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

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.

AI/ML Overview

The provided FDA 510(k) K161119 document for the FUJIFILM SonoSite iViz Ultrasound System does not contain acceptance criteria or a study demonstrating the device meets such criteria in terms of diagnostic performance or clinical effectiveness.

Instead, this document focuses on establishing substantial equivalence to previously cleared predicate devices (K152983 and K133454) based on technological characteristics and adherence to recognized safety and performance standards for diagnostic ultrasound equipment.

Here's an analysis of the provided information concerning your questions:

1. A table of acceptance criteria and the reported device performance

No diagnostic acceptance criteria or performance metrics (e.g., sensitivity, specificity, accuracy) are reported for the Sonosite iViz Ultrasound System in this document. The tables (1.3-1, 1.3-2, 1.3-3) describe the Indications for Use for the system and its associated transducers, indicating which clinical applications (e.g., Fetal, Abdominal, Pediatric) are supported with different imaging modes (B-mode, M-mode, Color Doppler, etc.). The "P" in these tables signifies that these indications were Previously cleared by the FDA for the predicate devices, indicating that the new device supports the same established uses.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

No test set sample size or data provenance is mentioned. The document explicitly states: "The iViz Ultrasound System and transducers, subject of this submission, did not require clinical studies to support the determination of substantial equivalence." This means no new clinical data was generated or analyzed for this submission regarding diagnostic performance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. Since no clinical studies were performed for this submission, there were no experts establishing ground truth for a test set.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No clinical test set.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. No MRMC study was done, and this device is a general-purpose ultrasound system, not an AI-powered diagnostic algorithm.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a hardware and software system for diagnostic ultrasound, not a standalone algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

Not applicable. No new ground truth was established for the purpose of this submission's substantial equivalence determination. The "ground truth" for accepting the device's indications for use implicitly relies on the established safety and efficacy of the predicate devices.

8. The sample size for the training set

Not applicable. The document describes a medical device, an ultrasound system, not a machine learning model that would have a training set. The development process relies on engineering and medical device standards (e.g., IEC 60601 series, ISO 14971) rather than a "training set" of data in the AI sense.

9. How the ground truth for the training set was established

Not applicable. As above, no training set in the machine learning context is described.

Summary of what the document does provide regarding "acceptance criteria" and "study":

The "study" that proves this device meets "acceptance criteria" is essentially a documentation review demonstrating substantial equivalence to predicate devices and compliance with recognized safety and performance standards.

Acceptance Criteria (implied): The device is substantially equivalent to existing cleared devices (K152983 and K133454) in terms of:
- Intended Use and Indications for Use: The new device covers the same or a subset of indications as the predicates (Section 7 and Tables 1.3-1, 1.3-2, 1.3-3). The "P" in the tables indicates "previously cleared by FDA." New indications ("N") are also listed, showing some expansion.
- Technological Characteristics: Similar fundamental scientific technology, imaging modes, transducer types, and operating frequencies. Differences are noted but deemed not to raise new questions of safety or efficacy (Section 6, Table comparing features).
- Safety and Performance Standards: Compliance with a list of FDA-recognized safety standards for medical electrical equipment, biological evaluation, electromagnetic compatibility, usability, and acoustic output (Section 7, "Summary of Non-Clinical Tests" and table of standards).
Study (Proof): The specific "study" mentioned is the "Summary of Non-Clinical Tests" which involved:
- Evaluation for electrical, thermal, mechanical, and EMC safety.
- Cleaning/disinfection, biocompatibility, and acoustic output evaluation.
- Adherence to quality system elements like Design Phase Reviews, Risk Assessment, Requirements Development, and Verification and Validation.
- The document states, "The iViz Ultrasound System and transducers, subject of this submission, did not require clinical studies to support the determination of substantial equivalence." This means it was not a clinical effectiveness study.

In conclusion, this FDA submission is for a traditional medical device (ultrasound system) seeking market clearance based on substantial equivalence, not an AI/ML device requiring performance evaluation against diagnostic ground truth. Therefore, many of your specific questions related to AI/ML validation are not applicable to this document.

Summary

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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.

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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.'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)

K161119

Device Name

SonoSite iViz Ultrasound System

Indications for Use (Describe)

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)

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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	ColorDoppler	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

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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 body as follows:
Clinical Application	B	M	PWD	CWD	ColorDoppler	Combined(Spec.)	Other(Spec.)
Ophthalmic
Fetal
Abdominal	P	P			P	B+M; B+CD	1,3
Intra-operative (Abdominalorgans 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

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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 humanbody as follows:
Clinical Application	B	M	PWD	CWD	ColorDoppler	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 (Abdominalorgans 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

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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:	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:

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5) Intended Use:

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 UltrasoundSystem(This submission)	SonoSite iViz UltrasoundSystem(K152983)	SonoSite EdgeUltrasound System(K133454)
Intended Use	Diagnostic ultrasound imaging orfluid flow analysis of the humanbody	Diagnostic ultrasound imaging orfluid flow analysis of the humanbody	Diagnostic ultrasound imaging orfluid flow analysis of the humanbody
Indications forUse	Fetal - OBAbdominalPediatricSmall Organ (breast, thyroid,testicle, prostate)Musculo-skeletal (Conventional)Musculo-skeletal (Superficial)Cardiac AdultCardiac Pediatric	Fetal - OBAbdominalPediatricCardiac AdultCardiac Pediatric	OpthalmicFetal - OB/GYNAbdominalIntraoperative (abdominal organsand vascular)Intra-operative (Neuro.)PediatricSmall Organ (breast, thyroid,testicle, prostate)Neonatal CephalicAdult CephalicTrans-RectalTrans-VaginalMusculo-skeletal (Conventional)Musculo-skeletal (Superficial)Cardiac AdultCardiac PediatricTrans-esophageal (cardiac)Peripheral VesselNeedle guidance
TransducerTypes	Linear ArrayPhased Array	Phased Array	Linear ArrayCurved Linear ArrayIntracavitaryPhased ArrayStatic ProbesTrans-esophageal
TransducerFrequency	1.0 - 10.0 MHz	1.0 – 5.0 MHz	1.0 – 15.0 MHz
Modes ofOperation	B-mode Grayscale ImagingTissue Harmonic ImagingM-modeColor M-ModeColor Power DopplerZoomCombination Modes	B-mode Grayscale ImagingTissue Harmonic ImagingM-modeColor M-ModeColor Power DopplerZoomCombination Modes	B-mode Grayscale ImagingTissue Harmonic ImagingM-modeColor M-ModeColor Power DopplerZoomCombination Modes

Page 162 of 1851

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Feature	SonoSite iViz UltrasoundSystem(This submission)	SonoSite iViz UltrasoundSystem(K152983)	SonoSite EdgeUltrasound System(K133454)
	Velocity Color Doppler	Velocity Color Doppler	Continuous Wave (CW) DopplerSonoHD2 Noise ReductionSonoMB/MBe ImageCompoundingSteered CW DopplerVelocity Color DopplerTissue Doppler Imaging (TDI)
PW Doppler	Not available	Not available	Available
CW Doppler	Not available	Not available	Available
PatientContactMaterials	Transducers:Polysulfone UDEL P1700Poly-Vinyl-Chloride (PVC)Silicone Rubber	Transducers:Polysulfone UDEL P1700Poly-Vinyl-Chloride (PVC)Silicone Rubber	Transducers:Acrylonitrile-butadien-styrene(ABS)CycoloyDow Medical Adhesive, Type AEpoxy paste adhesivePolyethylene (PE) lonomerPolyetheretherketone (PEEK)Polysulfone UDEL P1700PolyurethanePoly-Vinyl-Chloride (PVC)Silicone RTV AdhesiveSilicone RubberUrethaneNeedle Guides:Acetal copolymerAcrylonitrile-butadien-styrene(ABS)
SystemCharacteristics	iViz:Handheld tablet7", 1920 x 1200 pixels LCDOperating system: AndroidiViz ultrasound software runningas an "app" on tabletSystem operates via batteryWireless 802.11 support for imagetransfer and over-the-air (OTA)software updates	iViz:Handheld tablet7", 1920 x 1200 pixels LCDOperating system: AndroidiViz ultrasound software runningas an "app" on tabletSystem operates via batteryWireless 802.11 support for imagetransfer and over-the-air (OTA)software updates	Edge:Handheld display and control12.1", 800 x 600 pixels, LCDOperating system: Windows CESystem operates via battery or ACpowerWireless 802.11 support for imagetransfer
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.

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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 andA2:2010/(R)2012 (Consolidated Text) Medical electrical equipment - Part 1: Generalrequirements 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 - Collateralstandard: 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: Generalrequirements 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 ultrasonicmedical diagnostic and monitoring equipment
IEC 62304	AAMI / ANSI / IEC 62304:2006, Medical device software - Software life cycleprocesses
IEC 62359	IEC 62359 Edition 2.0 2010-10-10. Ultrasonics - Field characterization - Testmethods for the determination of thermal and mechanical indices related to medicaldiagnostic ultrasonic fields [Including: Technical corrigendum 1 (2011)]
ISO 14971	ISO 14971:2007, Medical devices - Application of risk management to medicaldevices
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.

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.