(22 days)
The UGEO H60 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 Organs. Neonatal Cephalic. Adult Cephalic, Trans-rectal, Trans-vaginal, Muscular-Skeletal (Conventional, Superficial),Cardiac Adult, Cardiac Pediatric and Peripheral vessel.
The UGEO H60 is a general purpose, mobile, 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(including Directional Power Doppler mode, S-Flow), PW/CWSpectral Doppler mode, Harmonic imaging, Tissue Doppler imaging mode (real time 4D imaging mode) or as a combination of these modes. The UGEO H60 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 H60 has real time acoustic output display with two basic indices, a mechanical index and a thermal index, which are both automatically displayed.
The provided text is a 510(k) summary for the UGEO H60 Diagnostic Ultrasound System. It primarily focuses on demonstrating substantial equivalence to predicate devices and detailing the device's technical characteristics and intended uses.
Based on the provided information, the document does not contain details about specific acceptance criteria related to a performance study for the UGEO H60 Diagnostic Ultrasound System, nor does it describe a study to prove the device meets such criteria.
The "Summary of Clinical Tests" section explicitly states: "Not applicable. The subject of this submission, UGEO H60, did not require clinical studies to support substantial equivalence."
Therefore, I cannot provide the requested information about acceptance criteria and a study proving the device meets them from this document. The submission relies on demonstrating substantial equivalence to already cleared predicate devices (UGEO H60 (K122583) and UGEO HM70A (K130803)) regarding safety, effectiveness, and functionality, rather than on new performance studies with acceptance criteria.
The submission lists various bench and non-clinical tests conducted, which primarily focus on safety and compliance with recognized standards:
- Acoustic output
- Biocompatibility effectiveness
- Thermal, electrical, electromagnetic, and mechanical safety
The device was found to conform to applicable medical device safety standards, including UL 60601-1, CSA C22.2 No. 601.1, IEC60601-2-37, EN/IEC60601-1, EN/IEC60601-1-2, NEMA UD-2, NEMA UD-3, ISO10993-1, and ISO14971. These are compliance standards, not performance criteria with associated studies in the sense of accuracy, sensitivity, or specificity for a particular pathology or clinical outcome.
In summary, none of the requested information regarding acceptance criteria, performance studies, sample sizes, ground truth establishment, expert qualifications, or MRMC studies is present in this 510(k) summary. The document is a declaration of substantial equivalence based on technical characteristics and compliance with general safety standards.
§ 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.