AIXPLORER ULTRASOUND SYSTEM
Device Facts
| Record ID | K091970 |
|---|---|
| Device Name | AIXPLORER ULTRASOUND SYSTEM |
| Applicant | Supersonic Imagine |
| Product Code | IYN · Radiology |
| Decision Date | Aug 12, 2009 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1550 |
| Device Class | Class 2 |
Indications for Use
The SuperSonic Imagine AIXPLORER® ultrasound system and transducer are intended for general purpose pulse echo ultrasound imaging and Doppler fluid flow analysis of the human body.
Device Story
AIXPLORER® is a cart-based diagnostic ultrasound system. It uses linear array transducers to acquire pulse-echo ultrasound signals. The system processes these signals to generate B-Mode, Color Flow, Color Power, Pulsed Wave Doppler, and ShearWave™ Elastography images. It includes a scan converter, LCD monitor, and adjustable control panel with touch screen for clinician operation. The system performs measurements, calculations, image capture, and report generation. It is used in clinical settings for diagnostic imaging and biopsy guidance. By providing real-time visualization and quantitative elastography, it assists clinicians in evaluating tissue characteristics and anatomical structures, potentially improving diagnostic accuracy.
Clinical Evidence
No clinical data provided. Substantial equivalence is based on bench testing, including compliance with electrical safety standards (IEC 60601-1, IEC 60601-2-37) and acoustic output limits (NEMA UD-3).
Technological Characteristics
Cart-based ultrasound system with linear array transducers. Modes: B-Mode, Color Flow, Color Power, Pulsed Wave Doppler, ShearWave™ Elastography. Features: harmonic imaging, spatial compounding, biopsy guidance. Complies with IEC 60601-1 (safety) and IEC 60601-2-37 (ultrasonic diagnostic equipment). Acoustic output meets NEMA UD-3 and FDA Track 3 limits.
Indications for Use
Indicated for abdominal, small organs (breast, thyroid, testicle, prostate), musculoskeletal, superficial musculoskeletal, and peripheral vascular applications. Provides measurement of anatomical structures in these areas.
Regulatory Classification
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.
Predicate Devices
- Siemens Acuson S2000 TM Ultrasound System (K072786)
- Philips Ultrasound Boris Platform Diagnostic Ultrasound System (K030455)
Submission Summary (Full Text)
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## 510(k) Summary of Safety and Effectiveness
This summary of safety and effectiveness information is submitted in accordance with 21 CFR §807.92.
#### Submitter's name, address, telephone number, contact person 1)
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: 011 33 442 99 24 24
Distributed by: SuperSonic Imagine Inc. 8347 154" St NE Redmond, WA, 98052 USA Telephone: 425-284-6610
Corresponding Official:
Aurelie Gruener Regulatory Affairs Manager Telephone: 011 33 442 99 24 39
#### Name of the device, including the trade or proprietary name if applicable, the common or 2) usual name, and the classification name, if known:
Common/Usual Name: Diagnostic Ultrasound System with Accessories Proprietary Name: AIXPLORER®
Classification:
Requiatory Class: II Review Category: Tier 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 |
#### Substantially Equivalent/Predicate Devices 3)
Siemens Acuson S2000 TM Ultrasound System (K072786), 11/13/2007 Philips Ultrasound Boris Platform Diagnostic Ultrasound System (K030455), 3/13/2003
#### Description of Device ৰ ব
The SuperSonic Imagine AIXPLORER® system is a cart based ultrasound imaging system used to perform non-invasive diagnostic general purpose ultrasound imaging studies. The system contains a scan converter and can be coupled to a linear array transducer to produce images which are displayed on a LCD monitor. An adjustable control panel with integrated touch screen allows the user to perform an
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K091970
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ultrasound exam quickly and efficiently in accordance with ALARA principles. The system also allows the user to perform measurements and associated calculations, 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 external domes (subm as the predicate devices (see section 4.5.2 for predicate devices) and transducers for the imaging modes: B-Mode imaging, Color Flow imaging, Color Power imaging, Pulsed Wave Doppler, and Elastography Imaging.
## 5) Intended Use
The SuperSonic Imagine AIXPLORER® ultrasound system and transducer are intended for general purpose pulse echo ultrasound imaging and Doppler fluid flow analysis of the human body.
### 6) Indication for Use
The SuperSonic Imagine AIXPLORER® ultrasound system is indicated for use in the following applications: Abdominal, Small Organs, Musculoskeletal, Superficial Musculoskeletal and Peripheral Vascular.
The system also provides the ability to measure anatomical structures (abdominal, small organs, musculoskeletal, superficial musculoskeletal and peripheral vascular).
## 7) Safety Considerations
As a Track 3 ultrasound device, the SuperSonic Imagine AIXPLORER® ultrasound system is designed to comply with the "Standard For Real Time Display Of Thermal And Mechanical Acoustic Output Indices On Diagnostic Ultrasound Equipment (1992)" published by the National Electrical Manufacturers Association as UD -3. With respect to limits on acoustic outputs, the SuperSonic Imagine AIXPLORER® ultrasound system complies with the FDA guideline limits set in the September 30, 1997, 510(k) diagnostic ultrasound quidance.
With regard to general safety, the SuperSonic Imagine AIXPLORER® ultrasound system scanner is designed to comply with IEC 60101 -1 (2005) Medical Electrical Equipment, Part 1: General Requirements for Basic Safety and Essential Performance, and IEC 60601 - 2-37 (2007): Particular Requirements For The Safety Of Ultrasonic Medical Diagnostic And Monitoring Equipment.
| Mechanical Index | 1.9 (Maximum) |
|------------------|-------------------|
| TIS/TIB | 0.1 - 4.0 (Range) |
| ISPTA (d) | 720 mW/cm2 |
| ISPPA (d) | 0 - 700 W/cm2 |
The device's acoustic output limits are:
The limits are the same as predicate Track 3 devices. These considerations apply to all modes the system offers.
### 8) Comparison to Predicate Devices
The SuperSonic Imagine AIXPLORER® system and transducer are substantially equivalent to the predicate devices with regard to intended use, imaging capabilities, safety and effectiveness.
- The systems are all intended for diagnostic ultrasound imaging and fluid flow analysis. .
- The systems have the same clinical indications for use. .
- The systems have the same B-Mode (grayscale imaging) and Doppler capabilities. .
- The systems have similar capability in terms of harmonic imaging, spatial compound imaging, . elastography imaging and other image post-processing features to improve the image quality and aid in clinical evaluation and diagnosis.
- . The transducers are similar in materials, manufacture and clinical capability.
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- The systems are manufactured with materials which have been evaluated and found to be safe . for the intended use of the device.
- The systems have acoustic power levels which are below the applicable FDA limits. .
- The systems have similar capability in terms of performing measurements, capturing digital . images, reviewing and reporting studies.
- The systems have been found to be manufactured in compliance with approved electrical and . physical safety standards.
## 9) Conclusion
The documentation provided demonstrates that:
- 1) The system and transducer are substantially equivalent to the predicate devices.
- There are no new questions of safety and effectiveness concerning the SuperSonic Imagine 2) AIXPLORER® ultrasound system and transducer.
- The ultrasound device has been scientifically evaluated and has been demonstrated to be at 3) least as safe and effective as the predicate devices cited in item 3.
The system's acoustic power levels are below the applicable FDA limits.
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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized symbol consisting of three upward-pointing chevrons above a ribbon-like design.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Mr. Jacques Souquet, CEO SuperSonic Imagine, Inc. LES Jardin De La Duranne-Bat. E & F 510 Rue Rene Descartes 13857 Aix-en-Provence Cedex FRANCE
AUG 1 2 2009
Re: K091970
Trade/Device Name: AIXPLORER® Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, and ITX Dated: June 30, 2009 Received: July 1, 2009
Dear Mr. Souquet:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we 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). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
This determination of substantial equivalence applies to the following transducers intended for use with the AIXPLORER® Ultrasound System, as described in your premarket notification:
Transducer Model Number
## SL 15-4
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
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Page 2 - Mr. Jacques Souquet
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus permits your device to proceed to market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 796-5506. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrb/industry/support/index.html
If you have any questions regarding the content of this letter, please contact Joshua Nipper at (301) 796-6524.
Sincerely yours.
Joqui McWhany
Sanine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure(s)
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# Diagnostic Ultrasound Indications for Use
## 510(k) Number (if known): K091970
## Device Name: AIXPLORER® Ultrasound System
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
#### Indications for Use:
The SuperSonic Imagine AIXPLORER® ultrasound system is indicated for use in the following applicalions: Abdominal, Small Organs, Musculoskeletal, Superficial Musculoskeletal and Peripheral Vascular.
The system also provides the ability to measure anatomical structures (abdominal, small organs, musculoskeletal, superficial musculoskeletal and peripheral vascular).
Prescription Use XX
(Part 21 CFR 801 Subpari D) (21 CFR 801 Subpart C)
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Concurrence of CDRH, Office of Device Evaluation (ODE)
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Adam M. Whang
(Division Sign (Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number
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# Diagnostic Ultrasound Indications for Use
510(k) Number (if known): K091970
## Device Name: AIXPLORER® Ultrasound System
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follows:
| Clinical<br>Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combin<br>ed<br>(specify) | Notes |
|------------------------------------------------------------|---|---|---|-----|-----|------------------|----------------------|------------------------------|---------------------------|----------|
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | N | | N | | N | N | | 1, 2 | 3,4,5,6 |
| Intraoperative<br>(specify) | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ<br>(Breast, Thyroid,<br>Testicle,<br>Prostate) | | N | | N | | N | N | | 1, 2 | 3,4,5,6 |
| Neonatal<br>Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral<br>Vascular | | N | | N | | N | N | | 1, 2 | 3,4,5,6, |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | N | | N | | N | N | | 1, 2 | 3,4,5,6 |
| Musculo-skeletal<br>Superficial | | N | | N | | N | N | | 1, 2 | 3,4,5,6 |
| Other (specify) | | | | | | | | | | |
N= new indication; P= previously cleared by FDA; E= added under Appendix E Additional Comments:
Additorial ObRimonts.
1 : Combined modes include: B+Color,
2: Combined modes include: B+ ShearWave " Elastography
3: Harmonic Imaging
4: Spatial Compounding
4: Spalial Compounding
5: ShearWave™ Elastography
6: Imaging Guidance for Biopsies
Prescription Use XX OR Over The Counter Use
(Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)
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510(k) Number.
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# Diagnostic Ultrasound Indications for Use
510(k) Number (if known): K091970
Device Name: SL 15-4 Transducer (1D Linear Array Transducer) Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follows: :
| Clinical<br>Application | Modes of Operation | | | | | | | | Notes | |
|------------------------------------------------------------|--------------------|---|---|-----|-----|------------------|----------------------|------------------------------|-------|-----------------------|
| | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | | Combined<br>(specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | N | | N | | N | N | | 1, 2 | 3,4,5,6 |
| Intraoperative<br>(specify) | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ<br>(Breast, Thyroid,<br>Testicle,<br>Prostate) | | N | | N | | N | N | | 1,2 | 3.4.5,6 |
| Neonatal<br>Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral<br>Vascular | | N | | N | | N | N | | 1,2 | 3,4,5,6 |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | N | | N | | N | N | | 1,2 | 3.4,5.6 |
| Musculo-skeletal<br>Superficial | | N | | N | | N | N | | 1, 2 | 3.4.5.6 |
| Other (specify) | | | | | | | | | | |
N= new indicalion; P= previously cleared by FDA; E= added under Appendix E
Additional Comments:
1 : Combined modes include: B+Color,
2: Combined modes include: B+ ShearWave 14 Elastography
510(k) Number
3: Harmonic Imaging
4: Spalial Compounding
5: ShourWave™ Elastography
5: Shearwave Elastography
6: Imaging Guidance for Biopsies
Prescription Use _________ OR Over The Counter Use_
(Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)
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sion Sign-Off)
Sign of Reproductive, Abdominal, and Rudiological Device
