DP-9900 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM by SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD

Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: fetal organ, abdominal, pediatric, small organs, neonatal cephalic, cardiac, transvaginal, peripheral vascular, and musculo-sleletal (both conventional and superficial).

Device Description

The DP-9900 Digital Ultrasonic Diagnostic Imaging System is a general purpose, mobile, software controlled, ultrasound diagnostic system. This ultrasonic device is designed to project ultrasound waves into body tissue and to present the returned echo information on the monitor. The resulting information is displayed in B-Mode, M-Mode, or in the combined mode (i.e. B/M-Mode). This system is a Track 1 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 8.5 MHz.

AI/ML Overview

The provided document is a 510(k) premarket notification for the "DP-9900 Digital Ultrasonic Diagnostic Imaging System" and its associated transducers. This submission does not describe an AI medical device with specific performance metrics against acceptance criteria in the typical sense of AI algorithm evaluation. Instead, it demonstrates substantial equivalence to a predicate device for market clearance.

Therefore, many of the requested categories (e.g., sample size for test set, number of experts for ground truth, MRMC study, training set ground truth) are not applicable or cannot be extracted directly from this type of regulatory submission. The document focuses on technological characteristics, safety standards, and intended use as compared to a predicate device.

Here's an attempt to answer the questions based on the information provided, with an emphasis on what is not applicable or not specified for this type of device and submission.

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

The acceptance criteria for this device are implicitly tied to demonstrating "substantial equivalence" to a legally marketed predicate device (Toshiba SSA-325A JUST VISION 400 Ultrasound Imaging System K990490). This typically involves meeting comparable safety and effectiveness standards, rather than specific numerical performance metrics for an AI algorithm.

Acceptance Criteria (Implicit for Substantial Equivalence)	Reported Device Performance (DP-9900 Digital Ultrasonic Diagnostic Imaging System)
Safety:
- Conformance to medical device safety standards	- Conforms to IEC 60601-1 (electrical safety)
- Conformance to medical device safety standards	- Conforms to IEC 60601-1-2 (electromagnetic compatibility)
- Biocompatibility of patient contact materials	- Patient contact materials are biocompatible
- Acoustic output within safe limits	- Acoustic output measured and calculated per NEMA UD 2: 1998
- Software controlled device safety issues addressed	- Software safety issues addressed by hazard analysis and system validation
Effectiveness:
- Same fundamental technology as predicate	- Incorporates the same fundamental technology as predicate device
- Comparable intended use and clinical applications	- Intended for abdominal, gynecologic, obstetric, small parts, cardiac, fetal organ, pediatric, neonatal cephalic, transvaginal, peripheral vascular, musculo-skeletal (conventional and superficial) imaging. Similar to predicate.
- Diagnostic imaging capabilities	- Displays in B-Mode, M-Mode, or combined B/M-Mode
- Transducer compatibility and function	- Uses linear array and convex linear array probes with frequency range 2.5-8.5 MHz. Transducers are "Track 1" devices.
Overall conclusion of substantial equivalence	- Demonstrated to be as safe and effective as the legally marketed predicate device

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample size for test set: Not applicable and not specified. This submission is for an ultrasonic imaging system, not an AI algorithm evaluated on a dataset. The "testing" mentioned refers to laboratory verification of engineering specifications and safety standards, not an evaluation on clinical cases.
Data provenance: Not applicable. No clinical data or patient specific data is mentioned as being used for "testing" in the context of performance evaluation against a ground truth.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. No ground truth for a test set (in the context of image interpretation or diagnosis) was established or used for this regulatory submission.

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

Not applicable.

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 device.

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

Not applicable. This is not an AI device. The device itself is an "algorithm only" in the sense that it is a software-controlled ultrasound system, but its performance is judged on its ability to produce images comparable to a predicate, not on a diagnostic algorithm's output.

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

Not applicable. The "ground truth" here is the established safety and effectiveness of the predicate device and compliance with general performance standards for ultrasound systems, rather than a clinical ground truth for diagnostic accuracy.

8. The sample size for the training set

Not applicable. This is not an AI device that requires a training set.

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

Not applicable. This is not an AI device that requires a training set.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with three lines representing its wings and head. The eagle is facing to the right.

DEC 2 9 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Shenzhen Mindray Bio-Medical Electronics Co., Ltd. % Mr. Robert Mosenkis President Citech 5200 Butler Pike PLYMOUTH MEETING PA 19462-1298

Re: K043563

Trade Name: DP-9900 Digital Ultrasonic Diagnostic Imaging System Regulatory Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasonic transducer Regulatory Class: II Product Code: 90 IYO and ITX Dated: December 23, 2004 Received: December 27, 2004

Dear Mr. Mosenkis:

This letter corrects our substantially equivalent letter of January 11, 2005.

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 DP-9900 Digital Ultrasonic Imaging System, as described in your premarket notification:

Transducer Model Number

Image /page/0/Picture/13 description: The image shows two lines of text, one above the other. The top line reads "35C20HA", and the bottom line reads "35C50HA". The text is in a simple, sans-serif font and is underlined. The background is plain white.

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65EC10HA 75L38HA

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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

If you have any questions regarding the content of this letter, please contact Rodrigo C. Perez at (301) 594-1212.

Sincerely yours.

Nancy Brogdon

Nancy C. I rogdon Director. Division of Reproductive. Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure(s)

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Transducer System Model: DP 9900

510(k) Number(s)

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

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

N=new indication; P=previously cleared by FDA; E=added under Appendix E

Additional comments: Combined mode: B+M

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

Concurrence of CDRH, Office of Device Evaluation(ODE)

David h. Sypon

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

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Transducer System 35C20HA Model:

510(k) Number(s)

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

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

N=new indication; P=previously cleared by FDA; E=added under Appendix E

Additional comments: Combined mode: B+M

(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)

Diagnostic Ultrasound Indications for Use Form

Daniel A. Seymour

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

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Transducer × System Model: 35C50HA

510(k) Number(s)

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

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

N=new indication; P=previously cleared by FDA; E=added under Appendix E

Additional comments: Combined mode: B+M

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

Concurrence of CDRH, Office of Device Evaluation(ODE)

Daniel G. Lyon

(Division Sign Off) Division of Reproductive. and Radiological Devices 510(k) Number _

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System		Transducer	×
	Acres of Children	------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Model:		65EC10HA

510(k) Number(s)

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

	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
Transvaginal		N	N						N
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal
Conventional
Musculo-skeletal Superficial
Other (specify)

Additional comments: Combined mode: B+M

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

Concurrence of CDRH, Office of Device Evaluation(ODE)

David A. Lyon

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

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System		Transducer	×
Model:	75L38HA

510(k) Number(s)

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

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

N=new indication; P=previously cleared by FDA; E=added under Appendix E Additional comments: Combined mode: B+M

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

Concurrence of CDRH, Office of Device Evaluation(ODE)

David R. Larson

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

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Exhibit #B 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.

The assigned 510(k) number is: K043563.

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, Keji 12th Road South, Hi-tech Industrial Park, Nanshan, Shenzhen, 518057, P. R. China
● Date Prepared:

0ct 12, 2004

Name of the device:

Trade/Proprietary Name: DP-9900 Digital Ultrasonic Diagnostic Imaging System
. Common Name: Ultrasonic Imaging System and Transducers

● Classification Regulatory Class: II Review Category: Tier II

21CFR 892.1560 Ultrasonic Pulsed Echo Imaging System (90-1YO) 21CFR 892.1570 Diagnostic Ultrasound Transducer (90-ITX)

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Legally Marketed Predicate Device:

SSA-325A JUST VISION 400 Ultrasound Imaging System K990490

Description:

Statement of intended Use:

The system is a general-purpose, fully digital ultrasound system for abdominal, gynecologic and obstetric, small parts, and cardiac applications.

The DP-9900 digital ultrasonic diagnostic imaging system is intend to used for the following type of studies: fetal organ, abdominal, pediatric, small organs, neonatal cephalic, cardiac, transvaginal, peripheral vascular, and musculo-sleletal (both conventional and superficial). This device is intended to adult, pregnant woman, pediatric and neonate. The DP-9900 digital ultrasonic diagnostic imaging system is a prescription device intended to be used by or on the order of a physician or similarly qualified health care professional. This Device is not intended for home use.

Technological Characteristics:

The DP-9900 digital ultrasonic diagnostic imaging system incorporates the same fundamental technology as the predicate device. The device has been tested as Track I 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: 1998. All transducers used with the DP-9900 digital ultrasonic diagnostic imaging system are track 1. All patient contact

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materials are biocompatible.

The technology characteristics of the DP-9900 digital ultrasonic diagnostic imaging system do not affect the safety or efficacy of the device. Any safety issues raised by a software controlled medical device are either the same as the issues already addressed by the predicate device or are addressed in the system hazard analysis or in the system validation.

Testing:

Laboratory testing was conducted to verify that the DP-9900 digital ultrasonic diagnostic imaging system met all design specification and was substantially equivalent to the currently marketed Toshiba SSA-325A JUST VISION 400 Ultrasound Imaging System. The device has been found to conform to applicable medical device safety standards in regards to thermal, mechanical and electrical safety as well as biocompatibility. Acoustic output is measured and calculated according to "Acoustic Output Measuring Standard for Diagnostic Ultrasound Equipment (NEMA 1998)"

Applicable Standards

The DP-9900 digital ultrasonic diagnostic imaging system conforms to the following Standards:

NEMA UD 2 Acoustic Output Measurement Standard for Diagnostic ultrasound Equipment: 1998 IEC 60601-1 IEC 60601-1-2

Clinical Test:

No clinical testing was required

Conclusion:

The conclusions drawn from testing of the DP-9900 Digital Ultrasonic Diagnostic Imaging System demonstrates that the device is as safe and effective as the legally marketed predicate device, the SSA-325A JUST VISION 400 Ultrasound Imaging System, K#990490.

Regulation Number and Section

§ 892.1560 Ultrasonic pulsed echo imaging system.

(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.