VINNO E20, VINNO E10,VINNO E10P,VINNO E10E, VINNO X1,VINNO X1E,VINNO X1P, VINNO X2,VINNO X2E,VINNO X2P

{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 {2}------------------------------------------------ ## 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) | | |-------------------------------------------------------------------------------------------|-----------------------------------------------------------------------| | <div> <span> " </span> <span>Prescription Use (Part 21 CFR 801 Subpart D)</span> </div> | <div> <span>Over-The-Counter Use (21 CFR 801 Subpart C)</span> </div> | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # Section 5 510(k) summary K223917 #### 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 {4}------------------------------------------------ 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 {5}------------------------------------------------ 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.<br><br>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.<br><br>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.<br><br>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<br>healthcare professional qualified to direct the use of the<br>device in hospitals or clinics. | | | User qualification | Qualified healthcare professionals | Qualified physicians or sonographers | | Physical<br>Specification | Width:520mm;<br>Depth: 835mm;<br>Height: 1350mm;<br>Keyboard: Adjustable: +120mm (E20 applies)<br>Monitor: Adjustable: +150mm<br>Weight: Basic unit without accessories approx: 55kg; | Height: 1265 ~ 1415mm (with adjustable height) ;<br>1315mm (without adjustable height)<br>Width: 520mm ;<br>Depth: 670 mm ;<br>Weight:approx.55kg (with battery); | | Patient contact<br>materials | Probe housing: ABS<br>Probe lens: Silicon rubber<br>Comply with ISO10993 series | Probe housing: ABS<br>Probe lens: Silicon rubber<br>Comply with ISO10993 series | | Operating modes | B Mode、HAR Mode、CF Mode、PDI Mode、PW Mode、<br>CW Mode、Tissue Doppler (TD) mode、Tissue velocity<br>imaging (TVI) mode、M Mode、Color M (CM) mode、<br>4D | B-Mode、Tissue Harmonic and PSH、M-Mode、Color<br>Doppler Imaging、 Power Doppler Imaging and<br>Directional PDI、Pulsed Wave Doppler、Continuous<br>Wave Doppler、Free Xros M、TDI、UWN、Natural<br>Touch Elastography Imaging、Smart 3D、Real-time<br>4D、iScape View、Tissue Velocity/Energy Imaging | | Operating controls | Gain、Depth、TCG slides controls、B steer、2D Automatic<br>Optimization、Harmonic Imaging、Frequency 、 Focus<br>Position、Focus #、VFusion、VSpeckle、Dynamic Range、<br>Line Density、L/R and U/D | B-Mode、THI and PSH、M-Mode、Color Doppler<br>Imaging、Power Doppler Imaging and Directional<br>PDI、Pulsed Wave Doppler、iClear、iBeam、iTouch、<br>Zoom/iZoom、FCI、B steer、ExFOV Imaging、<br>iStation、iVision、Integrated 1 TB and hard drive、<br>3 active transducer connectors、DVD-RW driver、3<br>USB ports、Auto Doppler Calculation、Shared | | | | Service Package、Medsight、iStorage、Tutorial<br>function、Smart Installment Reminder | | Measurements | Distance (Lateral、Axial、Depth)、Perimeter (L&W、Ellipse、<br>Polygon、Spline、Trace)、Area (L&W、Ellipse、Polygon、<br>Spline、Trace)、Volume (L&W&H)、Angle、Time、Slope<br>(Velocity、Acceleration)、SV Depth、Velocity、Angle<br>Correction | Depth、Distance、Angle、Area (Ellipse、Trace、<br>Spline、Cross)、Trace Length、Double Distance、<br>Parallel、Volume (3-Distance、Ellipse、Ellipse+<br>Distance)、Length ratio、Area Ratio、IMT、B<br>Histogram、B Profile、Volume Flow、Color Velocity、<br>Time、Slope、Heart Rate、Velocity、Accleration、<br>D Trace、PS/ED | | Comments | Comments and bodymarks | Comments and bodymarks | | Probe types | Convex array<br>Linear array<br>Phased array<br>Volume convex array<br>Endocavity array<br>Micro convex array | Convex array<br>Linear array<br>Phased array | | Display monitor | 15.6 inch monitor | 15-inch/17-inch high resolution clor LED monitor | | Acoustic output | Comply with Track 3 limits:<br>Ispta.3≤720mW/cm²<br>MI≤1.9 | Comply with Track 3 limits:<br>Ispta.3≤720mW/cm²<br>MI≤1.9 | | Conformity<br>standards | IEC60601-1<br>IEC60601-1-2<br>IEC60601-2-37<br>NEMA UD 2 | IEC60601-1<br>IEC60601-1-2<br>IEC60601-2-37<br>NEMA UD 2 | | Peripherals | Color thermal printer<br>Black&White thermal printer | Analog Black/white video printer<br>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 | | {6}------------------------------------------------ {7}------------------------------------------------ {8}------------------------------------------------ {9}------------------------------------------------ #### 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.