(78 days)
No
The document does not mention AI, ML, or related terms, and the description focuses on standard ultrasound functionalities and measurements.
No
The device is clearly indicated as a "Diagnostic Ultrasound System" intended for acquiring and displaying ultrasound data to provide information for diagnosis, not for therapy.
Yes
The "Intended Use / Indications for Use" explicitly states "The Diagnostic Ultrasound System is applicable..." and the "Device Description" mentions that the system provides "software analysis packages performance to provide information based on which the competent health care professionals can make the diagnosis." The entire context consistently refers to it as a "Diagnostic Ultrasound System."
No
The device description explicitly lists multiple hardware components including the main unit, ultrasound probes, power adapter, connecting cable, probe extender, needle-guided bracket, batteries, mobile trolley, and ECG module.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Definition of IVD: In vitro diagnostics are tests performed on samples such as blood, urine, or tissue that have been taken from the human body to detect diseases or other conditions.
- Device Function: The description clearly states that the device is a "Diagnostic Ultrasound System." Ultrasound systems use sound waves to create images of internal body structures. This is an in vivo (within the living body) diagnostic method, not in vitro.
- Intended Use: The intended use describes imaging various anatomical sites within the body.
- Device Description: The components listed (main unit, probes, etc.) are consistent with an ultrasound system, not a device for analyzing biological samples.
Therefore, the Navi e/ Navi s/Navi X Diagnostic Ultrasound System is an in vivo diagnostic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The 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.
Product codes (comma separated list FDA assigned to the subject device)
IYN, ITX, IYO
Device Description
The Navi e/ Navi s/Navi X 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-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 Navi e/ Navi x/Navi X Diagnostic Ultrasound System consists of the main unit named Navi series, ultrasound probes, power adapter, connecting cable, probe extender, needle-guided bracket, batteries, mobile trolley, ECG module and batteries.
Three models for the main units are included in this submission, that is Navi s, Navi e and Navi X. Eight different models of probes are available for the Navi series.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
gynecology, obstetric, abdominal, pediatric, small parts (breast, testes, thyroid, etc.), neonatal cephalic, transcranial, cardiac, transvaginal, peripheral vascular, urology, orthopedic, and musculoskeletal (conventional and superficial)
Indicated Patient Age Range
adults, pregnant women, pediatric patients and neonates
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical data were provided in support of the substantial equivalence determination.
Biocompatibility testing: The biocompatibility evaluation for the Double Electric Breast Pump was conducted in accordance with the International Standard ISO 10993-1:2009/(R)2013. The biocompatible testing included Cytotoxicity, Sensitization, and Skin Irritation. The test results complied with ISO 10993-5:2009 and ISO 10993-10: 2010.
Electrical safety and electromagnetic compatibility (EMC): Electrical safety and EMC testing were conducted on the Diagnostic Ultrasound System. The device complies with the IEC 60601-1:2012 and IEC 60601-1-2:2007 standards.
Performance testing: The Diagnostic Ultrasound System, was tested according to IEC 60601-2-37:2007, and met the requirements. Performance testing was conducted to evaluate the clinic measurement accuracy and system sensitivity, and all of the tested parameters met the predefined acceptance criteria. Acoustic output measurement and real time display function were evaluated according to NEMA UD 2:2004 and NEMA UD 3:2004. All the devices met the requirements.
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.
Conclusion: The differences between the Navi e/Navi x/Navi X 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 Navi e/Navi x Diagnostic Ultrasound System should perform as intended in the specified use conditions.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image contains two logos. The logo on the left is the Department of Health & Human Services logo. The logo on the right is the FDA logo, which is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Shenzhen Wisonic Medical Technology Co., Ltd. % Jiang Xiaosan Regulatory Engineer 1st and 5th Floor,No. 6 Building, Pingshan Technology Park, Taoyuan Street. Nanshan Shenzhen, Guang Dong 518055 CHINA
May 9, 2018
Re: K180461
Trade/Device Name: Navi e/Navi x/Navi X Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, ITX, IYO Dated: February 7, 2018 Received: February 20, 2018
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. 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 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 - Jiang Xiaosan
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 mediation-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) K180461
Device Name
Navi e/Navi s/Navi X Diagnostic Ultrasound System
Indications for Use (Describe)
The 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.
| 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
Navi s/e/X
Diagnostic Ultrasound Indications For Use Format
System: Navi s/e/X Diagnostic Ultrasound System
N/A
Probe:
Diagnostic Ultrasound imaging or fluid flow analysis of the human body as Intended Use:
| Clinical Application follows: | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| General | |||||||||
| (Track 1 | |||||||||
| Only) | Specific (Track 1 & 3) | B | M | PWD | CWD | Color | |||
| Doppler | Amplitude | ||||||||
| Doppler | Combined | ||||||||
| (specify) | Other (specify) | ||||||||
| Ophthalmic | Ophthalmic | ||||||||
| Fetal | N | N | N | N | N | N | Note 1,4 | ||
| Abdominal | N | N | N | N | N | N | N | Note 1,4 | |
| Intra-operative (Specify*) | |||||||||
| Intra-operative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | N | N | N | N | N | N | N | Note 1,4 | |
| Small Organ (Specify**) | N | N | N | N | N | N | Note 1,4 | ||
| Neonatal Cephalic | N | N | N | N | N | N | N | Note 1,4 | |
| Fetal | |||||||||
| Imaging & | Adult Cephalic | N | N | N | N | N | N | N | Note 1,4 |
| Other | Trans-rectal | N | N | N | N | N | N | Note 1,4 | |
| Trans-vaginal | N | N | N | N | N | N | Note 1,4 | ||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card.) | |||||||||
| Musculo-skeletal | |||||||||
| (Conventional) | N | N | N | N | N | N | Note 1,4 | ||
| Musculo-skeletal | |||||||||
| (Superficial) | N | N | N | N | N | N | Note 1,4 | ||
| Intravascular | |||||||||
| Cardiac Adult | N | N | N | N | N | N | N | Note 1,4 | |
| Cardiac Pediatric | N | N | N | N | N | N | N | Note 1,4 | |
| Cardiac | Intravascular (Cardiac) | ||||||||
| Trans-esoph. (Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Peripheral | Peripheral vessel | N | N | N | N | N | N | Note 1,4 | |
| vessel | Other (Specify***) | N | N | N | N | N | N | Note 1,4 | |
| 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
Navi s/e/X
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
C5-1B
Navi s/e/X Diagnostic Ultrasound System
Navi s/e/X
Probe:
System:
Intended Use:
Diagnostic Ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| General | |||||||||
| (Track 1 | |||||||||
| Only) | Specific (Track 1 & 3) | B | M | PWD | CWD | Color | |||
| Doppler | Amplitude | ||||||||
| Doppler | Combined | ||||||||
| (specify) | Other (specify) | ||||||||
| Ophthalmic | Ophthalmic | ||||||||
| Fetal | N | N | N | N | N | N | Note 1, 4 | ||
| Abdominal | N | N | N | N | N | N | Note 1, 4 | ||
| Intra-operative (Specify*) | |||||||||
| Intra-operative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | N | N | N | N | N | N | Note 1, 4 | ||
| Small Organ (Specify**) | |||||||||
| Neonatal Cephalic | |||||||||
| Fetal Imaging | Adult Cephalic | ||||||||
| & Other | 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 | |||||||||
| Peripheral | Peripheral vessel | N | N | N | N | N | N | Note 1, 4 | |
| 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.
**Small organ-breast, thyroid, testes.
***Other use includes Urology.
Note1: Tissue Harmonic Imaging. The feature does not use contrast agents.
6
Navi s/e/X
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
L15-4B
Navi s/e/X
Probe:
Intended Use:
System:
Navi s/e/X Diagnostic Ultrasound System
Diagnostic Ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| General | ||||||||||
| (Track 1 | ||||||||||
| Only) | Specific (Track 1 & 3) | B | M | PWD | CWD | Color | ||||
| Doppler | Amplitude | |||||||||
| Doppler | Combined | |||||||||
| (specify) | Other (specify) | |||||||||
| Ophthalmic | Ophthalmic | |||||||||
| Fetal | ||||||||||
| Abdominal | N | N | N | N | N | N | Note 1, 4 | |||
| Intra-operative (Specify*) | ||||||||||
| Intra-operative (Neuro) | ||||||||||
| Laparoscopic | ||||||||||
| Pediatric | N | N | N | N | N | N | Note 1, 4 | |||
| Small Organ (Specify**) | N | N | N | N | N | N | Note 1, 4 | |||
| Neonatal Cephalic | N | N | N | N | N | N | Note 1, 4 | |||
| Fetal Imaging | Adult Cephalic | |||||||||
| & Other | Trans-rectal | |||||||||
| Trans-vaginal | ||||||||||
| Trans-urethral | ||||||||||
| Trans-esoph. (non-Card.) | ||||||||||
| Musculo-skeletal | ||||||||||
| (Conventional) | N | N | N | N | N | N | N | Note 1, 4 | ||
| Musculo-skeletal | N | N | N | N | N | N | Note 1, 4 | |||
| (Superficial) | ||||||||||
| Intravascular | ||||||||||
| Cardiac Adult | ||||||||||
| Cardiac Pediatric | ||||||||||
| Cardiac | Intravascular (Cardiac) | |||||||||
| Trans-esoph. (Cardiac) | ||||||||||
| Intra-cardiac | ||||||||||
| Peripheral | Peripheral vessel | N | N | N | N | N | N | N | Note 1, 4 | |
| 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.
**Small organ-breast, thyroid, testes.
***Other use includes Urology.
8
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
P4-1
Navi s/e/X
System:
Probe:
Intended Use: Diagnostic Ultrasound imaging or fluid flow analysis of the human body as follows:
Navi s/e/X Diagnostic Ultrasound System
| Clinical Application | Mode of Operation | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| General | ||||||||||
| (Track 1 | ||||||||||
| Only) | Specific (Track 1 & 3) | B | M | PWD | CWD | Color | ||||
| Doppler | Amplitude | |||||||||
| Doppler | Combined | |||||||||
| (specify) | Other (specify) | |||||||||
| Ophthalmic | Ophthalmic | |||||||||
| Fetal | ||||||||||
| Abdominal | N | N | N | N | N | N | N | Note 1,4 | ||
| Intra-operative (Specify*) | ||||||||||
| Intra-operative (Neuro) | ||||||||||
| Laparoscopic | ||||||||||
| Pediatric | N | N | N | N | N | N | N | Note 1,4 | ||
| Small Organ (Specify**) | ||||||||||
| Neonatal Cephalic | N | N | N | N | N | N | N | Note 1,4 | ||
| Fetal Imaging | ||||||||||
| & Other | Adult Cephalic | N | N | N | N | N | N | N | Note 1,4 | |
| 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 1,4 | ||
| Cardiac Pediatric | N | N | N | N | N | N | N | Note 1,4 | ||
| Cardiac | Intravascular (Cardiac) | |||||||||
| Trans-esoph. (Cardiac) | ||||||||||
| Intra-cardiac | ||||||||||
| Peripheral | ||||||||||
| 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
Navi s/e/X
*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
Navi s/e/X
System:
Probe: LH15-6
Intended Use: Diagnostic Ultrasound imaging or fluid flow analysis of the human body as follows:
Navi s/e/X Diagnostic Ultrasound System
| Clinical Application | Mode of Operation | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| General | ||||||||||
| (Track 1 | ||||||||||
| Only) | Specific (Track 1 & 3) | B | M | PWD | CWD | Color | ||||
| Doppler | Amplitude | |||||||||
| Doppler | Combined | |||||||||
| (specify) | Other (specify) | |||||||||
| Ophthalmic | Ophthalmic | |||||||||
| Fetal | ||||||||||
| Abdominal | N | N | N | N | N | N | Note 1,4 | |||
| Intra-operative (Specify*) | N | N | N | N | N | N | Note 1,4 | |||
| Intra-operative (Neuro) | ||||||||||
| Laparoscopic | ||||||||||
| Pediatric | N | N | N | N | N | N | Note 1,4 | |||
| Small Organ (Specify**) | N | N | N | N | N | N | Note 1,4 | |||
| Neonatal Cephalic | N | N | N | N | N | N | Note 1,4 | |||
| 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 | |||
| Musculo-skeletal | ||||||||||
| (Superficial) | N | N | N | N | N | N | Note 1,4 | |||
| Intravascular | ||||||||||
| Cardiac Adult | ||||||||||
| Cardiac Pediatric | ||||||||||
| Cardiac | Intravascular (Cardiac) | |||||||||
| Trans-esoph. (Cardiac) | ||||||||||
| Intra-cardiac | ||||||||||
| Peripheral | ||||||||||
| vessel | Peripheral vessel | N | N | N | N | N | N | Note 1,4 | ||
| Other (Specify***) |
Additional comments: Combined modes--B+M, PW+B, Color + B, PW +Color+ B, Power + PW +B.
*Intraoperative includes abdominal, thoracic, and vascular etc.
12
Navi s/e/X
**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
Navi s/e/X
System:
EV10-4 Probe:
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Intended Use:
Navi s/e/X Diagnostic Ultrasound System
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| General | |||||||||
| (Track 1 | |||||||||
| Only) | Specific (Track 1 & 3) | B | M | PWD | CWD | Color | |||
| Doppler | Amplitude | ||||||||
| Doppler | Combined | ||||||||
| (specify) | Other (specify) | ||||||||
| Ophthalmic | Ophthalmic | ||||||||
| Fetal | N | N | N | N | N | N | Note 1,4 | ||
| 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 | ||
| Trans-vaginal | N | N | N | N | N | N | Note 1,4 | ||
| 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 | |||||||||
| Peripheral | |||||||||
| vessel | Peripheral vessel | ||||||||
| Other (Specify***) | N | N | N | N | N | N | Note 1,4 | ||
| 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
Navi s/e/X
*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
C7-2
Navi s/e/X
Probe:
System:
Intended Use:
Navi s/e/X Diagnostic Ultrasound System
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| General | |||||||||
| (Track 1 | |||||||||
| Only) | Specific (Track 1 & 3) | B | M | PWD | CWD | Color | |||
| Doppler | Amplitude | ||||||||
| Doppler | Combined | ||||||||
| (specify) | Other (specify) | ||||||||
| Ophthalmic | Ophthalmic | ||||||||
| Fetal | N | N | N | N | N | N | Note 1, 4 | ||
| Abdominal | N | N | N | N | N | N | Note 1, 4 | ||
| Intra-operative (Specify*) | |||||||||
| Intra-operative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | N | N | N | N | N | N | Note 1, 4 | ||
| Small Organ (Specify**) | |||||||||
| Neonatal Cephalic | |||||||||
| Fetal Imaging | |||||||||
| & Other | 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 | |||||||||
| Peripheral | |||||||||
| vessel | Peripheral vessel | N | N | N | N | N | N | Note 1, 4 | |
| 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.
16
Navi s/e/X
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)
17
Navi s/e/X Diagnostic Ultrasound System
Navi s/e/X
Probe: L15-4NB
Intended Use:
System:
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| General | ||||||||||
| (Track 1 | ||||||||||
| Only) | Specific (Track 1 & 3) | B | M | PWD | CWD | Color | ||||
| Doppler | Amplitude | |||||||||
| Doppler | Combined | |||||||||
| (specify) | Other (specify) | |||||||||
| Ophthalmic | Ophthalmic | |||||||||
| Fetal | ||||||||||
| Abdominal | N | N | N | N | N | N | Note 1, 4 | |||
| Intra-operative (Specify*) | ||||||||||
| Intra-operative (Neuro) | ||||||||||
| Laparoscopic | ||||||||||
| Pediatric | N | N | N | N | N | N | Note 1, 4 | |||
| Small Organ (Specify**) | N | N | N | N | N | N | Note 1, 4 | |||
| Neonatal Cephalic | N | N | N | N | N | N | Note 1, 4 | |||
| 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 | |||
| Musculo-skeletal | ||||||||||
| (Superficial) | N | N | N | N | N | N | Note 1, 4 | |||
| Intravascular | ||||||||||
| Cardiac Adult | ||||||||||
| Cardiac Pediatric | ||||||||||
| Cardiac | Intravascular (Cardiac) | |||||||||
| Trans-esoph. (Cardiac) | ||||||||||
| Intra-cardiac | ||||||||||
| Peripheral | ||||||||||
| vessel | Peripheral vessel | N | N | N | N | N | N | Note 1, 4 | ||
| 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.
18
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)
19
C8-3
Navi s/e/X
Probe:
System:
Intended Use:
Navi s/e/X Diagnostic Ultrasound System
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| General | |||||||||
| (Track 1 | |||||||||
| Only) | Specific (Track 1 & 3) | B | M | PWD | CWD | Color | |||
| Doppler | Amplitude | ||||||||
| Doppler | Combined | ||||||||
| (specify) | Other (specify) | ||||||||
| Ophthalmic | Ophthalmic | ||||||||
| Fetal | N | N | N | N | N | N | Note 1, 4 | ||
| Abdominal | N | N | N | N | N | N | Note 1, 4 | ||
| Intra-operative (Specify*) | |||||||||
| Intra-operative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | N | N | N | N | N | N | Note 1, 4 | ||
| Small Organ (Specify**) | |||||||||
| Neonatal Cephalic | |||||||||
| Fetal Imaging | |||||||||
| & Other | 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 | |||||||||
| Peripheral | |||||||||
| vessel | Peripheral vessel | N | N | N | N | N | N | Note 1, 4 | |
| 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.
20
Navi s/e/X
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)
21
Image /page/21/Picture/0 description: The image shows the word "wisonic" in red font. The font is bold and sans-serif. The word is slightly blurred, suggesting that the image may have been taken out of focus or that the original image was of low resolution. The background is white.
510(k) Summary
In accordance with 21 CFR 807.92 the following summary of information is provided:
-
- SUBMITTER
Product Code:
- SUBMITTER
Model
Classification Name
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
| Contact Person: | Xiaosan Jiang |
|---|---|
| Regulatory Engineer | |
| Shenzhen Wisonic Medical Technology Co., LTD. | |
| Tel: (+86)-755 86007788-8003 | |
| Fax: (+86)-755 86007799 | |
| Date prepared | Feb 7, 2018 |
| 2. DEVICE | |
| Device Name: | Navi e/ Navi s/ Navi X Diagnostic Ultrasound System |
| Common/Usual Name: | Diagnostic Ultrasound System |
| Regulation number | 21 CFR 892.1550 |
| Regulation Name | Ultrasonic pulsed doppler imaging system |
| Regulation Class: | II |
3. PREDICATE/ REFERENCE DEVICE
Predicate device:K143475, TE7 Diagnostic Ultrasound System Reference device 1:K131690, M7/M7T Diagnostic Ultrasound System
IYN, ITX, IYO
Navi e/ Navi s/ Navi X
System, Imaging, Pulsed Doppler, Ultrasonic
22
nce device 2:K140254,EZONO 4000 Ultrasound System Reference device 3:K161999,AIXPLORER® Ultrasound Diagnostic System The predicate device and reference devices have not been subject to a design-related recall.
4. DEVICE DESCRIPTION
The Navi e/ Navi s/Navi X 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-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 Navi e/ Navi x/Navi X Diagnostic Ultrasound System consists of the main unit named Navi series, ultrasound probes, power adapter, connecting cable, probe extender, needle-guided bracket, batteries, mobile trolley, ECG module and batteries
Three models for the main units are included in this submission, that is Navi s, Navi e and Navi X. Eight different models of probes are available for the Navi series.
5. INDICATIONS FOR USE
The Navi e/ Navi s/Navi X ultrasonic diagnostic 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.
23
Image /page/23/Picture/0 description: The image shows the word "wisonic" in red font. The font is bold and sans-serif. The letters are closely spaced together. There are three small dots above the "i" in "wisonic".
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE 6. DEVICE
Navi e/s/X ultrasonic diagnostic system is comparable with and substantially equivalent to these predicate devices:
| Predicate Device | Manufacturer | Model | 510(k) Control Number |
|---|---|---|---|
| Predicate | Mindray | TE7 | K143472 |
| Reference device 1 | EZONO AG | EZONO 4000 | K140254 |
| Reference device 2 | Mindray | M7/M7T | K100830 |
| Reference device 3 | Supersonic | Aixplorer | K161999 |
Compared to the predicate devices TE7 (K143472),
The proposed device has the same intended uses, except for trans-esoph (Cardiac). The Navi e/Navi s/Navi X do not support trans-esoph (Cardiac) application. The intended use of Navi e/Navi s/Navi X is smaller than that of TE7.
The proposed device has the same structure. The clinical application is the same, and the performance is similar.
The proposed device has the same image scan mode, probe types and image parameters.
The proposed device has the same probe ports.
The proposed device has the same capability in term of measurements and calculation functions .
The proposed device has the same function, except for Needle Guide System(NGS), which 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 K140254.
This difference in technological characteristics do not raise different questions of safety and effectiveness as compared to the predicate device.
7. NON-CLINICAL DATA
24
non-clinical data were provided in support of the substantial equivalence determination.
Biocompatibility testing
The biocompatibility evaluation for the Double Electric Breast Pump 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:
- Cytotoxicity
- Sensitization
- Skin Irritation
The ultrasonic probes and glue of the 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 the 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 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.
Acoustic output measurement and real time display function were evaluated in the Ultrasonic Diagnostic System, according to the standards NEMA UD 2:2004, Acoustic
25
urement Standard for Diagnostic Ultrasound Equipment, and NEMA UD 3:2004, Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment, respectively. All the device met the requirements.
The performance of the device was compared with the predicate devices, 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, Navi e/Navi X Diagnostic Ultrasound System, does not require animal studies to support substantial equivalence.
8. CLINICAL DATA
The subject of this premarket submission, Navi e/Navi X Diagnostic Ultrasound System, did not require clinical studies to support substantial equivalence.
9. CONCLUSION
The differences between the Navi e/Navi x/Navi X 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 Navi e/Navi x 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 Navi e/Navi X Diagnostic Ultrasound System is as safe and as effective as the predicate devices.