Fujifilm Sonosite Vevo MD Imaging System

• K Number: K160674
• Device Name: Fujifilm Sonosite Vevo MD Imaging System
• Manufacturer: FUJIFILM SONOSITE, INC.
• Date Cleared: 2016-04-19 ( 40 days)
• Product Code: IYN ITX IYO
• Regulation Number: 892.1550

Intended Use

The Vevo MD Imaging System is a general purpose imaging system intended for use by a qualified physician for evaluation by ultrasound imaging or fluid flow analysis of the human body. Specific clinical applications and exam types include: Abdominal Pediatric Small Organ (breast, thyroid, testicles, prostrate) Musculoskeletal (conventional) Musculoskeletal (superficial) Peripheral vessel Dermatological

Device Description

The Vevo MD system is a high frequency general purpose, software controlled, diagnostic Imaging System used to acquire and display high-resolution, real-time ultrasound data in 2D, Color Doppler, and M-Mode. The Vevo MD System is comprised of transducers responsible for ultrasound signal generation and recording, and a main unit that controls the transducers, processes the acoustic data, and processes and displays images.

Predicate Devices

K133134, K062571

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a standard ultrasound imaging system with image processing capabilities, but there is no mention of AI, ML, or related concepts in the device description, intended use, or performance studies.

Therapeutic

No
The device is described as a "general purpose imaging system intended for use by a qualified physician for evaluation by ultrasound imaging or fluid flow analysis of the human body," and its function is to "acquire and display high-resolution, real-time ultrasound data." This indicates its purpose is diagnostic imaging, not direct therapy.

Diagnostic

Yes

The "Device Description" section explicitly states that the Vevo MD system is a "diagnostic Imaging System."

SaMD (Software as a Medical Device)

No

The device description explicitly states the system is comprised of transducers and a main unit, which are hardware components.

IVD (In Vitro Diagnostic)

Based on the provided information, the Vevo MD Imaging System 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 involves imaging within the body, not testing samples outside the body.
• Device Description: The description focuses on generating and processing ultrasound signals to create images of internal structures. This is characteristic of an in-vivo imaging device.
• Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or performing tests on these samples outside of the body, which are the defining features of an IVD.

The Vevo MD Imaging System is a general purpose in-vivo diagnostic imaging system.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Vevo MD Imaging System is a general purpose imaging system intended for use by a qualified physician for evaluation by ultrasound imaging or fluid flow analysis of the human body.

Specific clinical applications and exam types include:
Abdominal
Pediatric
Small Organ (breast, thyroid, testicles, prostrate)
Musculoskeletal (conventional)
Musculoskeletal (superficial)
Peripheral vessel
Dermatological

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

IYN, ITX, IYO

Device Description

The Vevo MD system is a high frequency general purpose, software controlled, diagnostic Imaging System used to acquire and display high-resolution, real-time ultrasound data in 2D, Color Doppler, and M-Mode. The Vevo MD System is comprised of transducers responsible for ultrasound signal generation and recording, and a main unit that controls the transducers, processes the acoustic data, and processes and displays images.

Mentions image processing

processes the acoustic data, and processes and displays images.

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

ultrasound imaging

Anatomical Site

human body

Specific clinical applications and exam types include:
Abdominal
Pediatric
Small Organ (breast, thyroid, testicles, prostrate)
Musculoskeletal (conventional)
Musculoskeletal (superficial)
Peripheral vessel
Dermatological

Indicated Patient Age Range

The Vevo MD Imaging System uses ultra high frequency (UHF) series transducers that limit the imaging depth. For this reason imaging of abdominal organs or non-superficial musculoskeletal structure may be limited to neonatal and small pediatric patients and all imaging is limited to the maximum imaging depth of the transducer as indicated in the specifications for each transducer.

Intended User / Care Setting

Not Found

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 Vevo MD Imaging 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.

K133134, K062571

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 and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus 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

April 19, 2016

FUJIFILM SonoSite, Inc. c/o Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street, NW BUFFALO MN 55313

Re: K160674

Trade/Device Name: FUJIFILM SonoSite Vevo MD Imaging System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, ITX, IYO Dated: March 28, 2016 Received: March 29, 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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/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 [phone] or [phone] 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)

FBB K160674

Device Name

FUJIFILM SonoSite Vevo MD Imaging System

Indications for Use (Describe)

The Vevo MD Imaging System is a general purpose imaging system intended for use by a qualified physician for evaluation by ultrasound imaging or fluid flow analysis of the human body.

Specific clinical applications and exam types include:

Abdominal Pediatric Small Organ (breast, thyroid, testicles, prostrate) Musculoskeletal (conventional) Musculoskeletal (superficial) Peripheral vessel Dermatological

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

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 Vevo MD Imaqing System

System:	FUJIFILM SonoSite Vevo MD Imaging System
Transducer:	NA
Intended Use:	Diagnostic ultrasound imaging or fluid flow analysis of the human
body as follows:
Clinical Application	Mode of Operation
	B
(2D)	M	PWD	CWD	Color
Doppler	Combined
(Spec.)	Other
(Spec.)
Ophthalmic
Fetal
Abdominal	N	N			N	B(2D)+CD, B(2D)+M	1,2
Intra-operative (Abdominal
organs and vascular)
Intra-operative (Neuro.)
Laparoscopic
Pediatric	N	N			N	B(2D)+CD, B(2D)+M	1,2
Small Organ (breast, thyroid,
testicles, prostate)	N	N			N	B(2D)+CD, B(2D)+M	1,2
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skel. (Convent.)	N	N			N	B(2D)+CD, B(2D)+M	1,2
Musculo-skel. (Superfic.)	N	N			N	B(2D)+CD, B(2D)+M	1,2
Intra-luminal
Other (spec.)
Cardiac Adult
Cardiac Pediatric
Trans-esophageal (card.)
Other (spec.)
Peripheral vessel	N	N			N	B(2D)+CD, B(2D)+M	1,2
Other (spec.)	N	N			N	B(2D)+CD, B(2D)+M	1,2
DERMATOLOGY

Additional Comments:

1: The Vevo MD Imaging System uses ultra high frequency (UHF) series transducers that limit the imaging depth. For this reason imaging of abdominal organs or non-superficial musculoskeletal structure may be limited to neonatal and small pediatric patients and all imaging is limited to the maximum imaging depth of the transducer as indicated in the specifications for each transducer.

2: Includes imaging to assist in the placement of needles and catheters in vascular or other anatomical structures and imaging guidance for peripheral nerve block procedures.

4

Table 1.3.2: Diagnostic Ultrasound Indications for Use Form – FUJIFILM Vevo MD UHF-22 Ultrasound Transducer

System:	FUJIFILM SonoSite Vevo MD Imaging System
Transducer:	UHF-22
Intended Use:	Diagnostic ultrasound imaging or fluid flow analysis of the human
body as follows:
Clinical Application	Mode of Operation
	B (2D)	M	PWD	CWD	Color Doppler	Combined (Spec.)	Other (Spec.)
Ophthalmic
Fetal
Abdominal	N	N			N	B(2D)+CD, B(2D)+M	1,2
Intra-operative (Abdominal
organs and vascular)
Intra-operative (Neuro.)
Laparoscopic
Pediatric	N	N			N	B(2D)+CD, B(2D)+M	1,2
Small Organ (breast, thyroid,
testicles, prostate)	N	N			N	B(2D)+CD, B(2D)+M	1,2
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skel. (Convent.)	N	N			N	B(2D)+CD, B(2D)+M	1,2
Musculo-skel. (Superfic.)	N	N			N	B(2D)+CD, B(2D)+M	1,2
Intra-luminal
Other (spec.)
Cardiac Adult
Cardiac Pediatric
Trans-esophageal (card.)
Other (spec.)
Peripheral vessel	N	N			N	B(2D)+CD, B(2D)+M	1,2
Other (spec.)
DERMATOLOGY

Additional Comments:

1: The Vevo MD Imaging System uses ultra high frequency (UHF) series transducers that limit the imaging depth. For this reason imaging of abdominal organs or non-superficial musculoskeletal structure may be limited to neonatal and small pediatric patients and all imaging is limited to the maximum imaging depth of the transducer as indicated in the specifications for each transducer.

2: Includes imaging to assist in the placement of needles and catheters in vascular or other anatomical structures and imaging guidance for peripheral nerve block procedures.

5

Table 1.3.3: Diagnostic Ultrasound Indications for Use Form – Fujifilm Vevo MD UHF-48 Ultrasound Transducer

System:	FUJIFILM SonoSite Vevo MD Imaging System
Transducer:	UHF-48
Intended Use:	Diagnostic ultrasound imaging or fluid flow analysis of the human
	body as follows:
Clinical Application	Mode of Operation
	B				Color	Combined	Other
	(2D)	M	PWD	CWD	Doppler	(Spec.)	(Spec.)
Ophthalmic
Fetal
Abdominal
Intra-operative (Abdominal
organs and vascular)
Intra-operative (Neuro.)
Laparoscopic
Pediatric	N	N			N	B(2D)+CD, B(2D)+M	1,2
Small Organ (breast, thyroid,	N	N			N	B(2D)+CD, B(2D)+M	1,2
testicles, prostate)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skel. (Convent.)	N	N			N	B(2D)+CD, B(2D)+M	1,2
Musculo-skel. (Superfic.)	N	N			N	B(2D)+CD, B(2D)+M	1,2
Intra-luminal
Other (spec.)
Cardiac Adult
Cardiac Pediatric
Trans-esophageal (card.)
Other (spec.)
Peripheral vessel	N	N			N	B(2D)+CD, B(2D)+M	1,2
Other (spec.)	N	N			N	B(2D)+CD, B(2D)+M	1,2
DERMATOLOGY

Additional Comments:

1: The Vevo MD Imaging System uses ultra high frequency (UHF) series transducers that limit the imaging depth. For this reason imaging of abdominal organs or non-superficial musculoskeletal structure may be limited to neonatal and small pediatric patients and all imaging is limited to the maximum imaging depth of the transducer as indicated in the specifications for each transducer.

2: Includes imaging to assist in the placement of needles and catheters in vascular or other anatomical structures and imaging guidance for peripheral nerve block procedure.

6

Table 1.3.4: Diagnostic Ultrasound Indications for Use Form – Fujifilm Vevo MD UHF-70 Ultrasound Transducer

System:	FUJIFILM SonoSite Vevo MD Imaging System
Transducer:	UHF-70
Intended Use:	Diagnostic ultrasound imaging or fluid flow analysis of the human
body as follows:
Clinical Application	B
(2D)	M	PWD	CWD	Color
Doppler	Combined
(Spec.)	Other
(Spec.)
Ophthalmic
Fetal
Abdominal
Intra-operative (Abdominal
organs and vascular)
Intra-operative (Neuro.)
Laparoscopic
Pediatric	N	N			N	B(2D)+CD, B(2D)+M	1,2
Small Organ (breast, thyroid,
testicles, prostate)	N	N			N	B(2D)+CD, B(2D)+M	1,2
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skel. (Convent.)	N	N			N	B(2D)+CD, B(2D)+M	1,2
Musculo-skel. (Superfic.)	N	N			N	B(2D)+CD, B(2D)+M	1,2
Intra-luminal
Other (spec.)
Cardiac Adult
Cardiac Pediatric
Trans-esophageal (card.)
Other (spec.)
Peripheral vessel	N	N			N	B(2D)+CD, B(2D)+M	1,2
Other (spec.)	N	N			N	B(2D)+CD, B(2D)+M	1,2
DERMATOLOGY

Additional Comments:

1: The Vevo MD Imaging System uses ultra high frequency (UHF) series transducers that limit the imaging depth. For this reason imaging of abdominal organs or non-superficial musculoskeletal structure may be limited to neonatal and small pediatric patients and all imaging is limited to the maximum imaging depth of the transducer as indicated in the specifications for each transducer.

2: Includes imaging to assist in the placement of needles and catheters in vascular or other anatomical structures and imaging guidance for peripheral nerve block procedure.

7

Image /page/7/Picture/1 description: The image shows the word "SonoSite" in a bold, sans-serif font. The letters are all lowercase except for the "S" in both words, which are capitalized. The text is black and the background is white. The word is centered in the image.

· 21919 30th Dr. SE, Bothell, WA 98021-3904 USA · Telephone [phone] · Facsimile 1.425.951.1201 · www.sonos

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:	Scott E. Paulson
	Sr. Director, Regulatory Affairs and Quality Systems
E-mail:	[e-mail]
Telephone:	[phone]
Facsimile:	[phone]
Date prepared:	December 26 , 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 Vevo MD™ Imaging System (subject to change)

Classification Names

Name	FR Number	Product Code
Ultrasonic Pulsed Doppler Imaging System	892.1550	IYN
Diagnostic Ultrasound Transducer	892.1570	ITX
Ultrasonic Pulsed Echo Imaging System	892.1560	IYO

3) Identification of the predicate or legally marketed device:

SonoSite X-Porte ultrasound system (K133134) (Primary Predicate) EpiScan I-200 (K062571) (Secondary predicate)

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Image /page/8/Picture/0 description: The image shows the Fujifilm logo. The logo is black with a red accent on the letter "I". Below the logo is the text "Value from Innovation".

Image /page/8/Picture/1 description: The image shows the word "SonoSite" in a bold, sans-serif font. The letters are black and the background is white. The word is horizontally oriented and centered in the image.

• 21919 30th Dr. SE, Bothell, WA 98021-3904 USA • Telephone [phone] • Facsimile 1.425.951.1201 •

4) Device Description:

The Vevo MD system is a high frequency general purpose, software controlled, diagnostic Imaging System used to acquire and display high-resolution, real-time ultrasound data in 2D, Color Doppler, and M-Mode. The Vevo MD System is comprised of transducers responsible for ultrasound signal generation and recording, and a main unit that controls the transducers, processes the acoustic data, and processes and displays images.

5) Intended Use:

The intended uses of the SonoSite Vevo MD Imaging System as defined by FDA guidance documents, are:

Abdominal Pediatric Small Organ (breast, thyroid, testicles, prostate) Musculo-skel. (Convent.) Musculo-skel. (Superfic.) Peripheral vessel Dermatological

6) Technological Characteristics:

SonoSite Vevo MD and X-Porte Ultrasound Systems are both Track 3 devices that employ the same fundamental scientific technology. A comparison table is provided below.

| Feature | SonoSite Vevo MD
lmaging System
(this submission) | SonoSite X-Porte
Ultrasound System
K133134 | EpiScan
I-200
K062571 |
|--------------------------------------------|--------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Diagnostic
ultrasound imaging
or fluid flow analysis
of the human body | Diagnostic
ultrasound imaging
or fluid flow analysis
of the human body | High resolution ultrasound imaging for
wounds, superficial musculoskeletal
diagnosis and assessment,
plastic/reconstructive surgery planning
and assessment, dermatological
assessment and diagnosis, and
aesthetic application |
| Transducer
Types
Available | Linear Array | Linear Array
Curved Linear Array
Intracavitary
Phased Array | Scanning Element |
| Feature | SonoSite Vevo MD
Imaging System
(this submission) | SonoSite X-Porte
Ultrasound System
K133134 | EpiScan
l-200
K062571 |
| | | | |
| Transducer
Center
Frequency | 15-49MHz | 1.0 – 15.0 MHz | 20-50MHz |
| Acoustic
Output Display
& FDA Limits | MI Output Display
TI Output Display | Display Feature for
Higher Outputs
MI Output Display
TI Output Display | Not displayed |
| Modes of
Operation | B-mode (2-D
Grayscale Imaging
Color Doppler
Combination Modes
M-mode | 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
| B-Mode Greyscale or color imaging. |
| DICOM | DICOM 3.0 Store,
Modality Worklist,
Perform Procedure
Step (PPS), Storage
Commitment | DICOM 3.0 Store,
Print, Modality
Worklist, Perform
Procedure Step
(PPS), Storage
Commitment | Not available |
| IMT
Measurement | Manual
Measurement
available on the
ultrasound system
itself. | Not available | Not available |
| #Transmit
Channels | 64 digital channels | 128 digital channels | 1 channel |
| Feature | SonoSite Vevo MD
lmaging System
(this submission) | SonoSite X-Porte
Ultrasound System
K133134 | EpiScan
I-200
K062571 |
| #Receive
Channels | 64 digital channels | 64 digital channels
(128 digital channels
using Synthetic
Aperture) | 1 channel |
| 510(k) Track | Track 3 | Track 3 | Track 1 |

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Image /page/9/Picture/0 description: The image shows the Fujifilm logo. The logo is black, except for a red square with a white triangle cut out of the top right corner, which is placed above the "I" in Fujifilm. Below the logo is the text "Value from Innovation".

Image /page/9/Picture/1 description: The image shows the word "SonoSite" in a bold, sans-serif font. The letters are all lowercase except for the "S" in "SonoSite", which is capitalized. The word is black and is set against a white background. The dot on the "i" in "Site" is a perfect circle.

• 21919 30th Dr. SE, Bothell, WA 98021-3904 USA • Telephone [phone] • www.sonosite.com

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Image /page/10/Picture/1 description: The image shows the logo for SonoSite. The logo is in black and white and features the company name in a simple, sans-serif font. The dot over the 'i' in 'Site' is a prominent feature of the logo.

· 21919 30th Dr. SE, Bothell, WA 98021-3904 USA · Telephone [phone] · www.sonosite

7) Determination of Substantial Equivalence:

Summary of Non-Clinical Tests:

The Vevo MD Imaging 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: Design Phase Reviews, Risk Assessment, Requirements Development, System and Software Verification, Hardware Verification, Safety Compliance Verification, Clinical Validation. All patient contact materials are biocompatible and are materials that are already used in the predicate device or meet 10993.

The Vevo MD Imaging System is designed to comply with the following voluntary standards.

| Reference No. | Recognition
No. | Title |
|--------------------------|--------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| AAMI/ANSI/ISO
10993-1 | 2-156 | ISO 10993-1:2009, Biological evaluation of medical devices
-- Part 1: Evaluation and testing within a risk management
process |
| IEC 60601-1 | 19-5 | AAMI / ANSI ES60601-1:2005/(R)2012 And
C1:2009/(R)2012 And, A2:2010/(R)2012 (Consolidated
Text) Medical Electrical Equipment -- Part 1: General
Requirements For Basic Safety And Essential Performance
(lec 60601-1:2005, Mod). (General II (ES/EMC)) |
| IEC 60601-1-2 | 19-1 | IEC 60601-1-2:2007, Medical electrical equipment - Part 1-
2: General requirements for basic safety and essential
performance - Collateral standard: Electromagnetic
compatibility - Requirements and tests (Edition 3) |
| IEC 60601-2-37 | 12-209 | IEC 60601-2-37:2007, Particular Requirements for the
basic safety and essential performance of ultrasonic
medical diagnostic and monitoring equipment |

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Image /page/11/Picture/1 description: The image shows the word "SonoSite" in a bold, sans-serif font. The letters are black against a white background. The word appears to be a logo or brand name.

• 21919 30th Dr. SE, Bothell, WA 98021-3904 USA • Telephone [phone] • Facsimile 1.425.951.1201 • www.sonos

| Reference No. | Recognition
No. | Title |
|----------------|--------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| NEMA UD 2-2004 | 12-105 | Acoustic Output Measurement Standard for Diagnostic
Ultrasound Equipment |
| NEMA UD 3-2004 | 12-100 | Standard for Real-Time Display of Thermal and Mechanical
Acoustic Output Indices on Diagnostic Ultrasound
Equipment, American Institute of Ultrasound in Medicine |

Summary of Clinical Tests:

The Vevo MD Imaging 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 Vevo MD device and predicate both conform to applicable electromedical device safety standards with compliance verified through independent evaluation. The Vevo MD device and predicate both meet FDA requirements for Track 3 devices, share indications for use, have biosafety equivalence and are manufactured using the same ISO 13485 quality system. FUJIFILM SonoSite, Inc. believes that the Vevo MD Imaging System is substantially equivalent with regard to safety and effectiveness to the predicate device(s).