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.

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.

AI/ML Overview

The provided document is a 510(k) summary for an ultrasound system, not a document detailing the performance study of an AI/ML-based medical device. Therefore, it does not contain the specific information requested regarding acceptance criteria and performance study details for an AI-powered device.

The document discusses the substantial equivalence of the VINNO G86, G86E, M86, M86E, G65, G65P, G65E, G65D, G90, and G90E ultrasound devices to a predicate device (Resona 7 series). It focuses on safety and performance characteristics of generalized ultrasound systems, not a specific AI/ML diagnostic or assistive tool.

Key sections that would typically contain the requested information for an AI/ML device are missing or not applicable in this document:

Acceptance Criteria for an AI device: This document lists technical and safety standards (e.g., IEC 60601-1, NEMA UD 2) rather than diagnostic performance metrics (sensitivity, specificity, AUROC) for an AI output.
Study Proving Acceptance Criteria: The performance data section mentions biocompatibility, electrical safety, EMC, software V&V, and acoustic output testing, which are standard for all medical devices. It does not describe a clinical performance study for an AI algorithm's diagnostic accuracy.
Sample size for test set and data provenance: Not mentioned as there's no AI performance study described.
Number of experts and qualifications for ground truth: Not mentioned.
Adjudication method: Not mentioned.
MRMC comparative effectiveness study: Not mentioned.
Standalone (algorithm only) performance: Not mentioned.
Type of ground truth: Not mentioned.
Training set sample size and ground truth establishment: Not mentioned.

In summary, based on the provided text, it is not possible to answer the questions about acceptance criteria and the study proving the device meets them for an AI/ML powered medical device. The document describes a standard ultrasound system clearance, not one with an integral AI diagnostic or assistive component that would require such performance evaluations.

Summary

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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

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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

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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 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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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

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Regulation Number: 21 CFR 892.1550 Regulatory Class: II Product code: IYN, IYO, ITX Premarket Notification: K171233

IV Device description

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 Cephalicdiagnostic Ultrasound applications.This device is intended to use by, or by the order of,and under the supervision of an appropriately-trainedhealthcare professional qualified to direct the use ofthe device in hospitals or clinics.
User qualification	Qualified healthcare professionals	Qualified physicians or sonographers
PhysicalSpecification	Width: 605mm;Depth: 900mm;Height: 1320mm;Control panel adjustable:front-back movement range 150mmup-downmovement range 250mm , left-right rotation angle-60 degree~60 degree;Weight: Basic unit without accessories approx:90kg;Number of Probes:5	Dimension and Weight:Height:1180~~1571±10mmWidth: 545±10mm (mainunit)/510±10mm (control panel)Depth: 945~~1145±10mmWeight: approx. 135kg (no peripherals)
Patient contactmaterials	Probe housing: ABS,Probe lens: Silicon rubberComply with ISO10993 series	Probe housing: ABS,Probe lens: Silicon rubberComply with ISO10993 series
Operating modes	B, M,PWD CWD, Tissue Doppler, Color Doppler,Color M Doppler, Power Doppler, Tissue VelocityImaging, Harmonic Imaging, 3D/4D, Combine modes	B、THI and PSH (Phase Shift HarmonicImaging)、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、PulsedWave Doppler、Continuous Wave Doppler、TDI、Smart 3D (Freehand 3D)、4D、iScape View(Panoramic Imaging)、Natural TouchElastography Imaging、V Flow、RIMT、iFusion
Operating controls	Gain、Depth、TCG slides controls、B Steer、2DAutomatic Optimization 、 Harmonic Imaging 、Frequency、Focus Position、Focus #、VFusion、Dynamic Range、Line Density、VSharpen、L/R andU/D	Gain、depth、B、2D、Optimization、M、PWD、CWD、Color Doppler、Amplitude Doppler、Tissue Harmonic Imaging、Smart3D、4D、iScaoe、TDI、Color M、Biopsy Guidance、StrainElastography、Contrast imaging、UltrasoundFusion Imaging、V Flow、STE、STQ、Contrastimaging、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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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

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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.

Regulation Number and Section

N/A