(197 days)
No
The document does not mention AI, ML, deep learning, neural networks, or any related terms in the device description, intended use, or performance studies. The focus is on traditional ultrasound imaging modes and elastography.
No.
The device is described as an ultrasound diagnostic system, intended for imaging, measurement, and visualization of anatomical structures and fluid flow for diagnostic purposes, not for treating any condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that the devices are "ultrasound diagnostic systems and transducers." Furthermore, the text consistently refers to "ultrasound diagnostic systems" throughout the document and details their use for "imaging and measurement of anatomical structures" for various clinical applications, all of which aim to aid in diagnosis.
No
The device description clearly states it is a "cart based ultrasound imaging system" and includes hardware components like transducers, a scan converter, a monitor, and a control panel.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens derived from the human body. The intended use and device description clearly state that this is an ultrasound system used for non-invasive diagnostic imaging of the human body. It does not involve the analysis of blood, tissue, or other bodily fluids or substances.
- The device description focuses on imaging modalities and measurements performed directly on the patient. This includes B-Mode, M-mode, Doppler, 3D imaging, and elastography, all of which are applied externally or internally to the patient's body.
- The performance studies describe the clinical evaluation of the imaging capabilities and the added value of elastography in characterizing breast masses. This is consistent with the evaluation of an imaging device, not an IVD.
Therefore, the SuperSonic Imagine AIXPLORER® MACH / SUPERSONIC MACH range ultrasound diagnostic system is a medical imaging device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The SuperSonic Imagine AIXPLORER® MACH / SUPERSONIC MACH range ultrasound diagnostic systems and transducers are intended for general purpose pulse echo ultrasound imaging, soft tissue viscoelasticity imaging, doppler fluid flow analysis of the human body.
The SuperSonic Imagine AIXPLORER® MACH / SUPERSONIC 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 / SUPERSONIC 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 shearwave speed, beam attenuation, viscosity and stiffness measurements, the visualization of vascularization, microvascularization and perfusion of vascularization and perfusion may be used as an aid to clinical management of adult and pediatric patients with liver disease.
Furthermore, the SuperSonic Imagine AIXPLORER® MACH / SUPERSONIC MACH ultrasound diagnostic systems and associated transducers are intended for:
- Measurements of breast anatomical structures
- · Measurements of broad band shear waves speed and tissue stiffness in internal structures of the breast
- Visualization of breast structures and micro-vascularization
- Visualization of breast masses morphology using shearwave elastography and micro-vascularization 2D mapping
The shear waves speed and stiffness measurements may be used as an aid to management of women patients with breast masses, as shearwave elastography in conjunction with 2D gray scale imaging and vascularization provides added information to better characterize breast masses and improve the diagnostic accuracy of ultrasound.
Product codes (comma separated list FDA assigned to the subject device)
IYN, IYO, ITX
Device Description
The SuperSonic Imagine AIXPLORER® MACH / SUPERSONIC 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 submodes 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 and Strain Elastography.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Pulse echo ultrasound imaging, soft tissue viscoelasticity imaging, doppler fluid flow analysis
Anatomical Site
Abdominal, Small Organs, Musculoskeletal, Superficial Musculoskeletal, Vascular, Intraoperative, OB-GYN, Pelvic, Pediatric, Urology, Trans-rectal, Trans-vaginal and Neonatal/Adult Cephalic, Non-invasive Cardiac, liver, spleen, breast
Indicated Patient Age Range
adult and pediatric patients
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)
A clinical evaluation by literature route to support substantial equivalence and to widen the indications for use of AIXPLORER® MACH / SUPERSONIC MACH range Ultrasound Diagnostic Systems.
Summary of literature review: Owing to its correlation with cancer risk, real-time mapping of breast lesions stiffness has proven to produce important information to breast physicians that can improve the global management patients with breast lesions. Addition of Shear Wave elastography to conventional B-mode Ultrasound increased the specificity of breast mass assessment. It can significantly improve the positive predictive value of biopsy recommendation for probably benign and low suspicion breast lesions on ultrasound, while preserving the sensitivity of breast ultrasound. This been demonstrated in diagnostic settings. The addition of SWE evaluation of breast lesions also increases the inter-observer agreement on their global cancer risk assessment with ultrasound, thanks to its "almost perfect" intra-operator repeatability and high inter-observer reproducibility. The evaluation of breast cancers with SWE seem to contribute to defining more appropriate management strateqies thanks to more accurate cancer size measurements, to correlation with cancer aggressiveness and response to neo-adjuvant chemotherapy treatment.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
specificity of breast mass assessment, positive predictive value of biopsy recommendation for probably benign and low suspicion breast lesions on ultrasound, sensitivity of breast ultrasound, inter-observer agreement, intra-operator repeatability and high inter-observer reproducibility.
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.
AIXPLORER® MACH range Ultrasound Imaging System (K191007)
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.
Aplio i900, i800, i700 V2 (K173090), Resona 7 (K171233)
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
June 29, 2021
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA acronym with the agency's name on the right. The symbol on the left is a stylized representation of human services. To the right of the symbol is a blue square containing the acronym "FDA" in white letters. Next to the blue square, the words "U.S. FOOD & DRUG ADMINISTRATION" are written in blue.
SuperSonic Imagine % Jacques Souquet Chief Scientist and Innovation Officer Les Jardins de la Duranne- Bat E et F 510 rue René Descartes 13857Aix-en-Provence FRANCE
Re: K203645
Trade/Device Name: AIXPLORER® MACH30/ SUPERSONIC MACH30. AIXPLORER® MACH20/ SUPERSONIC MACH20, SUPERSONIC MACH40 Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: Class II Product Code: IYN, IYO, ITX Dated: April 12, 2021 Received: April 16, 2021
Dear Jacques Souquet:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For
Thalia, T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below
510(k) Number (if known) K203645
Device Name
AIXPLORER® MACH 30 / SUPERSONIC MACH30, AIXPLORER® MACH 20 / SUPERSONIC MACH20 and SUPERSONIC MACH 40
Indications for Use (Describe)
The SuperSonic Imagine AIXPLORER® MACH / SUPERSONIC MACH range ultrasound diagnostic systems and transducers are intended for general purpose pulse echo ultrasound imaging, soft tissue viscoelasticity imaging, doppler fluid flow analysis of the human body.
The SuperSonic Imagine AIXPLORER® MACH / SUPERSONIC 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 / SUPERSONIC 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 shearwave speed, beam attenuation, viscosity and stiffness measurements, the visualization of vascularization, microvascularization and perfusion of vascularization and perfusion may be used as an aid to clinical management of adult and pediatric patients with liver disease.
Furthermore, the SuperSonic Imagine AIXPLORER® MACH / SUPERSONIC MACH ultrasound diagnostic systems and associated transducers are intended for:
- Measurements of breast anatomical structures
- · Measurements of broad band shear waves speed and tissue stiffness in internal structures of the breast
- Visualization of breast structures and micro-vascularization
- Visualization of breast masses morphology using shearwave elastography and micro-vascularization 2D mapping
The shear waves speed and stiffness measurements may be used as an aid to management of women patients with breast masses, as shearwave elastography in conjunction with 2D gray scale imaging and vascularization provides added information to better characterize breast masses and improve the diagnostic accuracy of ultrasound.
| Type of Use (Select one or both, as applicable) | |||||
|---|---|---|---|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) X Over-The-Counter Use (21 CFR 801 Subpart C) | Prescription Use (Part 21 CFR 801 Subpart D) | X | Over-The-Counter Use (21 CFR 801 Subpart C) | ||
| Prescription Use (Part 21 CFR 801 Subpart D) | X | ||||
| Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
3
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
510(k) number (if known): K203645
Device Name: AIXPLORER® MACH 30 / SUPERSONIC MACH30, AIXPLORER® MACH 20 / SUPERSONIC MACH20, SUPERSONIC MACH40
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 | Color | |||
| Doppler | Combined (Specify) | Other* (Specify) | ||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal Imaging & | ||||||||
| Other | Fetal | P | P | P | P | P : 1, 3, 4, 11 | P : 5, 6, 10 | |
| Abdominal (including urolology): Liver, | ||||||||
| Kidney, Spleen... | P | P | P | P | P : 1, 2, 3, 4 | P : 5, 6, 7, 8, 9, 10, | ||
| 11, 13, 14, 15, 16, 21, 22 | ||||||||
| Intra-operative (Specify) vascular, | ||||||||
| abdominal, small organs | P | P | P | P : 1, 3, 4 | P: 5, 6, 8, 9 | |||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | P | P | P | P | P : 1, 2, 3, 4 | P : 5, 6, 7, 8, 9, 10, 11, | ||
| 13, 15, 16, 14, 18, 19, | ||||||||
| Small Organ (Breast, Thyroid, | ||||||||
| Testicle, Prostate, penis, etc...) | P | P | P | P : 1, 2, 3, 4, 12 | P : 6, 7, 8, 9, 10, 14, 15, | |||
| 18, 19, 20, 21 | ||||||||
| Neonatal Cephalic | P | P | P | P : 1, 2, 3, 4 | P : 5, 6, 7, 9 | |||
| Adult Cephalic | P | P | P | P : 1, 3, 4 | P : 5, 6 | |||
| Trans-rectal | P | P | P | P : 1, 2, 3, 4 | P : 5, 6, 7, 8 | |||
| Trans-vaginal | P | P | P | P | P : 1, 2, 3, 4 | P : 5, 6, 7, 8, 11 | ||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Musculo-skeletal (Conventional) | P | P | P | P : 1, 2, 3, 4 | P : 5, 6, 7, 8, 9, 10, 14, 15, | |||
| 19, 20 | ||||||||
| Musculo-skeletal (Superficial) | P | P | P | P : 1, 2, 3, 4 | P : 5, 6, 7, 8, 9, 10, 14, 15, | |||
| 19, 20 | ||||||||
| Intravascular | ||||||||
| GYN | P | P | P | P | P : 1, 2, 3, 4 | P : 5, 6, 7, 8, 11, 14 | ||
| Pelvic | P | P | P | P | P : 1, 2, 3, 4 | P: 5, 6, 7, 8, 11, 14 | ||
| Other (Specify) | ||||||||
| Cardiac | Cardiac Adult | P | P | P | P | P | P : 1, 3, 4, 11, 17, | |
| 18 | P : 5 | |||||||
| Cardiac Pediatric | ||||||||
| Intravascular (Cardiac) | ||||||||
| Trans-esoph. (Cardiac) | ||||||||
| Intra-cardiac | ||||||||
| Other (Specify) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | P | P | P | P : 1, 3, 4 | P : 5, 6, 8, 9, 10, 15 | ||
| Other (Specify) | P | P | P | P : 1, 3, 4 | P : 5, 6, 8, 9, 10, 15 | |||
| Clinical Application | Mode of Operation | |||||||
| General | ||||||||
| (Track 1 Only) | Specific | |||||||
| (Tracks 1 & 3) | B | M | PWD | CWD | Color | |||
| Doppler | Combined | |||||||
| (Specify) | Other* (Specify) | |||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal Imaging | ||||||||
| & Other | Fetal | |||||||
| Abdominal (including urolology): Liver, | ||||||||
| Kidney, Spleen... | P | P | P | P | P | P: 1, 2, 3, 4 | P: 5, 6, 7, 8, 9, 13,14, 15, | |
| 16, 21,22 | ||||||||
| Intra-operative (Specify) | ||||||||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | P | P | P | P | P | P: 1, 2, 3, 4 | P: 5, 6, 7, 8, 9, 15, 16, | |
| 14, 21, 22 | ||||||||
| Small Organ (for example Breast, Thyroid, | ||||||||
| Testicle, Prostate, penis, etc...) | P | P | P | P | P | P: 1, 2, 3, 4, | ||
| 12 | P: 5, 6, 7, 8, 9, 14, 15, 19, | |||||||
| 20, 21, 22 | ||||||||
| Neonatal Cephalic | P | P | P | P | P | N, 1, 2, 3, 4 | P: 5, 6, 7, 9 | |
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Musculo-skeletal (Conventional) | P | P | P | P | P | P: 1, 2, 3, 4 | P: 5, 6, 7, 8, 9, 14,15, 19, | |
| 20 | ||||||||
| Musculo-skeletal (Superficial) | P | P | P | P | P | P: 1, 2, 3, 4 | P: 5, 6, 7, 8, 9, 14, 15, 19, | |
| 20 | ||||||||
| Intravascular | ||||||||
| GYN | ||||||||
| Pelvic | ||||||||
| Other (Specify) | ||||||||
| Cardiac | Cardiac Adult | |||||||
| Cardiac Pediatric | ||||||||
| Intravascular (Cardiac) | ||||||||
| Trans-esoph. (Cardiac) | ||||||||
| Intra-cardiac | ||||||||
| Other (Specify) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | P | P | P | P | P | P: 1, 3, 4 | P: 5, 6, 8, 9, 15 |
| Other (Specify) | P | P | P | P | P | P: 1, 3, 4 | P: 5, 6, 8, 9, 15 | |
| N = new indication; P = Previously cleared by FDA (K191007) | ||||||||
| 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 | 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 | ||||||||
| Clinical Application | Mode of Operation | |||||||
| General | ||||||||
| (Track 1 Only) | Specific | |||||||
| (Tracks 1 & 3) | B | M | PWD | CWD | Color | |||
| Doppler | Combined | |||||||
| (Specify) | Other* (Specify) | |||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal Imaging & | ||||||||
| Other | Fetal | P | P | P | P | P: 1, 3, 4, 11 | P: 5, 6 | |
| Abdominal (including urolology), Liver, | ||||||||
| Kidney, Spleen. | P | P | P | P | P: 1, 2, 3, 4, 11 | P: 5, 6, 7, 8, 9, 13,14, 16, | ||
| 21, 22 | ||||||||
| Intra-operative (Specify) | ||||||||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | P | P | P | P: 1, 2, 3, 4 | P: 5, 6, 7, 8, 13,16, | |||
| 9, 14, 21, 22 | ||||||||
| Small Organ (Breast, Thyroid, Testicle, | ||||||||
| Prostate, penis, etc...) | P | P | P | P: 1, 2, 3, 4 | P: 5, 6, 7, 8 | |||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Musculo-skeletal (Conventional) | ||||||||
| Musculo-skeletal (Superficial) | ||||||||
| Intravascular | ||||||||
| GYN | P | P | P | P | P: 1, 2, 3, 4 | P: 5, 6, 7, 8, 14, 11 | ||
| Pelvic | P | P | P | P | P: 1, 2, 3, 4 | P: 5, 6, 7, 8, 14, 11 | ||
| Other (Specify) | ||||||||
| Cardiac | Cardiac Adult | |||||||
| Cardiac Pediatric | ||||||||
| Intravascular (Cardiac) | ||||||||
| Trans-esoph. (Cardiac) | ||||||||
| Intra-cardiac | ||||||||
| Other (Specify) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | P | P | P | P: 1, 3, 4 | P: 5, 6, 8 | ||
| Other (Specify) | P | P | P | P: 1, 3, 4 | P: 5, 6, 8 |
N = new indication; P = Previously cleared by FDA (K191007)
1: Combined modes include: B+ Color Flow
2: Combined modes include: B+ ShearWave™ Elastography
3: Combined modes include: B+ Pulsed Wave
4: Combined modes include: B+ Pulsed Wave + Color Flow
5: Harmonic Imaging
6: Spatial Compounding
7: ShearWave™ Elastography
8: Imaging Guidance for Biopsies
9: Panoramic Imaging
10: 3D Imaging
11: Combined modes include: B+ M mode
Prescription Use _ X
(Part 21 CFR 801 Subpart D)
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
19: Strain Elastography
20: Combined mode: B Mode + Strain + SWE
21: Vi PLUS
22: Att PLUS & SSp PLUS
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
5
Concurrence of CDRH; Office of In Vitro Diagnostics and Radiological Health (OIR)
Diagnostic Ultrasound Indications for Use
510(k) Number (if known): K203645
Device Name: L10-2 transducer (linear transducer, SSIP95103)
Intended Use: Diagnostic ultrasound imaging, soft tissue elasticity imaging, fluid flow analysis of the human body as follows:
9: Panoramic Imaging
10: 3D Imaging
11: Combined modes include: B+ M mode
Prescription Use _ X
(Part 21 CFR 801 Subpart D)
19: Strain Elastography;
20: Combined mode: B Mode + Strain + SWE
21: Vi PLUS
22: Att PLUS & SSp PLUS AND/OR
Over-The-Counter Use
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
6
510(k) Number (if known): K203645
Device Name: C6-1X transducer (curved array transducer, SSIP95101)
Intended Use: Diagnostic ultrasound imaging, soft tissue elasticity imaging, fluid flow analysis of the human body as follows:
N = new indication; P = Previously cleared by FDA (K191007)
2: Combined modes include: B+ ShearWave™ Elastography
4: Combined modes include: B+ Pulsed Wave + Color Flow
Additional Comments:
5: Harmonic Imaging
9: Panoramic Imaging
10: 3D 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
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
19: Strain Elastography
20: Combined mode: B Mode + Strain + SWE
21: Vi PLUS
- 22: Att PLUS & SSp PLUS
AND/OR
Prescription Use _ X (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
7
510(k) Number (if known): K203645
Device Name: E12-3 transducer (endocavitary transducer, SSIP95102)
Intended Use: Diagnostic ultrasound imaging, soft tissue elasticity imaging, fluid flow analysis of the human body as follows:
| General
(Track 1 Only) | Clinical Application
Specific
(Tracks 1 & 3) | B | M | PWD | CWD | Color
Doppler | Mode of Operation
Combined
(Specify) | Other* (Specify) |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------|---|-----|-----|------------------|--------------------------------------------|----------------------|
| Ophthalmic | Ophthalmic | | | | | | | |
| Fetal Imaging &
Other | Fetal | P | P | P | | P | P : 1, 3, 4, 11 | P : 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...) | P | | P | | P | P: 1, 2, 3, 4 | P: 5, 6, 7, 8 |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | P | P | P | | P | P: 1, 2, 3, 4 | P: 5, 6, 7, 8 |
| | Trans-vaginal | P | P | P | | P | P: 1, 2, 3, 4,
11 | P: 5, 6, 7, 8 |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | |
| | Musculo-skeletal (Conventional) | | | | | | | |
| | Musculo-skeletal (Superficial) | | | | | | | |
| | Intravascular | | | | | | | |
| | GYN | P | P | P | | P | P: 1, 2, 3, 4,
11 | P: 5, 6, 7, 8 |
| | Pelvic | P | P | P | | P | P: 1, 2, 3, 4,
11 | P: 5, 6, 7, 8 |
| | Other (Specify) | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | |
| | Cardiac Pediatric | | | | | | | |
| | Intravascular (Cardiac) | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | |
| | Intra-cardiac | | | | | | | |
| | Other (Specify) | | | | | | | |
| Peripheral
Vessel | Peripheral vessel | | | | | | | |
| | Other (Specify) | P | | P | | P | P: 1, 3, 4 | P: 5, 6, 8 |
| | Clinical Application | Mode of Operation | | | | | | |
| General
(Track 1 Only) | Specific
(Tracks 1 & 3) | B | M | PWD | CWD | Color
Doppler | Combined
(Specify) | Other* (Specify) |
| Ophthalmic | Ophthalmic | | | | | | | |
| Fetal Imaging &
Other | Fetal | | | | | | | |
| | Abdominal (including urolology):
Liver, Kidney, Spleen... | P | | P | | P | P: 1, 2, 3, 4 | P: 5, 6, 7, 8, 9, 10 |
| | Intra-operative (Specify) | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | P | | P | | P | P: 1, 2, 3, 4 | P: 5, 6, 7, 8, 9, 10 |
| | Small Organ (for example Breast,
Thyroid, Testicle, Prostate, penis,
etc...) | P | | P | | P | P: 1, 2, 3, 4 | P: 5, 6, 7, 8, 9, 10 |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | |
| | Musculo-skeletal (Conventional) | P | | P | | P | P: 1, 2, 3, 4 | P: 5, 6, 7, 8, 9, 10 |
| | Musculo-skeletal (Superficial) | P | | P | | P | P: 1, 2, 3, 4 | P: 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) | | | | | | | |
| Peripheral
Vessel | Peripheral vessel | P | | P | | P | P: 1, 3, 4 | P: 5, 6, 8, 9, 10 |
| | Other (Specify) | | | | | | | |
| N = new indication; P = Previously cleared by FDA (K191007) | | | | | | | | |
| 1: Combined modes include: B+ Color Flow
5: Harmonic Imaging
6: Spatial Compounding
7: ShearWave™ Elastography
8: Imaging Guidance for Biopsies
9: Panoramic Imaging
10: 3D Imaging
11: Combined modes include: B+ M mode | 12: Combined modes include: B Mode + Color flow + Shearwave™ Elastography
2: Combined modes include: B+ ShearWave™ Elastography
13: CEUS (Contrast Enhancement UltraSound)
3: Combined modes include: B+ Pulsed Wave
14: Angio PL.U.S (Color Doppler improvement)
4: Combined modes include: B+ Pulsed Wave + Color Flow
15: Needle PL.U.S
16: Brightness ratio
17: Combined mode include: B+ Continuous Wave
18: Combined mode include: B+ M mode + Color flow
19: Strain Elastography
20: Combined mode: B Mode + Strain + SWE
21: Vi PLUS
22: Att PLUS & SSp PLUS | | | | | | | |
| Prescription Use X AND/OR Over-The-Counter Use __
(Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) | | | | | | | | |
| Clinical Application | | Mode of Operation | | | | | | |
| General
(Track 1 Only) | Specific
(Tracks 1 & 3) | B | M | PWD | CWD | Color
Doppler | Combined
(Specify) | Other* (Specify) |
| Ophthalmic | Ophthalmic | | | | | | | |
| Fetal Imaging
& Other | Fetal | | | | | | | |
| | Abdominal (including urology): Liver,
Kidney, Spleen... | P | | P | P | P | P: 1, 2, 3, 4 | P: 5, 6, 7, 8, 9, 13 |
| | Intra-operative (Specify) | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | P | | P | P | P | P: 1, 2, 3, 4 | P: 5, 6, 7, 8, 9, 13 |
| | Small Organ (for example Breast, Thyroid,
Testicle, Prostate, penis, etc...) | P | | | | | P: 1, 2, 3, 4 | P: 5, 6, 7, 8, 9 |
| | Neonatal Cephalic | P | | P | P | P | P: 1, 2, 3, 4 | P: 5, 6, 7, 9 |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | |
| | Musculo-skeletal (Conventional) | P | | P | P | P | P: 1, 2, 3, 4 | P: 5, 6, 7, 8, 9 |
| | Musculo-skeletal (Superficial) | P | | P | P | P | P: 1, 2, 3, 4 | P: 5, 6, 7, 8, 9 |
| | Intravascular | | | | | | | |
| | GYN | | | | | | | |
| | Pelvic | | | | | | | |
| | Other (Specify) | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | |
| | Cardiac Pediatric | P | P | P | P | P | P: 1,3,4,11 | P: 5, 6 |
| | Intravascular (Cardiac) | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | |
| | Intra-cardiac | | | | | | | |
| | Other (Specify) | | | | | | | |
| Peripheral
Vessel | Peripheral vessel | P | | P | P | P | P: 1, 3, 4 | P: 5, 6, 8, 9 |
| | Other (Specify) | P | | P | P | P | P: 1, 3, 4 | P: 5, 6, 8, 9 |
N = new indication; P = Previously cleared by FDA (K191007)
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
Prescription Use
X
(Part 21 CFR 801 Subpart D)
5: Harmonic Imaging
6: Spatial Compounding
7: ShearWave™ Elastography
8: Imaging Guidance for Biopsies
9: Panoramic Imaging
10: 3D Imaging
11: Combined modes include: B+ M 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
19: Strain Elastography
20: Combined mode: B Mode + Strain + SWE
21: Vi PLUS
22: Att PLUS & SSp PLUS
AND/OR
(21 CFR 807 Subpart C)
Over-The-Counter Use
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
8
510(k) Number (if known): K203645
Device Name: LV16-5 transducer (motorized linear transducer, SSIP95108)
Intended Use: Diagnostic ultrasound imaging, soft tissue elasticity imaging, fluid flow analysis of the human body as follows:
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
9
510(k) Number (if known): K203645
Device Name: MC12-3 transducer (micro-curved transducer, SSIP95106)
Intended Use: Diagnostic ultrasound imaging, soft tissue elasticity imaging, fluid flow analysis of the human body as follows:
N = new indication; P = Previously cleared by FDA (K191007)
1: Combined modes include: B+ Color Flow
2: Combined modes include: B+ ShearWave™ Elastography
3: Combined modes include: B+ Pulsed Wave
4: Combined modes include: B+ Pulsed Wave + Color Flow
5: Harmonic Imaging
6: Spatial Compounding
7: ShearWave™ Elastography
8: Imaging Guidance for Biopsies
9: Panoramic Imaging
10: 3D Imaging
11: Combined modes include: B+ M 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
19: Strain Elastography
20: Combined mode: B Mode + Strain + SWE
- 21: Vi PLUS
22: Att PLUS & SSp PLUS
Prescription Use __ X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
10
510(k) Number (if known): K203645
Device Name: P5-1X transducer (Phased Array 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 | Color | |||
| Doppler | Combined | |||||||
| (Specify) | Other* (Specify) | |||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal Imaging | ||||||||
| & Other | Fetal | |||||||
| Abdominal (including urolology): Liver, | ||||||||
| Kidney, Spleen... | P | P | P | P | P | P: 1, 3, 4, 11, | ||
| 17 | P: 5, 6, 16 | |||||||
| Intra-operative (Specify) | ||||||||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| Small Organ (for example Breast, Thyroid, | ||||||||
| Testicle, Prostate, penis, etc...) | P | P | P | P | P: 1, 3, 4 | P: 5, 6 | ||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | P | P | P | P: 1, 3, 4 | P: 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 | P | P | P | P | P | P : 1, 3, 4, 11, | |
| 17, 18 | P: 5, 6 | |||||||
| Cardiac Pediatric | ||||||||
| Intravascular (Cardiac) | ||||||||
| Trans-esoph. (Cardiac) | ||||||||
| Intra-cardiac | ||||||||
| Other (Specify) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | P | P | P | P | P: 1, 3, 4, 17 | P: 5, 6 | |
| Other (Specify) | P | P | P | P | P: 1, 3, 4, 17 | P: 5, 6 |
3: Combined modes include: B+ Pulsed Wave
4: Combined modes include: B+ Pulsed Wave + Color Flow
graphy
14: Angio PL.U.S (Color Doppler improvement)
17: Combined mode include: B+ Continuous Wave
20: Combined mode: B Mode + Strain + SWE
18: Combined mode include: B+ M mode + Color flow
15: Needle PL.U.S
16: Brightness ratio
21: Vi PLUS
19: Strain Elastography
22: Att PLUS & SSp PLUS
5: Harmonic Imaging 6: Spatial Compounding
- Spatial Compounding
- ShearWave™ Elastography
7: ShearWave™ Elastography
8: Imaging Guidance for Biopsies
9: Panoramic Imaging
10: 3D Imaqinq
11: Combined modes include: B+ M mode
Prescription Use AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
11
510(k) Number (if known): K203645
Device Name: LH20-6 transducer (linear 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 1 | ||||||||
| Only) | Specific | |||||||
| (Tracks 1 & 3) | B | M | PWD | CWD | Color | |||
| Doppler | Combined | |||||||
| (Specify) | Other* (Specify) | |||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal | ||||||||
| Imaging & | ||||||||
| Other | Fetal | |||||||
| Abdominal (including urolology): Liver, | ||||||||
| Kidney, Spleen... | ||||||||
| Intra-operative (Specify) Vascular, | ||||||||
| abdominal, small organs | P | P | P | P | P: 1, 3, 4 | P: 5, 6, 915 | ||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | P | P | P | P | P: 1, 2, 3, 4 | P: 5, 6, 7, 915 | ||
| Small Organ (for example Breast, Thyroid, | ||||||||
| Testicle, Prostate, penis, etc...) | P | P | P | P | P: 1, 2, 3, 4 | P: 5, 6, 7, 915 | ||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Musculo-skeletal (Conventional) | P | P | P | P | P: 1, 2, 3, 4 | P: 5, 6, 7, 9, 15 | ||
| Musculo-skeletal (Superficial) | P | P | P | P | P: 1, 2, 3, 4 | P: 5, 6, 7, 9, 15 | ||
| Intravascular | ||||||||
| GYN | ||||||||
| Pelvic | ||||||||
| Other (Specify) | ||||||||
| Cardiac | Cardiac Adult | |||||||
| Cardiac Pediatric | ||||||||
| Intravascular (Cardiac) | ||||||||
| Trans-esoph. (Cardiac) | ||||||||
| Intra-cardiac | ||||||||
| Other (Specify) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | P | P | P | P | P: 1, 3, 4 | P: 5, 6, 9, 15 | |
| Other (Specify) | P | P | P | P | P: 1, 3, 4 | P: 5, 6, 9, 15 |
1: Combined modes include: B+ Color Flow
3: Combined modes include: B+ Pulsed Wave
2: Combined modes include: B+ ShearWave™ Elastography
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 include: B+ M mode + Color flow
19: Strain Elastography
20: Combined mode: B Mode + Strain + SWE
21: Vi PLUS 22: Att PLUS & SSp PLUS
11: Combined modes include: B+ M mode
Prescription Use (Part 21 CFR 801 Subpart D)
5: Harmonic Imaging
6: Spatial Compounding
9: Panoramic Imaging 10: 3D Imaging
7: ShearWave™ Elastography
8: Imaging Guidance for Biopsies
Over-The-Counter Use
(21 CFR 807 Subpart C)
(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) Diagnostic Ultrasound Indications for Use
12
510(k) Number (if known): K203645
Device Name: L18-5 transducer Linear Array 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 | Color | |||||||
| Doppler | Combined | |||||||||||
| (Specify) | Other* (Specify) | |||||||||||
| Ophthalmic | Ophthalmic | |||||||||||
| Fetal Imaging & | ||||||||||||
| Other | Fetal | |||||||||||
| Abdominal (including urolology): | ||||||||||||
| Liver, Kidney, Spleen... | P | P | P | P: 1, 2, 3, 4 | P: 5, 6, 7, 8, 9, 14, 15 | |||||||
| Intra-operative (Specify) | ||||||||||||
| Intra-operative (Neuro) | ||||||||||||
| Laparoscopic | ||||||||||||
| Pediatric | P | P | P | P: 1, 2, 3, 4 | P: 5, 6, 7, 8, 9, 14, 15 | |||||||
| Small Organ (for example Breast, | ||||||||||||
| Thyroid, Testicle, Prostate, Penis) | P | P | P | P: 1, 2, 3, 4, 12 | P: 5, 6, 7, 8, 9, 14, 19, 20 | |||||||
| Neonatal Cephalic | P | P | P | P: 1, 2, 3, 4 | P: 5, 6, 7, 9 | |||||||
| Adult Cephalic | ||||||||||||
| Trans-rectal | ||||||||||||
| Trans-vaginal | ||||||||||||
| Trans-urethral | ||||||||||||
| Trans-esoph. (non-Card.) | ||||||||||||
| Musculo-skeletal (Conventional) | P | P | P | P: 1, 2, 3, 4 | P: 5, 6, 7, 8, 9,14, 15, 19, | |||||||
| 20 | ||||||||||||
| Musculo-skeletal (Superficial) | P | P | P | P: 1, 2, 3, 4 | P: 5, 6, 7, 8, 9,14, 15, 19, | |||||||
| 20 | ||||||||||||
| Intravascular | ||||||||||||
| GYN | ||||||||||||
| Pelvic | ||||||||||||
| Other (Specify) | ||||||||||||
| Cardiac | Cardiac Adult | |||||||||||
| Cardiac Pediatric | ||||||||||||
| Intravascular (Cardiac) | ||||||||||||
| Trans-esoph. (Cardiac) | ||||||||||||
| Intra-cardiac | ||||||||||||
| Other (Specify) | ||||||||||||
| Peripheral | ||||||||||||
| Vessel | Peripheral vessel | P | P | P | P: 1, 3, 4 | P: 5, 6, 8, 9, 15 | ||||||
| Other (Specify) | P | P | P | P: 1, 3, 4 | P: 5, 6, 8, 9, 15 |
N = new indication; P = Previously cleared by FDA (K191007)
1: Combined modes include: B+ Color Flow
2: Combined modes include: B+ ShearWave™ Elastography
3: Combined modes include: B+ Pulsed Wave
4: Combined modes include: B+ Pulsed Wave + Color Flow
5: Harmonic Imaging
6: Spatial Compounding
7: ShearWave™ Elastography
8: Imaging Guidance for Biopsies
9: Panoramic Imaging
10: 3D Imaging
11: Combined modes include: B+ M mode
Prescription Use _ X (Part 21 CFR 801 Subpart D) 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
19: Strain Elastography
20: Combined mode: B Mode + Strain + SWE
21: Vi PLUS
22: Att PLUS & SSp PLUS
AND/OR
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)
Concurrence of CDRH; Office of In Vitro Diagnostics and Radiological Health (OIR) Diagnostic Ultrasound Indications for Use
13
510(k) Number (if known): K203645
Device Name: C9-2X transducer, curved array transducer (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 | Color | |||
| Doppler | Combined | |||||||
| (Specify) | Other* (Specify) | |||||||
| Ophthalmic | ||||||||
| Fetal Imaging & | ||||||||
| Other | Fetal | P | P | P | P | P: 1, 3, 4, 11 | P: 5, 6 | |
| Other | Abdominal (including urolology): | |||||||
| Liver, Kidney, Spleen... | P | P | P | P | P: 1, 2, 3, 4, 11 | P: 5, 6, 7, 8, 9, 13, 14, 16, | ||
| 21, 22 | ||||||||
| Intra-operative (Specify) | ||||||||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | P | P | P | P: 1, 2, 3, 4 | P: 5, 6, 7, 8, 13, 16 – N: 21, | |||
| 22 | ||||||||
| Small Organ (for example Breast, | ||||||||
| Thyroid, Testicle, Prostate, Penis) | P | P | P | P: 1, 2, 3, 4 | P: 5, 6, 7, 8 | |||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Musculo-skeletal (Conventional) | ||||||||
| Musculo-skeletal (Superficial) | ||||||||
| Intravascular | ||||||||
| GYN | P | P | P | P | P: 1, 2, 3, 4 | P: 5, 6, 7, 8, 14 | ||
| Pelvic | P | P | P | P | P: 1, 2, 3, 4 | P: 5, 6, 7, 8, 14 | ||
| Other (Specify) | ||||||||
| Cardiac | Cardiac Adult | |||||||
| Cardiac Pediatric | ||||||||
| Intravascular (Cardiac) | ||||||||
| Trans-esoph. (Cardiac) | ||||||||
| Intra-cardiac | ||||||||
| Other (Specify) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | P | P | P | P: 1, 3, 4 | P: 5, 6, 8 | ||
| Vessel | Other (Specify) | P | P | P | P: 1, 3, 4 | P: 5, 6, 8 |
1: Combined modes include: B+ Color Flow
2: Combined modes include: B+ ShearWave™ Elastography
3: Combined modes include: B+ Pulsed Wave
- 4: Combined modes include: B+ Pulsed Wave + Color Flow
5: Harmonic Imaging
6: Spatial Compounding
7: ShearWave™ Elastography
- 8: Imaging Guidance for Biopsies
9: Panoramic Imaging
10: 3D Imaging
11: Combined modes include: B+ M mode
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
13: CEUS (Contrast Enhancement UltraSound)
14: Angio PL.U.S (Color Doppler improvement)
20: Combined mode: B Mode + Strain + SWE
17: Combined mode include: B+ Continuous Wave
18: Combined mode include: B+ M mode + Color flow
12: Combined modes include: B Mode + Color flow + Shearwave™ Elastography
(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)
15: Needle PL.U.S
16: Brightness ratio
21: Vi PLUS
19: Strain Elastography
22: Att PLUS & SSp PLUS
14
K203645 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: Hologic Inc. 250 Campus Dr. Malborough, MA 01752 North America Telephone: 508-263-2900
Corresponding Official: Jacques Souquet Chief Innovation Officer Telephone: +33 442 99 24 35
Date: 2020.11.30
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 30 / SUPERSONIC MACH30, AIXPLORER® MACH 20 / SUPERSONICMACH20, SUPERSONIC MACH40
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
| Primary Predicate Device | AIXPLORER® MACH range Ultrasound Imaging System (K191007), cleared on
10/25/2019 |
|--------------------------|-------------------------------------------------------------------------------------|
| Reference devices | Aplio i900, i800, i700 V2 (K173090), cleared on 01/11/2018 |
| | Resona 7 (K171233) cleared on 09/12/2017 |
15
4) Description of Device
The SuperSonic Imagine AIXPLORER® MACH / SUPERSONIC 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 submodes 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 and Strain Elastography.
5) Indication for Use
The SuperSonic Imagine AIXPLORER® MACH / SUPERSONIC MACH range ultrasound diagnostic systems and transducers are intended for general purpose pulse echo ultrasound imaging, soft tissue viscoelasticity imaging, doppler fluid flow analysis of the human body.
The SuperSonic Imagine AIXPLORER® MACH / SUPERSONIC 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, OBGYN, Pelvic, Pediatric, Urology, Trans-rectal, Trans-vaginal and Neonatal/Adult Cephalic, Non-invasive Cardiac. In addition, the SuperSonic Imagine AIXPLORER® MACH / SUPERSONIC 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 and perfusion. - Quantification of abdominal vascularization and perfusion.
The shearwave speed, beam attenuation, viscosity and stiffness measurements, the brightness ratio, the visualization of vascularization, microvascularization and perfusion of vascularization and perfusion may be used as an aid to clinical management of adult and pediatric patients with liver disease.
Furthermore, the SuperSonic Imagine AIXPLORER® MACH / SUPERSONIC MACH ultrasound diagnostic systems and associated transducers are intended for:
- Measurements of breast anatomical structures
- Measurements of broad band shear waves speed and tissue stiffness in internal structures of the breast
- Visualization of breast structures and micro-vascularization
- Visualization of breast masses morphology using shearwave elastography and micro-vascularization 2D mapping
The shear waves speed and stiffness measurements may be used as an aid to management of women patients with breast masses, as shearwave elastography in conjunction with 2D gray scale imaging and vascularization provides added information to better characterize breast masses and improve the diagnostic accuracy of ultrasound.
16
| | SuperSonic Imagine | Canon Medical
System | Mindray medical
International | SuperSonic Imagine |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Aixplorer MACH range
sw V2
(Primary Predicate
Device) | Aplio i900, i800
and i700 V2.0
(Reference
Device) | Resona 7
(Reference
Device) | AIXPLORER® MACH /
SUPERSONIC MACH
range sw V3 |
| 510(k)
Number | K191007 | K173090 | K171233 | K203645 |
| Classification
Name | Ultrasonic Pulsed
Doppler Imaging
System (892.1550)
Ultrasonic Pulsed Echo
Imaging System
(892.1560)
Diagnostic Ultrasound
Transducer (892.1570) | Identical | Identical | Identical |
| Class | Class II | Identical | Identical | Identical |
| Intended Use | Diagnostic ultrasound
imaging, soft tissue
elasticity imaging, fluid
flow analysis of the
human body | Diagnostic
ultrasound
imaging or fluid
flow analysis of
the human body | Diagnostic
Ultrasound imaging
or fluid flow analysis
of the human body | Identical to K191007 |
| Indication for
use | The SuperSonic Imagine
AIXPLORER®
MACH range
ultrasound
diagnostic
systems and
transducers are
intended for
general purpose
pulse echo
ultrasound
imaging, soft
tissue
viscoelasticity
imaging, doppler
fluid flow analysis | The diagnostic
ultrasound
systems Aplio
i900 Model TUS-
Al900, Aplio i800
Model TUS-
Al800, Aplio i700
Model TUS-
Al700, Aplio i600
Model TUS-
Al600, are
indicated for the
visualisation of
structures, and
dynamic
processes with
the human body
using ultrasound
and to provide
image | The Resona
7/Resona
7CV/Resona
7EXP/Resona
7S/Resona 7OB
diagnostic
ultrasound system is
applicable for
adults, pregnant
women, pediatric
patients and
neonates. It is
intended for use in
fetal, abdominal,
intra-operative
(abdominal,
thoracic, and
vascular), pediatric,
small organ (breast,
thyroid, testes), | Identical to
primary
Predicate Device
K191007
The SuperSonic
Imagine
AIXPLORER®
MACH /
SUPERSONIC
MACH range
ultrasound
diagnostic
systems and
transducers are
intended for
general purpose
pulse echo
ultrasound
imaging, soft |
| 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,
Trans-rectal,
Trans-vaginal and
Neonatal/Adult
Cephalic, Noninvasive
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
of the human body | information for
diagnosis in the
following
applications :
fetal, abdominal,
intraoperative
(abdominal),
pediatric, small
organs,
transvaginal,
transrectal,
neonatal
cephalic, adult
cephalic, cardica
(both adult and
pediatric),
peripheral
vascular,
transoesophage
al,
musculoskeletal
(both
conventional
and superficial)
and
laparoscopic. | neonatal cephalic,
adult cephalic,
trans-rectal,
transvaginal,musculo-skeletal
(conventional,
superficial), cardiac
adult, cardiac
pediatric,
transesoph.
(cardiac), peripheral
vessel and urology
exams. | tissue
viscoelasticity
imaging, doppler
fluid flow
analysis of the
human body.
The SuperSonic
Imagine
AIXPLORER®
MACH /
SUPERSONIC
MACH ultrasound
diagnostic
systems and
associated
transducers are | |
6) Summary of Technological Characteristics – New Device compared to Predicates
17
18
| - Measurements of
brightness ratio
between liver and
kidney,
- Visualization of
abdominal
vascularization,
microvascularizati on
and perfusion, - Quantification of
abdominal
vascularization and
perfusion. The
shearwave speed,
beam attenuation,
viscosity and stiffness
measurements, the
brightness ratio, the
visualization of
vascularization,
microvascularization and
perfusion, the
quantification of
vascularization and
perfusion may be used as
an aid to clinical
management of adult and
pediatric patients with
liver disease. | | - 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,
microvascularizati
on and perfusion, - Quantification of
abdominal
vascularization
and perfusion.
The shearwave
speed, beam
attenuation,
viscosity and
stiffness
measurements,
the brightness
ratio, the
visualization of
vascularization,
microvascularizati
on and perfusion,
the quantification
of vascularization
and perfusion may
be used as an aid
to clinical
management of
adult and pediatric
patients with liver
disease.
Expansion for
K203645
Furthermore, the
SuperSonic
Imagine
AIXPLORER® MACH
/ SUPERSONIC
MACH ultrasound
diagnostic systems
and associated |
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | -- | ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
|---|
19
| | | | | transducers are
intended for:
- Measurements of
breast anatomical
structures - Measurements of
broad band shear
waves speed and
tissue stiffness in
internal structures
of the breast - Visualization of breast
structures and
microvascularization
-Visualization of breast
masses morphology
using shearwave
elastography and
microvascularization 2D
mapping |
|--------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|-----------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | General purpose,
mobile, software
controlled
diagnostic
ultrasound system.
To acquire
ultrasound data
and to display the
data in various
modes of
operation. | Identical | 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 | Identical |
| Clinical
Applications | Abdominal (liver,
kidney, spleen) | Identical | Identical | Identical |
| | Small organs (*) | Identical | Identical | Identical |
| | Musculoskeletal | Identical | Identical | Identical |
| | Fetal | Identical | Identical | Identical |
| | GYN | Identical | Identical | Identical |
| | Cardiac (non
invasive) | Cardiac | Identical | Identical to
K191007 |
| | Adult and
neonatal cephalic | Identical | Identical | Identical |
| | Pediatric | Identical | Identical | Identical |
| | Urology | Identical | Identical | Identical |
| | Vascular | Identical | Identical | Identical |
| | Peripheral
vascular | Identical | Identical | Identical |
| | Trans-rectal | Identical | Identical | Identical |
| | Trans-vaginal | Identical | Identical | Identical |
| Imaging
modes | | | | |
| Convention
al | B-Mode
(Harmonic,
Fundamental) | Identical | Identical | Identical |
| | M-Mode | Identical | Identical | Identical |
| | PW | Identical | Identical | Identical |
| | CW | CW | Identical | Identical to
K191007 |
20
21
| Color Doppler | Identical | Identical | Identical |
|---|---|---|---|
| Amplitude Doppler | Identical | Identical | Identical |
| Microvascular | |||
| (Angio PL.U.S) | --(**) | -- | Identical to |
| K191007 |
| Other | Spatial compounding, Panoramic | Identical | Identical | Identical |
|---|---|---|---|---|
| Contrast | Identical | Identical | Identical | |
| Combination of modes | Identical | Identical | Identical | |
| ShearWave | ||||
| Elastography | Identical | Identical | Identical | |
| Strain Elastography | Identical | Identical | Identical to | |
| K191007 | ||||
| Design | ||||
| Cart | Mobile cart based | |||
| product with control | ||||
| panel and monitor | Identical | Identical | Identical | |
| Controls | Typical ultrasound | |||
| imaging controls (gain, | ||||
| depth mode select...) | Identical | Identical | Identical | |
| Biopsy | ||||
| guide | Available | Identical | Available | Identical |
| Track | Track 3 (Acoustic Output | |||
| Display) | Identical | Identical | Identical | |
| Patient | ||||
| Contact | ||||
| Materials | Yes, per ISO 10993-1 | Identical | Identical | Identical |
| Acoustic | ||||
| Output | ||||
| within FDA | ||||
| guidelines | Yes, as per NEMA UD-3 | Identical | Identical | Identical |
| Image | ||||
| Review | Yes | Identical | Identical | Identical |
| Measureme | ||||
| nt Package | Yes | Identical | Identical | Identical |
| Calculation | ||||
| Package | Yes | Identical | Identical | Identical |
| Report | Yes | Identical | Identical | Identical |
| General | ||||
| Safety | Conforms to | |||
| IEC60601-1, | ||||
| 60601-12, 60601-37 | Identical | Identical | Identical | |
| Labeling | Conforms to 21 CFR Part | |||
| 801 | Conforms to 21 CFR Part | |||
| 801 | ||||
| The user interface | ||||
| includes a dedicated | ||||
| menu for Bi-Rads. This | ||||
| menu provides Bi-Rads | ||||
| lexicon classification | ||||
| which allows the user to | ||||
| classify the lesion | ||||
| according to Bi-Rads | ||||
| criteria. |
Bi-RADS (ACR***)
lexicon classification User
Interface is composed of
following information :
- Tissue Composition
- Masses :
• Shape
• Orientation
• Margin
• Echo Pattern
These information are
criteria for lesion
characterization
according to Bi-RADS
scoring to assess the risk
of lesion malignancy. |
22
23
Vol_002-22
*: Breast, Thyroid, Testicle, etc
**:--- means not applicable
*** American College of Radiology
24
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 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 AilXPLORER® MACH / SUPERSONIC 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 / SUPERSONIC 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 / SUPERSONIC MACH range Ultrasound Diagnostic Systems. Summary of literature review : Owing to its correlation with cancer risk, real-time mapping of breast lesions stiffness has proven to produce important information to breast physicians that can improve the global management patients with breast lesions. Addition of Shear Wave elastography to conventional B-mode Ultrasound increased the specificity of breast mass assessment. It can significantly improve the positive predictive value of biopsy recommendation for probably benign and low suspicion breast lesions on ultrasound, while preserving the sensitivity of breast ultrasound. This been demonstrated in diagnostic settings. The addition of SWE evaluation of breast lesions also increases the inter-observer agreement on their global cancer risk assessment with ultrasound, thanks to its "almost perfect" intra-operator repeatability and high inter-observer reproducibility. The evaluation of breast cancers with SWE seem to contribute to defining more appropriate management strateqies thanks to more accurate cancer size measurements, to correlation with cancer aggressiveness and response to neo-adjuvant chemotherapy treatment.
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
25
testing demonstrated that the submission device is at least as safe and effective as the predicate devices listed in item 3.