIXPLORER® & AIXPLORER® Ultimate Ultrasound Systems?

Supersonic Imagine filed the 510(k) submission for AIXPLORER® & AIXPLORER® Ultimate Ultrasound Systems (K171105).

What is the FDA product code for AIXPLORER® & AIXPLORER® Ultimate Ultrasound Systems?

IYN. It is classified under 21 CFR 892.1550 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for AIXPLORER® & AIXPLORER® Ultimate Ultrasound Systems?

510(k) clearance (submission type: Traditional).

What are the predicate devices for AIXPLORER® & AIXPLORER® Ultimate Ultrasound Systems?

Toshiba System, Diagnostic Ultrasound (K141459); AIXPLORER® Ultrasound Imaging System (K161999).

Who can help prepare an FDA 510(k) submission like AIXPLORER® & AIXPLORER® Ultimate Ultrasound Systems?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

AIXPLORER® & AIXPLORER® Ultimate Ultrasound Systems

K171105 · Supersonic Imagine · IYN · Jul 11, 2017 · Radiology

Device Facts

Record ID	K171105
Device Name	AIXPLORER® & AIXPLORER® Ultimate Ultrasound Systems
Applicant	Supersonic Imagine
Product Code	IYN · Radiology
Decision Date	Jul 11, 2017
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.1550
Device Class	Class 2
Attributes	Pediatric

Intended Use

The SuperSonic Imagine AIXPLORER® & AIXPLORER® Ultimate ultrasound diagnostic systems and transducers are intended for general purpose pulse echo ultrasound imaging, soft tissue elasticity imaging, Doppler fluid flow analysis of the human body. The SuperSonic Imagine AIXPLORER® & AIXPLORER® Ultimate ultrasound diagnostic systems are 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, Non-invasive Cardiac. The systems also provide the ability to measure anatomical structures (Abdominal. Small Organs, Musculoskeletal, Superficial Musculoskeletal, Peripheral Vascular, Intraoperative, GYN, Pelvic, Pediatric, Urology, Trans-rectal, Trans-vaginal, Neonatal/Adult Cephalic, Fetal/Obstetrics, Cardiac).

Device Story

Cart-based ultrasound system; utilizes various linear, curved, micro-convex, and phased array transducers. Inputs: acoustic signals processed via scan converter. Outputs: B-mode, M-mode, Color Flow (CFI, CPI, Angio PL.U.S), Pulsed Wave Doppler, 3D imaging, and ShearWave™ elastography displayed on LCD monitor. Operated by clinicians in clinical settings. System includes control panel, touch screen, and alphanumeric keyboard for patient data entry. Enables anatomical measurements, image capture, and report generation. Benefits: non-invasive diagnostic imaging and tissue elasticity assessment to support clinical decision-making.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, including electrical safety (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2), ultrasonic safety (IEC 60601-2-37), acoustic output measurement (NEMA UD 2, UD 3), and biocompatibility (ISO 10993-1).

Technological Characteristics

Cart-based ultrasound system; LCD monitor; touch screen/physical control interface. Transducers: linear, curved, micro-convex, phased array. Imaging modes: B-mode, M-mode, Color Flow, PW Doppler, 3D, ShearWave™ elastography. Connectivity: digital memory, external printer. Biocompatibility: ISO 10993-1 compliant. Safety: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37. Acoustic output: NEMA UD-2, UD-3. Software-controlled.

Indications for Use

Indicated for general purpose pulse echo ultrasound imaging, soft tissue elasticity imaging, and Doppler fluid flow analysis in patients requiring abdominal, small organ, musculoskeletal, superficial musculoskeletal, vascular, peripheral vascular, intraoperative, OB-GYN, pelvic, pediatric, urological, trans-rectal, trans-vaginal, neonatal/adult cephalic, or non-invasive cardiac examinations.

Regulatory Classification

Identification

An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Predicate Devices

Toshiba System, Diagnostic Ultrasound (K141459)
AIXPLORER® Ultrasound Imaging System (K161999)

Related Devices

K102041 — AIXPLORER · Supersonic Imagine · Oct 13, 2010
K121329 — AIXPLORER · Supersonic Imagine · Aug 24, 2012
K112255 — AIXPLORER · Supersonic Imagine · Aug 28, 2012
K142100 — AIXPLORER · Supersonic Imagine · Nov 20, 2014
K161999 — Aixplorer · Supersonic Imagine · Nov 16, 2016

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of three human profiles facing to the right, stacked on top of each other. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 July 11, 2017 Supersonic Imagine % Mr. Laurence Hermitte Quality & Regulatory Affairs Director Les Jardins de la Duranne 510, rue Rene Descartes - Bat E&F Aix-en-Provence Cedex 13857 FRANCE Re: K171105 Trade/Device Name: AIXPLORER® & AIXPLORER® Ultimate Ultrasound Systems Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed Doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: April 14, 2017 Received: April 17, 2017 Dear Mr. Hermitte: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (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. Michael D.'Hara For Robert Ochs. Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ### Indications for Use 510(k) Number (if known) K171105 #### Device Name AIXPLORER® & AIXPLORER® Ultimate Ultrasound Diagnostic Systems Indications for Use (Describe) The SuperSonic Imagine AIXPLORER® & AIXPLORER® Ultimate Ultrasound Diagnostic Systems and transducers are intended for general purpose pulse echo ultrasound imaging, soft tissue elasticity imaging, Doppler fluid flow analysis of the human body. The SuperSonic Imagine AIXPLORER® & AIXPLORER® Ultimate Ultrasound Diagnostic Systems are indicated for use in the following applications: Abdominal, Small Organs, Musculoskeletal, Superficial Musculoskeletal, Vascular, Peripheral Vascular, Intraoperative, OB-GYN, Pelvic, Pediatric, Urology, Trans-vaginal, Neonatal/Adult Cephalic, and Non-invasive Cardiac. The system also provides the ability to measure anatomical structures (Abdominal, Small Organs, Musculoskeletal, Superficial Musculoskeletal, Peripheral Vascular, Intraoperative, GYN, Pediatric, Urology, Trans-rectal, Transvaginal, Neonatal/Adult Cephalic, Fetal/Obstetrics, Cardiac). Type of Use (Select one or both, as applicable) > Prescription Use (Part 21 CFR 801 Subpart D) _ Over-The-Counter Use (21 CFR 801 Subpart C) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "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." FORM FDA 3881 (8/14) {3}------------------------------------------------ # 510(k) Summary of Safety and Effectiveness This summary of safety and effectiveness information is submitted in accordance with 21 CFR §807.92. #### 1) Submitter's name, address, telephone number, contact person Submitted by: SuperSonic Imagine, S.A. Les Jardins de la Duranne - Bât. E & F 510. rue René Descartes 13857 Aix-en-Provence Cedex France Telephone: +33 442 99 24 24 Distributed by: SuperSonic Imagine, Inc. Weston North America Telephone: +1(954) 660 3528 Corresponding Official: Jacques Souquet Chief Innovation Officer Telephone: +33 442 99 24 35 Date: 2017.03.31 #### Name of the device, including the trade or proprietary name if applicable, the common or usual 2) name, and the classification name, if known: Common/Usual Name: Diagnostic Ultrasound System with Accessories Proprietary Name: AIXPLORER® & AIXPLORER® Ultimate Ultrasound Diagnostic Systems 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 Toshiba System, Diagnostic Ultrasound (K141459), cleared on 10/28/2014 AIXPLORER® Ultrasound Imaging System (K161999), cleared on 11/16/2016 #### 4) Description of Device The SuperSonic Imagine AIXPLORER® & AIXPLORER® Ultimate are 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 {4}------------------------------------------------ quickly and efficiently in accordance with ALARA principles. The system also allows the user to perform measurements, capture images to digital memory or to an external device (such as a printer), and review diagnostic studies in the form of a report. The system functions in a manner identical to the predicate devices and transducers for the imaging modes: B-Mode (harmonic or fundamental), M-mode, Color Flow (and sub-modes as CFI-ColorFlow Imaging, CPI-ColorPower Imaging- also called Amplitude Doppler, dCPI, and Angio PL.U.S), Pulsed Wave Doppler, 3D imaging and for ShearWave™ elastography. ## 5) Intended Use The SuperSonic Imagine AIXPLORER® & AIXPLORER® Ultimate ultrasound diagnostic systems and transducers are intended for general purpose pulse echo ultrasound imaging, soft tissue elasticity imaging, Doppler fluid flow analysis of the human body. The SuperSonic Imagine AIXPLORER® & AIXPLORER® Ultimate ultrasound diagnostic systems are 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, Non-invasive Cardiac. The systems also provide the ability to measure anatomical structures (Abdominal. Small Organs, Musculoskeletal, Superficial Musculoskeletal, Peripheral Vascular, Intraoperative, GYN, Pelvic, Pediatric, Urology, Trans-rectal, Trans-vaginal, Neonatal/Adult Cephalic, Fetal/Obstetrics, Cardiac). | | Toshiba | SuperSonic Imagine | New devices | |---------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------| | | Toshiba Device (predicate) | SuperSonic Imagine AIXPLORER® (predicate) | SuperSonic Imagine AIXPLORER® & AIXPLORER® Ultimate (New devices) | | 510(k) Number | K141459 | K161999 | Unassigned | | Classification Name | Ultrasonic Pulsed Doppler Imaging System (892.1550) Ultrasonic Pulsed Echo Imaging System (892.1560) Diagnostic Ultrasound Transducer (892.1570) | Identical | Identical | | Class | Class II | Identical | Identical | | | Toshiba | SuperSonic Imagine | New devices | | Intended Use | Identical | Identical | Diagnostic ultrasound imaging, soft tissue elasticity imaging, fluid flow analysis of the human body | | General Description | General purpose, mobile, software controlled diagnostic ultrasound system. To acquire ultrasound data and to display the data in various modes of operation. | Identical | Identical | | | Consists of two parts: the system console and the transducer. The system console contains the user interface, a display, system electronics and optional peripherals (printers, etc...). | Identical | Identical | | | Includes physical knobs and buttons of the main control panel and the user interface which consists of a Touch Panel, to access additional less- frequently-used controls, and the Alphanumeric Keyboard to enter patient data and other text. | Identical | Identical | | SWE Dynamic Range | --- | Adjustable range capability and numeric display with scale | Identical to K161999 | | Clinical Applications | Abdominal, Small Organs* Musculoskeletal Superficial Musculoskeletal Fetal | Identical Identical Identical Identical Identical Identical | Identical Identical Identical Identical Identical Identical | | | Toshiba | SuperSonic Imagine | New devices | | | Cardiac | Identical | Identical | | | Adult and neonatal cephalic | Identical | Identical | | | Pediatric | Identical | Identical | | | Urology | Identical | Identical | | | Vascular | Identical | Identical | | | Peripheral Vascular | Identical | Identical | | | Intra-operative | Identical | Identical | | | Trans-rectal | Identical | Identical | | | Trans-vaginal | Identical | Identical | | Imaging Modes | | | | | | B-mode (Harmonic/Fundamental) | Identical | Identical | | | M-mode, | Identical | Identical | | | PW, CW (continuous Wave), | Identical | Identical | | Conventional | | --- | --- | | | Color Doppler, | Identical | Identical | | | Amplitude Doppler (CPI), | Identical | Identical | | | Microvascular SMI | Identical (called Angio PL.U.S) | Identical (called Angio PL.U.S) | | Other | Spatial Compounding, Panoramic, Contrast | Identical | Identical | | | Combination of modes | Identical | Identical | | Design | | | | | Cart | Mobile cart-based product with control panel and monitor | Identical | Identical | | Controls | Typical ultrasound imaging controls including power output, gain, depth, focus, freeze, PRF, mode select | Identical | Identical | | | Toshiba | SuperSonic Imagine | New devices | | Transducers | | | | | Transducer types | Linear Array Curved Array Phased Array | Identical Identical Identical | Identical Identical Identical | | | Motorized Linear Probe Microconvex probe | Identical Identical | Identical Identical | | Biopsy guide | Yes BEAM | Yes --- | Yes ldentical (called Needle PL.U.S.) | | Track | Track 3 (Acoustic Output Display) | Identical | Identical | | Patient Contact Materials | Yes, per ISO-10993-1 | Identical | Identical | | Acoustic Output within FDA quidelines | Yes, as per NEMA UD-3 | Identical | Identical | | | | | | | Image Review | Yes | ldentical | Identical | | Measurement Package | Yes | ldentical | ldentical | | Calculation Package | Yes | Identical | Identical | | Report | Yes | Identical | Identical | | General Safety | Conforms to IEC 60601- 1, IEC 60601-1-2, IEC 60601-2-37 | Identical | Identical | | | | | | | Labeling | Conforms to 21 CFR Part 801 | Identical | Identical | | General Description | Consists of two parts: the system console and the transducer. The system console contains the user interface, a display, system electronics and optional peripherals (printers, etc ). | Identical | Identical | | General Description SWE Dynamic Range | Includes physical knobs and buttons of the main control panel and the user interface which consists of a Touch | Identical | Identical | | Toshiba | SuperSonic Imagine | New devices | | | Panel, to access additional less- frequently-used controls, and the Alphanumeric Keyboard to enter patient data and other text. | | | | | --- | Adjustable range capability and numeric display with scale | Identical to K161999 | | # 6) Summary of Technological Characterisitics - New Device compared to Predicates {5}------------------------------------------------ {6}------------------------------------------------ {7}------------------------------------------------ {8}------------------------------------------------ Note: *: Breast, Thyroid, Testicle, etc #### 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 3.1 Edition | All applicable electrical, basic safety and essential performance tests. | | 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 "Accoustic Output Measurement Standard for Diagnostic Ultrasound Equipment". | | NEMA UD 3 (Rev. 2) | All tests applicable in order to demonstrate compliance with the "Standard For Real Time Display Of Thermal And Mechanical Acoustic Output Indices On Diagnostic Ultrasound Equipment". | | ISO 10993-1 | Applicable biocompatibility tests per FDA 510(k) Memorandum - #G95-1 - per the appropriate device category. | 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 non-clinical testing confirmed the substantial equivalence of the Aixplorer® Ultimate 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 {9}------------------------------------------------ Clinical data is not required as the Aixplorer® and Aixplorer® Ultimate Systems use 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.