(98 days)
The Hologic SuperSonic Imagine 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 Hologic SuperSonic SUPERSONIC MACH range ultrasound diagnosic systems are indicated for use in the following applications, for imaging and measurement of anatomical Small Organs, Musculoskeletal, Superficial Musculoskeletal, Vascular, Intraoperative, OB-GYN, Pelvic, Pediatric, Urology, Trans-rectal, Trans-vaginal and Neonatal/Adult Cephalic, Non-invasive Cardiac.
Modes of operation include: B-mode [2D ; 3D ; Panoramic Imaging; Spatial Compounding ], M-mode , Doppler [Continuous Wave (CW); Pulsed Wave (PW); Color and Power Doppler (Color Flow Imaging). Color Doppler (Angio PL.U.S) ], Strain Elastography, Tissue Harmonic Imaging, Contrast Enhanced Ultrasound Imaging (CEUS); Shear Wave Elastography (SWE); ShearWave dispersion Viscosity (Vi PLUS); Combination Modes [ (B/Color Flow) ; (B/SWE), ( B/ PW), {B/PW/Color Flow); (B/ M-mode); (B/Color flow/SWE); (B/M-mode/Color flow); (B/Strain Elastography/SWE)].
In addition, the Hologic SuperSonic SUPERSONIC MACH range 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 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 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.
This device is intended for use by, or by the order of, and under the supervision of a licensed physician qualified to use or direct the use of the device. This device is intended for use in hospital environment or physician's office, This system should only be used by trained Health Care Professionals (HCP) who are knowledgeable about the risk of excessive acoustic energy in the body, particularly in the case where a great amount of fluid is present in the scanning area.
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 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 ShearWaveTM elastography and Strain Elastography.
The provided text is a 510(k) Summary for an ultrasound diagnostic system. It explicitly states in section 8, "A brief discussion of the clinical tests submitted, referenced, or relied on in the premarket notification submission for a determination of substantial equivalence: Not applicable.".
Therefore, the document does not contain information regarding:
- Acceptance criteria and reported device performance (beyond compliance with technical standards).
- Details of a study proving the device meets acceptance criteria.
- Sample size used for a test set or data provenance.
- Number of experts used to establish ground truth or their qualifications.
- Adjudication method for a test set.
- Multi-reader multi-case (MRMC) comparative effectiveness study, effect size.
- Standalone algorithm performance.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
The document only discusses non-clinical tests (electrical safety, EMC, acoustic output, biocompatibility) which confirmed the device performs according to its intended use and complies with relevant standards. It concludes that the device is "at least as safe and effective as the predicate devices".
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October 28, 2022
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: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.
SuperSonic Imagine % Shalyna Bansropun Regulatory Affairs Manager Zac de l`enfant 135 rue Emilien Gautier Aix en Provence, 13290 FRANCE
Re: K222191
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: September 23, 2022 Received: September 28, 2022
Dear Shalyna Bansropun:
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
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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,
Yanna Kang, Ph.D. Assistant Director Mammography and Ultrasound Team DHT8C: Division of Radiological Imaging and Radiation Therapy Devices OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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510{k) Number (if known) K222191
Device Name
AIXPLORER® MACH 30 / SUPERSONIC MACH30, AIXPLORER® MACH 20 / SUPERSONIC MACH20 and SUPERSONIC MACH 40
Indications for Use (Describe)
The Hologic SuperSonic Imagine 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 Hologic SuperSonic SUPERSONIC MACH range ultrasound diagnosic systems are indicated for use in the following applications, for imaging and measurement of anatomical Small Organs, Musculoskeletal, Superficial Musculoskeletal, Vascular, Intraoperative, OB-GYN, Pelvic, Pediatric, Urology, Trans-rectal, Trans-vaginal and Neonatal/Adult Cephalic, Non-invasive Cardiac.
Modes of operation include: B-mode [2D ; 3D ; Panoramic Imaging; Spatial Compounding ], M-mode , Doppler [Continuous Wave (CW); Pulsed Wave (PW); Color and Power Doppler (Color Flow Imaging). Color Doppler (Angio PL.U.S) ], Strain Elastography, Tissue Harmonic Imaging, Contrast Enhanced Ultrasound Imaging (CEUS); Shear Wave Elastography (SWE); ShearWave dispersion Viscosity (Vi PLUS); Combination Modes [ (B/Color Flow) ; (B/SWE), ( B/ PW), {B/PW/Color Flow); (B/ M-mode); (B/Color flow/SWE); (B/M-mode/Color flow); (B/Strain Elastography/SWE)].
In addition, the Hologic SuperSonic SUPERSONIC MACH range 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 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 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.
This device is intended for use by, or by the order of, and under the supervision of a licensed physician qualified to use or direct the use of the device. This device is intended for use in hospital environment or physician's office, This system should only be used by trained Health Care Professionals (HCP) who are knowledgeable about the risk of excessive acoustic energy in the body, particularly in the case where a great amount of fluid is present in the scanning area.
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)
FORM FDA 3881 (6/20)
Page 1 of 6
PSL' Publishing Services (301) - 443.6740
Lt
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Image /page/3/Picture/0 description: The image shows the logo for Hologic SuperSonic Imagine. The word "HOLOGIC" is in dark blue, while "SUPERSONIC" is in gray. The word "Imagine" is in light blue. The TM symbol is next to the word "SUPERSONIC".
K222191
510(k) Summary
This summary of safety and effectiveness information is submitted in accordance with 21 CFR §807.92.
-
- Submitter's name, address, telephone number, contact person
| Submitted by: | Distributed by: |
|---|---|
| SuperSonic Imagine, S.A. | Hologic Headquarters. |
| Zac de l'Enfant 135 Rue Émilien Gautier | 250 Campus Drive |
| 13290 Aix-En-Provence | Marlborough, MA 01752 |
| FRANCE | USA |
| Telephone: +33(4) 42 99 24 24 | Tel: +1.508.263.2900 |
| E-mail: contactsFR@supersonicimagine.com | Fax: +1.781.280.0668 |
| E-mail: info@hologic.com |
Corresponding Official: Shalyna BANSROPUN, Quality and Regulatory Affairs Manager Telephone: +33(6) 77 23 08 42
Date: Sept-22-2022
-
- 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
- Name of the device, including the trade or proprietary name if applicable, the common or usual name, and the classification name, if known:
Proprietary Name:
- AIXPLORER® MACH / SUPERSONIC MACH Ultrasound Diagnostic Systems o
- O AIXPLORER® MACH 30 / SUPERSONIC MACH30,
- AIXPLORER® MACH 20 / SUPERSONIC MACH 20, O
- SUPERSONIC MACH 40 o
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 |
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Image /page/4/Picture/0 description: The image shows the logo for Hologic Supersonic Imagine. The word "HOLOGIC" is in blue, and the word "SUPERSONIC" is in gray and blue. The word "Imagine" is in gray.
3. Substantially Equivalent/Predicate Devices
| Primary Predicate Device | AIXPLORER® MACH range Ultrasound Imaging System (K203645), clearedon 06/29/2021 |
|---|---|
| Reference devices | AIXPLORER® MACH range Ultrasound Imaging System (K202455),cleared on 12/29/2020 |
| Aplio i900, i800, i700 V2 (K173090), cleared on 01/11/2018 | |
| Resona 7 (K171233) cleared on 09/12/2017 |
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 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 ShearWaveTM elastography and Strain Elastography.
5. Indication for Use
The Hologic SuperSonic Imagine 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 Hologic SuperSonic SUPERSONIC MACH range 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.
Modes of operation include: B-mode [2D ; 3D ; Panoramic Imaging; Spatial Compounding ], M-mode , Doppler [Continuous Wave (CW); Pulsed Wave (PW); Color and Power Doppler (Color Flow Imaging), Color Doppler (Angio PL.U.S) ], Strain Elastography, Tissue Harmonic Imaging, Contrast Enhanced Ultrasound Imaging (CEUS); ShearWave Elastography (SWE); ShearWave dispersion Viscosity (Vi PLUS); Combination Modes [ (B/Color Flow); (B/SWE); (B/PW); (B/PW/Color Flow); (B/Color flow/SWE); (B/CW) ; (B/Mmode/Color flow); (B/Strain Elastography/SWE)]."
In addition, the Hologic SuperSonic Imagine SUPERSONIC MACH range ultrasound diagnostic systems and associated transducers are intended for:
- -Measurements of abdominal anatomical structures,
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Image /page/5/Picture/0 description: The image shows the logo for Hologic Supersonic Imagine. The word "HOLOGIC" is in blue, and the words "SUPERSONIC" are in gray. The word "Imagine" is in light blue and is located below the word "SUPERSONIC".
- -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 brightness ratio, the visualization of vascularization 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.
Furthermore, the 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.
This device is intended for use by, or by the order of, and under the supervision of a licensed physician qualified to use or direct the use of the device is intended for use in hospital environment or physician's office.
This system should only be used by trained Health Care Professionals (HCP) who are knowledgeable about the risk of excessive acoustic energy in the body, particularly in the case where a great amount of fluid is present in the scanning area.
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Image /page/6/Picture/0 description: The image shows the logo for Hologic Supersonic Imagine. The word "HOLOGIC" is in blue, and the words "SUPERSONIC imagine" are in gray and blue. The word "SUPERSONIC" is in gray, and the word "imagine" is in blue.
6. Summary of Technological Characteristics – New Device compared to Predicates
| SuperSonic Imagine | SuperSonic Imagine | Canon MedicalSystem | Mindray medicalInternational | SuperSonic Imagine | |
|---|---|---|---|---|---|
| Aixplorer MACH range swV3(predicate) | Aixplorer MACH range swV2.1(Reference) | Aplio i900, i800 andi700 V2.0(Reference) | Resona 7(Reference) | AIXPLORER® MACH /SUPERONIC MACHrange sw V4 | |
| 510(k) Number | K203645 | K202455 | K173090 | K171233 | K222191 |
| ClassificationName | Ultrasonic Pulsed DopplerImaging System (892.1550)Ultrasonic Pulsed EchoImaging System (892.1560)Diagnostic UltrasoundTransducer (892.1570) | Ultrasonic Pulsed DopplerImaging System (892.1550)Ultrasonic Pulsed EchoImaging System (892.1560)Diagnostic UltrasoundTransducer (892.1570) | Identical | Identical | Identical |
| Class | Class II | Class II | Identical | Identical | Identical |
| Intended Use | Diagnostic ultrasound imaging,soft tissue elasticity imaging,fluid flow analysis of thehuman body | Diagnostic ultrasound imaging,soft tissue elasticity imaging,fluid flow analysis of thehuman body | Diagnosticultrasoundimaging or fluid flowanalysis of thehumanbody | Diagnostic Ultrasoundimaging or fluid flowanalysis of the humanbody | Identical to K203645 |
| SuperSonic Imagine | SuperSonic Imagine | Canon MedicalSystem | Mindray medicalInternational | SuperSonic Imagine | |
| Indication for Use | The SuperSonic ImagineAIXPLORER® MACH/SUPERSONIC MACH rangeultrasound diagnosticsystems and transducers areintended for general purposepulse echo ultrasoundimaging, soft tissueviscoelasticity imaging,doppler fluid flow analysis ofthe human body.The SuperSonic ImagineAIXPLORER® MACH/SUPERSONIC MACHultrasound diagnosticsystems are indicated for usein the following applications,for imaging andmeasurement of anatomicalstructures: Abdominal, SmallOrgans, Musculoskeletal,Superficial Musculoskeletal,Vascular, PeripheralVascular, Intraoperative, OB-GYN, Pelvic, Pediatric,Urology, Trans-rectal, Trans-vaginal and Neonatal/AdultCephalic, Non-invasiveCardiac.In addition, the SuperSonicImagine AIXPLORER®MACH/ SUPERSONICMACH ultrasound diagnosticsystems and associatedtransducers are intended for: | The SuperSonic ImagineAIXPLORER® MACH/SUPERSONIC MACH rangeultrasound diagnosticsystems and transducers areintended for general purposepulse echo ultrasoundimaging, soft tissueviscoelasticity imaging,doppler fluid flow analysis ofthe human body.The SuperSonic ImagineAIXPLORER® MACH/SUPERSONIC MACHultrasound diagnosticsystems are indicated for usein the following applications,for imaging andmeasurement of anatomicalstructures: Abdominal, SmallOrgans, Musculoskeletal,Superficial Musculoskeletal,Vascular, PeripheralVascular, Intraoperative, OB-GYN, Pelvic, Pediatric,Urology, Trans-rectal, Trans-vaginal and Neonatal/AdultCephalic, Non-invasiveCardiac.In addition, the SuperSonicImagine AIXPLORER®MACH/ SUPERSONICMACH ultrasound diagnosticsystems and associatedtransducers are intended for: | The diagnosticultrasoundsystems Aplio i900Model TUS-AI900, Aplio i800Model TUS-AI800, Aplio i700Model TUS-AI700, Aplio i600Model TUS-AI600, are indicatedfor the visualisation ofstructures, anddynamic processeswith the human bodyusing ultrasound andto provide imageinformation fordiagnosis in thefollowing applications: fetal, abdominal,intraoperative(abdominal),pediatric, smallorgans, transvaginal,transrectal, neonatalcephalic, adultcephalic, cardica(both adult andpediatric), peripheral | The Resona7/Resona7CV/Resona7EXP/Resona7S/Resona 7OBdiagnostic ultrasoundsystem is applicable foradults, pregnantwomen, pediatricpatients and neonates.It is intended for use infetal, abdominal, intra-operative (abdominal,thoracic, and vascular),pediatric, small organ(breast, thyroid, testes),neonatal cephalic, adultcephalic,trans-rectal,transvaginal,musculo-skeletal (conventional,superficial), cardiacadult, cardiac pediatric,transesoph. (cardiac),peripheral vessel andurology exams. | Identical to K203645Additional informationfor clarification on "Operator qualificationand device usesettings" and "mode ofoperation". |
| SuperSonic Imagine | SuperSonic Imagine | Canon MedicalSystem | Mindray medicalInternational | SuperSonic Imagine | |
| -Measurements of abdominalanatomical structures, | -Measurements of abdominalanatomical structures, | vascular,transoesophageal,musculoskeletal (bothconventional andsuperficial) andlaparoscopic. | |||
| - Measurements of broadband shear wave speed, andtissue stiffness in internalstructures of the liver and thespleen, | - Measurements of broadband shear wave speed, andtissue stiffness in internalstructures of the liver and thespleen, | ||||
| - Measurements ofbrightness ratio between liverand kidney, | - Measurements ofbrightness ratio between liverand kidney, | ||||
| - Visualization of abdominalvascularization,microvascularization andperfusion, | - Visualization of abdominalvascularization,microvascularization andperfusion, | ||||
| - Quantification of abdominalvascularization andperfusion. | - Quantification of abdominalvascularization andperfusion. | ||||
| The shearwave speed, beamattenuation, viscosity andstiffness measurements, thebrightness ratio, thevisualization ofvascularization,microvascularization andperfusion, the quantificationof vascularization andperfusion may be used as anaid to clinical management ofadult and pediatric patientswith liver disease. | The shearwave speed, beamattenuation, viscosity andstiffness measurements, thebrightness ratio, thevisualization ofvascularization,microvascularization andperfusion, the quantificationof vascularization andperfusion may be used as anaid to clinical management ofadult and pediatric patientswith liver disease. | ||||
| SuperSonic Imagine | SuperSonic Imagine | Canon MedicalSystem | Mindray medicalInternational | SuperSonic Imagine | |
| Furthermore, the SuperSonicImagine MACH ultrasounddiagnostic systems andassociated transducers areintended for: | |||||
| - Measurements of breastanatomical structures | |||||
| - Measurements of broadband shear waves speedand tissue stiffness ininternal structures of thebreast | |||||
| - Visualization of breaststructures and micro-vascularization | |||||
| - Visualization of breastmasses morphology usingshearwave elastography andmicro-vascularization 2Dmapping | |||||
| The shear waves speed andstiffness measurements maybe used as an aid tomanagement of womenpatients with breast masses,as shearwave elastographyin conjunction with 2D grayscale imaging andvascularization providesadded information to bettercharacterize breast massesand improve the diagnosticaccuracy of ultrasound. | |||||
| SuperSonic Imagine | SuperSonic Imagine | Canon MedicalSystem | Mindray medicalInternational | SuperSonic Imagine | |
| General purpose, mobile,software controlled diagnosticultrasound system. To acquireultrasound data and to displaythe data in various modes ofoperation. | General purpose, mobile,software controlled diagnosticultrasound system. To acquireultrasound data and to displaythe data in various modes ofoperation. | Identical | Identical | Identical | |
| GeneralDescription | Consists of two parts: thesystem console and thetransducer. The systemconsole contains the userinterface, a display, systemelectronics and optionalperipherals (printers, etc...). | 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) | Abdominal (liver, kidney,spleen) | Identical | Identical | Identical |
| Small organs (*) | Small organs (*) | Identical | Identical | Identical | |
| Musculoskeletal | Musculoskeletal | Identical | Identical | Identical | |
| Fetal | Fetal | Identical | Identical | Identical | |
| GYN | GYN | Identical | Identical | Identical | |
| Cardiac (non invasive) | Cardiac (non invasive) | Identical | Identical | Identical to K203645 | |
| Adult and neonatal cephalic | Adult and neonatal cephalic | Identical | Identical | Identical | |
| Pediatric | Pediatric | Identical | Identical | Identical | |
| Urology | Urology | Identical | Identical | Identical | |
| SuperSonic Imagine | SuperSonic Imagine | Canon MedicalSystem | Mindray medicalInternational | SuperSonic Imagine | |
| Vascular | Vascular | Identical | Identical | Identical | |
| Peripheral vascular | Peripheral vascular | Identical | Identical | Identical | |
| Trans-rectal | Trans-rectal | Identical | Identical | Identical | |
| Trans-vaginal | Trans-vaginal | Identical | Identical | Identical | |
| Imaging modes | |||||
| Conventional | B-Mode (Harmonic,Fundamental) | B-Mode (Harmonic,Fundamental) | Identical | Identical | Identical |
| M-Mode | M-Mode | Identical | Identical | Identical | |
| PW | PW | Identical | Identical | Identical | |
| CW | CW | Identical | Identical | Identical | |
| Color Doppler | Color Doppler | Identical | Identical | Identical | |
| Amplitude Doppler | Amplitude Doppler | Identical | Identical | Identical | |
| Microvascular (AngioPL.U.S) | Microvascular (AngioPL.U.S) | --- (**) | --- | Identical to K203645 | |
| Other | Spatial compounding,Panoramic | Spatial compounding,Panoramic | Identical | Identical | Identical |
| Contrast | Contrast | Identical | Identical | Identical to K202455 | |
| Combination of modes | Combination of modes | Identical | Identical | Identical | |
| ShearWave Elastography | ShearWave Elastography | Identical | Identical | Identical | |
| Strain Elastography | Strain Elastography | Identical | Identical | Identical | |
| SuperSonic Imagine | SuperSonic Imagine | Canon MedicalSystem | Mindray medicalInternational | SuperSonic Imagine | |
| Design | |||||
| Cart | Mobile cart based productwith control panel andmonitor | Mobile cart based productwith control panel andmonitor | Identical | Identical | Identical |
| Controls | Typical ultrasound imagingcontrols (gain, depth modeselect...) | Typical ultrasound imagingcontrols (gain, depth modeselect...) | Identical | Identical | Identical |
| Biopsy guide | Available | Available | Identical | Identical | Identical |
| Track | Track 3 (Acoustic OutputDisplay) | Track 3 (Acoustic OutputDisplay) | Identical | Identical | Identical |
| Patient ContactMaterials | Yes, per ISO 10993-1 | Yes, per ISO 10993-1 | Identical | Identical | Identical |
| Acoustic Outputwithin FDAguidelines | Yes, as per NEMA UD-3 | Yes, as per NEMA UD-3 | Identical | Identical | Identical |
| Software OperationSystem | Linux (Debian 9) | Linux (Debian 9) | Windows | Windows | Linux (Debian 11) |
| Image Review | Yes | Yes | Identical | Identical | Improvement of imagequality presets (Angio,Abdo & Thyroid, MSK,Ultrafast DopplerVascular). |
| MeasurementPackage | Yes | Yes | Identical | Identical | Identical |
| CalculationPackage | Yes | Yes | Identical | Identical | Identical |
| SuperSonic Imagine | SuperSonic Imagine | Canon MedicalSystem | Mindray medicalInternational | SuperSonic Imagine | |
| AutomatedProtocols | No | No | Yes | Yes | Inclusion of OptionalAutomated Protocolsfeature |
| Report | Yes | Yes | Identical | Identical | Identical |
| General Safety | Conforms to IEC60601-1,60601-1-2, 60601-2-37 | Conforms to IEC60601-1,60601-1-2, 60601-2-37 | Identical | Identical | Identical |
| Labeling | Conforms to 21 CFR Part801 | Conforms to 21 CFR Part801 | Identical | Identical | Identical |
{7}------------------------------------------------
SUPERSONIC"
"Woodle" "magine
{8}------------------------------------------------
SUPER imaqıne
{9}------------------------------------------------
SUPERSONIC"
SUPERSONIC"
Magine
{10}------------------------------------------------
SUPERSONIC"
"magine" magine
{11}------------------------------------------------
SUPERSONIC™
{12}------------------------------------------------
Image /page/12/Picture/0 description: The image contains the logo for Hologic Supersonic Imagine. The word "Hologic" is in blue, and the word "SUPERSONIC" is in gray. The word "Imagine" is in gray and is located below the other words.
{13}------------------------------------------------
HOLOGIC® SUPER imaqine
Note:
*: Breast, Thyroid, Testicle, etc
**:--- means not applicable
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Image /page/14/Picture/0 description: The image shows the logo for Hologic Supersonic Imagine. The word "HOLOGIC" is in dark blue, and the word "SUPERSONIC" is in gray. The word "Imagine" is in light blue and is located below the word "SUPERSONIC".
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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 essentialperformance tests. |
| IEC 60601-1-2 Ed.4 | All applicable testing pertaining to electromagneticcompatibility. |
| IEC 60601-2-37 Ed.2.1 | All applicable testing pertaining to the particularrequirements for the safety of ultrasonic medicaldiagnostic and monitoring equipment. |
| NEMA UD 2 (Rev. 3) | All tests applicable in order to demonstratecompliance with the "Accoustic Output MeasurementStandard for Diagnostic Ultrasound Equipment". |
| NEMA UD 3 (Rev. 2) | All tests applicable in order to demonstratecompliance with the "Standard For Real Time DisplayOf Thermal And Mechanical Acoustic Output IndicesOn Diagnostic Ultrasound Equipment". |
| ISO 10993-1 | Applicable biocompatibility tests per FDA 510(k)Memorandum - #G95-1 - per the appropriate devicecategory. |
The above testing confirmed that the Aixplorer® 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 Systems to the predicate device(s).
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- A brief discussion of the clinical tests submitted, referenced, or relied on in the premarket notification submission for a determination of substantial equivalence
Not applicable.
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.