(167 days)
Used during invasive medical diagnostic ultrasound imaging to couple sound waves between the patient and the medical imaging electronics, and to lubricate the insertion and passage of imaging devices.
Used in conjunction with transcutaneous ultrasound image guided biopsy and aspiration, intraoperative ultrasound imaging, endocavity ultrasound imaging and ophthalmic ultrasound imaging.
Intended for use in all diagnostic ultrasound procedures which currently use an ultrasound coupling gel or fluid alone or in combination with a latex, polyurethane or polyethylene transducer cover where sterility and in vivo biocompatibility are required.
VivoSonic - In Vivo Biocompatible Sterile Ultrasound Imaging Couplant
This document is a 510(k) premarket notification for a medical device called VivoSonic (Diagnostic Ultrasound Imaging Coupling Media). It does not contain information about acceptance criteria or a study proving that the device meets such criteria.
The purpose of a 510(k) submission is to demonstrate that the new device is "substantially equivalent" to a legally marketed predicate device, meaning it has the same intended use and technological characteristics as a legally marketed device that does not require premarket approval (PMA). This is a regulatory clearance process, not a performance study.
Therefore, I cannot provide the requested information based on the provided text, as it does not include:
- A table of acceptance criteria and the reported device performance
- Sample size used for the test set and data provenance
- Number of experts used to establish ground truth and their qualifications
- Adjudication method
- MRMC comparative effectiveness study results
- Standalone (algorithm only) performance
- Type of ground truth used
- Sample size for the training set
- How ground truth for the training set was established
The document primarily focuses on the regulatory aspects of the device, its intended use, and its substantial equivalence to other devices already on the market.
§ 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.