The M9/M9CV/M9T Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetal, abdominal, pediatric, small organ(breast, thyroid, testes), neonatal and adult cephalic, trans-rectal, trans-vaginal, musculo-skeletal(conventional, superficial), adult and pediatric cardiac, trans-esoph. (Cardiac), peripheral vessel , urology exams.

Device Description

M9/M9T/M9CV is a software controlled, ultrasonic diagnostic system. Its function is to acquire and display ultrasound data in B-Mode, PW-Mode, Color-Mode, Power/Dirpower Mode, THI, iScape mode, Color M, Elastography, LVO or the combined mode (i.e. 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.

AI/ML Overview

The provided document is a 510(k) premarket notification for the Shenzhen Mindray Bio-Medical Electronics Co., Ltd. M9/M9T/M9CV Diagnostic Ultrasound System. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria for a novel AI device.

Therefore, many of the requested details, such as specific acceptance criteria for an AI model's performance (e.g., sensitivity, specificity, AUC), sample sizes for test and training sets for an AI model, expert qualifications for ground truth, adjudication methods, MRMC studies, or standalone algorithm performance, are not applicable or not explicitly detailed in this type of submission.

This submission details the indications for use and non-clinical performance tests that confirm the device operates safely and effectively as an ultrasound system, comparing it to existing, legally marketed predicate devices.

Here's a breakdown of the information that can be extracted or inferred from the provided text, related to the nature of the submission:

1. A table of acceptance criteria and the reported device performance:

Since this is a 510(k) for an ultrasound system, the "acceptance criteria" are primarily related to safety, electrical, mechanical, and acoustic performance, and demonstrating that the device functions as intended for its specified clinical applications. The "reported device performance" is essentially that it complies with the referenced standards and is comparable to predicate devices. Specific quantitative performance targets for diagnostic accuracy (like sensitivity/specificity) for a novel AI algorithm detecting conditions are not present here because this is for a general ultrasound system.

Acceptance Criterion Type	Reported Device Performance (Compliance/Comparison)
Intended Use	Applicable for adults, pregnant women, pediatric patients, and neonates. Intended for use in fetal, abdominal, pediatric, small organ (breast, thyroid, testes), neonatal and adult cephalic, trans-rectal, trans-vaginal, musculo-skeletal (conventional, superficial), adult and pediatric cardiac, trans-esoph. (Cardiac), peripheral vessel, urology exams. (Matches predicate device functionalities).
Technological Characteristics	Same as predicate M9/M9 CV/M9T (K141010), comparable in key safety/effectiveness features. All systems transmit ultrasonic energy, perform post-processing for display of anatomic structures and fluid flow. (Comparable to predicate devices).
Acoustic Power Level	Below FDA limits. (Complies with FDA regulations).
Compliance with Standards	Complies with: UD 2, UD 3, AAMI/ANSI ES60601-1, IEC 60601-1-2, IEC 60601-2-37, ISO14971, ISO 10993-1, IEC 62304. (Meets recognized medical device safety and performance standards).
Transducer Compatibility	New transducers (C6-2Gs, L14-6Ws, P7-3s, L10-3s) are substantially equivalent with predicate DC-8 (K150080).
Measurements and Calculations	Same capabilities as predicate M9/M9T/M9CV (K141010), with added features (uterine artery's PI and RI growth curve, new CFEF formula in obstetric, Global Strain curve and peak shown increased) confirmed substantially equivalent with predicates Vivid q and Voluson E8.
Performance Specification	Same as predicate M9/M9T/M9CV K141010, with added functions (Auto EF, automated scan angle correction for PW, Q-path, MedTouch support) confirmed substantially equivalent with predicates Vivid q, DC-70, and TE7.
Biocompatibility	Evaluated and confirmed.
Cleaning and Disinfection	Effectiveness evaluated and confirmed.
Thermal, Electrical, Mechanical Safety	Evaluated and confirmed.
Quality Systems	Design, development, and quality process conform with 21 CFR 820, ISO 9001, and ISO 13485 quality systems.

2. Sample sized used for the test set and the data provenance:

Not applicable in this document. This submission does not describe a clinical performance study using a test set of patient data for a novel algorithm. It relies on non-clinical performance evaluations and comparisons to predicate devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. Ground truth establishment by experts for a test set is not part of this type of 510(k) submission for a general ultrasound system.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable. No test set requiring adjudication is described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This is not an AI-assisted diagnostic device where such a study would be performed to evaluate improvement in human reader performance.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

Not applicable. The device is an ultrasound system, not a standalone algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):

Not applicable in the context of diagnostic accuracy for a novel algorithm. The "ground truth" for this ultrasound system would be its adherence to established engineering, safety, and performance standards as verified through non-clinical testing and comparison to predicate devices, rather than a clinical ground truth for disease diagnosis.

8. The sample size for the training set:

Not applicable. There is no mention of a "training set" as this is not an AI/machine learning submission.

9. How the ground truth for the training set was established:

Not applicable. There is no mention of a "training set" or ground truth establishment for such a set.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles three stylized human profiles or a bird in flight, rendered in a dark color.

October 29, 2015

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. % Wu Zicui Engineer of Regulation Technical Department Keji 12th Road South, Hi-tech Industrial Park, Nanshan Shenzhen, Guangdong 518057 P.R. CHINA

Re: K152543

Trade/Device Name: M9/M9T/M9CV 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: August 27, 2015 Received: September 4, 2015

Dear Wu Zicui:

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 (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.

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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

Robert 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)

K152543

Device Name M9/M9T/M9CV

Indications for Use (Describe)

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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Diagnostic Ultrasound Indications For Use Format

M9/M9T 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
General(Track 1Only)	Specific (Track 1 & 3)	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	Combined(specify)	Other (specify)
Ophthalmic	Ophthalmic
	Fetal	P	P	P		P	P	P	Note 1, 2,4,5
	Abdominal	P	P	P	P	P	P	P	Note 1, 2,4,5
	Intra-operative (Specify*)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	P	P	P	P	P	P	P	Note 1, 2,4,5
	Small Organ (Specify**)	P	P	P	P	P	P	P	Note 1,2,5,6
FetalImaging &Other	Neonatal Cephalic	P	P	P	P	P	P	P	Note 1,2,4,5
	Adult Cephalic	P	P	P	P	P	P	P	Note 1, 2,4,5
	Trans-rectal	P	P	P	P	P	P	P	Note 1,2,4,5
	Trans-vaginal	P	P	P	P	P	P	P	Note 1, 2,4,5
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal(Conventional)	P	P	P	P	P	P	P	Note 1,2,4,5
	Musculo-skeletal (Superficial)	P	P	P	P	P	P	P	Note 1,2,5
	Intravascular
	Cardiac Adult	P	P	P	P	P	P	P	Note 1,2,3,4,5,7
	Cardiac Pediatric	P	P	P	P	P	P	P	Note 1,2,3,4,5
Cardiac	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)	P	P	P	P	P	P	P	Note 1, 3,4
	Intra-cardiac
Peripheralvessel	Peripheral vessel	P	P	P	P	P	P	P	Note 1,2,4,5
	Other (Specify***)	P	P	P	P	P	P	P	Note 1,2,4,5
	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 + 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.
	Note 2: iScape
	Note 3:TDI
	Note 4: Color M
	Note5: Biopsy Guidance
	Note6: Elastography
	Note7: 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)
Clinical Application	Mode of Operation
General(Track 1Only)	Specific (Track 1 & 3)	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	Combined(specify)	Other (specify)
Ophthalmic	Ophthalmic
FetalImaging &Other	Fetal
	Abdominal	P	P	P		P	P	P	Note 1,2,4,5
	Intra-operative (Specify*)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	P	P	P		P	P	P	Note 1,2,4,5
	Small Organ (Specify**)
	Neonatal Cephalic	P	P	P		P	P	P	Note 1,2,4,5
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal(Conventional)
	Musculo-skeletal (Superficial)
	Intravascular
	Cardiac Adult
Cardiac	Cardiac Pediatric	P	P	P		P	P	P	Note 1,2,4,5
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
Peripheralvessel	Peripheral vessel	P	P	P		P	P	P	Note 1,2,4,5
	Other (Specify***)
	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 + 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.
	Note 2: iScape
	Note 3:TDI
	Note 4: Color M
	Note5: Biopsy Guidance
	Note6: Elastography
	Note7: 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)

Clinical Application	Mode of Operation
General(Track 1Only)	Specific (Track 1 & 3)	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	Combined(specify)	Other (specify)
Ophthalmic	Ophthalmic
	Fetal	P	P	P		P	P	P	Note 1,2,4,5
	Abdominal	P	P	P		P	P	P	Note 1,2,4,5
	Intra-operative (Specify*)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	P	P	P		P	P	P	Note 1,2,4,5
	Small Organ (Specify**)
FetalImaging &Other	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal(Conventional)	P	P	P		P	P	P	Note 1,2,4,5
	Musculo-skeletal (Superficial)
	Intravascular
	Cardiac Adult
	Cardiac Pediatric
Cardiac	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
Peripheralvessel	Peripheral vessel	P	P	P		P	P	P	Note 1,2,4,5
	Other (Specify***)
	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 + 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.
	Note 2: iScape
	Note 3:TDI
	Note 4: Color M
Note5: Biopsy Guidance
Note6: Elastography
	Note7: 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)
Clinical Application	Mode of Operation
General
(Track 1	Specific (Track 1 & 3)	B	M	PWD	CWD	ColorDoppler	Amplitudee Doppler	Combined(specify)	Other (specify)
Only)
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**)	P	P	P		P	P	P	Note 1,2,5,6
Fetal	Neonatal Cephalic	P	P	P		P	P	P	Note 1,2,5
Imaging &	Adult Cephalic
Other	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal
	(Conventional)	P	P	P		P	P	P	Note 1,2,5
	Musculo-skeletal (Superficial)	P	P	P		P	P	P	Note 1,2,5
	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;					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.
	Note 2: iScape
	Note 3:TDI
	Note 4: Color M
	Note5: Biopsy Guidance
Note6: Elastography
	Note7: 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)

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

Transducer: C11-3s

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

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

Transducer: C5-1s

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

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

Transducer: L12-4s

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

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

M9/M9T Diagnostic Ultrasound System System:

Transducer: P7-3Ts

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

	Clinical Application		Mode of Operation
	General(Track 1Only)	Specific (Track 1 & 3)	B	M	PWD	CWD	ColorDoppler	Amplitudee Doppler	Combined(specify)	Other (specify)
	Ophthalmic	Ophthalmic
		Fetal
		Abdominal
		Intra-operative (Specify*)
		Intra-operative (Neuro)
		Laparoscopic
		Pediatric
		Small Organ (Specify**)
FetalImaging &Other		Neonatal Cephalic
		Adult Cephalic
		Trans-rectal
		Trans-vaginal
		Trans-urethral
		Trans-esoph. (non-Card.)
		Musculo-skeletal(Conventional)
		Musculo-skeletal (Superficial)
		Intravascular
		Cardiac Adult
		Cardiac Pediatric
Cardiac		Intravascular (Cardiac)
		Trans-esoph. (Cardiac)	P	P	P	P	P	P	P	Note 1, 3,4
		Intra-cardiac
Peripheralvessel		Peripheral vessel
		Other (Specify***)
	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 + 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.
	Note 2: iScape
Note 3:TDI
	Note 4: Color M
Note5: Biopsy Guidance
	Note6: Elastography
	Note7: 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)
	Clinical Application	Mode of Operation
General(Track 1Only)	Specific (Track 1 & 3)	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	Combined(specify)	Other (specify)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal	P	P	P	P	P	P	P	Note 1,2,4,5
	Intra-operative (Specify*)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	P	P	P	P	P	P	P	Note 1,2,4,5
	Small Organ (Specify**)
FetalImaging &Other	Neonatal Cephalic	P	P	P	P	P	P	P	Note 1,2,4,5
	Adult Cephalic	P	P	P	P	P	P	P	Note 1,2,4,5
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal(Conventional)
	Musculo-skeletal (Superficial)
	Intravascular
	Cardiac Adult	P	P	P	P	P	P	P	Note 1,2,3,4,5,7
	Cardiac Pediatric	P	P	P	P	P	P	P	Note 1,2,3,4,5
Cardiac	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
Peripheralvessel	Peripheral vessel
	Other (Specify***)
	N=new indication; P=previously cleared by FDA; E=added under 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.
	Note 2: iScape
Note 3:TDI
Note 4: Color M
Note5: Biopsy Guidance
Note6: Elastography
Note7: 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)
Clinical Application		Mode of Operation
General(Track 1Only)	Specific (Track 1 & 3)	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	Combined(specify)	Other (specify)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal	P	P	P	P	P	P	P	Note 1,4
	Intra-operative (Specify*)
	Intra-operative (Neuro)
	Laparoscopic
FetalImaging &Other	Pediatric	P	P	P	P	P	P	P	Note 1,4
	Small Organ (Specify**)
	Neonatal Cephalic	P	P	P	P	P	P	P	Note 1,4
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal(Conventional)
	Musculo-skeletal (Superficial)
	Intravascular
	Cardiac Adult
Cardiac	Cardiac Pediatric	P	P	P	P	P	P	P	Note 1, 3,4
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
Peripheralvessel	Peripheral vessel
	Other (Specify***)
	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 + 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.
Note 2: iScape
Note 3:TDI
Note 4:Color M
Note5: Biopsy Guidance
Note6: Elastography
Note7: 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)

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

SP5-1s Transducer:

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

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

Transducer: P10-4s

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

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

System:	M9/M9T Diagnostic Ultrasound System
---------	-------------------------------------

Transducer: L14-6Ns

Clinical Application			Mode of Operation
General(Track 1Only)	Specific (Track 1 & 3)	B	M	PWD	CWD	ColorDoppler	Amplitude Doppler	Combined(specify)	Other (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**)	P	P	P		P	P	P	Note 1,2,5,6
FetalImaging &Other	Neonatal Cephalic	P	P	P		P	P	P	Note 1,2,5
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal
	(Conventional)	P	P	P		P	P	P	Note 1,2,5
	Musculo-skeletal (Superficial)	P	P	P		P	P	P	Note 1,2,5
	Intravascular
	Cardiac Adult
	Cardiac Pediatric
Cardiac	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
Peripheralvessel	Peripheral vessel	P	P	P		P	P	P	Note 1,2,5
	Other (Specify***)
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 + 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.
Note 2: iScape
Note 3:TDI
Note 4: Color M
Note5: Biopsy Guidance
Note6: Elastography
Note7: 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)
	Clinical Application	Mode of Operation
	Specific (Track 1 & 3)	B	M	PWD	CWD	Color Doppler	Amplitude Doppler	Combined (specify)	Other (specify)
General(Track 1Only)	Ophthalmic
Ophthalmic	Fetal	P	P	P		P	P	P	Note 1,2,4,5
	Abdominal
	Intra-operative (Specify*)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
	Small Organ (Specify**)
FetalImaging &Other	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal	P	P	P		P	P	P	Note 1,2,4,5
	Trans-vaginal	P	P	P		P	P	P	Note 1, 2,4,5
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal(Conventional)
	Musculo-skeletal (Superficial)
	Intravascular
	Cardiac Adult
	Cardiac Pediatric
Cardiac	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
Peripheralvessel	Peripheral vessel
	Other (Specify***)	P	P	P		P	P	P	Note 1,2,4,5
	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 + 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.
	Note 2: iScape
	Note 3: TDI
	Note 4: Color M
	Note5: Biopsy Guidance
	Note6: Elastography
	Note7: 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)

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

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

Transducer: V11-3Ws

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

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

Transducer: CW2s

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

Clinical Application			Mode of Operation
General(Track 1Only)	Specific (Track 1 & 3)	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	Combined(specify)	Other (specify)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal
	Intra-operative (Specify*)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric				P
	Small Organ (Specify**)
FetalImaging &Other	Neonatal Cephalic
	Adult Cephalic				P
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal(Conventional)
	Musculo-skeletal (Superficial)
	Intravascular
	Cardiac Adult				P
	Cardiac Pediatric				P
Cardiac	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
Peripheralvessel	Peripheral vessel				P
	Other (Specify***)
	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 + 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.
Note 2: iScape
Note 3:TDI
Note 4: Color M
Note5: Biopsy Guidance
	Note6: Elastography
	Note7: 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)

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

Transducer: CW5s

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

Clinical Application		Mode of Operation
General(Track 1Only)	Specific (Track 1 & 3)	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	Combined(specify)	Other (specify)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal
	Intra-operative (Specify*)
	Intra-operative (Neuro)
	Laparoscopic
FetalImaging &Other	Pediatric				P
	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				P
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
Peripheralvessel	Peripheral vessel
	Other (Specify***)
	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 + 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.
	Note 2: iScape
		Note 3:TDI
		Note 4: Color M
		Note5: Biopsy Guidance
	Note6: Elastography
	Note7: 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)
Clinical Application					Mode of Operation
General(Track 1Only)	Specific (Track 1 & 3)	B	M	PWD	CWD	ColorDoppler	Amplitudee Doppler	Combined(specify)	Other (specify)
Ophthalmic	Ophthalmic
	Fetal	N	N	N	N	N	N	N	Note1,2,4,5
	Abdominal	N	N	N	N	N	N	N	Note1,2,4,5
	Intra-operative (Specify*)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	N	N	N	N	N	N	N	Note1,2,4,5
	Small Organ (Specify**)
Fetal	Neonatal Cephalic
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
vessel	Other (Specify***)
	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 + 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.
	Note 2: iScape
Note 3:TDI
Note 4: Color M
Note5: Biopsy Guidance
	Note6: Elastography
	Note7: 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)
	Clinical Application				Mode of Operation
General(Track 1Only)	Specific (Track 1 & 3)	B	M	PWD	CWD	ColorDoppler	Amplitude Doppler	Combined(specify)	Other (specify)
Ophthalmic	Ophthalmic
	Fetal
FetalImaging &Other	Abdominal	N	N	N		N	N	N	Note 1,2,5
	Intra-operative (Specify*)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	N	N	N		N	N	N	Note 1,2,5
	Small Organ (Specify**)	N	N	N		N	N	N	Note 1,2,5,6
	Neonatal Cephalic	N	N	N		N	N	N	Note 1,2,5
	Adult Cephalic
Other	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal(Conventional)	N	N	N		N	N	N	Note 1,2,5
	Musculo-skeletal (Superficial)	N	N	N		N	N	N	Note 1,2,5
	Intravascular
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac

Peripheralvessel	Peripheral vessel	N	N	N		N	N	N	Note 1,2,5
	Other (Specify***)
	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 + 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.
	Note 2: iScape
Note 3:TDI
Note 4: Color M
Note5: Biopsy Guidance
	Note6: Elastography
	Note7: 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)

Clinical Application			Mode of Operation
General(Track 1Only)	Specific (Track 1 & 3)	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	Combined(specify)	Other (specify)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal	P	P	P	P	P	P	P	Note 1, 2,4
	Intra-operative (Specify*)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	P	P	P	P	P	P	P	Note 1, 2,4
	Small Organ (Specify**)
FetalImaging &Other	Neonatal Cephalic	P	P	P	P	P	P	P	Note 1, 2,4
	Adult Cephalic	P	P	P	P	P	P	P	Note 1, 2,4
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal(Conventional)	P	P	P	P	P	P	P	Note 1, 2,4
	Musculo-skeletal (Superficial)
	Intravascular
	Cardiac Adult	P	P	P	P	P	P	P	Note 1, 2,3,4
	Cardiac Pediatric	P	P	P	P	P	P	P	Note 1, 2,3,4
Cardiac	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
Peripheralvessel	Peripheral vessel
	Other (Specify***)
	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 + 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.
	Note 2: iScape
Note 3:TDI
	Note 4: Color M
Note5: Biopsy Guidance
Note6: Elastography
	Note7: 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)

Clinical Application			Mode of Operation
General(Track 1Only)	Specific (Track 1 & 3)	B	M	PWD	CWD	ColorDoppler	Amplitudee Doppler	Combined(specify)	Other (specify)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal	N	N	N		N	N	N	Note 1,2
	Intra-operative (Specify*)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	N	N	N		N	N	N	Note 1,2
	Small Organ (Specify**)	N	N	N		N	N	N	Note 1,2,6
FetalImaging &Other	Neonatal Cephalic	N	N	N		N	N	N	Note 1,2
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal(Conventional)	N	N	N		N	N	N	Note 1,2
	Musculo-skeletal (Superficial)	N	N	N		N	N	N	Note 1,2
	Intravascular
	Cardiac Adult
	Cardiac Pediatric
Cardiac	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
Peripheralvessel	Peripheral vessel	N	N	N		N	N	N	Note 1,2
	Other (Specify***)
	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 + 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.
	Note 2: iScape
		Note 3:TDI
		Note 4: Color M
		Note5: Biopsy Guidance
	Note6: Elastography
	Note7: 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)

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

M9/M9T Diagnostic Ultrasound System System:

Transducer: C6-2Gs

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

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

M9/M9T Diagnostic Ultrasound System System:

Transducer: L14-6Ws

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

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

M9/M9T Diagnostic Ultrasound System System:

Transducer: P7-3s

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

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

M9/M9T Diagnostic Ultrasound System System:

Transducer: L10-3s

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

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

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 5658 Fax: +86 755 2658 2680

Contact Person:

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

Date Prepared: August 17, 2015

2. Device Name: M9/M9T/M9CV 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:

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

{19}------------------------------------------------

MHz.

4. Intended Use:

5. Comparison with Predicate Devices:

M9/M9T/M9CV Diagnostic Ultrasound System is comparable with and substantially equivalent to these predicate devices:

PredicateDevice	Manufacturer	Model	510(k)ControlNumber
1	Mindray	M9/M9 CV/M9T(Main predicatedevice)	K141010
2	Mindray	DC-8/DC-8PRO/DC-8 CV/DC-8EXP/DC-8S	K150080
3	GEHealthcare	Vivid q	K121062
4	Mindray	TE7	K143472
5	Mindray	DC-70/DC-70T/DC-70Pro/DC-70Exp/DC-70S	K150204
6	GEHealthcare	Voluson E8	K132913

Compared to the predicate devices M9/M9 CV/M9T (K 141010):

· M9/M9T/M9CV has the same technological characteristics, are comparable in key safety and effectiveness features, and have the same intended uses and basic operating modes All systems transmit ultrasonic energy into patients, 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.
· The transducers are same except for adding C6-2Gs, L14-6Ws, P7-3s and L10-3s.

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

All of the new added probes are substantial equivalent with the predicate DC-8(K150080).

It has the system acoustic power level which is below FDA limits and it is designed in compliance with same FDA recognized standards.
· M9/M9T/M9CV has the same capability in term of measurements and calculation functions except adding uterine artery's PI and RI growth curve, new CFEF formula in obstetric and Global Strain curve and peak showed increased. New added features are substantial equivalent with the predicates Vivid q and Voluson E8..
M9/M9T/M9CV has the same performance specification as the predicate device M9/M9T/M9CV K141010 except adding Auto EF, automated scan angle correction function for PW, Q-path and supporting MedTouch. New added functions are substantial equivalent with the predicates Vivid q. DC-70 and TE7.

6. Non-clinical Tests:

M9/M9T/M9CV 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.
I 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.
l 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 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, M9/M9T/M9CV Diagnostic Ultrasound System, does not require clinical studies to support substantial equivalence.

Conclusion:

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

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 M9/M9T/M9CV Diagnostic Ultrasound System is substantially equivalent with respect to safety and effectiveness to devices currently cleared for market.

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.