(16 days)
No
The document does not mention AI, ML, or related terms, and the description focuses on standard ultrasound imaging processing.
No.
The device is described as a diagnostic imaging system for evaluation, not for treating or monitoring a condition.
Yes
The 'Device Description' explicitly states: "The Vevo MD Imaging System is a high frequency general purpose, software controlled, diagnostic imaging system..."
No
The device description explicitly states the system is comprised of transducers and a main unit, which are hardware components.
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 describes an in-vivo (within the living body) diagnostic imaging system, not a device used to examine specimens taken from the body (in vitro).
- Device Description: The description details an ultrasound system that generates and records ultrasound signals and processes this data to display images of the human body. This aligns with in-vivo imaging.
- Anatomical Site: The listed anatomical sites are all parts of the human body, further supporting its use for in-vivo imaging.
- No mention of analyzing biological samples: There is no indication that this device is used to analyze blood, urine, tissue samples, or any other biological specimens, which is the hallmark of an IVD.
Therefore, the Vevo MD Imaging System is a diagnostic imaging system used for in-vivo ultrasound examinations, not an in-vitro diagnostic device.
N/A
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
Dermatological
Musculoskeletal (conventional)
Musculoskeletal (superficial)
Neonatal Cephalic
Ophthalmic
Pediatric
Peripheral vessel
Small Organ (breast, thyroid, testicles, prostate)
Product codes
IYN, IYO, ITX
Device Description
The Vevo MD Imaging System is a high frequency general purpose, software controlled, diagnostic imaging system used to acquire ad display high-resolution, real-time ultrasound data in 2D, Color Doppler, Power Doppler, PW Doppler and M-Mode. The Vevo MD Imaging 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
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Abdominal, Dermatological, Musculoskeletal, Neonatal Cephalic, Ophthalmic, Pediatric, Peripheral vessel, Small Organ (breast, thyroid, testicles, prostate)
Indicated Patient Age Range
Adult, Pediatric, Neonatal
Intended User / Care Setting
qualified physician
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)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
FUJIFILM SonoSite, Inc. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services, LLC 1394 25th Street, NW BUFFALO MN 55313
March 15, 2019
Re: K190476
Trade/Device Name: FUJIFILM SonoSite Vevo MD Imaging System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: Class II Product Code: IYN, IYO, ITX Dated: February 25, 2019 Received: February 27, 2019
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice
(https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Michael D. O'Hara
For
Thalia Mills, 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) K190476
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 Dermatological Musculoskeletal (conventional) Musculoskeletal (superficial) Neonatal Cephalic Ophthalmic Pediatric Peripheral vessel Small Organ (breast, thyroid, testicles, prostate)
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)
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:
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"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."
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
3
Table 1.3.1: Diagnostic Ultrasound Indications for Use Form - FUJIFILM SonoSite Vevo MD Imaging System
| System: | Vevo MD Imaging System | |||||||
|---|---|---|---|---|---|---|---|---|
| Transducer: | UHF22, UHF48, UHF70 | |||||||
| Intended Use: | Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | |||||||
| Mode of Operation | ||||||||
| Clinical Application | 2D | M | PWD | CWD | Color | |||
| Doppler | ||||||||
| (CD) | Power | |||||||
| Doppler | ||||||||
| (CPD) | Combined | |||||||
| (Spec.) | Other | |||||||
| (Spec.) | ||||||||
| Ophthalmic | N | 1,2,3 | ||||||
| Fetal | ||||||||
| Abdominal | P | P | N | P | N | 2D+CD, 2D+M, 2D+CPD, | ||
| 2D+PWD | 1,2,3 | |||||||
| Intra-operative (Abdominal | ||||||||
| organs and vascular) | ||||||||
| Intra-operative (Neuro.) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | P | P | N | P | N | 2D+CD, 2D+M, 2D+CPD, | ||
| 2D+PWD | 1,2 | |||||||
| Small Organ (breast, | ||||||||
| thyroid, testicles, prostate) | P | P | N | P | N | 2D+CD, 2D+M, 2D+CPD, | ||
| 2D+PWD | 1,2 | |||||||
| Neonatal Cephalic | N | N | N | N | N | 2D+CD, 2D+M, 2D+CPD, | ||
| 2D+PWD | 1,2 | |||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Musculo-skel. (Convent.) | P | P | N | P | N | 2D+CD, 2D+M, 2D+CPD, | ||
| 2D+PWD | 1,2 | |||||||
| Musculo-skel. (Superfic.) | P | P | N | P | N | 2D+CD, 2D+M, 2D+CPD, | ||
| 2D+PWD | 1,2 | |||||||
| Intra-luminal | ||||||||
| Other (spec.) | ||||||||
| Cardiac Adult | ||||||||
| Cardiac Pediatric | ||||||||
| Trans-esophageal (card.) | ||||||||
| Other (spec.) | ||||||||
| Peripheral vessel | P | P | N | P | N | 2D+CD, 2D+M, 2D+CPD, | ||
| 2D+PWD | 1,2 | |||||||
| Other (Dermatology) | P | P | N | P | N | 2D+CD, 2D+M, 2D+CPD, | ||
| 2D+PWD | 1,2 |
N= New Indicated Imaging Examination P=Previously Indicated Imaging Examination
Additional Comments/Other (Spec.):
I: The Vevo MD Imaging System uses ultra high frequency (UHF) series transducers that limit the imaging of abdominal organs or non-superficial musculoskeletal structure may be limited to neonatal and small pediative 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 needler or other anatomical structures and imaging guidance for peripheral nerve block procedures.
3: Abdominal and Ophthalmic clinical applications are indications for use for the UHF22 transducer only
Page 1 of 4
VOL 002 Section 1 General Information Section 003 Indications for Use
4
| System: | Vevo MD Imaging System | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Transducer: | UHF22 | ||||||||
| Intended Use: | Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | ||||||||
| Clinical Application | Mode of Operation | Combined | |||||||
| (Spec.) | Other | ||||||||
| (Spec.) | |||||||||
| B | |||||||||
| (2D) | M | PWD | CWD | Color | |||||
| Doppler | |||||||||
| (CD) | Power | ||||||||
| Doppler | |||||||||
| (CPD) | |||||||||
| Ophthalmic | N | 1,2,3 | |||||||
| Fetal | |||||||||
| Abdominal | P | P | N | P | N | 2D+CD, 2D+M, 2D+CPD, | |||
| 2D+PWD | 1,2,3 | ||||||||
| Intra-operative (Abdominal | |||||||||
| organs and vascular) | 1,2,3 | ||||||||
| Intra-operative (Neuro.) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | P | P | N | P | N | 2D+CD, 2D+M, 2D+CPD, | |||
| 2D+PWD | 1,2 | ||||||||
| Small Organ (breast, | |||||||||
| thyroid, testicles, prostate) | P | P | N | P | N | 2D+CD, 2D+M, 2D+CPD, | |||
| 2D+PWD | 1,2 | ||||||||
| Neonatal Cephalic | N | N | N | N | N | 2D+CD, 2D+M, 2D+CPD, | |||
| 2D+PWD | 1,2 | ||||||||
| Adult Cephalic | |||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card.) | |||||||||
| Musculo-skel. (Convent.) | P | P | N | P | N | 2D+CD, 2D+M, 2D+CPD, | |||
| 2D+PWD | 1,2 | ||||||||
| Musculo-skel. (Superfic.) | P | P | N | P | N | 2D+CD, 2D+M, 2D+CPD, | |||
| 2D+PWD | 1,2 | ||||||||
| Intra-luminal | |||||||||
| Other (spec.) | |||||||||
| Cardiac Adult | |||||||||
| Cardiac Pediatric | |||||||||
| Trans-esophageal (card.) | |||||||||
| Other (spec.) | |||||||||
| Peripheral vessel | P | P | N | P | N | 2D+CD, 2D+M, 2D+CPD, | |||
| 2D+PWD | 1,2 | ||||||||
| Other (Dermatology) | N | N | N | N | N | 2D+CD, 2D+M, 2D+CPD, | |||
| 2D+PWD | 1,2 |
N= New Indicated Imaging Examination P=Previously Indicated Imaging Examination
Additional Comments/Other (Spec.):
I: 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 imaging is limited to the maximum imaging depth of the transducer as indicated in the specifications for each transducer.
- Includes imaging to assist in the placement of needles and cather anatomical structures and imaging guidance for peripheral nerve block procedures.
3: Abdominal and Ophthalmic clinical applications are indications for use for the UHF22 transducer only
5
| System: | Vevo MD Imaging System | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Transducer: | UHF48 | ||||||||
| Intended Use: | Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | ||||||||
| Clinical Application | Mode of Operation | Other | |||||||
| (Spec.) | |||||||||
| B | |||||||||
| (2D) | M | PWD | CWD | Color | |||||
| Doppler | |||||||||
| (CD) | Power | ||||||||
| Doppler | |||||||||
| (CPD) | Combined | ||||||||
| (Spec.) | |||||||||
| Ophthalmic | |||||||||
| Fetal | |||||||||
| Abdominal | |||||||||
| Intra-operative (Abdominal | |||||||||
| organs and vascular) | |||||||||
| Intra-operative (Neuro.) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | P | P | N | P | N | 2D+CD, 2D+M, 2D+CPD, | |||
| 2D+PWD | 1,2 | ||||||||
| Small Organ (breast, | |||||||||
| thyroid, testicles, prostate) | P | P | N | P | N | 2D+CD, 2D+M, 2D+CPD, | |||
| 2D+PWD | 1,2 | ||||||||
| Neonatal Cephalic | N | N | N | N | N | 2D+CD, 2D+M, 2D+CPD, | |||
| 2D+PWD | 1,2 | ||||||||
| Adult Cephalic | |||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card.) | |||||||||
| Musculo-skel. (Convent.) | P | P | N | P | N | 2D+CD, 2D+M, 2D+CPD, | |||
| 2D+PWD | 1,2 | ||||||||
| Musculo-skel. (Superfic.) | P | P | N | P | N | 2D+CD, 2D+M, 2D+CPD, | |||
| 2D+PWD | 1,2 | ||||||||
| Intra-luminal | |||||||||
| Other (spec.) | |||||||||
| Cardiac Adult | |||||||||
| Cardiac Pediatric | |||||||||
| Trans-esophageal (card.) | |||||||||
| Other (spec.) | |||||||||
| Peripheral vessel | P | P | N | P | N | 2D+CD, 2D+M, 2D+CPD, | |||
| 2D+PWD | 1,2 | ||||||||
| Other (Dermatology) | P | P | N | P | N | 2D+CD, 2D+M, 2D+CPD, | |||
| 2D+PWD | 1,2 |
N= New Indicated Imaging Examination P=Previously Indicated Imaging Examination
Additional Comments/Other (Spec.):
19 101 820 800000000 1 100 16
1: The Vevo MD Imaging System uses ultra high frequency (UHF) series transducers that limit the imaging of abdominal organs or non-superficial musculoskelal structure may be limited to neonatal and small pediatric patients and all imaging is fimited 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 needler or other anatomical structures and imaging guidance for peripheral nerve block procedures.
FINAL TRANCE
6
| System: | Vevo MD Imaging System | |||||||
|---|---|---|---|---|---|---|---|---|
| Transducer: | UHF70 | |||||||
| Intended Use: | Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | |||||||
| Clinical Application | ||||||||
| B (2D) | M | PWD | CWD | Color Doppler (CD) | Power Doppler (CPD) | Combined (Spec.) | Other (Spec.) | |
| Ophthalmic | ||||||||
| Fetal | ||||||||
| Abdominal | ||||||||
| Intra-operative (Abdominal organs and vascular) | ||||||||
| Intra-operative (Neuro.) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | P | P | N | P | N | 2D+CD, 2D+M, 2D+CPD, 2D+PWD | 1,2 | |
| Small Organ (breast, thyroid, testicles, prostate) | P | P | N | P | N | 2D+CD, 2D+M, 2D+CPD, 2D+PWD | 1,2 | |
| Neonatal Cephalic | N | N | N | N | N | 2D+CD, 2D+M, 2D+CPD, 2D+PWD | 1,2 | |
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Musculo-skel. (Convent.) | P | P | N | P | N | 2D+CD, 2D+M, 2D+CPD, 2D+PWD | 1,2 | |
| Musculo-skel. (Superfic.) | P | P | N | P | N | 2D+CD, 2D+M, 2D+CPD, 2D+PWD | 1,2 | |
| Intra-luminal | ||||||||
| Other (spec.) | ||||||||
| Cardiac Adult | ||||||||
| Cardiac Pediatric | ||||||||
| Trans-esophageal (card.) | ||||||||
| Other (spec.) | ||||||||
| Peripheral vessel | P | P | N | P | N | 2D+CD, 2D+M, 2D+CPD, 2D+PWD | 1,2 | |
| Other (Dermatology) | P | P | N | P | N | 2D+CD, 2D+M, 2D+CPD, 2D+PWD | 1,2 |
N= New Indicated Imaging Examination P=Previously Indicated Imaging Examination
Additional Comments/Other (Spec.):
I 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 cather anatomical structures and imaging guidance for peripheral nerve block procedures.
7
SonoSite
510(K) Summary-K190476
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: | Anoush Frankian |
|---|---|
| Sr. Manager, Regulatory Affairs | |
| E-mail: | anoush.frankian@fujifilm.com |
| Telephone: | (425) 951-6824 |
| Facsimile: | (425) 491-8356 |
| Date prepared: | February 11, 2019 |
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
FUJIFILM SonoSite Vevo MD Imaging System
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:
FUJIFILM SonoSite Vevo MD Imaging System (K160674) (Primary Predicate) SonoSite X-Porte ultrasound system (K171437) (Reference Predicate)
4) Device Description:
The Vevo MD Imaging System is a high frequency general purpose, software controlled, diagnostic imaging system used to acquire ad display high-resolution, real-time ultrasound data in 2D, Color Doppler, Power Doppler, PW Doppler and M-Mode. The Vevo MD Imaging System is comprised of
8
Image /page/8/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 it, which is placed above the "I" in Fujifilm. Below the logo, in a smaller font, 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 all black and evenly spaced. The dot above the "i" in "Site" is a perfect circle.
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 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 Dermatological Musculoskeletal (conventional) Musculoskeletal (superficial) Neonatal Cephalic Ophthalmic
Pediatric
Peripheral vessel Small Organ (breast, thyroid, testicles, prostate)
6) Technological Characteristics:
The Vevo MD Imaging System subject of this submission and its primary predicate Vevo MD Imaging System (K160674) and reference predicate X-Porte (K171437) are all Track 3 devices that employ the same fundamental scientific technology. A comparison table is provided below.
| Feature | SonoSite VevoMD
Ultrasound System
(this submission) | SonoSite
VevoMD
Ultrasound
System
(K160674) | SonoSite X-Porte
Ultrasound System
(K171437) |
|-----------------------------------------------|------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Diagnostic
ultrasound imaging
or fluid flow analysis
of the human body | Diagnostic
ultrasound
imaging or fluid
flow analysis of
the human body | Diagnostic ultrasound
imaging or fluid flow
analysis of the human
body |
| Transducer
Types
Available | Linear Array | Linear Array | Linear Array
Curved Linear Array
Intracavitary
Phased Array |
| Transducer
Center
Frequency | 15-49MHz | 15-49MHz | 1.0 - 15.0 MHz |
| Feature | SonoSite VevoMD
Ultrasound System
(this submission) | SonoSite
VevoMD
Ultrasound
System
(K160674) | SonoSite X-Porte
Ultrasound System
(K171437) |
| Acoustic
Output
Display &
FDA Limits | MI Output Display
TI Output Display | MI Output
Display
TI Output Display | Display Feature for
Higher Outputs
MI Output Display
TI Output Display |
| Modes of
Operation | 2D Mode, Color
Doppler, M-Mode,
Power Doppler, PW
Doppler | 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
SonoHD2 Noise
Reduction
SonoMB/MBe Image
Compounding
Steered CW Doppler
Velocity Color
Doppler
Tissue Doppler
Imaging (TDI) |
| | | | |
| Feature | SonoSite VevoMD
Ultrasound System
(this submission) | SonoSite
VevoMD
Ultrasound
System
(K160674) | SonoSite X-Porte
Ultrasound System
(K171437) |
| DICOM | DICOM 3.0 Store,
Print, Modality
Worklist, Perform
Procedure Step
(PPS), Storage
Commitment | DICOM 3.0 Store,
Print, Modality
Worklist, Perform
Procedure Step
(PPS), Storage
Commitment | DICOM 3.0 Store,
Print, Modality
Worklist, Perform
Procedure Step (PPS),
Storage Commitment |
| IMT
Measurement | Manual
Measurement
available on the
ultrasound system
itself. | Manual
Measurement
available on the
ultrasound system
itself. | Not available |
| #Transmit
Channels | 64 digital channels | 64 digital
channels | 128 digital channels |
| #Receive
Channels | 64 digital channels | 64 digital
channels | 64 digital channels
(128 digital channels
using Synthetic
Aperture) |
| 510(k) Track | Track 3 | Track 3 | Track 3 |
9
Image /page/9/Picture/0 description: The image shows the Fujifilm logo. The logo is black, except for a small red square above the letter "I". Below the logo, the words "Value from Innovation" are written in a smaller, black font. The logo is simple and modern.
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Image /page/10/Picture/0 description: The image shows the Fujifilm logo. The logo consists of the word "FUJIFILM" in bold, black letters. The "I" in Fujifilm has a red square on the top right corner. Below the word "FUJIFILM" is the tagline "Value from Innovation".
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Image /page/11/Picture/0 description: The image shows the Fujifilm logo. The logo is black, except for a red accent on the "I" in Fujifilm. Below the logo is the text "Value from Innovation" in black.
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 | 2-220 | Biological evaluation of medical devices - Part 1:
Evaluation and testing within a risk management
process |
| IEC 60601-1 | 19-4 | Medical electrical equipment - Part 1: General
requirements for basic safety and essential
performance |
| IEC 60601-1-2 | 19-8 | Medical Electrical Equipment - Part 1-2: General
Requirements For Basic Safety And Essential
Performance - Collateral Standard: Electromagnetic
Disturbances - Requirements And Tests (Edition 4) |
| IEC 60601-2-37 | 12-293 | Particular Requirements for the basic safety and
essential performance of ultrasonic medical
diagnostic and monitoring equipment (Edition 2.1) |
| IEC 62359 | 12-316 | Ultrasonic - Field Characterization - Test Methods For
The Determination Of Thermal And Mechanical
Indices Related To Medical Diagnostic Ultrasonic
Fields |
| IEC 62304 | 13-79 | Medical Device Software - Software Life Cycle
Processes |
| ISO 14971 | 5-40 | Medical devices - Application of risk management to
medical devices |
| NEMA UD 2 | 12-105 | Acoustic Output Measurement Standard for
Diagnostic Ultrasound Equipment |
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Image /page/12/Picture/0 description: The image shows the Fujifilm logo. The logo is black, except for a red square on top of the letter 'I'. Below the logo is the text 'Value from Innovation' in black font. The logo is simple and modern.
Image /page/12/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 is horizontally oriented and centered in the image.
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 Ultrasound System is substantially equivalent with regard to safety and effectiveness to the predicate device(s).