(263 days)
The SONON Ultrasound Imaging System (Model: SONON 500L) 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), and thorax (thoracic/pleural motion and fluid detection imaging).
SONON 500L provides 4 modes: B (2D) mode, CF (Color Flow) mode, PW (Pulsed Wave) mode, M (Motion) mode.
SONON 500L is suitable for use in professional healthcare environment (hospital, clinic and medical office settings) by appropriately trained healthcare professional.
The SONON Ultrasound Imaging System, Model: SONON 500L, is a wireless ultrasound system that uses pulsed-echo / Doppler technology (Color Flow Doppler (CF Mode) / Brightness mode(2D B Mode) / Pulsed wave mode(PW Mode) / Motion mode(M mode); frequency: 4 MHz – 13MHz; module: linear; depth max: 6 cm) to transmit ultrasound images via wireless communication to a mobile device that utilizes the iOS or Android, or PC that uses Windows operating system.
The minimum requirements for the mobile devices that utilize the iOS, Android or Windows operating system for use with the SONON Ultrasound Imaging System, Model: SONON 500L are as follows:
Operating system versions
- iOS: iOS 11.0 or later
- Android: Android 5.0 (Lollipop) or later
- Windows (UWP): Windows 10 (64-bit) or later
Minimum specifications for mobile devices
- CPU: 1.7GHz
- Core: 8 cores
- RAM: 4GB
- Resolution: 2560 X 1600 (287ppi)
The SONON Ultrasound Imaging System is a TRACK 3, portable, general-purpose, software-controlled, hand-held diagnostic ultrasound system that consists of
(i) a commercial off-the-shelf iOS or Android mobile device or Windows PC
(ii) the SONON Ultrasound Imaging System software that runs as an app on the mobile device,
(iii) the battery-operated, hand-held SONON Ultrasound Imaging System transducer that communicates wirelessly with iOS or Android mobile devices or Windows PC and
(iv) the instructions for use manual, battery, charger, and power cords.
The mobile application of SONON 500L, which controls the probe, imaging capabilities and functionalities, can be downloaded to an iOS, Android mobile device or Windows PC and utilizes an icon touch-based user interface. The software enables ultrasound image capture and review, controls for time gain, dynamic range, display of mirror image, focal length, depth, brightness, contrast, linear/elliptical measurement, and image annotation, as well as storage and PACS transmission of images and videos. The SONON Ultrasound Imaging System allows the user to image in real time and review cine or freeze-frame images on the screen in a B-Mode with 2-dimensional scan format. The software also allows the user to save / edit patient and diagnosis information. An identification and password are required for accessing the SONON 500L app via the mobile device or PC. All information captured is saved in the app. If the app is removed and reinstalled, all stored information is lost and cannot be recovered.
The SONON ultrasound device utilizes pulsed-echo technology to determine the depth and location of tissue interfaces. Ultrasound imaging requires mechanical oscillation of crystals excited by electrical pulses, generating a piezoelectric effect. A number of these crystals make up a transducer, which converts one type of energy into another. Using pulse-echo transformation by the piezoelectric crystals, an ultrasound transducer converts electricity into sound.
The SONON ultrasound device measures the duration of an acoustic pulse travelling from the transmitter to the tissue interface and back to the receiver. Ultrasound waves emitted from the transducer propagate through various tissues and return to the transducer as reflected echoes. These echoes are then converted into high-frequency electrical signals by the crystals in the transducer. Next, the signals are amplified and further processed by several analog and digital circuits and software filters to adjust the frequency and time response, in order to finally generate a series of digital images.
The device components are not supplied sterile and do not require sterilization prior to use.
Here's a breakdown of the acceptance criteria and the study information for the SONON Ultrasound Imaging System (Model: SONON 500L), based on the provided FDA 510(k) Clearance Letter.
Disclaimer: This document is a 510(k) summary, which generally provides limited detail on specific performance acceptance criteria and study methodologies compared to a full submission. Therefore, some information might be missing or generalized. The document primarily focuses on demonstrating substantial equivalence to predicate devices rather than proving a novel device's performance against clinical endpoints.
1. Table of Acceptance Criteria and Reported Device Performance
The provided 510(k) summary does not explicitly list specific quantitative acceptance criteria (e.g., minimum accuracy, sensitivity, or specificity values) or detailed reported device performance against such metrics. Instead, it relies on demonstrating compliance with recognized standards and established engineering practices, as well as showing substantial equivalence to predicate devices.
The acceptance criteria are generally framed around compliance with safety and performance standards and equivalency to predicate devices.
| Acceptance Criteria Category | Specific Standard/Requirement | Reported Device Performance / Compliance |
|---|---|---|
| Biocompatibility | ISO 10993-1:2018 | Complied. Cytotoxicity, sensitization, and irritation/intracutaneous reactivity tests conducted. Test results indicated patient-contacting surfaces are biocompatible. |
| Cleaning & Disinfection Effectiveness | Similar to K151339 (SONON 300C) | Probe requires user processing for initial and after-each-use, similar to predicate. |
| Electrical Safety | ES 60601-1 (Edition 3.1) | Complied. |
| Electromagnetic Compatibility | IEC 60601-1-2 (Edition 4.0) | Complied. |
| Ultrasound Safety/Performance | IEC 60601-2-37 (Edition 2.1) | Complied. |
| Battery Safety | IEC 62133-2 (Edition 1.0) | Complied. |
| Software Validation | FDA Guidance: "The content of premarket submissions for software contained in medical devices, on May 11, 2005." | Designed and developed according to a software development process; verified and validated. Software is a "MODERATE" level of concern. |
| Acoustic Output Levels | FDA limits, IEC 62359 | Below Track 3 FDA limits. Measured, calculated, and derated following IEC 62359. "Changes in SONON 500L does not introduce risk related to excess acoustic output." |
| Basic Performance Parameters | Unspecified bench test parameters | "Met all performance requirements." (Specific metrics not provided) |
| Wireless Coexistence | ANSI C63.27:2017 | Complied. |
| Risk Management | AAMI TIR69:2017 | Risk management files updated in accordance with the standard. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not describe a "test set" in the context of clinical image data for evaluating diagnostic performance (e.g., sensitivity, specificity). The studies mentioned are primarily engineering verification and validation tests and compliance with standards.
- Sample Size for performance evaluation: Not applicable in the context of a diagnostic performance test set composed of patient data. Performance tests were bench tests using unspecified samples/units of the device.
- Data Provenance: Not applicable as no clinical image data set for diagnostic performance evaluation is described. The document indicates that no clinical studies or animal studies were conducted to support substantial equivalence.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. As noted above, no clinical studies with a diagnostic "test set" requiring expert-established ground truth were conducted.
4. Adjudication Method for the Test Set
Not applicable. No diagnostic test set requiring adjudication is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document explicitly states: "The subject of this premarket submission, SONON Ultrasound Imaging System (Model: SONON 500L), requires no clinical studies to support substantial equivalence." This implies there was no study comparing human readers with and without AI assistance for improved effectiveness.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
Not applicable. The SONON Ultrasound Imaging System is a hardware/software medical device that produces images for human interpretation. It is not an AI algorithm that provides a standalone diagnostic output. Therefore, an "algorithm only" performance would not be relevant in this context.
7. The Type of Ground Truth Used
For the engineering and safety tests, the "ground truth" was based on:
- Established standard requirements (e.g., ISO 10993 for biocompatibility, IEC 60601 series for electrical and ultrasound safety, FDA acoustic output limits).
- Design specifications and functional requirements of the device itself (for "basic performance and the output of the ultrasound equipment").
No pathology, expert consensus on clinical images, or outcomes data were used as ground truth, 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 that requires a "training set" of data for learning a diagnostic task. The software validation mentioned refers to the development and testing of the device's operating software, not an AI inference model.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" for an AI model described. The software validation ensures that the device's software functions as intended and meets its specifications, rather than learning from data.
§ 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.