(89 days)
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).
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.
Here's a breakdown of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly state specific acceptance criteria in terms of performance metrics (e.g., sensitivity, specificity, accuracy) for a device relying on AI. Instead, it focuses on demonstrating substantial equivalence to predicate devices through technical characteristics and non-clinical testing. The "reported device performance" is implicitly that it meets the same safety and performance standards as the predicate devices.
| Acceptance Criteria Category | Specific Acceptance Criteria (Not Explicitly Stated) | Device Performance (Implicitly Met) |
|---|---|---|
| Safety | Compliance with IEC 60601-1, IEC 60601-1-2 | Met |
| Performance (Technical) | Compliance with IEC 60601-2-37, NEMA UD 2, NEMA UD 3 | Met |
| Biocompatibility | Compliance with ISO 10993-1 | Met |
| Intended Use | Capability to perform listed applications | Met |
| Technological Equivalence | Similar imaging modes, controls, transducers, etc. | Met |
| Acoustic Output | Within FDA guidelines | Met |
2. Sample Size Used for the Test Set and Data Provenance
The document states: "Clinical data is not required as the Aixplorer® and Aixplorer® Ultimate Systems use the same technology and principles as predicate devices." Therefore, no specific test set data (sample size or provenance) is provided for clinical performance, as a clinical study was not deemed necessary for this 510(k) submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
As no clinical test set was submitted for the purpose of demonstrating substantial equivalence, there is no information on experts used to establish ground truth.
4. Adjudication Method for the Test Set
Since no clinical test set was submitted, there is no information on an adjudication method.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was done or reported in this document. The submission focuses on substantial equivalence to predicate devices, not on the improvement of human readers with AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
The device is an "Ultrasound Diagnostic System," which inherently involves a human operator to acquire and interpret images. While it includes "ShearWave™ elastography," which might involve some algorithmic processing, the document does not describe a standalone algorithm-only performance study for an AI component in isolation. The focus is on the integrated system.
7. Type of Ground Truth Used
Given that clinical data was not required for this submission, no specific ground truth (e.g., pathology, outcomes data, expert consensus) was referenced for a clinical study. The "ground truth" implicitly relied upon is the established safety and performance characteristics of the predicate ultrasound devices and the adherence of the new device to relevant international technical standards.
8. Sample Size for the Training Set
As there's no mention of an AI algorithm requiring a training set in the context of this 510(k) summary for clinical performance, no information on the sample size for a training set is provided. The submission focuses on device hardware and software equivalence to existing ultrasound technology.
9. How the Ground Truth for the Training Set Was Established
Since no training set is mentioned in the context of AI development for clinical performance, there is no information on how its ground truth would have been established.
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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.
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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.
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
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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)
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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. 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
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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 | SuperSonicImagine | New devices | |
|---|---|---|---|
| Toshiba Device(predicate) | SuperSonicImagineAIXPLORER®(predicate) | SuperSonic ImagineAIXPLORER® &AIXPLORER®Ultimate(New devices) | |
| 510(k)Number | K141459 | K161999 | Unassigned |
| ClassificationName | Ultrasonic PulsedDoppler Imaging System(892.1550)Ultrasonic Pulsed EchoImaging System(892.1560)Diagnostic UltrasoundTransducer (892.1570) | Identical | Identical |
| Class | Class II | Identical | Identical |
| Toshiba | SuperSonicImagine | New devices | |
| Intended Use | Identical | Identical | Diagnostic ultrasoundimaging, soft tissueelasticity imaging, fluidflow analysis of thehuman body |
| GeneralDescription | General purpose,mobile, softwarecontrolled diagnosticultrasound system. Toacquire ultrasound dataand to display the datain various modes ofoperation. | Identical | Identical |
| Consists of two parts:the system console andthe transducer. Thesystem console containsthe user interface, adisplay, systemelectronics and optionalperipherals (printers,etc...). | Identical | Identical | |
| Includes physical knobsand buttons of the maincontrol panel and theuser interface whichconsists of a TouchPanel, to accessadditional less-frequently-used controls,and the AlphanumericKeyboard to enterpatient data and othertext. | Identical | Identical | |
| SWEDynamicRange | --- | Adjustable rangecapability andnumeric display withscale | Identical to K161999 |
| ClinicalApplications | Abdominal,Small Organs*MusculoskeletalSuperficialMusculoskeletalFetal | IdenticalIdenticalIdenticalIdenticalIdenticalIdentical | IdenticalIdenticalIdenticalIdenticalIdenticalIdentical |
| Toshiba | SuperSonicImagine | New devices | |
| Cardiac | Identical | Identical | |
| Adult and neonatalcephalic | 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 (calledAngio PL.U.S) | Identical (called AngioPL.U.S) | |
| Other | Spatial Compounding,Panoramic,Contrast | Identical | Identical |
| Combination of modes | Identical | Identical | |
| Design | |||
| Cart | Mobile cart-basedproduct with controlpanel and monitor | Identical | Identical |
| Controls | Typical ultrasoundimaging controlsincluding power output,gain, depth, focus,freeze, PRF, modeselect | Identical | Identical |
| Toshiba | SuperSonicImagine | New devices | |
| Transducers | |||
| Transducertypes | Linear ArrayCurved ArrayPhased Array | IdenticalIdenticalIdentical | IdenticalIdenticalIdentical |
| Motorized Linear ProbeMicroconvex probe | IdenticalIdentical | IdenticalIdentical | |
| Biopsy guide | YesBEAM | Yes--- | Yesldentical (calledNeedle PL.U.S.) |
| Track | Track 3 (Acoustic OutputDisplay) | Identical | Identical |
| PatientContactMaterials | Yes, per ISO-10993-1 | Identical | Identical |
| AcousticOutput withinFDAquidelines | Yes, as per NEMA UD-3 | Identical | Identical |
| ImageReview | Yes | ldentical | Identical |
| MeasurementPackage | Yes | ldentical | ldentical |
| CalculationPackage | Yes | Identical | Identical |
| Report | Yes | Identical | Identical |
| GeneralSafety | Conforms to IEC 60601-1, IEC 60601-1-2, IEC60601-2-37 | Identical | Identical |
| Labeling | Conforms to 21 CFRPart 801 | Identical | Identical |
| GeneralDescription | Consists of two parts:the system console andthe transducer. Thesystem console containsthe user interface, adisplay, systemelectronics and optionalperipherals (printers,etc ). | Identical | Identical |
| GeneralDescriptionSWEDynamicRange | Includes physical knobsand buttons of the maincontrol panel and theuser interface whichconsists of a Touch | Identical | Identical |
| Toshiba | SuperSonicImagine | New devices | |
| Panel, to accessadditional less-frequently-used controls,and the AlphanumericKeyboard to enterpatient data and othertext. | |||
| --- | Adjustable rangecapability andnumeric display withscale | Identical to K161999 |
6) Summary of Technological Characterisitics - New Device compared to Predicates
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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 essentialperformance tests. |
| 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 "Accoustic OutputMeasurement Standard for Diagnostic UltrasoundEquipment". |
| NEMA UD 3 (Rev. 2) | All tests applicable in order to demonstratecompliance with the "Standard For Real TimeDisplay Of Thermal And Mechanical AcousticOutput Indices On Diagnostic UltrasoundEquipment". |
| ISO 10993-1 | Applicable biocompatibility tests per FDA 510(k)Memorandum - #G95-1 - per the appropriatedevice category. |
The above testing confirmed that the 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
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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.
§ 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.