Carnation series Diagnostic Ultrasound System

K230066 · Shenzhen Wisonic Medical Technology Co. , Ltd. · IYN · Sep 15, 2023 · Radiology

Device Facts

• Record ID: K230066
• Device Name: Carnation series Diagnostic Ultrasound System
• Applicant: Shenzhen Wisonic Medical Technology Co. , Ltd.
• Product Code: IYN · Radiology
• Decision Date: Sep 15, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1550
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

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 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.

Device Story

General-purpose diagnostic ultrasound system; utilizes linear, convex, and phased array transducers to acquire physiological data. Transforms ultrasound echoes into B-Mode, M-Mode, Color/Power Doppler, PW/CW Doppler, Holo PW, Tissue Harmonic/Doppler Imaging, and Panoramic images. Operated by qualified healthcare professionals in critical care, ER, and point-of-care settings. Includes automated measurement tools (e.g., wiCalc for diaphragm, vessel, cardiac function) and workflow/guidance modules (wiScan, wiGuide, wiNerve). wiGuide uses magnetic field detection for needle visualization; wiNerve provides anatomical structure recognition for education. Output displayed on touch screen for clinician review; assists in diagnosis and needle-guidance procedures. Benefits include improved workflow efficiency, standardized measurements, and enhanced needle visualization.

Clinical Evidence

Bench testing only. No clinical or animal studies were required to support substantial equivalence. Evidence includes biocompatibility testing (ISO 10993), electrical safety/EMC testing (IEC 60601 series), software verification/validation, and acoustic output measurement (NEMA UD 2-2004).

Technological Characteristics

General-purpose ultrasound system; touch screen interface. Supports linear, convex, phased array transducers. Modes: B, M, Color, Power, PW/CW Doppler, Holo PW, THI, TDI, AMM, CM, PANO. Connectivity: USB, network storage. Software: Moderate level of concern. Standards: IEC 60601-1, IEC 60601-2-37, IEC 60601-1-2, NEMA UD 2-2004.

Indications for Use

Indicated for adults, pregnant women, pediatric patients, and neonates for diagnostic ultrasound imaging, measurement, and analysis in fetal/obstetrics, abdominal/GYN, pediatrics, small organ, cephalic, trans-rectal, trans-vaginal, musculoskeletal, cardiac, peripheral vessel, urology, thoracic/pleural, and vascular access exams.

Regulatory Classification

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.

Predicate Devices

• Venue (K180599)

Reference Devices

• DC-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-85 Diagnostic Ultrasound System (K173471)
• Clivia series Diagnostic Ultrasound System (K211886)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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)

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.

Type of Use (Select one or both, as applicable)

| <div> <span> <svg fill="none" height="16" viewbox="0 0 16 16" width="16" xmlns="http://www.w3.org/2000/svg"> <path d="M13.6 2.4L5.6 10.4L2.4 7.2L0 9.6L5.6 15.2L16 4L13.6 2.4Z" fill="black"></path> </svg> </span> <span>Prescription Use (Part 21 CFR 801 Subpart D)</span> </div> | <div> <span> <svg fill="none" height="16" viewbox="0 0 16 16" width="16" xmlns="http://www.w3.org/2000/svg"> <rect height="15" rx="2.5" stroke="black" width="15" x="0.5" y="0.5"></rect> </svg> </span> <span>Over-The-Counter Use (21 CFR 801 Subpart C)</span> </div> |
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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, Pingshan<br>Technology Park, Taoyuan Street, Nanshan District<br>518055 Shenzhen, P.R.China |
| Contact Person: | Jiang Xiaosan |
| Tel: | ([phone] |
| Fax: | ([phone] |
| 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 Exp<br>Carnation Neo, Carnation+, Carnation Pro, Carnation<br>Ultra |
| 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

| Predicate<br>Device | Manufacturer | Device Name | 510(k) Control<br>Number |
|---------------------|-----------------------------------------------------------------------|---------------------------------------------------------------------------------|--------------------------|
| Predicate<br>device | GE Medical Systems<br>Ultrasound and Primary<br>Care Diagnostics, LLC | Venue | K180599 |
| Reference<br>device | Shenzhen Mindray<br>Bio-medical Electronics<br>Co., Ltd.. | DC-80/DC-80<br>PRO/DC-80<br>EXP/DC-80S/DC-85<br>Diagnostic Ultrasound<br>System | K173471 |

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| Reference device | Shenzhen Wisonic Medical Technology Co., Ltd. | Clivia series Diagnostic Ultrasound System | K211886 |
|------------------|-----------------------------------------------|--------------------------------------------|---------|
|------------------|-----------------------------------------------|--------------------------------------------|---------|

### 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.

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. 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.

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.

- 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)
- 4) wiCalc VTI (Velocity-Time Integral) is mainly used to calculate the Velocity-Time Integral automatically, so as to evaluate the cardiac function.
- 5) 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.
- 7) 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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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.

### 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:

| Predicate<br>Device | Manufacturer | Device Name | 510(k) Control<br>Number |
|---------------------|-----------------------------------------------------------------------|---------------------------------------------------------------------------------|--------------------------|
| Predicate<br>device | GE Medical Systems<br>Ultrasound and Primary<br>Care Diagnostics, LLC | Venue | K180599 |
| Reference<br>device | Shenzhen Mindray<br>Bio-medical Electronics<br>Co., Ltd.. | DC-80/DC-80<br>PRO/DC-80<br>EXP/DC-80S/DC-85<br>Diagnostic Ultrasound<br>System | K173471 |
| Reference<br>device | Shenzhen Wisonic<br>Medical Technology Co.,<br>Ltd. | Clivia series Diagnostic<br>Ultrasound 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.