The Carnation series Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It intended for use in Fetal/Obstetrics, abdominal/GYN, pediatrics, small organ(breast, thyroid, testes), neonatal cephalic, adult cephalic, trans-rectal, trans-vaginal, musculoskeletal(conventional and superficial), cardiac (adult and pediatric), peripheral vessel, urology, Thoracic/Pleural, Vascular Access exams.

The Camation series Diagnostic Ultrasound System is a general purpose diagnostic ultrasound system for use by qualified healthcare professionals. The clinical environments where the Carnation series can be used include critical care and emergency room environments, as well as point-of care areas in offices, clinical and hospital settings for diagnosis of patients.

Modes of operation include: B-Mode, Color-Mode, Power(Dirpower)-Mode, PW Doppler Mode, CW Doppler mode, Holo PW, Tissue Harmonic Imaging, Tissue Doppler Imaging(TDI), Anatomic M-mode(AMM), Color M Mode(CM), Panoramic Imaging(PANO), and combined mode.

Device Description

The proposed Carnation series Diagnostic Ultrasound System is a general-purpose, Track 3, diagnostic ultrasound device, intended for ultrasound imaging, measurement and analysis of the human body and fluid that provides digital acquisition, processing and display capabilities.

The Carnation series Diagnostic Ultrasound System is a touch screen controlled ultrasonic system. Its function is to acquire and display ultrasound data in B-Mode, M-Mode, Color-Mode, Power(Dirpower)-Mode, PW Doppler Mode, CW Doppler mode, Holo PW, Tissue Harmonic Imaging, Tissue Doppler Imaging(TDI), Anatomic M-mode(AMM), Color M Mode(CM), Panoramic Imaging(PANO), and combined mode. The system can also measure anatomical structures and offer software analysis packages performance to provide information based on which the competent health care professionals can make the diagnosis.

Holo PW is based on the echo planar imaging, and forms the planar data by emitting and receiving multiple beams to synchronously display the blood flow at multiple sampling gates.

The Carnation series Diagnostic Ultrasound System consists of the main unit, ultrasound probes, ECG lead wire, Magnetic cup, Foot switch, Scanner, USB headset, Camera and Black/white video printer.

The Carnation series Diagnostic Ultrasound System utilizes a variety of linear, convex, and phased array transducers which provide high imaging capability, supporting all standard acquisition modes. Some biopsy kits are available for needle-guidance procedures. The system also includes several automated measurement function: wiCalc_Diaph, wiCalc_Vas, wiCalc_Vol.Flow, Automatic trace, wiCalc_VTI, wiCalc_IVC, wiCalc_IMT, those measurement function can assist users to carry out relevant measurement automatically. The output results of those automatic measurement function are for reference only by users, and the final results need to be confirmed and modified by users based on professional knowledge.

The Carnation series Diagnostic Ultrasound System also include the function of wiScan, wiShow, wiGuide and wiNerve. wiScan is an easy-to-use quality assurance and workflow tool that automatically guides the user through an exam to ensure required steps are performed while reducing key strokes. wiShow is a teaching video recording software, which is an independent functional module integrated in the ultrasound diagnostic system. The function enables doctors to record and edit teaching videos, and export the video to a U disk or network storage. wiGuide uses the characteristics of the magnetic field to enhance the visualization effect of the needle by detecting the magnetized needle, and can better detect the position of the needle when it is in the human body. wiNerve is an education purpose tool, which aims to automatic recognition of different anatomical structures and display the recognized anatomical structures in different colors, to help doctors to improve the skills. The results of wiNerve are not used as diagnostic evidence.

Eight models for the main units are included in this submission, that is Carnation, Carnation Fast, Carnation T, Carnation Exp, Carnation Neo, Carnation+, Carnation Pro, Carnation Ultra. There are thirteen different models of probes: C6-1B-H. C6-2-H, C8-3-H, C9-3-H, EV11-3-H, L15-4WB-H, L15-4NB-H, L15-6-H, L22-10-H, L8-3-H, SP5-1-H, P8-3-H and P12-4-H are available for the Carnation series.

AI/ML Overview

The provided text is a 510(k) Summary for the Carnation series Diagnostic Ultrasound System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing extensive details on a specific study designed to meet pre-defined acceptance criteria for a novel device.

Therefore, much of the requested information regarding acceptance criteria, specific study designs, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, or standalone algorithm performance studies is not present in this document. The document explicitly states that clinical studies were not required to support substantial equivalence.

However, I can extract the information that is available:

1. Table of Acceptance Criteria and Reported Device Performance:

No specific "acceptance criteria" for device performance (e.g., sensitivity, specificity, accuracy) are reported in this document. The substantial equivalence argument is based on similarities in intended use, technological characteristics, and compliance with recognized standards.

Feature/Metric	Acceptance Criteria (Not explicitly defined in the document for performance)	Reported Device Performance (as implied by equivalence)
Intended Use	Covered by predicate device's intended use	Similar to predicate device (K180599), with all proposed indications covered by the predicate.
Operation Modes	Similar to predicate, with known differences covered by reference devices.	Similar to predicate (K180599), Holo PW covered by K211886, PANO by K173471.
Functions	Similar to predicate, with known differences covered by reference devices.	Similar to predicate, wiGuide and wiNerve similar to K211886.
Acoustic Power Levels	Below FDA limits.	Complies with FDA limits; same as predicate (K180599).
Biocompatibility	Complies with ISO 10993.	Cytotoxicity, Sensitization, Skin Irritation tests successful (in accordance with ISO 10993).
Electrical Safety & EMC	Complies with IEC 60601-1, IEC 60601-2-37, IEC 60601-1-2.	Complies with IEC 60601-1, IEC 60601-2-37 (safety), and IEC 60601-1-2 (EMC).
Software V&V	Complies with FDA guidance for "Moderate" level of concern.	Verification and validation testing conducted; documentation provided as recommended by FDA guidance.
Acoustic Testing	Complies with NEMA UD 2-2004 (R2009).	Conducted in accordance with NEMA UD 2-2004 (R2009).

2. Sample size used for the test set and the data provenance:

Sample Size for Test Set: Not applicable. The document states, "The subject of this premarket submission, Carnation series Diagnostic Ultrasound System, did not require clinical studies to support substantial equivalence." Therefore, there was no separate test set of data from clinical studies for performance evaluation.
Data Provenance: Not applicable for performance data. Non-clinical testing data (biocompatibility, electrical safety, EMC, software V&V, acoustic testing) was generated by the manufacturer.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable as no clinical test set was required or used for performance evaluation for substantial equivalence.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable as no clinical test set was required or used for performance evaluation for substantial equivalence.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

No MRMC comparative effectiveness study was done. The device is a "Diagnostic Ultrasound System" and the listed "wiCalc" and "wiNerve" functions are described as "measurement functions for reference only" or "education purpose tool" and "not used as diagnostic evidence." There is no indication of AI assistance for human readers in diagnostic interpretation being evaluated.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

No standalone algorithm performance study was reported. The device is a diagnostic ultrasound system, not an AI-driven interpretation algorithm meant to function independently for diagnosis. Its automated features are for reference/education.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

Not applicable for clinical performance evaluation. For non-clinical tests, "ground truth" would be the established standards and specifications (e.g., ISO 10993 for biocompatibility, IEC 60601 for electrical safety, NEMA UD 2 for acoustics).

8. The sample size for the training set:

Not applicable. The document does not describe the development or training of any AI model that would require a 'training set.' The automated functions ("wiCalc", "wiNerve") are not presented as AI models for diagnostic decision-making that would require extensive clinical training data.

9. How the ground truth for the training set was established:

Not applicable, as no training set for an AI model for diagnostic purposes is described.

Summary

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September 15, 2023

Image /page/0/Picture/1 description: The image contains 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.

Shenzhen Wisonic Medical Technology Co., Ltd. % Jiang Xiaosan Regulatory Manager 1st, 2nd, 5th & 6th Floor, No. 6 Building Pingshan Technology Park, Taoyuan Street, Nanshan District Shenzhen, Guangdong 518055 CHINA

Re: K230066

Trade/Device Name: Carnation series Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic Pulsed Doppler Imaging System Regulatory Class: Class II Product Code: IYN, ITX and IYO Dated: August 11, 2023 Received: August 17, 2023

Dear Jiang Xiaosan:

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

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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 (OS) 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) K230066

Device Name

Carnation series Diagnostic Ultrasound System

Indications for Use (Describe)

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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510(k) Summary K230066

In accordance with 21 CFR 807.92 the following summary of information is provided:

1. Submitter

Submitter:	Shenzhen Wisonic Medical Technology Co., Ltd..
Address:	1st, 2nd, 5th and 6th Floor, NO.6 Building, PingshanTechnology Park, Taoyuan Street, Nanshan District518055 Shenzhen, P.R.China
Contact Person:	Jiang Xiaosan
Tel:	(+86) 755 86007788
Fax:	(+86) 755 86007799
Date prepared	January 3, 2023
2. Device
Device Name:	Carnation series Diagnostic Ultrasound System
Common/Usual Name:	Diagnostic Ultrasound System
Models:	Carnation, Carnation Fast, Carnation T, Carnation ExpCarnation Neo, Carnation+, Carnation Pro, CarnationUltra
Regulation number:	21 CFR 892.1550
Regulation Name:	Ultrasonic pulsed doppler imaging system
Classification Name:	System, Imaging, Pulsed Doppler, Ultrasonic
Regulation Class:	II
Product Code:	IYN ITX IYO

3. Identification of Predicate Device

PredicateDevice	Manufacturer	Device Name	510(k) ControlNumber
Predicatedevice	GE Medical SystemsUltrasound and PrimaryCare Diagnostics, LLC	Venue	K180599
Referencedevice	Shenzhen MindrayBio-medical ElectronicsCo., Ltd..	DC-80/DC-80PRO/DC-80EXP/DC-80S/DC-85Diagnostic UltrasoundSystem	K173471

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Reference device	Shenzhen Wisonic Medical Technology Co., Ltd.	Clivia series Diagnostic Ultrasound System	K211886
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4. Device Description

Medical ultrasound imaging technology aims at exploring and acquiring human physiological or diagnosing information by using ultrasound wave as the information carrier. As one of four major imaging technologies, medical ultrasound technology is proved to be safe, convenient, inexpensive, and can be extensively applied in clinical diagnosis, recovery, and clinical screen guidance.

Holo PW is based on the echo planar imaging, and forms the planar data by emitting and receiving multiple beams to synchronously display the blood flow at multiple sampling gates. From the perspective of application, HOLO PW is different from conventional pulsed Doppler imaging (PW) mainly in the following two points:

Conventional PW has only one sampling gate, and there is a corresponding 1) spectrum diagram corresponding to the blood flow information of the sampling gate; HOLO PW is set as three sampling gates, and there are three spectral graphs corresponding to the blood flow information of sampling gates.
During film playback after freezing, the sampling gate position of 2) conventional PW is not adjustable; When imaging HOLO PW, there is a region of interest (ROI). After freezing, all three sampling gates can change

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within the ROI range, and the spectrum is refreshed with the change of sampling gate

The Carnation series Diagnostic Ultrasound System consists of the main unit, ultrasound probes, ECG lead wire, Magnetic cup, Foot switch, Scanner, USB headset, Camera and Black/white video printer.

1. wiCalc Diaph is used to automatically calculate the diaphragm movement amplitude (Diaph.Disp), diaphragm acceleration (Diaph.Accel), inspiratory time (Insp.Time), diaphragm speed (Diaph.Vel); and to evaluation the function of the diaphragm.
wiCalc Vas is used to automatically calculate the blood vessel depth, blood 2) vessel diameter, and blood vessel area of the short axis of the blood vessel.
wiCalc Vol.Flow is used to automatically calculate the volume of blood flow. 3)
1. wiCalc VTI (Velocity-Time Integral) is mainly used to calculate the Velocity-Time Integral automatically, so as to evaluate the cardiac function.
1. wiCalc IVC is used to automatically calculate the IVC inner diameter. It can be used to assessment the cardiac function and peripheral volume.
wiCalc IMT is used to automatically recognize the carotid and calculate the 6) vertical distance between the upper edge of the intima and the upper edge of the adventitia of the posterior wall of the blood vessel.
1. Automatic trace is used to traces the PW waveform automatcilly, and automatically measure heart rate(HR) and Peak Systolic Velocity (PS).

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5. Indications for use

The Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It intended for use in Fetal/Obstetrics, abdominal/GYN, pediatrics, small organ(breast, thyroid, testes), neonatal cephalic, adult cephalic, trans-rectal, trans-vaginal, musculoskeletal(conventional and superficial), cardiac (adult and pediatric), peripheral vessel, urology, Thoracic/Pleural, Vascular Access exams.

The Carnation series Diagnostic Ultrasound System is a general purpose diagnostic ultrasound system for use by qualified healthcare professionals. The clinical environments where the Carnation series can be used include critical care and emergency room environments, as well as point-of care areas in offices, clinical and hospital settings for diagnosis of patients.

Modes of operation include: B-Mode, M-Mode, Color-Mode, Power(Dirpower)-Mode,

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PW Doppler Mode, CW Doppler mode, Holo PW, Tissue Harmonic Imaging, Tissue Doppler Imaging(TDI), Anatomic M-mode(AMM), Color M Mode(CM), Panoramic Imaging(PANO), and combined mode.

6. Comparison with Predicate Devices

Carnation series Diagnostic Ultrasound System is comparable with and substantially equivalent to these predicate devices:

PredicateDevice	Manufacturer	Device Name	510(k) ControlNumber
Predicatedevice	GE Medical SystemsUltrasound and PrimaryCare Diagnostics, LLC	Venue	K180599
Referencedevice	Shenzhen MindrayBio-medical ElectronicsCo., Ltd..	DC-80/DC-80PRO/DC-80EXP/DC-80S/DC-85Diagnostic UltrasoundSystem	K173471
Referencedevice	Shenzhen WisonicMedical Technology Co.,Ltd.	Clivia series DiagnosticUltrasound System	K211886

Carnation series Diagnostic Ultrasound System is substantially equivalent to the predicate devices with regards to intended use, imaging capabilities, technological characteristics and safety and effectiveness:

The Proposed device and predicate device Venue (K180599) have similar intended use, the intend use of the Proposed device are covered in the intended use of the predicate device.
The proposed device has similar operation modes as the predicate device Venue (K180599), except for Holo PW and PANO(panoramic imaging). For Holo PW, it has been cleared in reference device (K211886). For PANO(panoramic imaging), it can be considered same as reference device (K173471);
The proposed device has the same function, except for wiGuide. The wiGuide ● detects the position and orientation of magnetized needles in the presence of the probe and displays this information relative to the ultrasound image. This function has similar operating principals and specifications as the reference device (K211886).

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The proposed device has the same function, except for wiNerve, it can be considered same as reference device (K211886).
The proposed device has similar Ports as the predicate device Venue (K180599).
The proposed device has similar Peripheral devices as the predicate device Venue (K180599), except for Magnetic cup and Foot switch. For Magnetic cup and Foot switch, it has been cleared in reference device (K211886).
The acoustic power levels of the proposed device are below the limits of FDA, which is the same as the predicate device (K180599).
The system is manufactured with materials which have been evaluated and found to be safe for the intended use of the device.
The Proposed device and predicate device Venue (K180599) have been designed in compliance with approved electrical and physical safety standards.

This difference in technological characteristics do not raise different questions of safety and effectiveness as compared to the predicate device.

7. Non-clinical data

The following non-clinical data were provided in support of the substantial equivalence determination.

7.1 Biocompatibility testing

The biocompatibility evaluation for the Carnation series Diagnostic Ultrasound System was conducted in accordance with the FDA Blue Book Memorandum #G95-1 "Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing,' and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices-Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA. The biocompatible testing included the following tests:

Cytotoxicity
Sensitization
Skin Irritation ●

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7.2 Electrical safety and electromagnetic compatibility (EMC)

Electrical safety and EMC testing were conducted on the Carnation series Diagnostic Ultrasound System. The device complies with the IEC 60601-1 and IEC 60601-2-37 standard for safety; and the IEC 60601-1-2 standard for EMC.

7.3 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.

7.4 Acoustic testing

Acoustic testing is conducted on the Carnation series Diagnostic Ultrasound System in accordance with the NEMA UD 2-2004 (R2009), acoustic output measurement standard for diagnostic ultrasound equipment revision 3.

7.5 Clinical study

The subject of this premarket submission, Carnation series Diagnostic Ultrasound System, did not require clinical studies to support substantial equivalence.

7.6 Animal Study

The subject of this premarket submission, Carnation series Diagnostic Ultrasound System, did not require animal studies to support substantial equivalence.

8. Conclusion

The differences between the Carnation series Diagnostic Ultrasound System and its predicate device do not raise different questions of safety and effectiveness.

The non-clinical data support the safety of the device and the performance testing report demonstrate that the Carnation series Diagnostic Ultrasound System should perform as intended in the specified use conditions and conform to applicable medical device safety standards.

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wisonic

From the results of performance data described, Shenzhen Wisonic concludes that the Carnation series Diagnostic Ultrasound System is substantially equivalent to the predicate in terms of safety and effectiveness.

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.