(364 days)
Not Found
No
The summary does not mention AI, ML, or any related terms, and the described functions (image acquisition, processing, display, measurement, analysis packages, and magnetic needle guidance) are standard for diagnostic ultrasound systems and do not inherently require AI/ML.
No.
The device is described as a diagnostic ultrasound system intended for imaging, measurement, and analysis for clinical diagnosis purposes, not for treating conditions.
Yes
The "Intended Use / Indications for Use" section explicitly states, "The device is general purpose diagnostic ultrasound system..." and "...The device is used in hospital, clinics and clinical point-of-care for diagnosis of patients." The "Device Description" also mentions that the systems "...provide information that is used for clinical diagnosis purposes."
No
The device description explicitly states that the VINNO 8, VINNO 6, and VINNO 5 are "laptop digital color ultrasonic diagnostic devices" that "transmit ultrasound waves into the body tissues and display the echo images." This indicates the presence of hardware components (transducers, processing units, display) beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states that this device is a "general purpose diagnostic ultrasound system" that "transmit ultrasound waves into the body tissues and display the echo images of the tissues and blood flow". It performs imaging, measurement, and analysis within the human body.
- Intended Use: The intended use describes imaging and analysis of human body and fluid for multiple clinical applications, not the analysis of specimens from the body.
Therefore, this device falls under the category of in vivo diagnostic imaging devices, not in vitro diagnostic devices.
N/A
Intended Use / Indications for Use
The device is general purpose diagnostic ultrasound system for use by qualified healthcare professionals. It is applicable for adults, pregnant women, pediatric patients and neonates.
The device is intended for ultrasound imaging, measurement and analysis of human body and fluid for multiple clinical applications including: abdominal (GYN and Urology), Thoracic/Pleural, Fetal/Ob, small organ (including breast, thyroid, testes), peripheral vessel, neonatal cephalic, pediatric, musculo-skeletal (conventional, superficial), transrectal, trans-vaginal, cardiac adult, cardiatric, magnetic Needle guidance and imaging guidance of interventional procedures (e.g. biopsy).
This device is intended to use by, or by the order of, and under the supervision of a licensed physician qualified to direct the use of the device.
The device is used in hospital, clinics and clinical point-of-care for diagnosis of patients.
Product codes
IYN, IYO, ITX
Device Description
The VINNO 8, VINNO 6, VINNO 5 ultrasound devices are laptop digital color ultrasonic diagnostic devices which transmit ultrasound waves into the body tissues and display the echo images of the tissues and blood flow accordingly. The devices are capable of digital acquisition, processing and display and operate from an integrated battery or separate power supply/charger. The systems also provide for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes. The VGuide NGS function detects the position and orientation of magnetized needles in the presence of the probe and displays this information relative to the ultrasound image. Spatial positioning of the needle, with respect to the ultrasound image, is then updated in real time. This guides the operator to better visualize the needle in the ultrasound image during ultrasound guided needling procedures.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
abdominal (GYN and Urology), Thoracic/Pleural, Fetal/Ob, small organ (including breast, thyroid, testes), peripheral vessel, neonatal cephalic, adult cephalic, pediatric, musculo-skeletal (conventional, superficial), trans-rectal, trans-vaginal, cardiac adult, cardiac pediatric
Indicated Patient Age Range
adults, pregnant women, pediatric patients and neonates
Intended User / Care Setting
Intended to use by, or by the order of, and under the supervision of a licensed physician qualified to direct the use of the device. The device is used in hospital, clinics and clinical point-of-care for diagnosis of patients.
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 following performance data were provided in support of the substantial equivalence determination:
Biocompatibility testing: Biocompatibility of the probes was evaluated in accordance with ISO 10993-1:2009. All evaluation acceptance criteria were met.
Electrical safety and electromagnetic compatibility (EMC): Electrical safety and EMC testing were conducted on the Ultrasound System. The system complies with the IEC 60601-1 and IEC 60601-2-37 for safety and the IEC 60601-1-2 for EMC.
Software Verification and Validation Testing: Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "moderate" level of concern.
Acoustic output testing: Acoustic output testing was performed according to NEMA UD2 and IEC60601-2-37.
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.
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
§ 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 logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
VINNO Technology (Suzhou) Co., Ltd. % Ms. Sherry Zhang Regulatory Affairs 5F Building A, 4F Building C No. 27 XinFa Rd. Suzhou Industrial Park Suzhou, Jiangsu 215123 CHINA
January 23, 2020
Re: K190120
Trade/Device Name: VINNO 8, VINNO 6, VINNO 5 Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: Class II Product Code: IYN, IYO, ITX Dated: December 6, 2019 Received: December 9, 2019
Dear Ms. Zhang:
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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-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'Hara
For
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for use
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
Indications for Use
510(k) Number (if known) K190120
Device Name VINNO 8, VINNO 6, VINNO5
Indications for Use (Describe)
The device is general purpose diagnostic ultrasound system for use by qualified healthcare professionals. It is applicable for adults, pregnant women, pediatric patients and neonates.
The device is intended for ultrasound imaging, measurement and analysis of human body and fluid for multiple clinical applications including: abdominal (GYN and Urology), Thoracic/Pleural, Fetal/Ob, small organ (including breast, thyroid, testes), peripheral vessel, neonatal cephalic, pediatric, musculo-skeletal (conventional, superficial), transrectal, trans-vaginal, cardiac adult, cardiatric, magnetic Needle guidance and imaging guidance of interventional procedures (e.g. biopsy).
This device is intended to use by, or by the order of, and under the supervision of a licensed physician qualified to direct the use of the device.
The device is used in hospital, clinics and clinical point-of-care for diagnosis of patients.
| 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.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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FORM FDA 3881 (7/17)
Page 1 of 1
PSC Publishing Services (301) 443-6740
3
510(k) summary
l Submitter
Device submitter: VINNO Technology (Suzhou) Co., Ltd. 5F Building A, 4F Building C No. 27 XinFa Rd. Suzhou Industrial Park, SuZhou 215123 Jiangsu China
Contact person: Sherry Zhang Regulatory Affairs Phone: +86 15850113783 Fax: +86 512 62873801 Email: Sherry.Zhang@vinno.com
Date of preparation: Dec 5th, 2019
II Device
Trade Name of Device: VINNO 8, VINNO 6, VINNO 5 Regulation name: Ultrasonic pulsed doppler imaging system Regulation Number: 21 CFR 892.1550 Requlatory Class: II Product code: IYN, IYO, ITX
III Predicate Devices
Trade name: LOGIQ e Regulation Name: Ultrasonic pulsed doppler imaging system Regulation Number: 21 CFR 892.1550 Regulatory Class: II Product code: IYN, IYO, ITX Premarket Notification: K151028
Trade name: CX50 Diagnostic Ultrasound System Regulation Name: Ultrasonic pulsed doppler imaging system Regulation Number: 21 CFR 892.1550 Regulatory Class: II Product code: IYN, IYO, ITX Premarket Notification: K162329
Trade name: eZono™ 4000 Ultrasound System Regulation Name: Ultrasonic pulsed doppler imaging system Regulation Number: 21 CFR 892.1550
4
Requlatory Class: II Product code: IYN, IYO, ITX Premarket Notification: K140254
IV Device description
The VINNO 8, VINNO 6, VINNO 5 ultrasound devices are laptop digital color ultrasonic diagnostic devices which transmit ultrasound waves into the body tissues and display the echo images of the tissues and blood flow accordingly. The devices are capable of digital acquisition, processing and display and operate from an integrated battery or separate power supply/charger.
Mode of operations for each probe supported by the VINNO 8, VINNO 6, VINNO 5 ultrasound devices is listed in below table.
| Probe | B | M | PWD | CWD | Tissue
Doppler | Color
Doppler | Color M
Doppler | Power
Doppler | Tissue
Velocity | Imaging
Harmonic | Imaging
3D/4D | CBI | EI | Combine
modes[1] | VINNO 5 | VINNO 6 | VINNO 8 |
|---------|---|---|-----|-----|-------------------|------------------|--------------------|------------------|--------------------|---------------------|------------------|-----|----|---------------------|---------|---------|---------|
| G2-5C | N | N | N | N | N | N | N | N | N | N | N | N | N | N | | | X |
| U5-15LE | N | N | N | N | N | N | N | N | N | N | N | N | N | N | | | X |
| S1-6P | N | N | N | N | N | N | N | N | N | N | N | N | N | N | | | X |
| F2-5C | N | N | N | N | N | N | N | N | N | N | N | N | N | N | X | X | X |
| F4-9E | N | N | N | N | N | N | N | N | N | N | N | N | N | N | X | X | X |
| G4-9M | N | N | N | N | N | N | N | N | N | N | N | N | N | N | X | X | X |
| F4-12L | N | N | N | N | N | N | N | N | N | N | N | N | N | N | X | X | X |
| D3-6C | N | N | N | N | N | N | N | N | N | N | N | N | N | N | X | X | X |
| G1-4P | N | N | N | N | N | N | N | N | N | N | N | N | N | N | X | X | X |
| X4-12L | N | N | N | N | N | N | N | N | N | N | N | N | N | N | | X | X |
| X6-16L | N | N | N | N | N | N | N | N | N | N | N | N | N | N | | X | X |
| X6-16LG | N | N | N | N | N | N | N | N | N | N | N | N | N | N | | X | X |
Note:
N = new indication; P = previously cleared by FDA
[1] Combined modes are: B/M, B/Color M, B/PWD, B/Color/PWD, B/Power/PWD;
The systems also provide for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes.
The VGuide NGS function detects the position and orientation of magnetized needles in
5
the presence of the probe and displays this information relative to the ultrasound image. Spatial positioning of the needle, with respect to the ultrasound image, is then updated in real time. This guides the operator to better visualize the needle in the ultrasound image during ultrasound guided needling procedures.
6
V Indications for use
The device is general purpose diagnostic ultrasound system for use by qualified healthcare professionals. It is applicable for adults, pregnant women, pediatric patients and neonates.
The device is intended for ultrasound imaging, measurement and analysis of human body and fluid for multiple clinical applications including: abdominal (GYN and Urology), Thoracic/Pleural, Fetal/Ob, small organ (including breast, thyroid, testes), peripheral vessel, neonatal cephalic, adult cephalic, pediatric, musculo-skeletal (conventional, superficial), trans-rectal, trans-vaginal, cardiac adult, cardiac pediatric, magnetic Needle guidance and imaging guidance of interventional procedures (e.g. biopsy).
This device is intended to use by, or by the order of, and under the supervision of a licensed physician qualified to direct the use of the device.
The device is used in hospital, clinics and clinical point-of-care for diagnosis of patients.
7
The detail indications for use of each probe are listed below.
| Anatomy/Region of Interest | Exam Type, Means of Access | Interventional Guidance | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Transducer | Fetal | Abdominal | Pediatric | Small Organ [2] | Neonatal Cephalic | Adult Cephalic | Cardiac Adult | Cardiac Pediatric | Peripheral vessel | Musculo-skeletal (Conventional) | Musculo-skeletal (Superficial) | Thoracic/Pleural | Trans-rectal | Trans-vaginal | Trans-urethral | Transesophageal | Intraoperative | Vascular Access | Nonvascular [1] | |
| G2-5C | N | N | N | N | ||||||||||||||||
| U5-15LE | N | N | N | N | N | N | N | |||||||||||||
| S1-6P | N | N | N | N | N | N | N | |||||||||||||
| X6-16L | N | N | N | N | N | N | N | |||||||||||||
| X6-16LG | N | N | N | N | N | N | N | |||||||||||||
| F2-5C | N | N | N | N | ||||||||||||||||
| F4-9E | N | N | N | N | N | |||||||||||||||
| G4-9M | N | N | N | N | N | N | ||||||||||||||
| F4-12L | N | N | N | N | N | N | N | |||||||||||||
| X4-12L | N | N | N | N | N | N | N | |||||||||||||
| D3-6C | N | N | ||||||||||||||||||
| G1-4P | N | N | N | N | N | N | N |
Notes:
8
N = new indication; P = previously cleared by FDA
[1] Nonvascular means Biopsy Guidance
[2] Small organs include breast, testes, thyroid
9
VI Comparison of technological characteristics with the predicate devices
The VINNO 8, VINNO 6, VINNO 5 ultrasound devices have the same technological characteristics and fundamental design as the predicate devices. The VINNO 8, VINNO 6, VINNO 5 ultrasound devices and the predicate device are all lap-top general purpose ultrasound devices designed to provide real-time images for diagnosis. The differences between the VINNO 8, VINNO 6, VINNO 5 ultrasound devices and predicate devices do not alter suitability of the proposed device for its intended use.
10
| Device
feature | VINNO 8, VINNO 6, VINNO 5
(subject device) | GE Healthcare LOGIQ e
K151028 (predicate device) | Philips CX50 Diagnostic
Ultrasound System K162329
(predicate device) |
|------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for
use | The device is intended for
ultrasound imaging,
measurement and analysis of
human body and fluid for multiple
clinical applications including:
abdominal (GYN and Urology),
Thoracic/Pleural, Fetal/Ob, small
organ (including breast, thyroid,
testes), peripheral vessel,
neonatal cephalic, adult cephalic,
pediatric, musculo-skeletal
(conventional, superficial),
trans-rectal, trans-vaginal,
cardiac adult, cardiac pediatric,
magnetic Needle guidance and
imaging guidance of
interventional procedures (e.g.
biopsy). | The LOGIQ e is intended for
ultrasound imaging,
measurement and analysis of the
human body for multiple clinical
applications including:
ophthalmic: fetal/ob; abdominal
(gyn & urology); pediatric; small
organ (breast, testes, thyroid);
neonatal and adult cephalic;
cardiac (adult & pediatric);
peripheral vascular;
musculoskeletal conventional &
superficial; transrectal;
transvaginal; transesophageal;
intraoperative (abdominal,
thoracic and peripheral);
thoracic/pleural for motion and
fluid detection and imaging
guidance of interventional
procedures (e.g. Nerve block;
vascular access). | Ophthalmic, Intraoperative,
Laparascopic, Fetal, Abdominal,
Pediatric, Small Organ, Adult
Cephalic, Neonatal Cephalic,
Trans-vaginal, Musculoskeletal,
Gynecological, Cardiac Adult,
Cardiac Pediatric, Trans-esoph,
Intracardiac echo, Peripheral
Vessel, Other (Carotid) |
| User | Qualified healthcare | Qualified physicians or | Qualified physicians or |
| qualification | professionals | sonographers | sonographers |
| Physical
Design | Laptop design with lithium
battery, also available to be used
with a mobile cart
1 probe port | Laptop design with lithium
battery, also available to be used
with a mobile cart
1 probe port | Laptop design with lithium
battery, also available to be used
with a mobile cart
1 probe port |
| Patient contact
materials | Probe housing: ABS,
Probe lens: Silicon rubber
Comply with ISO10993 series | Probe housing: ABS
Probe lens: Silicon rubber
Comply with ISO10993 series | Probe housing: ABS
Probe lens: Silicon rubber
Comply with ISO10993 series |
| Operating
modes | B, M, Color Flow, PDI, PWD,
CWD, Harmonic, 3D/4D, Color
M, Elastography, TVI/TVD,
Contrast agent imaging | B, M, M-Color Flow, Anatomical
M, Color Anatomical M, CFM,
PDI, High-Res PDI, CWD, PWD,
TVI/TVD, Needle Recognition,
3D | B, M, Anatomical M, Color M,
Color, CWD, Harmonic, PDI,
PWD, TDI, Power/Dirpower,
3D/4D, Elastography, Stress
Echo, Contrast agent imaging |
| Operating
controls | Gain, Depth, Focus, TGC, B
Steer, 2D Automatic
Optimization, Harmonic Imaging,
L/R, U/D, Frequency, PRF, Wall
Filter, Packet Size, Color Level,
Invert, Color Map, Line Density,
Sync Display, Persistence, Flash
Reduction, Base Line,
Transparency, Steer, Focus
Position, Focus Number,
VFusion, VSpeckle, Dynamic
Range | Depth, Gain, Focus, Auto
Optimize, MD cursor, Frequency,
CrossXBeam, TGC, Tilt,
Reserve, Dynamic Range, Line
Density, Grey Maps, Frame
Average, Colorize, Edge
Enhance, Steer, Rotation, Virtual
Convex, SRI HD, Virtual Apex,
Centerline, Rejection,
Suppression, Scan Area, LOGIQ
View, Fusion Background Area, | Depth, Gain, Dynamic Range,
TGC, Angle, Color Gain, Wall
Filter, Baseline, Sweep Speed,
Doppler DR, Colorize, iBeam,
iClear, TSI, Sync Display, Steer,
Focus Position, Focus Number,
iTouch |
| Measurements | Depth, Distance, Perimeter, Area, | Depth, Distance, Circumference, | Depth, Distance, Circumference, |
| | Volume, Angle, Stenosis, A/B ratio, Time, Speed, Heart Rate, Stenosis, A/B ratio, Acceleration, PS, ED, TAMAX, TAMEAN, RI, PI, PS.ED ratio, ED/PS ratio, Flow volume, MaxPG, MeanPG, Stroke Volume, Heart rate | Area, Angle, Stenosis, A/B ratio, Slope, Heart Rate, Velocity, Time, Acceleration, Frequency, TAMAX, TAMEAN, RI, PI, Ratios, Heart rate, Auto Doppler Trace function with automatic calculations | Area, Time, Heart Rate, Angle, Stenosis, A/B ratio, Volume, Auto volume measurements, Auto NT measurements, Auto OB measurement, Color Speed, Orthopaedic surgery |
| Comments | Comments and bodymarks | Comments and bodymarks | Comments and bodymarks |
| Probe types | Convex array
Linear array
Phased array | Convex array
Linear array
Sector array | Curved array
Linear array
Phased array |
| Display
monitor | 15.6 inch LCD monitor | 15 inch LCD monitor | 15.6 inch LCD monitor |
| Acoustic
output | Comply with Track 3 limits:
$Ispta.3≤720mW/cm²$
$MI≤1.9$ | Comply with Track 3 limits:
$Ispta.3≤720mW/cm²$
$MI≤1.9$ | Comply with Track 3 limits:
$Ispta.3≤720mW/cm²$
$MI≤1.9$ |
| Conformity
standards | IEC6061-1
IEC60601-1-2
IEC60601-2-37
NEMA UD 2 | IEC6061-1
IEC60601-1-2
IEC60601-2-37
NEMA UD 2 | IEC6061-1
IEC60601-1-2
IEC60601-2-37
NEMA UD 2 |
| Peripherals | LAN, USB storage device, HDMI,
Footswitch, Printers, ECG lead,
Mobile Cart, USB Bluetooth | LAN, USB storage device, HDMI,
Footswitch, Printers, USB ECG,
Barcode Scanner, External DVD
R/W, Mobile Cart | LAN, USB storage device, HDMI,
Footswitch, Printers, USB ECG,
Barcode Scanner, External DVD
R/W, Mobile Cart |
Table 1 Substantial equivalence discussion
11
12
13
VII Performance data
The following performance data were provided in support of the substantial equivalence determination.
Biocompatibility testing
Biocompatibility of the probes was evaluated in accordance with ISO 10993-1:2009. All evaluation acceptance criteria were met
Electrical safety and electromagnetic compatibility (EMC)
Electrical safety and EMC testing were conducted on the Ultrasound System. The system complies with the IEC 60601-1 and IEC 60601-2-37 for safety and the IEC 60601-1-2 for EMC.
Software Verification and Validation Testing
Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "moderate" level of concern.
Acoustic output testing
Acoustic output testing was performed according to NEMA UD2 and IEC60601-2-37.
VIII Conclusion
The VINNO 8, VINNO 6, VINNO 5 ultrasound devices are substantially equivalent to their predicate devices. The non-clinical testing demonstrates that the device is as safe, as effective and performs as well as the legally marketed device.