(170 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and provides no other indication of AI/ML use.
No.
The "Intended Use / Indications for Use" section explicitly states that the device is intended for "ultrasound imaging, measurement, display and analysis," which are diagnostic purposes, not therapeutic ones.
Yes
The "Intended Use / Indications for Use" section states the device is indicated for "neonatal cephalic diagnostic Ultrasound applications," and the predicate device is a "Diagnostic Ultrasound System."
No
The device description explicitly states it is a "professional digital color ultrasonic apparatus" that "transmits ultrasound waves into the body tissues and displays the echo images," indicating it includes hardware components for generating and receiving ultrasound signals.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use clearly states the device is for "ultrasound imaging, measurement, display and analysis of the human body and fluid." This describes a device that interacts directly with the patient's body to produce images and measurements.
- Device Description: The description explains that the device "transmits ultrasound waves into the body tissues and displays the echo images of the tissues and blood flow." This is the fundamental principle of ultrasound imaging, which is an in vivo (within the living body) diagnostic method.
- Lack of IVD Characteristics: An IVD device is typically used to examine specimens (like blood, urine, tissue samples) taken from the human body to provide information about a physiological or pathological state. There is no mention of analyzing such specimens in the provided text.
Therefore, this device is a medical imaging device used for in vivo diagnosis, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The device is intended for ultrasound imaging, measurement, display and analysis of the human body and fluid.
The operating modes supported by the device are B, M.PWD CWD, Tissue Doppler, Color Doppler, Power Doppler, Tissue Velocity Imaging, Harmonic Imaging, 3D/4D, Combine modes.
This device is indicated for Abdominal; Fetal; Obstetrics; gynecology;Trans-vagmal; Urology(including prostate); Transrectal; Cardiac(adult and pediatic); Peripheral Vascular; Small Organs/Parts(thyroid, breast, testicle); Musculoskeletal(Conventional and Superficial); Pediatrics(including neonatal cephalic diagnostic Ultrasound applications.
This device is intended to use by, or by the order of, and under the supervision of an appropriately-trained healtheare professional qualified to direct the use of the device in hospitals or clinics.
Product codes (comma separated list FDA assigned to the subject device)
IYN, IYO, ITX
Device Description
VINNO E20, VINNO E10, VINNO E10E, VINNO X1, VINNOX1E, VINNOX1E, VINNO X2, VINNO X2E, VINNO X2E ultrasound devices are professional digital color ultrasonic apparatus. It transmits ultrasound waves into the body tissues and displays the echo images of the tissues and blood flow accordingly.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Abdominal; Fetal; Obstetrics; gynecology; Trans-vagmal; Urology(including prostate); Transrectal; Cardiac(adult and pediatric); Peripheral Vascular; Small Organs/Parts(thyroid, breast, testicle); Musculoskeletal(Conventional and Superficial); Pediatrics(including neonatal cephalic diagnostic Ultrasound applications.
Indicated Patient Age Range
Adult and pediatric (including neonatal)
Intended User / Care Setting
appropriately-trained healthcare professional qualified to direct the use of the device in hospitals or clinics.
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 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 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
June 17, 2023
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. Food & Drug Administration" in blue.
VINNO Technology (Suzhou) Co., Ltd. % Cordelia Liu Regulatory Registered Engineer 5F Building A, 4F Building C No. 27 Xinfa Rd. Suzhou Industrial Park Suzhou, Jiangsu 215123 CHINA
Re: K223917
Trade/Device Name: VINNO E20, VINNO E10, VINNO E10P, VINNO E10E, VINNO X1, VINNO X1E, VINNO X1P, VINNO X2, VINNO X2E, VINNO X2P Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: Class II Product Code: IYN, IYO, ITX Dated: April 12, 2023 Received: May 17, 2023
Dear Cordelia Liu:
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
1
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 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,
Yanna S. Kang -S
Yanna Kang, Ph.D. Assistant Director Mammography and Ultrasound Team DHT8C: Division of Radiological Imaging and Radiation Therapy Devices OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K223917
Device Name
VINNO E20, VINNO E10, VINNO E10P, VINNO E10E, VINNO X1, VINNOXIE, VINNO X1P, VINNO X2, VINNO X2E, VINNO X2P
Indications for Use (Describe)
The device is intended for ultrasound imaging, measurement, display and analysis of the human body and fluid.
The operating modes supported by the device are B, M.PWD CWD, Tissue Doppler, Color Doppler, Power Doppler, Tissue Velocity Imaging, Harmonic Imaging, 3D/4D, Combine modes.
This device is indicated for Abdominal; Fetal; Obstetrics; gynecology;Trans-vagmal; Urology(including prostate); Transrectal; Cardiac(adult and pediatic); Peripheral Vascular; Small Organs/Parts(thyroid, breast, testicle); Musculoskeletal(Conventional and Superficial); Pediatrics(including neonatal cephalic diagnostic Ultrasound applications.
This device is intended to use by, or by the order of, and under the supervision of an appropriately-trained healtheare professional qualified to direct the use of the device in hospitals or clinics.
| 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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Section 5 510(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: Cordelia liu
Regulatory Registered Engineer Phone: +86 512 62873806 Fax: +86 512 62873801 Email: cordelia.liu@vinno.com
Date written: 2023-06-15
II Device
Trade Name of Device: VINNO E20, VINNO E10, VINNO E10E, VINNO X1, VINNOX1E, VINNOX1E, VINNO X1P, VINNO X2, VINNO X2E,VINNO X2P Regulation name: Ultrasonic pulsed doppler imaging system Regulation Number: 21 CFR 892.1550 Regulatory Class: II Product code: IYN, IYO, ITX
III Predicate Device
Trade name: DC-30/DC-32/DC-28/DC-26/DC-25 Diagnostic Ultrasound System Regulation Name: Ultrasonic pulsed doppler imaging system Regulation Number: 21 CFR 892.1550
Type text here
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Regulatory Class: II Product code: IYN, IYO, ITX Premarket Notification: K173369
IV Device description
VINNO E20, VINNO E10, VINNO E10E, VINNO X1, VINNOX1E, VINNOX1E, VINNO X2, VINNO X2E, VINNO X2E ultrasound devices are professional digital color ultrasonic apparatus. It transmits ultrasound waves into the body tissues and displays the echo images of the tissues and blood flow accordingly.
V Indications for use
The device is intended for ultrasound imaging, measurement, display and analysis of the human body and fluid.
The operating modes supported by the device are B, M, PWD CWD, Tissue Doppler, Color M Doppler, Power Dopler, Tissue Velocity Imaging, Harmonic Imaging, 3D/4D, Combine modes.
This device is indicated for Abdominal; Fetal; Obstetrics; gynecology; Trans-vaginal; Urology(including prostate); Cardiac(adult and pediatric); Peripheral Vascular; Small Organs/Parts(thyroid, breast, testicle); Musculo-skeletal(Convertional and Superficial); Pediatrics(including neonatal cephalic diagnostic Ultrasound applications.
This device is intended to use by, or by the order of, and under the supervision of an appropriately-trained healified to direct the use of the device in hospitals or clinics.
VI Comparison of technological characteristics with the predicate device
The VINNO E20, VINNO E10, VINNO E10E, VINNO X1, VINNOX1, VINNOX1E, VINNO X1P, VINNO X2, VINNO X2F ultrasound devices have the same technological characteristics and fundamental device. The VINNO E20, VINNO E10, VINNO E10P, VINNO X1, VINNOX1E, VINNOX1E, VINNO X2E, VINNO X2E, VINNO X2E, VINNO X2P utrasound devices and
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the predicate device are all lap-top general purpose ultrasound devices designed to provide real-time images for differences between the VINNO E20,VINNO E10P,VINNO E10E,VINNO X1,VINNOX1E,VINNO X1P,VINNO X2, VINNO X2E, VINNO X2P ultrasound devices and predicate device do not alter suitability of the proposed device for its intended use. The comparison and discussion between the subject device and the predicate device are listed in below table:
| Device feature | VINNO E20, VINNO E10, VINNO E10P, VINNO E10E, VINNO X1, VINNO X1E, VINNO X1P, VINNO X2, VINNO X2E, VINNO X2P(subject device) | Shenzhen Mindray Bio-medical Electronics CO.LTD DC-30 K173369 (predicate device) |
|---|---|---|
| Indications for use | The device is intended for ultrasound imaging, measurement, display and analysis of the human body and fluid. |
The operating modes supported by the device are B, M,PWD CWD, Tissue Doppler, Color Doppler, Color M Doppler, Power Doppler, Tissue Velocity Imaging, Harmonic Imaging, 3D/4D, Combine modes.
This device is indicated for Abdominal; Fetal; Obstetrics; gynecology;Trans-vaginal; Urology(including prostate); Trans-rectal; Cardiac(adult and pediatric); Peripheral Vascular; Small Organs/Parts(thyroid, breast, testicle); Musculo-skeletal(Conventional and Superficial); Pediatrics(including neonatal cephalic) and Adult Cephalic diagnostic Ultrasound applications.
This device is intended to use by, or by the order of, and | Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetal, abdominal, pediatric, small organ(breast, thyroid, testes), neonatal and adult cephalic, trans-rectal, trans vaginal,musculo-skeletal(conventional, superficial), cardiac(adult, pediatric) , peripheral vessel and urology exams. |
| | under the supervision of an appropriately-trained
healthcare professional qualified to direct the use of the
device in hospitals or clinics. | |
| User qualification | Qualified healthcare professionals | Qualified physicians or sonographers |
| Physical
Specification | Width:520mm;
Depth: 835mm;
Height: 1350mm;
Keyboard: Adjustable: +120mm (E20 applies)
Monitor: Adjustable: +150mm
Weight: Basic unit without accessories approx: 55kg; | Height: 1265 ~ 1415mm (with adjustable height) ;
1315mm (without adjustable height)
Width: 520mm ;
Depth: 670 mm ;
Weight:approx.55kg (with battery); |
| 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 |
| Operating modes | B Mode、HAR Mode、CF Mode、PDI Mode、PW Mode、
CW Mode、Tissue Doppler (TD) mode、Tissue velocity
imaging (TVI) mode、M Mode、Color M (CM) mode、
4D | B-Mode、Tissue Harmonic and PSH、M-Mode、Color
Doppler Imaging、 Power Doppler Imaging and
Directional PDI、Pulsed Wave Doppler、Continuous
Wave Doppler、Free Xros M、TDI、UWN、Natural
Touch Elastography Imaging、Smart 3D、Real-time
4D、iScape View、Tissue Velocity/Energy Imaging |
| Operating controls | Gain、Depth、TCG slides controls、B steer、2D Automatic
Optimization、Harmonic Imaging、Frequency 、 Focus
Position、Focus #、VFusion、VSpeckle、Dynamic Range、
Line Density、L/R and U/D | B-Mode、THI and PSH、M-Mode、Color Doppler
Imaging、Power Doppler Imaging and Directional
PDI、Pulsed Wave Doppler、iClear、iBeam、iTouch、
Zoom/iZoom、FCI、B steer、ExFOV Imaging、
iStation、iVision、Integrated 1 TB and hard drive、
3 active transducer connectors、DVD-RW driver、3
USB ports、Auto Doppler Calculation、Shared |
| | | Service Package、Medsight、iStorage、Tutorial
function、Smart Installment Reminder |
| Measurements | Distance (Lateral、Axial、Depth)、Perimeter (L&W、Ellipse、
Polygon、Spline、Trace)、Area (L&W、Ellipse、Polygon、
Spline、Trace)、Volume (L&W&H)、Angle、Time、Slope
(Velocity、Acceleration)、SV Depth、Velocity、Angle
Correction | Depth、Distance、Angle、Area (Ellipse、Trace、
Spline、Cross)、Trace Length、Double Distance、
Parallel、Volume (3-Distance、Ellipse、Ellipse+
Distance)、Length ratio、Area Ratio、IMT、B
Histogram、B Profile、Volume Flow、Color Velocity、
Time、Slope、Heart Rate、Velocity、Accleration、
D Trace、PS/ED |
| Comments | Comments and bodymarks | Comments and bodymarks |
| Probe types | Convex array
Linear array
Phased array
Volume convex array
Endocavity array
Micro convex array | Convex array
Linear array
Phased array |
| Display monitor | 15.6 inch monitor | 15-inch/17-inch high resolution clor LED 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 |
| Conformity
standards | IEC60601-1
IEC60601-1-2
IEC60601-2-37
NEMA UD 2 | IEC60601-1
IEC60601-1-2
IEC60601-2-37
NEMA UD 2 |
| Peripherals | Color thermal printer
Black&White thermal printer | Analog Black/white video printer
Analog Color video printer |
| USB DVDRW | Digital Black and White Video Printer | |
| ECG | Graph/text printer | |
| S-Video Output Cable | Footswitch | |
| Bluetooth dongle | ECG | |
| Wireless adapter | Built-in Battery | |
| External Foot switch | Built-in DVD R/W | |
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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 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 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 E20, VINNO E10, VINNO E10E, VINNO X1, VINNOX1E, VINNO X1P, VINNO X2, VINNO X2E, VINNO X2E ultrasound devices are substantially equivalent to the non-clinical testing demonstrates that the device is as safe, as effective and performs as well as the legally marketed device.