(368 days)
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, transcranial, cardiac, transvaginal, peripheral vascular, urology, orthopedic, and musculoskeletal (conventional and superficial) exams.
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.
The provided text describes the Clover 50/Clover60/Clover70 Diagnostic Ultrasound System and its substantial equivalence to predicate devices, focusing on non-clinical performance testing. It does not contain information about acceptance criteria and a study proving the device meets acceptance criteria in a clinical setting with human subjects, nor does it detail a standalone algorithm performance, MRMC study, or ground truth establishment relevant to AI.
However, it does describe the performance testing criteria and results for various measurement accuracies and modes of operation. It considers these performance tests as evidence for substantial equivalence, implying they serve as acceptance criteria for the device's technical functionality relative to the predicate devices.
Here's a breakdown of the information that can be extracted, addressing your points where possible:
1. Table of Acceptance Criteria and Reported Device Performance
The device's performance was compared against the listed predicate device (Mindray M7/M7T, K131690). The "acceptance criteria" are implied by the performance of the predicate device, which the new device aims to be "substantially equivalent" to or better. The table shows the performance of the Clover 70 model and compares it to the predicate device.
Note: The predicate device's performance appears to set the acceptance criteria for the new device. Both devices are marked 'S' (Same) indicating substantial equivalence in these performance metrics.
| Items | Acceptance Criteria (from predicate M7/M7T) | Clover 70 Reported Performance | Substantial Equivalence |
|---|---|---|---|
| Precision of 2D Images | |||
| Distance | Within ±3%; or when the measured value is less than 40mm, the error is less than 1.5mm | Max Error: 1.4% (Full screen) | S |
| Area (Trace) | Within ±7%; or when the measured value is less than 16 cm², the error is less than 1.2 cm² | -5.11% (Full screen) | S |
| Area (ellipse, circle) | Within ±7%; or when the measured value is less than 16 cm², the error is less than 1.2 cm² | 0.8% (Full screen) | S |
| Circumference | Within ±7%; or when the measured value is less than 16 cm², the error is less than 1.2 cm² | -0.47% (Full screen) | S |
| Angle | Within ±3% | -1.89% (Full screen) | S |
| Volume | Within ±10%; or when the measured value is less than 64 cm³, the error is less than 6.4 cm³ | 0.51% (Full screen) | S |
| Basic Time/Motion measurements | |||
| Distance | Within ±3%; or when the measured value is less than 40mm, the error is less than 1.5mm | -2% (Full screen) | S |
| Time | Within ±2% | 0 (Timeline Display) | S |
| Heart rate | Within ±4% | 0 (15-999 beats per minute) | S |
| Velocity (PW mode) | When angle ≤ 60°, ≤5% | C5-1: 4.3% max; L15-4: 3.3% max; LH15-6: 3.1% max; P4-1: 4.8% max; EV10-4: 3.3% max; P7-3: 5.0% max | S |
| Velocity (CW mode) | When angle ≤ 60°, ≤5% | P4-1: 4.8% max; P7-3: 4.3% max | S |
2. Sample size used for the test set and the data provenance
The document refers to "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." However, it does not specify the sample size used for this performance testing. It also does not mention data provenance (e.g., country of origin, retrospective or prospective) as this was non-clinical performance data, likely gathered in a lab or testing environment rather than a clinical dataset from patients.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided. The ground truth for this type of performance testing would typically be based on highly accurate physical measurements using calibrated equipment rather than expert human interpretation.
4. Adjudication method for the test set
This information is not provided. Given it's non-clinical performance metrics, an adjudication method (like 2+1, 3+1) would not be applicable in the same way as for clinical studies involving human interpretation.
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
There is no mention of an MRMC comparative effectiveness study or any AI component. The device described appears to be a traditional diagnostic ultrasound system and not an AI-powered device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
There is no mention of a standalone algorithm or AI performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the performance testing metrics (distance, area, velocity, etc.), the ground truth would likely be established using precise physical phantoms and calibrated measurement tools, rather than clinical expert consensus, pathology, or outcomes data. The document does not explicitly state the method, but this is standard for ultrasound system calibration and performance verification.
8. The sample size for the training set
There is no mention of a training set, as this is not an AI/ML device.
9. How the ground truth for the training set was established
There is no mention of a training set or its ground truth, as this is not an AI/ML device.
{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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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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(Track 1Only) | Specific (Track 1 & 3) | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | Combined(specify) | Other (specify) |
| Ophthalmic | Ophthalmic | ||||||||
| FetalImaging &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(Conventional) | N | N | N | N | N | N | Note 1,4,5 | ||
| Musculo-skeletal(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 | |||||||||
| Peripheralvessel | 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(Track 1Only) | Specific (Track 1 & 3) | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | Combined(specify) | Other (specify) | |
| Ophthalmic | Ophthalmic | Ophthalmic | ||||||||
| Fetal Imaging& 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(Conventional) | ||||||||||
| Musculo-skeletal(Superficial) | ||||||||||
| Intravascular | ||||||||||
| Cardiac Adult | ||||||||||
| Cardiac Pediatric | ||||||||||
| Cardiac | Intravascular (Cardiac) | |||||||||
| Trans-esoph. (Cardiac) | ||||||||||
| Intra-cardiac | ||||||||||
| Peripheralvessel | 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(Track 1Only) | Specific (Track 1 & 3) | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | Combined(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& Other | Adult Cephalic | |||||||||
| Trans-rectal | ||||||||||
| Trans-vaginal | ||||||||||
| Trans-urethral | ||||||||||
| Trans-esoph. (non-Card.) | ||||||||||
| Musculo-skeletal(Conventional) | N | N | N | N | N | N | Note 1, 4, 5 | |||
| Musculo-skeletal(Superficial) | N | N | N | N | N | N | Note 1, 4, 5 | |||
| Intravascular | ||||||||||
| Cardiac Adult | ||||||||||
| Cardiac Pediatric | ||||||||||
| Cardiac | Intravascular (Cardiac) | |||||||||
| Trans-esoph. (Cardiac) | ||||||||||
| Intra-cardiac | ||||||||||
| Peripheralvessel | 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(Track 1Only) | Specific (Track 1 & 3) | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | Combined(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& 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(Conventional) | |||||||||
| Musculo-skeletal(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 | |||||||||
| Peripheralvessel | 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(Track 1Only) | Specific (Track 1 & 3) | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | Combined(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& Other | Adult Cephalic | ||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card.) | |||||||||
| Musculo-skeletal(Conventional) | N | N | N | N | N | N | Note 1,4,5 | ||
| Musculo-skeletal(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(Track 1Only) | Specific (Track 1 & 3) | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | Combined(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& 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(Conventional) | |||||||||
| Musculo-skeletal(Superficial) | |||||||||
| Intravascular | |||||||||
| Cardiac Adult | |||||||||
| Cardiac Pediatric | |||||||||
| Cardiac | Intravascular (Cardiac) | ||||||||
| Trans-esoph. (Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Peripheralvessel | 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(Track 1Only) | Specific (Track 1 & 3) | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | Combined(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& 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(Conventional) | ||||||||||
| Musculo-skeletal(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 | ||||||||||
| Peripheralvessel | Peripheral vessel | |||||||||
| Other (Specify***) |
Additional comments: Combined modes-B+M, PW+B, Color + B, PW +Color+ B, Power + PW +B.
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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
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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(Track 1Only) | Specific (Track 1 & 3) | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | Combined(specify) | Other (specify) |
| Ophthalmic | Ophthalmic | ||||||||
| FetalImaging &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(Conventional) | |||||||||
| Musculo-skeletal(Superficial) | |||||||||
| Intravascular | |||||||||
| Cardiac | Cardiac Adult | ||||||||
| Cardiac Pediatric | |||||||||
| Intravascular (Cardiac) | |||||||||
| Trans-esoph. (Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Peripheralvessel | 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 |
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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: (+86) 755 86007788 Fax: (+86) 755 86007799
| Primary Contact | Mike Gu |
|---|---|
| Person: | Regulatory Affairs Manager |
| Guangzhou Osmunda Medical Device Technical ServiceCo., Ltd. | |
| Tel: (+86)-20-6231 6262 | |
| Fax: (+86) -20-8633 0253 | |
| Secondary Contact | Xiaosan Jiang |
| Person: | Regulatory Engineer |
| Shenzhen Wisonic Medical Technology Co., LTD. | |
| Tel: (+86)-755 86007788-8003 | |
| Fax: (+86)-755 86007799 | |
| Date prepared | Dec 22, 2017 |
| 2.DEVICE | |
| Device Name: | Clover 50/Clover60/Clover70 Diagnostic UltrasoundSystem |
| 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 |
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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.
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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/ReferenceDevice | 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:
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- 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%; orwhen themeasured valueis less than40mm, theerror is lessthan 1.5mm | S |
| Area(Trace) | Full screen | -5.11% | Full screen | Within±7%;or | S |
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| 510(k) Premarket Notification Submission | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| when themeasured valueis less than 16cm², the error isless than 1.2cm² | |||||||||
| Area(ellipse,circle) | Full screen | 0.8% | Full screen | Within±7%; orwhen themeasured valueis less than 16cm², the error isless than 1.2cm². | S | ||||
| Circumference | Full screen | -0.47% | Full screen | Within±7%; orwhen themeasured valueis less than 16cm², the error isless than 1.2cm². | S | ||||
| Angle | Full screen | -1.89% | Full screen | Within ±3% | S | ||||
| Volume | Full screen | 0.51% | Full screen | Within ± 10%;orwhenthemeasured valueis less than 64cm³, the error isless than 6.4cm³. | S | ||||
| Basic Time/Motion measurements | |||||||||
| Distance | Full screen | -2% | Full screen | Within ± 3%;orwhenthemeasured valueis less than 40mm, the error isless than 1.5mm. | S | ||||
| Time | TimelineDisplay | 0 | TimelineDisplay | Within ±2% | S | ||||
| Heart rate | 15-999beatsperminute | 0 | TimelineDisplay | within ±4% | S | ||||
| Velocity(PWmode) | 10-150cm/s(for LH15-6)10-200cm/s(for L15-4,EV10-4,P7-3)10-300cm/s(for C5-1,P4-1, D7-2) | C5-1:4.3%maximum valueL15-4:3.3%maximum valueLH15-6:3.1%maximum valueP4-1:4.8%maximum valueEV10-4:3.3%maximum value | 10-200cm/s(for 6C2s,L7-3s,P7-3s,V10-4s,V10-4Bs, 7L5s,L12-4s,7L4s,7LT4s,P7-3Ts)10-150cm/s(for L14-6s,L14-6Ns. | When angle $ $ 60°, ≤5% | S |
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| maximum valueP7-3:5.0%maximum value | P12-4s)10-300cm/s(for C5-2s,P4-2s,4CD4s) | K163712Page 6 of 5 | |||
|---|---|---|---|---|---|
| Velocity(CWmode) | 10-300cm/s(for P4-1,P7-3) | P4-1:4.8%maximum valueP7-3:4.3%maximum value | 10-300cm/s(for P12-4s,P4-2s,P7-3s,P7-3Ts) | When angle ≤60°, ≤5% | S |
| Meaning of symbols used in tables: S:same, D: Different , √:Available, x: Not available |
The performance of the device was compared with the predicate device, and it is concluded that the proposed device is substantially equivalent to the predicate device.
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, since a failure or latent flaw could indirectly result in minor injury to the patient or operator through incorrect or delayed information or through the action of a care provider. It demonstrates substantial equivalences to the predicate device.
Animal Study
The subject of this premarket submission, Clover 50/Clover60/Clover70 Diagnostic Ultrasound System, does not require animal studies to support substantial equivalence.
8. CLINICAL DATA
The subject of this premarket submission, Clover 50/Clover60/Clover70 Diagnostic Ultrasound System, did not require clinical studies to support substantial equivalence.
9. CONCLUSION
The differences between the Clover 50/Clover70 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 Clover 50/Clover60/Clover70
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Diagnostic Ultrasound System should perform as intended in the specified use conditions.
From the results of non-clinical data including the performance testing described, Shenzhen Wisonic concludes that the Clover 50/Clover60/Clover70 Diagnostic Ultrasound System is as safe and as effective as the predicate device.
§ 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.