Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a standard ultrasound system with various imaging modes and does not mention any AI or ML capabilities in the device description, intended use, or performance studies. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".

Therapeutic

No.
The device is described as a "Diagnostic Ultrasound System" and its intended use is to "acquire and display ultrasound data," indicating it is for diagnosis, not treatment.

Diagnostic

Yes
The Intended Use / Indications for Use section explicitly states that the "TE7/TE5 Diagnostic Ultrasound System..." and lists various medical exams it is intended for, all of which involve diagnosing conditions. Additionally, the Device Description section describes it as an "ultrasonic diagnostic system."

SaMD (Software as a Medical Device)

No

The device description explicitly states it is an "ultrasonic diagnostic system" that "employs an array of probes," indicating the presence of hardware components beyond just software.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
Device Function: The description clearly states that the TE7/TE5 is an ultrasonic diagnostic system. It uses ultrasound waves to create images of internal structures of the body. This is an in vivo (within the living body) diagnostic method, not an in vitro method.
Intended Use/Indications for Use: The listed applications (fetal, abdominal, cardiac, etc.) all involve imaging the body directly, not analyzing samples taken from the body.

Therefore, the TE7/TE5 Diagnostic Ultrasound System falls under the category of medical imaging devices, not in vitro diagnostics.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

TE7/TE5 Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetal, abdominal, intra-operative(abdominal, thoracic, and vascular), pediatric, small organ(breast, thyroid, testes), neonatal and adult cephalic, trans-esoph. (Cardiac), trans-rectal, trans-vaginal, musculo-skeletal (conventional, superficial), urology, peripheral vessel, adult and pediatric cardiac exams.

Product codes (comma separated list FDA assigned to the subject device)

IYN, IYO, ITX

Device Description

TE7/TE5 is a software controlled, ultrasonic diagnostic system. Its function is to acquire and display ultrasound data in B-Mode, M-Mode, PW-Mode, CW-mode, Color-Mode, Power/Dirpower Mode, THI, LVO, Color M, Smart 3D, TDI or the combined mode (i.e. B/M-Mode, B/PW-mode, B/PW/Color).. This system is a Track 3 device that employs an array of probes that include linear array and convex array with a frequency range of approximately 3.0 MHz to 13.5 MHz.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Diagnostic ultrasound imaging or fluid flow analysis

Anatomical Site

Fetal, Abdominal, Intra-operative (abdominal, thoracic, vascular), Pediatric, Small Organ (breast, thyroid, testes), Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Musculo-skeletal (conventional, superficial), Urology, Peripheral vessel, Cardiac adult, Cardiac pediatric.

Indicated Patient Age Range

Adults, pregnant women, pediatric patients and neonates.

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Not Found

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K160381, K152543, K152763, K131690

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 892.1550 Ultrasonic pulsed doppler imaging system.

(a)
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.(b)
Classification. Class II.

Summary

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July 13, 2016

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

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

Re: K161525

Trade/Device Name: TE7 Diagnostic Ultrasound, TE5 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: May 10, 2016 Received: June 2, 2016

Dear Ms. Zicui:

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 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.

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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 (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/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 (800) 638-2041 or (301) 796-7100 or at its Internet address

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

Sincerely yours,

Michael O'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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K161525 Device Name

TE7 Diagnostic Ultrasound System, TE5 Diagnostic Ultrasound System

Indications for Use (Describe)

TE7/TE5 Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetal, abdominal, intra-operative(abdominal, thoracic, and vascular), pediatric, small organ(breast, thyroid, testes), neonatal and adult cephalic, trans-esoph. (Cardiac), trans-rectal, trans-vaginal, musculo-skeletal (conventional, superficial), urology, peripheral vessel, adult and pediatric cardiac 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)
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