SonoSite SII Ultrasound System
Device Facts
| Record ID | K160734 |
|---|---|
| Device Name | SonoSite SII Ultrasound System |
| Applicant | FUJIFILM Sonosite, Inc. |
| Product Code | IYN · Radiology |
| Decision Date | Apr 5, 2016 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1550 |
| Device Class | Class 2 |
| Attributes | Pediatric, 3rd-Party Reviewed |
Indications for Use
The FUJIFILM SonoSite SII Ultrasound System is a general purpose ultrasound system intended for use by qualified physicians and healthcare professionals for evaluation by ultrasound imaging or fluid flow analysis of the human body. Specific clinical applications and exam types include: Ophthalmic Fetal - OB/GYN Abdominal Pediatric Small Organ (breast, thyroid, testicle, prostate) Neonatal Cephalic Adult Cephalic Trans-vaginal Musculo-skeletal (Conventional) Musculo-skeletal (Superficial) Cardiac Adult Cardiac Pediatric Peripheral Vessel
Device Story
SonoSite SII is a mountable, software-controlled diagnostic ultrasound system; acquires/displays high-resolution, real-time ultrasound data. Inputs: ultrasound signals via linear, curved linear, intracavitary, or phased array transducers (1.0–15.0 MHz). Processing: digital electronic design; utilizes B-mode, tissue harmonic imaging, M-mode, color M-mode, color power Doppler, and velocity color Doppler; features SonoHD2 noise reduction and SonoMB/MBe image compounding. Outputs: real-time images on 12.1" LCD. Used in clinical settings by physicians/healthcare professionals for diagnostic evaluation. Output aids clinical decision-making by providing anatomical visualization and fluid flow analysis. Benefits: non-invasive diagnostic imaging for various clinical applications. Operates on battery or AC power; supports wireless 802.11 image transfer.
Clinical Evidence
No clinical data. Substantial equivalence supported by non-clinical bench testing, including electrical, thermal, mechanical, and EMC safety, biocompatibility, and acoustic output measurements.
Technological Characteristics
Mountable diagnostic ultrasound system; 12.1" LCD; 128/128 beamformer. Materials: Cycoloy, polycarbonate, polysulfone UDEL P1700, PVC, silicone, urethane, acetal copolymer, ABS. Transducers: 1.0–15.0 MHz. Connectivity: 3 USB ports, wireless 802.11. Power: battery/AC. Standards: ISO 10993-1, IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-2-37, IEC 62304, IEC 62359, ISO 14971, NEMA UD 2-2004.
Indications for Use
Indicated for qualified physicians and healthcare professionals for ultrasound imaging or fluid flow analysis of the human body, including ophthalmic, fetal, OB/GYN, abdominal, pediatric, small organ (breast, thyroid, testicle, prostate), neonatal cephalic, adult cephalic, trans-vaginal, musculoskeletal (conventional/superficial), cardiac (adult/pediatric), and peripheral vessel applications, plus needle guidance.
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
- SonoSite Edge II Ultrasound System (K153626)
- SonoSite S Series (Maxx Series) Ultrasound System (K130173)
Submission Summary (Full Text)
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Image /page/0/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 image of three human profiles facing right, stacked on top of each other, with a flowing design below them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 5, 2016
FUJIFILM SonoSite, Inc. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services, LLC 1394 25th Street. NW BUFFALO MN 55313
Re: K160734
Trade/Device Name: SonoSite SII Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: March 16, 2016 Received: March 17, 2016
Dear Mr. Job:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Michael D. O'Hara
For
Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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# Indications for Use
510(k) Number (if known) TBD K160734
Device Name SonoSite SII Ultrasound System
#### Indications for Use (Describe)
The SonoSite SII Ultrasound System is a general purpose ultrasound system intended for use by qualified physicians and healthcare professionals for evaluation by ultrasound imaging or thuid flow analysis of the human body. Specific clinical applications and exam types include:
Ophthalmic Fetal - OB/GYN Abdominal Pediatric Small Organ (breast, thyroid, testicle, prostate) Neonatal Cephalic Adult Cephalic Trans-vaginal Musculo-skeletal (Conventional) Musculo-skeletal (Superficial) Cardiac Adult Cardiac Pediatric Peripheral Vessel
| Type of Use ( <i>Select one or both, as applicable</i> ) |
|----------------------------------------------------------|
|----------------------------------------------------------|
| <div> <input checked="true" type="checkbox"/> Research Use Only (R&D) 21 CFR 201.122 </div> | <div> <input type="checkbox"/> Some Therapeutic Use (21 CFR Part 312) </div> |
|---------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------|
|---------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------|
> Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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# 510(k) Summary
This summary of safety and effectiveness is provided as part of this Premarket Notification in compliance with 21 CFR, Part 807, Subpart E, Section 807.92.
#### 1) Submitter's name, address, telephone number, contact person:
FUJIFILM SonoSite, Inc. 21919 30th Drive SE Bothell, WA 98021-3904
| Corresponding Official: | Patricia Liau |
|-------------------------|-----------------------------|
| | Manager, Regulatory Affairs |
| E-mail: | Patricia.Liau@sonosite.com |
| Telephone: | (425) 951-6870 |
| Facsimile: | (425) 951-1201 |
| Date prepared: | March 2, 2016 |
#### 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
Diagnostic Ultrasound System with Accessories Proprietary Name
SonoSite SII Ultrasound System (subject to change)
Classification Names
| Name | FR Number | 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) Identification of the predicate or legally marketed device:
| SonoSite Edge II Ultrasound System | K153626 |
|---------------------------------------------------|---------|
| SonoSite S Series (Maxx Series) Ultrasound System | K130173 |
#### 4) Device Description:
The SonoSite SII Ultrasound System is a mountable style, full featured, general purpose, software controlled, diagnostic ultrasound system used to acquire and display high-resolution, real-time ultrasound data through multiple imaging modes. SII is a custom fabricated digital electronic design that readily lends itself to be configured for specific ultrasound imaging applications through different system feature selections. SII can operate on either battery or AC power.
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#### 5) Intended Use:
The FUJIFILM SonoSite SII Ultrasound System is a general purpose ultrasound system intended for use by qualified physicians and healthcare professionals for evaluation by ultrasound imaging or fluid flow analysis of the human body. Specific clinical applications and exam types include:
- Ophthalmic Fetal - OB/GYN Abdominal Pediatric Small Organ (breast, thyroid, testicle, prostate) Neonatal Cephalic Adult Cephalic Trans-vaginal Musculo-skeletal (Conventional) Musculo-skeletal (Superficial) Cardiac Adult Cardiac Pediatric Peripheral Vessel
#### 6) Technological Characteristics:
SonoSite Edge II and S Series Ultrasound Systems are both Track 3 devices that employ the same fundamental scientific technology. A comparison table is provided below.
| Feature | SonoSite SII Ultrasound<br>System<br>(This submission) | SonoSite Edge II<br>Ultrasound System<br>(K153626) | SonoSite S Series<br>Ultrasound System<br>(K130173) |
|---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Diagnostic ultrasound imaging or<br>fluid flow analysis of the human<br>body | Diagnostic ultrasound imaging or<br>fluid flow analysis of the human<br>body | Diagnostic ultrasound imaging or<br>fluid flow analysis of the human<br>body |
| Indications for<br>Use | Opthalmic<br>Fetal - OB/GYN<br>Abdominal<br>Pediatric<br>Small Organ (breast, thyroid,<br>testicle, prostate)<br>Neonatal Cephalic<br>Adult Cephalic<br>Trans-Vaginal<br>Musculo-skeletal (Conventional)<br>Musculo-skeletal (Superficial)<br>Cardiac Adult<br>Cardiac Pediatric<br>Peripheral Vessel<br>Needle guidance | Opthalmic<br>Fetal - OB/GYN<br>Abdominal<br>Pediatric<br>Small Organ (breast, thyroid,<br>testicle, prostate)<br>Neonatal Cephalic<br>Adult Cephalic<br>Trans-Vaginal<br>Musculo-skeletal (Conventional)<br>Musculo-skeletal (Superficial)<br>Cardiac Adult<br>Cardiac Pediatric<br>Trans-esophageal (cardiac)<br>Peripheral Vessel<br>Needle guidance | Opthalmic<br>Fetal - OB/GYN<br>Abdominal<br>Intra-operative (Abdominal organs<br>and vascular)<br>Intra-operative (Neuro.)<br>Laparoscopic<br>Pediatric<br>Small Organ (breast, thyroid,<br>testicle, prostate)<br>Neonatal Cephalic<br>Adult Cephalic<br>Trans-rectal<br>Trans-vaginal<br>Musculo-skeletal (Conventional)<br>Musculo-skeletal (Superficial)<br>Cardiac Adult<br>Cardiac Pediatric<br>Trans-esophageal (cardiac)<br>Peripheral Vessel<br>Needle guidance |
| Transducer<br>Types | Linear Array<br>Curved Linear Array<br>Intracavitary<br>Phased Array | Linear Array<br>Curved Linear Array<br>Intracavitary<br>Phased Array<br>Trans-esophageal | Linear Array<br>Curved Linear Array<br>Intracavitary<br>Phased Array<br>Static Probes<br>Trans-esophageal |
| Transducer<br>Frequency | 1.0 — 15.0 MHz | 1.0 - 15.0 MHz | 1.0 - 15.0 MHz |
| Feature | SonoSite SII Ultrasound<br>System<br>(This submission) | SonoSite Edge II<br>Ultrasound System<br>(K153626) | SonoSite S Series<br>Ultrasound System<br>(K130173) |
| Modes of<br>Operation | B-mode Grayscale Imaging<br>Tissue Harmonic Imaging | B-mode Grayscale Imaging<br>Tissue Harmonic Imaging | B-mode Grayscale Imaging<br>3D/4D Grayscale Imaging<br>Tissue Harmonic Imaging |
| | M-mode<br>Color M-Mode<br>Color Power Doppler<br>Zoom<br>Combination Modes | M-mode<br>Color M-Mode<br>Color Power Doppler<br>Zoom<br>Combination Modes<br>Pulsed Wave (PW) Doppler<br>Continuous Wave (CW) Doppler | M-mode<br>Anatomical M-Mode<br>Color M-Mode<br>Color Power Doppler<br>Zoom<br>Combination Modes<br>Pulsed Wave (PW) Doppler<br>Continuous Wave (CW) Doppler |
| | SonoHD2 Noise Reduction<br>SonoMB/MBe Image<br>Compounding<br>Velocity Color Doppler | SonoHD2 Noise Reduction<br>SonoMB/MBe Image<br>Compounding<br>Steered CW Doppler<br>Velocity Color Doppler<br>Tissue Doppler Imaging (TDI) | SonoRes/SonoHD Noise<br>Reduction<br>SonoMB Image Compounding<br>Steered CW Doppler<br>Velocity Color Doppler<br>Tissue Doppler Imaging (TDI) |
| PW Doppler | Not available | Available | Available |
| CW Doppler | Not available | Available | Available |
| Patient<br>Contact | Transducers: | Transducers: | Transducers:<br>Acrylonitrile-butadien-styrene<br>(ABS) |
| Materials | Cycoloy | Cycoloy<br>Epoxy paste adhesive<br>Polyethylene (PE) Ionomer<br>Polyetheretherketone (PEEK) | Cycoloy<br>Dow Medical Adhesive, Type A<br>Epoxy paste adhesive<br>Polyethylene (PE) Ionomer<br>Polyetheretherketone (PEEK) |
| | Polycarbonate<br>Polysulfone UDEL P1700<br>Poly-Vinyl-Chloride (PVC)<br>Silicone RTV Adhesive<br>Silicone Rubber<br>Urethane<br>Needle Guides:<br>Acetal copolymer<br>Acrylonitrile-butadien-styrene | Polycarbonate<br>Polysulfone UDEL P1700<br>Polyurethane<br>Poly-Vinyl-Chloride (PVC)<br>Silicone RTV Adhesive<br>Silicone Rubber<br>Urethane<br>Needle Guides:<br>Acetal copolymer<br>Acrylonitrile-butadien-styrene | Polycarbonate<br>Polysulfone UDEL P1700<br>Polyurethane<br>Poly-Vinyl-Chloride (PVC)<br>Silicone RTV Adhesive<br>Silicone Rubber<br>Urethane<br>Needle Guides:<br>Acetal copolymer<br>Acrylonitrile-butadien-styrene |
| System<br>Characteristics | (ABS)<br>SII:<br>Beamformer 128/128 using SA<br>(configurable)<br>Hand held display and control<br>Single 12.1" Liquid Crystal Display<br>(LCD)<br>256 gray shades on LCD | (ABS)<br>Edge II:<br>Beamformer 128/128 using SA<br>(configurable)<br>Hand held display and control<br>Single 12.1" Liquid Crystal Display<br>(LCD)<br>256 gray shades on LCD | (ABS)<br>S Series:<br>Beamformer 128/128 using SA<br>(configurable)<br>Hand held display and control<br>Single 10.4" Liquid Crystal Display<br>(LCD)<br>256 gray shades on LCD |
| | 3 USB ports | 2 USB ports | 3 USB ports |
| | Dimension: 11.5"(W) x 17.6" (L) x<br>4.8"(H) | Dimensions: 12.8"(W) x 12.1" (L) x<br>2.5"(H) | Dimensions: 11.6"(W) x 15.1" (L) x<br>6.1"(H) |
| | Weight: 12.6 lbs | Weight: 9.0 lbs | Weight: 8.5 lbs |
| | System operates via battery or AC<br>power<br>100 - 240V options, 50/60 Hz,<br>15VDC output | System operates via battery or AC<br>power<br>100 - 240V options, 50/60 Hz,<br>15VDC output | System operates via battery or AC<br>power<br>100 - 240V options, 50/60 Hz,<br>15VDC output |
| | Various obstetrical, cardiac,<br>volume, and M-mode<br>measurement and calculation | Various obstetrical, cardiac,<br>volume, M-mode, PW and CW<br>Doppler measurement and | Various obstetrical, cardiac,<br>volume, and M-mode<br>measurement and calculation |
| Feature | SonoSite SII Ultrasound<br>System<br>(This submission) | SonoSite Edge II<br>Ultrasound System<br>(K153626) | SonoSite S Series<br>Ultrasound System<br>(K130173) |
| | packages | calculation packages<br>ECG acquisition and display<br>capabilities<br>CW/PW Doppler Audio<br>Spectral Doppler Audio and image<br>storage on removable media | packages |
| | Wireless 802.11 support for image<br>transfer | Wireless 802.11 support for image<br>transfer | Wireless 802.11 support for image<br>transfer |
| 510(k) Track | Track 3 | Track 3 | Track 3 |
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### 7) Determination of Substantial Equivalence:
### Summary of Non-Clinical Tests:
The SonoSite SII Ultrasound System has been evaluated for electrical, thermal, mechanical, and EMC safety. Additionally, cleaning/disinfection, biocompatibility, and acoustic output have been evaluated, and the device has been found to conform to applicable mandatory medical device safety standards. Assurance of quality was established by employing the following elements of product development but were not limited to: Design Phase Reviews, Risk Assessment, Requirements Development, and Verification and Validation.
The SonoSite SII Ultrasound System is designed to comply with the following FDA recognized standards.
| Reference No. | Title |
|----------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| ISO 10993-1 | AAMI / ANSI / ISO 10993-1:2009/(R)2013, Biological evaluation of medical devices -<br>Part 1: Evaluation and testing within a risk management process |
| IEC 60601-1 | AAMI / ANSI ES60601-1:2005/(R)2012 and A1:2012,, C1:2009/(R)2012 and<br>A2:2010/(R)2012 (Consolidated Text) Medical electrical equipment - Part 1: General<br>requirements for basic safety and essential performance (IEC 60601-1:2005, MOD) |
| IEC 60601-1-2 | AAMI / ANSI / IEC 60601-1-2:2007(R)2012, Medical electrical equipment - Part 1-2:<br>General requirements for basic safety and essential performance - Collateral<br>standard: Electromagnetic compatibility - Requirements and tests (Edition 3) |
| IEC 60601-1-6 | IEC 60601-1-6 Edition 3.1 2013-10, Medical electrical equipment - Part 1-6: General<br>requirements for basic safety and essential performance - Collateral standard:<br>Usability |
| IEC 60601-2-37 | IEC 60601-2-37:2007 Edition 2.0 2007-08, Medical electrical equipment – Part 2-37:<br>Particular requirements for the basic safety and essential performance of ultrasonic<br>medical diagnostic and monitoring equipment |
| IEC 62304 | AAMI / ANSI / IEC 62304:2006, Medical device software - Software life cycle<br>processes |
| IEC 62359 | IEC 62359 Edition 2.0 2010-10-10, Ultrasonics - Field characterization - Test<br>methods for the determination of thermal and mechanical indices related to medical<br>diagnostic ultrasonic fields [Including: Technical corrigendum 1 (2011)] |
| ISO 14971 | ISO 14971:2007, Medical devices - Application of risk management to medical<br>devices |
| NEMA UD 2-2004 | Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment |
#### Summary of Clinical Tests:
The SonoSite SII Ultrasound System and transducers, subject of this submission, did not require clinical studies to support the determination of substantial equivalence.
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## 8) Conclusion:
Intended uses and other key features are consistent with traditional clinical practice and FDA guidance. The SonoSite SII system and predicates meet FDA requirements for Track 3 devices, share indications for use, have biosafety equivalence, and conform to applicable electromedical device safety standards. FUJIFILM SonoSite, Inc. believes that the SonoSite SII Ultrasound System is substantially equivalent with regard to safety and effectiveness to the predicate devices.
