(158 days)
A-View® catheters are intended for use in conjunction with TEE investigation of the upper mediastinum in anaesthetised patients. They allow visibility of the distal ascending aorta by TEE and permit the condition of the ascending aorta to be evaluated before surgery. A-View Catheters are limited for use in adult patients.
A-View Basic consists of only the catheter itself. The A-View catheter has three tubes connected by a Y-connector of which one holds a distal, large balloon, one holds a small, pilot balloon and the third holds a stop cock with two standard female luer connections. Both balloons are clear and colorless. On the main shaft a distance mark indicating 24 cm from the closest balloon shoulder is pointed out. A-View Plus consists of the catheter plus a standard 50 ml syringe with luer connector and a swivel Y-connector.
The provided text describes a medical device, the A-View® Basic and Plus Catheters, and its regulatory submission. It does not contain information about acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or training set details typically associated with AI/ML device evaluations.
Instead, this document is a 510(k) summary for a physical medical device (a catheter) intended for use in conjunction with Transesophageal Echocardiography (TEE). The "Performance Data" section indicates that the device's performance was assessed against established standards for risk management, biocompatibility, sterilization, and packaging.
Therefore, I cannot provide the requested information. The text clearly states:
- Performance Data: "Data is contained within this 510(k) demonstrating A-View catheters meet the requirements of ISO 14971 (Risk Management), ISO 10993 (Biocompatibility), EN 550 (Sterilization), and EN 868 (Packaging)."
This is not an AI/ML device submission, and therefore the types of performance data and studies you are asking for (e.g., related to AI model accuracy, human-in-the-loop performance, ground truth establishment, training set details) are irrelevant to this specific device submission.
§ 892.1570 Diagnostic ultrasonic transducer.
(a)
Identification. A diagnostic ultrasonic transducer is a device made of a piezoelectric material that converts electrical signals into acoustic signals and acoustic signals into electrical signals and intended for use in diagnostic ultrasonic medical devices. Accessories of this generic type of device may include transmission media for acoustically coupling the transducer to the body surface, such as acoustic gel, paste, or a flexible fluid container.(b)
Classification. Class II.