(139 days)
TE Air Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in abdominal, pediatric , thoracc/pleural (For detection of fluid and pleural motion/sliding.), adult and pediatric cardiac, neonatal and adult cephalic, and urology exams.
This device is a general purpose diagnostic ultrasound system intended for use by qualified and trained healthcare professionals for ultrasound imaging, measurement, display and analysis of the human body and fluid, which is intended to be used in a hospital or medical clinic.
Modes of operation include: B, M, PWD, Color Doppler, Amplitude Doppler, Combined mode(Color+B, Power+B), Tissue Harmonic Imaging, and TDI.
The TE Air Diagnostic Ultrasound System is a general purpose, software controlled, ultrasonic diagnostic system. Its function is to acquire and display ultrasound data in B, M, PWD, Color Doppler, Amplitude Doppler, Combined mode (Color+B, Power+B), Tissue Harmonic Imaging, and TDI mode.
TE Air consists of an app which can be installed on iOS or Android devices, and probes which use wireless technology for communication.
This system is a Track 3 device that employs phased array probes.
The provided FDA 510(k) summary for the Mindray TE Air Diagnostic Ultrasound System (K231685) does not include any information about acceptance criteria or a study proving the device meets them.
The submission focuses on establishing substantial equivalence without clinical studies. It states: "Not applicable. The subject of this submission, TE Air Diagnostic Ultrasound System, does not require clinical studies to support substantial equivalence."
Instead of performance criteria based on clinical outcomes, the submission relies on adherence to recognized safety and performance standards for non-clinical aspects, and comparison of technical features to a predicate device.
Therefore, for your request, I must report that the requested information (acceptance criteria, device performance table, sample sizes, ground truth establishment, expert qualifications, adjudication, MRMC studies, standalone performance, training set details) is not present in the provided document.
The document primarily discusses:
- Device Description: General purpose, software-controlled ultrasound system with B, M, PWD, Color Doppler, Amplitude Doppler, Combined mode (Color+B, Power+B), Tissue Harmonic Imaging, and TDI modes.
- Intended Use: Abdominal, pediatric, thoracic/pleural, adult and pediatric cardiac, neonatal and adult cephalic, and urology exams for adults, pregnant women, pediatric patients, and neonates.
- Comparison to Predicate: The subject device is compared to a primary predicate device (TE Air in K220051) and a reference device (TEX20 in K220242). The main changes from the primary predicate are the addition of "AutoEF" feature (cleared in TEX20) and support for Android OS and updated iOS.
- Non-clinical Tests: Evaluation for acoustic output, biocompatibility, cleaning and disinfection effectiveness, thermal, electrical, and mechanical safety, conforming to various IEC and ISO standards. The document explicitly states these non-clinical tests support the determination of substantial equivalence.
Without clinical study data, none of the requested performance metrics related to clinical accuracy or effectiveness (e.g., sensitivity, specificity, clinical improvement with AI assistance) can be provided from this document.
§ 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.