Fujifilm Sonosite Vevo MD Imaging System

K160674 · FUJIFILM Sonosite, Inc. · IYN · Apr 19, 2016 · Radiology

Device Facts

• Record ID: K160674
• Device Name: Fujifilm Sonosite Vevo MD Imaging System
• Applicant: FUJIFILM Sonosite, Inc.
• Product Code: IYN · Radiology
• Decision Date: Apr 19, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1550
• Device Class: Class 2
• Attributes: Pediatric, 3rd-Party Reviewed

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.

Device Story

High-frequency, software-controlled diagnostic ultrasound system; acquires/displays high-resolution, real-time 2D, Color Doppler, and M-Mode ultrasound data. Comprised of transducers for signal generation/recording and a main unit for control, acoustic data processing, and image display. Used by physicians in clinical settings. Provides visual output for anatomical evaluation, needle/catheter placement, and nerve block guidance. Benefits include high-resolution visualization of superficial structures and small anatomy.

Clinical Evidence

No clinical studies were required to support the determination of substantial equivalence. Evidence is based on bench testing, including electrical, thermal, mechanical, and EMC safety, as well as cleaning/disinfection, biocompatibility, and acoustic output verification.

Technological Characteristics

High-frequency diagnostic ultrasound system; 64 digital transmit/receive channels; transducer center frequencies 15-49MHz. Modes: B-mode (2D), Color Doppler, M-mode, and combinations. Materials are biocompatible per ISO 10993-1. Complies with IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, NEMA UD 2-2004, and NEMA UD 3-2004. Connectivity includes DICOM 3.0 (Store, Modality Worklist, PPS, Storage Commitment).

Indications for Use

Indicated for use by qualified physicians for ultrasound imaging or fluid flow analysis in abdominal, pediatric, small organ (breast, thyroid, testicles, prostate), musculoskeletal (conventional and superficial), peripheral vessel, and dermatological applications. Includes needle/catheter placement guidance and peripheral nerve block procedures. Imaging depth is limited by ultra-high frequency transducers; abdominal/non-superficial musculoskeletal imaging may be limited to neonatal and small pediatric patients.

Regulatory Classification

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.

Predicate Devices

• SonoSite X-Porte ultrasound system (K133134)
• EpiScan I-200 (k062571)

Submission Summary (Full Text)

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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

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# 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<br>body as follows: | | | | | | |
| Clinical Application | Mode of Operation | | | | | | |
| | B<br>(2D) | M | PWD | CWD | Color<br>Doppler | Combined<br>(Spec.) | Other<br>(Spec.) |
| Ophthalmic | | | | | | | |
| Fetal | | | | | | | |
| Abdominal | N | N | | | N | B(2D)+CD, B(2D)+M | 1,2 |
| Intra-operative (Abdominal<br>organs and vascular) | | | | | | | |
| Intra-operative (Neuro.) | | | | | | | |
| Laparoscopic | | | | | | | |
| Pediatric | N | N | | | N | B(2D)+CD, B(2D)+M | 1,2 |
| Small Organ (breast, thyroid,<br>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.

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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<br>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<br>organs and vascular) | | | | | | | |
| Intra-operative (Neuro.) | | | | | | | |
| Laparoscopic | | | | | | | |
| Pediatric | N | N | | | N | B(2D)+CD, B(2D)+M | 1,2 |
| Small Organ (breast, thyroid,<br>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.)<br>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.

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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.

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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<br>body as follows: | | | | | | |
| Clinical Application | B<br>(2D) | M | PWD | CWD | Color<br>Doppler | Combined<br>(Spec.) | Other<br>(Spec.) |
| Ophthalmic | | | | | | | |
| Fetal | | | | | | | |
| Abdominal | | | | | | | |
| Intra-operative (Abdominal<br>organs and vascular) | | | | | | | |
| Intra-operative (Neuro.) | | | | | | | |
| Laparoscopic | | | | | | | |
| Pediatric | N | N | | | N | B(2D)+CD, B(2D)+M | 1,2 |
| Small Organ (breast, thyroid,<br>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.

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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<br>lmaging System<br>(this submission) | SonoSite X-Porte<br>Ultrasound System<br>K133134 | EpiScan<br>I-200<br>K062571 |
|--------------------------------------------|--------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Diagnostic<br>ultrasound imaging<br>or fluid flow analysis<br>of the human body | Diagnostic<br>ultrasound imaging<br>or fluid flow analysis<br>of the human body | High resolution ultrasound imaging for<br>wounds, superficial musculoskeletal<br>diagnosis and assessment,<br>plastic/reconstructive surgery planning<br>and assessment, dermatological<br>assessment and diagnosis, and<br>aesthetic application |
| Transducer<br>Types<br>Available | Linear Array | Linear Array<br>Curved Linear Array<br>Intracavitary<br>Phased Array | Scanning Element |
| Feature | SonoSite Vevo MD<br>Imaging System<br>(this submission) | SonoSite X-Porte<br>Ultrasound System<br>K133134 | EpiScan<br>l-200<br>K062571 |
| | | | |
| Transducer<br>Center<br>Frequency | 15-49MHz | 1.0 – 15.0 MHz | 20-50MHz |
| Acoustic<br>Output Display<br>& FDA Limits | MI Output Display<br>TI Output Display | Display Feature for<br>Higher Outputs<br>MI Output Display<br>TI Output Display | Not displayed |
| Modes of<br>Operation | B-mode (2-D<br>Grayscale Imaging<br>Color Doppler<br>Combination Modes<br>M-mode | B-mode Grayscale<br>Imaging<br>Tissue Harmonic<br>Imaging<br>M-mode<br>Color M-Mode<br>Color Power Doppler<br>Zoom<br>Combination Modes<br>Pulsed Wave (PW)<br>Doppler<br>Continuous Wave<br>(CW) Doppler<br> | B-Mode Greyscale or color imaging. |
| DICOM | DICOM 3.0 Store,<br>Modality Worklist,<br>Perform Procedure<br>Step (PPS), Storage<br>Commitment | DICOM 3.0 Store,<br>Print, Modality<br>Worklist, Perform<br>Procedure Step<br>(PPS), Storage<br>Commitment | Not available |
| IMT<br>Measurement | Manual<br>Measurement<br>available on the<br>ultrasound system<br>itself. | Not available | Not available |
| #Transmit<br>Channels | 64 digital channels | 128 digital channels | 1 channel |
| Feature | SonoSite Vevo MD<br>lmaging System<br>(this submission) | SonoSite X-Porte<br>Ultrasound System<br>K133134 | EpiScan<br>I-200<br>K062571 |
| #Receive<br>Channels | 64 digital channels | 64 digital channels<br>(128 digital channels<br>using Synthetic<br>Aperture) | 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 [phone] • 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 [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<br>No. | Title |
|--------------------------|--------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| AAMI/ANSI/ISO<br>10993-1 | 2-156 | ISO 10993-1:2009, Biological evaluation of medical devices<br>-- Part 1: Evaluation and testing within a risk management<br>process |
| IEC 60601-1 | 19-5 | AAMI / ANSI ES60601-1:2005/(R)2012 And<br>C1:2009/(R)2012 And, A2:2010/(R)2012 (Consolidated<br>Text) Medical Electrical Equipment -- Part 1: General<br>Requirements For Basic Safety And Essential Performance<br>(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-<br>2: General requirements for basic safety and essential<br>performance - Collateral standard: Electromagnetic<br>compatibility - Requirements and tests (Edition 3) |
| IEC 60601-2-37 | 12-209 | IEC 60601-2-37:2007, Particular Requirements for the<br>basic safety and essential performance of ultrasonic<br>medical 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 [phone] • Facsimile 1.425.951.1201 • www.sonos

| Reference No. | Recognition<br>No. | Title |
|----------------|--------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| NEMA UD 2-2004 | 12-105 | Acoustic Output Measurement Standard for Diagnostic<br>Ultrasound Equipment |
| NEMA UD 3-2004 | 12-100 | Standard for Real-Time Display of Thermal and Mechanical<br>Acoustic Output Indices on Diagnostic Ultrasound<br>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).