(37 days)
The device is a general-purpose ultrasonic imaging instrument intended for use by a qualified physician for evaluation of Fetal/OB; Abdominal (GYN & Urology); Pediatric; Small Organ(breast, testes, thyroid); Cardiac (adult & pediatric); Peripheral Vascular, Musculo-skeletal Conventional & Superficial, Transrectal and Transvaginal.
The SonoTouch Series device is a compact and extremely portable ultrasound system consisting of a hand-carried console with the ability to dock it with a Docking station or mobile Docking cart. The primary means of control is graphical user interface implemented by a touch sensitive screen over the color LED display providing additional command input and keyboard entry. It utilizes interchangeable electronic-array transducers operating B-Mode (including Tissue Harmonic Imaging), M-Mode, Pulsed (PW) Doppler Mode, Continuous (CW) Doppler Mode, Color Doppler Mode, Power Doppler Mode, Directional Power Doppler Mode, or a combination of these modes. with digital acquisition, processing and display capability operating under a Linux OS. Powered by an integrated battery or from a separate power supply in the docking station or docking cart, the SonoTouch Series is used primarily where portability, size and convenience are essential.
The provided document is a 510(k) summary for the SonoTouch Series Diagnostic Ultrasound System. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than performing new clinical effectiveness studies with specific acceptance criteria and detailed performance reporting. Therefore, much of the requested information regarding acceptance criteria, study details, human reader performance, ground truth establishment, and sample sizes is not present in this document.
The document primarily states that the device is "substantially equivalent" to predicate devices (GE LOGIQ i, LOGIQ e, Vivid e Diagnostic Ultrasound (K102256)) based on its intended use, operating modes, grayscale imaging, acoustic output levels, and adherence to safety standards.
Here's a breakdown of what can be extracted and what is not available:
1. Table of acceptance criteria and the reported device performance
No specific acceptance criteria or quantitative performance metrics (e.g., sensitivity, specificity, accuracy) are provided in the document. The basis for acceptance is "substantial equivalence" to the predicate device.
| Acceptance Criteria Category | Acceptance Criteria (Not Explicitly Stated) | Reported Device Performance |
|---|---|---|
| Intended Use | Comparable to predicate device. | Device intended for Fetal/OB; Abdominal (GYN & Urology); Pediatric; Small Organ (breast, testes, thyroid); Cardiac (adult & pediatric); Peripheral Vascular, Musculo-skeletal Conventional & Superficial, Transrectal and Transvaginal. |
| Operating Modes | Comparable to predicate device. | B-Mode (including Tissue Harmonic Imaging), M-Mode, Pulsed (PW) Doppler Mode, Continuous (CW) Doppler Mode, Color Doppler Mode, Power Doppler Mode, Directional Power Doppler Mode, or a combination of these modes. |
| Imaging Quality | Comparable grayscale to predicate device. | "The systems have the same gray-scale." |
| Acoustic Output | Below applicable FDA limits. | "The systems have acoustic output levels below the applicable FDA limits." |
| Safety Standards | Adherence to specific product safety standards. | Designed to meet NEMA UD 2, NEMA UD 3, IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, IEC 10993-1. |
2. Sample size used for the test set and the data provenance
Not applicable for a 510(k) substantial equivalence submission, as it typically does not involve new clinical effectiveness studies with test sets in this manner. The comparison is based on the technical and functional characteristics of the device relative to the predicate.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. No ground truth establishment by experts for a test set is described.
4. Adjudication method for the test set
Not applicable. No test set or adjudication method is described.
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
Not applicable. This device is a diagnostic ultrasound system, not an AI-powered image analysis tool, and no MRMC study or AI assistance is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a hardware ultrasound system, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable. No ground truth is mentioned. The comparison is against a predicate device's established performance and safety.
8. The sample size for the training set
Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. No training set is involved.
Summary of the Study/Basis for Acceptance:
The "study" in this context is a technical and regulatory comparison against a legally marketed predicate device (GE LOGIQ i, LOGIQ e, Vivid e Diagnostic Ultrasound, K102256).
- Basis for Acceptance: The device is considered "substantially equivalent" in safety and effectiveness to the predicate devices. This means that it has the same intended use, fundamental technological characteristics, and safety and performance characteristics as the predicate, or that any differences do not raise new questions of safety and effectiveness.
- Proof: The documentation submitted (which is summarized here) asserts that:
- The SonoTouch Series has the same intended uses as the predicate devices (listed in detail across multiple pages for various transducers).
- It utilizes comparable operating modes (B-Mode, M-Mode, Doppler modes, etc.).
- It offers "the same gray-scale" imaging capabilities.
- Its acoustic output levels are below FDA limits.
- It adheres to relevant product safety standards (NEMA UD 2, NEMA UD 3, IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, IEC 10993-1).
This 510(k) summary does not contain information about clinical studies with specific performance metrics or statistical analyses typically found in PMAs or some de novo classifications. The acceptance is based on the regulatory pathway of substantial equivalence.
§ 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.