The device is intended for use by a qualified physician for ultrasound evaluation of fetal, abdominal, pediatric, neonatal cephalic, cardiac, small parts, transvaginal, transrectal, peripheral-vascular, muscular-skeletal(conventional and superficial).

Device Description

The M5 is a portable general purpose, mobile, software controlled, ultrasonic diagnostic system. Its function is to acquire and display ultrasound data in B-Mode, M-Mode, PW-Mode, Color-Mode, Power-Mode, Dirpower-Mode or the combined mode (i.e. B/M-Mode).This system is a Track 3 device that employs an array of probes that include linear array and convex linear array with a frequency range of approximately 2.5 MHz to 14 MHz.

AI/ML Overview

This 510(k) summary describes a diagnostic ultrasound system (M5) and its transducers. The document primarily focuses on regulatory information and intended use rather than specific performance studies with acceptance criteria, ground truth, or statistical analyses. Therefore, much of the requested information cannot be extracted from the provided text.

Here is the information that can be extracted or reasonably inferred:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria or detailed device performance metrics in terms of clinical accuracy or diagnostic efficacy. Instead, it refers to compliance with established standards and substantial equivalence to predicate devices. The "reported device performance" is implicitly that the device is "as safe and effective as the legally marketed predicate devices" for its stated intended uses.

Metric	Acceptance Criteria	Reported Device Performance
Safety	Conformance to IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, ISO 10993-1.	Conforms to applicable medical device safety standards.
Acoustic Output	Conformance to NEMA UD 2 Acoustic Output Measurement Standard: 2004 and NEMA UD 3 Output Display Standard.	Acoustic output is measured and calculated per NEMA UD 2 and NEMA UD 3.
Effectiveness	Substantially equivalent to predicate devices for stated intended uses.	Device is "as safe and effective as the legally marketed predicate devices."

2. Sample Size Used for the Test Set and Data Provenance

This information is not provided in the document. The filing refers to "testing" performed for safety and effectiveness but does not detail any clinical studies, their sample sizes, or data provenance (e.g., country of origin, retrospective/prospective nature).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the document, as no specific clinical study with ground truth establishment is detailed.

4. Adjudication Method for the Test Set

This information is not provided in the document, as no specific clinical study with adjudication is detailed.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

This information is not provided in the document. The device is a diagnostic ultrasound system; there is no mention of AI assistance or MRMC studies.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This information is not provided in the document. The device is a diagnostic ultrasound system, not an algorithm being tested in a standalone capacity.

7. The Type of Ground Truth Used

This information is not provided in the document, as no specific clinical study with ground truth is detailed. The basis for safety and effectiveness is primarily stated as conformance to standards and substantial equivalence to predicate devices, rather than a direct comparison against a clinical ground truth for a new indication.

8. The Sample Size for the Training Set

This information is not provided in the document. There is no mention of a "training set," which typically refers to data used for machine learning models.

9. How the Ground Truth for the Training Set Was Established

This information is not provided in the document for the reasons stated above.

Summary

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MAR 2 1 2008

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... ... ... ... ... ... ... ..............................................................................................................................................

510(K) SUMMARY Exhibit B

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 2658 2888 Fax: +86 755 2658 2680

Contact Person:

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

Date Prepared: January 31, 2008

2. Device Name: M5 Diagnostic Ultrasound System

Classification

Regulatory Class: II

Review Category: Tier II

21 CFR 892.1550 Ultrasonic Pulsed Doppler Imaging System' (90-IYN)

21 CFR 892.1560 Ultrasonic Pulsed Echo Imaging System (90-IYO)

21 CFR 892.1570 Diagnostic Ultrasound Transducer (90-ITX)

3. Marketed Device:

M5 Diagnostic Ultrasound System is substantially equivalent to the following devices: Mindray DC-6 (K#072164), GE Logiq 9 (K#061129) and GE Logiq E diagnostic ultrasound system (K#072797), Mindray DP-6600 (K#060949).

4. Device Description:

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5. Intended Use:

6. Safety Considerations:

The M5 Diagnostic Ultrasound System has been tested as Track 3 Device per the FDA Guidance document "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers" issued September 1997. The acoustic output is measured and calculated per NEMA UD 2 Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment: 2004 and NEMA UD 3 Output Display Standard. The device conforms to applicable medical device safety standards, such as IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37 and ISO 10993-1.

Conclusion:

The conclusions drawn from testing of the M5 Diagnostic Ultrasound System demonstrate that the device is as safe and effective as the legally marketed predicate devices.

0044 ﺴﺘﻌﻤﺎﺭ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤ

{2}------------------------------------------------

Image /page/2/Picture/2 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three human profiles incorporated into its design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the eagle in a circular fashion.

APR - 8 2008

.
.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Shenzhen Mindray Bio-Medical Electronics Co., Ltd. c/o Robert Mosenkis Citech 5200 Butler Pike Plymouth Meeting, PA 19462-1298

Re: K080640

Trade/Device Name: M5 Diagnostic Ultrasound System Regulation Number: 21 CFR 1550 Regulation Name: Ultrasonic pulsed Doppler imaging system Regulatory Class: Class II Product Code: IYN IYO ITX Dated: March 4, 2008 Received: March 6, 2008

Dear Mr. Mosenkis:

This letter corrects our substantially equivalent letter of March 21, 2008.

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we 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). 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.

This determination of substantial equivalence applies to the following transducers intended for use with the M5 Diagnostic Ultrasound System, as described in your premarket notification:

Transducer Model Number
3C5s
6C2s
6CV1s
7L4s
7L6s

{3}------------------------------------------------

10L4s
6LE7s
6LB7s

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.

This letter will allow you to begin marketing your device as described in your premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus permits your device to proceed to market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html

If you have any questions regarding the content of this letter, please contact Robert Phillips, Ph.D., at (240) 276-3666.

Sincerely yours,

hryu Thhly

Ancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosures

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

Diagnostic Ultrasound Indications for Use Form

System Model:

Transducer × MS

510(k) Number(s)

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(specify)	Other (specify)
Ophthalmic
Fetal		N	N	N		N	N		N	Note 1, 2, 3
Abdominal		N	N	N		N	N		N	Note 1, 2, 3
Intraoperative (specify)*
Intraoperative Neurological
Pediatric		N	N	N		N	N		N	Note 1, 2, 3
Small organ(specify)**		N	N	N		N	N		N	Note 2, 3
Neonatal Cephalic		N	N	N		N	N		N	Note 2, 3
Adult Cephalic		N	N	N		N	N		N	Note 2, 3
Cardiac		N	N	N		N	N		N	Note 2, 3
Transesophageal
Transrectal		N	N	N		N	N		N	Note 2
Transvaginal		N	N	N		N	N		N	Note 2, 3
Transurethral
Intravascular
Peripheral Vascular		N	N	N		N	N		N	Note 2, 3
Laparoscopic
Musculo-skeletal Conventional		N	N	N		N	N		N	Note 2, 3
Musculo-skeletal Superficial		N	N	N		N	N		N	Note 2, 3
Other (specify)***		N	N	N		N	N		N	Note 2, 3
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, etc.

*** Other use includes Urology/Prostate.

Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents.

Note 2: Smart3D

Note 3: iScape

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation(ODE)

Prescription USE (Per 21 CFR 801.109)

Aoyez 722

(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number

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

Diagnostic Ultrasound Indications for Use Form

System

Transducer ×

Model:

3C5s

510(k) Number(s)

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(specify)	Other (specify)
Ophthalmic
Fetal		N	N	N		N	N		N	Note 1, 2, 3
Abdominal		N	N	N		N	N		N	Note 1, 2, 3
Intraoperative (specify)*
Intraoperative Neurological
Pediatric		N	N	N		N	N		N	Note 1, 2, 3
Small organ(specify)**
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other (Urology)
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, etc.

Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents.

Note 2: Smart3D Note 3: iScape

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation(ODE)

Prescription USE (Per 21 CFR 801.109)

(Division Sign-Off)
Division of Reproductive, Abdominal and
Radiological Devices
510(k) Number K080640

0049

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

Diagnostic Ultrasound Indications for Use Form

System

Transducer

Model:

6C2s

510(k) Number(s)

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(specify)	Other (specify)
Ophthalmic
Fetal
Abdominal		N	N	N		N	N		N	Note 2, 3
Intraoperative (specify)*
Intraoperative Neurological
Pediatric		N	N	N		N	N		N	Note 2, 3
Small organ(specify)**
Neonatal Cephalic		N	N	N		N	N		N	Note 2, 3
Adult Cephalic		N	N	N		N	N		N	Note 2, 3
Cardiac		N	N	N		N	N		N	Note 2, 3
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other (specify)

Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents.

Note 2: Smart3D ..

Note 3: iScape

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation(ODE)

Prescription USE (Per 21 CFR 801.109)

Arzola Mr. Why

જ

(Division Sign-Off)
Division of Reproductive, Abdominal and Radiological Devices 510(k) Number

0050

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

Diagnostic Ultrasound Indications for Use Form

System

Transducer ×

Model:

6CV Is

510(k) Number(s)

Clinical Application	Mode of Operation
	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(specify)	Other (specify)
Ophthalmic
Fetal		N	N	N		N	N		N	Note 2, 3
Abdominal
Intraoperative (specify)*
Intraoperative Neurological
Pediatric
Small organ(specify)**
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal		N	N	N		N	N		N	Note 2, 3
Transvaginal		N	N	N		N	N		N	Note 2, 3
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other (specify)***		N	N	N		N	N		N	Note 2, 3
N=new indication; P=previously cleared by FDA; E=added under Appendix E
Additional comments: Combined modes: B+M, PW+B, Color + B, PW +Color+ B, PW +Color+ B, Power + PW +B.
* Intraoperative includes abdominal, thoracic, and vascular etc.
** Small organ-breast, thyroid, testes, etc.
*** Other use includes Urology.

Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents.

Note 2: Smart3D

Note 3: iScape

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation(ODE)

Prescription USE (Per 21 CFR 801.109)

Joseph P. Wiley

(Division Sign-Uff) Division of Reproductive, Abdominal and Radiological Galler

: Sun Sum or

0051

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

Diagnostic Ultrasound Indications for Use Form

System

Transducer ×

Model:

7L4s, 7L6s, 10L4s

510(k) Number(s)

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(specify)	Other (specify)
Ophthalrnic
Fetal
Abdominal
Intraoperative (specify)*
Intraoperative Neurological
Pediatric
Small organ(specify)**		N	N	N	N		N		N	Note 2, 3
Neonatal Cephalic		N	N	N	N		N		N	Note 2, 3
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular		N	N	N	N		N		N	Note 2, 3
Laparoscopic
Musculo-skeletal Conventional		N	N	N	N		N		N	Note 2, 3
Musculo-skeletal Superficial		N	N	N	N		N		N	Note 2, 3
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, etc.
Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents.
Note 2: Smart3D
Note 3: iScan

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation(ODE)

Prescription USE (Per 21 CFR 801.109)

(Division Sign-Off)

Division of Reproductive, Abdominal and Radiological Devices 510(k) Number

0052

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

Diagnostic Ultrasound Indications for Use Form

System

Transducer ×

Model:

6LE7s

510(k) Number(s)

Clinical Application	B	M	PW D	Color Doppler	Amplitude Doppler	Combined (specify)	Other (specify)
Ophthalmic
Fetal	N	N	N	N	N	N	Note 3
Abdominal
Intraoperative (specify)*
Intraoperative Neurological
Pediatric
Small organ(specify)**
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal	N	N	N	N	N	N	Note 3
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other (specify)***	N	N	N	N	N	N	Note 3
N=new indication; P=previously cleared by FDA; E=added under Appendix EAdditional 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, etc.

***Other use includes Urology.

Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents.

Note 2: Smart3D

Note 3: iScape

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation(ODE)

Prescription USE (Per 21 CFR 801.109)

Avanth M. Wz

(Division Sign-Off) (Division Sign-On)
Division of Reproductive, Abdominal and Radiological Devices 510(k) Number

0053

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

Diagnostic Ultrasound Indications for Use Form

Transducer System 6LB7s Model:

510(k) Number(s)

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(specify)	Other (specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (specify)*
Intraoperative Neurological
Pediatric
Small organ(specify)**
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal		N	N	N		N	N		N	Note 2,3
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other (specify) ***		N	N	N		N	N		N	Note 2,3
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, etc.
***Other use includes Urology/Prostate.
Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents.
Note 2: Smart3D

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation(ODE)

Prescription USE (Per 21 CFR 801.109)

Arne M. Whtry

(Division Sign-Off) (Division of Reproductive, Abdominal and Radiological Devices 510(k) Number J

0054

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.