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

Device Description

The DP-9900 Digital Ultrasonic Diagnostic Imaging System with added transducer 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 10 MHz. This modification will provide users with a wider selection of probe characteristics. And tissue harmonic imaging enhances over image performance.

AI/ML Overview

The provided 510(k) summary for the DP-9900 Digital Ultrasonic Diagnostic Imaging System does not include acceptance criteria or a study proving that the device meets specific acceptance criteria in terms of clinical performance metrics.

Instead, the submission focuses on demonstrating substantial equivalence to a predicate device based on technological characteristics and adherence to safety standards. The "testing" section primarily describes engineering verification and conformation to general safety standards for medical devices and acoustic output.

Here's a breakdown of the requested information based on the provided text, highlighting what is present and what is absent:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
N/A (No specific clinical performance acceptance criteria are mentioned for the device's diagnostic capabilities. The submission focuses on substantial equivalence to a predicate device regarding safety and efficacy, and conformity to general medical device standards.)	N/A (No specific clinical performance metrics are reported. The document states that "the technology characteristics of the DP-9900 digital ultrasonic diagnostic imaging system with these modifications do not affect the safety or efficacy of the device" and that "the device is as safe, as effective as well as the legally marketed predicate devices.")

2. Sample Size for the Test Set and Data Provenance

Sample Size for Test Set: Not applicable (No clinical test set for performance evaluation against specific criteria was required or performed).
Data Provenance: Not applicable.

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

Not applicable (No clinical test set with expert ground truth was required or performed).

4. Adjudication Method for the Test Set

Not applicable (No clinical test set with adjudicated ground truth was required or performed).

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Was an MRMC study done? No.
Effect size of human readers with AI vs. without AI assistance: Not applicable. This is a diagnostic ultrasound system, not an AI-powered image analysis tool for interpretation.

6. Standalone (Algorithm Only) Performance Study

Was a standalone study done? No. This is a diagnostic imaging device, not a standalone algorithm.

7. Type of Ground Truth Used

Not applicable (No clinical performance evaluation requiring ground truth was described).

8. Sample Size for the Training Set

Not applicable (This submission describes a hardware and software system, not a machine learning model that requires a training set of data for performance).

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

Not applicable.

Summary of Findings from the Provided Text:

The 510(k) submission for the DP-9900 Digital Ultrasonic Diagnostic Imaging System with added transducer is a substantial equivalence (SE) submission, not one that relies on clinical performance data against specific acceptance criteria. The core argument for clearance is that the modified device (with added transducers) shares the same fundamental technology as its predicate devices and conforms to applicable safety standards.

The document explicitly states: "No clinical testing was required." This indicates that the FDA did not deem a clinical study necessary to prove the device's safety and effectiveness for its intended use, likely because its technological characteristics and intended use were very similar to existing, legally marketed predicate devices. The focus was on engineering verification and compliance with standards such as NEMA UD 2, IEC 60601-1, and IEC 60601-1-2 for acoustic output, electrical safety, thermal safety, and biocompatibility.

Summary

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Exhibit A 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: _ K053346

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:

I.i 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:

November 15, 2005

Name of the device:

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

Classification .

Regulatory Class: II Review Category: Tier II

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

.. "

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Legally Marketed Predicate Device:

DP-9900 Digital Ultrasonic Diagnostic Imaging System K043563 SSA-530A Famio Diagnostic Ultrasound System K051500

Description:

Statement of intended Use:

The DP-9900 Digital Ultrasonic Diagnostic Imaging System with added transducer is a general-purpose, fully digital ultrasound system for abdominal, gynecologic and obstetric, small parts, and cardiac applications.

The system is intended to use 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 Device 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 with added transducer incorporates the same fundamental technology as the predicate devices. The device has been tested as Track 1 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. All transducers used with the DP-9900 digital ultrasonic diagnostic imaging system are track 1. All patient contact materials are biocompatible.

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The technology characteristics of the DP-9900 digital ultrasonic diagnostic imaging system with these modifications do not affect the safety or efficacv of the device.

Testing:

Laboratory testing was conducted to verify that the DP-9900 digital ultrasonic diagnostic imaging system with added transducer met all design specification and was substantially equivalent to the currently marketed Predicate Device as above. 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"

Applicable Standards

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

NEMA UD 2 Acoustic Output Measurement Standard for Diagnostic ultrasound Equipment 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 with added transducer demonstrates that the device is as safe, as effective as well as the legally marketed predicate devices.

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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health and Human Services, USA. The seal features a circular design with the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" arranged around the perimeter. Inside the circle is an emblem of an eagle with its wings spread, symbolizing the department's mission to protect and promote the health and well-being of the nation.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

2005 DEC 9

Shenzhen Mindray Bio-Medical Electronics Co., Ltd. % Ms. Susan Goldstein-Falk Official Correspondent mdi Consultants, Inc. 55 Northern Blvd., Suite 200 GREAT NECK NY 11021

Re: K053346

Trade Name: DP-9900 Digital Ultrasonic Diagnostic Imaging System Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulation Number: 21 CFR 892.1570 Regulation Name: Diagostic ultrasonic transducer Regulatory Class: II Product Code: IYO and ITX Dated: November 15, 2005 Received: December 2, 2005

Dear Ms. Goldstein-Falk:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your Section 3 roxif present in 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 Interslate commerce prob to thay 20, 1777, 19, 1777, 19, 1777, 1978, 1999, 1999, 1999, 1999, 1999, 1999, 1999, 1999, 1999, 1999, 1999, 1999, 1999, 1999, 1999, 1999, 1999, 199 Americallents, of to devices markets Act (Act). You may, therefore, market the device, subject to rederal rood, Drug, and Cooments Fest et. The general controls provisions of the Act include the general controls provisions of the 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 This delemination of Substanial Squarial System, as described in your premarket notification:

Transducer Model Number

35C50HA 75L60HA

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Page 2 - Ms. Goldstein-Falk

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), If your device is classified (300 above) ifrols. Existing major regulations affecting your device FDA it may be subject to such additional controls: Title 21, Parts 800 to 898. In addition, FDA can be found in the Code of Peachartogenening your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that 1 DA 3 issuates of woulder with other requirements of the Act that FDA has made a decienmancin also Joinistered by other Federal agencies. You must of any Federal statutes and regulations and admitted to: registration and listing (21 Comply with an the Act 3 requirements) nortally, which and manufacturing practice requirements as set CFR Part 807); labeling (21 CFR Part 601); good manat 820); and if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR Part 820); and 11 GFR 1000 forth in the quality systems (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 nothication. The I Dry miding of successification 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 If you desire specific advice for your act (240) 276-0120. Also, please note the regulation entitled, p Colliati the Office of Othephand (21 (21CFR Part 807.97). You may obtain "Misbranding by reference to premainer itsultities under the Act from the Division of Small other general information on your responsive Assistance at its toll-free number (800) 638-2041 or Manufacturers, International and Collsaner Prosistantes agov/cdrh/industry/support/index.html

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

Sincerely yours,

David A. Bergerson

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

Enclosure(s)

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Diagnostic Ultrasound Indications for Use Form

Transducer System × DP 9900 Model:

510(k) Number(s)

ﻛﺮ ﺍﻟﻤﺮﺍﺟﻊ ﺍﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ

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		P	P						P	N
Abdominal		P	P						P	N
Intraoperative (specify)
Intraoperative Neurological
Pediatric		P	P						P
Small organ(specify)		P	P						P
Neonatal Cephalic		P	P						P
Adult Cephalic
Cardiac		P	P						P
Transesophageal
Transrectal		P	P						P
Transvaginal		P	P						P
Transurethral
Intravascular
Peripheral Vascular		P	P						P
Laparoscopic
Musculo-skeletal		P	P						P
Conventional
Musculo-skeletal Superficial		P	P						P
Other (specify)

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

Combined mode: B+M ' Additional comments:

*Other: Tissue Harmonic Imaging. The feature does not use contrast agents

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

Concurrence of CDRH, Office of Device Evaluation(ODE)

Daniel A. Cheyrum

0028

Prescription USE (Per 21 CFR 801.109)

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

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Diagnostic Ultrasound Indications for Use Form

System Model: Transducer ×

3565014A

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		P	P	P					P	N
Abdominal		P	P	P					P	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

*Other: Tissue Harmonic Imaging. The feature does not use contrast agents

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

Concurrence of CDRH, Office of Device Evaluation(ODE)

Daniel G. Ayres
(Division Sign-Off)

0022

ﻓ

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

Prescription USE (Per 21 CFR 801.109)

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Diagnostic Ultrasound Indications for Use Form

System

× Transducer

Model: 75L60HA

510(k) Number(s)

Intended Usc: 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)		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)

Daniel A. Legron

Prescription USE (Per 21 CFR 801.109)

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K053346 0031

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.