(435 days)
Ultra Phonic® Free Conductivity Gel is intended for general use as a non-sterile transmission media for acoustically coupling a transducer to a human body surface during external therapeutic ultrasound imaging procedures. It is placed on the patient's skin or on the transducer prior to initiating an ultrasound examination.
Ultra/Phonic® Free Conductivity Gel is an aqueous, non-sterile ultrasound conducting medium for use during non-invasive ultrasonic medical procedures. It is placed between the ultrasound transducer and the patient, eliminating air at the contact surface while providing lubrication. This provides an acoustic pathway between the transducer and the skin. This uninterrupted pathway allows the transducer to send sound waves which enter the body, and to receive echoes from tissues and structures without unexpected interference. When the echoes are received by the scanner, it analyzes them to determine how strong they are, and how long they took to be received after transmission. That information is then processed and outputted to a display as an image which is used for diagnostic and therapeutic purposes by health care professionals.
It is packaged in 5L Cubitainers and 250 mL bottles.
Major characteristics include:
- Non-sensitizing, non-irritating
- Water soluble, non-staining, and easily cleanable
- Does not contain oil or fatty matter
- Does not damage the probe
- pH level is 6.25 ± 0.25 @ 25°C
- Resists thinning and decomposition when exposed to perspiration and body heat
- Sheer thinning gel is easy to apply, but doesn't run or drip
- High viscosity allows for thick application, adapting to contours and hair to minimize interference
This document describes the premarket notification (510(k)) for the Ultra/Phonic® Free Conductivity Gel, a diagnostic ultrasonic transducer accessory. The focus of the provided text is on demonstrating the substantial equivalence of the new device to existing predicate devices, rather than a detailed algorithm performance study for an AI-powered device. Therefore, many of the requested elements for AI/algorithm performance (e.g., test set sample size, ground truth details, MRMC studies) are not applicable or not present in this document.
Here's the information that can be extracted and a clear indication of what is not applicable based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly defined by the properties of the predicate and reference devices, as the goal is to demonstrate "substantial equivalence." The reported performance focuses on acoustic properties and biocompatibility.
| Property | Acceptance Criteria (Predicate/Reference) | Reported Performance (Ultra/Phonic® Free Conductivity Gel) | Met/Not Met |
|---|---|---|---|
| Acoustic Properties | Similar to Sonishield™ 100 & Ecogel 100 | Virtually identical to human skin; Similar to other coupling gels | Met |
| Sound velocity (m/sec) | Sonishield™ 100: 1497 ms-1 at 30°C | 1488 ms-1 at 22.5°C | Met (considered virtually identical despite temp diff) |
| Density (kg/m3) | Sonishield™ 100: 1023 kg/ m3 at 30°C | 1018 kg/ m3 at 22.5°C | Met (considered virtually identical despite temp diff) |
| Acoustic impedance (kg/m2 sec) | Sonishield™ 100: 1.53 MRayls at 30°C | 1.51 MRayls at 22.5°C | Met (considered virtually identical despite temp diff) |
| Attenuation coefficient (a/f) | Sonishield™ 100: 0.04 ± 0.0042 f | 0.0185 + 0.01335 $f^{1.0894}$ | Met (considered virtually identical) |
| Biocompatibility | Non-sensitizing, non-irritating | Non-sensitizing, non-irritating | Met |
| USP Antimicrobial Effectiveness Test | Log reductions > 5 for bacterial, no increase yeast/molds in 14/28 days | Log reductions > 5 for all 14 and 28 day bacterial counts; yeasts and molds decreased | Met |
| In Vitro Cytotoxicity (ISO 10993-5:2009) | Pass | Not met (considered cytotoxic) | Not Met (but mitigated by RIPT) |
| Human-Repeated-Insult-Patch-Test (RIPT) | No potential for dermal irritation/allergic sensitization | No potential for dermal irritation or allergic contact sensitization | Met (mitigated cytotoxicity concern) |
| Physical/Chemical Properties | (Based on comparison table with predicates) | (See detailed characteristics in comparison table) | Met |
| Ingredients (Salt free, Dye free, Alcohol free, Formaldehyde free, Perfume Free) | Similar to Sonishield™ 100 (Ecogel had green coloring) | All free | Met |
| pH | Sonishield™ 100: 4.5 – 6.5; Ecogel 100: 6.5 ± 0.75 | 6.25 ± 0.25 @ 25°C | Met |
| Viscosity (CPS) | Sonishield™ 100: 80,000 – 120,000; Ecogel 100: 35,000 - 40,000 | 600,000 ± 300,000 | Met (difference acknowledged, but deemed equivalent in function) |
| Boiling Point | Sonishield™ 100: > 200°C; Ecogel 100: 100°C | > 200°C | Met |
2. Sample size used for the test set and the data provenance:
- Acoustic performance: The document states that the acoustic properties of the gel were evaluated and compared to human skin and other coupling gels. No specific sample size (number of gels tested, or number of measurements) is provided for this evaluation. The data provenance is implied to be laboratory testing.
- Antimicrobial Effectiveness Test: The test followed USP (Category 2) standards, involving specific bacterial and fungal strains (Staphylococcus aureus ATCC 6538, Escherichia coli ATCC 8739, Pseudomonas aeruginosa ATCC 9027, Aspergillus brasiliensis ATCC 16404, Candida albicans ATCC 10231). The sample size typically refers to the number of replicates per microbial challenge, which are standard for this test method.
- Biocompatibility (Skin Irritation, Skin Sensitization, Cytotoxicity): These refer to ISO 10993-10 and ISO 10993-5:2009 standards. These are in vitro or animal tests that follow specific protocols for sample sizes of cells or animals. The document does not specify the exact number of animals or cell cultures used but confirms that tests were conducted according to the stated ISO standards.
- Human-Repeated-Insult-Patch-Test (RIPT): This is a human clinical study. The document does not specify the number of human subjects used but indicates that such testing was performed. Data provenance is likely the testing laboratory.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. This device is a medical accessory (ultrasound gel), not an AI-powered diagnostic algorithm requiring expert "ground truth" for classification. The "truth" is established by physical/chemical measurements and biological assays.
4. Adjudication method for the test set:
Not applicable (refer to point 3).
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This is not an AI-powered diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an AI-powered diagnostic device.
7. The type of ground truth used:
The "ground truth" for this device revolves around its physical, chemical, and biological properties:
- Acoustic Properties: Measured values (sound velocity, density, acoustic impedance, attenuation coefficient).
- Biocompatibility: Results of standardized in vitro and in vivo tests adhering to ISO 10993 guidelines, and the USP antimicrobial test.
- Functional Properties: pH, viscosity, ingredients, etc., measured via standard laboratory methods.
8. The sample size for the training set:
Not applicable. This is not an AI-powered device that requires a training set.
9. How the ground truth for the training set was established:
Not applicable (refer to point 8).
§ 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.