SonoSite iViz Ultrasound System
Device Facts
| Record ID | K180704 |
|---|---|
| Device Name | SonoSite iViz Ultrasound System |
| Applicant | FUJIFILM Sonosite, Inc. |
| Product Code | IYN · Radiology |
| Decision Date | Apr 13, 2018 |
| Decision | SESE |
| Submission Type | Abbreviated |
| Regulation | 21 CFR 892.1550 |
| Device Class | Class 2 |
| Attributes | Pediatric, 3rd-Party Reviewed |
Intended Use
The SonoSite iViz Ultrasound System is a general purpose ultrasound system and non-continuous patient monitoring platform intended for use in clinical care by qualified physicians and healthcare professionals for evaluation by ultrasound imaging or fluid flow analysis. Specific clinical applications and exam types include: Fetal - OB/GYN Abdominal Pediatric Small Organ (breast, thyroid, testicles, prostate) Musculo-skel. (Convent.) Musculo-skel. (Superfic.) Cardiac Adult Cardiac Pediatric Peripheral vessel Ophthalmic
Device Story
Handheld, battery-operated digital ultrasound tablet; connects to active transducers for real-time imaging. Used in clinical care by physicians/healthcare professionals for diagnostic imaging or fluid flow analysis. Supports B-mode, M-mode, Color Doppler, and Tissue Harmonic Imaging. Features SonoHD3 speckle reduction. Connectivity via Bluetooth and wireless network for image transfer and OTA software updates. Output displayed on 7-inch LCD screen; assists clinicians in evaluating anatomy and pathology; facilitates clinical decision-making through high-resolution visualization.
Clinical Evidence
No clinical data required; substantial equivalence supported by bench testing, including electrical, thermal, mechanical, and EMC safety, biocompatibility, and acoustic output measurements per recognized standards (ISO 10993-1, IEC 60601-1, IEC 60601-2-37, NEMA UD 2-2004).
Technological Characteristics
Handheld tablet (7-inch, 1920x1200 LCD); Android-based software; battery-operated. Transducers use Polysulfone UDEL P1700, PVC, and silicone rubber. Imaging modes: B-mode, M-mode, Color Doppler, Tissue Harmonic Imaging, SonoHD3 speckle reduction. Connectivity: Wireless 802.11, Bluetooth. Standards: IEC 60601-1, IEC 60601-1-2, IEC 62304, ISO 10993-1.
Indications for Use
Indicated for use by qualified physicians and healthcare professionals for diagnostic ultrasound imaging or fluid flow analysis in fetal, OB/GYN, abdominal, pediatric, small organ (breast, thyroid, testicle, prostate), musculoskeletal (conventional and superficial), adult and pediatric cardiac, peripheral vessel, and ophthalmic applications.
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 iViz Ultrasound System (K162288)
- SonoSite Edge Ultrasound System (K133454)
- SonoSite Edge II Ultrasound System (K162045)
Reference Devices
- L25x/13-6 MHz Transducer (K162045)
- C60x/5-2 MHz transducer (K133454)
- L38v/10-5 MHz transducer (K162288)
Related Devices
- K152983 — FUJIFILM SonoSite iViz Ultrasound System · FUJIFILM Sonosite, Inc. · Nov 12, 2015
- K162288 — SonoSite iViz Ultrasound System · FUJIFILM Sonosite, Inc. · Sep 8, 2016
- K161119 — SonoSite iViz Ultrasound System · FUJIFILM Sonosite, Inc. · May 13, 2016
- K193510 — Terason uSmart3200T Ultrasound System · Teratech Corporation · Jan 28, 2020
- K113663 — SONIXTABLET ULTRASOUND SCANNER · Ultrasonix Medical Corporation · Jan 25, 2012
Submission Summary (Full Text)
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April 13, 2018
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the seal of the Department of Health & Human Services. To the right of the seal is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font size below it. The logo is simple and professional, and it is easily recognizable.
FUJIFILM SonoSite, Inc. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services, LLC 1394 25th Street. NW BUFFALO MN 55313
Re: K180704
Trade/Device Name: SonoSite iViz Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic Pulsed Doppler Imaging System Regulatory Class: Class II Product Code: IYN, IYO, ITX Dated: March 15, 2018 Received: March 19, 2018
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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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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Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn
(http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Michael D. O'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) K180704
Device Name SonoSite iViz Ultrasound System
#### Indications for Use (Describe)
The SonoSite iViz Ultrasound System is a general purpose ultrasound system and non-continuous patient monitoring platform intended for use in clinical care by qualified physicians and healthcare professionals for evaluation by ultrasound imaging or fluid flow analysis. Specific clinical applications and exam types include:
Fetal - OB/GYN Abdominal Pediatric Small Organ (breast, thyroid, testicles, prostate) Musculo-skel. (Convent.) Musculo-skel. (Superfic.) Cardiac Adult Cardiac Pediatric Peripheral vessel Ophthalmic
Type of Use (Select one or both, as applicable)
| <div style="display:inline-block;"><span style="font-size: 20px; vertical-align: middle;">☑</span></div> Prescription Use (Part 21 CFR 801 Subpart D) | <div style="display:inline-block;"><span style="font-size: 20px; vertical-align: middle;">☐</span></div> Over-The-Counter Use (21 CFR 801 Subpart C) |
|-------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|
|-------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|
> Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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Table 1.3-1: Diagnostic Ultrasound Indications for Use Form – FUJIFILM SonoSite iViz Ultrasound System
| System: | FUJIFILM SonoSite iViz Ultrasound System | | | | | | | | | | | |
|-------------------------------------------------------|-------------------------------------------------------------------|---|-----|-----|------------------|---------------------|------------------|--|--|--|--|--|
| Transducer: | N/A | | | | | | | | | | | |
| Intended Use: | Diagnostic ultrasound imaging or fluid flow analysis of the human | | | | | | | | | | | |
| | body as follows: | | | | | | | | | | | |
| Clinical Application | Mode of Operation | | | | | | | | | | | |
| | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Spec.) | Other<br>(Spec.) | | | | | |
| Ophthalmic | N | N | | | N | B+M; B+CD | 1,3 | | | | | |
| Fetal | P | P | | | P | B+M; B+CD | 1-3 | | | | | |
| Abdominal | P | P | | | P | B+M; B+CD | 1-3 | | | | | |
| Intra-operative (Abdominal<br>organs and vascular) | | | | | | | | | | | | |
| Intra-operative (Neuro.) | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | |
| Pediatric | P | P | | | P | B+M; B+CD | 1-3 | | | | | |
| Small Organ (breast, thyroid,<br>testicles, prostate) | P | P | | | P | B+M; B+CD | 1,3 | | | | | |
| Neonatal Cephalic | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | |
| Trans-rectal | | | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | | | |
| Trans-urethral | | | | | | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | | | | | | |
| Musculo-skel. (Convent.) | P | P | | | P | B+M; B+CD | 1,3 | | | | | |
| Musculo-skel. (Superfic.) | P | P | | | P | B+M; B+CD | 1,3 | | | | | |
| Intra-luminal | | | | | | | | | | | | |
| Other (spec.) | | | | | | | | | | | | |
| Cardiac Adult | P | P | | | P | B+M; B+CD | 1-3 | | | | | |
| Cardiac Pediatric | P | P | | | P | B+M; B+CD | 1-3 | | | | | |
| Trans-esophageal (card.) | | | | | | | | | | | | |
| Other (spec.) | | | | | | | | | | | | |
| Peripheral vessel | P | P | | | P | B+M; B+CD | 1,3 | | | | | |
| Other (spec.) | | | | | | | | | | | | |
N= new indication; P= previously cleared by FDA; E= added under this appendix
#### Additional Comments:
1: Color Doppler includes Power/Velocity/Variance
2: Tissue Harmonic Imaging (THI)
3: SonoHD3 Imaging (Speckle Reduction)
All items marked "P" were previously cleared in 510(k) K162288.
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Table 1.3-2: Diagnostic Ultrasound Indications for Use Form – L38v/10-5 MHz Transducer
| System: | FUJIFILM SonoSite iViz Ultrasound System | | | | | | |
|-------------------------------------------------------|---------------------------------------------------------------------------------------|---|-----|-----|------------------|---------------------|------------------|
| Transducer: | L38v/10-5 MHz Transducer | | | | | | |
| Intended Use: | Diagnostic ultrasound imaging or fluid flow analysis of the human<br>body as follows: | | | | | | |
| Clinical Application | Mode of Operation | | | | | | |
| | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Spec.) | Other<br>(Spec.) |
| Ophthalmic | N | N | | | N | | 1,3 |
| Fetal | | | | | | | |
| Abdominal | P | P | | | P | B+M; B+CD | 1,3 |
| Intra-operative (Abdominal<br>organs and vascular) | | | | | | | |
| Intra-operative (Neuro.) | | | | | | | |
| Laparoscopic | | | | | | | |
| Pediatric | P | P | | | P | B+M; B+CD | 1,3 |
| Small Organ (breast, thyroid,<br>testicles, prostate) | P | P | | | P | B+M; B+CD | 1,3 |
| Neonatal Cephalic | | | | | | | |
| Adult Cephalic | | | | | | | |
| Trans-rectal | | | | | | | |
| Trans-vaginal | | | | | | | |
| Trans-urethral | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | |
| Musculo-skel. (Convent.) | P | P | | | P | B+M; B+CD | 1,3 |
| Musculo-skel. (Superfic.) | P | P | | | P | B+M; B+CD | 1,3 |
| Intra-luminal | | | | | | | |
| Other (spec.) | | | | | | | |
| Cardiac Adult | N | N | | | N | B+M; B+CD | 1-3 |
| Cardiac Pediatric | N | N | | | N | B+M; B+CD | 1-3 |
| Trans-esophageal (card.) | | | | | | | |
| Other (spec.) | | | | | | | |
| Peripheral vessel | P | P | | | P | B+M; B+CD | 1,3 |
| Other (spec.) | | | | | | | |
N= new indication; P= previously cleared by FDA; E= added under this appendix
#### Additional Comments:
1: Color Doppler includes Power/Velocity/Variance
2: Tissue Harmonic Imaging (THI)
3: SonoHD3 Imaging (Speckle Reduction)
All items marked "P" were previously cleared in 510(k) K162288, K133454 and K162045.
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Table 1.3-3: Diagnostic Ultrasound Indications for Use Form – P21v/5-1 MHz Transducer
| System: | FUJIFILM SonoSite iViz Ultrasound System | | | | | | |
|----------------------------------------------------|------------------------------------------------------------------------------------|---|-----|-----|---------------|------------------|---------------|
| Transducer: | P21v/5-1 MHz Transducer | | | | | | |
| Intended Use: | Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | | | | | | |
| Clinical Application | Mode of Operation | | | | | | |
| | B | M | PWD | CWD | Color Doppler | Combined (Spec.) | Other (Spec.) |
| Ophthalmic | | | | | | | |
| Fetal | P | P | | | P | B+M; B+CD | 1-3 |
| Abdominal | P | P | | | P | B+M; B+CD | 1-3 |
| Intra-operative (Abdominal organs and vascular) | | | | | | | |
| Intra-operative (Neuro.) | | | | | | | |
| Laparoscopic | | | | | | | |
| Pediatric | P | P | | | P | B+M; B+CD | 1-3 |
| Small Organ (breast, thyroid, testicles, prostate) | | | | | | | |
| Neonatal Cephalic | | | | | | | |
| Adult Cephalic | | | | | | | |
| Trans-rectal | | | | | | | |
| Trans-vaginal | | | | | | | |
| Trans-urethral | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | |
| Musculo-skel. (Convent.) | | | | | | | |
| Musculo-skel. (Superfic.) | | | | | | | |
| Intra-luminal | | | | | | | |
| Other (spec.) | | | | | | | |
| Cardiac Adult | P | P | | | P | B+M; B+CD | 1-3 |
| Cardiac Pediatric | P | P | | | P | B+M; B+CD | 1-3 |
| Trans-esophageal (card.) | | | | | | | |
| Other (spec.) | | | | | | | |
| Peripheral vessel | | | | | | | |
| Other (spec.) | | | | | | | |
N= new indication; P= previously cleared by FDA; E= added under this appendix
#### Additional Comments:
1: Color Doppler includes Power/Velocity/Variance
2: Tissue Harmonic Imaging (THI)
3: SonoHD3 Imaging (Speckle Reduction)
All items marked "P" were previously cleared in 510(k) K152983.
{6}------------------------------------------------
Table 1.3-4: Diagnostic Ultrasound Indications for Use Form – C60v/5-2 MHz Transducer
| System: | FUJIFILM SonoSite iViz Ultrasound System | | | | | | |
|-------------------------------------------------------|-------------------------------------------------------------------|---|-----|-----|---------------|------------------|---------------|
| Transducer: | C60v/5-2 MHz Transducer | | | | | | |
| Intended Use: | Diagnostic ultrasound imaging or fluid flow analysis of the human | | | | | | |
| | body as follows: | | | | | | |
| Clinical Application | Mode of Operation | | | | | | |
| | B | M | PWD | CWD | Color Doppler | Combined (Spec.) | Other (Spec.) |
| Ophthalmic | | | | | | | |
| Fetal | N | N | | | N | B+M; B+CD | 1-3 |
| Abdominal | N | N | | | N | B+M; B+CD | 1-3 |
| Intra-operative (Abdominal<br>organs and vascular) | | | | | | | |
| Intra-operative (Neuro.) | | | | | | | |
| Laparoscopic | | | | | | | |
| Pediatric | N | N | | | N | B+M; B+CD | 1-3 |
| Small Organ (breast, thyroid,<br>testicles, prostate) | | | | | | | |
| Neonatal Cephalic | | | | | | | |
| Adult Cephalic | | | | | | | |
| Trans-rectal | | | | | | | |
| Trans-vaginal | | | | | | | |
| Trans-urethral | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | |
| Musculo-skel. (Convent.) | N | N | | | N | B+M; B+CD | 1-3 |
| Musculo-skel. (Superfic.) | N | N | | | N | B+M; B+CD | 1-3 |
| Intra-luminal | | | | | | | |
| Other (spec.) | | | | | | | |
| Cardiac Adult | | | | | | | |
| Cardiac Pediatric | | | | | | | |
| Trans-esophageal (card.) | | | | | | | |
| Other (spec.) | | | | | | | |
| Peripheral vessel | | | | | | | |
| Other (spec.) | | | | | | | |
N= new indication; P= previously cleared by FDA; E= added under this appendix
#### Additional Comments:
1: Color Doppler includes Power/Velocity/Variance
- 2: Tissue Harmonic Imaging (THI)
- 3: SonoHD3 Imaging (Speckle Reduction)
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Table 1.3-5: Diagnostic Ultrasound Indications for Use Form – L25v/13-6 MHz Transducer
| System: | FUJIFILM SonoSite iViz Ultrasound System | | | | | | | | | | |
|----------------------------------------------------|---------------------------------------------------------------------------------------|---|-----|-----|---------------|------------------|---------------|--|--|--|--|
| Transducer: | L25v/13-6 MHz Transducer | | | | | | | | | | |
| Intended Use: | Diagnostic ultrasound imaging or fluid flow analysis of the human<br>body as follows: | | | | | | | | | | |
| Clinical Application | Mode of Operation | | | | | | | | | | |
| | B | M | PWD | CWD | Color Doppler | Combined (Spec.) | Other (Spec.) | | | | |
| Ophthalmic | N | N | | | N | B+M; B+CD | 1,3 | | | | |
| Fetal | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | |
| Intra-operative (Abdominal organs and vascular) | | | | | | | | | | | |
| Intra-operative (Neuro.) | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | |
| Small Organ (breast, thyroid, testicles, prostate) | N | N | | | N | B+M; B+CD | 1,3 | | | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Trans-rectal | | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | | |
| Trans-urethral | | | | | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | | | | | |
| Musculo-skel. (Convent.) | N | N | | | N | B+M; B+CD | 1,3 | | | | |
| Musculo-skel. (Superfic.) | N | N | | | N | B+M; B+CD | 1,3 | | | | |
| Intra-luminal | | | | | | | | | | | |
| Other (spec.) | | | | | | | | | | | |
| Cardiac Adult | N | N | | | N | B+M; B+CD | 1-3 | | | | |
| Cardiac Pediatric | N | N | | | N | B+M; B+CD | 1-3 | | | | |
| Trans-esophageal (card.) | | | | | | | | | | | |
| Other (spec.) | | | | | | | | | | | |
| Peripheral vessel | N | N | | | N | B+M; B+CD | 1,3 | | | | |
| Other (spec.) | | | | | | | | | | | |
N= new indication; P= previously cleared by FDA; E= added under this appendix
#### Additional Comments:
1: Color Doppler includes Power/Velocity/Variance
2: Tissue Harmonic Imaging (THI)
3: SonoHD3 Imaging (Speckle Reduction)
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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: | Sudipta Chakrabarti |
|-------------------------|-----------------------------------|
| | Sr. Regulatory Affairs Specialist |
| E-mail: | sudipta.chakrabarti@fujifilm.com |
| Telephone: | (425) 951-1371 |
| Facsimile: | (425) 951-1201 |
| Date prepared: | February 12, 2018 |
# 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 iViz Ultrasound System
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:
Primary Predicates
| SonoSite iViz Ultrasound System | K162288 |
|------------------------------------|---------|
| SonoSite Edge Ultrasound System | K133454 |
| SonoSite Edge II Ultrasound System | K162045 |
Reference Predicates
L25x/13-6 MHz Transducer, previously cleared in the primary predicate Edge II 510(k) submission (K162045)
C60x/5-2 MHz transducer, previously cleared in the primary predicate Edge 510(k) submission (K133454) L38v/10-5 MHz transducer, previously cleared in the primary predicate iViz 510(k) submission (K162288)
{9}------------------------------------------------
# 4) Device Description:
The SonoSite iViz Ultrasound System is a highly featured, general purpose, software controlled, diagnostic ultrasound system used to acquire and display high-resolution, real-time ultrasound data through multiple imaging modes. iViz is a custom fabricated digital electronic handheld tablet that is highly portable, battery-operated, and consists of an active transducer that connects to and is controlled by the tablet. iViz supports Bluetooth and wireless network connectivity for image transfer and over-the-air (OTA) software updates.
# 5) Intended Use:
The SonoSite iViz Ultrasound System is a general purpose ultrasound system and non-continuous patient monitoring platform intended for use in clinical care by qualified physicians and healthcare professionals for evaluation by ultrasound imaging or fluid flow analysis. Specific clinical applications and exam types include:
- Fetal OB/GYN Abdominal Pediatric Small Organ (breast, thyroid, testicles, prostate) Musculo-skel. (Convent.) Musculo-skel. (Superfic.) Cardiac Adult Cardiac Pediatric Peripheral vessel Ophthalmic
# 6) Technological Characteristics:
SonoSite iViz and Edge Ultrasound Systems are Track 3 devices that employ the same fundamental scientific technology. A comparison table is provided below.
| Feature | SonoSite iViz<br>Ultrasound<br>System<br>(This submission) | SonoSite iViz<br>Ultrasound System<br>(K162288) | SonoSite Edge<br>Ultrasound System<br>(K133454) | SonoSite Edge II<br>Ultrasound System<br>(K162045) |
|------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Diagnostic<br>ultrasound imaging<br>or fluid flow analysis<br>of the human body | Diagnostic ultrasound<br>imaging or fluid flow<br>analysis of the human<br>body | Diagnostic ultrasound<br>imaging or fluid flow<br>analysis of the human<br>body | Diagnostic ultrasound<br>imaging or fluid flow<br>analysis of the human<br>body |
| Indications for<br>Use | Fetal - OB/GYN<br>Abdominal<br>Pediatric<br>Small Organ<br>(breast, thyroid,<br>testicle, prostate)<br>Musculo-skeletal<br>(Conventional)<br>Musculo-skeletal<br>(Superficial)<br>Cardiac Adult<br>Cardiac Pediatric<br>Peripheral Vessel<br>Ophthalmic | Fetal - OB<br>Abdominal<br>Pediatric<br>Small Organ (breast,<br>thyroid, testicle, prostate)<br>Musculo-skeletal<br>(Conventional)<br>Musculo-skeletal<br>(Superficial)<br>Cardiac Adult<br>Cardiac Pediatric<br>Peripheral Vessel | Ophthalmic<br>Fetal - OB/GYN<br>Abdominal<br>Intraoperative (abdominal<br>organs and vascular)<br>Intra-operative (Neuro.)<br>Pediatric<br>Small Organ (breast,<br>thyroid, testicle, prostate)<br>Neonatal Cephalic<br>Adult Cephalic<br>Trans-Rectal<br>Trans-Vaginal<br>Musculo-skeletal<br>(Conventional)<br>Musculo-skeletal<br>(Superficial)<br>Cardiac Adult<br>Cardiac Pediatric<br>Trans-esophageal | Ophthalmic<br>Fetal - OB/GYN<br>Abdominal<br>Pediatric<br>Small Organ (breast,<br>thyroid, testicle, prostate)<br>Neonatal Cephalic<br>Adult Cephalic<br>Trans-Rectal<br>Trans-Vaginal<br>Musculo-skeletal<br>(Conventional)<br>Musculo-skeletal<br>(Superficial) |
| Feature | SonoSite iViz<br>Ultrasound<br>System<br>(This submission) | SonoSite iViz<br>Ultrasound System<br>(K162288) | SonoSite Edge<br>Ultrasound System<br>(K133454) | SonoSite Edge II<br>Ultrasound System<br>(K162045) |
| | | | (cardiac)<br>Peripheral Vessel<br>Needle guidance | Cardiac Adult<br>Cardiac Pediatric<br>Trans-esophageal<br>(cardiac)<br>Peripheral Vessel<br>Needle guidance |
| Transducer<br>Types | Linear Array<br>Phased Array<br>Curved Array | Linear Array<br>Phased Array | Linear Array<br>Curved Linear Array<br>Intracavitary<br>Phased Array<br>Static Probes<br>Trans-esophageal | Linear Array<br>Curved Linear Array<br>Intracavitary<br>Phased Array<br>Trans-esophageal |
| Transducer<br>Frequency | 1.0 - 13.0 MHz | 1.0 - 10.0 MHz | 1.0 - 15.0 MHz | 1.0 - 15.0 MHz |
| Modes of<br>Operation | B-mode Grayscale<br>Imaging<br>Tissue Harmonic<br>Imaging<br>M-mode<br>Color M-Mode<br>Color Power<br>Doppler<br>Zoom<br>Combination Modes<br>SonoHD3 Noise<br>Reduction<br>Velocity Color<br>Doppler | B-mode Grayscale<br>Imaging<br>Tissue Harmonic Imaging<br>M-mode<br>Color M-Mode<br>Color Power Doppler<br>Zoom<br>Combination Modes<br>SonoHD3 Noise<br>Reduction<br>Velocity Color Doppler | B-mode Grayscale Imaging<br>Tissue Harmonic Imaging<br>M-mode<br>Color M-Mode<br>Color Power Doppler<br>Zoom<br>Combination Modes<br>Pulsed Wave (PW)<br>Doppler<br>Continuous Wave (CW)<br>Doppler<br>SonoHD2 Noise Reduction<br>SonoMB/MBe Image<br>Compounding<br>Steered CW Doppler<br>Velocity Color Doppler<br>Tissue Doppler Imaging<br>(TDI) | B-mode Grayscale<br>Imaging<br>Tissue Harmonic Imaging<br>M-mode<br>Color M-Mode<br>Color Power Doppler<br>Zoom<br>Combination Modes<br>Pulsed Wave (PW)<br>Doppler<br>Continuous Wave (CW)<br>Doppler<br>SonoHD2 Noise<br>Reduction<br>SonoMB/MBe Image<br>Compounding<br>Steered CW Doppler<br>Velocity Color Doppler<br>Tissue Doppler Imaging<br>(TDI) |
| PW Doppler | Not available | Not available | Available | Available |
| CW Doppler | Not available | Not available | Available | Available |
| Patient Contact<br>Materials | Transducers:<br>Polysulfone UDEL<br>P1700<br>Poly-Vinyl-Chloride<br>(PVC)<br>Silicone Rubber | Transducers:<br>Polysulfone UDEL P1700<br>Poly-Vinyl-Chloride (PVC)<br>Silicone Rubber | Transducers:<br>Acrylonitrile-butadien-<br>styrene (ABS)<br>Cycoloy<br>Dow Medical Adhesive,<br>Type A<br>Epoxy paste adhesive<br>Polyethylene (PE) Ionomer<br>Polyetheretherketone<br>(PEEK)<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-<br>styrene (ABS) | Transducers:<br>Acrylonitrile-butadien-<br>styrene (ABS)<br>Cycoloy<br>Epoxy paste adhesive<br>Polyethylene (PE)<br>lonomer<br>Polyetheretherketone<br>(PEEK)<br>Polycarbonate<br>Polysulfone UDEL P1700<br>Polyurethane<br>Poly-Vinyl-Chloride (PVC)<br>Silicone RTV Adhesive<br>Silicone Rubber |
| Feature | SonoSite iViz<br>Ultrasound<br>System<br>(This submission) | SonoSite iViz<br>Ultrasound System<br>(K162288) | SonoSite Edge<br>Ultrasound System<br>(K133454) | SonoSite Edge II<br>Ultrasound System<br>(K162045) |
| System<br>Characteristics | iViz:<br>Handheld tablet<br>7", 1920 x 1200<br>pixels LCD<br>Operating system:<br>Android<br>iViz ultrasound<br>software running as<br>an "app" on tablet<br>System operates<br>via battery<br>Wireless 802.11<br>support for image<br>transfer and over-<br>the-air (OTA)<br>software updates | iViz:<br>Handheld tablet<br>7", 1920 x 1200 pixels<br>LCD<br>Operating system: Android<br>iViz ultrasound software<br>running as an "app" on<br>tablet<br>System operates via<br>battery<br>Wireless 802.11 support<br>for image transfer and<br>over-the-air (OTA)<br>software updates | Edge:<br>Handheld display and<br>control<br>12.1", 800 x 600 pixels,<br>LCD<br>Operating system:<br>Windows CE<br>System operates via<br>battery or AC power<br>Wireless 802.11 support<br>for image transfer | Urethane<br>Needle Guides:<br>Acetal copolymer<br>Acrylonitrile-butadien-<br>styrene (ABS)<br>Edge II:<br>Beamformer 128/128<br>using SA (configurable)<br>Hand held display and<br>control<br>Single 12.1" Liquid Crystal<br>Display (LCD)<br>256 gray shades on LCD<br>2 USB ports<br>Dimensions: 12.8"(W) x<br>12.1" (L) x 2.5"(H)<br>Weight: 9.0 lbs<br>System operates via<br>battery or AC power<br>Battery life: 1.5 - 4 hour<br>operation per charge<br>100 - 240V options, 50/60<br>Hz, 15VDC output<br>Various obstetrical,<br>cardiac, volume, M-mode,<br>PW and CW Doppler<br>measurement and<br>calculation packages<br>ECG acquisition and<br>display capabilities<br>CW/PW Doppler Audio<br>Spectral Doppler Audio<br>and image storage on<br>removable media |
| Feature | SonoSite iViz<br>Ultrasound<br>System<br>(This submission) | SonoSite iViz<br>Ultrasound System<br>(K162288) | SonoSite Edge<br>Ultrasound System<br>(K133454) | SonoSite Edge II<br>Ultrasound System<br>(K162045) |
| | | | | Wireless 802.11 (b/g/n)<br>support for image transfer |
| 510(k) Track | Track 3 | Track 3 | Track 3 | Track 3 |
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# 7) Determination of Substantial Equivalence:
# Summary of Non-Clinical Tests:
The iViz 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 iViz 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 iViz Ultrasound System and transducers, subject of this submission, did not require clinical studies to support the determination of substantial equivalence.
#### 8) Conclusion:
Intended uses and other key features are consistent with traditional clinical practice and FDA guidance. The iViz 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 iViz Ultrasound System is substantially equivalent with regard to safety and effectiveness to the predicate devices.
