(232 days)
The SC1 Ultrasound Imaging System (Model: SC1) is intended for diagnostic ultrasound echo imaging, measurement, and analysis of the human body for general clinical applications including musculoskeletal (MSK), vascular, small parts (breast, thyroid) through B mode. Flow detection is possible using PWD (Power Doppler) mode.
SC1 is a transportable ultrasound system intended for use in environments where healthcare is provided by healthcare professionals.
The SC1 Handheld ultrasound imaging system, Model: SC1, is a general purpose, software-controlled, diagnostic ultrasound system that uses pulsed-echo technology (B Mode (Power Doppler); Frequency: 5 - 13 MHz; module: linear; depth max: 10 cm) to transmit ultrasound images via wired communication to a mobile device that utilizes the Android operating system. Its function is to acquire ultrasound data and to display the data in operation.
The SC1 Handheld ultrasound imaging system is a portable, general-purpose, software-controlled, hand-held diagnostic ultrasound system that consists of (i) the battery-operated, SC1L (Linear type Ultrasound Probe) that communicates wired with Android mobile device, (ii) the software that runs as an app on the mobile device, (iii) batteries, charger (Cradle), cable, power cord, and magnetizers (option), (iv) the instructions for use manual.
The SC1 App software can be downloaded to an Android mobile device and utilizes an icon touch-based user interface. The software enables ultrasound image review, controls for depth, gain, linear measurement.
The SC1 App software allows the user to image in real time and review freeze-frame images on the screen in a B-Mode and PD-Mode, 2-dimensional scan format.
SC1 Handheld ultrasound system is only intended for acquisition and real time diagnosis. SC1 Handheld ultrasound system (SC1 probe and SC1 app) provides functions on patient data (entering new patient information, editing patient data saving, storing, or transferring patient information). It is possible to connect to the PACS DICOM network (hospital network) to get the list of exams and export recorded exams. However, there is no option to export patient data via a USB cable.
Physician who is responsible for interpreting ultrasound images must be available in the room to provide diagnosis in real time.
SC1 Handheld ultrasound imaging system utilizes pulsed-echo technology to determine the depth and location of tissue interfaces, and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. Ultrasound waves are emitted from the transducer, propagate through tissues, and return to the transducer as reflected echoes. The returned echoes are then converted into electrical impulses by transducer crystals and further processed in order to form the ultrasound image presented on the screen.
The device components are not supplied sterile and do not require sterilization prior to use.
The provided text is a 510(k) summary for the FCU Co., Ltd. SC1 Handheld Ultrasound Imaging system (Model: SC1). While it details the device, its intended use, comparison to predicate devices, and various non-clinical tests conducted (electrical safety, EMC, software validation, biocompatibility), it explicitly states that "No clinical studies were considered necessary and performed."
Therefore, based on the provided document, the device's acceptance criteria related to clinical performance and the study proving it meets those criteria cannot be described as no such studies were conducted or reported in this 510(k) summary.
However, I can extract information regarding the non-clinical performance and the general acceptance criteria inferred from regulatory compliance.
Based on the provided 510(k) summary, here's what can be inferred about acceptance criteria (primarily non-clinical) and the "study" (non-clinical testing) conducted:
Since no clinical studies were performed, the "study that proves the device meets the acceptance criteria" refers to the non-clinical performance testing and regulatory compliance activities.
1. Table of Acceptance Criteria and Reported Device Performance (Non-Clinical)
| Acceptance Criteria Category | Specific Acceptance Criteria (Inferred from Standards & Claims) | Reported Device Performance (from "Non-Clinical Test Summary") |
|---|---|---|
| Electrical Safety | Compliance with IEC 60601-1:2005/A1:2012 (3.1 edition) + National Difference: General requirements for basic safety and essential performance. | "The test results demonstrated that the proposed device complies with the following standards: IEC 60601-1:2005/A1:2012 (3.1 edition) + National Difference" |
| Electromagnetic Compatibility (EMC) | Compliance with IEC 60601-1-2:2014 (4.1 edition): General requirements for safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests. | "The test results demonstrated that the proposed device complies with the following standards: IEC 60601-1-2:2014 (4.1 edition)" |
| Usability | Compliance with IEC 60601-1-6:2010/AMD1:2013: General requirements for basic safety and essential performance - Collateral standard: Usability. | "The test results demonstrated that the proposed device complies with the following standards: IEC 60601-1-6:2010/AMD1:2013" |
| Basic Safety & Essential Performance of Ultrasound Equipment | Compliance with IEC 60601-2-37:2007/AMD1:2015: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment. | "The test results demonstrated that the proposed device complies with the following standards: IEC 60601-2-37:2007/AMD1:2015" |
| Acoustic Output Levels | Below Track 3 FDA limits in accordance with June 2019 ultrasound systems guidance document AND compliance with IEC 60601-2-37:2007+AMD1:2015. | "Compliance with IEC 60601-2-37:2007+AMD1:2015" and "Below Track 3 FDA limits in accordance with June 2019 ultrasound systems guidance document" (as stated in comparison table for both subject and predicate). |
| Software Validation & Cybersecurity | Basic documentation level of concern according to IEC 62304:2006+AMD1:2015, ANSI/UL 2900-1:2017, and FDA guidances ("The Content of Premarket Submissions for Device Software Functions, June, 2023" and "Cybersecurity in Medical Devices: Quality System considerations and Content of Premarket Submissions, September, 2023"). Risk management in accordance with ISO 14971:2019. | "Software was designed and developed according to a software development process and was verified and validated. The software information is provided in accordance with 'IEC 62304:2006+AMD1:2015', 'ANSI/UL 2900-1:2017' and FDA guidance: The Content of Premarket Submissions for Device Software Functions, June, 2023 and 'Cybersecurity in Medical Devices: Quality System considerations and Content of Premarket Submissions, September, 2023' and 'ISO 14971:2019 Medical Devices - Application of Risk Management to Medical Devices'." |
| Biocompatibility | Patient-contacting parts conform to ISO 10993-1:2018 (Biological evaluation of medical devices), including Cytotoxicity (ISO 10993-5:2009), Intracutaneous (intradermal) reactivity (ISO 10993-10:2010), and Skin sensitization (ISO 10993-10:2010). | "The part of SC1 in contact with the patient was verified and demonstrated for the safety of materials through the biocompatibility test in accordance with ISO 10993-1:2018. - Cytotoxicity test according to ISO 10993-5:2009 - Intracutaneous (intradermal) reactivity test according to ISO 10993-10:2010 - Skin sensitization test according to ISO 10993-10:2010" |
| Ultrasound Imaging Performance | Defined performance characteristics (Axial, Lateral Resolution; Axial, Lateral distance; B-mode and Combined(B+PD) mode display; Max depth) are met. (Specific quantitative acceptance values are not provided in this summary, only that tests were conducted). | "The additional performance test has been conducted to support the technological characteristics of the SC1. The performance of the SC1 has been defined as follows: - Axial, Lateral Resolution - Axial, Lateral distance - B-mode and Combined(B+PD) mode display - Max depth" (Implies successful completion without specific results given). |
2. Sample size used for the test set and the data provenance:
- Test Set (Non-Clinical): Not applicable in the traditional sense of a clinical test set. The "test set" for non-clinical performance refers to the physical device and its software being subjected to various engineering and lab-based tests. The document does not specify the number of individual devices or software builds tested, but implies that "the proposed device" (singular, referring to the model) underwent these tests.
- Data Provenance: The tests were conducted to demonstrate compliance with international standards (IEC, ISO, ANSI/UL) and FDA guidances. The manufacturing and testing entity is FCU Co., Ltd., based in Daejeon, Republic of Korea. The testing would be prospective in the sense that the device was actively tested to demonstrate compliance, not retrospectively analyzed from patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. As no clinical studies were performed, there was no clinical "ground truth" to establish through expert review for a test set. Ground truth for non-clinical tests is based on physical measurements, software validation protocols, and adherence to engineering specifications and regulatory standards by qualified testing personnel.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. This is a concept related to clinical image interpretation by multiple readers. For non-clinical validation, "adjudication" typically refers to engineering review, quality assurance checks, and regulatory body assessment, not a specific consensus method for data labeling.
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:
- No, a MRMC comparative effectiveness study was explicitly NOT done. The document states: "No clinical studies were considered necessary and performed." This device is an imaging system, not an AI-assisted diagnostic tool in the sense of providing automated interpretations.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable in the context of an AI algorithm. This device is an ultrasound imaging system. Its "performance" is about image acquisition, display, and measurement capabilities, not an AI algorithm making diagnostic decisions. When it refers to "software validation," it's about the functionality, safety, and reliability of the operational software, not an AI model's diagnostic accuracy.
7. The type of ground truth used:
- For non-clinical performance: The "ground truth" is adherence to established engineering specifications, published international standards (e.g., IEC for electrical safety, ISO for biocompatibility), and regulatory guidance documents. This is determined through physical measurements, simulated environments, and compliance testing.
- For clinical performance: None. No clinical ground truth was established, as no clinical studies were performed.
8. The sample size for the training set:
- Not applicable. This device is an ultrasound imaging system, not an AI model trained on a dataset. The software enables image review and control, not AI inference.
9. How the ground truth for the training set was established:
- Not applicable. See point 8.
§ 892.1560 Ultrasonic pulsed echo imaging system.
(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.