EMP-2100 Full Digital Ultrasound Diagnostic System is a general-purpose, digital ultrasound diagnostic system for abdomen, gynecology, obstetric, urology, small-parts, and cardiology application.

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-skeletal(both conventional and superficial). The device is intended to adult, pregnant woman, pediatric and neonate.

The system is a prescription device intended to be used by or on the order of a physician or similar qualified health care professional. This device is not intended for home use.

Device Description

EMP-2100 Full Digital Ultrasound Diagnostic Device is a portable digital ultrasonic diagnostic B/W system applied in ultrasound diagnostic examination of abdomen, gynecology, obstetric, urology, small-parts, and cardiology application.

It is designed to produce ultrasound waves into body tissue and to present the returned echo information on the monitor. The resulting information is displayed in five display modes as listed below. This system is a Track 1 device that employs an array of probes that include linear array, convex linear array and microconvex linear array with a frequency range of approximately 2.5MHz~7.5MHz.

The subject device is not for life-supporting or life-sustaining, not for implant. The device or transducers are not provided sterile and the transducer does not need sterilization and the transducer is reusable but does not need re-sterilization.

The system consists of a main unit, a display and four transducers.

AI/ML Overview

The provided 510(k) summary for the EMP-2100 Full Digital Ultrasound Diagnostic System is primarily a substantially equivalent analysis comparing the device to a predicate device (DP-6600 Digital Ultrasonic Diagnostic Imaging System). It does not contain the acceptance criteria and a detailed study report that proves the device meets those criteria, as typically found in comprehensive performance studies for AI/CAD devices.

Instead, the submission focuses on demonstrating that the EMP-2100 device is as safe and effective as the predicate device by highlighting similarities and explaining that any differences do not affect basic design principles, usage, effectiveness, or safety.

Therefore, many of the requested details about acceptance criteria, specific performance metrics, sample sizes, ground truth establishment, and expert involvement for a study proving acceptance criteria are not present in this document because this type of study was not performed or detailed as part of this 510(k) submission.

Here's a breakdown of what can be extracted and what is not available based on the provided text:

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

Acceptance Criteria: The document implies that the acceptance criterion is "substantially equivalent" to the predicate device in terms of effectiveness and safety. However, no specific quantitative or qualitative acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds) are provided in a table format.
Reported Device Performance: The only performance test explicitly mentioned is a "Clinical Measurement Effectiveness Test" to evaluate its measurement accuracy. No specific results, metrics (like accuracy values), or detailed findings from this test are reported. The document states: "The subject device has same classification information, same indication for use, similar product design, same performance effectiveness, performance safety as the predicate device." This is a general statement rather than specific performance data.

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

Not available. The document mentions a "Clinical Measurement Effectiveness Test" but does not provide any details about the sample size (number of patients or cases), data provenance, or whether it was retrospective or prospective.

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 available. Since the details of the "Clinical Measurement Effectiveness Test" are not provided, there is no information on how ground truth was established, who the experts were, or their qualifications.

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

Not available. No details on adjudication methods for any test set are provided.

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 done/Not applicable. This device is an ultrasound diagnostic system (hardware and software for imaging), not an AI/CAD system intended to assist human readers in interpretation. Therefore, a MRMC study evaluating human reader improvement with AI assistance would not be relevant to this product.

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

Not applicable. This is a diagnostic imaging system, not an algorithm being tested in isolation. The "Clinical Measurement Effectiveness Test" would likely involve the system's ability to acquire and display accurate measurements, which is an inherent function of the device.

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

Not available. The document does not specify the type of ground truth used for the "Clinical Measurement Effectiveness Test."

8. The sample size for the training set

Not applicable/Not available. As this is a traditional ultrasound system and not an AI/Machine Learning product, there is no concept of a "training set" in the context of algorithm development.

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

Not applicable/Not available. (See point 8).

Summary of what is present:

The submission highlights that the EMP-2100 is substantially equivalent to the predicate device (DP-6600 Digital Ultrasonic Diagnostic Imaging System) based on:

Same classification information and intended use.
Similar product design.
"Same performance effectiveness" (general statement, no specific metrics provided).
"Performance safety" (general statement, verified by electrical safety and EMC testing to IEC 60601-1 and 60601-1-2, and biocompatibility testing to ISO 10993-1).

The core of the "proof" that the device meets acceptance criteria ("effectiveness and safety") is the claim of substantial equivalence to a legally marketed predicate device, rather than a detailed study demonstrating quantitative performance metrics against specific, pre-defined acceptance thresholds.

Summary

{0}------------------------------------------------

Ko81873

JUL 1 6 2008

moer of Shenzhen Emperor Electronic Technology Co., Ltd

Appendix VI 510(k) Summary

As Required by CFR 807.92

Submission Date: May 21, 2008

2. Sponsor Information

Shenzhen Emperor Electronic Technology Co., Ltd. 2/F, Building7, Tian'an Nanyou Industrial Area, Nanshan District, Shenzhen, 518054, China Contact Person: Ms. Cheng Guiyuan Tel: +86-755-26073381 Fax: +86-755- 26419886

3. Submission Correspondent:

Ms. Diana Hong Shanghai Mid-Link Business Consulting Co., Ltd Suite 8D, Zhongshan Zhongxin Mansion No.19, Lane 999, Zhongshan No.2 Road(S) Shanghai, 200030, China.

4. Subject Device Information

Trade/Proprietary Name: EMP-2100 Full Digital Ultrasound A Device Diagnostic Device
Device Classification Name: System, Imaging, Pulsed echo, Ultrasonic ア Transducer, Ultrasonic, Diagnostic
A Device Common Name: Ultrasonic pulsed echo imaging system
ア Review Panel: Radiology
ア Product Code: 90-IYO & 90-ITX
ア Regulation Number: 892.1560
Device Class: II
A Review Category: Tier II
A Intended Use:

EMP-2100 Full Digital Ultrasound Diagnostic System is a general-purpose, digital ultrasound diagnostic system for abdomen, gynecology, obstetric, urology, small-parts, and cardiology application.

The system is intended to use for the following type of studies: fetal organ, abdominal, pediatric, small organs, neonatal cephalic, cardiac, transvaginal,

{1}------------------------------------------------

Peror Shenzhen Emperor Electronic Technology Co., Ltd

peripheral vascular, and musculo-skeletal(both conventional and superficial). The device is intended to adult, pregnant woman, pediatric and neonate.

The system is a prescription device intended to be used by or on the order of a physician or similar qualified health care professional. This device is not intended for home use.

5. Predicate Device:

DP-6600 Digital Ultrasonic Diagnostic Imaging System with added transducers K-number: K060949

Product Code: IYO

Intended Use:

The system 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, and peripheral vascular and musculo-skeletal (both conventional and superficial).

This device is intended to adult, pregnant woman, pediatric and neonate. The 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.

Manufactured by:

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

6. Device Description

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

Shenzhen Emperor Electronic Technology Co., Ltd

Transducer Model	Type	NominalFrequency	Application	Track
C080-13G	Micro Convex	6.5 MHz	gynecology, obstetric, urology and transvaginal	1
L096-42C	Liner Probe	6.5 MHz	small-parts, neonatal cephalic, peripheral vascular andmusculo-skeletal	1
C096-20A	Micro Convex	3.5 MHz	cardiology, pediatric, abdomen, gynecology and obstetric	1
C128-50	Convex	3.5 MHz	abdomen, pediatric, gynecology and obstetric	1

The system consists of a main unit, a display and four transducers.

7. Technology Characteristics

Table VI-2 Technology Characteristics

Display Mode	B,B/B,4B,B/M,M
Gray Scales	256
Frame rate	60 frames/second max.(various according different probes and the frequency)
Display	10"SVGA
Video output	PAL-D
Digital Scanning Converter	576 ×460 ×8 bits
Zoom	11 levels, partial zoom
Body mark	38 types indicating probe positions
Power Supply	AC 100~~240V, 47~~60Hz
Input Power	200 VA
Continuous Operation Period	>8 hours
Dimensions	365 (height) ×292 (width) ×380 (depth)
Weight	Net weight 10 Kg
Working Condition	Temperature 5°C -40°C, relative humidity up to 90%RH
Storage Condition	Temperature -5-40°C, relative humidity up to 90%RH (no waterdrop) air pressure 70-106Kpa

8. Effectiveness and Safety Considerations

Effectiveness:

Clinical Measurement Effectiveness Test was conducted on the subject device to evaluate its measurement accuracy.

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

Shenzhen Emperor Electronic Technology Co., Ltd

Safety Considerations:

The Electrical Safety Testing following IEC 60601-1 and Electromagnetic Compatibility Testing following IEC 60601-1-2 was conducted on the subject device

Guideline "INFORMATION FOR MANUFACTURERS Per FDA SEEKING MARKETING CLEARANCE OF DIAGNOSTIC ULTRASOUND SYSTEMS AND TRANSDUERS" dated May 1, 1997 and with regard to Table I Initial Evaluation Tests for Consideration and Table 2 Supplementary Evaluation Tests for Consideration in ISO 10993-1:2003(E), Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing, the necessary tests for Biocompatibility Testing includes: Cytotoxicity, Sensitization, Irritation.

9. Substantially Equivalent Analysis

The subject device has same classification information, same indication for use, similar product design, same performance effectiveness, performance safety as the predicate device.

The differences are included as followings:

Scanning angle

Linear probe width

Micro-convex probe scanning angle

Power supply: 110V±10%, 230V±10% vs 100~240VAC±10%

Volume and Weight: 306 mm (W)*426 mm (L)*357 mm (H), 12KG vs 86 mm(W)*385 mm(L)*306 mm(H), 11KG

Image Process: the subject device does not have Line Density as the predicate device Storage: 16 images in main unit vs 100 images in main unit

Operation Environment: Temperature 5°C -40°C relative humidity 30-80%RH vs Temperature 5°C-40°C ,relative humidity 30-85%RH

Storage Environment .: Temperature -5-40°C ,relative humidity 30-80%(no water drop) air pressure 86-106Kpa vs Temperature -22℃ -55℃ . relative humidity 30-85% (no condensation) air pressure 70-106Kpa

Display Mode

The differences above between the subject device and predicate device do not affect the basic design principle, usage, effectiveness and safety of the subject device. And no question is raised regarding to effectiveness and safety.

No new unique technology is applied in the subject device. Most of the main aspects on effectiveness and safety between the subject device and predicate device are same. The

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

PCI CI Shenzhen Emperor Electronic Technology Co., Ltd

differences are slight so that no substantial influence on the effectiveness and safety.

10. Substantially Equivalent Determination

The subject device, EMP-2100 Full Digital Ultrasound Diagnostic Device, is substantially equivalent to the predicate device, DP-6600 Digital Ultrasonic Diagnostic Imaging System with added transducers

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

Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare, with three lines representing the branches of government. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 1 6 2008

Shenzhen Emperor Electronic Technology Co., Ltd % Mr. Morten Simon Christensen Staff Engineer & FDA Accredited Person Program Coordinator, Program Reviewer Underwriters Laboratories, Inc. UL Silicon Valley Office 455 E. Trimble Road SAN JOSE CA 95131-1230

Re: K081873

Trade/Device Name: EMP-2100 Full Digital Ultrasound Diagnostic System Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: II Product Code: IYO and ITX Dated: June 24, 2008 Received: July 2, 2008

Dear Mr. Christensen:

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 EMP-2100 Full Digital Ultrasound Diagnostic System, as described in your premarket notification:

Transducer Model Number

C128-50
C080-13G
L096-42C
C096-20A

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

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 A. Phillips, Ph.D. at (240) 276-3666.

Sincerely yours.

Arque M. Whan

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

Enclosure(s)

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

Indication for Use

510(k) Number:

Device Name: EMP-2100 Full Digital Ultrasound Diagnostic System

Indications for Use:

EMP-2100 Full Digital Ultrasound Diagnostic System is a general-purpose, digital ultrasound diagnostic system for abdomen, gynecology, obstetric, urology, small-parts, and cardiology application.

The system is a prescription device intended to be used by or on the order of a physician or similar qualified health care professional. This device is not intended for home use.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-off)

Page 1 of __ 1

Division of Reproductive. Abdomina Radiological Devices 510(k) Number

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

Fill out one form for each ultrasound system and each transducer.

Device Name: EMP-2100 Full Digital Ultrasound Diagnostic System (C128-50 Transducer)

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(B/M)	Other(specify)
Ophthalmic
Fetal		N	N						N
Abdominal		N	N						N
Intraoperative (specify)
Intraoperative Neurological
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
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 Comments:

(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)

Aoguih Whag

ductive. Andominal 510(k) Nu

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

Fill out one form for each ultrasound system and each transducer.

Device Name: EMP-2100 Full Digital Ultrasound Diagnostic System (C080-13G Transducer) 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 Amplitude Color Combined Other Doppler Doppler Velocity (B/M) (specify) Imaging Ophthalmic Fetal Abdominal Intraoperative (specify) Intraoperative Neurologica Pediatric Small Organ (specify) Neonatal Cephalic Adult Cephalic Transesophageal Transrectal Transvaginal N N N Transurethral N N N Intravascular Peripheral Vascular Laparoscopic Musculo-skeletalConventional Musculo-skeletal Superficial

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

(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)

Other (specify)

forpaitm Whay

(Division Sian-Off) 510(k) Number

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

Fill out one form for each ultrasound system and each transducer.

Device Name: EMP-2100 Full Digital Ultrasound Diagnostic System (L096-42C Transducer)

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(B/M)	Other(specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (specify)
Intraoperative Neurologica
Pediatric
Small Organ (specify)		N	N						N
Neonatal Cephalic		N	N						N
Adult Cephalic
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular		N	N						N
Laparoscopic
Musculo-skeletalConventional		N	N						N
Musculo-skeletal Superficial		N	N						N
Other (specify)

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

が出来ました。 2007年07月27日 10:00:00 【送料無料】 2007年07月10日 10:00 【送料無料】 2007/08/07 11:00 【送料無料】 2007/08/08 11:00 【送料無料】 2007/08/08 11:00 【

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

のお気になる。

Vornthethun

Prescription Use (Per 21 CFR 801.109)

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

(Division Sign-Off)/
Division of Reproductive, Abdominal and
Radiological Devices
510(k) Number K081873

{11}------------------------------------------------

Fill out one form for each ultrasound system and each transducer.

Device Name: EMP-2100 Full Digital Ultrasound Diagnostic System (C096-20A Transducer)

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

Clinical Application	A	B	M	Combined(B/M)
Ophthalmic
Fetal
Abdominal	N	N	N	N
Intraoperative (specify)
Intraoperative Neurologica
Pediatric	N	N	N	N
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletal Superficial
Other (specify)
Cardiac	N	N	N	N

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

(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)

Tomik Whing

(Division Sign-Off) Reproductive. Abdominal and

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.