Aco Apache Ultrasound System
Device Facts
| Record ID | K231509 |
|---|---|
| Device Name | Aco Apache Ultrasound System |
| Applicant | Aco Healthcare Co., Ltd. |
| Product Code | IYN · Radiology |
| Decision Date | Oct 24, 2023 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1550 |
| Device Class | Class 2 |
| Attributes | Pediatric |
Indications for Use
Diagnostic ultrasound imaging and fluid flow analysis
Device Story
Portable color ultrasound system; acquires ultrasound data via probe; transfers real-time scan data wirelessly to off-the-shelf mobile device (Android/iOS). Probe utilizes 64-channel beamforming architecture. Apache App on mobile device provides user interface for mode/setting control, image display, acquisition, and storage. Used by trained healthcare professionals in clinics, hospitals, and point-of-care. Output allows visualization of anatomical structures and fluid flow for diagnostic assessment; aids clinical decision-making by providing real-time diagnostic imaging.
Clinical Evidence
No clinical data. Bench testing only. Performance verified through non-clinical testing including measurement accuracy, system sensitivity, thermal, mechanical, and electrical safety, biocompatibility (ISO 10993), and acoustic output (NEMA UD 2).
Technological Characteristics
Portable ultrasound system; 64-channel beamforming probe; Li-Ion battery; wireless connectivity (IEEE 802.11g/n, Bluetooth). Compatible with Android/iOS mobile devices. Compliant with IEC 60601-1, IEC 60601-2-37, IEC 62304, and ISO 10993 standards. Software-controlled imaging modes: B, M, Color Doppler, Power Doppler, PW Doppler.
Indications for Use
Indicated for diagnostic ultrasound imaging and fluid flow analysis in Abdominal, Fetal/Obstetric, Gynecological, Fetal Echo, Musculo-skeletal (conventional and superficial), Small Organ (breast, scrotum, thyroid), Cephalic (adult), Peripheral Vessel, Carotid, Urology, FAST/EFAST, Lung, Ocular, Nerve, Cardiac (Pediatric and Adult), and Pediatric applications. Used in B, Color Doppler, M, Power Doppler, PW Doppler, and combined modes. Intended for use by trained healthcare professionals in physician offices, clinics, hospitals, and point-of-care settings.
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
- Clarius Ultrasound Scanner (K213436)
Submission Summary (Full Text)
{0}------------------------------------------------
October 24, 2023
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION".
Aco Healthcare Co., Ltd. % Henry Huang Manager of Product Marketing 1F, No.8-1, Nandong Rd., Pingzhen Dist. Taovuan City. 324 TAIWAN
Re: K231509
Trade/Device Name: Aco Apache Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic Pulsed Doppler Imaging System Regulatory Class: Class II Product Code: IYN, IYO, ITX Dated: September 13, 2023 Received: September 21, 2023
Dear Henry Huang:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
{1}------------------------------------------------
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
# Yanna S. Kang -S
Yanna Kang Assistant Director Mammography and Ultrasound Team DHT8C: Division of Radiological Imaging and Radiation Therapy Devices OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
{2}------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
#### Indications for Use
510(k) Number (if known)
K231509
Device Name "Aco Apache" Ultrasound System
#### Indications for Use (Describe)
The Apache Ultrasound System is intended for diagnostic ultrasound imaging and fluid flow analysis in the following applications: Abdominal, Fetal/Obstetric, Gynecological, Fetal Echo, Musculo-skeletal (conventional and superficial), Small Organ (including breast, scrotum, thyroid), Cephalic (adult), Peripheral Vessel, Carotid, Urology, FAST/EFAST, Lung, Ocular, Nerve, Cardiac (Pediatric and Adult) and Pediatric. The system provides diaging in B, Color Doppler, M, Power Doppler and Combined (B+M; B+CD ; B+PD) modes. The clinical environments where the system can be used include physician offices, clinics, hospitals, and clinical point of care for diagnosis of patients except environments where intensity of electromagnetic disturbances is high. The Apache Ultrasound System is a portable ultrasound system intended for use in environments where is provided by trained healthcare professionals.
| Type of Use (Select one or both, as applicable) | |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| <span style="padding-right: 5px;"> <div style="display: inline-block; vertical-align: middle;"> <div style="border: 1px solid black; width: 10px; height: 10px; text-align: center;">X</div> </div> </span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="padding-right: 5px;"> <div style="display: inline-block; vertical-align: middle;"> <div style="border: 1px solid black; width: 10px; height: 10px;"></div> </div> </span> 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}------------------------------------------------
## K231509
## 510(K) Summary
| Submitter: | Aco Healthcare Co., Ltd.<br>Address: 1F, No.8-1, Nandong Rd., Pingzhen Dist.,<br>Taoyuan City 324, Taiwan<br>Tel: +886-3-5820446 |
|--------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Official Contact: | Henry Huang<br>Address: 1F, No.8-1, Nandong Rd., Pingzhen Dist.,<br>Taoyuan City 324, Taiwan |
| Email | Henry.huang@acohealthcare.com |
| Date Prepared: | May 12th, 2023 |
| Device Name: | Aco Apache Ultrasound System |
| Regulation Number: | 21 CFR 892.1550, 892.1560, 892.1570 |
| Classification Name: | Ultrasonic Pulsed Doppler Imaging System<br>Ultrasonic Pulsed Echo Imaging System<br>Diagnostic Ultrasonic Transducer |
| Regulation Class | Class II |
| Product Code: | IYN |
| Subsequent Product Code: | IYO, ITX |
| Intended Use | Diagnostic ultrasound imaging and fluid flow analysis |
| Indications for Use: | The Aco Apache Ultrasound System is intended for<br>diagnostic ultrasound imaging and fluid flow analysis in<br>the following applications: Abdominal, Fetal/Obstetric,<br>Gynecological, Fetal Echo, Musculo-skeletal<br>(conventional and superficial), Small Organ (including<br>breast, scrotum, thyroid), Peripheral Vessel, Carotid,<br>Urology, FAST/EFAST, Lung, Ocular, Cephalic (adult),<br>Nerve, and Pediatric. The system provides diagnostic<br>ultrasound imaging in B, M, Color Doppler, Power<br>Doppler, PW Doppler and Combined (B+M; B+CD;<br>B+PD) modes. The clinical environments where the system |
{4}------------------------------------------------
can be used include physician offices, clinics, hospitals, and clinical point-of-care for diagnosis of patients except environments where intensity of of electromagnetic disturbances is high. The Apache Ultrasound System is a portable ultrasound system intended for for use in environments where healthcare is provided by trained healthcare professionals.
#### Device Description
The Aco Apache Ultrasound System is a portable color ultrasound imaging system, capable of producing high detail resolution intended for clinical diagnostic imaging applications through wireless communication with an off-the-shelf (OTS) mobile device. This system is a general purpose, software controlled, diagnostic ultrasound system. Its basic function is to acquire ultrasound data and display the image in B-Mode, M-Mode, Color Doppler mode, Power Doppler mode, PW mode or a combination of these modes.
The Apache Probe processes the ultrasound signal and transfers real-time scan image data to the Apache App through the wireless connection with the mobile device. The 64-channel beamforming architecture of the probe maximizes the utility of all imaging transducer elements to enhance the diagnostic utility and confidence provided by the system. The Apache App provides the interface for mode/setting control and image display, acquisition, and storage functions. The Apache App is compatible with Android and iOS based mobile devices. Verified devices include Samsung Galaxy Tab S6, Samsung Galaxy Tab S6 Lite, Samsung Galaxy Tab S7, Samsung Galaxy Tab S7 FE, Samsung Galaxy Tab S8, Samsung Galaxy S10, Samsung Galaxy S21, Xiaomi Pad 5, Google Pixel 4, Google Pixel 6, HTC U11, LG G85 ThinQ, iPhone 11, iPhone 12, iPhone 14, iPad Pro 11-inch (Gen2), iPad Air (Gen4), iPad Air (Gen5), iPad 9.
The clinical environments where the system can be used include physician offices, clinics, hospitals, and clinical point-of-care for diagnosis of patients except environments where intensity of electromagnetic disturbances is high.
{5}------------------------------------------------
The Apache Ultrasound System is a portable ultrasound system intended for use in environments where healthcare is provided by trained healthcare professionals.
#### Predicate Device
Equivalent devices are referred to as predicate devices in alignment with the FDA's standard terminology for comparable devices. The predicate device selected to demonstrate equivalence is the Clarius Ultrasound Scanner (K213436).
#### Determination of Substantial Equivalence
The subject device "Aco Apache Ultrasound System" is a Track 3 system that adopt the same fundamental scientific technology as the predicate device "Clarius Ultrasound Scanner (K213436)". All indications for use introduced by the Aco Apache Ultrasound System are same to at least one model of the predicate devices. Comparison between the predicate device and subject device is provided below:
| Description | Subject Device | Predicate Device |
|----------------------|-------------------------------------------------------|-------------------------------------------------------|
| | Aco Apache Ultrasound System | Clarius Ultrasound System (K213436) |
| Product Name | Apache Ultrasound System | Clarius Ultrasound Scanner |
| Prescription/OTC use | Prescription Use | Prescription Use |
| Regulation Number | 21 CFR 892.1550<br>21 CFR 892.1560<br>21 CFR 892.1570 | 21 CFR 892.1550<br>21 CFR 892.1560<br>21 CFR 892.1570 |
| Product Code | IYN, IYO, ITX | IYN, IYO, ITX |
| 510(k) Track | Track 3 | Track 3 |
{6}------------------------------------------------
| Intended Use | Diagnostic ultrasound imaging and<br>fluid flow analysis | diagnostic ultrasound imaging and<br>fluid flow analysis | |
|---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Indications for<br>use | Ophthalmic | Ophthalmic | |
| | Fetal<br>Fetal<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | | |
| | Abdominal<br>. | Abdominal | |
| | | Intraoperative (non-neurological) | |
| | Pediatric<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | Pediatric<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | |
| | Small Organ<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | Small Organ<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | |
| | Cephalic (adult)<br> | Cephalic (adult) | |
| | | Trans-rectal | |
| | | Trans-vaginal | |
| | Musculo-skeletal (conventional) | Musculo-skeletal (conventional) | |
| | Musculo-skeletal (Superficial) | Musculo-skeletal (Superficial) | |
| | Urology | Urology | |
| | Gynecology<br>��������������������������������������������������������������������� | Gynecology | |
| | Cardiac (Adult) | Cardiac (Adult) | |
| | Cardiac (Pediatric) | Cardiac (Pediatric) | |
| | Peripheral vessel<br>����������������������������������������������������������������������������� | Peripheral Vessel | |
| | Carotid | Carotid<br> | |
| | Needle Guidance | Needle Guidance | |
| Portability | Portable Ultrasound System | Portable Ultrasound System | |
| Power Source | Li-Ion Battery | Li-Ion Battery | |
| Wireless<br>Communication | Wireless communication via IEEE<br>Wireless communication via IEEE<br>802.11g/n<br>802.11g/n Bluetooth | | |
| Display and<br>Control | Android or iOS mobile device<br>Android or iOS mobile device | | |
{7}------------------------------------------------
| Mode of operation | |
|---------------------------------------------|----------------------------------------------------|
| - B-Mode | - B-Mode |
| - M-Mode | - M-Mode |
| - Color Doppler | - Color Doppler |
| - Power Doppler | - Power Doppler |
| - PW Doppler | - PW Doppler |
| - Combined<br>(B+M; B+CD; B+PD) | - Combined<br>(B+M; B+CD; B+PD, B+PWD) |
## Non-Clinical Test
Non-clinical performance tests include measurement accuracy, system sensitivity, thermal, mechanical, electrical safety, patient-contact materials, cleaning and disinfection, software and acoustic output.
The non-clinical test results show the device is compliant with the following standards, and it is safe and effective for its intended use and performance.
| Rec. Number | Standard | Title of Standard |
|-------------|-------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 19-4 | ANSI/AAMI ES60601-<br>1:2005/(R)2012 and<br>A1:2012 | Medical Electrical Equipment - Part 1: General Requirements<br>for Basic Safety and Essential Performance |
| 19-46 | ANSI/AAMI ES60601-<br>1:2005/(R)2012 and<br>A1:2012 and AMD2:2021 | Medical Electrical Equipment - Part 1: General Requirements<br>for Basic Safety and Essential Performance |
| 19-8 | ANSI/AAMI IEC 60601-1-<br>2:2014 | Medical electrical equipment - Part 1-2: General<br>requirements for basic safety and essential performance -<br>Collateral Standard: Electromagnetic Capability -<br>Requirements and tests. |
| 19-36 | ANSI/AAMI IEC 60601-1-<br>2:2014+ AMD1:2020 | Medical electrical equipment - Part 1-2: General<br>requirements for basic safety and essential performance -<br>Collateral Standard: Electromagnetic Capability -<br>Requirements and tests. |
| 5-132 | IEC 60601-1-6:2010+<br>AMD1:2013+AMD2:2020 | Medical electrical equipment - Part 1-6: General<br>requirements for basic safety and essential performance<br>-Collateral standard: Usability |
| 12-293 | IEC 60601-2-37:2007+<br>AMD1:2015 | Medical electrical equipment - Part 2-37: Particular<br>requirements for the basic safety and essential performance of<br>ultrasonic medical diagnostic and monitoring equipment. |
| 19-33 | IEC 62133-2:2017+<br>AMD1:2021 | Secondary Cells and Batteries Containing Alkaline or Other<br>Non-Acid Electrolytes - Safety Requirements for Portable<br>Sealed Secondary Cells, And for Batteries Made from Them,<br>For Use in Portable Applications - Part 2: Lithium systems |
| 5-129 | IEC 62366-1:2015+<br>AMD1:2020 | Medical Devices - Part 1: Application of Usability Engineering<br>to Medical Devices |
| 2-258 | ISO 10993-1:2018 | Biological evaluation of medical devices - Part 1: Evaluation<br>and testing within a risk management process |
| 2-245 | ISO 10993-5:2009 | Biological Evaluation of Medical Devices - Part 5: Tests for In |
{8}------------------------------------------------
| | | Vitro Cytotoxicity |
|-------|------------------------------|----------------------------------------------------------------------------------------------------|
| 2-296 | ISO 10993-10:2021 | Biological Evaluation of Medical Devices - Part 10: Tests for<br>Irritation and Skin Sensitization |
| 2-289 | ISO 10993-12:2021 | Biological Evaluation of Medical Devices - Part 12: Sample<br>preparation and reference materials |
| 2-291 | ISO 10993-23:2021 | Biological Evaluation of Medical Devices - Part 23: Tests for<br>irritation |
| 13-79 | IEC 62304:2006+<br>AMD1:2015 | Medical Device Software - Software Life Cycle Processes |
| 5-125 | ISO 14971:2019 | Medical Devices - Applications of Risk Management to Medical<br>Devices |
| N/A | NEMA UD 2:2004 (R2009) | Acoustic Output Measurement Standard for Diagnostic<br>Ultrasound Equipment |
Quality assurance measures applied to the system design and development include, but were not limited to risk analysis, product specifications, design reviews and verification and validation.
## Clinical Testing
Aco Apache Ultrasound System introduces no new indications for use, modes, features, or technologies relative to the predicate devices (Clarius Ultrasound Scanner) that require clinical testing. The clinical safety and effectiveness of ultrasound systems with these characteristics are well accepted for both predicate and subject devices.
#### Conclusion
Aco Apache Ultrasound System is substantially equivalent to the predicate device. Aco Apache Ultrasound System function in a manner similar to and are intended for the same use as the predicate device. Based on the predicate device comparison of indications for use, labeling, acoustic output and general safety and effectiveness information, as well as the non-clinical performance test results, it is concluded that this device is as safe and effective as the predicate device for its intended use and performance and is substantially equivalent to the predicate device.
