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.

AI/ML Overview

The provided text describes the FUJIFILM SonoSite Vevo MD Imaging System, an ultrasonic pulsed doppler imaging system, and the rationale for its substantial equivalence to predicate devices, rather than detailing a specific study to prove its performance against acceptance criteria for a new AI/CAD device.

The document states that "The Vevo MD Imaging System and transducers, subject of this submission, did not require clinical studies to support the determination of substantial equivalence." This indicates that no specific performance study, as typically described for AI/CAD devices, was conducted or presented in this submission to demonstrate the device meets new acceptance criteria. Instead, the submission relies on the device's technological similarity and compliance with safety standards to established predicate devices.

Therefore, many of the requested categories regarding acceptance criteria and performance study specifics cannot be extracted directly from this document.

However, I can provide information based on what is available:

1. Table of Acceptance Criteria and Reported Device Performance:

Since no specific performance study against new acceptance criteria is presented, a direct table cannot be created. The document focuses on showing the device's intended use and technical specifications are similar to legally marketed predicate devices, implying that their established performance is the "acceptance criterion" for substantial equivalence.

Acceptance Criteria (Implied by Predicate Equivalence)	Reported Device Performance (FUJIFILM SonoSite Vevo MD Imaging System)
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body for specific clinical applications (Abdominal, Pediatric, Small Organ, Musculoskeletal (Conventional & Superficial), Peripheral vessel, Dermatological).	Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body for: Abdominal, Pediatric, Small Organ (breast, thyroid, testicles, prostate), Musculo-skel. (Convent.), Musculo-skel. (Superfic.), Peripheral vessel, Dermatological.(Matches the specific clinical applications of the predicate devices and is consistent with traditional clinical practice and FDA guidance.)
Technological Characteristics: Comparable modes of operation (2D, M-mode, Color Doppler), frequency range, and digital channel count to predicate devices.	Modes of Operation: B-mode (2-D Grayscale Imaging), M-mode, Color Doppler, Combination Modes (B(2D)+CD, B(2D)+M).Transducer Center Frequency: 15-49 MHz.Transmit Channels: 64 digital channels.Receive Channels: 64 digital channels.(These specifications are presented in comparison tables to demonstrate substantial equivalence to the SonoSite X-Porte ultrasound system (K133134) and EpiScan I-200 (K062571). While some differences exist (e.g., X-Porte has 128 transmit channels and additional modes), the submission argues for overall substantial equivalence.)
Safety and Effectiveness: Conformance to applicable mandatory medical device safety standards (electrical, thermal, mechanical, EMC, cleaning/disinfection, biocompatibility, acoustic output).	Compliance with Standards: Evaluated for electrical, thermal, mechanical, and EMC safety. Cleaning/disinfection, biocompatibility, and acoustic output evaluated. Conforms to applicable mandatory medical device safety standards and voluntary standards including ISO 10993-1, IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, NEMA UD 2-2004, NEMA UD 3-2004.Biocompatibility: All patient contact materials are biocompatible and are either used in predicate devices or meet 10993 standards.Quality Assurance: Established through Design Phase Reviews, Risk Assessment, Requirements Development, System and Software Verification, Hardware Verification, Safety Compliance Verification, Clinical Validation (this refers to the process verification, not a clinical study on patient outcomes).
Track: Classified as a Track 3 device, consistent with the primary predicate.	Track: Track 3 device.(The predicate SonoSite X-Porte is also a Track 3 device, while the EpiScan I-200 is a Track 1 device, indicating a range of comparison.)

The following points cannot be answered as the document explicitly states no clinical studies were required for this 510(k) submission to support the determination of substantial equivalence. The submission does not describe a performance study as typically seen for AI/CAD devices with new acceptance criteria.

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

Not applicable as no performance study was conducted.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable as no performance study was conducted.

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

Not applicable as no performance study was conducted.

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 as this is not an AI/CAD product and no comparative effectiveness study was done.

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

Not applicable as this is not an AI/CAD product and no standalone performance study was done.

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

Not applicable as no performance study was conducted. The ground truth for proving substantial equivalence relies on the established safety and efficacy of the predicate devices and the new device's compliance with engineering and safety standards.

8. The sample size for the training set:

Not applicable as no AI/CAD model is discussed, and thus no training set.

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

Not applicable as no AI/CAD model is discussed, and thus no training set.

Summary

{0}------------------------------------------------

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.

{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/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 (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)

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

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 humanbody as follows:
Clinical Application	Mode of Operation
	B(2D)	M	PWD	CWD	ColorDoppler	Combined(Spec.)	Other(Spec.)
Ophthalmic
Fetal
Abdominal	N	N			N	B(2D)+CD, B(2D)+M	1,2
Intra-operative (Abdominalorgans 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 humanbody 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 (Abdominalorgans 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:

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:

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 humanbody as follows:
Clinical Application	B(2D)	M	PWD	CWD	ColorDoppler	Combined(Spec.)	Other(Spec.)
Ophthalmic
Fetal
Abdominal
Intra-operative (Abdominalorgans 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:

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 1.425.951.1200 · 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:	Scott.Paulson@sonosite.com
Telephone:	(425) 951-6926
Facsimile:	(425) 491-8356
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)

{8}------------------------------------------------

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 1.425.951.1200 • Facsimile 1.425.951.1201 •

4) Device Description:

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 MDlmaging System(this submission)	SonoSite X-PorteUltrasound SystemK133134	EpiScanI-200K062571
Intended Use	Diagnosticultrasound imagingor fluid flow analysisof the human body	Diagnosticultrasound imagingor fluid flow analysisof the human body	High resolution ultrasound imaging forwounds, superficial musculoskeletaldiagnosis and assessment,plastic/reconstructive surgery planningand assessment, dermatologicalassessment and diagnosis, andaesthetic application
TransducerTypesAvailable	Linear Array	Linear ArrayCurved Linear ArrayIntracavitaryPhased Array	Scanning Element
Feature	SonoSite Vevo MDImaging System(this submission)	SonoSite X-PorteUltrasound SystemK133134	EpiScanl-200K062571

TransducerCenterFrequency	15-49MHz	1.0 – 15.0 MHz	20-50MHz
AcousticOutput Display& FDA Limits	MI Output DisplayTI Output Display	Display Feature forHigher OutputsMI Output DisplayTI Output Display	Not displayed
Modes ofOperation	B-mode (2-DGrayscale ImagingColor DopplerCombination ModesM-mode	B-mode GrayscaleImagingTissue HarmonicImagingM-modeColor M-ModeColor Power DopplerZoomCombination ModesPulsed Wave (PW)DopplerContinuous Wave(CW) Doppler	B-Mode Greyscale or color imaging.
DICOM	DICOM 3.0 Store,Modality Worklist,Perform ProcedureStep (PPS), StorageCommitment	DICOM 3.0 Store,Print, ModalityWorklist, PerformProcedure Step(PPS), StorageCommitment	Not available
IMTMeasurement	ManualMeasurementavailable on theultrasound systemitself.	Not available	Not available
#TransmitChannels	64 digital channels	128 digital channels	1 channel
Feature	SonoSite Vevo MDlmaging System(this submission)	SonoSite X-PorteUltrasound SystemK133134	EpiScanI-200K062571
#ReceiveChannels	64 digital channels	64 digital channels(128 digital channelsusing SyntheticAperture)	1 channel
510(k) Track	Track 3	Track 3	Track 1

{9}------------------------------------------------

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 1.425.951.1201 • www.sonosite.com

{10}------------------------------------------------

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 1.425.951.1201 · 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.	RecognitionNo.	Title
AAMI/ANSI/ISO10993-1	2-156	ISO 10993-1:2009, Biological evaluation of medical devices-- Part 1: Evaluation and testing within a risk managementprocess
IEC 60601-1	19-5	AAMI / ANSI ES60601-1:2005/(R)2012 AndC1:2009/(R)2012 And, A2:2010/(R)2012 (ConsolidatedText) Medical Electrical Equipment -- Part 1: GeneralRequirements 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 essentialperformance - Collateral standard: Electromagneticcompatibility - Requirements and tests (Edition 3)
IEC 60601-2-37	12-209	IEC 60601-2-37:2007, Particular Requirements for thebasic safety and essential performance of ultrasonicmedical diagnostic and monitoring equipment

{11}------------------------------------------------

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 1.425.951.1200 • Facsimile 1.425.951.1201 • www.sonos

Reference No.	RecognitionNo.	Title
NEMA UD 2-2004	12-105	Acoustic Output Measurement Standard for DiagnosticUltrasound Equipment
NEMA UD 3-2004	12-100	Standard for Real-Time Display of Thermal and MechanicalAcoustic Output Indices on Diagnostic UltrasoundEquipment, 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).

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.