(31 days)
The UGEO PT60A Diagnostic Ultrasound System and transducers are intended for diagnostic ultrasound imaging and fluid analysis of the human body.
The clinical applications include: Fetal/Obstetrics, Abdominal, Gynecology, Pediatric, Small Organ, Adult Cephalic, Trans-rectal, Trans-vaginal, Muscular-Skeletal (Conventional, Superficial), Urology, Cardiac Adult, Cardiac Pediatric and Peripheral vessel.
The UGEO PT60A is a general purpose, hand-held, software controlled, diagnostic ultrasound system. Its function is to acquire ultrasound data and to display the data as B mode. M mode, Color Doppler imaging, Power Doppler imaging, PW Spectral Doppler mode, Harmonic imaging or as a combination of these modes. The UGEO PT60A 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 PT60A has real time acoustic output display with two basic indices, a mechanical index and a thermal index, which are both automatically displayed.
This document is a 510(k) Premarket Notification for the UGEO PT60A Diagnostic Ultrasound System. It aims to demonstrate substantial equivalence to previously cleared devices rather than proving the device meets acceptance criteria through clinical studies.
Therefore, many of the requested sections regarding acceptance criteria and study details are not explicitly present in the provided text. However, based on the information provided, here's what can be extracted:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for this device are implicitly tied to demonstrating substantial equivalence to its predicate devices by meeting the same safety, effectiveness, and functionality standards. The device performance is generally stated as being comparable to these predicates across various features and clinical applications.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Safety (e.g., meeting medical device safety standards) | Conforms to UL 60601-1, CSA C22.2 No. 601.1, IEC60601-2-37, EN/IEC60601-1, EN/IEC60601-1-2 (EMC), NEMA UD-2 & UD-3, ISO10993-1 (Biocompatibility), ISO14971 (Risk Management). |
| Effectiveness (e.g., comparable diagnostic imaging capabilities) | Acquires ultrasound data and displays it as B mode, M mode, Color Doppler, Power Doppler, PW Spectral Doppler, Harmonic imaging, or combinations. Provides measurement and analysis packages. |
| Functionality (e.g., presence of key features and clinical applications) | Supports clinical applications including Fetal/Obstetrics, Abdominal, Gynecology, Pediatric, Small Organ, Adult Cephalic, Trans-rectal, Trans-vaginal, Muscular-Skeletal, Urology, Cardiac Adult/Pediatric, Peripheral vessel (See detailed tables in original text for specific transducer capabilities). Features like Quick Scan, Spatial Compound Imaging (MultiVision), and ClearVision are present. |
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. The submission states: "Summary of Clinical Tests: Not applicable. The subject of this submission, UGEO PT60A, did not require clinical studies to support substantial equivalence." This is a regulatory clearance based on substantial equivalence to existing devices, not a study demonstrating performance on a test set.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable, as no clinical studies were required or conducted to establish new ground truth for this submission.
4. Adjudication Method for the Test Set
Not applicable, as no clinical studies were required or conducted.
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 an ultrasound system, not an AI-assisted diagnostic tool. No AI-related MRMC studies were conducted or mentioned.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable, as this is a medical imaging device, not an algorithm, and the submission explicitly states clinical studies were not required.
7. The Type of Ground Truth Used
Not applicable. The basis for clearance is substantial equivalence to predicate devices, implying that the established performance and safety of those predicates serve as the "ground truth" for comparison.
8. The Sample Size for the Training Set
Not applicable. This is a conventional medical imaging device, not a machine learning algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable.
§ 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.