DC-60/DC-60S/DC-60 Exp/DC-55 Diagnostic Ultrasound System

K182636 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · IYN · Jan 10, 2019 · Radiology

Device Facts

• Record ID: K182636
• Device Name: DC-60/DC-60S/DC-60 Exp/DC-55 Diagnostic Ultrasound System
• Applicant: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
• Product Code: IYN · Radiology
• Decision Date: Jan 10, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1550
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: DC-60/DC-60S/DC-60 Exp/DC-55 Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetal, abdominal, pediatric, small organ(breast, thyroid, testes), neonatal and adult cephalic, trans-rectal, trans-vaginal, musculo-skeletal(conventional, superficial), adult and pediatric cardiac. peripheral vessel and urology exam.

Device Story

The DC-60/DC-60S/DC-60 Exp/DC-55 is a software-controlled diagnostic ultrasound system. It uses various transducer arrays (linear, convex, phased) to transmit ultrasonic energy into the body and process received echoes. The system generates B-Mode, M-Mode, PW-Mode, CW-Mode, Color-Mode, Power/Dirpower Mode, THI, contrast imaging (for LVO), iScape, Color M, TDI, 3D/4D, and Elastography images. It is used in clinical settings by healthcare professionals for anatomical visualization and fluid flow analysis. Output is displayed on-screen for clinical assessment, measurement, and diagnosis. The device aids in clinical decision-making by providing diagnostic imaging for various patient populations and organ systems. Benefits include non-invasive visualization of internal structures and blood flow.

Clinical Evidence

No clinical data. Substantial equivalence is supported by bench testing, including acoustic output measurements, biocompatibility, cleaning/disinfection effectiveness, and thermal, electrical, and mechanical safety testing in accordance with FDA-recognized standards (e.g., IEC 60601-1, IEC 60601-2-37, NEMA UD 2).

Technological Characteristics

Software-controlled diagnostic ultrasound system. Probes: linear, convex, phased arrays. Modes: B, M, PW, CW, Color, Power/Dirpower, THI, 3D/4D, Elastography, TDI. Connectivity: standard ultrasound system interfaces. Safety standards: AAMI/ANSI ES60601-1, IEC 60601-1-2, IEC 60601-2-37, NEMA UD 2. Biocompatibility: ISO 10993-1. Software: IEC 62304.

Indications for Use

Indicated for adults, pregnant women, pediatric patients, and neonates. Applications include fetal, abdominal, pediatric, small organ (breast, thyroid, testes), neonatal and adult cephalic, trans-rectal, trans-vaginal, musculoskeletal (conventional, superficial), adult and pediatric cardiac, peripheral vessel, and urology 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

• DC-60 (K152545)

Reference Devices

• DC-8 (K170277)
• DC-80 (K173471)
• Resona 7 (K171233)
• M9 (K171034)
• ZS3 (K171891)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

January 10, 2019

Shenzhen Mindray Bio-Medical Electronics Co., LTD Jiang Haosen Engineer of Technical Regulation Keji 12th Road South, Hi-tech Industrial Park Shenzhen, Guangdong 518057 CHINA

Re: K182636

Trade/Device Name: DC-60/DC-60S/DC-60 Exp/DC-55 Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic Pulsed Doppler Imaging System Regulatory Class: Class II Product Code: IYN, IYO, ITX Dated: December 26, 2018 Received: December 28, 2018

Dear Jiang Haosen:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Hse 2. Nils

for Robert A. Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

# 510(k) Number (if known)

# K182636

Device Name

DC-60/DC-60S/DC-60 Exp/DC-55 Diagnostic Ultrasound System

### Indications for Use (Describe)

DC-60/DC-60S/DC-60 Exp/DC-55 Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetal, abdominal, pediatric, small organ(breast, thyroid, testes), neonatal and adult cephalic, trans-rectal, trans-vaginal, musculo-skeletal(conventional, superficial), adult and pediatric cardiac. peripheral vessel and urology exam.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|--|
|-------------------------------------------------|--|

[X] Prescription Use (Part 21 CFR 801 Subpart D)

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

### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

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"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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# Diagnostic Ultrasound Indications For Use Format

DC-60/DC-60S/DC-60 Exp/DC-55 Diagnostic Ultrasound System System:

Transducer: N/A

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

| Clinical Application | Mode of Operation | | | | | | | | | |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------|---|-----|-----|------------------|----------------------|-----------------------|---------------------|--|
| General(Track 1<br>Only) | Specific (Track 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Combined<br>(specify) | Other (specify) | |
| Ophthalmic | Ophthalmic | | | | | | | | | |
| | Fetal | P | P | P | | P | P | P | Note 1, 2,3,4,6,7 | |
| | Abdominal | P | P | P | P | P | P | P | Note 1, 2,3,4,6,7 | |
| | Intra-operative (Specify*) | | | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | | | |
| | Laparoscopic | | | | | | | | | |
| | Pediatric | P | P | P | | P | P | P | Note 1,2,4,7 | |
| | Small Organ (Specify**) | P | P | P | | P | P | P | Note 1,2,4,7,8 | |
| | Neonatal Cephalic | P | P | P | P | P | P | P | Note 1, 2,4,6,7 | |
| Fetal Imaging & | Adult Cephalic | P | P | P | P | P | P | P | Note 1, 2,4,6,7 | |
| Other | Trans-rectal | P | P | P | | P | P | P | Note 1, 2,3,4,6,7 | |
| | Trans-vaginal | P | P | P | | P | P | P | Note 1, 2,3,4,6,7 | |
| | Trans-urethral | | | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | | | |
| | Musculo-skeletal<br>(Conventional) | P | P | P | | P | P | P | Note 1,2,4,7,8 | |
| | Musculo-skeletal<br>(Superficial) | P | P | P | | P | P | P | Note 1, 2,4,7,8 | |
| | Intravascular | | | | | | | | | |
| | Cardiac Adult | P | P | P | P | P | P | P | Note 1, 2,4,5,6,7,9 | |
| | Cardiac Pediatric | P | P | P | P | P | P | P | Note 1, 2,4,5,6,7,9 | |
| Cardiac | Intravascular (Cardiac) | | | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | | | |
| | Intra-cardiac | | | | | | | | | |
| Peripheral | Peripheral vessel | P | P | P | P | P | P | P | Note 1, 2,4,6,7 | |
| vessel | Other (Specify***) | N | N | N | N | N | N | N | Note 1, 2,4,7 | |
| | 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 | | | | | | | | | |
| | ** Small organ-breast, thyroid, testes. | | | | | | | | | |
| | ***Other use includes Urology. | | | | | | | | | |
| | Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents. | | | | | | | | | |
| | Note 2: Smart3D | | | | | | | | | |
| | Note 3:4D(Real-time 3D) | | | | | | | | | |
| | Note 4: iScape | | | | | | | | | |
| | Note5: TDI | | | | | | | | | |
| | Note6: Color M | | | | | | | | | |
| | Note7: Biopsy Guidance | | | | | | | | | |
| | Note8: Elastography | | | | | | | | | |
| | Note9: Contrast imaging(contrast agent for LVO) | | | | | | | | | |
| | (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED) | | | | | | | | | |
| | Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) | | | | | | | | | |
| Clinical Application | | Mode of Operation | | | | | | | | |
| General (Track<br>1 Only) | Specific (Track 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Combined<br>(specify) | Other (specify) | |
| Ophthalmic | Ophthalmic | | | | | | | | | |
| | Fetal | P | P | P | P | P | P | P | Note 1, 2, 4,6,7 | |
| | Abdominal | P | P | P | P | P | P | P | Note 1, 2, 4,6,7 | |
| | Intra-operative (Specify*) | | | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | | | |
| | Laparoscopic | | | | | | | | | |
| | Pediatric | | | | | | | | | |
| | Small Organ (Specify**) | | | | | | | | | |
| | Neonatal Cephalic | | | | | | | | | |
| Fetal Imaging & | Adult Cephalic | | | | | | | | | |
| Other | Trans-rectal | | | | | | | | | |
| | Trans-vaginal | | | | | | | | | |
| | Trans-urethral | | | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | | | |
| | Musculo-skeletal | | | | | | | | | |
| | (Conventional) | | | | | | | | | |
| | Musculo-skeletal | | | | | | | | | |
| | (Superficial) | | | | | | | | | |
| | Intravascular | | | | | | | | | |
| | Cardiac Adult | | | | | | | | | |
| | Cardiac Pediatric | | | | | | | | | |
| Cardiac | Intravascular (Cardiac) | | | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | | | |
| | Intra-cardiac | | | | | | | | | |
| Peripheral | Peripheral vessel | P | P | P | | P | P | P | Note 1, 2, 4,6,7 | |
| vessel | 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、PW +Color+B、PW +Color+B、Power + PW +B. | | | | | | | | | |
| | * Intraoperative includes abdominal, thoracic, and vascular etc. | | | | | | | | | |
| | ** Small organ-breast, thyroid, testes. | | | | | | | | | |
| | ***()ther use includes Urology. | | | | | | | | | |
| | Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents. | | | | | | | | | |
| | Note 2: Smart3D | | | | | | | | | |
| | Note 3:4D(Real-time 3D) | | | | | | | | | |
| | Note 4: iScape | | | | | | | | | |
| | Note5: TDI | | | | | | | | | |
| | Note6: Color M | | | | | | | | | |
| | Note7: Biopsy Guidance | | | | | | | | | |
| | Note8: Elastography | | | | | | |…