The NTU-USB ultrasound USB box is a general ultrasound imaging system intended for use by a qualified physician or sonographer for clinical diagnosis. Specific clinical applications and exam types include:

Small Organ (Breast)
Peripheral Vessel

Device Description

The NTU-USB Ultrasound USB box is a standalone ultrasound system which can perform real-time anatomical imaging of Small Organs/Parts (e.g. Breast) and blood flow measurements of Peripheral Vascular. Users include ultrasound imaging technicians (sonographers) and physicians. The NTU-USB Ultrasound USB box may be used in a hospital (e.g. imaging laboratory, emergency room, patient bedside, operating room), medical clinic, physician's office or a mobile imaging center.

The NTU-USB Ultrasound USB box consists of two major components: 1) USB box; and, 2) Transducer. The USB box housed the microprocessor, memory, amplifiers and a power supply for the microprocessor. The USB box performs the calculations involved in processing the data to produce the displayed ultrasound image.

The USB box is designed to connect with a Windows x86platform PC/laptop (not included in this product) and a compatible linear transducer. It receives command and display on the UI of the PC/laptop and following sends electrical currents to and receives electrical pulses from the compatible transducer.

The system provides qualified physicians with a friendly workflow and sufficient image quality for the following applications:

B (2D) mode, ColorDoppler (CD), Pulsed Wave Doppler (PW) mode

Available with the system is a Linear array transducer allowing for many clinical applications. Accessories include an AC adaptor and a USB 3.0 cable. Case studies can be stored to USB memory stick, DVD, and other industry standard archiving devices using the connected PC/laptop.

The NTU-USB ultrasound USB Box contain the hardware and software which collect and pro-process 'rough' data and send it via USB 3.0 connection to a Windows based PC. The main application software is NTU-USB SW running on the PC, it is receiving data, processing and showing image/data on the screen. The main user interface shows an ultrasound image, controls and drop-out menus. The ultrasound images and calculated/measured data can be stored in memory.

AI/ML Overview

This document is a 510(k) summary for the NTU-USB Ultrasound USB Box, which is a regulatory submission to the FDA. It does not contain a study proving the device meets specific acceptance criteria in terms of diagnostic performance or clinical effectiveness. Instead, it demonstrates substantial equivalence to predicate devices by showing compliance with applicable performance standards and safety evaluations.

Therefore, many of the requested sections about specific diagnostic performance acceptance criteria and a dedicated study showing the device meets these criteria cannot be filled from the provided text.

However, I can extract information related to the device's technical performance and safety evaluations as presented in the 510(k) summary.

Here's the breakdown of what can be inferred from the document:

1. A table of acceptance criteria and the reported device performance:

The document focuses on showing compliance with general safety and performance standards for ultrasound devices, rather than specific diagnostic accuracy metrics. The "acceptance criteria" here are the requirements of these standards.

Acceptance Criteria (Standard/Requirement)	Reported Device Performance (Compliance)
IEC 60601-1:2005+AMD1:2012 (General safety)	Designed, manufactured, tested, and certified to comply
IEC 60601-1-2:2014 (Electromagnetic compatibility)	Designed, manufactured, tested, and certified to comply
IEC 60601-2-37:2007/AMD1:2015 (Ultrasonic medical diagnostic and monitoring equipment safety)	Designed, manufactured, tested, and certified to comply
NEMA UD 2-2004 (R2009) (Acoustic Output Measurement Standard)	Designed, manufactured, tested, and certified to comply; Maximum acoustic output level is under FDA recommended limit and power level is displayed.
NEMA UD 3-2004 (R2009) (Real-Time Display of Acoustic Output Indices)	Designed, manufactured, tested, and certified to comply
ISO 10993-1:2009 (Biological evaluation - general)	Conducted on the subject device
ISO 10993-5:2009 (Biocompatibility - in vitro cytotoxicity)	Conducted on the subject device
ISO 10993-10:2010 (Biocompatibility - irritation and skin sensitization)	Conducted on the subject device
IEC 62304:2006/AMD1:2015 (Medical device software life cycle processes)	Designed, manufactured, tested, and certified to comply
Cleaning and disinfection effectiveness	Tested and determined to be in full compliance
Equivalence to predicate devices (for intended use)	Substantially equivalent to predicate devices (LogicScan 128 EXT-1Z Kit, K113184; MicrUs EXT-1H, K161968) for Small Organ (Breast) and Peripheral Vessel applications.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

The document states, "No additional clinical testing is required, as the indications for use are not a novel indication as shown by the predicate devices." This means there was no specific clinical test set used to establish diagnostic performance for this submission. The "testing" referred to is against technical and safety standards, not a clinical trial. Therefore, information about sample size, country of origin, or retrospective/prospective nature of a clinical test set is not provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

Not applicable, as no clinical test set for diagnostic performance was conducted.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable, as no clinical test set for diagnostic performance was conducted.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. The NTU-USB Ultrasound USB Box is described as a "general ultrasound imaging system" and does not mention any AI capabilities for diagnostic assistance. The submission focuses on device safety and general imaging capabilities, not comparative diagnostic effectiveness studies or AI integration.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This device is a hardware and software system for generating ultrasound images, not an algorithm for standalone diagnostic interpretation. It is intended for use by a "qualified physician or sonographer."

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):

Not applicable, as no clinical test set for diagnostic performance was conducted. The "ground truth" for the submission is the compliance with established medical device performance and safety standards.

8. The sample size for the training set:

Not applicable, as no clinical training set for a diagnostic algorithm was used or mentioned. The "training" for this device would refer to its own internal software development and validation against engineering specifications, not a clinical data training set for AI.

9. How the ground truth for the training set was established:

Not applicable, as this information is not relevant to the type of device and submission described.

Summary

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

Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the U.S. Food & 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 letters "FDA" in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text. The word "Administration" is on the second line.

National Taiwan University % Pai-Chi Li Professor No. 1, Sec. 4, Roosevelt Rd. Taipei 10617, Taiwan REPUBLIC OF CHINA

July 11th, 2018

Re: K173486

Trade/Device Name: NTU-USB Ultrasound USB Box Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: June 20, 2018 Received: June 21, 2018

Dear Pai-Chi Li:

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. Iisting 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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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.

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

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 mediation-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 (1-800-638-2041 or 301-796-7100).

Sincerely,

Jeff Baughman

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

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

Indications for UseSee PRA Statement below.510(k) Number (if known)K173486NTU-USB Ultrasound USB Box2 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 thetime to review instructions, search existing data sources, gather and maintain the data needed and completeand review the collection of information. Send comments regarding this burden estimate or any other aspectof this information collection, including suggestions for reducing this burden, to:Department of Health and Human ServicesFood and Drug AdministrationOffice of Chief Information OfficerPaperwork Reduction Act (PRA) StaffPRAStaff@fda.hhs.gov"An agency may not conduct or sponsor, and a person is not required to respond to, a collection ofinformation unless it displays a currently valid OMB number."Page 1 of 1PSC Publishing Services (101) 443-6740		Expiration Date: 06/30/2020



Indications for Use (Describe)The NTU-USB ultrasound USB box is a general ultrasound imaging system intended for use by a qualified physician orsonographer for clinical diagnosis. Specific clinical applications and exam types include:1. Small Organ (Breast)2. Peripheral VesselType of Use (Select one or both, as applicable)	Device Name









FORM FDA 3881 (7/17)


		EF

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

Diagnostic Ultrasound Indications For Use Format

System: NTU-USB Ultrasound USB Box

Transducer: Qisda L7.5 transducer

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

body as follows:

Clinical Application		Mode of Operation
General(Track 1 Only)	Specific(Tracks 1 & 3)	B	M	PWD	CWD	ColorDoppler	Combined(Specify)	Other*(Specify)
Ophthalmic	Ophthalmic
Fetal Imaging& Other	Fetal
	Abdominal
	Intra-operative (Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
	Small Organ (Specify)	N*
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal(Conventional)
	Musculo-skeletal(Superficial)
	Intravascular
	Other (Specify)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
Clinical Application		Mode of Operation
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other (Specify)
PeripheralVessel	Peripheral vessel	N		N		N
	Other (Specify)

{4}------------------------------------------------

510(k) submission NTU-USB Ultrasound USB Box

N = new indication

Note * : Small Organ is Breast

{5}------------------------------------------------

510(k) Summary

1. Identifying Information

Manufacturer	NTU
Address	No. 1, Sec. 4, Roosevelt Rd., Taipei 10617, Taiwan
Telephone	+886-2-3366-9637
Fax	+886-2-2365-3186
Web	www.ntu-usb.com
E-mail	paichi@ntu.edu.tw
Contact	Pai-Chi Li/ Professor
Name of Device	NTU-USB Ultrasound USB Box

Class and Predicate Information 2.

Classification Name	FR. Number	Product Code
Ultrasonic pulsed doppler imaging system	892.1550	IYN
Ultrasonic pulsed echo imaging system	892.1560	IYO
Diagnostic ultrasonic transducer	892.1570	ITX

Common name	Ultrasound USB Box
Proprietary name	NTU-USB
Class	Regulatory Class II
Primary predicate device	LogicScan 128 EXT-1Z Kit (K113184);
Reference device	MicrUs EXT-1H (K161968)

{6}------------------------------------------------

Indication for Use 3.

The NTU-USB Ultrasound USB box is a general ultrasound imaging system intended for use by a qualified physician or sonographer for clinical diagnosis. Specific clinical applications and exam types include:

1. Small Organ (Breast)
1. Peripheral Vessel

Device Description 4.

The system provides qualified physicians with a friendly workflow and sufficient image quality for the following applications:

B (2D) mode, ColorDoppler (CD), Pulsed Wave Doppler (PW) mode

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

Performance Standards 5.

The NTU-USB Ultrasound USB box has been designed, manufactured, tested, and certified to comply with the following internationally recognized standards:

IEC 60601-1:2005+AMD1:2012: Medical electrical equipment part 1: General requirements for safety.
IEC 60601-1-2:2014: Medical electrical equipment part 1-2: General requirements for basic safety and essential performance. Collateral standard: Electromagnetic compatibility - Requirements and tests.
O IEC 60601-2-37:2007/AMD1:2015: Amendment 1 - Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment
NEMA UD 2-2004 (R2009): Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment
0 NEMA UD 3-2004 (R2009): Standard for Real-Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment
ISO 10993-1:2009 Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process
ISO 10993-5:2009 Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxicity
O ISO 10993-10:2010 Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization
O IEC 62304:2006/AMD1:2015 Amendment 1 - Medical device software - Software life cycle processes

{8}------------------------------------------------

General Safety and Effectiveness 6.

The NTU-USB ultrasound USB Box is similar to currently distributed ultrasonic pulsed echo imaging systems. There are no technological characteristics or features or indications for use in this Submission that are not previously evaluated and approved in the predicate devices, nor are there such technologies, features and indications for use not commonly used in the practice of diagnostic ultrasound. The NTU-USB ultrasound USB Box and its accessories are designed for compliance to all applicable medical devices safety standards. Prior release for manufacturing, all such devices, so designed, are tested and determined to be in full compliance with acoustic output, biocompatibility, cleaning and disinfection effectiveness. No additional clinical testing is required, as the indications for use are not a novel indication as shown by the predicate devices in Section 1.5 Predicate Device Comparison. Maximum acoustic output level is under by the FDA recommended limit and power level is displayed all the time.

Patient Contact Material 7.

The material of probe, coming in contact with patient are:

PC/ABS
SILICONE

The following biocompatibility standards are conducted on the subject device: ISO-10993-1:2009, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing within a risk management process

ISO-10993-5:2009, Biological Evaluation of Medical Devices Part 5: Tests for in vitro cytotoxicity

ISO-10993-10:2010, Biological Evaluation of Medical Devices Part 10: Tests for irritation and skin sensitization

8. Conclusion

Verification and validation testing has been conducted on the NTU-USB Ultrasound USB Box. This premarket notification submission demonstrates that the NTU-USB Ultrasound USB Box is substantially equivalent to the predicate devices.

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.