K Number

Device Name

VINNO 6PRO, VINNO 6EXP, VINNO 5PRO, VINNO 5EXP, VINNO 3, VINNO 3PRO, VINNO 3EXP

Manufacturer

VINNO Technology (Suzhou) Co.,Ltd.

Date Cleared

2022-12-21

(174 days)

Product Code

IYN ITX IYO

Regulation Number

892.1550

Intended 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 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, clinical point-of-care for diagnosis of patients. 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, CBI, EI, Combine modes.

Device Description

The VINNO 6EXP, VINNO 6PRO, VINNO 5EXP, VINNO 5PRO, VINNO 3, VINNO 3EXP, VINNO 3PRO 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.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K190120

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and there are no other indicators of AI/ML use in the provided text.

Therapeutic

No
The device is described as a "general purpose diagnostic ultrasound system" intended for "ultrasound imaging, measurement and analysis" for various clinical applications, which are diagnostic in nature. It obtains images of the body to aid in diagnosis, not to provide treatment.

Diagnostic

Yes

The 'Intended Use / Indications for Use' section explicitly states, "The device is general purpose diagnostic ultrasound system for use by qualified healthcare professionals." and "The device is used in hospital, clinical point-of-care for diagnosis of patients."

SaMD (Software as a Medical Device)

The device description explicitly states it is a "laptop digital color ultrasonic diagnostic device" and mentions hardware components like an integrated battery and power supply/charger, indicating it is a hardware device with integrated software, not a software-only device.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use clearly states that the device is a "general purpose diagnostic ultrasound system" for imaging, measurement, and analysis of the human body and fluid. This is a description of an in vivo diagnostic device, meaning it is used to examine the body directly.
Device Description: The description reinforces this by explaining that the device "transmit[s] ultrasound waves into the body tissues and display the echo images of the tissues and blood flow." This is the fundamental principle of ultrasound imaging, which is an in vivo technique.
Lack of IVD Characteristics: An IVD device is typically used to examine specimens (like blood, urine, tissue samples) outside of the body to obtain diagnostic information. There is no mention of analyzing samples or using reagents, which are common characteristics of IVDs.

Therefore, this device falls under the category of an in vivo diagnostic imaging system, not an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

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 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, clinical point-of-care for diagnosis of patients. 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, CBI, EI, Combine modes.

Product codes (comma separated list FDA assigned to the subject device)

IYN, IYO, ITX

Device Description

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

qualified healthcare professionals / hospital, 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)

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.

Non-clinical 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.

K190120

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

Regulation Number and Section

§ 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.

Summary

December 21, 2022

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: K221911

Trade/Device Name: VINNO 6PRO, VINNO 6EXP, VINNO 5PRO, VINNO 5EXP, VINNO 3, VINNO 3PRO, VINNO 3EXP Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic Pulsed Doppler Imaging System Regulatory Class: Class II Product Code: IYN, IYO, ITX Dated: November 9, 2022 Received: November 21, 2022

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 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 mediation-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

Indications for Use

510(k) Number (if known) K221911

Device Name

VINNO 6EXP, VINNO 6PRO, VINNO 5EXP, VINNO 5PRO, VINNO 3, VINNO 3EXP, VINNO 3PRO

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.

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.

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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K221911

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: 2022-12-19

II Device

Trade Name of Device: VINNO 6EXP,VINNO 6PRO,VINNO 5EXP,VINNO 5PRO, VINNO 3, VINNO 3EXP, VINNO 3PRO 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: VINNO 8, VINNO 6, VINNO 5 Regulation Name: Ultrasonic pulsed doppler imaging system Regulation Number: 21 CFR 892.1550 Regulatory Class: II Product code: IYN, IYO, ITX Premarket Notification: K190120

IV Device description

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. 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, CBI, El, Combine modes.

VI Comparison of technological characteristics with the predicate devices

The VINNO 6EXP, VINNO 6PRO, VINNO 5EXP, VINNO 5PRO, VINNO 3, VINNO 3EXP, VINNO 3PRO ultrasound devices have the same technological characteristics and fundamental design as the predicate devices. The VINNO 6, 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.

See the following table for details on the comparison of technical features with the predicate device:

| Technological

characteristics	Subject device	Predicate device	Comparison
Indications for use	The device is intended for
ultrasound imaging,
measurement and analysis of
human body and fluid for multiple
clinical applications including:	The device is intended for
ultrasound imaging,
measurement and analysis of
human body and fluid for multiple
clinical applications including:	No
difference
	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).	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).
Design	This device is designed for the
safety of the patient and operator.
This product is designed to fully
comply with the EN60601-1-2
(IEC60601-1-2),
Class A, in medical electric
equipment EMC regulations.	This device is designed for the
safety of the patient and operator.
This product is designed to fully
comply with the EN60601-1-2
(IEC60601-1-2),
Class A, in medical electric
equipment EMC regulations.	The subject
device was
consistent
with the
predicate
device in
terms of
Material	The probe materials based on the biocompatibility test were all
composed of a shell and a lens, the probe of the predicate device
could cover the subject device, and the probe materials passed the
biocompatibility test.		design,
material,
chemical
composition,
Chemical
composition	NA
Our device does not involve the composition of chemical.		and energy
source, and
Energy source	This device can produce and use the radiation RF energy.
Ultrasound system utilizes ultrasound energy that must be coupled to
the patient by direct physical contact In order to assure optimal
transmission of energy between the patient and probe, a conductive
gel or couplant must be applied liberally to the patient where scanning
will be performed.		there was
no
difference
Imaging features	See Table 1 of the article for details		The imaging
features of
the subject
device can
be covered
by
the
predicated
device
Key functionalities
	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	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	No
difference
Measurements	Depth, Distance, Perimeter, Area,
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	Depth, Distance, Perimeter, Area,
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	No
difference
Probes	Convex array
Linear array
Phased array	Convex array
Linear array
Phased array	The subject
device was
consistent
with the
predicate
device in
terms of
probes
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	No
difference

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 6EXP, VINNO 6PRO, VINNO 5EXP, VINNO 5PRO, VINNO 3, VINNO 3EXP, VINNO 3PRO 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.

Table 1
Product	VINNO 8	VINNO 6EXP	VINNO 6PRO	VINNO 5EXP	VINNO 5PRO	VINNO 3EXP	VINNO 3PRO
2D Imaging
Features
Frequency range	25Mhz	25Mhz	25Mhz	25Mhz	25Mhz	25Mhz	25Mhz
VFusion	X	X	X	X	X	X	X
VSpeckle I	X	X	X	X	X	X	X
VTissue	X	X	X	O	O	O	O
Auto optimization	X	X	X	X	X	X	X
Easy Compare	X	X	X	X	X	X	X
Duplex/Triplex	X	X	X	X	X	X	X
CW Mode	X	X	X	O	-	-	-
PW Mode	X	X	X	X	X	X	X
Zoom	X	X	X	X	X	X	X
FULL screen	X	X	X	X	X	X	X
B Mode	X	X	X	X	X	X	X
M Mode	X	X	X	X	X	X	X
CF Mode	X	X	X	X	X	X	X
PDI Mode	X	X	X	X	X	X	X
B+CF
simultaneously	X	X	X	X	X	X	X
TView	X	X	X	X	X	X	X
Pview	O	O	O	O	O	O	O
TD Mode	X	X	X	-	-	-	-
Tissue Velocity
Imaging (TVI)	O	O	O	-	-	-	-
Auto IMT	X	X	X	O	O	O	O
Auto EF	O	O	O	O	O	O	O
Auto Bladder	X	X	X	X	X	X	X
Elastography	O	O	O	-	-	-	-
Contrast Agent
imaging	O	-	-	-	-	-	-
Needle
enhancement	O	O	O	O	O	O	O
SGC (Scanline gain
compensation)	O	O	O	O	O	O	O
Stress Echo	X	X	O	O	O	O	O
Flow Volume	O	O	O	O	O	O	O
3D/4D Imaging
Features
3D imaging	X	X	X	X	X	X	X	X
Real-time
grayscale 4D	X	X	X	X	X	X	X	X
Tomographic
display (Mcut)	X	X	X	O	O	O	O	O
HQ (High Quality)
3D/4D	O	O	O	O	O	O	O	O
STIC Mode	O	O	O	-	-	-	-	-
Magic cut	X	O	O	O	O	O	O	O
Free view	X	O	O	O	O	O	O	O
Free 3D	O	O	O	O	O	O	O	O
Export 3D data for
3D printer	X	O	O	O	O	O	O	O