Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document does not mention AI, ML, deep learning, or any related terms in the device description, intended use, or performance studies. The listed features like SonoHD3 Imaging (Speckle Reduction) are standard image processing techniques, not necessarily indicative of AI/ML.

Therapeutic

No
This device is an ultrasound system intended for diagnostic imaging and fluid flow analysis, not for therapeutic treatment.

Diagnostic

Yes
The device description states that the SonoSite iViz Ultrasound System is a "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)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use clearly states it's for "evaluation by ultrasound imaging or fluid flow analysis of the human body." This is a diagnostic imaging device used on the patient, not a device that analyzes samples from the patient (which is the core of an IVD).
Device Description: The description details a system that acquires and displays real-time ultrasound data using a transducer applied to the body. This aligns with in-vivo imaging, not in-vitro analysis.
Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any of the typical components associated with IVD devices.

This device is a diagnostic ultrasound system, which falls under a different regulatory category than IVDs.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The FUJIFILM 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 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

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasound

Anatomical Site

Human body, Fetal, Abdominal, Pediatric, Cardiac Adult, Cardiac Pediatric

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Qualified physicians and healthcare professionals in clinical care.

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.

K133454, K133833

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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol of three human profiles facing to the right, arranged in a stacked, overlapping manner.

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

November 12, 2015

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

Re: K152983

Trade/Device Name: FUJIFILM 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: October 8, 2015 Received: October 13, 2015

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,

Robert Ocks

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) BB K152983

Device Name FUJIFILM SonoSite iViz Ultrasound System

Indications for Use (Describe)

The FUJIFILM 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 Cardiac Adult Cardiac Pediatric

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

Registration Use (Part 21 CFR 601 Subpart D)
Over-The-Counter Use (21 CFR 601 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	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
organs and vascular)
Intra-operative (Neuro.)
Laparoscopic
Pediatric	N	N			N	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	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
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)

Prescription Use (Per 21 CFR 801.109)

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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	N	N			N	B+M; B+CD	1-3
Abdominal	N	N			N	B+M; B+CD	1-3
Intra-operative (Abdominal
organs and vascular)
Intra-operative (Neuro.)
Laparoscopic
Pediatric	N	N			N	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	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
Other (spec.)

Table 1.3-2: Diagnostic Ultrasound Indications for Use Form – P21v/5-1 Transducer

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)

Prescription Use (Per 21 CFR 801.109)

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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: | September 28, 2015 |

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 Edge Ultrasound System	K133454
Philips Nuvis Ultrasound System	K133833

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 FUJIFILM SonoSite iViz Ultrasound System is a general purpose ultrasound system and non-

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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 Cardiac Adult Cardiac Pediatric

6) Technological Characteristics:

SonoSite iViz and Edge, and Philips Nuvis 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 Edge
Ultrasound System
(K133454) | Philips Nuvis Ultrasound
System
(K133833) |
|-------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------|
| 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
Cardiac Adult
Cardiac Pediatric | Ophthalmic
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 | Fetal - OB
Abdominal
Other (Urology)
Other (Gynecology)
Other (Fetal Echo) |
| Transducer
Types | Phased Array | Linear Array
Curved Linear Array
Intracavitary
Phased Array
Static Probes
Trans-esophageal | Curved Linear Array |
| Transducer
Frequency | 1.0 – 5.0 MHz | 1.0 - 15.0 MHz | 2.0 – 5.0 MHz |
| Modes of
Operation | B-mode Grayscale Imaging
Tissue Harmonic Imaging
M-mode
Color M-Mode
Color Power Doppler
Zoom
Combination Modes
SonoHD3 Noise Reduction
Velocity Color Doppler | B-mode Grayscale Imaging
Tissue Harmonic Imaging
M-mode
Color M-Mode
Color Power Doppler
Zoom
Combination Modes
Pulsed Wave (PW) Doppler
Continuous Wave (CW) Doppler
SonoHD2 Noise Reduction
SonoMB/MBe Image
Compounding
Steered CW Doppler
Velocity Color Doppler
Tissue Doppler Imaging (TDI) | B-mode Grayscale Imaging
Color Power Doppler
Combination Modes
Velocity Color Doppler |

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| Feature | SonoSite iViz Ultrasound
System
(This submission) | SonoSite Edge
Ultrasound System
(K133454) | Philips Nuvis Ultrasound
System
(K133833) |
|---------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| PW Doppler | Not available | Available | Not available |
| CW Doppler | Not available | Available | Not available |
| Patient
Contact
Materials | 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) Ionomer
Polyetheretherketone (PEEK)
Polysulfone UDEL P1700
Polyurethane
Poly-Vinyl-Chloride (PVC)
Silicone RTV Adhesive
Silicone Rubber
Urethane
Needle Guides:
Acetal copolymer
Acrylonitrile-butadien-styrene
(ABS) | Information not publicly available |
| System | iViz: | Edge: | Nuvis: |
| Characteristics | 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 | 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 | Handheld tablet (COTS Nexus 7)
7", 1280 x 800 pixels LCD
Operating system: Android
Nuvis ultrasound software running
as an "app" on COTS tablet
System operates via battery
Wireless 802.11 support for image
transfer (non-DICOM) |
| 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.

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

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Reference No.	Title
	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.