(63 days)
No
The summary describes a standard ultrasound system with image processing capabilities, but there is no mention of AI or ML in the intended use, device description, or performance studies.
No
The device is strictly described for diagnostic ultrasound imaging and fluid flow analysis, with no mention of therapeutic applications.
Yes
The "Intended Use / Indications for Use" section explicitly states that "The Apache Ultrasound System is intended for diagnostic ultrasound imaging and fluid flow analysis." The "Device Description" also refers to it as a "general purpose, software controlled, diagnostic ultrasound system."
No
The device description explicitly states that the "Apache Ultrasound System" includes an "Apache Probe" which processes ultrasound signals and transfers data wirelessly. This probe is a hardware component, making the system more than just software.
Based on the provided information, the Apache Ultrasound System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body. The Apache Ultrasound System is used for diagnostic imaging of the human body itself, not for analyzing samples taken from the body.
- The intended use and device description clearly state that the system is for diagnostic ultrasound imaging and fluid flow analysis within the body. It acquires ultrasound data and displays images of internal structures.
- There is no mention of analyzing blood, urine, tissue, or any other biological specimen.
Therefore, the Apache Ultrasound System falls under the category of a medical imaging device, not an IVD.
N/A
Intended Use / Indications for Use
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), Peripheral Vessel, Carotid, Urology, and Pediatric. The system provides diagnostic ultrasound imaging in B, Color Doppler, M, PW and Combined (B+M; B+CD) modes. The clinical environments where the system can be used include physician offices, clinics, 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 healthcare is provided by trained healthcare professionals.
Product codes
IYN, IYO, ITX
Device Description
The 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, PW mode and Color Doppler 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 S7, Samsung Galaxy S10, Samsung Galaxy S21, Google Pixel 4, HTC U11, LG G85 ThinQ, iPhone 11, iPhone 12, iPad Pro 11-inch (Gen2), and iPad Air (Gen4).
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 healthcare is provided by trained healthcare professionals.
Mentions image processing
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.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Abdominal, Fetal/Obstetric, Gynecological, Fetal Echo, Musculo-skeletal (conventional and superficial), Small Organ (including breast, scrotum, thyroid), Peripheral Vessel, Carotid, Urology, and Pediatric.
Indicated Patient Age Range
Pediatric
Intended User / Care Setting
trained healthcare professionals in physician offices, clinics, hospitals, and clinical point-of-care for diagnosis of patients.
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)
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. Apache Ultrasound System introduces no new indications for use, modes, features, or technologies relative to the predicate devices (Clarius 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
June 25, 2021
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font size below that.
Aco Healthcare Co,. Ltd. % Henry Huang Manager of Product and Marketing Rm. 520, Bldg. 53, No. 195, Sec. 4, Chungshin Rd., Chutung Hsinchu, 31057 TAIWAN (R.O.C.)
Re: K211232
Trade/Device Name: 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: April 19, 2021 Received: April 23, 2021
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 (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 located 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.
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
1
801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 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 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 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,
For
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
510(k) Number (if known)
Device Name 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), Peripheral Vessel, Carotid, Urology, and Pediatric. The system provides diagnostic ultrasound imaging in B, Color Doppler, M, PW and Combined (B+M; B+CD) modes. The clinical environments where the system can be used include physician offices, clinics, 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) __ Over-The-Counter Use (21 CFR 801 Subpart C) > Prescription Use (Part 21 CFR 801 Subpart D) 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." FORM FDA 3881 (6/20) Page 1 of 1 EF PSC Publishing Services (301) 443-6740
3
510(K) Summary
K211232
| Submitter: | Aco Healthcare Co,. Ltd.
Address: Rm. 520, Bldg. 53, No. 195, Sec. 4, Chunghsing
Rd., Chutung, Hsinchu, 31057, Taiwan(R.O.C.)
+886-3-5820446 |
|--------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Official Contact: | Henry Huang
Address: Rm. 520, Bldg. 53, No. 195, Sec. 4, Chunghsing
Rd., Chutung, Hsinchu, 31057, Taiwan(R.O.C.) |
| Email | Henry.huang@acohealthcare.com |
| Date Prepared: | April 19th, 2021 |
| Device Name: | Apache Ultrasound System |
| Common Name: | Diagnostic Ultrasound System and Accessories |
| Regulation Number: | 21 CFR 892.1550, 892.1560, 892.1570 |
| Classification Name: | Ultrasonic Pulsed Doppler Imaging System
Ultrasonic Pulsed Echo Imaging System
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 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), Peripheral Vessel, Carotid, Urology, and
Pediatric. The system provides diagnostic ultrasound
imaging in B, Color Doppler, M, PW and Combined (B+M;
B+CD) modes. The clinical environments where the
system can be used include physician offices, clinics, |
4
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 healthcare is provided by trained healthcare professionals.
Device Description
The 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, PW mode and Color Doppler 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 S7, Samsung Galaxy S10, Samsung Galaxy S21, Google Pixel 4, HTC U11, LG G85 ThinQ, iPhone 11, iPhone 12, iPad Pro 11-inch (Gen2), and iPad Air (Gen4).
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 healthcare is provided by trained healthcare professionals.
5
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 (K192107).
Determination of Substantial Equivalence
The subject device "Apache Ultrasound System" is a Track 3 system that adopt the same fundamental scientific technology as the predicate device "Clarius Scanner (K192107)". All indications for use introduced by the 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 |
|---|---|---|
| Apache Ultrasound System | Clarius Ultrasound System | |
| (K192107) | ||
| Product Name | Apache Ultrasound System | Clarius Ultrasound Scanner |
| Prescription/OTC | ||
| use | Prescription Use | Prescription Use |
| Regulation | ||
| Number | 21 CFR 892.1550 | 21 CFR 892.1550 |
| Product Code | IYN, IYO, ITX | IYN, IYO, ITX |
| 510(k) Track | Track 3 | Track 3 |
| Intended Use | Diagnostic ultrasound imaging and | |
| fluid flow analysis | diagnostic ultrasound imaging and | |
| fluid flow analysis | ||
| Indications for | ||
| use | Ophthalmic | |
| Fetal | Fetal | |
| Abdominal | Abdominal | |
| Intraoperative (Abdominal organs & | ||
| Vascular) | ||
| Small Organ (Thyroid, Scrotum, | ||
| Breast) | Small Organ (Thyroid, Prostate, | |
| Scrotum, Breast) | ||
| Cephalic (adult) | ||
| Trans-rectal | ||
| Trans-vaginal | ||
| Musculo-skeletal (conventional) | Musculo-skeletal (conventional) | |
| Musculo-skeletal (superficial) | Musculo-skeletal (superficial) | |
| Urology | Urology | |
| Gynecology | Gynecology | |
| Cardiac (adult) | ||
| Cardiac(pediatric) | ||
| Peripheral vessel | Peripheral vessel | |
| Needle guidance | ||
| Pediatric | Pediatric | |
| Carotid | Carotid | |
| Portability | Portable Ultrasound System | Portable Ultrasound System |
| Power Source | Li-Ion Battery | Li-Ion Battery |
| Wireless | ||
| Communication | Wireless communication via IEEE | |
| 802.11g/n | Wireless communication via IEEE | |
| 802.11g/n Bluetooth | ||
| Display and | ||
| Control | Android or iOS mobile device | Android or iOS mobile device |
| Mode of | ||
| operation | - B-Mode |
- M-Mode
- Color Doppler
- PW Doppler
- Combined
(B+M; B+CD) | - B-Mode - M-Mode
- Color Doppler
- Power Doppler
- PW Doppler
- Combined
(B+M; B+CD; B+PD, B+PWD) |
6
7
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.
| Reference No. | Title of Standard |
|---|---|
| AAMI/ANSI | |
| ES60601-1 | Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential |
| Performance AAMI / ANSI ES60601-1:2005/(R)2012 And A1:2012, C1:2009/(R)2012 And | |
| A2:2010/(R)2012 (Consolidated Text) Medical Electrical Equipment - Part 1: General | |
| Requirements for Basic Safety and Essential Performance (IEC 60601-1:2005, Mod). (General II | |
| (ES/EMC)) | |
| IEC 60601-1-2 | Medical electrical equipment - Part 1-2: General requirements for basic safety and |
| essential performance - Collateral Standard: Electromagnetic Capability - Requirements | |
| and tests. (4th Edition) | |
| IEC 60601-1-6 | Medical electrical equipment - Part 1-6: General requirements for basic safety and |
| essential performance -Collateral standard: Usability | |
| IEC 60601-2-37 | Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and |
| essential performance of ultrasonic medical diagnostic and monitoring equipment. | |
| IEC 62133 | Secondary Cells and Batteries Containing Alkaline or Other Non-Acid Electrolytes - Safety |
| Requirements for Portable Sealed Secondary Cells, And for Batteries Made from Them, For | |
| Use in Portable Applications [Including: Corrigendum 1 (2013)] | |
| IEC 62366 | Consolidated Version Medical Devices - Application of Usability Engineering to Medical |
| Devices | |
| ISO 10993-1 | Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk |
| management process | |
| ISO 10993-5 | Biological Evaluation of Medical Devices - Part 5: Tests for In Vitro Cytotoxicity |
| ISO 10993-10 | Biological Evaluation of Medical Devices - Part 10: Tests for Irritation and Skin Sensitization |
| IEC 62304 | Medical Device Software - Software Life Cycle Processes |
| ISO 14971 | Medical Devices - Applications of Risk Management to Medical Devices |
8
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
Apache Ultrasound System introduces no new indications for use, modes, features, or technologies relative to the predicate devices (Clarius 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
Apache Ultrasound System is substantially equivalent to the predicate device. The 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.