(21 days)
The UGEO H70c Diagnostic Ultrasound System and transducers are intended for diagnostic ultrasound imaging and fluid analysis of the human body.
The clinical applications include:Fetal, Abdominal.Pediatric, Small Organ, Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Muscular-Skeletal (Conventional, Superficial), Cardiac Adult, Cardiac Pediatric, Peripheral vessel.
The UGEO H70c is a general purpose, hand-held, software controlled, diagnostic uitrasound system. Its function is to acquire ultrasound data and to display the data as B mode, M mode, Color Doppler imaging. Power Doppler imaging(including Directional Power Doppler mode: S-Flow), PW/CWSpectral Doppler mode, Harmonic imaging, Tissue Doppler imaging, 3D imaging mode (real time 4D imaging mode), Elastoscan Mode or as a combination of these modes. The UGEO H70c also gives the operator the ability to measure anatomical structures and offers analysis packages that provide information that is used to make a diagnosis by competent health care professionals. The UGEO H70c has real time acoustic output display with two basic indices, a mechanical index, which are both automatically displayed.
The provided text describes the UGEO H70c Diagnostic Ultrasound System and its various transducers. It lists the intended uses and technical characteristics of the device, primarily focusing on demonstrating substantial equivalence to predicate devices (ACCUVIX A30, UGEO G60, and MySono U6). The document is a 510(k) Premarket Notification, which is a submission to the FDA to demonstrate that the device is at least as safe and effective as a legally marketed device.
However, the provided text does not contain any information about specific acceptance criteria, a study that proves the device meets acceptance criteria, sample sizes used for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC comparative effectiveness studies, standalone algorithm performance, or how ground truth for training sets was established.
The document outlines the intended uses and modes of operation for the main system and each transducer (e.g., Fetal, Abdominal, Pediatric, Small Organ applications with B, M, PWD, CWD, Color Doppler modes). The "P" in the tables indicates that an application was "previously cleared by FDA" with the cited predicate devices (K1123339 for ACCUVIX A30, K122583 for UGEO G60, K113381 for MySono U6). "N" indicates a "new indication" for the specific transducer.
Therefore, based solely on the provided text, I cannot complete the requested table or answer most of the questions, as this specific information is not present within the provided regulatory document.
The document states:
- "The UGEO H70c is substantially equivalent with respect to safety, effectiveness, and functionality to the ACCUVIX A30 Diagnostic Ultrasound System (K112339), UGEO G60 Diagnostic Ultrasound System (K122583) and MySono U6 Diagnostic Ultrasound System (K113381)." This statement implies that performance information for the predicate devices would be used to demonstrate equivalency, but the performance data itself is not included here.
- "All systems transmit ultrasonic energy into patients, then perform post processing of received echoes to generate on-screen display of anatomic structures and fluid flow within the body. All system allow for specialized measurements of structures and flow, and calculations." This describes the general function, not specific performance metrics.
To answer your request thoroughly, a study report or clinical data section that details the performance evaluation would be necessary, which is absent from the provided 510(k) summary and indications for use statements.
§ 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.