Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a standard ultrasound imaging system and does not mention any AI or ML capabilities. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".

Therapeutic

No

This device is described as a "Diagnostic ultrasound imaging or fluid flow analysis" system, and its purpose is to "project ultrasound waves into body tissue and to present the returned echo information on the monitor" for diagnostic purposes, not for treatment.

Diagnostic

Yes

The "Intended Use / Indications for Use" section explicitly states "Diagnostic ultrasound imaging or fluid flow analysis of the human body." The "Device Description" also refers to the system as a "general purpose, mobile, software controlled, ultrasound diagnostic system."

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a "system" and includes "an array of probes," which are hardware components. The performance studies also mention testing for thermal, mechanical, and electrical safety, which are relevant to hardware.

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 medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body.
Device Function: The description clearly states that this device is an "ultrasonic diagnostic imaging system" that "project[s] ultrasound waves into body tissue and to present the returned echo information on the monitor." This is a form of in vivo (within the living body) imaging.
Intended Use: The intended use is for "Diagnostic ultrasound imaging or fluid flow analysis of the human body," which is performed directly on the patient.

Therefore, since the device operates by imaging the inside of the body using ultrasound and does not analyze specimens taken from the body, it does not fit the definition of an In Vitro Diagnostic.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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

DP-9900 Digital Ultrasonic Diagnostic Imaging System:

Clinical Application	B	M	Combined (specify)
Fetal	N	N	N
Abdominal	N	N	N
Pediatric	N	N	N
Small organ(specify)	N	N	N
Neonatal Cephalic	N	N	N
Cardiac	N	N	N
Transrectal	N	N	N
Transvaginal	N	N	N
Peripheral Vascular	N	N	N
Musculo-skeletal Conventional	N	N	N
Musculo-skeletal Superficial	N	N	N

35C20HA Transducer:

Clinical Application	B	M	Combined (specify)
Abdominal	N	N	N
Pediatric	N	N	N
Cardiac	N	N	N

35C50HA Transducer:

Clinical Application	A	B	M	PWD	CWD	Color Doppler	Amplitude Doppler	Color Velocity Imaging	Combined (specify)	Other (specify)
Fetal		N	N						N
Abdominal		N	N						N

65EC10HA Transducer:

Clinical Application	A	B	M	PWD	CWD	Color Doppler	Amplitude Doppler	Color Velocity Imaging	Combined (specify)	Other (specify)
Transrectal		N	N						N
Transvaginal		N	N						N

75L38HA Transducer:

Clinical Application	B	M	Combined (specify)
Pediatric			N
Small organ(specify)	N	N	N
Neonatal Cephalic	N	N	N
Peripheral Vascular	N	N	N
Musculo-skeletal Conventional	N	N	N
Musculo-skeletal Superficial	N	N	N

Product codes (comma separated list FDA assigned to the subject device)

90 IYO, ITX

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.

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 (Conventional and 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. 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

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)".

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

No clinical testing was required.

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

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K990490

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

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

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.

1

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)

2

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	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	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

3

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	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	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 .

4

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	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	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 _

5

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	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	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

6

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	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	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

7

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)

8

Legally Marketed Predicate Device:

SSA-325A JUST VISION 400 Ultrasound Imaging System K990490

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.

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

9

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.