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510(k) Data Aggregation
(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 | < 0.05 |
2. Sample Size and Data Provenance
The document does not specify a separate "test set" and corresponding sample size for the acoustic performance evaluation. The acoustic properties (Sound velocity, Density, Acoustic impedance, Attenuation coefficient) were measured for the Konix® Ultrasound Gel.
The data provenance for the comparison values (e.g., human skin sound velocity and acoustic impedance) is from published scientific literature:
- Ogura, I., Kidikoro, T., linuma, K., Tanaka, K. and Matsuda, A. "Measurement of Acoustic Impedance of Skin" Ultrasound in Medicine, Vol. 4, RC 78.7, U4 A 5a, page 535 (1978).
The study for Konix® Ultrasound Gel itself appears to be a prospective measurement of its physical properties. The country of origin of the device manufacturer is Turkey.
3. Number of Experts and Qualifications for Ground Truth
This type of device (ultrasound gel) does not typically involve expert review for establishing ground truth in the way medical imaging algorithms do. The "ground truth" for comparison for acoustic properties comes from established scientific literature regarding human skin properties. Therefore, there were no "experts" in the traditional sense involved in establishing ground truth for a test set of images or clinical outcomes.
4. Adjudication Method
Not applicable. The study involved direct measurements of the physical properties of the gel and comparison to published scientific data. There was no adjudication of expert opinions.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was done. This type of study is suitable for AI algorithms that assist human readers in interpreting medical images, which is not applicable to an ultrasound gel.
6. Standalone Performance Study
Yes, a standalone study was performed. The non-clinical performance evaluation focused on directly measuring the acoustic properties of the Konix® Ultrasound Gel itself, rather than its performance in conjunction with human interpretation. The study states: "Konix® Ultrasound Gel was evaluated for its acoustic performance."
7. Type of Ground Truth Used
The ground truth used was established scientific literature and physical properties of human skin and other commonly used ultrasound coupling gels. For example, the reported longitudinal velocity of skin (1,518 m/sec) and acoustic impedance of skin (1.6 kg/m²s) were referenced from a scientific publication (Ogura, 1978).
8. Sample Size for the Training Set
Not applicable. This device is an ultrasound gel, not an AI algorithm that requires a training set. The "study" here involves physical property measurements and comparison, not machine learning model training.
9. How Ground Truth for the Training Set Was Established
Not applicable. As this is not an AI algorithm, there was no training set or ground truth established for such a set.
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