(319 days)
Konix® Ultrasound Gel is intended for general use as a nonsterile transmission media for acoustically coupling a transducer to a human body surface during external, diagnostic ultrasound imaging procedures. It is placed on the patient's skin prior to initiating an ultrasound examination. It is indicated for prescription use only.
Konix® Ultrasound Gel consists of deionized water, carbomer, triethanolamine, monopropylene glycol, 5-chloro-2-methyl-4-isothiazolin-3-one and 2-methyl-4-isothiazolin-3 one and is a type of conductive medium, i.e., scanning gel, used in ultrasound diagnostic techniques. A scanning gel acts as a couplant that provides an acoustic pathway between the transducer and the skin. In addition, the gel eliminates air (a disruptive influence) from the interface and adapts the contours of the probe to the skin.
The major characteristics of Konix® Ultrasound Gel include:
- . Hypoallergenic, non-irritating
- Water soluble, non-staining and easily cleanable .
- Does not contain oil and fatty matter .
- Free from formaldehyde and salt .
- No toxic effects .
- Produced as a completely harmless material .
- No smell ◆
- Vacuum treated production .
- Not-damageable to the probe .
- . Does not contain air bubbles
- pH level is 7 .
The Konix® Ultrasound Gel is a medical device designed for general use as a non-sterile transmission medium for acoustically coupling a transducer to a human body surface during external, diagnostic ultrasound imaging procedures. The device's acceptance criteria and studies are primarily focused on demonstrating its acoustic performance and equivalence to existing predicate devices.
1. Acceptance Criteria and Reported Device Performance
The acceptance criteria for Konix® Ultrasound Gel were based on its acoustic properties being virtually identical to human skin and other commonly used coupling gels in the United States.
| Acceptance Criteria / Characteristic | Target Value (based on human skin/optimal average) | Reported Device Performance (Konix® Ultrasound Gel) |
|---|---|---|
| Sound velocity (m/sec) at 30°C | 1,518 (human skin), 1,520 (optimal average) | 1,516 |
| Density (kg/m³) at 30°C | Not specified as clear target, but comparable | 0.98 x 10-3 |
| Acoustic impedance (kg/m² sec) at 30°C | 1.6 (human skin) | 1.49 |
| Attenuation coefficient as a function of frequency, a/f (dB/(cm-MHz)) | Not explicitly stated, but "low" is desired |
§ 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.