(155 days)
Dynarex Ultrasound Gel is intended for use as an ultrasound coupling media for use with the any Ultrasound System, Ultrasound procedures including diagnostic and elective prenatal scans.
Dynarex Ultrasound Gel is an electroconductive gel media used with ultrasonic pulsed echo imaging system. The gel is intended to facilitate projecting a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver.
Apply the ultrasound gel to the treatment area. Remove after treatment with a tissue or towel. For external use only.
Contraindications: Not for use with defibrillators.
Dynarex Ultrasound Gel is a viscous, clear blue, water soluble gel. Typical packaging configurations for the Dynarex Ultrasound Gel is 250 ml plastic bottle, 1 Liter plastic bottle and 5liter plastic container. Other sizes may become available.
The provided text describes a 510(k) premarket notification for Dynarex Ultrasound Gel, seeking substantial equivalence to a predicate device, LiquaSonic Ultrasound Gel. The study focuses on demonstrating the new device's technological characteristics are comparable to the predicate.
Here's an analysis based on your requested information:
1. A table of acceptance criteria and the reported device performance
| Technological Characteristics / Metric | Acceptance Criteria (Predicate Device K841871) | Reported Device Performance (Dynarex Ultrasound Gel K102637) |
|---|---|---|
| Acoustic Speed Measurement (m/s) | 1549.5 | 1530.1 |
| Acoustic Attenuation Coefficient - Avg. 3 Lots (dB/cm/MHz) |
§ 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.