Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary does not mention AI, ML, deep learning, or any related terms, and the device description focuses on standard ultrasound modes and image processing.

Therapeutic

No
The device is described as an "ultrasonic diagnostic system" intended to "acquire and display ultrasound data" and "generate onscreen display of anatomic structures and fluid flow within the body." Its purpose is diagnostic imaging, not treatment or therapy.

Diagnostic

Yes

Explanation: The "Intended Use / Indications for Use" section explicitly states "TE7 Diagnostic Ultrasound System is applicable for adults, pregnant women and neonates." and the "Device Description" section states "TE7 is a software controlled, ultrasonic diagnostic system." These statements confirm its purpose in diagnosis.

SaMD (Software as a Medical Device)

No

The device is described as a "software controlled, ultrasonic diagnostic system" that employs "an array of probes." This indicates the device includes hardware components (the probes and the system itself) in addition to the software control. The performance studies also mention testing for acoustic output, biocompatibility, and electrical/mechanical safety, which are relevant to hardware components.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside the body.
Device Function: The description clearly states that the TE7 Diagnostic Ultrasound System uses ultrasound to "acquire and display ultrasound data" and "generate onscreen display of anatomic structures and fluid flow within the body." This is a form of in vivo (within the living body) imaging.
Intended Use: The intended use lists various anatomical sites and patient populations for ultrasound imaging, all of which involve examining the body directly.

Therefore, the TE7 Diagnostic Ultrasound System is a medical imaging device, not an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

TE7 Diagnostic Ultrasound System is applicable for adults, pregnant woments 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-raginal, musculo-skeletal(conventional, superficial), urology,Peripheral vessel, Adult and Pediatric cardiac exams.

Product codes (comma separated list FDA assigned to the subject device)

IYN, IYO, ITX

Device Description

TE7 is a software controlled, ultrasonic diagnostic system. Its function is to acquire and display ultrasound data in B-Mode, M-Mode, PW-Mode, CW-Mode, Power/Dirpower Mode, THI, LVO or the combined mode (i.e. Color-Mode , B/M-Mode, B/PW-mode, B/PW/Color).

This system is a Track 3 device that employs an array of probes that include linear array and convex array with a frequency range of approximately 3.0 MHz to 10.0 MHz.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasound

Anatomical Site

Fetal, abdominal, Intra-operative (abdominal, thoracic, and vascular), Pediatric, small organ (breast, thyroid, testes), neonatal and adult cephalic, trans-esoph. (Cardiac), trans-rectal, trans-vaginal, musculo-skeletal (conventional, superficial), urology, Peripheral vessel, Adult and Pediatric cardiac exams.

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)

Not applicable. The subject of this submission, TE7 Diagnostic Ultrasound System, does not require clinical studies to support substantial equivalence.

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.

K141010, K131690

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.

Not Found

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

Regulation Number and Section

§ 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.

Summary

0

Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized image of three human profiles facing to the right, stacked on top of each other.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

Shenzhen Mindray Bio-Medical Electronics Co., Ltd. % Mr. Mark Job Regulatory Technology Services, LLC 1394 25th Street NW BUFFALO MN 55313

January 2, 2015

Re: K143472

Trade/Device Name: TE7 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: October 31, 2014 Received: December 5, 2014

Dear Mr. Job:

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 mav 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 (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); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

1

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Michael D.'Hara for

Janine Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

2

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.

510(k) Number (if known)

K143472

Device Name TE7

Indications for Use (Describe)

TE7 Diagnostic Ultrasound System is applicable for adults, pregnant woments 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-raginal, musculo-skeletal(conventional, superficial), urology,Peripheral vessel, Adult and Pediatric cardiac 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)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

3

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.qov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

4

Diagnostic Ultrasound Indications For Use Format

System: TE7 Diagnostic Ultrasound System

Transducer: N/A

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

Clinical Application		Mode of Operation
General
(Track 1
Only)	Specific (Track 1 & 3)	B	M	PWD	CWD	Color
Doppler	Amplitu
de
Doppler	Combine
d
(specify)	Other
(specify)
Ophthalmic	Ophthalmic
	Fetal	N	N	N	N	N	N	N	Note 1,2
	Abdominal	N	N	N	N	N	N	N	Note 1,2
	Intra-operative (Specify*)	N	N	N	N	N	N	N	Note 1,2
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	N	N	N	N	N	N	N	Note 1,2
	Small Organ (Specify**)	N	N	N	N	N	N	N	Note 1,2
	Neonatal Cephalic	N	N	N	N	N	N	N	Note 1,2
Fetal
Imaging &	Adult Cephalic	N	N	N	N	N	N	N	Note 1,2
Other	Trans-rectal	N	N	N	N	N	N	N	Note 1,2
	Trans-vaginal	N	N	N	N	N	N	N	Note 1,2
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal
(Conventional)	N	N	N	N	N	N	N	Note 1,2
	Musculo-skeletal
(Superficial)	N	N	N	N	N	N	N	Note 1,2
	Intravascular
	Cardiac Adult	N	N	N	N	N	N	N	Note 1,2,3
	Cardiac Pediatric	N	N	N	N	N	N	N	Note 1,2
Cardiac	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)	N	N	N	N	N	N	N	Note 1
	Intra-cardiac
Peripheral	Peripheral vessel	N	N	N	N	N	N	N	Note 1,2
vessel	Other (Specify***)	N	N	N	N	N	N	N	Note 1,2
	N=new indication; P=previously cleared by FDA; E=added under Appendix E
	Additional comments: Combined modes--B+M、PW+B、Color + B、Power + B、PW +Color+B、Power
	* 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)
	(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
	Concurrence of CDRH, Office of Device Evaluation(ODE)
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
de
Doppler	Combined
(specify)	Other
(specify)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal	P	P	P		P	P	P	Note 1,2
	Intra-operative (Specify*)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	P	P	P		P	P	P	Note 1,2
	Small Organ (Specify**)
	Neonatal Cephalic	P	P	P		P	P	P	Note 1,2
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	P	P	P		P	P	P	Note 1,2
Cardiac	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
Peripheral	Peripheral vessel	P	P	P		P	P	P	Note 1,2
vessel	Other (Specify***)
N=new indication; P=previously cleared by FDA(K141010); E=added under Appendix E
Additional comments: Combined modes--B+M、PW+B、Color + B、Power + B、PW+Color+B、Power
*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)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
Concurrence of CDRH, Office of Device Evaluation(ODE)
Prescription USE (Per 21 CFR 801.109)
Clinical Application		Mode of Operation
General
(Track 1
Only)	Specific (Track 1 & 3)	B	M	PWD	CWD	Color
Doppler	Amplitu
de
Doppler	Combine
d
(specify)	Other
(specify)
Ophthalmic	Ophthalmic
	Fetal	P	P	P		P	P	P	Note 1,2
	Abdominal	P	P	P		P	P	P	Note 1,2
	Intra-operative (Specify*)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	P	P	P		P	P	P	Note 1,2
	Small Organ (Specify**)
	Neonatal Cephalic
Fetal	Adult Cephalic
Imaging &
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	P	P	P		P	P	P	Note 1,2
vessel	Other (Specify***)
	N=new indication; P=previously cleared by FDA(K131690); E=added under Appendix E
	Additional comments: Combined modes--B+M、PW+B、Color + B、Power + B、PW+Color+B、Power
*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)
	(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
	Concurrence of CDRH, Office of Device Evaluation(ODE)
	Prescription USE (Per 21 CFR 801.109)
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	Amplitu
de
Doppler	Combine
d
(specify)	Other
(specify)
Ophthalmic	Ophthalmic
Fetal
Imaging &
Other	Fetal
	Abdominal
	Intra-operative (Specify*)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
	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)	P	P	P	P	P	P	P	Note 1
	Intra-cardiac
Peripheral
vessel	Peripheral vessel
	Other (Specify***)
N=new indication; P=previously cleared by FDA(K131690); E=added under Appendix E
Additional comments: Combined modes--B+M、PW+B、Color + B、Power + B、PW +Color+B、Power
*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)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
Concurrence of CDRH, Office of Device Evaluation(ODE)
Prescription USE (Per 21 CFR 801.109)
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	Amplitu
de
Doppler	Combined
(specify)	Other
(specify)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal	P	P	P		P	P	P	Note 1,2
	Intra-operative (Specify*)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	P	P	P		P	P	P	Note 1,2
	Small Organ (Specify**)	P	P	P		P	P	P	Note 1,2
	Neonatal Cephalic
Fetal
Imaging &	Adult Cephalic
Other	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal
(Conventional)	P	P	P		P	P	P	Note 1,2
	Musculo-skeletal
(Superficial)	P	P	P		P	P	P	Note 1,2
	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
vessel	Other (Specify***)
	N=new indication; P=previously cleared by FDA(K131690); E=added under Appendix E
	Additional comments: Combined modes--B+M、PW+B、Color + B、Power + B、PW+Color+ B、Power
	*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)
	(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
	Concurrence of CDRH, Office of Device Evaluation(ODE)
	Prescription USE (Per 21 CFR 801.109)

Prescription USE (Per 21 CFR 801.109)

5

System: TE7 Diagnostic Ultrasound System

Transducer: C11-3s

6

System: TE7 Diagnostic Ultrasound System

Transducer: C5-2s Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

7

System: TE7 Diagnostic Ultrasound System

Transducer: P7-3Ts

8

System:		TE7 Diagnostic Ultrasound System
---------	--	----------------------------------

Transducer: L12-4s

9

Clinical Application		Mode of Operation
General
(Track 1
Only)	Specific (Track 1 & 3)	B	M	PWD	CWD	Color
Doppler	Amplitu
de
Doppler	Combine
d
(specify)	Other
(specify)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal	P	P	P		P	P	P	Note 1,2
	Intra-operative (Specify*)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	P	P	P		P	P	P	Note 1,2
	Small Organ (Specify**)	P	P	P		P	P	P	Note 1,2
	Neonatal Cephalic
Fetal
Imaging &	Adult Cephalic
Other	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal	P	P	P		P	P	P	Note 1,2
	(Conventional)
	Musculo-skeletal
(Superficial)	P	P	P		P	P	P	Note 1,2
	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
vessel	Other (Specify***)
	N=new indication; P=previously cleared by FDA(K131690); E=added under Appendix E
	Additional comments: Combined modes--B+M、PW+B、Color + B、PW+Color+B、Power
	*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)
	(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
	Concurrence of CDRH, Office of Device Evaluation(ODE)
Prescription USE (Per 21 CFR 801.109)
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	Amplitu
de
Doppler	Combine
d
(specify)	Other
(specify)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal
	Intra-operative (Specify*)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	P	P	P		P	P	b	Note 1,2
	Small Organ (Specify**)	P	P	P		P	P	P	Note 1,2
	Neonatal Cephalic	P	P	P		P	P	b	Note 1,2
Fetal
Imaging &	Adult Cephalic
Other	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal
(Conventional)	P	P	P		P	P	P	Note 1,2
	Musculo-skeletal
(Superficial)	P	P	P		P	P	P	Note 1,2
	Intravascular
	Cardiac Adult
	Cardiac Pediatric
Cardiac	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
Peripheral	Peripheral vessel	P	P	P		P	P	b	Note 1,2
vessel	Other (Specify***)
	N=new indication; P=previously cleared by FDA(K131690); E=added under Appendix E
	Additional comments: Combined modes-B+M、PW+B、Color + B、PW+Color+B、Power
	* 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)
	(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
	Concurrence of CDRH, Office of Device Evaluation(ODE)
	Prescription USE (Per 21 CFR 801.109)
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
	Abdominal
	Intra-operative (Specify*)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	P	P	P		P	P	P	Note 1,2
	Small Organ (Specify**)	P	P	P		P	P	P	Note 1,2
	Neonatal Cephalic
Fetal
Imaging &
Other	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal
(Conventional)	P	P	P		P	P	P	Note 1,2
	Musculo-skeletal
(Superficial)	P	P	P		P	P	P	Note 1,2
	Intravascular
	Cardiac Adult
	Cardiac Pediatric
Cardiac	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
Peripheral
vessel	Peripheral vessel	P	P	P		P	P	P	Note 1,2
	Other (Specify***)
N=new indication; P=previously cleared by FDA(K131690); E=added under Appendix E
Additional comments: Combined modes--B+M、PW+B、Color + B、Power + B、PW+Color+B、Power
*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)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
Concurrence of CDRH, Office of Device Evaluation(ODE)
Prescription USE (Per 21 CFR 801.109)
Clinical Application		Mode of Operation
General
(Track 1
Only)	Specific (Track 1 & 3)	B	M	PWD	CWD	Color
Doppler	Amplitu
de
Doppler	Combine
d
(specify)	Other
(specify)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal	P	P	P	P	P	P	b	Note 1,2
	Intra-operative (Specify*)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	P	P	P	P	b	b	b	Note 1,2
	Small Organ (Specify**)
	Neonatal Cephalic	P	P	P	P	P	P	b	Note 1,2
Fetal
Imaging &	Adult Cephalic	P	P	P	P	P	b	b	Note 1,2
Other	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, 2,3
	Cardiac Pediatric	P	P	P	P	b	b	P	Note 1,2
Cardiac	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
Peripheral	Peripheral vessel
vessel	Other (Specify***)
	N=new indication; P=previously cleared by FDA(K131690); E=added under Appendix E
	Additional comments: Combined modes-B+M、PW+B、Color + B、PW +Color+B、Power
	*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)
	(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
	Concurrence of CDRH, Office of Device Evaluation(ODE)
	Prescription USE (Per 21 CFR 801.109)
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	Amplitu
de
Doppler	Combine
d
(specify)	Other
(specify)
Ophthalmic	Ophthalmic
Fetal
Imaging &
Other	Fetal	P	P	P		P	P	P	Note 1,2
	Abdominal
	Intra-operative (Specify*)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
	Small Organ (Specify**)
	Neonatal Cephalic
	Adult Cephalic
Other	Trans-rectal	P	P	P		P	P	P	Note 1,2
	Trans-vaginal	P	P	P		P	P	P	Note 1,2
	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***)	P	P	P		P	P	P	Note 1,2
	N=new indication; P=previously cleared by FDA(K141010); E=added under Appendix E
	Additional comments: Combined modes--B+M、PW+B、Color + B、Power + B、PW +Color+B、Power
	* 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)
	(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
	Concurrence of CDRH, Office of Device Evaluation(ODE)
	Prescription USE (Per 21 CFR 801.109)
Clinical Application		Mode of Operation
General
(Track 1
Only)	Specific (Track 1 & 3)	B	M	PWD	CWD	Color
Doppler	Amplitude
de
Doppler	Combined
(specify)	Other
(specify)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal	P	P	P		P	P	P	Note 1,2
	Intra-operative (Specify*)	P	P	P		P	P	P	Note 1,2
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	P	P	P		P	P	P	Note 1,2
	Small Organ (Specify**)	P	P	P		P	P	P	Note 1,2
	Neonatal Cephalic	P	P	P		P	P	P	Note 1,2
Fetal
Imaging &
Other	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal
(Conventional)	P	P	P		P	P	P	Note 1,2
	Musculo-skeletal
(Superficial)	P	P	P		P	P	P	Note 1,2
	Intravascular
	Cardiac Adult
	Cardiac Pediatric
Cardiac	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
Peripheral
vessel	Peripheral vessel	P	P	P		P	P	P	Note 1,2
	Other (Specify***)
	N=new indication; P=previously cleared by FDA(K131690); E=added under Appendix E
	Additional comments: Combined modes--B+M、PW+B、Color + B、Power + B、PW+Color+B、Power
	* 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)
	(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
	Concurrence of CDRH, Office of Device Evaluation(ODE)
Prescription USE (Per 21 CFR 801.109)

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

System: TE7 Diagnostic Ultrasound System

Transducer: L7-3s

10

System: TE7 Diagnostic Ultrasound System

Transducer: L14-6s

11

System: TE7 Diagnostic Ultrasound System

Transducer: L14-6Ns

12

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

System: TE7 Diagnostic Ultrasound System

Transducer: P4-2s

13

System: TE7 Diagnostic Ultrasound System

Transducer: V11-3Ws

14

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

System: TE7 Diagnostic Ultrasound System

Transducer: 7LT4s

15

510(K) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92(c).

The assigned 510(k) number is: _______________________________________________________________________________________________________________________________________________

1. Submitter:

Shenzhen Mindray Bio-medical Electronics Co., LTD Mindray Building, Keji 12th Road South, Hi-tech Industrial Park, Nanshan, Shenzhen, 518057, P. R. China

Tel: +86 755 8188 5640 Fax: +86 755 2658 2680

Contact Person:

Yang Zhaohui Shenzhen Mindray Bio-medical Electronics Co., LTD Mindray Building, Keji 12th Road South, Hi-tech Industrial Park, Nanshan, Shenzhen, 518057, P. R. China

October 29, 2014 Date Prepared:

2. Device Name: TE7 Diagnostic Ultrasound System

Classification

Regulatory Class: II

Review Category: Tier II

21 CFR 892.1550 Ultrasonic Pulsed Doppler Imaging System (IYN)

21 CFR 892.1560 Ultrasonic Pulsed Echo Imaging System (IYO)

21 CFR 892.1570 Diagnostic Ultrasound Transducer (ITX)

3. Device Description:

16

TE7 is a software controlled, ultrasonic diagnostic system. Its function is to acquire and display ultrasound data in B-Mode, M-Mode, PW-Mode, CW-Mode, Power/Dirpower Mode, THI, LVO or the combined mode (i.e. Color-Mode , B/M-Mode, B/PW-mode, B/PW/Color).

This system is a Track 3 device that employs an array of probes that include linear array and convex array with a frequency range of approximately 3.0 MHz to 10.0 MHz.

4. Intended Use:

TE7 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-rectal, trans-vaginal, musculo-skeletal(conventional, superficial), urology, Peripheral vessel, Adult and Pediatric cardiac exams.

5. Comparison with Predicate Devices:

TE7 Diagnostic Ultrasound System is comparable with and substantially equivalent to these predicate devices:

Predicate Device	Manufacturer	Model	510(k) Number	Control
1	Mindray	M9	K141010
2	Mindray	M7	K131690

TE7 has the same technological characteristics, is comparable in key safety and effectiveness features, and has the same intended uses and basic operating modes as the predicate devices. All systems transmit ultrasonic energy into patients and perform post processing of received echoes to generate onscreen display of anatomic structures and fluid flow within the body. All systems allow for specialized measurements of structures and flow, and calculations.

. Subject device TE7has the same intended uses as the predicated device M7(K131690)

17

Subject Device	Predicate device
TE7	M7(K131690)
TE7 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-rectal, trans-vaginal,
musculo-skeletal(conventional, superficial),
urology, Peripheral vessel, Adult and Pediatric
cardiac exams.	The M7/M7T 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), neonatal
cephalic, trans-cranial, cardiac, trans-vaginal,
trans-rectal, peripheral vascular, urology,
orthopedic, and muscular-skeletal (conventional
and superficial), Intra-operative and
Trans-esophageal (cardiac) exams.

All of the patient contact material of the TE7are the same as that of the predicated device M7(K131690).
The acoustic power levels of TE7 are below the limits of FDA, which is the same as the predicated device M7(K131690).
TE7 is designed in compliance with the FDA recognized electrical and physical safety standard, which is the same as the predicated device M7(K131690).
TE7 has the same imaging modes as the predicated device M7(K131690): B, M, Color Doppler, PWD, CWD, Amplitude Doppler, Anatomical M Mode and combined mode).
. TE7 has some special functions: LVO, and iNeedle All of them are identical as the predicated device M9(K141010).
TE7 has the same capacity in term of making comments and body marks on the images, reporting patient exam results as the predicated device M7(K131690).
TE7 has similar probes as the predicated device M9(K141010) and M7(K131609):

| Subject device TE7 | Predicated device
M9(K141010) | Predicated device
M7(K131690) | NOTE |
|--------------------|----------------------------------|----------------------------------|------|
| C5-2s | / | C5-2s | Same |
| L12-4s | / | L12-4s | Same |

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L7-3s	/	L7-3s	Same
P4-2s	SP5-1s	P4-2s	Same
P7-3Ts	/	P7-3Ts	Same
L14-6s	/	L14-6s	Same
L14-6Ns	/	L14-6Ns	Same
V11-3Ws	V11-3WE	/	Same
C11-3s	C11-3s	/	Same
7LT4s	/	7LT4s	Same

TE7 has the same measurement and calculation functions as the predicated device M9(K141010).

6. Non-clinical Tests:

TE7 Diagnostic Ultrasound System has been evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness as well as thermal, electrical and mechanical safety, and has been designed to conform with applicable medical safety standards. This device has been tested and evaluated under the following standards:

UD 2 Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment.
UD 3 Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment
. AAMI / ANSI ES60601-1 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance.
. IEC 60601-1-2 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests (Edition 3)
. IEC 60601-2-37 Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment
. ISO14971 Medical devices - Application of risk management to medical devices
. ISO 10993-1 Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process
. IEC 62366 Medical devices - Application of usability engineering to medical

19

devices

IEC 62304 Medical device software Software life cycle processes
These non-clinical tests relied on in this premarket notification submission can support the determination of substantial equivalence of the subject device.

7. Clinical Studies

Not applicable. The subject of this submission, TE7 Diagnostic Ultrasound System, does not require clinical studies to support substantial equivalence.

Conclusion:

Intended uses and other key features are consistent with traditional clinical practices, FDA guidelines and established methods of patient examination. The design, development and quality process of the manufacturer confirms with 21 CFR 820, ISO 9001 and ISO 13485 quality systems. The device conforms to applicable medical device safety standards. Therefore, the TE7 Diagnostic Ultrasound System is substantially equivalent with respect to safety and effectiveness to devices currently cleared for market.