(358 days)
Advance Medical Designs, Inc. Sterile Ultrasound Gel is intended for general use as a sterile transmission media for acoustically coupling a transducer to a human body surface during external therapeutic and diagnostic ultrasound imaging procedures. It is placed on the patient's intact skin prior to initiating an ultrasound examination. It is indicated for prescription use only.
Advance Medical Designs, Inc. Sterile Ultrasound Gel consists of deionized water, glycerin, butylene glycol, glyceryl acrylic acid copolymer, propylene glycol, carbomer, phenoxyethanol, cellulose gum, sodium hydroxide, hydroxyethlcellulose, ethylhexylglycerin. It is a type of conductive medium (i.e.) scanning gel used in ultrasound therapeutic and diagnostic imaging techniques. A scanning gel acts as a couplant that provides an acoustic pathway between transducer and the intact skin. In addition, the gel eliminates air (a disruptive influence) from the interface and adapts to the contours of the probe to the intact skin.
The major characteristics of Advance Medical Designs, Inc. Sterile Ultrasound Gel:
- Hypoallergenic, non-irritating
- Water soluble, non-staining and easily cleanable
- Free from formaldehyde and salt
- Does not contain oil or fatty matter
- No toxic effects
- Vacuum treated production
- Produced as a completely harmless material
- Does not damage the probe
- Does not contain air bubbles
This document is a 510(k) premarket notification for a medical device: Advance Medical Designs, Inc. Sterile Ultrasound Gel. The FDA has reviewed and determined that the device is substantially equivalent to legally marketed predicate devices.
The information provided does not describe an acceptance criteria study for an AI-powered device or a study involving human readers. Instead, it describes a medical device clearance process for an ultrasound gel, which is a physical product, not a software algorithm.
Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth for an AI device. This document pertains to a traditional medical device (ultrasound gel) and its substantial equivalence to a predicate device.
§ 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.