DC-40/DC-35/DC-45/DC-40S/DC-40 Pro Diagnostic Ultrasound System

K162845 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · IYN · Dec 15, 2016 · Radiology

Device Facts

• Record ID: K162845
• Device Name: DC-40/DC-35/DC-45/DC-40S/DC-40 Pro Diagnostic Ultrasound System
• Applicant: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
• Product Code: IYN · Radiology
• Decision Date: Dec 15, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1550
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The DC-40/DC-35/DC-45/DC-40S/DC-40 Pro 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 cephalic.adult cephalic.trans-rectal, trans-vaginal, musculo-skeletal(supertional), musculo-skeletal(superficial), cardiac adult, cardiac pediatric and peripheral vessel exams.

Device Story

General-purpose, mobile, software-controlled diagnostic ultrasound system; acquires and displays ultrasound images. Inputs: ultrasonic energy transmitted into patients via linear, convex, or phased array probes (3-10 MHz); receives and processes echoes. Outputs: B-mode, M-mode, PW/CW Doppler, Color/Power/Dirpower Doppler, THI, 3D/4D, iScape, TDI, Color M, Biopsy Guidance, and Elastography images. Used in clinical settings by healthcare professionals for anatomical and fluid flow visualization. Output aids clinicians in diagnostic measurements and calculations; supports clinical decision-making through non-invasive imaging.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, including acoustic output measurements, biocompatibility, and electrical/mechanical safety testing per recognized standards (e.g., IEC 60601 series, ISO 10993-1, UD 2, UD 3).

Technological Characteristics

Mobile ultrasound system; linear, convex, and phased array transducers (3-10 MHz). Imaging modes: B, M, PW, CW, Color, Power/Dirpower, THI, 3D/4D, iScape, TDI, Color M, Elastography. Software-controlled; complies with IEC 62304, IEC 62366, and ISO 14971. Patient-contact materials tested per ISO 10993-1. Acoustic output conforms to UD 2 and UD 3.

Indications for Use

Indicated for adults, pregnant women, pediatric patients, and neonates for diagnostic ultrasound imaging or fluid flow analysis in fetal, abdominal, pediatric, small organ (breast, thyroid, testes), neonatal cephalic, adult cephalic, trans-rectal, trans-vaginal, musculoskeletal (conventional/superficial), cardiac (adult/pediatric), and peripheral vessel 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-N3 (K140030)
• DC-60 (K152545)
• Resona 7 (K162267)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle or bird with three human profiles incorporated into its design.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

December 15, 2016

Shenzhen Mindray Bio-Medical Electronics Co., Ltd. % Zhai Pei Engineer of Technical Regulation Department Mindray Building, Keji 12th Road South, Hi-tech Industrial Park, Nanshan Shenzhen, Guangdong 518057 CHINA

Re: K162845

Trade/Device Name: DC-40/DC-35/DC-45/DC-40 Pro Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: September 28, 2016 Received: October 11, 2016

Dear Zhai Pei:

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. 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Michael D'Hara

For

Robert 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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### Indications for Use

510(k) Number (if known)

K162845

#### Device Name

DC-40/DC-35/DC-45/DC-40S/DC-40 Pro Diagnostic Ultrasound System

Indications for Use (Describe)

The DC-40/DC-35/DC-45/DC-40S/DC-40 Pro 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 cephalic.adult cephalic.trans-rectal, trans-vaginal, musculo-skeletal(supertional), musculo-skeletal(superficial), cardiac adult, cardiac pediatric and peripheral vessel exams.

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

V Prescription Use (Part 21 CFR 801 Subpart D)

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

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| | Intended Use: Diagnostic Ultrasound imaging or fluid flow analysis of the human body as follows: | | | | | | | | | |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------|-------------------|-----|-----|------------------|----------------------|-----------------------|-------------------|--|
| | Clinical Application | Mode of Operation | | | | | | | | |
| General<br>(Track 1) | Specific (Track 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Combined<br>(specify) | Other (specify) | |
| Ophthalmic | Ophthalmic | | | | | | | | | |
| | Fetal | N | N | N | | N | N | N | Note 1, 2,3, 4,6 | |
| | Abdominal | N | N | N | N | N | N | N | Note 1, 2,3, 4,6 | |
| | Intra-operative | | | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | | | |
| | Laparoscopic | | | | | | | | | |
| | Pediatric | N | N | N | | N | N | N | Note 1, 2, 4,6,7 | |
| | Small Organ | N | N | N | | N | N | N | Note 1,2, 4,6,7 | |
| | Neonatal Cephalic | N | N | N | | N | N | N | Note 1, 2, 4,6,7 | |
| Fetal Imaging<br>& Other | Adult Cephalic | N | N | N | N | N | N | N | Note 1, 2,4,6, | |
| | Trans-rectal | N | N | N | | N | N | N | Note 1, 2, 4,6, | |
| | Trans-vaginal | N | N | N | | N | N | N | Note 1, 2, 4,6, | |
| | Trans-urethral | | | | | | | | | |
| | Trans-esoph. (non- | | | | | | | | | |
| | Musculo-skeletal<br>(Conventional) | N | N | N | | N | N | N | Note 1, 2, 4,6,7 | |
| | Musculo-skeletal<br>(Superficial) | N | N | N | | N | N | N | Note 1,2, 4,6,7 | |
| | Intravascular | | | | | | | | | |
| | Cardiac Adult | N | N | N | N | N | N | N | Note 1, 2,4,5,6, | |
| | Cardiac Pediatric | N | N | N | N | N | N | N | Note 1, 2,4,5,6, | |
| 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=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 +1 | | | | | | | | | |
| | *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 | | | | | | | | | |
| Clinical Application | | Mode of Operation | | | | | | | | |
| General<br>(Track 1 | Specific (Track 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Combined<br>(specify) | Other (specify) | |
| Ophthalmic | Ophthalmic | | | | | | | | | |
| | Fetal | N | N | N | N | N | N | N | Note 1, 2, 4,6,7 | |
| | Abdominal | N | N | N | N | N | N | N | Note 1, 2, 4,6,7 | |
| | Intra-operative | | | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | | | |
| | Laparoscopic | | | | | | | | | |
| | Pediatric | N | N | N | N | N | N | N | Note 1, 2, 4,6,7 | |
| | Small Organ | | | | | | | | | |
|…