(54 days)
Ultrasound Transmission Gels are ultrasound couplants intended to be used on intact skin during non-invasive medical ultrasound procedures to couple sound waves between a patient and the medical imaging electronics. The gels are intended for use in all diagnostic ultrasound procedures which require coupling gel or fluid. The gels can be used during the procedures that involved adults and pediatrics in professional healthcare facility.
The Ultrasound Transmission Gels, which shall be colorless or light-colored transparent , are non-irritating, non-sensitizing acoustic couplants intended for use as a scanning gel in medical diagnostic ultrasound procedures. The gel is an accessory used to couple sound waves between the patient and the medical imaging electronic transducers during diagnostic ultrasound procedures. The Ultrasound Transmission Gels are composed of purified water, glycerin, polyethylene glycol, carbomer, sodium hydroxide and phenoxyethanol. It is a type of conductive medium that enables a tight bond between the skin and the probe or transducer, allowing the waves to transmit directly to the tissues beneath and to the parts that need to be imaged. As such, the gel is formulated to serve as a lubricant and improve the acoustic transmission of sound waves to create the ultrasound image. The subject device is available in the below sizes: 5q/baq, 10g/baq, 15q/baq, 16q/baq, 20g/bag, 22g/bag, 25g/bag, individual, single-use packet. As the device is single use device, which is individually packaged sterile devices. The packaging is compatible with the product's Gamma sterilization method. The sterilization validation confirms the packaging is qualified bacterial film to maintain the sterilization condition of the device.
The provided document describes the regulatory submission for "Ultrasound Transmission Gels" and does not contain information about an AI-powered medical device. Therefore, it is not possible to answer the request with the provided information.
The document details the technical characteristics and non-clinical testing of an ultrasound couplant (gel) to demonstrate its substantial equivalence to a predicate device. This involves material composition, sterilization, biocompatibility, and physical properties like sound velocity, acoustic impedance, and viscosity. There is no mention of algorithms, AI, machine learning, or any form of software that would involve diagnostic performance metrics, training sets, or expert adjudication.
Specifically, the document states:
- "No clinical study is included in this submission."
- The device is a physical product (gel) used to facilitate ultrasound imaging, not an image analysis software.
Therefore, the requested information regarding acceptance criteria for AI performance, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance is not applicable to this 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.