(155 days)
Not Found
No
The summary does not mention AI, ML, or any related terms, and the description focuses on standard ultrasound imaging modes and safety/performance testing.
No
The device is described as an ultrasound imaging system for diagnostic purposes, not for treatment.
Yes.
The "Intended Use / Indications for Use" section explicitly states "This device is indicated for... diagnostic Ultrasound applications."
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 IVD (In Vitro Diagnostic).
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.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are performed outside the body (in vitro).
- Device Description: The description confirms it "transmits ultrasound waves into the body tissues and displays the echo images of the tissues and blood flow accordingly." This is a description of an in-vivo (within the body) diagnostic imaging device.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or laboratory procedures, which are hallmarks of IVD devices.
Therefore, this device falls under the category of medical imaging devices, not in vitro diagnostics.
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; Transvagmal; Urology(including prostate); Trans rectal; Cardiac(adult and child); Peripheral Vascular; Small Organs/Parts(thyroid, breast, testicle), Musculoskeletal(Conventional and Superficial); Pediatrics(including neonatal cephalic); interventional(nerve block and vascular access); Intraoperative (abdominal, brain) and Adult 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 G86,VINNO G86E, VINNO M86E, VINNO G65, VINNO G65, VINNO G65E, VINNO G65D, VINNO G65D, VINNO G90, VINNO G90E 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; Transvagmal; Urology(including prostate); Trans rectal; Cardiac(adult and child); Peripheral Vascular; Small Organs/Parts(thyroid, breast, testicle), Musculoskeletal(Conventional and Superficial); Pediatrics(including neonatal cephalic); interventional(nerve block and vascular access); Intraoperative (abdominal, brain); Adult Cephalic
Indicated Patient Age Range
Adult and child (Cardiac); Pediatrics (including neonatal cephalic)
Intended User / Care Setting
appropriately-trained healtheare 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): Testing was 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: Testing was conducted 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: Testing was performed according to NEMA UD2 and IEC60601-2-37.
Conclusion: The VINNO G86,VINNO G86E, VINNO M86E, VINNO G65, VINNO G65, VINNO G65E, VINNO G65D, VINNO G65D, VINNO G90, VINNO G90E ultrasound devices are substantially equivalent to predical testing demonstrates that the device is as safe, as effective and performs as well as the legally marketed device.
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 23, 2023
Image /page/0/Picture/1 description: The image shows 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.
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: K230160
Trade/Device Name: VINNO G86, VINNO G86E, VINNO G65, VINNO G65P, VINNO G65E, VINNO G65D, VINNO M86, VINNO M86E, VINNO G90, VINNO G90E Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: Class II Product Code: IYN. IYO. ITX Dated: May 23, 2023 Received: May 30, 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 and Part 809); 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) K230160
Device Name
VINNO G86, VINNO G86E, VINNO M86, VINNO M86E, VINNO G65P, VINNO G65E, VINNO G65E, VINNO G65D, VINNO G90, VINNO G90E
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; Transvagmal; Urology(including prostate); Trans rectal; Cardiac(adult and child); Peripheral Vascular; Small Organs/Parts(thyroid, breast, testicle), Musculoskeletal(Conventional and Superficial); Pediatrics(including neonatal cephalic); interventional(nerve block and vascular access); Intraoperative (abdominal, brain) and Adult 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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3
K#(K230160 )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: 2023-06-22
II Device
Trade Name of Device: VINNO G86, VINNO M86, VINNO M86, VINNO G65, VINNO G65P, VINNO G65E, VINNO G65D, VINNO G90, VINNO G90E 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: Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 70B Diagnostic Ultrasound System Regulation Name: Ultrasonic pulsed doppler imaging system
4
Regulation Number: 21 CFR 892.1550 Regulatory Class: II Product code: IYN, IYO, ITX Premarket Notification: K171233
IV Device description
VINNO G86,VINNO G86E, VINNO M86E, VINNO G65, VINNO G65, VINNO G65E, VINNO G65D, VINNO G65D, VINNO G90, VINNO G90E 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 Doppler, Tissue Velocity Imaging, Harmonic Imaging, 3D/4D, Combine modes.
This device is indicated for Abdominal; Fetal/Obstetrics; Gynecology; Transvaginal; Trans rectal; Cardiat(adult and child); Peripheral Vascular; Small Organs(thyroid, breast, testicle), Musculo-skeletal(Conventional and Superficial); Pediatrics(including neonatal cephalic); interventional(nerve block and vascular (abdominal, brain) and Adult 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
VINNO G86,VINNO G86E, VINNO M86E, VINNO G65, VINNO G65, VINNO G65E, VINNO G65D, VINNO G65D, VINNO
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G90E ultrasound devices have the same technological characteristics and fundamental device. The VINNO G86, VINNO G86E, VINNO M86, VINNO G65, VINNO G65, VINNO G65E, VINNO G65D, VINNO G65D, VINNO G90, VINNO G90E 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 theVINNO G86, VINNO M86, VINNO M86, VINNO G65, VINNO G65F, VINNO G65E, VINNO G65D, VINNO G90, VINNO G90E ultrasound devices and predicate device do not alter suitability of the proposed device for its intended use.
| Device feature | VINNO G86,VINNO G86E , VINNO M86, VINNO M86E, VINNO G65, VINNO G65P, VINNO G65E, VINNO G65D, VINNO G90, VINNO G90E(subject device) | Shenzhen Mindray Bio-medical Electronics Co.LTD Resona 7 K171233 (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; Transvaginal; Urology(including prostate); Trans rectal; Cardiac(adult and child); Peripheral Vascular; Small Organs/Parts(thyroid, breast, testicle), Musculo-skeletal (Conventional and Superficial); | The Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB diagnostic ultrasound system is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetal, abdominal, intra-operative (abdominal, thoracic, and vascular), pediatric, small organ (breast, thyroid, testes), neonatal cephalic, adult cephalic, trans-rectal, trans-vaginal,musculo-skeletal (conventional, superficial), cardiac adult, cardiac pediatric, trans-esoph. (cardiac), peripheral vessel and urology exams. |
| Pediatrics(including neonatal cephalic);
interventional(nerve block and vascular access);
Intraoperative (abdominal, brain) and Adult Cephalic
diagnostic Ultrasound applications.
This device is intended to use by, or by the order of,
and 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: 605mm;
Depth: 900mm;
Height: 1320mm;
Control panel adjustable:
front-back movement range 150mmup-down
movement range 250mm , left-right rotation angle
-60 degree60 degree;1571±10mm
Weight: Basic unit without accessories approx:
90kg;
Number of Probes:5 | Dimension and Weight:Height:
1180
Width: 545±10mm (main
unit)/510±10mm (control panel)
Depth: 945~1145±10mm
Weight: approx. 135kg (no peripherals) |
| 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, M,PWD CWD, Tissue Doppler, Color Doppler,
Color M Doppler, Power Doppler, Tissue Velocity
Imaging, Harmonic Imaging, 3D/4D, Combine modes | B、THI and PSH (Phase Shift Harmonic
Imaging)、M-Mode/Color M、Free Xros M
(Anatomical M-mode)、Free Xros M (Curved |
| | | Anatomica M-mode)、Color Doppler Imaging、
Power Doppler Imaging/Directional PDI、Pulsed
Wave Doppler、Continuous Wave Doppler、TDI、
Smart 3D (Freehand 3D)、4D、iScape View
(Panoramic Imaging)、Natural Touch
Elastography Imaging、V Flow、RIMT、iFusion |
| Operating controls | Gain、Depth、TCG slides controls、B Steer、2D
Automatic Optimization 、 Harmonic Imaging 、
Frequency、Focus Position、Focus #、VFusion、
Dynamic Range、Line Density、VSharpen、L/R and
U/D | Gain、depth、B、2D、Optimization、M、PWD、
CWD、Color Doppler、Amplitude Doppler、
Tissue Harmonic Imaging、Smart3D、4D、
iScaoe、TDI、Color M、Biopsy Guidance、Strain
Elastography、Contrast imaging、Ultrasound
Fusion Imaging、V Flow、STE、STQ、Contrast
imaging、Needle Navigation、GYN/Pelvic |
| Measurements | Depth、Distance、Length、Width、Perimeter、Area、
Volume、Angle、Stenosis、A and B ratio、Diameter、
Speed、Heart rate、Anatomic depth、Time interval、
Acceleration | Distance、Ellipse、Trace、Spline、Cross、Angle、
Double Dist、Trace Len、Trace Len (Spline)、
Parallel、IMT、Rectangle、Depth、Time、
Acceleration、Ratio、Volume Flow、AutoCalc |
| Comments | Comments and bodymarks | Comments and bodymarks |
The comparison and discussion between the subject device and the predicate devices are listed in below table:
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7
8
| Probe types | Convex array | Curved array |
|---|---|---|
| Linear array | Linear array | |
| Phased array | Phased array | |
| Volume Convex array | ||
| Endocavity array | ||
| Micro Convex array | ||
| Curve array | ||
| Display monitor | 21.5 inch LCD monitor | 21.5-inch high resolution color LED monitor |
| Acoustic output | Comply with Track 3 limits: | Comply with Track 3 limits: |
| lspta.3 $\le$ 720mW/cm² | lspta.3 $\le$ 720mW/cm² | |
| MI $\le$ 1.9 | MI $\le$ 1.9 | |
| Conformity | IEC60601-1 | IEC60601-1 |
| standards | IEC60601-1-2 | IEC60601-1-2 |
| IEC60601-2-37 | IEC60601-2-37 | |
| NEMA UD 2 | NEMA UD 2 | |
| Peripherals | DVDRW、Foot Switch、Color thermal printer、 | Black and White printer、 Color Digital printer、 |
| Bluetooth、 | Graph/text printer、Photo printer、Built-in DVR、 | |
| Black&White thermal printer、ECG、Card sound lead | Footswitch、ECG、PCG、Barcode reader、Build-in | |
| wire、Pulse lead wire、 S-Video Output Cable、 | Wireless adapter | |
| Wireless adapter |
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
9
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 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 G86,VINNO G86E, VINNO M86E, VINNO G65, VINNO G65, VINNO G65E, VINNO G65D, VINNO G65D, VINNO G90, VINNO G90E ultrasound devices are substantially equivalent to predical testing demonstrates that the device is as safe, as effective and performs as well as the legally marketed device.