(470 days)
As stated on Label: Contact medium for ultrasonic and electrical transmission gel.
Konix® Sterile Gel is sterilized by gamma irradiation and intended for use in all diagnostic ultrasound procedures that currently use an ultrasound coupling gel or other fluid, alone or in combination with a transducer cover, where sterlility and in vivo biocompatibility are required. It can be used on the skin where the risk for infections is especially high, especially with oven tissue Doppler applications; and can be used for cystoscopic and ultrasound examinations.
Konix® Serile Gel can be used on the skin or in open tissue where there is a risk for infections, such as in open tissue Doppler applications. It can be used during surgery; for cystoscopic and vaginal ultrasound and Doppler examinations; for cardiac surgery and ultrasound procedures; and as a lubricant in biopsy applications
Konix® Sterile Gel is an in vivo biocompatible sterile couplant intended for use as a scanning gel in surgical procedures, biopsies and similar sterile applications. It is used to couple sound waves between the patient and medical imaging electronic transducers during intraoperative and intracavitary medical diagnostic ultrasound imaging procedures such as transcutaneous ultrasound image guided biopsy and aspiration, doppler examinations of organ and tissue intraoperative ultrasound imaging, intra-cavity ultrasound imaging, and gel infusion sonography.
Major characteristics include:
- No toxic effects; produced as a completely harmiess material .
- Hypoallergenic; non-irritating; no cytotoxicity .
- Water soluble, non-staining and easily cleanable
- Does not contain any lipid components .
- Free from formaldehyde and salt .
- Odorless .
- Gamma radiated to assure sterility .
- Will not damage the probe .
- Does not contain air bubbles .
- pH = 7 .
The provided document is a 510(k) Summary for the Konix® Sterile Gel, an ultrasound coupling gel. The submission is not for an AI/ML device, but for a medical device that establishes substantial equivalence to a predicate device. Therefore, many of the typical acceptance criteria and study design details for AI/ML performance evaluation (like sample size for test sets, data provenance, ground truth establishment by experts, MRMC studies, standalone performance, etc.) are not applicable here.
Instead, the submission focuses on demonstrating the physical, chemical, and biological properties of the Konix® Sterile Gel are substantially equivalent to a legally marketed predicate device (Sterile Aquasonic® 100 Ultrasound Gel).
Here's an analysis of the provided information, framed as closely as possible to your requested structure, while acknowledging the nature of this submission:
Acceptance Criteria and Device Performance for Konix® Sterile Gel
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for Konix® Sterile Gel are implicitly defined by its physical, chemical, and performance characteristics being comparable to, or within acceptable ranges relative to, the predicate device and established standards for sterile ultrasound gels.
| Characteristic | Acceptance Criteria (Predicate/Standard) | Reported Konix® Sterile Gel Performance | Meets Criteria? |
|---|---|---|---|
| General Properties | Sterile, Hypoallergenic, Non-cytotoxic, Non-sensitizing, Water soluble, Non-staining, Easily cleanable, No lipid components, Free from formaldehyde and salt, Odorless, Will not damage probe, No air bubbles | All reported as met/present | Yes |
| pH | Predicate: 6.5 - 6.95; Release Specification: 6.50-7.50 | 6.5 ± 0.75 | Yes |
| Density (g/cm³) | Predicate: 1.03; Release Specification: 0.683-1.283 | 0.983 | Yes |
| Acoustic Impedance (10⁵gm/cm²) | Predicate: 1.60; Close to human dermis (1.6 kg/m²s) | 1.45 (1.49 kg/m²s in performance test) | Yes (similar) |
| Speed of Sound (m/s) | Close to skin (1518 m/s) | 1516 | Yes (similar) |
| Viscosity (cp) | High viscosity (Predicate is viscous); Performance: 100,000-200,000 | 100,000-200,000 | Yes |
| Sterility | Gamma radiated to assure sterility; Zero CFU/Gm | Confirmed sterile post-radiation | Yes |
| Shelf-Life | Stable for three years | Stable for three years | Yes |
| Cytotoxicity | Non-cytotoxic | Proved negative | Yes |
| Sensitization | Non-sensitizing | Proved negative | Yes |
| Irritation | Non-irritating | Proved negative | Yes |
| Systemic Toxicity | Not toxic | Proved negative | Yes |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set: Not applicable in the context of an AI/ML performance evaluation with a "test set" of cases. The "testing" here refers to laboratory and biocompatibility tests of the gel's properties.
- Data Provenance: The document does not specify the country of origin for the reported test results, but the submitter is from Turkey. The data appears to be from laboratory testing related to the product's physical, chemical, and biological characteristics, performed prospectively as part of product development and regulatory submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Not applicable. The "ground truth" for this device relates to established scientific and medical standards for gel properties (e.g., pH, density, sterility) and biocompatibility testing interpretation, not expert consensus on medical image interpretations. The "ground truth" is determined by validated laboratory methods and standard toxicology protocols.
4. Adjudication Method for the Test Set
- Not applicable. This concept relates to resolving disagreements among multiple expert readers in diagnostic classification tasks, which is not relevant for evaluating the physical and biological properties of an ultrasound gel.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of AI vs. Without AI Assistance
- No. This is not an AI/ML device. MRMC studies are specific to evaluating human reader performance with and without AI assistance in diagnostic tasks.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not applicable. This term is specific to AI/ML algorithm performance. The Konix® Sterile Gel's "standalone" performance is its intrinsic physical, chemical, and biological properties, which were characterized through various laboratory tests as detailed in the "Performance Test," "Sterility and Shelf-Life," and "Additional Tests" sections.
7. The Type of Ground Truth Used
The ground truth used for evaluating Konix® Sterile Gel consists of:
- Laboratory Measurements: Quantifiable physical and chemical properties (pH, density, viscosity, acoustic impedance, speed of sound).
- Microbiological Standards: Demonstrated absence of microbial growth (sterility) confirmed by standard culture methods.
- Biocompatibility Protocols: Results from in vitro cytotoxicity, in vivo sensitization, irritation tests, and mouse systemic toxicity tests, which are assessed against established pass/fail criteria from standard biological evaluation frameworks (e.g., ISO 10993).
- Shelf-Life Stability: Demonstrated stability over time for specified properties.
8. The Sample Size for the Training Set
- Not applicable. There is no "training set" in the context of an AI/ML model for this device. The development of the gel involved formulation and testing, not machine learning training.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As there is no training set for an AI/ML model, there is no ground truth establishment in that sense. The "ground truth" for the gel's formulation and development would involve standard chemical engineering and pharmaceutical development processes, ensuring ingredients meet quality standards, and the final product has the desired characteristics.
§ 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.