NTU-USB Ultrasound USB Box

{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 Use<br>See PRA Statement below.<br>510(k) Number (if known)<br>K173486<br>NTU-USB Ultrasound USB Box<br>2 Prescription Use (Part 21 CFR 801 Subpart D)<br>Over-The-Counter Use (21 CFR 801 Subpart C)<br>CONTINUE ON A SEPARATE PAGE IF NEEDED.<br>This section applies only to requirements of the Paperwork Reduction Act of 1995.<br>*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*<br>The burden time for this collection of information is estimated to average 79 hours per response, including the<br>time to review instructions, search existing data sources, gather and maintain the data needed and complete<br>and review the collection of information. Send comments regarding this burden estimate or any other aspect<br>of this information collection, including suggestions for reducing this burden, to:<br>Department of Health and Human Services<br>Food and Drug Administration<br>Office of Chief Information Officer<br>Paperwork Reduction Act (PRA) Staff<br>PRAStaff@fda.hhs.gov<br>"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of<br>information unless it displays a currently valid OMB number."<br>Page 1 of 1<br>PSC Publishing Services (101) 443-6740 | | Food and Drug Administration | Expiration Date: 06/30/2020 | |-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|------------------------------|-----------------------------| | | | | | | | | | | | | | | | | Indications for Use (Describe)<br>The NTU-USB ultrasound USB box is a general ultrasound imaging system intended for use by a qualified physician or<br>sonographer for clinical diagnosis. Specific clinical applications and exam types include:<br>1. Small Organ (Breast)<br>2. Peripheral Vessel<br>Type 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<br>(Track 1 Only) | Specific<br>(Tracks 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify) | Other*<br>(Specify) | | Ophthalmic | Ophthalmic | | | | | | | | | Fetal Imaging<br>& 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<br>(Conventional) | | | | | | | | | | Musculo-skeletal<br>(Superficial) | | | | | | | | | | Intravascular | | | | | | | | | | Other (Specify) | | | | | | | | | Cardiac | Cardiac Adult | | | | | | | | | | Cardiac Pediatric | | | | | | | | | | Intravascular (Cardiac) | | | | | | | | | Clinical Application | | Mode of Operation | | | | | | | | | Trans-esoph. (Cardiac) | | | | | | | | | | Intra-cardiac | | | | | | | | | | Other (Specify) | | | | | | | | | Peripheral<br>Vessel | 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) - 2. Peripheral Vessel #### Device Description 4. 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. {7}------------------------------------------------ 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. #### 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.