Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on standard ultrasound technology and features.

Therapeutic

No.
The device is described as a "diagnostic ultrasound system" intended for "evaluation by ultrasound imaging or fluid flow analysis," which indicates its purpose is for diagnosis rather than direct treatment or therapy.

Diagnostic

Yes
The "Device Description" explicitly states, "The SonoSite iViz Ultrasound System is a highly featured, general purpose, software controlled, diagnostic ultrasound system."

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a "custom fabricated digital electronic handheld tablet" with an "active transducer," indicating it includes significant hardware components beyond just software.

IVD (In Vitro Diagnostic)

Based on the provided information, the SonoSite iViz Ultrasound System is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use describes the system as a "general purpose ultrasound system and non-continuous patient monitoring platform intended in clinical care by qualified physicians and healthcare professionals for evaluation by ultrasound imaging or fluid flow analysis of the human body." This clearly indicates the device is used for imaging and analysis within the human body, not on samples taken from the body.
Device Description: The description details a system with a transducer that connects to a tablet to acquire and display real-time ultrasound data. This is consistent with in-vivo imaging, not in-vitro testing.
Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other components typically associated with in-vitro diagnostics.

In-vitro diagnostics are devices used to examine specimens, such as blood, urine, or tissue, that have been taken from the human body to provide information for diagnosis, monitoring, or screening. The SonoSite iViz Ultrasound System operates by sending and receiving sound waves to create images of internal structures, which is an in-vivo process.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The SonoSite iViz Ultrasound System is a general purpose ultrasound system and non-continuous patient monitoring platform intended in clinical care 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: Fetal - OB, Abdominal, Pediatric, Small Organ (breast, thyroid, testicles, prostate), Musculo-skel. (Convent.), Musculo-skel. (Superfic.), Cardiac Adult, Cardiac Pediatric.

Product codes (comma separated list FDA assigned to the subject device)

IYN, IYO, ITX

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasound

Anatomical Site

Fetal, Abdominal, Pediatric, Small Organ (breast, thyroid, testicles, prostate), Musculo-skeletal (Conventional), Musculo-skeletal (Superficial), Cardiac Adult, Cardiac Pediatric

Indicated Patient Age Range

Not Found

Intended User / Care Setting

qualified physicians and healthcare professionals

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

The iViz Ultrasound System and transducers, subject of this submission, did not require clinical studies to support the determination of substantial equivalence.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K152983, K133454

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 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.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol. The logo is black and white.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

May 13, 2016

FUJIFILM Sonosite, Inc. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street, NW BUFFALO MN 55313

Re: K16119

Trade/Device Name: Sonosite iViz Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: April 18, 2016 Received: April 20, 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.

1

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.'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

2

Indications for Use

510(k) Number (if known)

K161119

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 in clinical care 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:

Fetal - OB Abdominal Pediatric Small Organ (breast, thyroid, testicles, prostate) Musculo-skel. (Convent.) Musculo-skel. (Superfic.) Cardiac Adult Cardiac Pediatric

Type of Use (Select one or both, as applicable)
-------------------------------------------------

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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3

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	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, testes, 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	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.

Prescription Use (Per 21 CFR 801.109)

Page 2 of 4

4

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 body as follows:
Clinical Application	B	M	PWD	CWD	Color
Doppler	Combined
(Spec.)	Other
(Spec.)
Ophthalmic
Fetal
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)	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
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)

All items marked "P" were previously cleared in 510(k) K133454.

Prescription Use (Per 21 CFR 801.109)

Page 3 of 4

5

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	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.

Prescription Use (Per 21 CFR 801.109)

Page 4 of 4

6

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:	April 7, 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 iViz 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 iViz Ultrasound System	K152983
SonoSite Edge Ultrasound System	K133454

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.

7

5) Intended Use:

The SonoSite iViz Ultrasound System is a general purpose ultrasound system and non-continuous patient monitoring platform intended in clinical care 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:

Fetal - OB Abdominal Pediatric Small Organ (breast, thyroid, testicles, prostate) Musculo-skel. (Convent.) Musculo-skel. (Superfic.) Cardiac Adult Cardiac Pediatric

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 Ultrasound
System
(This submission) | SonoSite iViz Ultrasound
System
(K152983) | SonoSite Edge
Ultrasound System
(K133454) |
|-------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Diagnostic ultrasound imaging or
fluid flow analysis of the human
body | Diagnostic ultrasound imaging or
fluid flow analysis of the human
body | Diagnostic ultrasound imaging or
fluid flow analysis of the human
body |
| Indications for
Use | Fetal - OB
Abdominal
Pediatric
Small Organ (breast, thyroid,
testicle, prostate)
Musculo-skeletal (Conventional)
Musculo-skeletal (Superficial)
Cardiac Adult
Cardiac Pediatric | Fetal - OB
Abdominal
Pediatric
Cardiac Adult
Cardiac Pediatric | Opthalmic
Fetal - OB/GYN
Abdominal
Intraoperative (abdominal organs
and vascular)
Intra-operative (Neuro.)
Pediatric
Small Organ (breast, thyroid,
testicle, prostate)
Neonatal Cephalic
Adult Cephalic
Trans-Rectal
Trans-Vaginal
Musculo-skeletal (Conventional)
Musculo-skeletal (Superficial)
Cardiac Adult
Cardiac Pediatric
Trans-esophageal (cardiac)
Peripheral Vessel
Needle guidance |
| Transducer
Types | Linear Array
Phased Array | Phased Array | Linear Array
Curved Linear Array
Intracavitary
Phased Array
Static Probes
Trans-esophageal |
| Transducer
Frequency | 1.0 - 10.0 MHz | 1.0 – 5.0 MHz | 1.0 – 15.0 MHz |
| Modes of
Operation | B-mode Grayscale Imaging
Tissue Harmonic Imaging
M-mode
Color M-Mode
Color Power Doppler
Zoom
Combination Modes | B-mode Grayscale Imaging
Tissue Harmonic Imaging
M-mode
Color M-Mode
Color Power Doppler
Zoom
Combination Modes | B-mode Grayscale Imaging
Tissue Harmonic Imaging
M-mode
Color M-Mode
Color Power Doppler
Zoom
Combination Modes |

Page 162 of 1851

8

| Feature | SonoSite iViz Ultrasound
System
(This submission) | SonoSite iViz Ultrasound
System
(K152983) | SonoSite Edge
Ultrasound System
(K133454) |
|---------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Velocity Color Doppler | Velocity Color Doppler | Continuous Wave (CW) Doppler
SonoHD2 Noise Reduction
SonoMB/MBe Image
Compounding
Steered CW Doppler
Velocity Color Doppler
Tissue Doppler Imaging (TDI) |
| PW Doppler | Not available | Not available | Available |
| CW Doppler | Not available | Not available | Available |
| Patient
Contact
Materials | Transducers:
Polysulfone UDEL P1700
Poly-Vinyl-Chloride (PVC)
Silicone Rubber | Transducers:
Polysulfone UDEL P1700
Poly-Vinyl-Chloride (PVC)
Silicone Rubber | Transducers:
Acrylonitrile-butadien-styrene
(ABS)
Cycoloy
Dow Medical Adhesive, Type A
Epoxy paste adhesive
Polyethylene (PE) lonomer
Polyetheretherketone (PEEK)
Polysulfone UDEL P1700
Polyurethane
Poly-Vinyl-Chloride (PVC)
Silicone RTV Adhesive
Silicone Rubber
Urethane
Needle Guides:
Acetal copolymer
Acrylonitrile-butadien-styrene
(ABS) |
| System
Characteristics | iViz:
Handheld tablet
7", 1920 x 1200 pixels LCD
Operating system: Android
iViz ultrasound software running
as an "app" on tablet
System operates via battery
Wireless 802.11 support for image
transfer and over-the-air (OTA)
software updates | iViz:
Handheld tablet
7", 1920 x 1200 pixels LCD
Operating system: Android
iViz ultrasound software running
as an "app" on tablet
System operates via battery
Wireless 802.11 support for image
transfer and over-the-air (OTA)
software updates | Edge:
Handheld display and control
12.1", 800 x 600 pixels, LCD
Operating system: Windows CE
System operates via battery or AC
power
Wireless 802.11 support for image
transfer |
| 510(k) Track | Track 3 | Track 3 | Track 3 |

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.

9

Reference No.	Title
ISO 10993-1	AAMI / ANSI / ISO 10993-1:2009/(R)2013, Biological evaluation of medical devices -
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
A2:2010/(R)2012 (Consolidated Text) Medical electrical equipment - Part 1: General
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:
General requirements for basic safety and essential performance - Collateral
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
requirements for basic safety and essential performance - Collateral standard:
Usability
IEC 60601-2-37	IEC 60601-2-37:2007 Edition 2.0 2007-08, Medical electrical equipment – Part 2-37:
Particular requirements for the basic safety and essential performance of ultrasonic
medical diagnostic and monitoring equipment
IEC 62304	AAMI / ANSI / IEC 62304:2006, Medical device software - Software life cycle
processes
IEC 62359	IEC 62359 Edition 2.0 2010-10-10. Ultrasonics - Field characterization - Test
methods for the determination of thermal and mechanical indices related to medical
diagnostic ultrasonic fields [Including: Technical corrigendum 1 (2011)]
ISO 14971	ISO 14971:2007, Medical devices - Application of risk management to medical
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.