(89 days)
Not Found
No
The document describes a standard ultrasound system and its functionalities, with no mention of AI or ML in the device description, intended use, or performance studies. The name "AIXPLORER" is likely a brand name and not indicative of AI technology based on the provided information.
No
The device is described as an "Ultrasound Diagnostic System" intended for "general purpose pulse echo ultrasound imaging, soft tissue elasticity imaging, Doppler fluid flow analysis" and "non-invasive diagnostic general purpose ultrasound imaging studies." This indicates diagnostic, not therapeutic, use.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "Ultrasound Diagnostic Systems" and is intended for "general purpose pulse echo ultrasound imaging" and "Doppler fluid flow analysis of the human body." The "Device Description" also refers to it as an "ultrasound imaging system used to perform non-invasive diagnostic general purpose ultrasound imaging studies."
No
The device description explicitly states it is a "cart based ultrasound imaging system" and includes hardware components like transducers, a scan converter, LCD monitor, and control panel.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health.
- Device Description: The description clearly states that the SuperSonic Imagine AIXPLORER® & AIXPLORER® Ultimate are "cart based ultrasound imaging system used to perform non-invasive diagnostic general purpose ultrasound imaging studies."
- Intended Use: The intended use describes imaging and analysis of the human body, not analysis of specimens taken from the body.
- Input Modality: Ultrasound is a non-invasive imaging technique that does not involve the analysis of in vitro specimens.
The device is a diagnostic imaging system that uses ultrasound to visualize structures within the body. This is distinct from the function of an IVD.
N/A
Intended Use / Indications for 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-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).
Product codes (comma separated list FDA assigned to the subject device)
IYN, IYO, ITX
Device Description
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Abdominal, Small Organs, Musculoskeletal, Superficial Musculoskeletal, Vascular, Peripheral Vascular, Intraoperative, OB-GYN, Pelvic, Pediatric, Urology, Trans-rectal, Trans-vaginal, Neonatal/Adult Cephalic, Non-invasive Cardiac, Fetal/Obstetrics
Indicated Patient Age Range
Neonatal/Adult Cephalic, Pediatric, Adult
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)
Clinical data is not required as the Aixplorer® and Aixplorer® Ultimate Systems use the same technology and principles as predicate devices.
Non-clinical testing was conducted per the following standards to support a determination of substantial equivalence to the predicate devices:
- 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).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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)
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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.