(349 days)
The SONON Ultrasound Imaging System (Model: SONON 300C) is intended for diagnostic ultrasound echo imaging, measurement, and analysis of the human body for general clinical applications including obstetrics (OB), gynecology (GY) and general (abdominal) imaging. The system operating modes is B (Brightness), CF (color flow), PW (pulsed wave), M (motion). The intended to be used in a hospital or medical clinic is used by appropriately trained healthcare professionals, including radiologists, sonographers, technologists, and clinicians, in a medical facility.
The SONON Ultrasound Imaging System, Model: SONON 300C, is a wireless ultrasound system that uses pulsed-echo technology (frequency: 3.5 MHz; module: convex) 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 SONON Ultrasound Imaging System is a portable, general-purpose, softwarecontrolled, 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, and (iv) the instructions for use manual, battery, charger, and power cords. The SONON software 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, color flow, 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 and Color Flow Doppler (CF Mode) Mode with 2-dimensional scan format. In addition, PW (pulsed wave) mode displays different wave velocities and directions in a spectrum. Moreover, in M mode (also known as "motion mode"), the changes over time on a line graph appears in a spectrum. All images and data collected are stored in the mobile app. If the app is removed and reinstalled, all stored information is lost and cannot be recovered. The SONON 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 does not contain information about acceptance criteria and the study proving the device meets them in the context of diagnostic performance (e.g., sensitivity, specificity, accuracy). Instead, it focuses on demonstrating substantial equivalence to a predicate device through engineering changes and performance tests related to safety, electrical, mechanical, and software aspects.
The document discusses the following types of performance criteria and tests, but not diagnostic performance criteria:
1. Table of Acceptance Criteria and Reported Device Performance (Non-Diagnostic):
| Acceptance Criteria Category | Specific Criteria/Tests Conducted | Reported Performance (or outcome of test) |
|---|---|---|
| Software | Adherence to IEC 62304:2006/AMD1:2015 | Conducted (details not quantified) |
| Adherence to AAMI TIR 57:2016 | Conducted (details not quantified) | |
| Cybersecurity | Implementation of cybersecurity measures as per FDA Guidance "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices" (Oct 2, 2014) | Cybersecurity risk identified, mitigation controls implemented, verification and validation confirm implementation and acceptance criteria met. |
| Acoustic Output | Acoustic output exposure levels below Track 3 FDA limits (per "Marketing Clearance of Diagnostic Ultrasound Systems and Transducers", June 2019) | Device complies with requirements. |
| Clinical Measurement Range Accuracies | Verification of vertical/horizontal resolution, maximal viewing depth, vertical/horizontal distance accuracy, acoustic output frequency | Device met pre-defined acceptance criteria. |
| Wi-Fi Connectivity | Performance equivalent to predicate devices for 2.4 GHz and 5 GHz support | Performance test conducted to ensure equivalence. |
| Thermal, Electrical, Mechanical Safety & EMC | Compliance with IEC 60601-1:2005/AMD1:2012, IEC 60601-2-37:2007/AMD1:2015, IEC 60601-1-2:2014, IEC 62133-2:2017 | Results show changes are acceptable in terms of electromagnetic compatibility and electrical safety. |
Missing Information (based on the provided text):
The document explicitly states:
- No clinical test nor animal study was performed to support substantial equivalence. Therefore, no information is available regarding:
- Diagnostic performance acceptance criteria (e.g., sensitivity, specificity, accuracy).
- Sample size used for a test set for diagnostic performance.
- Data provenance for diagnostic performance.
- Number of experts used to establish ground truth.
- Adjudication method.
- Multi Reader Multi Case (MRMC) comparative effectiveness study.
- Standalone algorithm performance (as there's no diagnostic algorithm described for evaluation).
- Type of diagnostic ground truth used.
- Sample size for training set (as there's no mention of a training set for a diagnostic algorithm).
- How ground truth for a training set was established.
The submission focuses entirely on bench testing and verification/validation of engineering changes compared to a predicate device, rather than a de novo clinical performance study of the device's diagnostic capabilities. The substantial equivalence argument relies on the fact that existing predicate devices have established safety and effectiveness for similar intended uses and the changes to the current device do not introduce new questions of safety or effectiveness.
§ 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.