DC-90/DC-90S/DC-90Q/DC-95/DC-95S/DC-88/DC-88S/DC-80A/DC-80A Exp/DC-80A Pro/DC-8X/DC-8Q/DC-81/DC-82 Diagnostic Ultrasound System

K190206 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · IYN · Mar 8, 2019 · Radiology

Device Facts

• Record ID: K190206
• Device Name: DC-90/DC-90S/DC-90Q/DC-95/DC-95S/DC-88/DC-88S/DC-80A/DC-80A Exp/DC-80A Pro/DC-8X/DC-8Q/DC-81/DC-82 Diagnostic Ultrasound System
• Applicant: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
• Product Code: IYN · Radiology
• Decision Date: Mar 8, 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: 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 exams.

Device Story

The DC-90/DC-80A series is a mobile, software-controlled diagnostic ultrasound system. It acquires and displays ultrasound images using various modes (B, M, PW, CW, Color, Color M, Power/Dirpower, TDI, THI, iScape, 3D/4D, Elastography, Contrast imaging). The system utilizes an array of probes (linear, convex, phased) to transmit ultrasonic energy into the patient and processes received echoes to generate anatomical and fluid flow images. It is intended for use by clinicians in clinical settings for diagnostic imaging and measurements. The system includes features like biopsy guidance and advanced analysis tools (STE, STQ, Smart Pelvic, Dehaze). Output is displayed on-screen for the healthcare provider to perform measurements and calculations, aiding in clinical decision-making and patient diagnosis.

Clinical Evidence

No clinical data. Substantial equivalence is supported by bench testing, including software validation, cybersecurity testing, acoustic output measurement, biocompatibility, and electrical/mechanical safety testing in compliance with recognized standards (e.g., IEC 60601-1, IEC 60601-2-37, ISO 10993-1).

Technological Characteristics

Mobile ultrasound system; supports linear, convex, and phased array probes. Features include B, M, PW, CW, Color, Power, TDI, THI, iScape, 3D/4D, Elastography, and Contrast imaging. Hardware includes 128-channel signal path, dual hard disks (128G SSD + 1T HDD), and battery power. Software functions include STE, STQ, Smart Pelvic, and Dehaze. Complies with 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, abdominal, pediatric, small organ, cephalic, trans-rectal, trans-vaginal, musculo-skeletal, cardiac, peripheral vessel, and urology ultrasound 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-70 (K181637)

Reference Devices

• Resona 7 (K171233)

Submission Summary (Full Text)

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

Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue.

March 8, 2019 Shenzhen Mindray Bio-Medical Electronics Co., Ltd. % Zhang Wei Engineer of Technical Regulation Keji 12th Road South, Hi-tech Industrial Park Shenzhen, Guangdong 518057 CHINA Re: K190206 Trade/Device Name: DC-90/DC-90S/DC-90Q/DC-95/DC-95S/DC-88/DC-88S/ DC-80A/DC/80A Exp/DC-80A Pro/DC-8X/DC-80/DC-81/DC82 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, LLZ Dated: January 25, 2019 Received: February 4, 2019

Dear Zhang Wei:

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

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

requirements, including, but not limited to: registration and listing (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 (DICE(@fda.hhs.gov) or phone [phone] or 301-796-7100).

Sincerely.

Jeff Rogge

for Thalia Mills, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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

## Indications for Use

### 510(k) Number (if known)

K190206

#### Device Name

DC-90/DC-90S/DC-900/DC-95/DC-95/DC-88/DC-888/DC-80A/DC-80A Pro/DC-80A Pro/DC-80/DC-80/DC-81/DC-81/DC-81 Diagnostic Ultrasound System

### Indications for Use (Describe)

DC-90/DC-90S/DC-900/DC-95/DC-95S/DC-88/DC-80A/DC-80A Exp/DC-80A Pro/DC-80A Pro/DC-8X/DC-80/DC-80/DC-80/DC-80/DC-81/ DC-82 Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetal, abdominal, pediatic, small organ(breast, thyroid, testes), neonatal and adult cephalic, transrectal, trans-vaginal, musculo-skeletal(conventional, superficial), adult and pediative cardiac, peripheral vessel and urology exams.

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

> 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:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"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."

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

| System: | DC-90/DC-90S/DC-90Q/DC-95/DC-95S/DC-88/DC-88S/DC-80A/DC-80A Exp/DC-80A Pro/DC- 8X/DC-8Q/DC-81/DC-82 Diagnostic Ultrasound 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<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 Imaging<br>& Other | Fetal | N | N | N | | N | N | N | Note 1, 2,3, 4, 6, 7 | | |
| | Abdominal | N | N | N | N | N | N | N | Note 1, 2,3,<br>4,6,7,9,11,12 | | |
| | Intra-operative (Specify*) | | | | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | | | | |
| | Laparoscopic | | | | | | | | | | |
| | Pediatric | N | N | N | N | N | N | N | Note 1, 2, 4,6,7 | | |
| | Small Organ (Specify**) | N | N | N | N | N | N | N | Note 1,2, 4,7,8,11,12 | | |
| | Neonatal Cephalic | N | N | N | N | N | N | N | Note 1, 2, 4,6,7 | | |
| | Adult Cephalic | N | N | N | N | N | N | N | Note 1,2,4,6,7 | | |
| | Trans-rectal | N | N | N | N | N | N | N | Note 1, 2,3, 4, 6, 7, 8 | | |
| | Trans-vaginal | N | N | N | N | N | N | N | Note 1, 2,3, 4, 6, 7, 8 | | |
| | Trans-urethral | | | | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | | | | |
| | Musculo-skeletal<br>(Conventional) | N | N | N | | N | N | N | Note 1, 2,<br>4,6,7,8,11,12 | | |
| | Musculo-skeletal<br>(Superficial) | N | N | N | | N | N | N | Note 1, 2, 4,7,8,11,12 | | |
| | Intravascular | | | | | | | | | | |
| | Cardiac Adult | N | N | N | N | N | N | N | Note 1, 2,4,5,6,7,10 | | |
| | Cardiac Pediatric | N | N | N | N | N | N | N | Note 1, 2, 4,5,6,7 | | |
| Cardiac | Intravascular (Cardiac) | | | | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | | | | |
| | Intra-cardiac | | | | | | | | | | |
| Peripheral<br>vessel | Peripheral vessel | N | N | N | | N | N | N | Note 1, 2, 4,6,7 | | |
| | Other (Specify***) | N | N | N | | N | N | N | Note 1, 2, 4, 6, 7,8 | | |
| | 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 | | | | | | | | | | |
| | Note 5: TDI | | | | | | | | | | |
| | Note 6: Color M | | | | | | | | | | |
| | Note 7: Biopsy Guidance | | | | | | | | | | |
| | Note 8: Strain Elastography | | | | | | | | | | |
| | Note 9: Contrast imaging (Contrast agent for Liver) | | | | | | | | | | |
| | Note 10: Contrast imaging(contrast agent for LVO) | | | | | | | | | | |
| | Note 11: STE<br>Note 12: STQ | | | | | | | | | | |
| | (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED) | | | | | | | | | | |
| | Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) | | | | | | | | | | |
| | Prescription USE (Per 21 CFR 801.109) | | | | | | | | | | |
| | | | | | | | | | | | |
| System: | DC-90/DC-90S/DC-90Q/DC-95/DC-95S/DC-88/DC-88S/DC-80A/DC-80A Exp/DC-80A Pro/DC- | | | | | | | | | | |
| 8X/DC-8Q/DC-81/DC-82 Diagnostic Ultrasound System | | | | | | | | | | | |
| Transducer: | C11-3E | | | | | | | | | | |
| Intended Use: | Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | | | | | | | | | | |
| | Clinical Application<br>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 | | | | | | | | | | |
| | Fetal | | | | | | | | | | |
| | Abdominal | N | N | N | N | N | N | N | Note 1, 2, 4,6,7 | | |
| | Intra-operative (Specify*) | | | | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | | | | |
| | Laparoscopic | | | | | | | | | | |
| | Pediatric | N | N | N | N | N | N | N | Note 1, 2, 4,6,7 | | |
| | Small Organ (Specify**) | | | | | | | | | | |
| | Neonatal Cephalic | N | N | N | N | N | N | N | Note 1, 2, 4,6,7 | | |
| Fetal Imaging<br>& Other | Adult Cephalic | | | | | |…