(108 days)
Not Found
No
The document describes a standard diagnostic ultrasound system with image processing capabilities, but there is no mention of AI or ML being used for image analysis, interpretation, or any other function.
No
The device is described as intended for "diagnostic ultrasound imaging and fluid flow analysis" and "clinical diagnostic imaging applications," indicating its use for diagnosis rather than therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states, "The Apache Ultrasound System (Model: C62) is intended for diagnostic ultrasound imaging and fluid flow analysis." The "Device Description" also refers to it as a "diagnostic ultrasound system."
No
The device description clearly states that the "Apache Ultrasound System" is a portable color ultrasound imaging system that includes a probe with a 64-channel beamforming architecture. While it utilizes an app on an off-the-shelf mobile device for the user interface and display, the core ultrasound data acquisition and processing hardware (the probe) is a physical component of the medical device system.
No, the Apache Ultrasound System (Model: C62) is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Apache Ultrasound System Function: The Apache Ultrasound System uses ultrasound waves to create images of internal body structures. It does not analyze biological specimens.
- Intended Use: The intended use clearly states "diagnostic ultrasound imaging and fluid flow analysis" in various anatomical areas. This is a form of in vivo imaging, meaning it's performed on a living organism.
The information provided consistently describes a medical imaging device used for visualizing internal anatomy, which falls under the category of medical devices, but not specifically IVD devices.
N/A
Intended Use / Indications for Use
The Apache Ultrasound System (Model: C62) is intended for diagnostic ultrasound imaging and fluid flow analysis in the following applications: Abdominal, Fetal/Obstetric, Gynecological, Fetal Echo, Musculo-skeletal (conventional), Urology, and Pediatric. The system provides diagnostic ultrasound imaging in B, Color Doppler, and M 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 and Color Doppler or a combination of these modes. The Apache 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 user interface for mode/setting control and image display, acquisition and storage functions. The Apache App is compatible with Android based mobile devices. Verified devices include Samsung Galaxy S10, Google Pixel 4, HTC U11, and LG G85 ThinQ.
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
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Abdominal, Fetal/Obstetric, Gynecological, Fetal Echo, Musculo-skeletal (conventional), Urology, and Pediatric.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Trained healthcare professionals in physician offices, clinics, hospitals, and clinical point-of-care, except environments with high intensity of electromagnetic disturbances.
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
Nonclinical performance tests show compliance to the following standards: AAMI/ANSI ES60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-2-37, IEC 62133, IEC 62366, ISO 10993-1, ISO 10993-5, ISO 10993-10, IEC 62304, ISO 14971, NEMA UD 2. 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.
The 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
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
Image /page/0/Picture/0 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 acronym along with the full name of the agency on the right. The FDA acronym is in blue, and the full name of the agency, "U.S. Food & Drug Administration," is in a smaller font size below the acronym.
November 12, 2020
Compal Electronics, Inc. % DK Lee Director of Product and Marketing No. 581, 581-1, Ruiguang Rd., Neihu Dist. Taipei City, 11492 TAIWAN
Re: K202074
Trade/Device Name: Apache Ultrasound System (Model C62) Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: Class II Product Code: IYN, IYO, ITX Dated: October 5, 2020 Received: October 7, 2020
Dear DK Lee:
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
1
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) 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 (OS) 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,
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
Indications for Use
510(k) Number (if known) K202074
Device Name
Appache Ultrasound System (Model: C62)
Indications for Use (Describe)
The Apache Ultrasound System (Model: C62) is intended for diagnostic ultrasound imaging and fluid flow analysis in the following applications: Abdominal, Fetal/Obstetric, Gynecological, Fetal Echo, Musculo-skeletal (conventional), Urology, and Pediatric. The system provides diagnostic ultrasound imaging in B, Color Doppler, and M 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.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
K202074
510(k) Summary
| Submitter: | Compal Electronics, Inc. |
|---|---|
| Address: No. 581, 581-1, Ruiguang Rd., Neihu Dist. | |
| Taipei City, 11492, Taiwan(R.O.C.) | |
| Phone: +886-2- 87978599 | |
| Official Contact: | DK Lee |
| Address: Rm. 140, Bldg. 52, No. 195, Sec. 4, Chunghsing Rd., Chutung, Hsinchu, 31057, Taiwan(R.O.C.) | |
| dk.lee@acosmartcare.com | |
| Date Prepared: | October 5th, 2020 |
| Device Name: | Apache Ultrasound System (Model: C62) |
| Regulation Number: | 21 CFR 892.1550, 892.1560, 892.1570 |
| Regulation Name | Ultrasonic Pulsed Doppler Imaging System |
| Ultrasonic Pulsed Echo Imaging System | |
| Diagnostic Ultrasonic Transducer | |
| Regulatory Class | Class II |
| Product Code: | IYN, IYO, ITX |
| Intended Use | Diagnostic ultrasound imaging and fluid flow analysis |
| Indications for Use: | The Apache Ultrasound System (Model: C62) is intended |
| for diagnostic ultrasound imaging and fluid flow analysis | |
| in the following applications: Abdominal, Fetal/Obstetric, | |
| Gynecological, Fetal Echo, Musculo-skeletal | |
| (conventional), Urology, and Pediatric. The system | |
| provides diagnostic ultrasound imaging in B, Color | |
| Doppler, and M 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 |
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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 and Color Doppler or a combination of these modes. The Apache 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 user interface for mode/setting control and image display, acquisition and storage functions. The Apache App is compatible with Android based mobile devices. Verified devices include Samsung Galaxy S10, Google Pixel 4, HTC U11, and LG G85 ThinQ.
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.
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).
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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 | ||
| Model: C62 | Clarius Ultrasound System | |
| (K192107) | ||
| Model: C3 HD | ||
| 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 | - Abdominal |
- Fetal
- Gynecological
- Urology
- Pediatric
- Fetal Echo | - Abdominal
- Fetal
- Gynecological
- Urology
- Pediatric
- Fetal Echo
- Intraoperative (non-
neurological) - Cephalic (adult)
- Musculo-skeletal
(conventional) |
| | | - Peripheral vessel |
| | | - Carotid |
| | | - Procedural guidance of needles into the body. |
| 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 mobile device | Android or iOS mobile device |
| Mode of operation | - B-Mode | - B-Mode |
| | - M-Mode | - M-Mode |
| | - Color Doppler | - Color Doppler |
| | | - Power Doppler |
| | | - PW Doppler |
| | - Combined (B+M; B+CD) | - Combined (B+M; B+CD; B+PD, B+PWD) |
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Non-clinical test
Nonclinical performance tests show compliance to the following standards:
| 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 |
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| 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 |
| NEMA UD 2 | Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment - Revision 3 |
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
The 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.