DC-3, DC-3T DIAGNOSTIC ULTRASOUND SYSTEM

K081320 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · IYN · May 27, 2008 · Radiology

Device Facts

• Record ID: K081320
• Device Name: DC-3, DC-3T DIAGNOSTIC ULTRASOUND SYSTEM
• Applicant: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
• Product Code: IYN · Radiology
• Decision Date: May 27, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1550
• Device Class: Class 2
• Attributes: Pediatric, 3rd-Party Reviewed

Intended Use

The DC-3/DC-3T diagnostic ultrasound system is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetal -OB/GYN, abdominal, pediatric, small parts (breast, thyroid, testicle, etc), neonatal cephalic, transvaginal, transrectal, peripheral vascular, and musculoskeletal (conventional and superficial) exams.

Device Story

The DC-3/DC-3T is a mobile, software-controlled diagnostic ultrasound system. It utilizes linear and convex array probes (2.5–12 MHz) to acquire ultrasound data. The system processes signals to display images in B-Mode, M-Mode, PW-Mode, Color-Mode, Power-Mode, Dirpower-Mode, and combined modes (e.g., B+M, PW+B). It includes features such as Tissue Harmonic Imaging, Smart3D, and iScape. Used in clinical settings by healthcare professionals, the system provides real-time visualization of internal structures to assist in diagnostic decision-making across various clinical applications. The output is displayed on the system monitor for clinician interpretation.

Clinical Evidence

Bench testing only. The device was tested per FDA guidance for Track 3 diagnostic ultrasound systems, including acoustic output measurements per NEMA UD 2 and NEMA UD 3, and electrical/mechanical safety per IEC 60601 series and ISO 10993-1 biocompatibility standards.

Technological Characteristics

Mobile diagnostic ultrasound system; linear and convex array transducers (2.5–12 MHz); modes: B, M, PW, Color, Power, Dirpower, and combined; features: Tissue Harmonic Imaging, Smart3D, iScape; conforms to IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, and ISO 10993-1.

Indications for Use

Indicated for adults, pregnant women, pediatric patients, and neonates for fetal, OB/GYN, abdominal, pediatric, small parts (breast, thyroid, testicle), neonatal cephalic, transvaginal, transrectal, peripheral vascular, and musculoskeletal exams.

Regulatory Classification

Identification

An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Predicate Devices

• Mindray M5 (K080640)
• Mindray DC-6 (K072164)

Submission Summary (Full Text)

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#### 510(K) SUMMARY Exhibit B

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(c).

The assigned 510(k) number is: 1081320

# 1. 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: [phone] Fax: [phone]

### 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 18, 2008

2. Device Name: DC-3/DC-3T Diagnostic Ultrasound System

### Classification

Regulatory Class: II Review Category: Tier II 21 CFR 892.1550 Ultrasonic Pulsed Doppler Imaging System (90-1YN) 21 CFR 892.1560 Ultrasonic Pulsed Echo Imaging System (90-1YO) 21 CFR 892.1570 Diagnostic Ultrasound Transducer (90-ITX)

#### 3. Marketed Device:

DC-3/DC-3T Diagnostic Ultrasound System is substantially equivalent to the following devices: Mindray M5 (K#080640), Mindray DC-6 (K#072164).

### 4. Device Description:

The DC-3/DC-3T is a general purpose, mobile, software controlled, ultrasonic

. : `

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diagnostic system. Its function is to acquire and display ultrasound data in B-Mode, M-Mode, PW-Mode, Color-Mode, Power-Mode, Dirpower-Mode or the combined mode (i.c. B/M-Mode). This system is a Track 3 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 12 MHz.

## 5. Intended Use:

The DC-3/DC-3T diagnostic ultrasound system is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetal -OB/GYN, abdominal, pediatric, small parts (breast, thyroid, testicle, etc), neonatal cephalic, transvaginal, transrectal, peripheral vascular, and musculoskeletal (conventional and superficial) exams.

## 6. Safety Considerations:

The DC-3/DC-3T Diagnostic Ultrasound System has been tested as Track 3 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 and NEMA UD 3 Output Display Standard. The device conforms to applicable medical device safety standards, such as IFC 60601-1, IEC 60601-1-2, IEC 60601-2-37 and ISO 10993-1.

## Conclusion:

The conclusions drawn from testing of the DC-3/DC-3T Diagnostic Ultrasound System demonstrate that the device is as safe and effective as the legally marketed predicate devices.

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

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Image /page/2/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized design of three human profiles facing right, arranged in a row. The profiles are connected and form a single, flowing shape. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the top half of the logo.

JUL 3 2008 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: K081320

Trade/Device Name: DC-3 and DC-3T Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, and ITX Dated: May 9, 2008 Received: May 12, 2008

Dear Mr. Mosenkis:

This letter corrects our substantially equivalent letter of May 27, 2008.

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 DC-3 and DC-3T, as described in your premarket notification: -

Transducer Model Number

3C5A 6CV 1 7L4A, 7L6, 10L4

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Page 2 - Mr. Mosenkis

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 [phone]. 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 [phone] or [phone] 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 Lauren Hefner at ' [phone].

Sincerely yours,

lori In Whang

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

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×

#### Diagnostic Ultrasound Indications for Use Form

System Model:

Transducer DC-3, DC-3T

510(k) Number(s)

| | Mode of Operation | | | | | | | | | |
|----------------------------------------------------------------------------------------------------|-------------------|---|---|---------|-----|------------------|----------------------|------------------------------|-----------------------|-----------------|
| Clinical Application | A | B | M | PW<br>D | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(specify) | Other (specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | N | N | N | | N | N | | N | Note 1, 2, 3 |
| Abdominal | | N | N | N | | N | N | | N | Note 1, 2, 3 |
| Intraoperative (specify)* | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | | N | N | N | | N | N | | N | Note 1, 2, 3 |
| Small organ(specify)** | | N | N | N | | N | N | | N | Note 2, 3 |
| Neonatal Cephalic | | N | N | N | | N | N | | N | Note 2, 3 |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | N | N | N | | N | N | | N | Note 2, 3 |
| Transvaginal | | N | N | N | | N | N | | N | Note 2, 3 |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | N | N | N | | N | N | | N | Note 2, 3 |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal Conventional | | N | N | N | | N | N | | N | Note 2, 3 |
| Musculo-skeletal Superficial | | N | N | N | | N | N | | N | Note 2, 3 |
| Other (specify) *** | | N | N | N | | N | N | | N | Note 2, 3 |
| N=new indication; P=previously cleared by FDA; E=added under Appendix E | | | | | | | | | | |
| Additional comments: Combined modes: B+M. PW+B. Color + B. PW +Color+B. PW +Color+B. Power + PW+B. | | | | | | | | | | |

*Intraoperative includes abdominal, thoracic, and vascular etc.

**Small organ-breast, thyroid, testes, etc.

***Other use includes Urology/Prostate.

Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents.

Note 2: Smart3D

Note 3: iScape

(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)

tonui m. Whang

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

0071

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## Diagnostic Ultrasound Indications for Use Form

System Transducer ×

Model: 510(k) Number(s) 3C5A

| Clinical Application | Mode of Operation | | | | | | | | | |
|-------------------------------------------------------------------------|-------------------|---|---|---------|-----|------------------|----------------------|------------------------------|-----------------------|-----------------|
| | A | B | M | PW<br>D | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(specify) | Other (specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | N | N | N | | N | N | | N | Note 1, 2, 3 |
| Abdominal | | N | N | N | | N | N | | N | Note 1, 2, 3 |
| Intraoperative (specify)* | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | | N | N | N | | N | N | | N | Note 1, 2, 3 |
| Small organ(specify)** | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal Conventional | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | |
| Other (Urology) | | | | | | | | | | |
| N=new indication; P=previously cleared by FDA; E=added under Appendix E | | | | | | | | | | |

*Intraoperative includes abdominal, thoracic, and vascular etc.

**Small organ-breast, thyroid, testes, etc.

Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents.

Note 1: Tissue Harmonic Imaging. The fea

Note 2: Smart3D

Note 3: iScape

(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)

Toni M. Whay

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

0072

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#### Diagnostic Ultrasound Indications for Use Form

------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

| System | |
|------------|-------|
| Model: | 6CV I |
| Transducer | X |

510(k) Number(s)

***_*****_** и на исковое заявление

| | Mode of Operation | | | | | | | | | |
|---------------------------------------------------------------------------------------------------|-------------------|---|---|---------|-----|------------------|----------------------|------------------------------|-----------------------|-----------------|
| Clinical Application | A | B | M | PW<br>D | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(specify) | Other (specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | N | N | N | | N | N | | N | Note 2, 3 |
| Abdominal | | | | | | | | | | |
| Intraoperative (specify)* | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small organ(specify)** | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | N | N | N | | N | N | | N | Note 2, 3 |
| Transvaginal | | N | N | N | | N | N | | N | Note 2, 3 |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal Conventional | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | |
| Other (specify) *** | | N | N | N | | N | N | | N | Note 2, 3 |
| N=new indication; P=previously cleared by FDA; E=added under Appendix E | | | | | | | | | | |
| Additional comments: Combined modes: B+M, PW+B, Color + B, Power + B, PW +Color+ B, Power + PW+B. | | | | | | | | | | |

*Intraoperative includes abdominal, thoracic, and vascular etc.

**Small organ-breast, thyroid, testes, etc.

***Other use includes Urology.

Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents.

Note 2: Smart3D

Note 3: iScape

(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)

Asque M. Whag

of Reproductive, Abdominal ar Radiologica vices 510(k) Numb

0073

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

Mindray Co. Ltd.- DC-3/DC-3T Diagnostic Ultrasound System

## Diagnostic Ultrasound Indications for Use Form

| System | Transducer | X |
|------------------|-----------------|---|
| Model: | 7L4A, 7L6, 10L4 | |
| 510(k) Number(s) | | |

| | Mode of Operation | | | | | | | | | |
|---------------------------------------------------------------------------------------------------|-------------------|---|---|---------|-----|------------------|----------------------|------------------------------|-----------------------|-----------------|
| Clinical Application | A | B | M | PW<br>D | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(specify) | Other (specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intraoperative (specify)* | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small organ(specify) ** | N | N | N | N | | N | N | | N | Note 2, 3 |
| Neonatal Cephalic | N | N | N | N | | N | N | | N | Note 2, 3 |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | N | N | N | N | | N | N | | N | Note 2, 3 |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal Conventional | N | N | N | N | | N | N | | N | Note 2, 3 |
| Musculo-skeletal Superficial | N | N | N | N | | N | N | | N | Note 2, 3 |
| Other (specify) | | | | | | | | | | |
| N=new indication; P=previously cleared by FDA; E=added under Appendix E | | | | | | | | | | |
| Additional comments:Combined modes: B+M, PW+B, Color + B, Power + B, PW +Color+ B, Power + PW +B. | | | | | | | | | | |
| *Intraoperative includes abdominal, thoracic, and vascular etc. | | | | | | | | | | |

** Small organ-breast, thyroid, testes, etc.

Note I: Tissue Harmonic Imaging. The feature does not use contrast agents.

Note 2: Smart3D

Note 3: iScape

(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)

Torquato Weiz

ie Ahdor Divisio Radio 510(k) Nu

0074