(531 days)
The Wireless Probe Type Ultrasound Scanner (Model: CProbe; Type: Type C, Type CT, Type CL) is intended for diagnostic ultrasound echo imaging, measurement, and analysis of the human body for general clinical applications including obstetrics (OB), gynecology (GY) and general (abdominal) imaging. The part of this device to contact with the patient is the probe head.
The Wireless Probe Type Ultrasound Scanner (Model: CProbe; Type: Type C, Type L, Type CT, Type CL) is a wireless ultrasound system that uses pulsed-echo technology to transmit ultrasound images via wireless communication to a mobile device that utilizes the iOS operating system.
The Wireless Probe Type Ultrasound Scanner is a portable, general-purpose, software-controlled, hand-held diagnostic ultrasound system that consists of (i) a commercial off-the-shelf iOS mobile device, (ii) the Wireless Probe Type Ultrasound Scanner software that runs as an app on the mobile device, (iii) the battery-operated, hand-held Wireless Probe Type Ultrasound Scanner transducer that communicates wirelessly with iOS mobile devices, and (iv) the instructions for use manual, USB Cable for Charging.
The Wireless Probe Type Ultrasound Scanner utilizes pulsed-echo technology to determine the depth and location of tissue interfaces, and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. Ultrasound waves are emitted from the transducer, propagate through tissues, and return to the transducer as reflected echoes. The returned echoes are then converted into electrical impulses by transducer crystals and further processed in order to form the ultrasound image presented on the screen.
The provided text does not contain information about acceptance criteria or a study proving that the device meets those criteria, as it relates to AI performance metrics. This document is a 510(k) summary for a medical device (Wireless Probe Type Ultrasound Scanner) seeking market clearance from the FDA.
The summary focuses on demonstrating substantial equivalence to existing predicate devices based on:
- Intended Use: The device has the same diagnostic ultrasound echo imaging, measurement, and analysis indications for general clinical applications (OB, GY, abdominal imaging) as the primary predicate device.
- Technological Characteristics: The device employs the same basic operating principles (pulsed-echo ultrasound, B, BM, Color Doppler, PDI, PW modes) and similar features (biopsy guideline, harmonic function) as the predicate devices. Differences mentioned (e.g., image display unit size, specific frequency ranges) are deemed not to affect core usage or substantial equivalence.
- Safety and Effectiveness: Compliance with recognized international standards for biocompatibility (ISO 10993), electrical safety (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2), and performance safety (IEC 60601-2-37), as well as FCC radio frequency testing.
Crucially, the document explicitly states: "Clinical testing was not performed for Wireless Probe Type Ultrasound Scanner (Model: CProbe; Type: Type C, Type L, Type CT, Type CL) as part of the submission." This means there is no performance study evaluating the device's diagnostic accuracy or comparing it with other methods (human readers, AI assistance, etc.) presented in this document.
Therefore, I cannot populate the table or answer the specific questions about acceptance criteria, test set details, expert ground truth adjudication, MRMC studies, standalone performance, or training set details as these are not discussed in the provided text.
§ 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.