(85 days)
The SuperSonic Imagine AIXPLORER® MACH 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® MACH ultrasound diagnostic systems are indicated for use in the following applications, for imaging and measurement of anatomical structures: Abdominal, Small Organs, Musculoskeletal, Superficial Musculoskeletal, Vascular, Peripheral Vascular, Intraoperative, OB-GYN, Pelvic, Pediatric, Urology, Transrectal, Trans-vaginal and Neonatal/Adult Cephalic, Non-invasive Cardiac.
In addition, the SuperSonic Imagine AIXPLORER® MACH ultrasound diagnostic systems and associated transducers are intended for:
-
Measurements of abdominal anatomical structures,
-
Measurements of broad band shear wave speed, and tissue stiffness in internal structures of the liver and the spleen,
-
Measurements of brightness ratio between liver and kidney,
-
Visualization of abdominal vascularization, microvascularization and perfusion,
-
Quantification of abdominal vascularization and perfusion.
The shear wave speed and stiffness measurements, the brightness ratio, the visualization of vascularization,
microvascularization and perfusion, the quantification of vascularization may be used as an aid to clinical management of adult and pediatric patients with liver disease.
The SuperSonic Imagine AIXPLORER® MACH systems are cart based ultrasound imaging systems 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-directional Color Power Imaging and Angio PL.U.S), Pulsed Wave Doppler, Continuous Wave Doppler, 3D imaging, CEUS-Contrast Enhanced Ultrasound Imaging and for ShearWave™ elastography.
The provided document is a 510(k) Summary for the SuperSonic Imagine AIXPLORER® MACH Ultrasound Diagnostic Systems. It describes the device, its intended use, and its substantial equivalence to predicate devices, supported by non-clinical testing and clinical evaluation via literature review. No primary clinical study data with specific acceptance criteria and detailed performance metrics of the device are present in this document.
Therefore, many of your requested details cannot be extracted from this specific 510(k) summary as it does not contain a primary clinical study description with acceptance criteria, sample sizes, expert ground truth establishment, or multi-reader multi-case study data.
Here's a breakdown of what can be extracted and what information is not available from this document:
1. A table of acceptance criteria and the reported device performance
- Not Available. This document does not specify quantitative acceptance criteria for device performance nor does it report specific performance metrics from a clinical study for the AIXPLORER® MACH systems.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Available. The document states that a "clinical evaluation by literature route" was performed, indicating no new primary clinical test set was used for the AIXPLORER® MACH device for this submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Available. Since no new primary clinical test set was used, there is no information on experts establishing ground truth for such a set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Available. As no new primary clinical test set was used, no adjudication method is mentioned.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not Available. This document does not describe an MRMC comparative effectiveness study. The AIXPLORER® MACH is an ultrasound diagnostic system and is not presented as an AI-assisted reading device in this context. The "AIXPLORER® MACH" name refers to the product family and not necessarily a specific AI algorithmic component for interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Available. This document describes an ultrasound diagnostic system, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Available. Since no new primary clinical study was conducted for this submission, no specific ground truth type is mentioned for a test set. The clinical evaluation relied on literature, implying that existing, previously established diagnostic methods or outcomes referenced in that literature would have served as de facto ground truth for those earlier studies.
8. The sample size for the training set
- Not Applicable / Not Available. This document describes the 510(k) clearance for an ultrasound diagnostic system, which is a hardware and software system for image acquisition and display, not a machine learning algorithm requiring a "training set" in the typical sense. Any internal algorithm development for image processing would not be detailed in this summary with specific training set sizes.
9. How the ground truth for the training set was established
- Not Applicable / Not Available. See point 8.
Summary of available information regarding compliance and equivalence:
The document focuses on establishing substantial equivalence to previously cleared predicate devices:
Non-Clinical Testing:
Non-clinical testing was performed according to several international and FDA-recognized standards to support substantial equivalence:
- IEC 60601-1 Ed.3.1 (Electrical, basic safety, and essential performance)
- IEC 60601-1-2 Ed.4 (Electromagnetic compatibility)
- IEC 60601-2-37 Ed.2.1 (Particular requirements for safety of ultrasonic medical diagnostic and monitoring equipment)
- NEMA UD 2 (Rev. 3) (Acoustic Output Measurement Standard)
- NEMA UD 3 (Rev. 2) (Real Time Display of Thermal and Mechanical Acoustic Output Indices)
- ISO 10993-1 (Biocompatibility)
The document states: "All data fell within pre-determined product specifications and external standard requirements. Results of non-clinical testing confirmed the substantial equivalence of the Aixplorer® MACH Systems to the predicate device(s)."
Clinical Evaluation:
A clinical evaluation was conducted "by literature route" to support substantial equivalence and to potentially expand the indications for use. This means existing scientific literature and studies related to similar ultrasound technologies and their clinical performance were reviewed, rather than conducting a new, dedicated clinical trial for the AIXPLORER® MACH systems themselves.
Conclusion stated in the document:
"The manufacturer and the design and development of the submission device comply with 21 CFR Part 820 and ISO 13485 (2016) Quality Standards. The submission device, designed to comply with applicable safety standards, is tested during the manufacturing process to ensure compliance with these standards. Performance testing demonstrated that the submission device is at least as safe and effective as the predicate devices listed in item 3."
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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
May 29, 2018
SuperSonic Imagine % Laurence Hermitte Quality & Regulatory Affairs Director Les jardins de la Duranne - Bat E&F - 510 rue Rene Descartes Aix-en-Provence, 13857 FRANCE
Re: K180572
Trade/Device Name: AIXPLORER® MACH Ultrasound Diagnostic Systems AIXPLORER® MACH 30, AIXPLORER® MACH 20, AIXPLORER® MACH 10 Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: March 8, 2018 Received: March 12, 2018
Dear Laurence 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 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);
{1}------------------------------------------------
Page 2 - Laurence Hermitte
and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Michael D. O'HaraFor
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) K180572
Device Name
AIXPLORER MACH Ultrasound Diagnostic Systems AIXPLORER MACH 30, AIXPLORER MACH 20, AIXPLORER MACH 10
Indications for Use (Describe)
The SuperSonic Imagine AIXPLORER® MACH 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® MACH ultrasound diagnostic systems are indicated for use in the following applications, for imaging and measurement of anatomical structures: Abdominal, Small Organs, Musculoskeletal, Superficial Musculoskeletal, Vascular, Peripheral Vascular, Intraoperative, OB-GYN, Pelvic, Pediatric, Urology, Transrectal, Trans-vaginal and Neonatal/Adult Cephalic, Non-invasive Cardiac.
In addition, the SuperSonic Imagine AIXPLORER® MACH ultrasound diagnostic systems and associated transducers are intended for:
-
Measurements of abdominal anatomical structures,
-
Measurements of broad band shear wave speed, and tissue stiffness in internal structures of the liver and the spleen,
-
Measurements of brightness ratio between liver and kidney,
-
Visualization of abdominal vascularization, microvascularization and perfusion,
-
Quantification of abdominal vascularization and perfusion.
The shear wave speed and stiffness measurements, the brightness ratio, the visualization of vascularization,
microvascularization and perfusion, the quantification of vascularization may be used as an aid to clinical management of adult and pediatric patients with liver disease.
| 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.
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{3}------------------------------------------------
510(k) number (if known):
Device Name: AIXPLORER® MACH 30 (SSIP95030), AIXPLORER® MACH 20 (SSIP95020) and AIXPLORER® MACH 10 (SSIP95010) Ultrasound Diagnostic Systems
Intended Use: Diagnostic ultrasound imaging, soft tissue elasticity imaging, fluid flow analysis of the human body as follows:
| Clinical Application | ||||||||
|---|---|---|---|---|---|---|---|---|
| General(Track 1 Only) | Specific(Tracks 1 & 3) | B | M | PWD | CWD | ColorDoppler | Combined (Specify) | Other* (Specify) |
| Ophthalmic | Ophthalmic | |||||||
| Fetal Imaging &Other | Fetal | N | N | N | N | N | N 1, 3, 4, 11 | N 5, 6, 10 |
| Abdominal (including urolology): Liver,Kidney, Spleen... | N | N | N | N | N | N 1, 2, 3, 4 | N 5, 6, 7, 8, 9, 10, 11,13,14, 16 | |
| Intra-operative (Specify) vascular,abdominal, small organs | N | N | N | N 1, 3, 4 | N 5, 6, 8, 9 | |||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | N | N | N | N | N | N 1, 2, 3, 4 | N 5, 6, 7, 8, 9, 10, 11, 13,16 | |
| Small Organ (Breast, Thyroid,Testicle, Prostate, penis, etc...) | N | N | N | N 1, 2, 3, 4,12 | N 5, 6, 7, 8, 9, 10, 14 | |||
| Neonatal Cephalic | N | N | N | N 1, 2, 3, 4 | N 5, 6, 7, 9 | |||
| Adult Cephalic | N | N | N | N 1, 3, 4 | N 5, 6 | |||
| Trans-rectal | N | N | N | N 1, 2, 3, 4 | N 5, 6, 7, 8 | |||
| Trans-vaginal | N | N | N | N | N | N 1, 2, 3, 4 | N 5, 6, 7, 8, 11 | |
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Musculo-skeletal (Conventional) | N | N | N | N 1, 2, 3, 4 | N 5, 6, 7, 8, 9, 10, 14 | |||
| Musculo-skeletal (Superficial) | N | N | N | N 1, 2, 3, 4 | N 5, 6, 7, 8, 9, 10, 14 | |||
| Intravascular | ||||||||
| GYN | N | N | N | N | N | N 1, 2, 3, 4 | N 5, 6, 7, 8 11, 14 | |
| Pelvic | N | N | N | N | N | N 1, 2, 3, 4 | N 5, 6, 7, 8,11, 14 | |
| Other (Specify) | ||||||||
| Cardiac | Cardiac Adult | N | N | N | N | N | N 1, 3, 4, 11, 17,18 | N, 5 |
| Cardiac Pediatric | ||||||||
| Intravascular (Cardiac) | ||||||||
| Trans-esoph. (Cardiac) | ||||||||
| Intra-cardiac | ||||||||
| Other (Specify) | ||||||||
| PeripheralVessel | Peripheral vessel | N | N | N | N, 1, 3, 4 | N, 5, 6, 8, 9, 10 | ||
| Other (Specify) | N | N | N | N, 1, 3, 4 | N, 5, 6, 8, 9, 10 |
N = new indication;
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
Prescription Use X (Part 21 CFR 801 Subpart D) 11: Combined modes include: B+ M mode
12: Combined modes include: B Mode + Color flow +
Shearwave™ Elastography
-
13: CEUS (Contrast Enhancement UltraSound)
14: Angio PL.U.S (Color Doppler improvement) -
15: Needle PL.U.S
-
16: Brightness ratio
-
17: Combined mode include: B+ Continuous Wave
-
18: Combined mode include: B+ M mode + Color flow
Over-The-Counter Use
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
AND/OR
{4}------------------------------------------------
510(k) Number (if known):
Device Name: L10-2 transducer (SSIP95103)
Intended Use: Diagnostic ultrasound imaging, soft tissue elasticity imaging, fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General(Track 1 Only) | Specific(Tracks 1 & 3) | B | M | PWD | CWD | ColorDoppler | Combined(Specify) | Other* (Specify) |
| Ophthalmic | Ophthalmic | |||||||
| Fetal Imaging& Other | Fetal | |||||||
| Abdominal (including urolology): Liver,Kidney, Spleen... | N | N | N | N | N | N, 1, 2, 3, 4 | N, 5, 6, 7, 8, 9, 13,14, 15,16 | |
| Intra-operative (Specify) | ||||||||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | N | N | N | N | N | N, 1, 2, 3, 4 | N, 5, 6, 7, 8, 9, 15, 16 | |
| Small Organ (for example Breast, Thyroid,Testicle, Prostate, penis, etc...) | N | N | N | N | N | N, 1, 2, 3, 4,12 | N, 5, 6, 7, 8, 9, 1415 | |
| Neonatal Cephalic | N | N | N | N | N | N, 1, 2, 3, 4 | N, 5, 6, 7, 9 | |
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Musculo-skeletal (Conventional) | N | N | N | N | N | N, 1, 2, 3, 4 | N, 5, 6, 7, 8, 9, 1415 | |
| Musculo-skeletal (Superficial) | N | N | N | N | N | N, 1, 2, 3, 4 | N, 5, 6, 7, 8, 9, 1415 | |
| Intravascular | ||||||||
| GYN | ||||||||
| Pelvic | ||||||||
| Other (Specify) | ||||||||
| Cardiac | Cardiac Adult | |||||||
| Cardiac Pediatric | ||||||||
| Intravascular (Cardiac) | ||||||||
| Trans-esoph. (Cardiac) | ||||||||
| Intra-cardiac | ||||||||
| Other (Specify) | ||||||||
| PeripheralVessel | Peripheral vessel | N | N | N | N | N | N, 1, 3, 4 | N, 5, 6, 8, 915 |
| Other (Specify) | N | N | N | N | N | N, 1, 3, 4 | N, 5, 6, 8, 915 |
N = new indication;
5: Harmonic Imaging
6: Spatial Compounding
7: ShearWave™ Elastography
8: Imaging Guidance for Biopsies
Additional Comments:
1: Combined modes include: B+ Color Flow 2: Combined modes include: B+ ShearWave™ Elastography
3: Combined modes include: B+ Pulsed Wave
9: Panoramic Imaging
10: 3D Imaging
11: Combined modes include: B+ M mode
4: Combined modes include: B+ Pulsed Wave + Color Flow 12: Combined modes include: B Mode + Color flow + Shearwave™
Elastography
13: CEUS (Contrast Enhancement UltraSound)
14: Angio PL.U.S (Color Doppler improvement)
- 15: Needle PL.U.S
- 16: Brightness ratio
17: Combined mode include: B+ Continuous Wave
18: Combined mode incluseds: B+ M mode + Color flow Over-The-Counter Use
AND/OR
Prescription Use X (Part 21 CFR 801 Subpart D)
(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)
{5}------------------------------------------------
510(k) Number (if known):
Device Name: C6-1X transducer (SSIP95101)
Intended Use: Diagnostic ultrasound imaging, soft tissue elasticity imaging, fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General(Track 1 Only) | Specific(Tracks 1 & 3) | B | M | PWD | CWD | ColorDoppler | Combined(Specify) | Other* (Specify) |
| Ophthalmic | Ophthalmic | |||||||
| Fetal Imaging &Other | Fetal | N | N | N | N | N | N 1, 3, 4, 11 | N 5, 6 |
| Abdominal (including urolology), Liver,Kidney, Spleen. | N | N | N | N | N | N 1, 2, 3, 4, 11 | N 5, 6, 7, 8, 9, 13,14, 16, | |
| Intra-operative (Specify) | ||||||||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | N | N | N | N | N | N 1, 2, 3, 4 | N 5, 6, 7, 8, 13,16 | |
| Small Organ (Breast, Thyroid, Testicle,Prostate, penis, etc...) | N | N | N | N | N | N 1, 2, 3, 4 | N 5, 6, 7, 8 | |
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Musculo-skeletal (Conventional) | ||||||||
| Musculo-skeletal (Superficial) | ||||||||
| Intravascular | ||||||||
| GYN | N | N | N | N | N | N 1, 2, 3, 4 | N 5, 6, 7, 8, 14 | |
| Pelvic | N | N | N | N | N | N 1, 2, 3, 4 | N 5, 6, 7, 8, 14 | |
| Other (Specify) | ||||||||
| Cardiac | Cardiac Adult | |||||||
| Cardiac Pediatric | ||||||||
| Intravascular (Cardiac) | ||||||||
| Trans-esoph. (Cardiac) | ||||||||
| Intra-cardiac | ||||||||
| Other (Specify) | ||||||||
| PeripheralVessel | Peripheral vessel | N | N | N | N | N | N 1, 3, 4 | N 5, 6, 8 |
| Other (Specify) | N | N | N | N | N | N 1, 3, 4 | N 5, 6, 8 |
N = new indication;
Additional Comments:
5: Harmonic Imaging
6: Spatial Compounding 7: ShearWave™ Elastography
- 1: Combined modes include: B+ Color Flow
3: Combined modes include: B+ Pulsed Wave
4: Combined modes include: B+ Pulsed Wave + Color Flow
9: Panoramic Imaging 2: Combined modes include: B+ ShearWave™ Elastography 10: 3D Imaging
- 3D Imaging
- Combining data
11: Combined modes include: B+ M modes
- 12: Combined modes include: B Mode + Color flow + Shearwave™
Elastography
13: CEUS (Contrast Enhancement UltraSound)
14: Angio PL.U.S (Color Doppler improvement)
- 15: Needle PL.U.S.
- 16: Brightness ratio
17: Combined mode include: B+ Continuous Wave
18: Combined mode incluseds: B+ M mode + Color flow
Prescription Use X (Part 21 CFR 801 Subpart D)
8: Imaging Guidance for Biopsies
- AND/OR
- Over-The-Counter Use
(21 CFR 807 Subpart C)
{6}------------------------------------------------
510(k) Number (if known):
Device Name: E12-3 transducer (SSIP95102)
Intended Use: Diagnostic ultrasound imaging, soft tissue elasticity imaging, fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| General(Track 1 Only) | Specific(Tracks 1 & 3) | B | M | PWD | CWD | ColorDoppler | Combined(Specify) | Other* (Specify) | |
| Ophthalmic | Ophthalmic | ||||||||
| Fetal Imaging &Other | Fetal | N | N | N | N | N 1, 3, 4, 11 | N 5, 6 | ||
| Abdominal (including urolology): Liver, Kidney,Spleen... | |||||||||
| Intra-operative (Specify) | |||||||||
| Intra-operative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | |||||||||
| Small Organ (for example Breast, Thyroid,Testicle, Prostate, penis, etc...) | N | N | N | N | N1, 2, 3, 4 | N 5, 6, 7, 8 | |||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Trans-rectal | N | N | N | N | N 1, 2, 3, 4 | N 5, 6, 7, 8 | |||
| Trans-vaginal | N | N | N | N | N1, 2, 3, 4,11 | N5, 6, 7, 8 | |||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card.) | |||||||||
| Musculo-skeletal (Conventional) | |||||||||
| Musculo-skeletal (Superficial) | |||||||||
| Intravascular | |||||||||
| GYN | N | N | N | N | N 1, 2, 3, 4,11 | N 5, 6, 7, 8 | |||
| Pelvic | N | N | N | N | N1, 2, 3, 4,11 | N 5, 6, 7, 8 | |||
| Other (Specify) | |||||||||
| Cardiac | Cardiac Adult | ||||||||
| Cardiac Pediatric | |||||||||
| Intravascular (Cardiac) | |||||||||
| Trans-esoph. (Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Other (Specify) | |||||||||
| PeripheralVessel | Peripheral vessel | ||||||||
| Other (Specify) | N | N | N | N 1, 3, 4 | N 5, 6, 8 |
N = new indication; N
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
-
Needle / L.O.
-
Brightness ra
-
Brightness ratio
-
Combined mode include
-
Combined mode include: B+ Continuous Wave
-
Combined mode include: B+ M mode + Color
Prescription Use X (Part 21 CFR 801 Subpart D)
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
9: Panoramic Imaging
10: 3D Imaging
11: Combined modes include: B+ M modes
12: Combined modes include: B Mode + Color flow + Shearwave™ Elastography
Liistography
13. CEUS (Con
13: CEUS (Contrast Enhancement UltraSound) 14: Angio PL.U.S (Color Doppler improvement)
15: Needle PL.U.S.
16: Brightness ratio
17: Combined mode include: B+ Continuous Wave
18: Combined mode incluseds: B+ M mode + Color flow
AND/OR Over-The-Counter Use
(21 CFR 807 Subpart C)
{7}------------------------------------------------
510(k) Number (if known):
Device Name: LV16-5 transducer (SSIP95108)
Intended Use: Diagnostic ultrasound imaging, soft tissue elasticity imaging, fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General(Track 1 Only) | Specific(Tracks 1 & 3) | B | M | PWD | CWD | ColorDoppler | Combined(Specify) | Other* (Specify) |
| Ophthalmic | Ophthalmic | |||||||
| Fetal Imaging &Other | Fetal | |||||||
| Abdominal (including urolology):Liver, Kidney, Spleen... | N | N | N | N | N 1, 2, 3, 4 | N 5, 6, 7, 8, 9, 10 | ||
| Intra-operative (Specify) | ||||||||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | N | N | N | N | N 1, 2, 3, 4 | N 5, 6, 7, 8, 9, 10 | ||
| Small Organ (for example Breast, NThyroid, Testicle, Prostate, penis,etc...) | N | N | N | N | N 1, 2, 3, 4 | N 5, 6, 7, 8, 9, 10 | ||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Musculo-skeletal (Conventional) | N | N | N | N | N 1, 2, 3, 4 | N 5, 6, 7, 8, 9, 10 | ||
| Musculo-skeletal (Superficial) | N | N | N | N | N 1, 2, 3, 4 | N 5, 6, 7, 8, 9, 10 | ||
| Intravascular | ||||||||
| GYN | ||||||||
| Pelvic | ||||||||
| Other (Specify) | ||||||||
| Cardiac | Cardiac Adult | |||||||
| Cardiac Pediatric | ||||||||
| Intravascular (Cardiac) | ||||||||
| Trans-esoph. (Cardiac) | ||||||||
| Intra-cardiac | ||||||||
| Other (Specify) | ||||||||
| PeripheralVessel | Peripheral vessel | N | N | N | N | N 1, 3, 4 | N 5, 6, 8, 9, 10 | |
| Other (Specify) |
N = new indication;
Additional Comments:
5: Harmonic Imaging
- 1: Combined modes include: B+ Color Flow 2: Combined modes include: B+ ShearWave™ Elastography
3: Combined modes include: B+ Pulsed Wave
9: Panoramic Imaging
10: 3D Imaging
11: Combined modes include: B+ M modes
12: Combined modes include: B Mode + Color flow + Shearwave™
4: Combined modes include: B+ Pulsed Wave + Color Flow
6: Spatial Compounding
7: ShearWave™ Elastography
- 8: Imaging Guidance for Biopsies
- Elastography
13: CEUS (Contrast Enhancement UltraSound)
14: Angio PL.U.S (Color Doppler improvement)
- 15: Needle PL.U.S.
- 16: Brightness ratio
17: Combined mode include: B+ Continuous Wave
18: Combined mode incluseds: B+ M mode + Color flow
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
{8}------------------------------------------------
510(k) Number (if known):
Device Name: MC12-3 transducer (SSIP95106)
Intended Use: Diagnostic ultrasound imaging, soft tissue elasticity imaging, fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| General(Track 1 Only) | Specific(Tracks 1 & 3) | B | M | PWD | CWD | ColorDoppler | Combined(Specify) | Other* (Specify) | |
| Ophthalmic | Ophthalmic | ||||||||
| Fetal Imaging& Other | Fetal | ||||||||
| Abdominal (including urolology): Liver,Kidney, Spleen... | N | N | N | N | N | N, 1, 2, 3, 4 | N, 5, 6, 7, 8, 9, 13 | ||
| Intra-operative (Specify) | |||||||||
| Intra-operative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | N | N | N | N | N | N, 1, 2, 3, 4 | N, 5, 6, 7, 8, 9, 13 | ||
| Small Organ (for example Breast, Thyroid,Testicle, Prostate, penis, etc...) | N | N | N | N | N | N, 1, 2, 3, 4 | N, 5, 6, 7, 8, 9 | ||
| Neonatal Cephalic | N | N | N | N | N | N, 1, 2, 3, 4 | N, 5, 6, 7, 9 | ||
| Adult Cephalic | |||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card.) | |||||||||
| Musculo-skeletal (Conventional) | N | N | N | N | N | N, 1, 2, 3, 4 | N, 5, 6, 7, 8, 9 | ||
| Musculo-skeletal (Superficial) | N | N | N | N | N | N, 1, 2, 3, 4 | N, 5, 6, 7, 8, 9 | ||
| Intravascular | |||||||||
| GYN | |||||||||
| Pelvic | |||||||||
| Other (Specify) | |||||||||
| Cardiac | Cardiac Adult | ||||||||
| Cardiac Pediatric | N | N | N | N | N | N 1,3,4,11 | N, 5, 6 | ||
| Intravascular (Cardiac) | |||||||||
| Trans-esoph. (Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Other (Specify) | |||||||||
| PeripheralVessel | Peripheral vessel | N | N | N | N | N | N, 1, 3, 4 | N, 5, 6, 8, 9 | |
| Other (Specify) | N | N | N | N | N | N, 1, 3, 4 | N, 5, 6, 8, 9 |
N = new indication; P = previously cleared by FDA (K171105)
4: Combined modes include: B+ Pulsed Wave + Color Flow
Additional Comments:
5: Harmonic Imaging
6: Spatial Compounding
7: ShearWave™ Elastography
8: Imaging Guidance for Biopsies
1: Combined modes include: B+ Color Flow
3: Combined modes include: B+ Pulsed Wave
9: Panoramic Imaging
2: Combined modes include: B+ ShearWave™ Elastography 10: 3D Imaging
11: Combined modes include: B+ M modes
12: Combined modes include: B Mode + Color flow + Shearwave™
Elastography
13: CEUS (Contrast Enhancement UltraSound)
14: Angio PL.U.S (Color Doppler improvement)
- 15: Needle PL.U.S.
- 16: Brightness ratio
- 17: Combined mode include: B+ Continuous Wave
- 18: Combined mode incluseds: B+ M mode + Color flow
X Prescription Use
-
Over-The-Counter Use (21 CFR 807 Subpart C)
(Part 21 CFR 801 Subpart D) -
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
AND/OR
Concurrence of CDRH; Office of In Vitro Diagnostics and Radiological Health (OIR)
{9}------------------------------------------------
510(k) Number (if known):
Device Name: P5-1X transducer (SSIP95107)
Intended Use: Diagnostic ultrasound imaging, soft tissue elasticity imaging, fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General(Track 1 Only) | Specific(Tracks 1 & 3) | B | M | PWD | CWD | ColorDoppler | Combined(Specify) | Other* (Specify) |
| Ophthalmic | Ophthalmic | |||||||
| Fetal Imaging& Other | Fetal | |||||||
| Abdominal (including urolology): Liver,Kidney, Spleen... | N | N | N | N | N | N 1, 3, 4, 11,17 | N 5, 6, 16 | |
| Intra-operative (Specify) | ||||||||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| Small Organ (for example Breast, Thyroid,Testicle, Prostate, penis, etc...) | N | N | N | N | N 1, 3, 4 | N 5, 6 | ||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | 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 | N | N | N | N | N | N 1, 3, 4, 11,17, 18 | N, 5, 6 |
| Cardiac Pediatric | ||||||||
| Intravascular (Cardiac) | ||||||||
| Trans-esoph. (Cardiac) | ||||||||
| Intra-cardiac | ||||||||
| Other (Specify) | ||||||||
| PeripheralVessel | Peripheral vessel | N | N | N | N | N | N 1, 3, 4, 17 | N 5, 6 |
| Other (Specify) | N | N | N | N | N | N 1, 3, 4, 17 | N 5, 6 |
N = new indication; N Additional Comments:
5: Harmonic Imaging
6: Spatial Compounding
7: ShearWave™ Elastography
8: Imaging Guidance for Biopsies
1: Combined modes include: B+ Color Flow
3: Combined modes include: B+ Pulsed Wave
4: Combined modes include: B+ Pulsed Wave + Color Flow
9: Panoramic Imaging
2: Combined modes include: B+ ShearWave™ Elastography 10: 3D Imaging
11: Combined modes include: B+ M modes
12: Combined modes include: B Mode + Color flow + Shearwave™ Elastography
13: CEUS (Contrast Enhancement UltraSound)
14: Angio PL.U.S (Color Doppler improvement)
15: Needle PL.U.S.
- 16: Brightness ratio
17: Combined mode include: B+ Continuous Wave
18: Combined mode incluseds: B+ M mode + Color flow
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use
(21 CFR 807 Subpart C)
{10}------------------------------------------------
510(k) Number (if known):
Device Name: LH20-6 transducer (SSIP95104)
Intended Use: Diagnostic ultrasound imaging, soft tissue elasticity imaging, fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General(Track 1Only) | Specific(Tracks 1 & 3) | B | M | PWD | CWD | ColorDoppler | Combined(Specify) | Other* (Specify) |
| Ophthalmic | Ophthalmic | |||||||
| FetalImaging &Other | Fetal | |||||||
| Abdominal (including urolology): Liver,Kidney, Spleen... | ||||||||
| Intra-operative (Specify) Vascular,abdominal, small organs | N | N | N | N | N | N 1, 3, 4 | N 5, 6, 915 | |
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | N | N | N | N | N | N 1, 2, 3, 4 | N 5, 6, 7, 915 | |
| Small Organ (for example Breast, Thyroid,Testicle, Prostate, penis, etc...) | N | N | N | N | N | N 1, 2, 3, 4 | N 5, 6, 7, 915 | |
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Musculo-skeletal (Conventional) | N | N | N | N | N | N 1, 2, 3, 4 | N 5, 6, 7, 915 | |
| Musculo-skeletal (Superficial) | N | N | N | N | N | N 1, 2, 3, 4 | N 5, 6, 7, 915 | |
| Intravascular | ||||||||
| GYN | ||||||||
| Pelvic | ||||||||
| Other (Specify) | ||||||||
| Cardiac | Cardiac Adult | |||||||
| Cardiac Pediatric | ||||||||
| Intravascular (Cardiac) | ||||||||
| Trans-esoph. (Cardiac) | ||||||||
| Intra-cardiac | ||||||||
| Other (Specify) | ||||||||
| PeripheralVessel | Peripheral vessel | N | N | N | N | N | N 1, 3, 4 | N 5, 6, 915 |
| Other (Specify) | N | N | N | N | N | N 1, 3, 4 | N 5, 6, 915 |
N = new indication;
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 Imaqing
10: 3D Imaging
11: Combined modes include: B+ M modes
12: Combined modes include: B Mode + Color flow + Shearwave™
Elastography
13: CEUS (Contrast Enhancement UltraSound)
14: Angio PL.U.S (Color Doppler improvement)
- 15: Needle PL.U.S.
- 16: Brightness ratio
17: Combined mode include: B+ Continuous Wave
- 18: Combined mode incluseds: B+ M mode + Color flow
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
{11}------------------------------------------------
510(k) Number (if known):
Device Name: L18-5 transducer (SSIP95100)
Intended Use: Diagnostic ultrasound imaging, soft tissue elasticity imaging, fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General(Track 1 Only) | Specific(Tracks 1 & 3) | B | M | PWD | CWD | ColorDoppler | Combined(Specify) | Other* (Specify) |
| Ophthalmic | Ophthalmic | |||||||
| Fetal Imaging & FetalOther | Abdominal (including urolology):Liver, Kidney, Spleen... | N | N | N | N 1, 2, 3, 4 | N 5, 6, 7, 8, 9, 1415 | ||
| Intra-operative (Specify) | ||||||||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | N | N | N | N 1, 2, 3, 4 | N 5, 6, 7, 8, 91515 | |||
| Small Organ (for example Breast,Thyroid, Testicle, Prostate, Penis) | N | N | N | N 1, 2, 3, 4, 12 | N 5, 6, 7, 8, 9, 14 | |||
| Neonatal Cephalic | N | N | N | N1, 2, 3, 4 | N 5, 6, 7, 9 | |||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Musculo-skeletal (Conventional) | N | N | N | N 1, 2, 3, 4 | N 5, 6, 7, 8, 9,1415 | |||
| Musculo-skeletal (Superficial) | N | N | N | N 1, 2, 3, 4 | N 5, 6, 7, 8, 9,1415 | |||
| Intravascular | ||||||||
| GYN | ||||||||
| Pelvic | ||||||||
| Other (Specify) | ||||||||
| Cardiac | Cardiac Adult | |||||||
| Cardiac Pediatric | ||||||||
| Intravascular (Cardiac) | ||||||||
| Trans-esoph. (Cardiac) | ||||||||
| Intra-cardiac | ||||||||
| Other (Specify) | ||||||||
| PeripheralVessel | Peripheral vessel | N | N | N | N 1, 3, 4 | N 5, 6, 8, 915 | ||
| Other (Specify) | N | N | N | N 1, 3, 4 | N 5, 6, 8, 915 |
N = new indication;
Additional Comments:
5: Harmonic Imaging
6: Spatial Compounding
7: ShearWave™ Elastography
8: Imaging Guidance for Biopsies
- 1: Combined modes include: B+ Color Flow
3: Combined modes include: B+ Pulsed Wave
9: Panoramic Imaging 2: Combined modes include: B+ ShearWave™ Elastography
10: 3D Imaging
11: Combined modes include: B+ M modes 4: Combined modes include: B+ Pulsed Wave + Color Flow
12: Combined modes include: B Mode + Color flow + Shearwave™ Elastography
13: CEUS (Contrast Enhancement UltraSound)
14: Angio PL.U.S (Color Doppler improvement)
- 15: Needle PL.U.S.
- 16: Brightness ratio
- 17: Combined mode include: B+ Continuous Wave
- 18: Combined mode incluseds: B+ M mode + Color flow
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use
(21 CFR 807 Subpart C)
{12}------------------------------------------------
510(k) Number (if known):
Device Name: C9-2X (SSIP95105)
Intended Use: Diagnostic ultrasound imaging, soft tissue elasticity imaging, fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General(Track 1 Only) | Specific(Tracks 1 & 3) | B | M | PWD | CWD | ColorDoppler | Combined(Specify) | Other* (Specify) |
| Ophthalmic | Ophthalmic | |||||||
| Fetal Imaging & Other | Fetal | N | N | N | N | N | N 1, 3, 4, 11 | N 5, 6 |
| Other | Abdominal (including urolology):Liver, Kidney, Spleen... | N | N | N | N | N | N 1, 2, 3, 4, 11 | N 5, 6, 7, 8, 9, 13, 14, 16 |
| Intra-operative (Specify) | ||||||||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | N | N | N | N | N 1, 2, 3, 4 | N 5, 6, 7, 8, 13, 16 | ||
| Small Organ (for example Breast,Thyroid, Testicle, Prostate, Penis) | N | N | N | N | N 1, 2, 3, 4 | N 5, 6, 7, 8 | ||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Musculo-skeletal (Conventional) | ||||||||
| Musculo-skeletal (Superficial) | ||||||||
| Intravascular | ||||||||
| GYN | N | N | N | N | N | N, 1, 2, 3, 4 | N, 5, 6, 7, 8, 14 | |
| Pelvic | N | N | N | N | N | N, 1, 2, 3, 4 | N, 5, 6, 7, 8, 14 | |
| Other (Specify) | ||||||||
| Cardiac | Cardiac Adult | |||||||
| Cardiac Pediatric | ||||||||
| Intravascular (Cardiac) | ||||||||
| Trans-esoph. (Cardiac) | ||||||||
| Intra-cardiac | ||||||||
| Other (Specify) | ||||||||
| PeripheralVessel | Peripheral vessel | N | N | N | N | N | N, 1, 3, 4 | N, 5, 6, 8 |
| Other (Specify) | N | N | N | N | N | N, 1, 3, 4 | N, 5, 6, 8 |
N = new indication;
5: Harmonic Imaging
6: Spatial Compounding
7: ShearWave™ Elastography
8: Imaging Guidance for Biopsies
Additional Comments:
- 1: Combined modes include: B+ Color Flow 3: Combined modes include: B+ Pulsed Wave
4: Combined modes include: B+ Pulsed Wave + Color Flow
9: Panoramic Imaging
2: Combined modes include: B+ ShearWave™ Elastography 10: 3D Imaging
11: Combined modes include: B+ M modes
12: Combined modes include: B Mode + Color flow + Shearwave™
- Elastography
13: CEUS (Contrast Enhancement UltraSound)
14: Angio PL.U.S (Color Doppler improvement)
- 15: Needle PL.U.S.
- 16: Brightness ratio
17: Combined mode include: B+ Continuous Wave
18: Combined mode incluseds: B+ M mode + Color flow
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use
(21 CFR 807 Subpart C)
{13}------------------------------------------------
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: 2018.02.09
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: Ultrasound Diagnostic System with Accessories Proprietary Name: AIXPLORER® MACH Ultrasound Diagnostic Systems AIXPLORER® MACH 30, AIXPLORER® MACH 20 AIXPLORER®MACH 10
Classification: 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 (K173021), cleared on 01/09/2018 FibroScan (K160524), cleared on 03/18/2016 Epiq 7 (K163120) cleared on 01/10/2017
{14}------------------------------------------------
4) Description of Device
The SuperSonic Imagine AIXPLORER® MACH systems are cart based ultrasound imaging systems 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-directional Color Power Imaging and Angio PL.U.S), Pulsed Wave Doppler, Continuous Wave Doppler, 3D imaging, CEUS-Contrast Enhanced Ultrasound Imaging and for ShearWave™ elastography.
5) Indication for Use
The SuperSonic Imagine AIXPLORER® MACH 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® MACH ultrasound diagnostic systems are indicated for use in the following applications, for imaging and measurement of anatomical structures: Abdominal, Small Organs, Musculoskeletal, Superficial Musculoskeletal, Vascular, Intraoperative, OB-GYN, Pelvic, Pediatric, Urology, Trans-rectal, Trans-vaginal and Neonatal/Adult Cephalic, Non-invasive Cardiac.
In addition, the SuperSonic Imagine AIXPLORER® MACH range ultrasound diagnostic systems and associated transducers are intended for:
- i Measurements of abdominal anatomical structures,
- -Measurements of broad band shear wave speed, and tissue stiffness in internal structures of the liver, the spleen and other biological tissue in the abdomen,
- -Measurements of brightness ratio between liver, kidney, and other biological structures of the abdomen,
- -Visualization of abdominal vascularization, microvascularization and perfusion,
- -Quantification of abdominal vascularization and perfusion.
The shear wave speed and stiffness measurements, the brightness ratio, the visualization of vascularization, microvascularization and perfusion, the quantification and perfusion may be used as an aid to clinical management of pediatric and adult patients with liver disease.
{15}------------------------------------------------
6) Summary of Technological Characterisitics – New Device compared to Predicates
| AIXPLORER®&AIXPLORER® Ultimate(predicates) | EPIQ 7(predicate) | FibroScan® 530Compact(predicate) | AIXPLORER®MACH range | |
|---|---|---|---|---|
| 510(k) Number | K173021 | K163120 | K160524 | Unassigned |
| Classification Name | Ultrasonic Pulsed DopplerImaging System (892.1550)Ultrasonic Pulsed EchoImaging System (892.1560)Diagnostic UltrasoundTransducer (892.1570) | Identical toK173021 | Ultrasonic PulsedEcho ImagingSystem (892.1560)DiagnosticUltrasoundTransducer(892.1570) | Identical toK173021 |
| Class | Class II | Identical | Identical | Identical |
| Intended Use | Diagnostic ultrasoundimaging, soft tissueelasticity imaging, fluid flowanalysis of the human body | Diagnosticultrasound imagingor fluid flow analysisof the human body | DiagnosticUltrasound imagingor fluid flow analysisof the human body | Identical to K173021 |
| General Description | General purpose, mobile,software controlleddiagnostic ultrasoundsystem. To acquireultrasound data and todisplay the data in variousmodes of operation. | Identical | Identical | Identical |
| Consists of two parts: thesystem console and thetransducer. The systemconsole contains the userinterface, a display, systemelectronics and optionalperipherals (printers,etc...). | Identical | Identical | Identical | |
| ClinicalApplications | Abdominal (liver, kidney,spleen) | Identical | Identical | Identical |
| Small organs (*) | Identical | -- | Identical | |
| AIXPLORER®&AIXPLORER® Ultimate(predicates) | EPIQ 7(predicate) | FibroScan® 530Compact(predicate) | AIXPLORER®MACH range | |
| Musculoskeletal | Identical | -- | Identical | |
| Fetal | Identical | -- | Identical | |
| GYN | Identical | -- | Identical | |
| Cardiac (non invasive) | Cardiac | -- | Identical toK173021 | |
| Adult and neonatalcephalic | Identical | -- | Identical | |
| Pediatric | Identical | Identical | Identical | |
| Urology | Identical | -- | Identical | |
| Vascular | Identical | -- | Identical | |
| Peripheral vascular | Identical | -- | Identical | |
| Trans-rectal | Identical | -- | Identical | |
| Trans-vaginal | Identical | -- | Identical | |
| Imaging modes | ||||
| B-Mode (Harmonic,Fundamental) | Identical | -- | Identical | |
| M-Mode | Identical | Identical | Identical | |
| PW | Identical | -- | Identical | |
| Conventional | CW | -- | -- | Identical toK163120 |
| Color Doppler | Identical | -- | Identical | |
| Amplitude Doppler | Identical | -- | Identical | |
| Microvascular (AngioPL.U.S) | ---(**) | -- | Identical toK173021 | |
| Other | Spatial compounding,Panoramic | Identical | -- | Identical |
| Contrast | Identical | -- | Identical | |
| AIXPLORER®&AIXPLORER® Ultimate(predicates) | EPIQ 7(predicate) | FibroScan® 530Compact(predicate) | AIXPLORER®MACH range | |
| --- (has specific | ||||
| Combination of modes | Identical | modes: A-mode,CAP). | Identical | |
| ShearWave Elastography | Identical | VCTE | Identical | |
| Design | ||||
| Cart | Mobile cart based productwith control panel andmonitor | Identical | Identical | Identical |
| Controls | Typical ultrasoundimaging controls (gain,depth mode select...) | Identical | Identical | Identical |
| Biopsy guide | Available | Identical | -- | Identical |
| Track | Track 3 (Acoustic OutputDisplay) | Identical | Identical | Identical |
| Patient ContactMaterials | Yes, per ISO 10993-1 | Identical | Identical | Identical |
| Acoustic Outputwithin FDAguidelines | Yes, as per NEMA UD-3 | Identical | Identical | Identical |
| Image Review | Yes | Identical | Identical | Identical |
| MeasurementPackage | Yes | Identical | Identical | Identical |
| CalculationPackage | Yes | Identical | Identical | Identical |
| Report | Yes | Identical | Identical | Identical |
| General Safety | Conforms to IEC60601-1,60601-1-2, 60601-2-37 | Identical | Identical | Identical |
| Labeling | Conforms to 21 CFR Part801 | Identical | Identical | Identical |
{16}------------------------------------------------
{17}------------------------------------------------
Note:
*: Breast, Thyroid, Testicle, etc
**:--- means not applicable
:: --- means not applicable
{18}------------------------------------------------
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- 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.
- A brief discussion of the non clinical tests submitted, referenced, or relied on in the premarket notification submission for a determination of substantial equivalence
| Reference Standard | Tests Performed |
|---|---|
| IEC 60601-1 Ed.3.1 | All applicable electrical, basic safety and essential performance tests. |
| IEC 60601-1-2 Ed.4 | All applicable testing pertaining to electromagnetic compatibility. |
| IEC 60601-2-37 Ed.2.1 | 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® MACH Systems perform 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® MACH 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
The subject of this premarket submission required a clinical evaluation by literature route to support substantial equivalence and to widen the indications for use of Aixplorer® MACH range Ultrasound Diagnostic Systems.
9) Conclusion
The manufacturer and the design and development of the submission device comply with 21 CFR Part 820 and ISO 13485 (2016) Quality Standards. The submission device, designed to comply with applicable safety standards, is tested during the manufacturing process to ensure compliance with these standards. Performance testing demonstrated that the submission device is at least as safe and effective as the predicate devices listed 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.