TE7/TE5 Diagnostic Ultrasound System

K180912 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · IYN · Jul 30, 2018 · Radiology

Device Facts

• Record ID: K180912
• Device Name: TE7/TE5 Diagnostic Ultrasound System
• Applicant: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
• Product Code: IYN · Radiology
• Decision Date: Jul 30, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1550
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

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

Device Story

The TE7/TE5 Diagnostic Ultrasound System is a software-controlled diagnostic ultrasound device used in clinical settings by healthcare professionals. It utilizes an array of probes (linear, convex, phased) to transmit ultrasonic energy into the body and process received echoes. The system displays anatomical structures and fluid flow in various modes, including B-Mode, M-Mode, PW-Mode, CW-Mode, Color-Mode, Power/Dirpower Mode, THI, LVO, Color M, Smart 3D, and TDI. It supports combined modes such as B/M, B/PW, and B/PW/Color. The device assists clinicians in diagnostic imaging and fluid flow analysis, facilitating clinical decision-making through real-time visualization and measurement of internal structures. It includes features like needle-guided brackets, eSpacial Navi, Auto EF, and contrast imaging for liver applications, providing diagnostic benefits across a wide range of patient populations and clinical applications.

Clinical Evidence

No clinical data. Substantial equivalence is supported by non-clinical bench testing, including acoustic output measurements, biocompatibility, cleaning/disinfection effectiveness, and electrical/mechanical safety testing in compliance with recognized standards (e.g., IEC 60601-1, IEC 60601-2-37, ISO 10993-1).

Technological Characteristics

Ultrasonic pulsed doppler/echo imaging system. Employs linear, convex, and phased array transducers. Features include B-Mode, M-Mode, PW/CW-Doppler, Color/Amplitude Doppler, THI, LVO, Color M, Smart 3D, TDI, and eSpacial Navi. Software-controlled; complies with IEC 60601-1, IEC 60601-1-2, and IEC 60601-2-37. Biocompatible materials per ISO 10993-1. Connectivity and form factor consistent with standard diagnostic ultrasound systems.

Indications for Use

Indicated for adults, pregnant women, pediatric patients, and neonates. Intended for use in fetal, abdominal, intra-operative (abdominal, thoracic, and vascular), pediatric, small organ (breast, thyroid, testes), neonatal and adult cephalic, trans-esophageal (cardiac), trans-rectal, trans-vaginal, musculo-skeletal (conventional, superficial), urology, peripheral vessel, adult and pediatric cardiac, and ophthalmic 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

• TE7 (K161525)

Reference Devices

• ZS3 (K171891)
• DC-70 (K163690)
• eZono 4000 (K140254)
• Resona 7 (K171233)
• M9 (K171034)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA text logo on the right. The FDA text logo is in blue and reads "FDA U.S. FOOD & DRUG ADMINISTRATION".

July 30th, 2018 Shenzhen Mindray Bio-Medical Electronics Co., Ltd. % Yang ZhaoHui Engineer of Technical Regulation Depart Mindray Building, Keji 12th Road South, Hi-tech Industrial Park Nanshan Shenzhen, Guangdong 518057 P.R. CHINA

Re: K180912

Trade/Device Name: TE7/TE5 Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: July 4, 2018 Received: July 9, 2018

Dear Yang ZhaoHui:

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);

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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 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,

Jeff Ballegoo

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

Enclosure

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## Indications for Use

510(k) Number (if known)

K180912

Device Name TE7/TE5 Diagnostic Ultrasound System

Indications for Use (Describe)

TE7/TE5 Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetal, abdominal, Intra-operative(abdominal, thoracic, and vascular), Pediatric ,small organ(breast, thyroid. testes), neonatal and adult cephalic. trans-esoph. (Cardiac), trans-vaginal, musculo-skeletal (conventional, superficial), urology, Peripheral vessel, Adult and Pediatric cardiac, ophthalmic exams.

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

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# TE7/TE5 Diagnostic Ultrasound Indications For Use For Use Format
TE7/TE5 Diagnostic Ultrasound System

System:
Transducer:

N/A

| Intended Use: | Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows | |
|----------------------|-----------------------------------------------------------------------------------|-------------------|
| Clinical Application | | Mode of Operation |

| Clinical Application | | Mode of Operation | | | | | | | | | |
|-------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------|-------------------|-------------------|-----|--------------------------------------|--------------------------------------|-----------------------|-----------------------|--------------------|--|
| General (Track<br>1 Only) | Specific (Track 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Combined<br>(specify) | Other<br>(specify) | | |
| Ophthalmic | Ophthalmic | N | N | N | | N | N | N | Note 1,2,6 | | |
| Fetal Imaging<br>& Other | Fetal | P | P | P | | P | P | P | Note 1,2,5 | | |
| | Abdominal | P | P | P | P | P | P | P | Note 1,2,5,6,7,8 | | |
| | Intra-operative (Specify* | P | P | P | | P | P | P | Note 1,2 | | |
| | Intra-operative (Neuro) | | | | | | | | | | |
| | Laparoscopic | | | | | | | | | | |
| | Pediatric | P | P | P | P | P | P | P | Note 1,2,5,6,8 | | |
| | Small Organ (Specify**) | P | P | P | | P | P | P | Note 1,2,6,8 | | |
| | Neonatal Cephalic | P | P | P | P | P | P | P | Note 1,2,5 | | |
| | Adult Cephalic | P | P | P | P | P | P | P | Note 1,2,5 | | |
| | Trans-rectal | P | P | P | | P | P | P | Note 1,2,5 | | |
| | Trans-vaginal | P | P | P | | P | P | P | Note 1,2,5 | | |
| | Trans-urethral | | | | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | | | | |
| | Musculo-skeletal<br>(Conventional) | P | P | P | | P | P | P | Note 1,2,5,6,8 | | |
| | Musculo-skeletal<br>(Superficial) | P | P | P | | P | P | P | Note 1,2,6,8 | | |
| | Intravascular | | | | | | | | | | |
| Cardiac | Cardiac Adult | P | P | P | P | P | P | P | Note 1,2,3,4,5 | | |
| | Cardiac Pediatric | P | P | P | P | P | P | P | Note 1,2,4,5 | | |
| | Intravascular (Cardiac) | | | | | | | | | | |
| | Trans-esoph. (Cardiac) | P | P | P | P | P | P | P | Note 1,4,5 | | |
| | Intra-cardiac | | | | | | | | | | |
| Peripheral<br>vessel | Peripheral vessel | P | P | P | P | P | P | P | Note 1,2,5,6,8 | | |
| | Other (Specify***) | P | P | P | P | P | P | P | Note 1,2,5 | | |
| N=new indication; P=previously cleared by FDA (K161525) ; E=added under Appendix E | | | | | | | | | | | |
| 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. | | | | | | | | | | | |
| Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents. | | | | | | | | | | | |
| Note2: Biopsy Guidance | | | | | | | | | | | |
| Note3: Contrast imaging (Contrast agent for LVO) | | | | | | | | | | | |
| Note4: TDI | | | | | | | | | | | |
| Note5: Color M | | | | | | | | | | | |
| Note6: Smart 3D | | | | | | | | | | | |
| Note7: Contrast imaging (Contrast agent for Liver) | | | | | | | | | | | |
| Note8: eSpacial Navi | | | | | | | | | | | |
| (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED) | | | | | | | | | | | |
| Concurrence of CDRH, Office of Device Evaluation(ODE) | | | | | | | | | | | |
| Clinical Application | | | | | | Mode of Operation | | | | | |
| General (Track 1 Only) | Specific (Track 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Combined<br>(specify) | Other<br>(specify) | | |
| Ophthalmic | Ophthalmic | | | | | | | | | | |
| | Fetal | | | | | | | | | | |
| | Abdominal | P | P | P | | P | P | P | Note 1,2,5 | | |
| | Intra-operative (Specify*) | | | | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | | | | |
| | Laparoscopic | | | | | | | | | | |
| | Pediatric | P | P | P | | P | P | P | Note 1,2,5 | | |
| | Small Organ (Specify**) | | | | | | | | | | |
| | Neonatal Cephalic | P | P | P | | P | P | P | Note 1,2,5 | | |
| | Adult Cephalic | | | | | | | | | | |
| Fetal Imaging<br>& Other | Trans-rectal | | | | | | | | | | |
| | Trans-vaginal | | | | | | | | | | |
| | Trans-urethral | | | | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | | | | |
| | Musculo-skeletal<br>(Conventional) | | | | | | | | | | |
| | Musculo-skeletal<br>(Superficial) | | | | | | | | | | |
| | Intravascular | | | | | | | | | | |
| | Cardiac Adult | | | | | | | | | | |
| Cardiac | Cardiac Pediatric | P | P | P | | P | P | P | Note 1,2,5 | | |
| | Intravascular (Cardiac) | | | | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | | | | |
| | Intra-cardiac | | | | | | | | | | |
| Peripheral<br>vessel | Peripheral vessel | P | P | P | | P | P | P | Note 1,2,5 | | |
| | Other (Specify***) | | | | | | | | | | |
| | N=new indication; P=previously cleared by FDA | | | | | (K161525) ; E=added under Appendix E | | | | | |
| | 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. | | | | | | | | | | |
| | Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents. | | | | | | | | | | |
| | Note2: Biopsy Guidance | | | | | | | | | | |
| | Note3: Contrast imaging (Contrast agent for LVO) | | | | | | | | | | |
| | Note4: TDI | | | | | | | | | | |
| | Note5: Color M | | | | | | | | | | |
| | Note6: Smart 3D | | | | | | | | | | |
| | Note7: Contrast imaging (Contrast agent for Liver) | | | | | | | | | | |
| | Note8: eSpacial Navi | | | | | | | | | | |
| | (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED) | | | | | | | | | | |
| | Concurrence of CDRH, Office of Device Evaluation(ODE) | | | | | | | | | | |
| Clinical Application | | | | Mode of Operation | | | | | | | |
| General (Track<br>1 Only) | Specific (Track 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Combined<br>(specify) | Other<br>(specify) | | |
| Ophthalmic | Ophthalmic | | | | | | | | | | |
| | Fetal | P | P | P | | P | P | P | Note 1,2,5 | | |
| | Abdominal | P | P | P | | P | P | P | Note 1,2,5,7 | | |
| | Intra-operative (Specify* | | | | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | | | | |
| | Laparoscopic | | | | | | | | | | |
| | Pediatric | P | P | P | | P | P | P | Note 1,2,5 | | |
| | Small Organ (Specify**) | | | | | | | | | | |
| | Neonatal Cephalic | | | | | | | | | | |
| Fetal Imaging | Adult Cephalic | | | | | | | | | | |
| & Other | 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 | Peripheral vessel | P | P | P | | P | P | P | Note 1,2,5 | | |
| vessel | Other (Specify***) | | | | | | | | | | |
| | N=new indication; P=previously cleared by FDA | | | | | (K161525) ; E=added under Appendix E | | | | | |
| | 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. | | | | | | | | | | |
| | Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents. | | | | | | | | | | |
| | Note2: Biopsy Guidance | | | | | | | | | | |
| | Note3: Contrast imaging (Contrast agent for LVO) | | | | | | | | | | |
| | Note4: TDI | | | | | | | | | | |
| | Note5: Color M | | | | | | | | | | |
| | Note6: Smart 3D | | | | | | | | | | |
| | | Note7: Contrast imaging (Contrast agent for Liver) | | | | | | | | | |
| | Note8: eSpacial Navi | | | | | | | | | | |
| | (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED) | | | | | | | | | | |
| | Clinical Application | | Mode of Operation | | | | | | | | |
| | General (Track<br>1 Only) | Specific (Track 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Combined<br>(specify) | Other<br>(specify) | |
| Ophthalmic | | Ophthalmic | | | | | | | | | |
| | | Fetal | | | | | | | | | |
| | | Abdominal | | | | | | | | | |
| | | Intra-operative (Specify* | | | | | | | | | |
| | Fetal Imaging<br>& Other | Intra-operative (Neuro) | | | | | | | | | |
| | | Laparoscopic | | | | | | | | | |
| | | Pediatric | | | | | | | | | |
| | | 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) | P | P | P | P | P | P | P | Note 1,4,5 | |
| | Peripheral<br>vessel | Intra-cardiac | | | | | | | | | |
| | | Peripheral vessel | | | | | | | | | |
| | | Other (Specify***) | | | | | | | | | |
| | | N=new indication; P=previously cleared by FDA | | | | | (K161525) ; E=added under Appendix E | | | | |
| | | Additional comments: Combined modes--B+M, PW+B, Color + B, Power+B, PW+Color+B, Power + PW +B. | | | | | | | |…