FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

The AU6 ultrasound imaging system is intended to be used by a physician for diagnostic imaging in cardiac, abdominal, peripheral vessel and fetal applications.
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Fetal, Abdominal, Intraoperative (specify) Abdominal, Intraoperative (specify) Peripheral vascular, Intraoperative Neurological, Pediatric, Small Organ (specify), Neonatal Cephalic, Adult Cephalic, Cardiac, Tranesophageal, Transrectal, Transvaginal, Transurethral, Intravascular, Peripheral Vascular, Laparoscopic, Musculo-skeletal Conventional, Musculo-skeletal Superficial, Other - Urological.
Small organs (specifically, thyroid, testicles and breast; Peripheral vascular to include Vein Mapping & Scierotherapy

Device Description

Ultrasound Imaging System

AI/ML Overview

The Biosound Esaote AU6 Diagnostic Ultrasound System is not an AI/ML device therefore the questions related to acceptance criteria and studies which are relevant to AI/ML devices are not applicable. But, it is a medical device and it has its own set of acceptance criteria and the methods used for the study. I have summarized this information below from the provided text.

Acceptance Criteria and Device Performance:

The device's performance is gauged by whether it can provide diagnostic ultrasound imaging or fluid flow analysis for various clinical applications, either as a "new indication" (N), "previously cleared by FDA" (P), or "added under Appendix E" (E). The specific modes of operation (A, B, M, PWD, CWD, Color Doppler CFM, Amplitude Doppler PD, Color Velocity Imaging) are listed for each clinical application.

Clinical Application	Mode of Operation (A)	Mode of Operation (B)	Mode of Operation (M)	Mode of Operation (PWD)	Mode of Operation (CWD)	Mode of Operation (CFM)	Mode of Operation (PD)	Mode of Operation (CVI)	Combined (specify)	Other (specify)
Fetal		P	P	P		P	P	N/A	B+PW+CFM+M+PD
Abdominal		P	P	P		P	P	N/A	B+PW+CFM+M+PD
Intraoperative (Abdominal)		P	P	P		P	P	P	B+PW+CFM+M+PD
Intraoperative (Peripheral vascular)		E	E	E		E	E	E	B+PW+CFM+M+PD
Intraoperative Neurological		N/A	N/A	N/A	N/A	N/A	N/A	N/A
Pediatric		N/A	N/A	N/A	N/A	N/A	N/A	N/A
Small Organ (Thyroid, Testicles, Breast)	P	P	P	P		P	P	N/A	B+PW+CFM+M+PD	Vein Mapping & Sclerotherapy
Neonatal Cephalic		P	P	P		P	P	N/A	B+PW+CFM+M+PD
Adult Cephalic	N	N	N	N	N	N	N	N/A	B+PW+CFM+M+PD
Cardiac	N	N	N	N	N	N	N	N/A	B+PW+CFM+M+PD
Transesophageal	N	N	N	N	N	N	N	N/A	B+PW+CFM+M+PD
Transrectal	N	N	N	N/A	N/A	N	N	N/A	B+PW+CFM+M+PD
Transvaginal	N	N	N	N/A	N/A	N	N	N/A	B+PW+CFM+M+PD
Transurethral	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A
Intravascular	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A
Peripheral Vascular		P	P	P		P	P	P	B+PW+CFM+M+PD	Vein Mapping & Sclerotherapy
Laparoscopic	P	P	P	N/A	N/A	P	P	N/A	B+PW+CFM+M+PD
Musculo-skeletal Conventional	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A
Musculo-skeletal Superficial	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A
Other-Urological	N	N	N	N/A	N/A	N	N	N/A	B+PW+CFM+M+PD

Note: 'A' refers to Annular Array, but in the tables provided for indications, 'A' seems to represent an imaging mode, similar to B, M, PWD, CWD. Given the context of a diagnostic ultrasound system, 'A' likely refers to A-mode imaging, although it's not explicitly defined as such in the provided text. The tables use 'P' for previously cleared by FDA, 'N' for new indication, and 'E' for added under Appendix E.

Study Information (Based on a Traditional Medical Device Clearance):

Sample size used for the test set and the data provenance: Not applicable. For a traditional medical device like an ultrasound system, the "test set" in the AI/ML sense (where a predefined dataset is used to evaluate algorithm performance) isn't directly relevant. The evaluation of substantial equivalence typically involves engineering tests, phantom studies, and possibly clinical studies. The document does not specify particular clinical trial data or patient sample sizes. The data provenance is implied to be from the manufacturer (Biosound Esaote) based on their submission to the FDA. The nature of the submission (510(k)) indicates a comparison to a legally marketed predicate device, rather than a de novo submission requiring extensive clinical studies from scratch.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as understood in AI/ML (e.g., expert annotations on images) is not the primary method for evaluating a medical imaging device for 510(k) clearance. The "ground truth" for a device like this would be established through performance specifications, adherence to standards, and comparison to the predicate device's established efficacy and safety.
Adjudication method for the test set: Not applicable. Adjudication methods are typically used in clinical trials or for complex image interpretation tasks, which are not detailed in this 510(k) summary for an ultrasound system.
If a multi-reader, multi-case (MRMC) comparative effectiveness study was done: Not applicable. MRMC studies are specific to evaluating the diagnostic accuracy of imaging interpretations, often when comparing new AI-assisted workflows to traditional human reading. This document describes a medical imaging device itself, not an AI/ML algorithm that assists human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. The Biosound Esaote AU6 is a diagnostic ultrasound system, not an AI/ML algorithm, and as such, it operates with a human operator. Its performance is inherent to the system's ability to generate images, not as a standalone interpretive algorithm.
The type of ground truth used: For a traditional ultrasound system 510(k), the "ground truth" is established through:
- Predicate Device Comparison: The primary method for 510(k) clearance is demonstrating substantial equivalence to a legally marketed predicate device (Esaote AU5, K980468 in this case). This means showing the new device is as safe and effective as the predicate.
- Performance Specifications: The device must meet documented performance specifications for imaging modes, frequencies, transducer types, acoustic output, and other technical characteristics.
- Safety Standards: Compliance with relevant electrical safety and biocompatibility standards.
- Clinical Utility (Implied): The intended uses (cardiac, abdominal, peripheral vessel, fetal) are established categories for which ultrasound is a recognized diagnostic tool. The device is expected to perform within the established clinical utility of such systems.
The sample size for the training set: Not applicable. This is not an AI/ML device, so there is no "training set."
How the ground truth for the training set was established: Not applicable, as there is no training set for this type of device.

Summary

Regulation Number and Section

§ 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.