(174 days)
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.
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.
The provided 510(k) summary does not contain performance criteria or a study proving that the device meets specific acceptance criteria in the manner typically requested for AI/ML devices. This submission focuses on establishing substantial equivalence to a predicate ultrasound device through technical comparisons and compliance with general safety and performance standards, rather than evaluating a specific AI algorithm's diagnostic performance against established criteria.
However, based on the information provided, here's what can be extracted and inferred:
1. Table of Acceptance Criteria and Reported Device Performance
Since this is not an AI/ML device with specific diagnostic performance metrics (like sensitivity, specificity, AUC) for a particular medical condition, the "acceptance criteria" revolve around demonstrating comparable safety and effectiveness to the predicate device.
| Acceptance Criteria Category | Specific Criteria (Implicitly Met by Predicate Equivalence) | Reported Device Performance (as demonstrated by non-clinical testing) |
|---|---|---|
| Biocompatibility | Meet ISO 10993-1:2009 standards for probes. | All evaluation acceptance criteria were met. |
| Electrical Safety | Comply with IEC 60601-1 standards. | The system complies with IEC 60601-1. |
| EMC (Electromagnetic Compatibility) | Comply with IEC 60601-1-2 standards. | The system complies with IEC 60601-1-2. |
| Software Verification & Validation | Follow FDA's "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" for "moderate" level of concern software. | Software verification and validation testing were conducted, and documentation was provided as recommended. |
| Acoustic Output | Comply with Track 3 limits (Ispta.3 ≤ 720mW/cm², MI ≤ 1.9) according to NEMA UD2 and IEC 60601-2-37. | Acoustic output testing was performed according to NEMA UD2 and IEC60601-2-37, and the device complies with Track 3 limits (explicitly stated). |
| General Performance | Perform as safely and effectively as the predicate device for its intended uses and technological characteristics. | Non-clinical testing demonstrates that the device is as safe, as effective, and performs as well as the legally marketed device (predicate). |
2. Sample Size Used for the Test Set and Data Provenance
This information is not applicable in the context of this 510(k) summary. This submission is for an ultrasound system, not an AI diagnostic algorithm. There is no "test set" of patient data used for diagnostic performance evaluation of an AI algorithm in this document. The performance data discussed are related to engineering and safety standards (biocompatibility, electrical safety, etc.), not a clinical performance study using patient data.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not applicable. There is no "ground truth" to be established by experts for a test set in this kind of submission, as it doesn't involve the evaluation of an AI algorithm's diagnostic accuracy.
4. Adjudication Method
This information is not applicable for the same reasons as above.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
This information is not applicable as this is not an AI-assisted diagnostic device being evaluated for its impact on human reader performance.
6. Standalone Performance Study
This information is not applicable as this is not an AI algorithm requiring standalone performance evaluation. The device itself is a standalone ultrasound system.
7. Type of Ground Truth Used
This information is not applicable as there is no diagnostic AI algorithm being evaluated. The "ground truth" for the device's claims are the established engineering standards and specifications (e.g., IEC 60601-1) and the performance characteristics of the predicate device.
8. Sample Size for the Training Set
This information is not applicable. There is no AI algorithm being trained.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable. There is no AI algorithm being trained.
In summary: The provided document is a 510(k) summary for a general-purpose diagnostic ultrasound system. Its "acceptance criteria" and "proof" primarily revolve around demonstrating substantial equivalence to a legally marketed predicate device by showing that it meets relevant safety, electromagnetic compatibility, software validation, and acoustic output standards, and that its technical characteristics and indications for use are the same. It does not involve the type of AI/ML performance study described in the prompt.
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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.
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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
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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.
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.
| 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
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.
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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:
| Technologicalcharacteristics | Subject device | Predicate device | Comparison |
|---|---|---|---|
| Indications for use | The device is intended forultrasound imaging,measurement and analysis ofhuman body and fluid for multipleclinical applications including: | The device is intended forultrasound imaging,measurement and analysis ofhuman body and fluid for multipleclinical applications including: | Nodifference |
| abdominal (GYN and Urology),Thoracic/Pleural, Fetal/Ob, smallorgan (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 andimaging guidance ofinterventional procedures (e.g.biopsy). | abdominal (GYN and Urology),Thoracic/Pleural, Fetal/Ob, smallorgan (including breast, thyroid,testes), peripheral vessel,neonatal cephalic, adult cephalic,pediatric, musculo-skeletal(conventional, superficial),trans-rectal, trans-vaginal, cardiacadult, cardiac pediatric, magneticNeedle guidance and imaging guidance ofinterventional procedures (e.g. biopsy). | ||
| Design | This device is designed for thesafety of the patient and operator.This product is designed to fullycomply with the EN60601-1-2(IEC60601-1-2),Class A, in medical electricequipment EMC regulations. | This device is designed for thesafety of the patient and operator.This product is designed to fullycomply with the EN60601-1-2(IEC60601-1-2),Class A, in medical electricequipment EMC regulations. | The subjectdevice wasconsistentwith thepredicatedevice interms of |
| Material | The probe materials based on the biocompatibility test were allcomposed of a shell and a lens, the probe of the predicate devicecould cover the subject device, and the probe materials passed thebiocompatibility test. | design,material,chemicalcomposition, | |
| Chemicalcomposition | NAOur device does not involve the composition of chemical. | and energysource, and | |
| Energy source | This device can produce and use the radiation RF energy.Ultrasound system utilizes ultrasound energy that must be coupled tothe patient by direct physical contact In order to assure optimaltransmission of energy between the patient and probe, a conductivegel or couplant must be applied liberally to the patient where scanningwill be performed. | there wasnodifference | |
| Imaging features | See Table 1 of the article for details | The imagingfeatures ofthe subjectdevice canbe coveredbythepredicateddevice | |
| 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, SyncDisplay, Persistence, FlashReduction, Base Line,Transparency, Steer, FocusPosition, Focus Number, VFusion,VSpeckle, Dynamic Range | Gain, Depth, Focus, TGC, B Steer,2D Automatic Optimization,Harmonic Imaging,L/R, U/D, Frequency, PRF, WallFilter, Packet Size, Color Level,Invert, Color Map, LineDensity, Sync Display, Persistence,Flash Reduction, Base Line,Transparency, Steer, FocusPosition, Focus Number, VFusion,VSpeckle, Dynamic Range | Nodifference | |
| Measurements | Depth, Distance, Perimeter, Area,Volume, Angle, Stenosis, A/Bratio, 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/Bratio, 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 | Nodifference |
| Probes | Convex arrayLinear arrayPhased array | Convex arrayLinear arrayPhased array | The subjectdevice wasconsistentwith thepredicatedevice interms ofprobes |
| Acoustic output | Comply with Track 3 limits:Ispta.3 $≤$ 720mW/cm²MI $≤$ 1.9 | Comply with Track 3 limits:Ispta.3 $≤$ 720mW/cm²MI $≤$ 1.9 | Nodifference |
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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
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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.
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| Table 1 | ||||||||
|---|---|---|---|---|---|---|---|---|
| Product | VINNO 8 | VINNO 6EXP | VINNO 6PRO | VINNO 5EXP | VINNO 5PRO | VINNO 3EXP | VINNO 3PRO | |
| 2D ImagingFeatures | ||||||||
| 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+CFsimultaneously | 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 VelocityImaging (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 Agentimaging | O | - | - | - | - | - | - | |
| Needleenhancement | O | O | O | O | O | O | O | |
| SGC (Scanline gaincompensation) | 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 ImagingFeatures | ||||||||
| 3D imaging | X | X | X | X | X | X | X | X |
| Real-timegrayscale 4D | X | X | X | X | X | X | X | X |
| Tomographicdisplay (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 for3D printer | X | O | O | O | O | O | O | O |
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§ 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.