Clover 50/Clover60/Clover70 Diagnostic Ultrasound System

K163712 · Shenzhen Wisonic Medical Technology Co. , Ltd. · IYN · Jan 2, 2018 · Radiology

Device Facts

• Record ID: K163712
• Device Name: Clover 50/Clover60/Clover70 Diagnostic Ultrasound System
• Applicant: Shenzhen Wisonic Medical Technology Co. , Ltd.
• Product Code: IYN · Radiology
• Decision Date: Jan 2, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1550
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Clover 50/Clover60/Clover70 Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in gynecology, obstetric, abdominal, pediatric, small parts (breast, testes, thyroid, etc.), neonatal cephalic, transcranial, cardiac, transvaginal, peripheral vascular, urology, orthopedic, and musculoskeletal (conventional and superficial) exams.

Device Story

Mobile software-controlled ultrasonic system; acquires/displays ultrasound data in B, M, Color, Power (Dirpower), PW, CW, and combined modes. System components: main unit (Clover 50/60/70), probes, power adapter, cables, needle-guided bracket, batteries, trolley, and case. Used in clinical settings by healthcare professionals to measure anatomical structures and perform software analysis. Output: ultrasound images and measurements for diagnostic decision-making. Benefits: non-invasive visualization of internal structures and fluid flow for clinical assessment.

Clinical Evidence

Bench testing only. No clinical data required. Performance testing evaluated measurement accuracy (distance, area, volume, heart rate, velocity) and system sensitivity against predefined acceptance criteria. Biocompatibility (ISO 10993), electrical safety (IEC 60601-1), and EMC (IEC 60601-1-2) testing performed.

Technological Characteristics

Mobile diagnostic ultrasound system; B, M, Color, Power, PW, CW modes. Materials: probes/glue biocompatible per ISO 10993. Connectivity: internal wireless adapter, HDMI port. Software-controlled. Safety standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37.

Indications for Use

Indicated for adults, pregnant women, pediatric patients, and neonates for diagnostic ultrasound imaging or fluid flow analysis in gynecology, obstetric, abdominal, pediatric, small parts, neonatal cephalic, transcranial, cardiac, transvaginal, peripheral vascular, urology, orthopedic, and musculoskeletal 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

• M7/M7T Diagnostic Ultrasound System (K131690)

Reference Devices

• M9/M9T/M9CV Diagnostic Ultrasound System (K152543)
• AIXPLORER® Ultrasound Diagnostic System (K161999)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The FDA logo is composed of two parts: the Department of Health & Human Services logo on the left and the FDA acronym followed by the full name of the agency, "U.S. Food & Drug Administration," on the right. The FDA acronym and the agency's name are in blue.

Shenzhen Wisonic Medical Technology Co. Ltd. % Mr. Mike Gu Regulatory Affairs Manager Guangzhou Osmunda Medical Device Technical Services Co. Ltd. 8-9th FL, R&D Building, No. 26, Qinglan Street, Planyu District Guangzhou, Guangdong 51000 P.R. CHINA

Re: K163712

Trade/Device Name: Clover 50/Clover60/Clover70 Diagnostic Ultrasonic System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: December 20, 2017 Received: December 28, 2017

Dear Mr. Gu:

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. 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.

January 2, 2018

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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);

{1}------------------------------------------------

## Page 2 - Mr. Mike Gu

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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Michael D. O'Hara For

Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

## Indications for Use

510(k) Number (if known) K163712

Device Name

Clover 50/Clover60/Clover70 Diagnostic Ultrasound System

Indications for Use (Describe)

The Clover 50/Clover60/Clover70 Diagnostic Ultrasound System is applicable for adults, pregnant women, pediative patients and neonates. It is intended for use in gynecology, obstetric, abdominal, pediatric, small parts (breast, testes, thyroid, etc.), neonatal cephalic, transvagmal, perpheral vascular, urology, orthopedic, and musculoskeletal (conventional and superficial) exams.

| Type of Use (Select one or both, as applicable) | |
|---------------------------------------------------------------------------------|-----------------------------------------------------------------------|
| <div> <span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span>Over-The-Counter Use (21 CFR 801 Subpart C)</span> </div> |

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{3}------------------------------------------------

Clover 50/60/70

## Diagnostic Ultrasound Indications For Use Format

System: Clover 50/60/70 Ultrasonic Diagnostic System

N/A

Probe:

Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Intended Use:

| Clinical Application | Mode of Operation | | | | | | | | |
|----------------------------------------------------------------------------|------------------------------------|---|---|-----|-----|------------------|----------------------|-----------------------|-------------------|
| General<br>(Track 1<br>Only) | Specific (Track 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Combined<br>(specify) | Other (specify) |
| Ophthalmic | Ophthalmic | | | | | | | | |
| Fetal<br>Imaging &<br>Other | Fetal | N | N | N | | N | N | N | Note 1, 2, 3, 4,5 |
| | Abdominal | N | N | N | N | N | N | N | Note 1, 2, 4,5 |
| | Intra-operative (Specify*) | | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| | Pediatric | N | N | N | N | N | N | N | Note 1, 3, 4,5 |
| | Small Organ (Specify**) | N | N | N | | N | N | N | Note 1,4,5 |
| | Neonatal Cephalic | N | N | N | N | N | N | N | Note 1,4,5 |
| | Adult Cephalic | N | N | N | N | N | N | N | Note 1,4,5 |
| | Trans-rectal | N | N | N | N | N | N | N | Note 1,4,5 |
| | Trans-vaginal | N | N | N | N | N | N | N | Note 1,4,5 |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | | |
| | Musculo-skeletal<br>(Conventional) | N | N | N | | N | N | N | Note 1,4,5 |
| | Musculo-skeletal<br>(Superficial) | N | N | N | | N | N | N | Note 1,4,5 |
| | Intravascular | | | | | | | | |
| | Cardiac Adult | N | N | N | N | N | N | N | Note 1,2,3,4,5 |
| Cardiac | Cardiac Pediatric | N | N | N | N | N | N | N | Note 1,2,3,4,5 |
| | Intravascular (Cardiac) | | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | | |
| | Intra-cardiac | | | | | | | | |
| | | | | | | | | | |
| Peripheral<br>vessel | Peripheral vessel | N | N | N | | N | N | N | Note 1,4,5 |
| | Other (Specify***) | N | N | N | | N | N | N | Note 1,4,5 |
| N=new indication; P=previously cleared by FDA; E=added under this appendix | | | | | | | | | |

Additional comments: Combined modes-B+M, PW+B, Color + B, PW +Color+B, Power + PW +B.

*Intraoperative includes abdominal, thoracic, and vascular etc.

**Small organ-breast, thyroid, testes.

***Other use includes Urology.

Note1: Tissue Harmonic Imaging. The feature does not use contrast agents.

{4}------------------------------------------------

Clover 50/60/70

Note2: 4D(Real-time 3D)

Note3: TDI

Note4: Biopsy Guidance

Note5: Anatomic M

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)

Concurrence of CDRH, Office of Device Evaluation(ODE)

{5}------------------------------------------------

C5-1

Clover 50/60/70

System: Probe:

Intended Use:

Clover 50/60/70 Ultrasonic Diagnostic System

Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

| | Clinical Application | | Mode of Operation | | | | | | | |
|--------------------------|------------------------------|------------------------------------|-------------------|---|-----|-----|------------------|----------------------|-----------------------|-----------------|
| | General<br>(Track 1<br>Only) | Specific (Track 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Combined<br>(specify) | Other (specify) |
| Ophthalmic | Ophthalmic | Ophthalmic | | | | | | | | |
| Fetal Imaging<br>& Other | | Fetal | N | N | N | | N | N | N | Note 1, 4, 5 |
| | | Abdominal | N | N | N | | N | N | N | Note 1, 4, 5 |
| | | Intra-operative (Specify*) | | | | | | | | |
| | | Intra-operative (Neuro) | | | | | | | | |
| | | Laparoscopic | | | | | | | | |
| | | Pediatric | N | N | N | | N | N | N | Note 1, 4, 5 |
| | | Small Organ (Specify**) | | | | | | | | |
| | | Neonatal Cephalic | | | | | | | | |
| | | Adult Cephalic | | | | | | | | |
| | | Trans-rectal | | | | | | | | |
| | | Trans-vaginal | | | | | | | | |
| | | Trans-urethral | | | | | | | | |
| | | Trans-esoph. (non-Card.) | | | | | | | | |
| | | Musculo-skeletal<br>(Conventional) | | | | | | | | |
| | | Musculo-skeletal<br>(Superficial) | | | | | | | | |
| | | Intravascular | | | | | | | | |
| | | Cardiac Adult | | | | | | | | |
| | | Cardiac Pediatric | | | | | | | | |
| Cardiac | | Intravascular (Cardiac) | | | | | | | | |
| | | Trans-esoph. (Cardiac) | | | | | | | | |
| | | Intra-cardiac | | | | | | | | |
| Peripheral<br>vessel | | Peripheral vessel | N | N | N | | N | N | N | Note 1, 4, 5 |
| | | Other (Specify***) | | | | | | | | |

N=new indication; P=previously cleared by FDA; E=added under this appendix

Additional comments: Combined modes-B+M, PW+B, Color + B, PW +Color+ B, Power + PW +B.

*Intraoperative includes abdominal, thoracic, and vascular etc.

**Small organ-breast, thyroid, testes.

***Other use includes Urology.

Note1: Tissue Harmonic Imaging. The feature does not use contrast agents.

{6}------------------------------------------------

Clover 50/60/70

Note2: 4D(Real-time 3D)

Note3: TDI

Note4: Biopsy Guidance

Note5: Anatomic M

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)

Concurrence of CDRH, Office of Device Evaluation(ODE)

{7}------------------------------------------------

L15-4

Clover 50/60/70

Probe:

System:

Intended Use:

Clover 50/60/70 Ultrasonic Diagnostic System

Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

| Clinical Application | | | Mode of Operation | | | | | | | |
|------------------------------|----------------------------------------------------------------------------|---|-------------------|-----|-----|------------------|----------------------|-----------------------|-----------------|--|
| General<br>(Track 1<br>Only) | Specific (Track 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Combined<br>(specify) | Other (specify) | |
| Ophthalmic | Ophthalmic | | | | | | | | | |
| | Fetal | | | | | | | | | |
| | Abdominal | N | N | N | | N | N | N | Note 1, 4, 5 | |
| | Intra-operative (Specify*) | | | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | | | |
| | Laparoscopic | | | | | | | | | |
| | Pediatric | N | N | N | | N | N | N | Note 1, 4, 5 | |
| | Small Organ (Specify**) | N | N | N | | N | N | N | Note 1, 4, 5 | |
| | Neonatal Cephalic | N | N | N | | N | N | N | Note 1, 4, 5 | |
| Fetal Imaging<br>& Other | Adult Cephalic | | | | | | | | | |
| | Trans-rectal | | | | | | | | | |
| | Trans-vaginal | | | | | | | | | |
| | Trans-urethral | | | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | | | |
| | Musculo-skeletal<br>(Conventional) | N | N | N | | N | N | N | Note 1, 4, 5 | |
| | Musculo-skeletal<br>(Superficial) | N | N | N | | N | N | N | Note 1, 4, 5 | |
| | Intravascular | | | | | | | | | |
| | Cardiac Adult | | | | | | | | | |
| | Cardiac Pediatric | | | | | | | | | |
| Cardiac | Intravascular (Cardiac) | | | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | | | |
| | Intra-cardiac | | | | | | | | | |
| Peripheral<br>vessel | Peripheral vessel | N | N | N | | N | N | N | Note 1, 4, 5 | |
| | Other (Specify***) | | | | | | | | | |
| | N=new indication; P=previously cleared by FDA; E=added under this appendix | | | | | | | | | |

Additional comments: Combined modes-B+M, PW+B, Color + B, PW +Color+ B, Power + PW +B.

*Intraoperative includes abdominal, thoracic, and vascular etc.

**Small organ-breast, thyroid, testes.

***Other use includes Urology.

{8}------------------------------------------------

Clover 50/60/70

Note1: Tissue Harmonic Imaging. The feature does not use contrast agents.

Note2: 4D(Real-time 3D)

Note3: TDI

Note4: Biopsy Guidance

Note5: Anatomic M

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)

Concurrence of CDRH, Office of Device Evaluation(ODE)

{9}------------------------------------------------

Clover 50/60/70

System:

P4-1 Probe:

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clover 50/60/70 Ultrasonic Diagnostic System

| | | Mode of Operation | | | | | | | |
|----------------------------------------------------------------------------|------------------------------------|-------------------|---|-----|-----|------------------|----------------------|-----------------------|-----------------|
| General<br>(Track 1<br>Only) | Specific (Track 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Combined<br>(specify) | Other (specify) |
| Ophthalmic | Ophthalmic | | | | | | | | |
| | Fetal | | | | | | | | |
| | Abdominal | N | N | N | N | N | N | N | Note 1,3,4,5 |
| | Intra-operative (Specify*) | | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| | Pediatric | N | N | N | N | N | N | N | Note 1,3,4,5 |
| | Small Organ (Specify**) | | | | | | | | |
| | Neonatal Cephalic | N | N | N | N | N | N | N | Note 1,3,4,5 |
| Fetal Imaging<br>& Other | Adult Cephalic | N | N | N | N | N | N | N | Note 1,3,4,5 |
| | Trans-rectal | | | | | | | | |
| | Trans-vaginal | | | | | | | | |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | | |
| | Musculo-skeletal<br>(Conventional) | | | | | | | | |
| | Musculo-skeletal<br>(Superficial) | | | | | | | | |
| | Intravascular | | | | | | | | |
| | Cardiac Adult | N | N | N | N | N | N | N | Note 1,3,4,5 |
| | Cardiac Pediatric | N | N | N | N | N | N | N | Note 1,3,4,5 |
| Cardiac | Intravascular (Cardiac) | | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | | |
| | Intra-cardiac | | | | | | | | |
| Peripheral<br>vessel | Peripheral vessel | | | | | | | | |
| | Other (Specify***) | | | | | | | | |
| N=new indication; P=previously cleared by FDA; E=added under this appendix | | | | | | | | | |

Additional comments: Combined modes--B+M, PW+B, Color + B, PW +Color+ B, Power + PW +B.

{10}------------------------------------------------

### Shenzhen Wisonic Medical Technology Co., LTD.

# wisonic

Clover 50/60/70

*Intraoperative includes abdominal, thoracic, and vascular etc.

**Small organ-breast, thyroid, testes.

***Other use includes Urology.

Note1: Tissue Harmonic Imaging. The feature does not use contrast agents.

Note2: 4D(Real-time 3D)

Note3: TDI

Note4: Biopsy Guidance

Note5: Anatomic M

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)

### Concurrence of CDRH, Office of Device Evaluation(ODE)

{11}------------------------------------------------

Clover 50/60/70

System:

Probe: LH15-6

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clover 50/60/70 Ultrasonic Diagnostic System

| Clinical Application | | | Mode of Operation | | | | | | |
|----------------------------------------------------------------------------|------------------------------------|---|-------------------|-----|-----|------------------|----------------------|-----------------------|-----------------|
| General<br>(Track 1<br>Only) | Specific (Track 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Combined<br>(specify) | Other (specify) |
| Ophthalmic | Ophthalmic | | | | | | | | |
| | Fetal | | | | | | | | |
| | Abdominal | N | N | N | | N | N | N | Note 1,4,5 |
| | Intra-operative (Specify*) | N | N | N | | N | N | N | Note 1,4,5 |
| | Intra-operative (Neuro) | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| | Pediatric | N | N | N | | N | N | N | Note 1,4,5 |
| | Small Organ (Specify**) | N | N | N | | N | N | N | Note 1,4,5 |
| | Neonatal Cephalic | N | N | N | | N | N | N | Note 1,4,5 |
| Fetal Imaging<br>& Other | Adult Cephalic | | | | | | | | |
| | Trans-rectal | | | | | | | | |
| | Trans-vaginal | | | | | | | | |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | | |
| | Musculo-skeletal<br>(Conventional) | N | N | N | | N | N | N | Note 1,4,5 |
| | Musculo-skeletal<br>(Superficial) | N | N | N | | N | N | N | Note 1,4,5 |
| | Intravascular | | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | | |
| | Cardiac Pediatric | | | | | | | | |
| | Intravascular (Cardiac) | | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | | |
| | Intra-cardiac | | | | | | | | |
| Peripheral | Peripheral vessel | N | N | N | | N | N | N | Note 1,4,5 |
| vessel | Other (Specify***) | | | | | | | | |
| N=new indication; P=previously cleared by FDA; E=added under this appendix | | | | | | | | | |

Additional comments: Combined modes--B+M, PW+B, Color + B, PW +Color+ B, Power + PW +B.

*Intraoperative includes abdominal, thoracic, and vascular etc.

{12}------------------------------------------------

Clover 50/60/70

**Small organ-breast, thyroid, testes.

***Other use includes Urology.

Note1: Tissue Harmonic Imaging. The feature does not use contrast agents.

Note2: 4D(Real-time 3D)

Note3: TDI

Note4: Biopsy Guidance

Note5: Anatomic M

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)

Concurrence of CDRH, Office of Device Evaluation(ODE)

{13}------------------------------------------------

Clover 50/60/70

System:

EV10-4 Probe:

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clover 50/60/70 Ultrasonic Diagnostic System

| Clinical Application | | Mode of Operation | | | | | | | |
|----------------------------------------------------------------------------|------------------------------------|-------------------|---|-----|-----|------------------|----------------------|-----------------------|-----------------|
| General<br>(Track 1<br>Only) | Specific (Track 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Combined<br>(specify) | Other (specify) |
| Ophthalmic | Ophthalmic | | | | | | | | |
| | Fetal | N | N | N | | N | N | N | Note 1,4,5 |
| | Abdominal | | | | | | | | |
| | Intra-operative (Specify*) | | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| | Pediatric | | | | | | | | |
| | Small Organ (Specify**) | | | | | | | | |
| | Neonatal Cephalic | | | | | | | | |
| Fetal Imaging<br>& Other | Adult Cephalic | | | | | | | | |
| | Trans-rectal | N | N | N | | N | N | N | Note 1,4,5 |
| | Trans-vaginal | N | N | N | | N | N | N | Note 1,4,5 |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | | |
| | Musculo-skeletal<br>(Conventional) | | | | | | | | |
| | Musculo-skeletal<br>(Superficial) | | | | | | | | |
| | Intravascular | | | | | | | | |
| | Cardiac Adult | | | | | | | | |
| | Cardiac Pediatric | | | | | | | | |
| Cardiac | Intravascular (Cardiac) | | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | | |
| | Intra-cardiac | | | | | | | | |
| Peripheral<br>vessel | Peripheral vessel | | | | | | | | |
| | Other (Specify***) | N | N | N | | N | N | N | Note 1,4,5 |
| N=new indication; P=previously cleared by FDA; E=added under this appendix | | | | | | | | | |

Additional comments: Combined modes--B+M, PW+B, Color + B, PW +Color+ B, Power + PW +B.

{14}------------------------------------------------

### Shenzhen Wisonic Medical Technology Co., LTD.

# wisonic

Clover 50/60/70

*Intraoperative includes abdominal, thoracic, and vascular etc.

**Small organ-breast, thyroid, testes.

***Other use includes Urology.

Note1: Tissue Harmonic Imaging. The feature does not use contrast agents.

Note2: 4D(Real-time 3D)

Note3: TDI

Note4: Biopsy Guidance

Note5: Anatomic M

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)

### Concurrence of CDRH, Office of Device Evaluation(ODE)

{15}------------------------------------------------

Clover 50/60/70

System: Probe:

P7-3

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clover 50/60/70 Ultrasonic Diagnostic System

| Clinical Application | | | Mode of Operation | | | | | | | |
|------------------------------|------------------------------------|---|-------------------|-----|-----|------------------|----------------------|-----------------------|-----------------|--|
| General<br>(Track 1<br>Only) | Specific (Track 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Combined<br>(specify) | Other (specify) | |
| Ophthalmic | Ophthalmic | | | | | | | | | |
| | Fetal | | | | | | | | | |
| | Abdominal | N | N | N | N | N | N | N | Note 1,3,4,5 | |
| | Intra-operative (Specify*) | | | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | | | |
| | Laparoscopic | | | | | | | | | |
| | Pediatric | N | N | N | N | N | N | N | Note 1,3,4,5 | |
| | Small Organ (Specify**) | | | | | | | | | |
| | Neonatal Cephalic | N | N | N | N | N | N | N | Note 1,3,4,5 | |
| Fetal Imaging<br>& Other | Adult Cephalic | N | N | N | N | N | N | N | Note 1,3,4,5 | |
| | Trans-rectal | | | | | | | | | |
| | Trans-vaginal | | | | | | | | | |
| | Trans-urethral | | | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | | | |
| | Musculo-skeletal<br>(Conventional) | | | | | | | | | |
| | Musculo-skeletal<br>(Superficial) | N | N | N | N | N | N | N | Note 1,3,4,5 | |
| | Intravascular | | | | | | | | | |
| Cardiac | Cardiac Adult | N | N | N | N | N | N | N | Note 1,3,4,5 | |
| | Cardiac Pediatric | N | N | N | N | N | N | N | Note 1,3,4,5 | |
| | Intravascular (Cardiac) | | | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | | | |
| | Intra-cardiac | | | | | | | | | |
| Peripheral<br>vessel | Peripheral vessel | | | | | | | | | |
| | Other (Specify***) | | | | | | | | | |

Additional comments: Combined modes-B+M, PW+B, Color + B, PW +Color+ B, Power + PW +B.

{16}------------------------------------------------

### Shenzhen Wisonic Medical Technology Co., LTD.

# wisonic

Clover 50/60/70

*Intraoperative includes abdominal, thoracic, and vascular etc.

**Small organ-breast, thyroid, testes.

***Other use includes Urology.

Note1: Tissue Harmonic Imaging. The feature does not use contrast agents.

Note2: 4D(Real-time 3D)

Note3: TDI

Note4: Biopsy Guidance

Note5: Anatomic M

{17}------------------------------------------------

# uisonic

Clover 50/60/70

Clover 50/60/70 Ultrasonic Diagnostic System System: Probe: D7-2 Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Intended Use:

| Clinical Application | | Mode of Operation | | | | | | | |
|---------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|-------------------|---|-----|-----|------------------|----------------------|-----------------------|-----------------|
| General<br>(Track 1<br>Only) | Specific (Track 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Combined<br>(specify) | Other (specify) |
| Ophthalmic | Ophthalmic | | | | | | | | |
| Fetal<br>Imaging &<br>Other | Fetal | N | N | N | | N | N | N | Note 1,2, 4, 5 |
| | Abdominal | N | N | N | | N | N | N | Note 1,2, 4, 5 |
| | Intra-operative (Specify*) | | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| | Pediatric | N | N | N | | N | N | N | Note 1,2, 4, 5 |
| | Small Organ (Specify**) | | | | | | | | |
| | Neonatal Cephalic | | | | | | | | |
| | Adult Cephalic | | | | | | | | |
| | Trans-rectal | | | | | | | | |
| | Trans-vaginal | | | | | | | | |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | | |
| | Musculo-skeletal<br>(Conventional) | | | | | | | | |
| | Musculo-skeletal<br>(Superficial) | | | | | | | | |
| | Intravascular | | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | | |
| | Cardiac Pediatric | | | | | | | | |
| | Intravascular (Cardiac) | | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | | |
| | Intra-cardiac | | | | | | | | |
| Peripheral<br>vessel | Peripheral vessel | N | N | N | | N | N | N | Note 1,2, 4, 5 |
| | Other (Specify***) | | | | | | | | |
| | N=new indication; P=previously cleared by FDA; E=added under this appendix | | | | | | | | |
| | Additional comments: Combined modes--B+M, PW+B, Color + B, Power + B, PW +Color+B, Power + PW +B. | | | | | | | | |
| *Intraoperative includes abdominal, thoracic, and vascular etc. | | | | | | | | | |
| **Small organ-breast, thyroid, testes. | | | | | | | | | |
| ***Other use includes Urology. | | | | | | | | | |
| Note1: Tissue Harmonic Imaging. The feature does not use contrast agents. | | | | | | | | | |
| Note2: 4D(Real-time 3D) | | | | | | | | | |
| | Note3: TDI | | | | | | | | |
| | Note4: Biopsy Guidance | | | | | | | | |
| Note5: Anatomic M | | | | | | | | | |

{18}------------------------------------------------

## Shenzhen Wisonic Medical Technology Co., LTD.

Image /page/18/Picture/1 description: The image shows the word "wisonic" in red font. The font is bold and sans-serif. The word is slightly blurred, but still legible. The background is white.

Clover 50/60/70

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)

Concurrence of CDRH, Office of Device Evaluation(ODE)

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# 510(k) Summary

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

# 1. SUBMITTER

Shenzhen Wisonic Medical Technology Co., LTD. 1st and 5th Floor, NO.6 Building, Pingshan Technology Park, Taoyuan Street, Nanshan, Shenzhen. Guangdong, 518055, P.R. CHINA Tel: [phone] Fax: [phone]

| Primary Contact | Mike Gu |
|---------------------|-----------------------------------------------------------------|
| Person: | Regulatory Affairs Manager |
| | Guangzhou Osmunda Medical Device Technical Service<br>Co., Ltd. |
| | Tel: [phone] |
| | Fax: (+86) -20-8633 0253 |
| Secondary Contact | Xiaosan Jiang |
| Person: | Regulatory Engineer |
| | Shenzhen Wisonic Medical Technology Co., LTD. |
| | Tel: [phone]-8003 |
| | Fax: [phone] |
| Date prepared | Dec 22, 2017 |
| 2.<br>DEVICE | |
| Device Name: | Clover 50/Clover60/Clover70 Diagnostic Ultrasound<br>System |
| Common/Usual Name: | Diagnostic Ultrasound System |
| Regulation number | 21 CFR 892.1550 |
| Regulation Name | Ultrasonic pulsed doppler imaging system |
| Regulation Class: | II |
| Product Code: | IYN, ITX, IYO |
| Classification Name | System, Imaging, Pulsed Doppler, Ultrasonic |
| Model: | Clover 50. Clover60. Clover70 |

{20}------------------------------------------------

#### PREDICATE/REFERENCE DEVICE 3.

Predicate device: K131690, M7/M7T Diagnostic Ultrasound System Reference device 1: K152543, M9/M9T/M9CV Diagnostic Ultrasound System Reference device 2: K161999, AIXPLORER® Ultrasound Diagnostic System The predicate device and reference devices have not been subject to a design-related recall.

#### 4. DEVICE DESCRIPTION

The Clover 50/Clover60/Clover70 Diagnostic Ultrasound System is a mobile software controlled ultrasonic system. Its function is to acquire and display ultrasound data in B-Mode, M-Mode, Color-Mode, Power (Dirpower)-Mode, PW-Mode, CW-mode, and the 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.

The Clover 50/Clover60/Clover70 Diagnostic Ultrasound System consists of the main unit named clover series, ultrasound probes, power adapter, connecting cable, probe extender, needle-guided bracket, batteries, mobile trolley and travelling case.

Three models for the main units are included in this submission that is Clover 50, Clover 60 and Clover 70. Seven different models of probes are available for the Clover series.

#### 5. INDICATIONS FOR USE

The Clover 50/Clover60/Clover70 Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in gynecology, obstetric, abdominal, pediatric, small parts (breast, testes, thyroid, etc.), neonatal cephalic, transcranial, cardiac, transvaginal, peripheral vascular, urology, orthopedic, and musculoskeletal (conventional and superficial) exams.

{21}------------------------------------------------

#### COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE 6. DEVICE

Clover 50/Clover60/Clover70 Diagnostic Ultrasound System is comparable with and substantially equivalent to these predicate or reference devices:

| Predicate/Reference<br>Device | Manufacturer | Model | 510(k) Number |
|-------------------------------|--------------|-------------|---------------|
| Predicate device | Mindray | M7/M7T | K131690 |
| Reference device 1 | Mindray | M9/M9CV/M9T | K152543 |
| Reference device 2 | Supersonic | Aixplorer | K161999 |

Compared to the predicate device M7/M7T (K131690), the proposed device has the intended uses, except for trans-esoph (Cardiac). The same Clover 50/Clover60/Clover70 Diagnostic Ultrasound System do not support transrectal, intraoperative and transesophageal (cardiac) exams. The intended use of Clover 50/Clover60/Clover70 Diagnostic Ultrasound System is smaller than that of M7/M7T.

The proposed device has the same structure and system configuration, except for the internal wireless adapter and HDMI port. The internal wireless adapter and HDMI port of the proposed device are identical to those of the reference device, M9/M9CV/M9T (K152543).

The proposed device has the same function and features, except for adding multi-PW imaging support. The new added function is substantially equivalent to that of the reference device, Aixplorer (K161999).

All the above differences 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.

## Biocompatibility testing

The biocompatibility evaluation for the Ultrasound Diagnostic System was conducted in accordance with the International Standard ISO 10993-1:2009/(R)2013, "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:

{22}------------------------------------------------

- Cytotoxicity
- Sensitization
- Skin Irritation

The ultrasonic probes and glue of the Clover 50/Clover60/Clover70 Diagnostic Ultrasound System are considered to contact directly with human body for a duration of less than 24 hours. The test results of cytotoxicity, sensitization and skin irritation complied with ISO 10993-5:2009, Biological evaluation of medical devices - Part 5: Tests for In Vitro cytotoxicity and ISO 10993-10: 2010, Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization. It demonstrates substantial equivalences to the predicate device.

# Electrical safety and electromagnetic compatibility (EMC)

Electrical safety and EMC testing were conducted on on the Clover 50/Clover60/Clover70 Diagnostic Ultrasound System. The device complies with the IEC 60601-1:2012, standard for safety and the IEC 60601-1-2:2007, standard for EMC. It demonstrates substantial equivalences to the predicate device.

# Performance testing

The Clover 50/Clover60/Clover70 Diagnostic Ultrasound System, was tested according to IEC 60601-2-37:2007, and met the requirements of IEC 60601-2-37, Medical Electrical Equipment – Part 2-37: Particular Requirements for the Safety of Ultrasonic Medical Diagnostic and Monitoring Equipment.

Performance testing was conducted on the Clover 50/Clover60/Clover70 Diagnostic Ultrasound System, to evaluate the clinic measurement accuracy and system sensitivity, and all of the tested parameters met the predefined acceptance criteria. The comparisons of performance of Clover 50/Clover60/Clover70 Diagnostic Ultrasound System to predicate devices are listed in the table below.

| Items | Clover 70 | | M7/M7T | | |
|------------------------|-------------|-----------|-------------|---------------------------------------------------------------------------------------------------------|---|
| Precision of 2D Images | | | | | |
| | Value range | Max Error | Value range | Error | |
| Distance | Full screen | 1.4% | Full screen | Within±3%; or<br>when the<br>measured value<br>is less than<br>40mm, the<br>error is less<br>than 1.5mm | S |
| Area(Trace) | Full screen | -5.11% | Full screen | Within±7%;or | S |

{23}------------------------------------------------

K163712

| | | | | 510(k) Premarket Notification Submission | | | | | |
|--------------------------------|------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------|---|--|--|--|--|
| | | | | when the<br>measured value<br>is less than 16<br>cm², the error is<br>less than 1.2<br>cm² | | | | | |
| Area(ellipse,<br>circle) | Full screen | 0.8% | Full screen | Within±7%; or<br>when the<br>measured value<br>is less than 16<br>cm², the error is<br>less than 1.2<br>cm². | S | | | | |
| Circumference | Full screen | -0.47% | Full screen | Within±7%; or<br>when the<br>measured value<br>is less than 16<br>cm², the error is<br>less than 1.2<br>cm². | S | | | | |
| Angle | Full screen…