Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on standard ultrasound technology and software functions without mentioning AI/ML capabilities.

Therapeutic

No
The device is described as a "Digital Ultrasonic Diagnostic Imaging System" used for "Diagnostic ultrasound imaging or fluid flow analysis," indicating its purpose is diagnosis, not therapy.

Diagnostic

Yes
The "Intended Use / Indications for Use" section explicitly states "Diagnostic ultrasound imaging or fluid flow analysis of the human body," and the "Device Description" refers to it as a "Digital Ultrasonic Diagnostic Imaging System" designed to present "returned echo information on the monitor" for diagnosis.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a "Digital Ultrasonic Diagnostic Imaging System with added transducer" and mentions hardware components like transducers and acoustic lenses.

IVD (In Vitro Diagnostic)

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

Here's why:

IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
Device Function: The description clearly states that this device is an "ultrasonic diagnostic system" that "project[s] ultrasound waves into body tissue and to present the returned echo information on the monitor." This is an in vivo (within the living body) imaging technique, not an in vitro test.
Intended Use: The intended use is for "Diagnostic ultrasound imaging or fluid flow analysis of the human body," which aligns with in vivo imaging.
Lack of Mention of Samples: There is no mention of analyzing samples taken from the body.

Therefore, this device falls under the category of medical imaging devices, not in vitro diagnostics.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for 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.

Product codes

IYO, ITX

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. The modification will provide users with an additional transducer and change the acoustic lens of some transducers along with the addition of software functions.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasound

Anatomical Site

Fetal, Abdominal, Pediatric, Small organ, Neonatal Cephalic, Cardiac, Transrectal, Transvaginal, Peripheral Vascular, Musculo-skeletal, Musculo-skeletal Superficial

Indicated Patient Age Range

adult, pregnant woman, pediatric and neonate.

Intended User / Care Setting

used by or on the order of a physician or similarly qualified health care professional. This Device is not intended for home use.

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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"
No clinical testing was required

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K053346

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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.

Summary

0

JUN - 1 2006 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: K o ( 1189

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:
April 20, 2006

Name of the device:

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

· Classification

Regulatory Class: Review Category: Tier

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

1

Legally Marketed Predicate Device:

Ko 61189

DP-9900 Digital Ultrasonic Diagnostic Imaging System K053346

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. The modification will provide users with an additional transducer and change the acoustic lens of some transducers along with the addition of software functions.

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 device. 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

2

061189

are track 1. All patient contact materials are biocompatible. 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.

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.

3

Image /page/3/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 text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" arranged around the perimeter. Inside the circle is a stylized symbol of three human figures, represented by flowing lines, suggesting a sense of movement and connection.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Shenzhen Mindray Bio-Medical Electronics Co., Ltd. c/o Ms. Susan Goldstein-Falk Official Correspondent mdi Consultants, Inc. JUN - 1 2006 55 Northern Blvd., Suite 200 GREAT NECK 11021

Re: K061189

Tradename: DP-9900 Digital Ultrasonic Diagnostic Imaging System Regulation Number : 21 CFR §892.1560 Regulation Name: Diagnostic pulsed echo imaging system Product Code: IYO Regulation Number : 21 CFR §892.1570 Regulation Name: Diagnostic ultrasound transducer Product Code: ITX Regulatory Class: II Dated: April 20, 2006 Received: April 28, 2006

Dear Ms. Goldstein-Falk:

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 Diagnostic Imaging System as described in your premarket notification:

Transducer Model Number

75L60HB

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.

4

Page 2 - Ms. Goldstein-Falk

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 A. Phillips, Ph.D. at (301) 594-1212.

Sincerely yours,

Daniel R. Syzman

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

Enclosures

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1189

Diagnostic Ultrasound Indications for Use Form

Transducer System ×

DP-9900 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	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(specify)	Other*
(specify)
Ophthalmic
Fetal		P	P				P	P
Abdominal		P	P				P	P
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

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)

David A. Lymm

Prescription USE (Per 21 CFR 801.109)

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number	K061189 0029

6

Ko 61189

Diagnostic Ultrasound Indications for Use Form

System Transducer ×

75L60HB 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	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	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)

David A. Lynn

Prescription USE (Per 21 CFR 801.109)

(Division Sign-Off)
Division of Reproductive, Abdominal, 0030
and Radiological Devices
510(k) Number K061189